Astra Aktiebolag v. Andrx Pharmaceuticals, Inc.

Opinion and Order

I. Introduction 1

Pursuant to 28 U.S.C. § 1407, the Judicial Panel on Multidistrict Litigation consolidated for pre-trial purposes before this court the patent infringement suits filed by Astra Aktiebolag, Aktiebolaget Hassle, Astra Merck Enterprises Inc., Astra Merck Inc., KBI-E Inc., KBI Inc., Astra Pharmaceuticals L.P., and AstraZeneca L.P. in response to various pharmaceutical companies’ requests for permission from the Food and Drug Administration (“FDA”) to market generic versions of Prilosec®, As-tra’s highly profitable gastric acid inhibiting drug. At various points in this litigation, Plaintiffs have asserted as many as eight different patents against Defendants. At the time of trial, five of those patents remained in the suit. This consolidated trial resolves claims raising issues of infringement and validity asserted in eight different lawsuits involving four groups of Defendants. 2 The case was tried to the court sitting without a jury, for fifty-two trial days between December 6, 2001, and June 13, 2002. The court has considered over six thousand pages of trial testimony, volumes of deposition testimony, thousands of exhibits, and pre-trial and post-trial briefing submitted by all parties. The court has made determinations as to the relevance and materiality of the evidence and assessed the credibility of each witness. Upon the record before the court, pursuant to Federal Rule of Civil Procedure 52(a), the court finds the following facts to have been proven by the appropriate standard of proof and sets forth its conclusions of law.

For the reasons stated below, the court finds the following: Defendant Genpharm literally infringes claims 1, 5, 6, 8, 9,10,12, and 14 of the ’505 patent and claims 1, 6, 7, 10, 11, 12, and 13 of the ’230 patent. Defendant Genpharm does not infringe claim *433 11 of the ’505 patent or claim 15 of the ’230 patent. Defendants Cheminor literally infringe claims 1, 5, 10, and 14 of the ’505 patent and claims 1, 6, 12, and 13 of the ’230 patent. Defendants Cheminor do not infringe claim 9 of the ’505 patent or claim 11 of the ’230 patent. Defendant Andrx literally infringes claims 1, 5, 6, 8, and 10 of the ’505 patent and claims 1, 6, 7, 10, and 13 of the ’230 patent. Defendant Andrx does not infringe claims 3 or 11 of the ’505 patent or claim 15 of the ’230 patent. Defendants KUDCo do not infringe the asserted claims of the ’505 and ’280 patents. The asserted claims of the ’505 and ’230 patents are valid. Claim 1 of the ’342 patent is invalid as anticipated.

A. The Parties

Plaintiff Astra Aktiebolag is a company organized and existing under the laws of Sweden, having its principal place of business at Sódertalje, Sweden. Plaintiff Ak-tiebolaget Hassle (“Hassle”) is a company organized and existing under the laws of Sweden, having its principal place of business at Molndal, Sweden. Plaintiff Astra Merck Enterprises, Inc. is a Delaware corporation, having its principal place of business at Wilmington, Delaware. Plaintiff Astra Merck, Inc. is a Delaware corporation, having its principal place of business at Wayne, Pennsylvania. Plaintiff KBI-E, Inc. is a Delaware corporation, having its principal place of business at Wilmington, Delaware. Plaintiff KBI, Inc. is a Delaware corporation having its principal place of business at Whitehouse Station, New Jersey. Plaintiff Astra Pharmaceuticals, L.P. is a limited partnership organized under the laws of Delaware having its principal place of business at Wayne, Pennsylvania. Plaintiff AstraZ-eneca, L.P. is a limited partnership organized under the laws of Delaware having its principal place of business at Wayne, Pennsylvania. Plaintiffs are referred to collectively as “Astra.”

Defendant Andrx Pharmaceuticals, Inc. (“Andrx”) is a Florida corporation, having its principal place of business at Davie, Florida. Defendant Cheminor Drugs, Ltd. is a public, limited-liability company incorporated and existing under the laws of India and having a principal place of business in Hyderabad, India. Defendant Reddy-Cheminor, Inc. is a New Jersey corporation, having its principal place of business at Ridgewood, New Jersey. Defendant Schein Pharmaceutical, Inc. is a Delaware corporation, having its principal place of business at Florham Park, New Jersey. These three Defendants are referred to collectively as “Cheminor.” Defendant Genpharm Inc. (“Genpharm”) is a Canadian corporation, having its principal place of business in Ontario, Canada. Defendant Kremers Urban Development Co., a wholly-owned subsidiary of Schwarz Pharma, Inc. (“Schwarz”), is a Wisconsin corporation, having its principal place of business in Mequon, Wisconsin. Defendant Schwarz is a Delaware corporation, having its principal place of business at Mequon, Wisconsin. These last two Defendants are referred to collectively as “KUDCo.”

B. Development of Omeprazole and Astra’s Formulations

Omeprazole was the first of a class of medicines called “proton pump inhibitors.” (Carlsson Tr. 157:14-19.) 3 Omeprazole is used in formulations to treat many acid- *434 related diseases, including peptic ulcer disease, reflux disease, and Zollinger-Ellison syndrome. (Carlsson Tr. 159:13-19.) As-tra’s Prilosec® formulation is the result of more than twenty years of research by scientists at Astra’s predecessor company, Hassle, in Sweden. (Carlsson Tr. at 219:9-13.) The research that resulted in Prilosec® began in 1967 with the start of Project 826. The goal of Project 826 was to develop a drug that could inhibit gastric acid secretion. (Carlsson Tr. at 161:9-13; P656.) In January of 1979, twelve years after the start of Project 826, Astra scientists first made the compound omeprazole. (Carlsson Tr. at 160:11-12, 161:9-13, 171:1-2.) Omeprazole inhibits the production of gastric acid through a unique mechanism. It is taken up and concentrated within the acid-producing parietal cells that line the stomach. In the parietal cell, omeprazole is transformed to its active species, which binds to the proton pump, the enzyme that produces acid, thereby inhibiting acid production. (Carlsson Tr. at 167:16-168:19.)

Even once the compound itself had been developed, the task of turning the compound omeprazole into a viable medicine proved to be formidable. (Carlsson Tr. at 170:10-171:20.) Before omeprazole could be used as a medicine, Astra had to establish the compound’s safety and efficacy in animals and in human beings. In addition, Astra’s scientists needed to develop a formulation or dosage form that would deliver the compound to the proper site of action in the body and remain stable both in the body and on the shelf. (Carlsson Tr. 171:8-20.) A group of Astra scientists set out to develop an oral dosage form for omeprazole and its related compounds, (Pilbrant Tr. 1587:2-5), and their work ultimately culminated in the patents at issue in this case. Drs. .Ake Pilbrant 4 and Kurt Lovgren 5 were a part of that team, and they are two of the named inventors on Astra’s ’505 and ’230 patents. (Lovgren Tr. 1741:8-18; Pilbrant Tr. 1317:12-14, 1318:21-22; PI, P2A.) Omeprazole proved to be a particularly difficult and challenging molecule to formulate. Omeprazole is an exceptionally acid labile compound, which means that it degrades quickly in acidic environments like the stomach. (Langer Tr. 295:1-23; Pilbrant Tr. 1587:6-15.) 6 Omeprazole is also sensitive to heat, moisture, organic solvents, and, to some degree, light. (Carlsson Tr. 172:19-22, 179:14-21; Pilbrant Tr. 1323:25-1324:9, 1641:11-15; Lovgren Tr. 1747:4-11; P916 at 114.) Overcoming omeprazole’s multi- *435 pie sensitivities proved to be a substantial challenge, and Astra considered a number of different approaches to make an oral formulation. (Pilbrant Tr. 1328:12-20.)

First, Astra’s formulation scientists tried dissolving omeprazole in oil to protect the omeprazole from gastric juice, but this approach did not work because omeprazole is unstable in oil. (Pilbrant Tr. 1328:21— 1329:11.) A very rapidly dissolving dosage form was investigated on the theory that the rate of absorption of omeprazole into the body would be faster than the rate of degradation in the stomach. That also did not work; more than 50% of the drug was lost due to degradation. (Pilbrant Tr. 1329:12-1330:8.) Omeprazole was administered with food on the theory that food would increase the pH in the stomach and allow the omeprazole to survive long enough to be absorbed. This approach also failed; almost 90% of the dose was lost. (Pilbrant Tr. 1330:9-1331:2.) Studies to determine the target point in the digestive system for omeprazole release were undertaken, and Astra’s formulation scientists concluded that omeprazole should be released in the proximal part of the small intestine. (Pilbrant Tr. 1326:25-1328:7; 1587:16-21.)

When Astra first tested omeprazole in humans, a buffered suspension was used to make the highly acidic stomach environment more alkaline. (Carlsson Tr. 172:4-13.) Although this buffered suspension was not practical for commercial use, it was used in initial studies in humans, the “Phase I” studies. (Carlsson Tr. 172:14-18.) Drs. Pilbrant and Lovgren decided to try enteric-coated formulations to see if an enteric coat would protect the omeprazole from gastric acid in the stomach. (Pil-brant Tr. 1331:3-1332:4, 1587:25-1588:5.) An enteric coating is typically a polymer film that is insoluble in stomach acid, but soluble in the intestine, (Pilbrant Tr. 1331:8-22, 1332:5-11), so the enteric-coat-ing protects material that degrades in the acidic environment of the stomach until it reaches the small intestine. Drs. Pilbrant and Lovgren did a number of pre-formulation studies to determine whether enteric coatings, which are polymeric polyacids, would have a deleterious effect on omepra-zole. The results of the studies showed that the enteric coating materials had approximately the same interaction as most other common pharmaceutical excipients if these excipients did not contain a lot of water. Astra determined that an enteric coating was a viable approach to explore further. (Pilbrant Tr. 1331:17-1333:9.)

The Astra scientists studied a number of different types of cores to be used in formulation, including tablet and pellet-type cores. (Pilbrant Tr. 1333:21-24.) Astra also tried a number of different processes for making pellet-type cores. First, Dr. Pilbrant and his group tested cores formed by compressing omeprazole together with pharmaceutical excipients. The Astra scientists also experimented with melt granu-lations, in which omeprazole was dissolved or dispersed in material that had been heated to its melting point and then cooled down to form a solid core. Dr. Pilbrant and his group constructed cores by depositing an active' drug layer of omeprazole onto an inert sugar sphere. Finally, the Astra scientists experimented with extrusion spheronization. Astra eventually settled on that extrusion spheronization process for preparing its cores. (Pilbrant Tr. 1333:25-1335:4.) In Astra’s extrusion spheronization work, water was added to a powder mixture to make a dough. When the plasticity was suitable, the dough was pressed through a machine to make spaghetti-like strings. These strings were then sectioned in small parts that were put on a rotating plate where the small parts were rounded. (Pilbrant Tr. 1335:5-14.)

*436 After making and testing numerous formulations, Astra eventually arrived at a formulation used in Phase II clinical experiments. The Phase II formulation consisted of a core containing omeprazole mixed together with some excipients and alkaline reacting compounds (“ARCs”) and an enteric coating that covered the core and included hydroxypropyl methylcellu-lose phthalate (“HPMCP”). (Pilbrant Tr. 1339:6-11; Lovgren Tr. 1747:22-1748:6.) While the Phase II formulation was adequate for conducting short term Phase II clinical trials, it did not solve all the issues related to omeprazole formulation. (Carls-son Tr. 174:6-11.) For example, Dr. Pil-brant and other Astra scientists realized that the Phase II formulation would discol- or on long term storage. Also, although Phase II formulations were ordinarily colored off-white to light beige, Dr. Pilbrant and others observed that sometimes the formulation would become discolored during the enteric coating process. (PI, col. 1:52-56; Pilbrant Tr. 1339:18-1340:22, 1591:15-25; Lovgren Tr. 1751:3-13.) The Astra scientists were also concerned because the Phase II formulation had limited gastric acid stability. Gastric acid resistance is a measure of how effective the formulation is in resisting attack by acidic solutions. (Pilbrant Tr. 1341:18-1342:14.) The Phase II formulation had inferior gastric acid resistance and often proved to be below Astra’s requirement of greater than 85% gastric acid resistance. (Lovgren Tr. 4941:14-4942:2.) An orally-administered formulation can remain in the patient’s stomach for as long as two hours. If the enteric coating fails during that time, the omeprazole will be destroyed. Testing for gastric resistance is, therefore, a requirement. If, as with the Phase II formulation, only 75% of the production batch passes the test, a very large percentage of the production cannot be sold. (Pilbrant Tr. 1341:9-1342:20.) Thus, Astra was not satisfied with the Phase II formulation’s gastric resistance (too much of it degraded in the stomach) or with its long-term storage stability (the omeprazole degraded and became discolored) and concluded that the formulation would not be suitable for marketing as a dosage form. (Pilbrant Tr. 1339:21-1340:22, 1341:8-17, 1342:10-14; Carlsson Tr. 174:10-12, 183:20-21, 213:1-7.) The shelf-life of the Phase II formulation would be no more than about 18 months. (Lovgren Tr. 1732:24-1733:5.) There were also concerns expressed by foreign regulators about discoloration. (Carlsson Tr. 216:14-20, 217:13-16; Pil-brant Tr. 1381:6-10.) Accordingly, even after developing the Phase II formulation, Astra sought to solve these problems.

To develop a new formulation that could be used in Phase III long term clinical trials and sold commercially, Astra tested many potential formulations. Some had good stability in the gastric juice in the stomach, but inadequate shelf-life stability. Others had adequate shelf-life stability but inadequate stability in the stomach. (Carlsson Tr. 183:20-184:10; P609.) Drs. Pilbrant and Lovgren and the other Astra scientists tried numerous approaches to solve the dual, and apparently conflicting, problems of long term stability and adequate gastric acid resistance. (Pilbrant Tr. 1344:3-1345:23.) Including certain alkaline substances in the core as with the Phase II formulation solved the problem of the chemical stability of omeprazole by stabilizing the omeprazole during manufacturing and storage, but it exacerbated the problem of gastric acid resistance. (Pil-brant Tr. 1344:9-23.) During development, the Astra scientists learned that if the amount of alkaline material in the core was increased, this could weaken the en-teric coat and decrease gastric acid resistance. This would increase the risk that water would leak in through the enteric coating and promote a reaction between the acidic enteric coating and the alkaline *437 material in the core, which in turn would cause degradation of the enteric coating and worsen gastric acid resistance. (Pil-brant Tr. 1344:24-1345:23, 1610:1-5.) Water permeation has a deleterious effect on the omeprazole core because, if sufficient water diffuses in, it may cause an alkaline solution inside the coating to dissolve the enteric coating from the inside, which, in turn, will worsen gastric acid resistance. (Pilbrant Tr. 1345:12-23.)

To solve the gastric resistance problem without sacrificing stability, Astra tried numerous modifications to the formulation. (See Pilbrant Tr. 1345:24-1349:15.) For example, Drs. Pilbrant and Lovgren tried to make the enteric coating tighter — less permeable to gastric juice. (Pilbrant Tr. 1345:24:-1346:4.) Dr. Pilbrant tried a thicker enteric coating, and he tried to make the enteric coating more hydrophobic, or water-repellent, by adding hydrophobic plasticizers of different kinds. (Pil-brant Tr. 1346:5-1347:4.) Dr. Pilbrant tried adding a water insoluble polymer within the enteric-coating itself to see if that would improve diffusion tightness. (Pilbrant Tr. 1347:5-18.) He tried mixing different enteric coating materials. He even tried putting one enteric coating on top of another to see if that would improve tightness. (Pilbrant Tr. 1347:19-1348:4.) Dr. Pilbrant tried putting an outer coating with a hydrophobic substance on top of the enteric coating, and he tried this with different amounts of the hydrophobic substance. Astra found, however, that if they used only a small amount of hydrophobic substance, it did not improve gastric acid resistance. On the other hand, if they used a large amount of hydrophobic substance outside the enteric coating, this improved gastric acid resistance, but it caused reduced omeprazole release. (Pil-brant Tr. 1348:5-17.) None of these things worked to improve gastric resistance, and repeated attempts to improve the tightness of the enteric coat had failed. (Pilbrant Tr. 1345:9-1349:15.)

Ultimately, Drs. Pilbrant and Lovgren decided to try to use a subcoating between the omeprazole-containing core and the enteric coating. (Pilbrant Tr. 1348:18-22; Lovgren 1786:7-25.) It was thought that a hydrophobic coating, one which would be impermeable to water, might solve the problem, but Astra did not try that approach because they had already experimented with a hydrophobic outer coating and found that it did not work. (Pilbrant 1348:18-1349:11.) Eventually, the Astra scientists decided to experiment with a water soluble subcoat, but it was thought that the approach would not keep water from leaking in through the enteric coating. (Pilbrant Tr. 1349:16-1350:2.) Experimenting with the water soluble subcoat, however, revealed that it actually increased both gastric acid resistance and long term stability. (Pil-brant Tr. 1349:16-1350:6.) The Astra scientists also noticed that the subcoat reduced the sporadic discoloration that could occur during the enteric-coating process as well as the discoloration upon long term storage, which had been observed in the Phase II formulation. (Pilbrant Tr. 1592:6-22.) A formulation that included omeprazole with an alkaline reacting compound (“ARC”) in the core, a water soluble subcoat, and an enteric coating was selected for Phase III clinical trials. (Pil-brant Tr. 1339:6-11, 1351:5-10; Lovgren Tr. 1747:22-1748:6.) After testing its Phase III formulation, Astra patented its invention and obtained FDA approval to market Prilosec®. The Phase III formulation proved to be more stable than the Phase II formulation. (Pilbrant Tr. 1720:22-1721:16, 1731:16-19.) The Phase III formulation is the same as the one that Astra ultimately has used on the market, except that the amount of the enteric-coating polymer is slightly increased in the market formulation. (Pil- *438 brant Tr. 1597:5-12.) There are no differences in long term stability between the Phase III formulation and the market formulation. (Pilbrant Tr. 1600:6-20.)

The gastric acid resistance data for the Phase II (not subcoated) omeprazole pellets formulation were typically in the 82%-89% range. (P934; Lovgren Tr. 4937:7-11.) This level of gastric acid resistance was considered unacceptable because, with an 85% gastric acid resistance test limit, many batches would fail the test and have to be discarded. (Lovgren Tr. 4938:12-4939:22.) The formulation ultimately claimed in the ’505 patent, the Phase III formulation, typically exhibited gastric acid resistance of about 96%. (P907; Lovgren Tr. 4940:12-4941:13.) This improved gastric acid resistance was considered important because it greatly reduced the risk of discarding borderline batches. (Lovgren Tr. 4941:14-4942:7.) The Phase III formulation proved to have consistent gastric acid resistance that was well above Astra’s 85% requirement and remained stable for over three years on storage. (P907 at AA00075815; Lovgren Tr. 4941:3-4942:2, 4942:10-16.) The first application for ome-prazole was filed with the FDA in 1986, and Prilosec® was finally approved for use in the United States in 1989. (Carlsson Tr. 186:12-17.) Astra filed patent applications for its omeprazole formulation inventions in 1986. The formulation described in U.S. Patent Nos. 4,786,505 (the “ ’505 patent”) and 4,853,230 (the “ ’230 patent”) includes the three main elements that Drs. Pilbrant and Lovgren employed to make the Phase III formulation. (Pilbrant Tr. 1321:2-16; PI; P2A.) The commercial Pri-losec® formulation is covered by the ’505 and ’230 patents and is substantially identical to Example 2 of the ’505 patent.

C. Patent Litigation Under the Hateh-Waxman Act

These infringement actions arise out of Abbreviated New Drug Applications (“AN-DAs”) filed by Defendants. The Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. § 355 and 35 U.S.C. § 271(e) (1994)), also known as the Hateh-Waxman Act, amended the Federal Food, Drug, and Cosmetic Act (“FDCA”), Pub.L. No. 52-675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301-397 (1994)), to permit filing of an ANDA to expedite FDA approval of a generic version of a drug previously approved by the FDA. See Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1244 (Fed.Cir.2000). Under the Hateh-Waxman Act, an applicant may file an ANDA with the FDA requesting approval to market a generic drug without undergoing the same expensive and time-consuming FDA approval process undergone by the maker of the branded version of the drug, often called the pioneer drug, by (1) demonstrating that the generic drug is the bioequivalent of the branded drug and (2) certifying that manufacturing, marketing and selling the drug will not infringe the patent rights held by the patentee of the pioneer drug.

The statute prescribes a precisely defined four-step procedure for litigating patent disputes between the innovator drug company and the generic applicant. See 21 U.S.C. § 355(j)(2)(A)(vn) et seq. The holder of the New Drug Application for the pioneer drug lists all of its patents that claim the drug or a use of the drug in the book entitled New Drug Products with Therapeutic Equivalence Evaluations (referred to as the “Orange Book”) published by the FDA. See 21 U.S.C. § 355(b)(1). In its ANDA, a generic applicant must certify one of the following four statements with respect to the patents listed under the pioneer drug in the Orange Book: no patent information has been filed (“Paragraph I” certification), the patent has expired (“Paragraph II” certification), the patent *439 soon will expire on a specified date (“Paragraph III” certification), or the patent “is invalid or will not be infringed by the manufacture, use, or sale of the new drug” covered by the ANDA (“Paragraph IV” certification). 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV). Only one type of certification is pertinent here: a so-called “Paragraph IV” certification. In a Paragraph IV certification, the generic manufacturer seeks to obtain FDA approval before a listed patent expires and asserts that the patent listed in the Orange Book is either not infringed or invalid. Following the issuance of a Paragraph IV certification, the Hateh-Waxman Act requires the generic company to give notice of the Paragraph IV certification to the innovator who listed the patent with the FDA. 21 U.S.C. § 355(j)(2)(B). The FDA can approve an ANDA containing a Paragraph IV certification unless the patent holder files suit within forty-five days of receiving notice of a Paragraph IV certification having been filed with the FDA. 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2). If a patent infringement action is timely brought, final marketing approval of the ANDA cannot occur before expiration of thirty months or a decision of a court. See 21 U.S.C. § 355(j)(5)(B)(iii).

The term of Astra’s basic omeprazole patent covering the chemical formula for omeprazole and its administration for gastric acid inhibition, U.S. Patent No. 4,255,-431 (the “ ’431 patent”) expired on October 5, 2001. 7 The ’431 patent is not, however, the only patent Astra has listed for ome-prazole in the Orange Book. The other patents at issue in this litigation were also listed. Defendants have each issued Paragraph IV certifications against the patents-in-suit. Defendants certified in their ANDA submissions for generic omeprazole that the patents-in-suit are “invalid or will not be infringed by the manufacture, use, or sale” of their generic products. See 21 U.S.C. § 3550')(2)(A)(vii)(IV). Based on those ANDA filings, Astra filed a patent infringement suit pursuant to 35 U.S.C. § 271(e)(2)(A), alleging that the generic omeprazole formulations for which Defendants seek approval will infringe or induce infringement of the asserted claims.

Although no actual infringement has taken place because Defendants’ omepra-zole products have not been released in the market, section 271(e)(2)(A) “definefs] a new (and somewhat artificial) act of infringement for a very limited and technical purpose that relates only to certain drug applications.” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). Section 271(e)(2)(A) provides a patentee with a cause of action for patent infringement based solely upon the filing of an ANDA containing a Paragraph IV certification implicating a plaintiffs patent rights. The artificial infringement arising by operation of law is an integral part of a statutory scheme designed to allow pharmaceutical manufacturers to market, and the public to purchase, generic drugs as soon as possible after the expiration of patents covering the pioneer drug. The infringement suit under section 271(e)(2) permits the paten-tee, in this ease Astra, “to challenge the certification — i.e. to assert inter alia that the commercial manufacture, use or sale of the new drug would infringe its patent.” Glaxo, Inc. v. Boehringer Ingelheim Corp., 954 F.Supp. 469, 473 (D.Conn.1996) (emphasis added). The patentee’s challenge to the certification provides the court with a justiciable controversy, permitting it to efficiently resolve patent issues in advance of the generic drug’s release.

*440 As an initial matter, Defendants challenge Astra’s standing to assert any method of treatment claims against Defendants on the grounds that there has been no direct infringement, so Astra cannot prove actual intent to induce infringement on Defendants’ part. In response, Astra argues that no proof of intent is required because the infringement claims are all cognizable under 35 U.S.C. § 271(e)(2)(A). The question of whether a pioneer drug company holding a patent covering a method of using a drug may sue a generic manufacturer based solely on an ANDA filing is a novel issue of law. See Allergan, Inc. v. Alcon Labs., Inc., 200 F.Supp.2d 1219, 1225 (C.D.Cal.2002). This court knows of only two other cases dealing squarely with this issue. See Allergan, 200 F.Supp.2d 1219; Warner-Lambert Co. v. Apotex Corp., No. 98 C 4293, 1999 WL 259946 (N.D.Ill. Apr. 8, 1999).

“Statutory interpretation begins with the plain language of the statute. If the text of the statute is clear, this Court looks no further in determining the statute’s meaning.” United States v. Mendoza, 244 F.3d 1037, 1042 (9th Cir.2001). When the language of the statute is plain, the duty of interpretation does not arise, and the court is limited to enforcing the statute according to its own terms. Manley v. Secretary of HHS, 18 Cl.Ct. 799, 813 (1989). Consequently, this court looks to the plain language of section 271(e)(2)(A) to determine whether Astra has alleged infringement properly. Section 271(e)(2)(A) states that “it shall be an act of infringement to submit an [ANDA] for a drug claimed in a patent or the use of which is claimed in a patent.” 35 U.S.C. § 271(e)(2)(A). The plain language of section 271(e)(2)(A) makes clear that the contemplated act of infringement is the submission of an ANDA for a drug, the use of which is claimed in a patent. Here, Astra filed suit pursuant to section 271(e)(2)(A) alleging that the generic omeprazole products for which Defendants were seeking approval would infringe Astra’s patents because Defendants were seeking approval for uses of omeprazole falling squarely within the scope of the asserted method of use claims. Thus, Astra claims that Defendants directly infringed the method of use claims by filing their AND As.

At least one other court has concluded that a pioneer drug company may properly bring suit for direct infringement of a patent when an ANDA filed by a generic drug maker directly covers a method of use claimed in the pioneer drug company’s patent. In Allergan, the patent at issue covered the drug which was the subject of the ANDA, but it did not cover the particular method of use for which the generic drug company sought approval. In concluding that section 271(e)(2) did not apply, the Allergan court noted that under the Hateh-Waxman statutory framework, it is “the filing of a Paragraph IV certification that puts into process the notice to the patentee allowing it to bring suit under Section 271(e)(2).” Allergan, 200 F.Supp.2d at 1230. When a generic drug company seeks approval for an indication that is not protected by the patent, that generic should not be required to file a Paragraph IV certification, so section 271(e)(2) is not implicated. See Allergan, 200 F.Supp.2d at 1230. Conversely, where a generic drug company seeks approval for an indication that is covered by a patent, a Paragraph IV certification is required, and section 271(e)(2), which entitles a pioneer drug company to bring suit for direct infringement, is implicated. Allergan, 200 F.Supp.2d at 1229-30 (“Infringement actions under Section 271(e)(2) must therefore be limited to the Controlling Use Patents,” which that court defined as “all use patents which claim an indication for the drug which the applicant is seeking approval.”) (quoting H.R.Rep. No. 98-857(11) at 13, 1984 U.S.C.C.A.N. at 2697). Since *441 the method of use claims for which the court considers infringement proof in this case are controlling use claims, Astra has properly brought suit under section 271(e)(2)(A) for direct infringement. As such, the court need not consider issues related to a claim for inducement under section 271(b), and Astra need not establish any inducement or intent on the part of Defendants to establish infringement of either claim 10 of the ’505 patent or claim 13 of the ’230 patent, both methods of treating gastrointestinal disease. 8

II. Claim Construction

A. Legal Standards

In the first of the two steps necessary to the infringement analysis, the court construes the allegedly infringed patent claims to establish their meaning and scope. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir.1995), aff 'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996); Graco, Inc. v. Binks Mfg. Co., 60 F.3d 785, 791 (Fed.Cir.1995). The interpretation of patent claims through claim construction is a determination made as a matter of law. Markman v. Westview Instruments, Inc., 517 U.S. 370, 384, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). The court construes the claims of each patent according to the hierarchy of evidence articulated in Markman, looking first to the intrinsic evidence of the patent. 52 F.3d at 979 (“To ascertain the meaning of claims, we consider three sources: The claims, the specification, and the prosecution history.”) (internal citations omitted). The court begins with the language of the disputed claims, which define the scope of the invention and the rights of the paten-tee. Markman, 517 U.S. at 373-74, 116 S.Ct. 1384; Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed.Cir.1999); Bell Comms. Research, Inc. v. Vitalink Comms. Corp., 55 F.3d 615, 619 (Fed.Cir.1995). It is the claims that define the invention. See Autogiro Co. v. United States, 181 Ct.Cl. 55, 384 F.2d 391, 395-96 (1967). They are the measure against which validity and infringement are gauged. See SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 (Fed.Cir.1985). The court may consider not only the language of the disputed claims themselves, but also the language of the unasserted claims. Claims should be construed as they would by a person of ordinary skill in the art. Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1302 (Fed.Cir.1997). Moreover, the court must construe the words of the claim as of the time of the invention or when the application was first filed. Leggett & Platt, Inc. v. Hickory Springs Mfg. Co., 285 F.3d 1353, 1357 (Fed.Cir.2002). Thus, the focus in construing disputed claim terms is not the subjective intent of the inventor or examiner; rather, it is the objective test of what one of ordinary skill in the art at the time of the invention would have understood a claim term to mean. See Markman, 52 F.3d at 977.

Each and every word in a claim must be construed to have meaning. Exxon Chemical Patents, Inc. v. Lubrizol Corp., 64 F.3d 1553, 1557 (Fed.Cir.1995). The terms of a claim are generally given their ordinary and customary meaning as *442 of the date of the application for the patent. See Kopykake Enters. v. Lucks Co., 264 F.3d 1377, 1383 (Fed.Cir.2001). They must also be read in accordance with the precepts of English grammar. In re Hyatt, 708 F.2d 712, 714 (Fed.Cir.1983). This strong presumption “in favor of the ordinary meaning of claim language as understood by one of ordinary skill in the art” may be overcome where: “1) the pat-entee has chosen to become his or her own lexicographer by clearly and explicitly defining the claim term; or 2) where a claim term would deprives the claim of clarity such that there is no means by which the scope of the claim may be ascertained from the language used.” Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001) (quotations omitted). When a patentee chooses to be his own lexicographer and uses terms in a manner other than their ordinary meaning, the intended definition of the term must be “clearly stated in the patent specification or file history.” Vitronics, 90 F.3d at 1582; see also Novo Nordisk of N. Am. v. Genentech, Inc., 77 F.3d 1364, 1368 (Fed.Cir.1996); Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387 (Fed.Cir.1992).

In that respect, resort to the specification provides guidance. See Vi-tronics, 90 F.3d at 1582. The court must look to the specification and the file history to see if the inventor varied the ordinary meaning of particular claim terms or if a claim term is unclear. Phonometrics, Inc. v. N. Telecom Inc., 133 F.3d 1459, 1466 (Fed.Cir.1998). Specifications can be the “single best guide to the meaning of a disputed term” and, therefore, are “always highly relevant to the claim construction analysis.” Novo Nordisk A/S v. Becton Dickinson & Co., No. 96 Civ. 9506, 2000 WL 294852, at *2 (S.D.N.Y. Mar. 21, 2000); see Comark Communications, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed.Cir. 1998) (using specifications to ascertain the meaning of the claim term as it is used by the inventor in the context of the entirety of his invention); Amhil Enters. Ltd. v. Wawa, Inc., 81 F.3d 1554, 1559 (Fed.Cir.1996) (recognizing that the “entire specification” should be considered in interpreting claim language). A patentee need not deliberately or precisely define a term in a lexicographical manner, but may provide a definition by implication. Vitronics, 90 F.3d at 1582. Thus, the Court of Appeals for the Federal Circuit has “specifically held that the written description of the preferred embodiments can provide guidance as to the meaning of the claims” that are to be construed, “even if the guidance is not provided in explicit definitional format.” Bell Atlantic Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268-70 (Fed.Cir.2001) (citing SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1344 (Fed.Cir.2001)).

This court must be careful when turning to the specification for guidance during claim construction. Examples may aid in the proper construction of a claim term; however, the scope of a claim is not necessarily limited by the examples. Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1303 (Fed.Cir.1997). Similarly, preferred embodiments like those often present in a specification are not claim limitations. Laitram Corp. v. Cambridge Wire Cloth Co., 863 F.2d 855, 865 (Fed.Cir.1988). It is improper either to limit the claim to preferred embodiments or examples in the specification or to broaden the scope of a claim to include embodiments not covered by the claim language. See Novo Nordisk of N. Am. v. Genentech, 77 F.3d 1364, 1369 (Fed.Cir.1996); Transmatic, Inc. v. Gulton Indus., Inc., 53 F.3d 1270, 1278 (Fed.Cir.1995); compare Ekchian, 104 F.3d at 1303, with Philip v. Mayer Rothkopf Indus., *443 Inc., 635 F.2d 1056, 1061 (2d Cir.1980). This is not to say that resort to the specification should be avoided. The court can and should use the specification to define claim terms. See Phonometrics, Inc. v. Northern Telecom, Inc., 133 F.3d 1459, 1466 (Fed.Cir.1998) (“[Patentee] of course argues that additional limitations cannot be imported into a claim from the written description. We may, however, construe a specifically claimed limitation in light of the specification, which is all we do here.”); Ethicon Endo-Surgery, Inc. v. United States Surgical Corp., 93 F.3d 1572, 1578 (Fed.Cir.1996) (“Here, the district court did not import an additional limitation into the claim; instead, it looked to the specification to aid its interpretation of a term already in the claim, an entirely appropriate practice.”).

As noted, aside from the claim language and the specification, a proper claim construction analysis requires consideration of the patent prosecution history. Markman, 52 F.3d at 980 (“The court has broad power to look as a matter of law to the prosecution history of the patent in order to ascertain the true meaning of language used in the patent claims.”). The specification and prosecution history are toth important evidence of “the problem the inventor was attempting to solve,” which is critical to properly construing the scope and meaning of the claims of the patent. CVI/Beta Ventures, Inc. v. Tura LP, 112 F.3d 1146, 1160 (Fed.Cir.1997) (citing Applied Materials v. Advanced Semiconductor Materials, 98 F.3d 1563, 1573 (Fed.Cir.1996)). Like the specification, the prosecution history is intrinsic evidence and is “often of critical significance in determining the meaning of the claims.” Vitronics, 90 F.3d at 1582; see Alpex Computer Corp. v. Nintendo Co. Ltd., 102 F.3d at 1220. In addition, prior art considered by the United States Patent and Trademark Office (“USPTO”) during prosecution of a patent comprises intrinsic evidence for claim construction. Vitronics, 90 F.3d at 1583. These three items — the claim language, the specification, and the prosecution history — are the intrinsic evidence and are the primary evidentiary sources for claim construction.

In most situations, a thorough consideration of the intrinsic evidence will resolve any ambiguity in a disputed claim term. Vitronics, 90 F.3d at 1583. When the meaning cannot be determined by intrinsic evidence, a court may turn to extrinsic evidence to construe the claims in a patent. Vitronics, 90 F.3d at 1584. Extrinsic evidence “consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises” and may be useful to show the state of the art at the time of the invention. Markman, 52 F.3d at 980. “The court may, in its discretion, receive extrinsic evidence in order ‘to aid the court in coming to a correct conclusion’ as to the ‘true meaning of the language employed’ in the patent.” Markman, 52 F.3d at 980 (internal quotations omitted); see also Key Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 716 (Fed.Cir.1998) (holding that trial court can hear extrinsic evidence to educate itself about patent and relevant technology, but may not use extrinsic evidence to vary or contradict claim terms). When consideration of extrinsic evidence is necessary to understand the meaning of claim terms, the court may consider testimony on how people skilled in the art would understand technical terms in the claims. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1475 (Fed.Cir.1998) (“The objective of claim interpretation is to discern the meaning of the claim terms to one of ordinary skill in the art at the time of the invention.”) Where the intrinsic evidence unambiguously describes the scope of the patent, however, it is improper to rely on extrinsic *444 evidence to alter the meaning of the claims. See Vitronics, 90 F.3d at 1584. Thus, in most instances, a thorough consideration of the intrinsic evidence alone will resolve any ambiguity in a disputed claim term, and the court may not rely on extrinsic evidence to construe the scope of a claim term unless the court first finds that the term is ambiguous even in light of the intrinsic evidence. See Vitronics, 90 F.3d at 1583-85.

B. The ’505 and ’230 Patents 9

Astra filed the patent application that led to the ’505 patent in the USPTO on April 20, 1987. Astra also filed the patent application that led to the ’230 patent on April 20, 1987. Both applications claim priority based on a United Kingdom patent application filed on April 30, 1986. There are no substantive differences between either the ’505 patent application or the ’230 patent application and the British priority document. (Lovgren Tr. 1742:24-1743:3, 1745:3-8; compare PI, and P2A, mth P1056 and P8A.) 10 The ’505 patent discloses particular oral pharmaceutical formulations for the drug molecule ome-prazole, processes for making those formulations, and methods of treating gastrointestinal disease using those formulations. (PI, col. 1:5-11.) The ’505 patent also describes some of the difficulties involved in making an omeprazole formulation. (See, e.g., PI, col. 1:21-34.) The problems discussed in the specifications of the ’505 and ’230 patents include the very same problems identified in the development *445 history described above. (See PI, cols. 1-15; P2A cols. 1-4.) For example, omepra-zole is unstable in stomach acid, where it degrades rapidly unless special precautions are followed. (See, e.g., PI, col. 1:17-39.) The omeprazole molecule is also sensitive to moisture and organic solvents. (PI, col. 1:33-34.) Despite that sensitivity to solvents, omeprazole is not very soluble in the water found in bodily fluids. (Pil-brant Tr. 1325:1-3.) Consequently, the drug is difficult to handle and formulate.

The ’505 patent claims a new formulation that, among other things, permits the omeprazole drug molecule to pass unharmed through the stomach’s acidic environment and to dissolve rapidly in the upper portion of the small intestine. (PI, col. 3:14-18, col. 5:19-58.) The ’505 patent inventors were faced with multiple problems of improving manufacturing stability, storage stability, and stability of the formulation in the stomach while maintaining the bioavailability of the omeprazole molecule. 11 (PI, col. 1:40 — col. 2:13, col. 14:64 — col. 16:40.) The solution to the multiple stability problems associated with omeprazole devised by the inventors was a formulation that comprises (1) a core region containing omeprazole and an ARC or an alkaline salt of omeprazole optionally mixed with an ARC; (2) an inert subcoat-ing that is water soluble or rapidly disintegrating in water and disposed on the core region; and (c) an outer enteric layer disposed on the subcoating. (See, e.g., PI, col. 3:20-32.) As a result, the omeprazole in the patented formulation is available for absorption into the bloodstream, while, at the same time, possessing superior stability. (PI, col. 3:14-20.)

Like the ’505 patent, the ’230 patent relates to particular oral pharmaceutical formulations, processes for making those formulations, and methods of treating gastrointestinal disease using those formulations. (P2A, col. 1:5-12.) The ’230 patent differs from the ’505 patent in that it covers a class of benzimidazole compounds, including omeprazole, and their salts, not just omeprazole. (P2A, col. 1:28 — col. 2:33.) The intrinsic evidence for both patents overlaps. The ’505 and ’230 patent claims share much common language, common background provided by their specifications, and prosecution histories that overlapped both in time and in substance. Not surprisingly, because the ’505 and ’230 patents have the same inventors and their inventive and claimed subject matters overlap, the claim language for those two patents also overlaps. The court acknowledges that the claims in each of these patents must be construed independently. Lemelson v. TRW, Inc., 760 F.2d 1254, 1267 (Fed.Cir.1985) (“[T]he scope of each individual claim must be examined on its own merits, apart from that of other claims, even in the same patent.”). However, the claims of the ’505 and ’230 patents that have been asserted against Defendants often are directly paired together with no material differences between the corresponding claims in the two patents; moreover, the parties’ claim construction arguments are, for the most part, identical for the paired claims of the ’505 and ’230 patents. Therefore, the court will analyze the disputed terms within the ’505 and ’230 patents by first addressing the terms occurring within corresponding claims in both patents. The court will then address the few remaining claim construction issues that are pertinent to the ’230 patent alone.

Astra asserts claims 1, 5, 6, 8-12, and 14 of the ’505 patent against all Defendants. *446 Astra also asserts claim 3 of the ’505 patent against Defendant Andrx alone. Claims 2 through 9 and claims 11 through 13 of the ’505 patent are product claims that depend on claim 1, but then add other features. In contrast to product claims like claim 1, claim 10 of the ’505 patent is a method of treatment claim, and claim 14 is a process claim. Astra asserts claims 1, 6, and 13 of the ’230 patent against all Defendants. Astra also asserts claims 7, 10-13, and 15 of the ’230 patent against various Defendants. Dependent product claims add features to claim 1 of the ’230 patent. Claim 12 of the ’230 patent is an independent process claim.

The first claim of the ’505 patent specifies a pharmaceutical product that includes three elements:

1. An oral pharmaceutical preparation comprising

(a) a core region comprising an effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline omeprazole salt alone;

(b) an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said subcoat-ing comprising one or more layers of materials selected from among tablet ex-cipients and polymeric film-forming compounds; and

(c) an outer layer disposed on said sub-coating comprising an enteric coating.

(PI, col. 16:42-54.) Claim 1 of the ’230 patent, also a product claim, specifies:

1. A pharmaceutical preparation comprising:

(a)an alkaline reacting core comprising an acid-labile pharmaceutically active substance and an alkaline reacting compound different from said active substance, an alkaline salt of an acid-labile pharmaceutically active substance, or an alkaline salt of an acid-labile pharmaceu-tically active substance and an alkaline reacting compound different from said active substance;

(b) an inert subcoating which rapidly dissolves or disintegrates in water disposed on said core region, said subcoat-ing comprising one or more layers comprising materials selected from the group consisting of tablet excipients, film-forming compounds and alkaline compounds; and

(c) an enteric coating layer surrounding said subcoating layer, wherein the sub-coating layer isolates the alkaline reacting core from the enteric coating layer such that the stability of the preparation is enhanced.

(P2A, col. 13:1-20.)

The preamble of both claims 1 calls for a “pharmaceutical preparation,” which must be oral in the case of the ’505 patent. This simply means any dosage form taken via the mouth. (See, e.g., PI, Ex. 2, col. 7:55— col. 8:34 (pellets); PI, Exs. 9, 10, col. 11:43 — col. 12:36 (tablets).) “Comprising” is a transitional term used in patent claims to mean that the claim includes, but is not limited to, the elements thereafter presented. Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l, Inc., 246 F.3d 1336, 1348 (Fed.Cir.2001) (“In the parlance of patent law, the transition ‘comprising’ creates a presumption that the recited elements are only a part of the device, that the claim does not exclude additional, unrecited elements.”). In the context of the preamble of claims 1 of the ’505 and ’230 patents, then, “comprising” means that parts (a), (b), and (c) of claims 1 must be present, but that other elements may also be present. Thus, claims 1 contain three common structural components that are recited in subpara-graphs (a), (b), and (c) in both the patents. Subparagraphs (a) and (b) of each claim *447 contain the claim limitations that are strongly contested by the parties.

C. Part “(a)” of Claims 1

1. The Terms “Core” and “Core Region”

The court finds that the terms “core” and “core region” are synonymous in the context of the ’505 and ’230 patents; thus, the court construes the term “core region” to have the same meaning as the term “core.” This construction is apparent from the language of the claims themselves. The term “core region” does not appeal’ anywhere in either patent except in certain claims, including claims 1 of the ’505 and ’230 patents. In those claims of the ’505 and ’230 patents where the terms “core region” and “core” appear, they are used interchangeably. For example, claim 1 of the ’505 patent requires “[a]n oral pharmaceutical preparation comprising (a) a core region.” (PI, col. 16:42-43 (emphasis added).) Claim 5 of the ’505 patent, however, requires “[a] preparation according to claim 1 wherein the alkaline core comprises .... ” Claim 5 depends from claim 1 and references “the alkaline core.” (PI, col. 16:65-66 (emphasis added).) Thus, the term “core” in claim 5 must be referring to the “core region” in claim 1. Claim 12 of the ’505 patent also refers back to the “core region” in claim 1 when it requires “[a] preparation according to claim 1, wherein the core comprises (PI, col. 18:4-5 (emphasis added).) Similar examples occur in the claims of the ’230 patent. Indeed, the only place where the term “core region” appears in the ’230 patent is in element (b) of claim 1, where the term “core region” is preceded by the word “said,” which in patent claim drafting indicates that the specific claim term “core region” has been previously introduced. Manual of Patent Examining Procedure, 7th ed., § 2173.05(e), at 2100-168. Since the phrase “said core region” in claim 1(b) has no antecedent basis and refers back to the term “alkaline reacting core” in element (a), the term “core region” in element (b) must be referring to the term “core” in element (a). Finally, there is no language in the specification or the claims of either patent to suggest what, if anything, beyond the core region would be encompassed by the term “core”; accordingly, “core region” must be defined to be synonymous with the term “core” because “a patent claim may be interpreted only as broadly as its unambiguous scope.” Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 93 F.3d 1572, 1581 (Fed.Cir.1996) (citations omitted). 12

The court defines the terms “core” and “core region” to mean the portion of the patented preparation that lies beneath the subcoating and contains the active ingredient and, in the case of omeprazole as the active ingredient, an ARC. The claim language itself expressly states that the “core region” is the portion of the formulation that lies beneath the inert subcoating, which is “disposed on” the core region. (PI, col. 16:48-50; P2A, col. 13:10-11.) Also, the discussion of the subcoating in the patents makes it clear that the entire mixture, whether called the “alkaline core” or the “alkaline reacting core” is the core to which the subeoating is applied. (PI, col. 4:3-58, see particularly col. 4:4, 13, 31; *448 P2A, col. 8:66 — col. 9:52, see particularly col. 8:67, col. 9:6-8.)

The court’s construction of the terms “core” and “core region” includes cores made by conventional pharmaceutical procedures. (See PI, col. 3:1-11, col. 16:43-47.) The primary dispute concerning these terms is whether they encompass cores wherein the active substance is coated or sprayed onto a sugar seed. Based on the briefing submitted on claim construction as well as the evidence introduced at trial, the court finds that, in the abstract, a person of ordinary skill in the art could consider the sugar sphere itself to be a “core,” but that same person could also consider the sugar sphere plus the active layer sprayed onto it to be a “core.” 13 Defendant Genpharm’s construction for the term “core,” which would exclude cores made by layering onto sugar spheres, incorrectly focuses attention on this abstract situation and away from the meaning a person of ordinary skill in the art reading these two patents would attach to the term “core.” For example, Genp-harm cites to a definition for the term “core” in a non-technical dictionary. Cf. Hoechst Celanese Corp. v. BP Chemicals Ltd., 78 F.3d 1575, 1580-81 (Fed.Cir.1996) (finding general dictionary definition secondary to specific meaning of technical term as used and understood by those of ordinary skill in the art). Even though the term “core” when applied to coated sugar spheres might be limited to the sphere itself in the abstract, the court finds that in the context of these two patents a person of ordinary skill in the art would understand the term “core” to encompass not only the sugar sphere but also the active layer sprayed or coated onto the sugar sphere.

The patent specifications expressly state that cores may be made “by conventional pharmaceutical procedures,” (PI, col. 3:66-68; P2A, col. 8:62-64), and some of the conventional pharmaceutical procedures that may be used to prepare cores are expressly disclosed in the patent specifications and file histories. Conventional pharmaceutical procedures for making cores may include, but are not necessarily limited to, cores formed by extrusion and spheronization, cores made by layering on sugar seeds, and cores made by tabletting techniques. (See, e.g., PI, col. 1:57 — col. 2:4, col. 3:1 — col. 4:2, col. 16:43-47 (the powder mixture is formulated into pellets, tablets or capsules, which are used as cores for further processing, such as applying the subcoat) (emphasis added); see also Story Tr. 3737:10-13 (testifying that the technique of layering active drug on sugar sphere seeds was known prior to 1986); P921 at 12:3-4, 14:20-15:3.) Tablet cores are found in Example 1 of the ’505 patent. (PI, col. 6:29-65.) Extruded and spheronized cores are described in Example 2. (PI, col. 7:55 — col. 8:34.) The ’505 patent specification also expressly references active-coated sugar seeds as “cores.” The ’505 patent specification states that WO No. 85/03436 (the “ ’436 application”) describes pharmaceutical preparations containing cores, (PI, col. 3:1-2), and the ’436 application, a part of the prosecution history, acknowledges that active coated sugar seeds are a type of core “widely used in the known art.” (Astra’s Cl. Constr. Mem., Ex. 4, ’436 application at 12:4-19; App. 1, ’505 Prosecution History at 166.)

*449 Contrary to arguments made by Second Wave Defendants Mylan and Eon, Astra’s citation to the ’436 application in the ’505 and ’230 patents and their file histories does not serve as a disclaimer of a sugar core with a layer of the active ingredient. The ’505 and ’230 patents never explicitly adopt an active-coated sugar core as part of one of the examples or preferred embodiments for the claimed invention described in the specification; however, the specification need not describe every possible way of making the product. SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121-22 (Fed.Cir.1985). Far from expressly disclaiming the method of laying the active ingredient on a sugar sphere that is described in the ’436 application cited in the patents, Astra claimed cores formed by that method in its patent by claiming any formulation with cores made by conventional pharmaceutical techniques.

Defendant Genpharm would graft onto the claims a requirement of homogeneity in order to exclude a core that is built on a sugar seed. {See Story Tr. 3712:4-18, 3719:7-3720:5, 3725:2-13, 3720:12-3721:5 (testifying that one of ordinary skill in the art would conclude that “core” as used in the ’505 and ’230 patents is a homogenous mixture of omeprazole, alkaline compounds, and excipients, with the omepra-zole uniformly distributed throughout the core).) For intrinsic support within the ’505 patent, Genpharm relies on the sentences bridging columns 3 and 4 of the ’505 patent, which describe using a mixture of omeprazole and other materials to form “small beads” by conventional procedures, which are “used as cores for further processing.” {See PI, col. 3:66 — col. 4:2; see also P2A, col. 8:62-65.) The flaw in Genpharm’s logic is reading the reference to a powder mixture “formulated into small beads” as excluding a mixture coated onto sugar seeds. There is no question that coating a sugar seed with an active substance is a conventional procedure, and nothing in the language Genpharm highlights excludes coating the mixture onto sugar seeds to form the small beads.

Genpharm also relies on references in the patents to the subcoating as the “first layer.” {See, e.g., P2A, col. 8:1-3.) Those references, however, concern the first layer of the invention — the subcoating. They do not exclude making small beads using the conventional sugar seed process before applying the “first layer” of the invention, which is the subcoating. 14 Genpharm’s definition is also based on consideration of a subset of the examples included in the ’505 patent specification. By requiring a homogenous core, Genpharm adopts a definition for “core” and “core region” that is limited to those cores made by particular processes, which do not include cores made by spraying active ingredients onto a sugar seed. Since it is improper to read a limitation from the specification into the claims or to limit the claims to examples in the specification, see Tate Access Floors, Inc. v. Maxcess Techs., Inc., 222 F.3d 958, 966-67 (Fed.Cir.2000); Ekchian v. Home Depot, Inc., 104 F.3d 1299, 1303 (Fed.Cir.1997), the court will not limit the definition of the terms “core” and “core region” to exclude cores made by spraying or coating a sugar seed. The claims themselves do not contain any process limitations, and, as such, cores produced by any “conventional pharmaceutical procedure” are covered by claim 1.

Genpharm’s construction is not only inconsistent with the intrinsic evidence but also with the testimony of those skilled in *450 the art, who testified, both at the trial and throughout discovery, that the terms “core” and “core region” mean the portion of the pharmaceutical preparation that lies beneath the subcoat. Dr. Auslander, KUDCo’s expert, understood the term “core region” to refer to “everything under the subcoat ... [I]t contains all the ome-prazole plus the alkaline-reacting compound.” (Auslander Tr. 2687:23-2688:14.) Likewise, in an opinion based on his experience as a formulator for the past thirty years, Cheminor’s expert Dr. Porter recognized that the term “core region” refers to the “material under the sub coating.” (Astra’s Resp. to Defs.’ Cl. Constr. Briefs, Ex. 34, Porter Dep. Tr. 45:4-14.) Chemi-nor’s formulators identified the core of a formulation in its development reports as “core (sucrose, drug and meglumine).” (Astra’s Resp. to Defs.’ Cl. Constr. Briefs, Ex. 39, Omeprazole Capsules — Development Report at 5; see also Ex. 40, portion of Development Report of Omeprazole Capsules 10, 20 & 40 mg at CD-V-00065-68, 70, 75, 77.) Andrx’s former President and Chief Formulator, Dr. Chen, similarly referred to his layered sugar seed pellet as a core. 15 (P1312, Chen Dep. Tr. 347:7-18.)

Genpharm’s own Development Report refers to the nonpareil sugar seed together with the active, omeprazole-containing drug layer and HPMC subcoating as the “protected core.” (P20 at G13549; P19 at G13038.) Even Dr. Story, Genpharm’s expert, admitted at trial that he had used the word “core” to refer to a sugar seed that is layered with active ingredients during his testimony in Australia concerning a foreign counterpart to the ’505 patent. (Story Tr. 3736:2-4, 3805:12-3806:12.) The process Dr. Story was describing in his Australian testimony is the process used by Genpharm to build up the active material on its sugar seeds. (Story Tr. 3805:12-3806:12.) Dr. Story agreed that formulation scientists, including those who worked with him, would interpret the term “core” to mean an inner seed with an active coating. (Story Tr. 3803:13-18.) Dr. Story further agreed that the term “core” in column 3 of the ’505 patent refers to the portion of the formulation where the omeprazole is mixed with the ARC, (Story Tr. 3800:20-3801:2; see PI, col. 3:20-26), and that the reference to a “powder mixture” in that same column is a mixture of omeprazole and the ARC and other excipi-ents, which can be formulated into, among other things, “pellets,” (Story Tr. 3801:6-19; see PI, col. 3:66-68). In the context of the ’505 patent, “pellets” means “cores.” (Story Tr. 3801:20-22.) Finally, Genp-harm’s own purported person of ordinary skill in the art, Dr. Marshall, when preparing the expert reports Genpharm submitted, identified the ingredients of a “Formulation of cores/granules” to include both “Omeprazole” and the “Sucrose [sugar] spheres.” (P1299, Marshall Report No. 3, at 4.) In summary, Dr. Story’s testimony at trial in support of Genpharm’s claim construction is outweighed by the intrinsic evidence and the testimony of those skilled in the art, including Dr. Story himself. Accordingly, the court declines to adopt Genpharm’s proposed claim construction, which would graft onto the core a require *451 ment for complete homogeneity and unnecessarily limit the conventional pharmaceutical processes by which the core could be created by excluding the process of layering the drug substance onto sugar spheres.

2. The Term “Alkaline Reacting Compound”

Subparagraph (a) of claim 1 of the ’505 patent requires that the core contain a “material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline omeprazole salt alone.” (PI, col. 16:43-47.) That claim language presents alternatives any one of which may be present to meet the claim requirement. See In re Driscoll, 562 F.2d 1245, 1249 (C.C.P.A.1977). Claim 1 of the ’230 patent presents a similar set of three options for the core: an acid labile pharmaceutically active substance and an ARC, an alkaline salt of an acid labile pharmaceutically active substance, or an alkaline salt of an acid labile pharmaceutically active substance and an ARC. (See P2A, col. 13:2-9.) The acid labile compound and the ARC must be different substances. (P2A, col. 13:2-9.) Astra asserts infringement by all Defendants only under the first of the three options: omeprazole, which is an acid-labile pharmaceutically active substance, plus an ARC.

The term “alkaline” standing on its own represents a concept that is well understood by those skilled in the arts of formulation and chemistry. It is fundamental chemistry that an “alkaline” substance is a basic substance — a non-acidic, non-neutral compound having a pH greater than 7. 16 (See Auslander Tr. 2515:4-2516:9; Pilbrant Tr. 1459:24-1460:4.) While the ordinary meaning of the word “alkaline” may be clear, the court finds that without resort to the specification the meaning of the phrase “alkaline reacting compound” is not clear now and was not clear at the time of the patent. See Bell Atlantic Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001). Rather, the phrase “alkaline reacting compound” is a shorthand term that the paten-tees created for use in the ’505 and ’230 patents, and one of ordinary skill in the art would not understand what is meant by this phrase prior to issuance of the ’505 and ’230 patents. {See Auslander Tr. 2513:14-2514:9; Story Tr. 3759:13-18; see also Langer Tr. 386:17-24 (analyzing me-glumine in terms of disclosure in specification).) Since the phrase “alkaline reacting compound” has no unambiguous meaning outside the ’505 and ’230 patents, it must be defined in the context of those patents. Since the patentees chose to act as their own lexicographer, the court must rely on the intrinsic evidence, particularly the specification, to determine the meaning of the phrase See Itron, Inc. v. CellNet Data Systems, Inc., 34 F.Supp.2d 1135, 1141 (D.Minn.1999) (If the inventors choose to be “their own lexicographers” with regard to a particular claim term, “the court must adopt their definition.”), aff'd per curiam, 243 F.3d 563 (Fed.Cir.2000). Here the patentees’ own testimony leaves no doubt that the specifications of the ’505 and ’230 patents are the “single best guide” to the meaning of the term “alkaline reacting compound.” See Bell Atlantic, 262 F.3d at 1268 (quoting Vitronics, 90 F.3d at 1582). Kurt Lovgren, one of the inventors, testified that the terms “alkaline reacting compound” and “alkaline buffering compound” mean the same thing in the ’505 and ’230 patents. (Lovgren Dep. Tr. 548:2-11.) *452 He further testified that the definition of those terras was to be found in the specifications of the patents. (Id. at 543:11-18 (“The meaning of alkaline buffering compound is a meaning and an understanding that is obtained in the specification of the patent.”).)

The clearest indication of what the phrase “alkaline reacting compound” means in the ’505 and ’230 patents is found in the detailed description of the invention under the subheading “Cores.” (See Aus-lander Tr. 2520:1-9; Langer Tr. 653:24-654:6.) The term “alkaline reacting, otherwise inert pharmaceutically acceptable substance (or substances)” is characterized in the patent specifications. Specifically, the patents state:

Omeprazole is mixed with inert, preferably water soluble, conventional pharmaceutical constituents to obtain the preferred concentration of omeprazole in the final mixture and with an alkaline reacting, otherwise inert, pharmaceuti-cally acceptable substance (or substances), which creates a “miero-pH” around each omeprazole particle of not less than pH = 7, preferably not less than pH = 8, when water is adsorbed to the particles of the mixture or when water is added in small amounts to the mixture.

The stabilizing, high pH-value in the powder mixture can also be achieved by using an alkaline reacting salt of ome-prazole such as the sodium, potassium, magnesium, calcium etc. salts of omepra-zole, which are described in e.g. EP-A2-No. 124 495, either alone or in combination with a conventional buffering substance as previously described.

(PI, col. 3:38-47, 59-65; see also P2A, col. 8:33-42.) This portion of the specifications defines the ARC — namely, an alkaline or basic compound that must create a micro-pH around the omeprazole particles of not less than pH 7. (Auslander Tr. 2520:1-2521:13; Langer Tr. 652:18-654:22.) See Vitronics Corp., 90 F.3d at 1582; Itron, Inc., 34 F.Supp.2d at 1141. This description of the ARC is recited in the patent “as being the invention itself and not only one way of utilizing it;” therefore, the scope of the claims, which would otherwise be utterly unclear, must be limited to the definition of the ARC provided here. See Modine Mfg. Co. v. U.S. Int’l Trade Comm’n, 75 F.3d 1545, 1551 (Fed.Cir.1996), abrogated on other grounds, Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558 (Fed.Cir.2000). Because the proper definition is found only in the specification, the scope of the term “alkaline reacting compound” is limited by the disclosure in the specification. Had Astra wanted broader disclosure, they should have used terms that would have been understood more broadly. See generally Superior Fireplace Co. v. Majestic Prods. Co., 270 F.3d 1358 (Fed.Cir.2001).

After defining the term “alkaline reacting compound,” the specifications of both patents then proceed to list numerous substances that the inventors considered to be ARCs. (See, e.g., PI, col. 3:47-59.) Alkaline reacting compounds

can be chosen among, but are not restricted to substances such as the sodium, potassium, calcium, magnesium and aluminium salts of phosphoric acid, carbonic acid, citric acid or other suitable weak inorganic or organic acids; substances normally used in antacid preparations such as aluminium, calcium and magnesium hydroxides; magnesium oxide or composite substances, such as Al2 03»6Mg0»C02»12H20 (Mg6Al2 (OH)16 C03»4H20), Mg0»Al203«2Si02»nH20 or similar compounds; organic pH-buffering substances such as trihydroxymethy-laminomethane or other similar, phar-maceutically acceptable pH-buffering substances.

*453 (PI, col. 3:47-59; see also P2A col. 8:43-55.) Based on the claim language, these and other disclosures in the specifications of the patents, the statements Astra made about the prior art in the patents themselves and during the prosecution history, and the admissions of Astra’s own experts, the court finds that an alkaline reacting compound is (1) a pharmaceutically acceptable alkaline, or basic, substance having a pH greater than 7 that (2) stabilizes the omeprazole or other acid labile compound by (3) reacting to create a micro-pH of not less than 7 around the particles of omepra-zole or other acid labile compound.

a. The ARC Must Be Alkaline

Numerous dictionaries and treatises confirm that the word “alkaline” refers to a basic substance having a pH of greater than 7. (See Auslander Tr. 2515:13-2516:9.) The court is free to consult dictionaries at any time to help determine the meaning of the claim terms, provided that the dictionary definition does not contradict any definition found in or ascertained by a reading of the patent documents. Vitronics, 90 F.3d at 1584 n. 6; see also Interactive Gift Express, Inc. v. CompuServe, Inc., 256 F.3d 1323, 1332 n. 1 (Fed.Cir.2001). So, assuming that the patentees’ definition does not contradict the plain meaning of the word “alkaline” as revealed in dictionaries and technical treatises, the claimed ARC in the ’505 and ’230 patents must be a non-acidic, non-neutral compound having a pH greater than 7. Various disclosures in the specifications of the ’505 and ’230 patents confirm that an alkaline reacting compound is, first and foremost, an alkaline or basic compound. The patent specifications indicate that omeprazole is susceptible to degradation in acid media and that the degradation reaction “proceeds rapidly” in neutral media, like pH 7, “while at higher pH values the stability in solution is much better.” (PI, col. 1:21-29; P2A, col. 8:11-17.) Thus, the patent teaches one of ordinary skill in the art that the ARC, which is in direct contact with the omeprazole, cannot be acidic or neutral, but must be a basic compound with a pH of greater than 7. (Auslander Tr. 2516:10-2517:10.) Indeed, the specifications of the ’505 and ’230 patents distinguish a prior art invention, British Patent GB-A-No. 1,485,676 (the “ ’676 patent”), from the invention of the ’505 and ’230 patents, by explaining that the prior art formulation could not be adapted for use with omeprazole because “the presence of an acid in contact with omeprazole in the cores would give a result that omeprazole [would be] degraded.” (PI, col. 2:59-68 (emphasis added); see also P2A, col. 5:25-35.) Thus, this portion of the patent specification emphasizes to one of ordinary skill in the art that the formulation cannot contain an acidic compound in contact with omeprazole. (Aus-lander Tr. 2517:17-2519:4.) Moreover, the Outline of the Invention section of each patent emphasizes that the ARC is, first and foremost, an alkaline compound. (PI col. 3:13-21 (“Cores containing omeprazole mixed with alkaline compounds”); P2A col. 7:61-66; see Auslander Tr. 2519:5-25). The ’505 and ’230 patent specifications go on to list various types of compounds as examples of ARCs within the meaning of the patents. {See PI, col. 3:47-59; P2A, col. 8:43-55.) All of the examples listed in the specifications are well recognized alkaline substances. (Auslander Tr. 2521:23-2522:12.) Even further light is shed on the fact that “alkaline reacting substances” must be basic when it is considered that the claims of the ’505 and ’230 patents both allow for the absence of such a substance only when omeprazole is formulated as an “alkaline omeprazole salt.” The ’505 patent, for example, references a European Patent, EP-A2-No. 124,495 to describe those salts' — all of which are basic. (PI, col. 3:59-65.) Thus, this disclosure in both patents teaches one of ordinary skill in the *454 art that an ARC must be alkaline, and cannot be acidic or neutral.

The prosecution history of each patent confirms the court’s construction of the term “alkaline reacting compound” to require alkalinity. During the prosecution of the application that issued as the ’505 patent, the patent examiner rejected the application based on several references. (G2, Office Action of 12/1/87, at 2-3.) One of those references was the ’676 patent. (Id.) As discussed in the ’505 patent specification, this reference describes the use of a core containing “pharmaceutically acceptable acid” with the active drug in the core. (Pl, col. 2:59-69.) In response to the rejection, Astra amended the claims in its application and, while referring specifically to the core containing omeprazole and the ARC, argued that “[according to the invention, the omeprazole is either in the form of an alkaline salt, or is compounded with an alkaline material.” (G2, Amendment of 3/1/8, at 5 (emphasis added).) This discussion, in the context of the claimed invention, unambiguously states that the omeprazole is compounded with an alkaline material and confirms that the ARC must be an alkaline material with a pH greater than 7. (Auslander Tr. 2530:6-13; see generally Auslander Tr. 2528:25-2530:13.) In that same amendment, Astra further stated that “an acid containing core would be unsuitable for use with omeprazole because the acid would degrade the omeprazole.” (G2, Amendment of 3/1/88, at 8.) This strongly teaches one of ordinary skill in the art that the ARC, which is in direct contact with the omeprazole in the formulation, must not be acidic. (Auslander Tr. 2530:14-2531:11.) Astra is correct that this last statement, in isolation, might be considered a general description of the invention in the prosecution history that would not be understood to limit the invention. See York Prods., Inc. v. Central Tractor Farm & Family Ctr., 99 F.3d 1568, 1575 (Fed.Cir.1996) (“Unless altering claim language to escape an examiner rejection, a patent applicant only limits claims during prosecution by clearly disavowing claim coverage.”). The entire March 1, 1988, amendment, however, makes it clear that Astra was explaining the meaning of claim language to escape the examiner’s rejection, thereby disavowing claim coverage. Arguments and amendments made during the prosecution of a patent application must be examined to determine the meaning of terms in the claims. Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1576 (Fed.Cir.1995). The prosecution history limits the interpretation of the claim terms so as to exclude any interpretation that was disclaimed during prosecution. Id.; ZMI Corp. v. Cardiac Resuscitator Corp., 844 F.2d 1576, 1580 (Fed.Cir.1988). Simply put, claims may not be construed one way in order to obtain their allowance and in a different way when asserted against an accused infringer. Southwall, 54 F.8d at 1576; Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1562 (Fed.Cir.1991); Lemelson v. General Mills, Inc., 968 F.2d 1202, 1206 (Fed.Cir.1992) (“[T]he prosecution history gives insight into what the applicant originally claimed as the invention, and often what the applicant gave up in order to meet the Examiner’s objections.”). In a December 18, 1988 amendment made during the prosecution of the ’230 patent that occurred simultaneously with that of the ’505 patent, the Astra applicants attached the identical amendment, which included the same arguments for patentability as discussed with respect to the ’505 patent. Accordingly, these unambiguous statements in the prosecution histories of the ’505 and ’230 patents further support the interpretation that the ARC must be alkaline. See, e.g., Southwall Techs., Inc., 54 F.3d at 1576; see also Desper Products, Inc. v. QSound Labs., Inc., 157 F.3d 1325, 1335- *455 36 (Fed.Cir.1998). Indeed, having affirmatively relied on this interpretation during prosecution to obtain allowance of the patent claims, Astra is estopped from asserting a contrary claim interpretation at trial. See Senmed, Inc. v. Richard-Allan Medical Indus., 888 F.2d 815, 820 (Fed.Cir.1989).

Although extrinsic evidence may not be used to vary or contradict the claim language, it is worthy to note that in this case, the extrinsic evidence directly confirms the claim construction gleaned by the court from the intrinsic evidence. Vi-tronics, 90 F.3d at 1585. One of the named inventors of the patents admitted at his deposition that to achieve a micro-pH around each omeprazole particle of not less than 7, as required by the specification, (see PI, col. 3:38-47; P2A, col. 8:33— 42), the ARC must necessarily be alkaline — a non-acidic, non-neutral, basic substance having a pH greater than 7. (See Pilbrant Tr. 1465:6-1466:8.) 17 Additional extrinsic evidence shows that during the development of Astra’s omeprazole formulation, Astra determined that to achieve sufficient stability, it needed to include an alkaline material in the core with omepra-zole, and it chose disodium hydrogen phosphate dihydrate 18 as the alkaline compound. (Carlsson Tr. 228:25-230:5, 231:21-232:3; G148 at 9612106-07.) Dr. Enar Carlsson, who was Astra’s project leader for the development of Prilosec®, did not recall Astra ever trying materials of pH less than 7 in the core to solve the stability problem. (Carlsson Tr. 232:4-15.) Thus, a person of ordinary skill in the art would understand that an ARC, as that term is used in the ’505 and ’230 patents, must be an alkaline or basic compound,

b. Stability Through Micro-pH

As discussed above, based on the disclosures in the specification, a person of ordinary skill would also understand that the ARC must stabilize the omeprazole or acid labile compound in the core by creating a micro-pH of not less than 7 around the particles of the active ingredient: (See PI, col. 3:38 — 47; P2A, col. 8:33-42.) The ARC must be understood to stabilize the active ingredient in the formulation through creation of a micro-pH of not less than seven around the particles of the active ingredient not only because the specifications say so, but also because it makes sense in light of the goals this invention sought to achieve. As a practical matter, the goal is to stabilize and protect the omeprazole in the core. (Auslander Tr. 2520:24-2521:8; see also Langer Tr. 682:5-18.) Indeed, Astra’s experts Dr. Langer and Dr. Davies 19 ■ candidly admitted that the ARC *456 claimed in the patents is an alkaline or basic compound that must create a micro-pH of not less than pH 7 around the omeprazole particles, thereby stabilizing the omeprazole. 20 (Langer Tr. 653:8-654:23, 5106:1-13; Davies Tr. 1209:18-1210:16,1221:19-1222:8.)

Astra has taken the position that claims 1 simply have no micro-pH range limitation whatsoever. (See, e.g., Astra’s Cl. Constr. Mem. at 17.) The court finds, however, that the creation of a micro-pH of not less than 7 around the omeprazole particles is not merely a preferred embodiment of the invention, as Astra argues. The disclosure in the patents teaches that this is a required element in the definition of an ARC, and nothing elsewhere in the patents teaches or suggests otherwise. (Auslander Tr. 2521:9-13; see PI, col. 3:38-47; P2A, col. 8:33-42.) Astra’s suggestion that the creation of the micro-pH as set forth in the specifications is a “preferred embodiment” is based on a misreading of the patents. The words “preferred” and “preferably” are used in the specifications only to modify the “desired concen *457 tration of omeprazole in the final mixture” and the micro-pH value of “not less than 8.” (PI, col. 3:38-47; P2A, col. 8:33-42.) Recognizing that those two features are preferred embodiments, Defendants do not argue that either of those features form part of the proper claim interpretation of the term “alkaline reacting compound.”

Astra also argues that Defendants are improperly trying to read the miero-pH claim limitation from dependent claim 5 of the ’505 patent into claim 1, and that the legal theory of claim differentiation precludes Defendants’ proposed construction. (See Astra’s Cl. Constr. Mem. at 17.) Under claim differentiation, a limitation contained in a dependent claim may not be imported into the independent claim from which it depends. Karlin Techn., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 972 (Fed.Cir.1999); Transmatic, Inc. v. Gulton Indus., 53 F.3d 1270, 1277-78 (Fed.Cir.1995). There is presumed to be a difference in meaning and scope when different words or phrases are used in separate claims. To the extent that the absence of such difference in meaning and scope would make a claim superfluous, the doctrine of claim differentiation states the presumption that the difference between the claims is significant. Tandon Corp. v. U.S. Int’l Trade Comm’n, 831 F.2d 1017, 1023 (Fed.Cir.1987). Astra’s argument misses the point, however, that the relevant narrowing limitation in claim 5 is the specific numerical pH range of 7 to 12, which includes an upper bound. Claim 5 of the ’505 patent is narrower than claim 1 because it has a narrower numerical pH range. The “alkaline reacting compound” of claim 1 must create a micro-pH of not less than 7, but there is no specified upper limit on pH in claim 1, which covers a range of pH from 7 to 14. Claim 5, however, explicitly specifies a narrower pH range. (PI, col. 16:43-47, 16:65-68; Aus-lander Tr. 2535:13-2536:15.) The difference, and what may not be read into claim 1, is the specific numerical range of pH 7 to 12 recited into claim 5. Excluding the pH range from 12 to 14 in claim 5 is not insignificant. There are medical concerns involved with the use of formulations containing caustic, or very high pH, substances. For example, the use of omepra-zole salts, which are very basic, may cause etching lesions or other gastrointestinal problems. (Lovgren Tr. 4930:3-4931:1; Langer Tr. 5148:4-5149:11.) Claim 6 of the ’230 patent is narrower than claim 1 of that patent for the same reasons that claim 5 of the ’505 patent is narrower than claim 1 of the ’505 patent. (PI, col. 16:42-68; Lovgren Tr. 1864:4-1865:13; compare PI, col. 16:43-47,16:65-68, with P2A, col. 13:2-9,14:4-8.) Thus, narrowed claims 5 and 6, which set a maximum pH value of 12, clearly satisfy the presumption of claim differentiation; they are different from claim 1 because they have an upper limit for micro-pH. See Mantech Envtl. Corp. v. Hudson Envtl. Servs., 152 F.3d 1368, 1372 (Fed.Cir.1998) (finding the patentee’s argument based on claim differentiation “unavailing” given that the narrowing language of the dependent claim alone distinguished its scope from that of the independent claim); Manchak v. Chem. Waste Mgmt., Inc., No. 98-1530, 217 F.3d 860, 1999 WL 1103364, at *5 (Fed.Cir. Dec. 6, 1999) (unpublished opinion) (holding that the doctrine of claim differentiation “is inapplicable where one or more added limitations distinguishes the allegedly superfluous dependent claim from its parent independent claim”). Moreover, the doctrine of claim differentiation cannot override the clear statements of scope in the specifications and prosecution histories, which overcome any presumption arising from the doctrine. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1302 (Fed.Cir.1999). Simply put, claim differentiation cannot broaden claims beyond their correct scope. Toro Co., 199 F.3d at 1302.

*458 Astra’s arguments against the micro-pH requirement fail for another reason. It is a fundamental concept in patent claim drafting that each element of a claim must have an antecedent basis; otherwise, the claim would be rejected as indefinite under 35 U.S.C. § 112. Manual of Patent Examining Procedure (“MPEP”) § 2173.05(e), Lack of Antecedent Basis. Section 2173.05(e) of the MPEP states that

“[a] claim is indefinite [under 35 U.S.C. § 112] when it contains words or phrases whose meaning is unclear. The lack of clarity could arise where a claim refers to ‘said lever’ or ‘the lever’ where the claim contains no earlier recitation or limitation of a lever and where it would be unclear as to what element the limitation was making reference.”

In claim 5 of the ’505 patent and claim 6 of the ’230 patent, each of which covers a preparation “according to claim 1,” the term “micro-environment” is preceded by the word “the.” The use of this definite article mandates that the term “micro-environment” was previously used in claims 1. Indeed, the antecedent basis for this term is derived from the fact that the phrase “alkaline reacting compound” of claims 1 includes, by definition, the element of micro-pH. If this were not true, then the term “micro-environment” would lack antecedent basis, rendering claim 5 of the ’505 patent and claim 6 of the ’230 patent invalid due to indefiniteness. Therefore, the court must construe the term “alkaline reacting compound” to require the creation of a micro-pH of at least 7 around the particles of the active ingredient. See Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1344 (Fed.Cir.1998) (“[I]f the claim is susceptible to a broader and a narrower meaning, and the narrower one is clearly supported by the intrinsic evidence while the broader one raises questions of enablement under § 112, [the court must] adopt the narrower of the two.”). Whenever a claim is susceptible to one construction that would render it valid and another construction that would render it invalid, the claim will be construed to sustain its validity. Rhine v. Casio, Inc., 183 F.3d 1342, 1345 (Fed.Cir.1999).

Astra’s proposed definition of the term “alkaline reacting compound,” a substance that when added to omeprazole can increase pH, is not only unsupported but also contradicted by the disclosures of the ’505 and ’230 patents. For example, if a substance with a pH of 6.8 is added to omeprazole, which Astra contends has a pH of 6.4, 21 and the resulting pH is increased, the substance would be within Astra’s definition of ARC. The substance, however, would be acidic, and, therefore, its use would be completely inconsistent with the disclosures of the ’505 and ’230 patents. (See P1, col. 3:26-28, 38-47, col. 5:29-33.) There is no disclosure in the patents that the ARC can be acidic or a substance that simply increases pH when added to an acid labile compound, like omeprazole. (See generally P1; P2A.) As-tra’s argument that an ARC is anything that can raise the pH when added to ome-prazole is directly contradicted by the numerous teachings in the patents that the alkaline compound must be truly alkaline, with a pH of not less than 7.

c. The Entire Core Need Not Be Alkaline

The court does not agree with Defendants’ argument that the core as a whole, as opposed to simply the ARC, must also be alkaline. 22 That aspect of Defendants’ *459 definition improperly requires the entire core to have a pH greater than 7 even though the claims themselves contain no such limitation and the specification expressly permits otherwise. In support of this argument, KUDCo cites to the portion of the ’505 patent file history where Astra distinguished the invention over the teachings of the ’676 patent. KUDCo misinterprets what Astra said about the ’676 patent. Astra explained in its amendment to the PTO that “[t]he formulation [described in the ’676 patent] cannot be adopted for a pharmaceutical dosage form containing omeprazole, as the presence of an acid in contact with omeprazole in the cores would give a result that omeprazole was degraded.” (PI, col. 2:64-68 (emphasis added).) The ’505 patent does not teach that the core must not contain any acidic components or that the pH of the entire core as a whole must exceed 7. It only states that if an acid is in the core, it must not be in contact with the omeprazole. The ’505 patent also allows that the pH of the entire core may be less than 7, yet still contain an ARC. For example, the ’505 patent recognizes that cores containing ARCs may have a pH below 7 when suspended in water. At column 5, the patent states:

The alkaline reacting core material and/or alkaline salt of the active ingredient, omeprazole, enhances the stability of omeprazole. The cores [alkaline reacting core] suspended in water forms a solution or a suspension which has a pH, which is higher than that of a solution in which the polymer used for en-teric coating is just soluble.

(PI, col. 5:23-29.) According to this statement, the pH of the core is only limited to being a value higher than the pH at which the enteric coating dissolves. Extrinsic evidence confirms that enteric coats begin to become soluble at pH values higher than those ordinarily present in the stomach, about pH 5. (Langer Tr. 299:6-8.) According to the patent itself, some enteric coatings dissolve at pH values below 7. For instance, as indicated in Table 5, formulation Example 3 dissolved at pH 6.0. (PI, col. 14:19-33.) Thus, the ’505 patent teaches that the pH of the entire core can be less than 7 and as low as 6. This is possible, for example, where a formulator ensures that the environment around the omeprazole particles contains ARC even though other regions of the core contain acidic components that lower the pH.

In support of their attempt to restrict the pH of the entire core to values in excess of pH 7, Defendants rely on the inclusion of the terms “alkaline core” and “alkaline reacting core” in the patents. However, the use of those terms, which do not appear in claims 1, does not support importation of such a claim limitation, even with respect to claims containing the terms. A reading of both specifications makes clear that the terms “alkaline core” and “alkaline reacting core” are being used as shorthand for cores containing either an alkaline reacting compound or an alkaline salt of the active ingredient. The ’505 patent uses the phrase “alkaline core” as a synonym for a core that contains an ARC, as may be seen from the following passages in the ’505 patent:

In order to enhance the storage stability the cores which contain omeprazole must also contain alkaline reacting constituents. When such an alkaline core is enteric coated ....

(PI, col. 1:57-60 (emphasis added).)

Cores containing omeprazole mixed with alkaline compounds or an alkaline salt of omeprazole optionally mixed with an alkaline compound are coated with two or more layers, whereby the first layer/layers is/are soluble in water o[r] rapidly disintegrating in water and con-sistís) of non-acidic, otherwise inert pharmaceutically acceptable substances. *460 This/these first layerfiayers separates/separate the alkaline core material from the outer layer, which is an enteric coating.

(PI, col. 3:21-29 (emphasis added).)

Thus, the special preparation according to the invention consists of cores containing omeprazole mixed with an alkaline reacting compound or cores containing an alkaline salt of omeprazole optionally mixed with an alkaline reacting compound.The cores are coated with an inert reacting water soluble or in water rapidly disintegrating coating, optionally containing a pH-buffering substance, which separates the alkaline cores from the enteric coating.

(PI, col. 5:19-33 (emphasis added).) Because one of ordinary skill would understand “alkaline core” to refer to any core containing an ARC or an alkaline salt of omeprazole, such a person would not understand that the entirety of the core necessarily must have a pH above 7. Similar to the definition of “alkaline core” in the ’505 patent, the term “alkaline reacting core” in the ’230 patent means a core that contains either an ARC or an alkaline salt of an acid labile compound. The patent specification confirms this construction. 23 (See P2A, col. 3:66 — col. 4:43 (“In order to enhance the storage stability, the cores which contain the acid labile substance must also contain alkaline reacting constituents. When such an alkaline core ....”) (emphasis added); P2A, col. 10:14-25 (“Thus the special preparation according to the invention consists of cores containing the acid labile compound mixed with an alkaline reacting compound or .... The cores are coated with a water soluble or in water rapidly disintegrating coating, optionally containing a pH-buffering substance, which separates the alkaline cores from the enteric coating.”) (emphasis added).)

In a similar vein, the patent claims do not require that a substance be proven to create a micro-pH of not less than 7 around every single, individual ome-prazole particle present in the core of a formulation. The law is plain, infringement need not be perfect to be infringement. Shamrock Techs., Inc. v. Medical Sterilization, Inc., 903 F.2d 789, 792 (Fed.Cir.1990) (inefficient infringement is still infringement). Unless it is expressly excluded by the claim language, the term “substantially” is understood as being incorporated into every patent claim. See AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1250 (Fed.Cir.2001) (stating that, with respect to a patent for which the parties generally agreed that a “layer” requires a “uniform” chemical composition, absent any specific statement in the patent of chemical uniformity as a characteristic of a layer, the layer must be understood as only “substantially” uniform.). KUDCo at *461 tempts to inappropriately add to “alkaline reacting compound” a requirement that it provide a microenvironment pH of not less than 7 around each omeprazole particle. However, claim terms must be construed practically, and a patent is infringed even if the infringement is less than perfect. See Shamrock Techs. Inc., 903 F.2d at 792. The examples in the patents demonstrate that the inventors did not contemplate that each and every particle of omeprazole must be enclosed perfectly in a microenvi-ronment pH of at least 7 by the ARC. Table 3 of the patent shows that even when using the invention, some degradation of omeprazole occurs. (PI, col. 7:12— 28.) Thus, complete inclusion of every particle of omeprazole was not deemed essential to the invention, and the court will not import such perfectionism into the definition of the term “alkaline reacting compound” where it is not called for by the claims.

d. Other Limitations

Cheminor seeks a construction of the term “alkaline reacting compound” that would limit claims 1(a) to the narrowed classes of alkaline reacting compounds identified in the specification. Cheminor’s proposal unduly limits the claim to specific embodiments in the specification. Karlin Tech., Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 973 (Fed.Cir.1999). Moreover, limiting the alkaline reacting compounds solely to those listed is directly contradictory to the patent specification, which expressly states that the list was not meant to be exhaustive. (PI, col. 3:54-56.) The language of claims 1 does not require that every specific alkaline reacting substance alleged to be infringing be identified or listed in the specification. See Specialty Composites v. Cabot Corp., 845 F.2d 981, 989 (Fed.Cir.1988) (finding unlisted plasticizers within the scope of the claims). Although the definition of the term “alkaline reacting compound” must be found in the specification in light of the other intrinsic evidence, that definition is one based on the function of the ARC, not its identity. Therefore, the appropriate inquiry is whether a particular compound has the required properties to perform the functions required of an ARC, not whether the compound is included in a non-exhaustive list of examples in the specification. See Specialty Composites, 845 F.2d at 987 (“The emphasis is on the suitability of any plasticizer that will achieve the specified properties, not on the particular class of plasticizer.”).

Cheminor also argues that the ARC must be water soluble and “otherwise inert.” Once again, Cheminor’s attempt to define the ARC as a water soluble compound is an attempt to read a preferred embodiment into claims 1. Nothing in the claim language requires water solubility of the ARC, and the specification does not contain such a limitation. Even the portions of the specification relied on by Che-minor to define alkaline reacting compounds refer to practically insoluble ARCs. (PI, col. 3:48-50 (referring to Mg6Al2(OH)16 C03»4H20 (hydrotalcite)); Astra’s Cl. Constr. Mem. of 11/5/01, Ex. 10, Martin-dale 13th ed. at 886 (1993).) Similarly, the court rejects Cheminor’s argument as to “otherwise inert” because the requirement is not contained in the claims. While the phrase is used in the specification of the patents relative to alkaline reacting substances, (PI, col. 3:41-42), “inert” is not in the claim as a modifier of “alkaline reacting compound,” and it should not be imported into the claim. Also, other portions of the specifications do not include that language. (See, e.g., PI, col. 1:57-59; P2A, col. 3:66-68.)

Accordingly, based on the claim language, the numerous disclosures in the specifications of the ’505 and the ’230 patents, the statements Astra made about the prior art and the claimed invention during *462 prosecution, and the admissions of Astra’s own experts, the court finds that the term “alkaline reacting compound” means:

' (1) a pharmaceutically acceptable basic substance having a pH greater than 7.0

(2) that stabilizes the omeprazole or acid labile active compound

(3) by reacting to create a micro-pH of not less than 7.0 around the particles of omeprazole or active acid labile compound.

3. The Term “Effective Amount”

Subpart (a) of claim 1 of the ’505 patent requires an “effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound,” (PI, col. 16:43^45), and the parties dispute the meaning of the phrase “effective amount.” 24 The dispute between Astra and the four Defendants before the court boils down to a disagreement over whether the phrase “effective amount” applies to the omeprazole alone or to both the omeprazole and the alkaline reacting compound in the core. Astra argues for the former, while Defendants prefer the latter construction. The Second Wave Defendants also weigh in to argue that the claimed oral structure cannot be construed to encompass a capsule containing multiple “core regions,” each one of which does not have an “effective amount” of omeprazole because claim 1 of the ’505 patent requires a single core region that contains the entire “effective amount.” The court agrees with the Second Wave Defendants in so far as the court finds that each core or core region must contain an “effective amount.” 25 The plain language of subpart (a) of claim 1 dictates that finding. The question remains — an effective amount of what? 26

*463 Astra’s proposed construction of the claim term “effective amount” is a therapeutically effective amount of omeprazole sufficient to reduce gastric acid secretion. Under Astra’s proposed construction, such an effective amount is a daily dose that can range from 1 to 400 mg of omeprazole, depending on the individual. This range is the only therapeutically effective amount of omeprazole disclosed in the ’505 patent specification. (See PI, col. 6:12-20, and ’505 Certificate of Correction.) The court declines to adopt Astra’s proposed construction. The term “effective amount” in claims 1 and 14 of the ’505 patent does not have the word “therapeutically” associated with it, and therefore, contrary to Astra’s proposed construction, a person of ordinary skill in the art understands the term “effective amount” in claims 1 and 14 to have a different- meaning than the phrase “therapeutically effective amount,” which appears in claim 10. (PI, col. 16:43, 17:25, 18:15; Auslander Tr. 2538:7-2540:15; Langer Tr. 735:8-740:5.) On its face, claim 1 cannot be construed so that the “effective amount” requirement only refers to the amount of the omeprazole. First, the term “effective amount” modifies the phrase “a material selected from the group consisting of.” Simple grammar rules indicate that the “effective amount” requirement applies to whatever, alone or in combination, constitutes the “material.” Claim 1 also makes clear that the “material” is the group consisting of (1) omepra-zole plus an ARC; (2) an alkaline omepra-zole salt plus an ARC; and (3) an alkaline omeprazole salt alone. (PI, col. 16:43-47.) If the court were to define “effective amount” solely by the active ingredient, then in any given formulation the effective amount of “an alkaline omeprazole salt plus an alkaline reacting compound” would always be the same as the effective amount of “an alkaline omeprazole salt alone,” because in those formulations the alkaline omeprazole salt is the active ingredient. Such a construction would thus effectively write out part of claim 1 — option 2 — as redundant, and is inconsistent with the specification’s teaching that the alkaline salt can be mixed beneficially with an ARC, as stated in option 2. (See PI, Exs. 7 & 8, Col. 10:66-Col. 11:41, Comparative Ex. V, Col. 13:41-65.) The claim requires “an effective amount of material,” not just an effective amount of active ingredient.

Having determined that the term “effective amount” applies to all substances required as part of the “material” required in claim 1(a), the court now concerns itself with the combination of omeprazole plus an ARC, which is the only option in claim 1(a) asserted by Plaintiffs against Defendants. The court finds that the term “effective amount” applies to both omeprazole and the ARC and requires an amount of each substance such that the combination of omeprazole plus the ARC meets the stated goal of the invention of stabilizing the omeprazole. (Accord Auslander Tr. 2539:8-2540:15.) That is, the term “effective amount” is a relative term. It requires that the ARC and omeprazole be present in the “material” in an appropriate ratio such that the ARC stabilizes the omeprazole. The ARC is used in the claimed formulation to improve storage stability. (Langer Tr. 740:6-741:2, see also Langer Tr. 735:8-740:5.) Therefore, an “effective amount” of an ARC in relation to a chosen amount of omeprazole in a given formulation is an amount sufficient to stabilize the omeprazole in the formulation’s core. (Langer Tr. 740:23-741:15; *464 see generally Langer Tr. 735:8-741:15.) As the specification discloses, that stabilization is achieved by using an ARC in the core to create a micro-pH around the ome-prazole particles of not less than pH 7.

D. Part “(b)” of Claims 1

1. Ordinary Meaning of the Term Subcoating

Part (b) of claim 1 of the ’505 patent requires “an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said sub-coating comprising one or more layers of materials selected from among tablet ex-cipients and polymeric film-forming compounds.” (PI, col. 16:48-52; see also P2A, col. 13:10-15.) Part (b) of claim 1 of the ’230 patent does not contain any material differences. (See P2A, col. 13:10-15.) The meaning of the term “subcoating” is apparent simply from a reading of the claims and the ordinary meaning of the terms contained therein. The subcoating is a layer of material that “coats” and is “disposed on” the core region; therefore, it must be physically on or in contact with that core region. The plain meaning of the noun “coating” requires a “material that will form a continuous film over a surface.” McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed. at 394 (1994). See Interactive Gift Express Inc. v. CompuServe, Inc., 256 F.3d 1323, 1331 n. 1 (Fed.Cir.2001) (“Dictionaries, which are a form of extrinsic evidence, hold a special place and may sometimes be considered along with the intrinsic evidence” when determining the ordinary meaning of claim terms.); Vitronics, 90 F.3d at 1584 n. 6. A “coating,” like a film, must conform to the contours of the thing it “coats.” The sub-coating is also “sub,” under or beneath, the enteric coating layer. In the context of the claims of the ’505 and ’230 patents, the court finds that the “subcoating” claim limitation requires a coating or covering that is physically on, or in contact with, and conforms to the contours of the core region. 27 The patent specifications support the court’s finding that the patentees employed the ordinary meaning of the term “subcoating.” The ’505 patent describes “subcoated pellets” where the subcoating “was sprayed on the uncoated pellets.” (PI, col. 8:6-15.) An additional four examples of subcoated pellets use this same technique. (PI, col. 8:55-62, col. 9:25-32, col. 10:8-10, col. 11:17-27.) Another sub-coated core using a drying coating technique is described as well. (PI, col. 11:68— col. 12:22; see also P2A, col. 12:1-22.) In each of these coatings, the subcoating is physically on, in contact with, and conforms to the contours of the core region. In conclusion, a subcoating is a layer that is physically on and conforms to the contours of a core and is underneath another layer — -the enteric coating.

Defendants misconstrue the term sub-coating by (1) attempting to broaden the claims by ignoring the prosecution history in which the applicant and the examiner acknowledged that the claimed subcoatings do not include a capsule separating layer, (2) ignoring basic grammar rules to require more than one material in the sub-coating, (3) attempting to narrow the claims by reading process limitations and the preferred embodiment from the specification into the claims, and (4) requiring a super-coat with no imperfections — a standard that no formulation meets in the real world.

2. Gelatine Capsules Are Not Subcoatings

Defining the term “subcoating” to encompass gelatine capsules, Genpharm fo *465 cuses on the word “subcoating” and finds it synonymous with the term “separating layer” while ignoring the requirement of the claims that the subcoating be “disposed on the core region.” Genpharm adopts this construction largely to create a definition for the claim term so broad that it encompasses certain aspects in the prior art that Genpharm then argues invalidate the patents. Turning first to the intrinsic evidence relative to Genpharm’s argument, the claims in question all use the language “subcoat;” they do not mention the term “separating layer,” which appears only in the specification. Genpharm is correct, however, that both subcoatings and gelatine capsules are types of separating layers; the patent specification itself makes that clear. When read in context, the specifications disclose that a subcoating is a type of separating layer. For that reason, when describing subcoating techniques in column 4 of the ’505 patent, the specification acknowledges “the subcoating layer, in the following defined as the separating layer.” The specification then goes on to describe other separating layers such as gelatine capsules, (PI, col. 4:57-58); however, the specification nowhere suggests that every separating layer is a sub-coat. Thus, the specifications of the ’505 and ’230 patents describe two types of separating layers — subcoatings and capsules. (PI, col. 4:3-58; P2A, col. 8:66 — col. 9:52.) Genpharm’s assertion that the ’505 and ’230 patents expressly teach that hard gelatine capsules are subcoatings is simply erroneous. The portions of the patents to which Genpharm refers do not use the word “subcoating.” {See PI, col. 3:66-68, 4:57-58; P2A, col. 8:62-65, col. 9:51-52.) The first part in each patent states only that the powder mixture can be formulated into hard gelatine or soft gelatine capsules. The second reference in both patents says the gelatine capsule can serve as a “separating layer.” Thus, according to the specification, both subcoatings and gelatine capsules are different species of the generic term “separating layer.”

The fact that the specification expressly states that a gelatine capsule also can serve as a “separating layer,” (PI, col. 4:57-58), does not mean a gelatine capsule is a subcoating. In fact, gelatine capsules are not subcoatings. This is understood from the plain meaning of the term “capsule,” which is defined as “a soluble shell in which drugs are enclosed for oral administration,” McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed. at 308 (1994), “a small gelatineous case containing medicine,” New Webster’s Dictionary and Thesaurus at 66 (1992), and “a shell usu. of gelatine for packaging something (as a drug or vitamins); also: usu. medicinal or nutritional preparation for oral use consisting of the shell and its contents,” Merriam Webster’s Collegiate Dictionary, 10th ed. at 170 (1993). As is apparent, the appropriate definitions for gelatine capsules are clearly incompatible with the requirements of a subcoating when that term is understood based upon its ordinary meaning as it appears in the claims of the ’505 and ’230 patents.

The prosecution history makes it unequivocally clear that gelatine capsules are not subcoatings. After the patent examiner had already granted the claims, Astra petitioned USPTO to consider a reference by authors Pilbrant and Cederberg. That reference mentions enteric-coated capsules containing omeprazole: “The dosage form — a tablet, a capsule, or granules — is coated with a polymer, which is insoluble in acid media but soluble in neutral to alkaline media [ie., an enteric coating].” (P84, Pilbrant & Cederberg at 115, left column (emphasis added).) In distinguishing the ’505 patent application over Pil-brant & Cederberg, Astra argued that the reference “does not, however, disclose preparations having a subcoating layer, *466 such as in the claimed invention.” (P7A at 2-3, ’505 File History, Petition for Consideration of Prior Art After Payment of Issue Fee of 9/16/88 (App. 1, ’505 Pros. History at 279-80); P8A at 5-6, ’230 File History, Amendment of 12/19/88.) The USPTO granted Astra’s petition and the ’505 patent was issued over the Pil-brant and Cederberg reference. (’505 Pros. History at 282.) Astra’s statement in the prosecution history that the enteric-coated gelatine capsule in the Pilbrant and Cederberg reference was not the subcoat of the claimed invention and the USPTO’s subsequent allowance of the application excludes the possibility that gelatine capsules are “subcoatings” as required by the ’505 patent claims. Goldtouch Techns. Inc. v. Microsoft Corp., No. A99CA336ss, 2000 WL 85555, at *3 (W.D.Tex. Jan. 14, 2000) (excluding possibility during claim construction that claims covered matters disclaimed during prosecution history). Simply put, a gelatine capsule is not a “subcoating” within the meaning of the claimed invention of either the ’505 or the ’230 patent.

In support of its argument that gelatine capsules are subcoatings as that term is understood in the claims of the ’505 and ’230 patents, Genpharm relies heavily on statements made by Astra when it filed patent applications corresponding to the ’505 and ’230 patents in various foreign jurisdictions. Genpharm improperly seeks to rely on these foreign proceedings, since Genpharm has not even tried to lay a foundation for its argument that foreign prosecutions should be considered on an issue of United States law— namely, claim construction. See Heidelberger Druckmaschinen AG v. Hantscho Commercial Prods. Inc., 21 F.3d 1068, 1072 n. 2 (Fed.Cir.1994); Medtronic, Inc. v. Daig Corp., 789 F.2d 903, 907-08 (Fed.Cir.1986). The cases cited by Genpharm for the proposition that certain statements made by a patentee in connection with counterpart foreign applications may be relevant to claim construction of a United States patent, Tanabe Seiyaku Co. v. Inter. Trade Comm’n, 109 F.3d 726, 733 (Fed.Cir.1997); Caterpillar Tractor Co. v. Berco, SpA, 714 F.2d 1110, 1116 (Fed.Cir.1983), both relate to analysis under the doctrine of equivalents, a question of fact. See Insta-Foam Prods., Inc. v. Universal Foam Sys., Inc., 906 F.2d 698, 702 (Fed.Cir.1990). Even assuming the alleged foreign “admissions” are admissible, however, they fail to support Genpharm’s position.

During the prosecution of Astra’s European omeprazole formulation patent application that corresponds to the ’505 and ’230 patents on July 27, 1990, the European Patent Office (“EPO”) rejected Astra’s application for lack of novelty, citing EP-A-124 495 (the “ ’495 patent”). (11/5/01 Hovden Deck, Ex. 7.) The ’495 patent discloses a formulation that contains an alkaline omeprazole salt in a hard gelatine capsule that is enteric coated. (11/5/01 Hovden Decl., Ex. 8.) The examiner stated that the ’495 patent referred to omeprazole salts in cores that were filled in hard or soft gelatin capsules allegedly functioning as a subcoat or separating layer. The following appeared at page 7 of the European application, lines 11-12: “In case of gelatin capsules the gelatin capsule itself serves as separating layer.” (11/5/01 Hovden Deck, Ex. 9.) To overcome the examiner’s lack of novelty rejection based on the gelatine capsule formulation disclosed in the ’495 patent, Astra made the following amendments to its application on November 23,1990:

D1 [the ’495 salts patent] is the Applicant’s own patent. According to D1 it is either enteric coated granules or a powder that are filled into the hard gelatine capsules or a solution that is filled into the soft capsules. The wording on page 7, lines 11 and 12 in our specification, which the Examiner has pointed out and *467 also the lines 31-34 on page 5 of our specification has been amended on the attached copies of said pages in order to define the invention without difficulty and clearly restrict us from Dl.

(11/5/01 Hovden Decl., Ex. 10, at 2.) In a follow-up communication from Astra to the European Patent Office three days later, Astra directly addressed the issue of whether a separating layer-capsule falls within the meaning of the term subcoating in the patent claims:

We refer to our letter of November 23, 1990 and would like to further define the difference between citation Dl [the ’495 salts patent] and this application. Please be informed that the enteric coated granules in Dl have no subcoating. As this was obvoius [sic] to us we forgot to stress this important difference. As a consequence we are enclosing a further amended page 4, where this is clarified and we kindly ask the Examiner to perform this amendment in the file copies.

(Astra’s Resp. to Defs.’ Cl. Constr. Briefs, Ex. 64, Margareta Linderoth’s 11/26/90 Letter to EPO.) The amendment provided the following changes to the European Specification, handwritten in at the bottom of page 4 of Exhibit 64: “E-P-A-124 495 describes enteric coated granules without subcoating or powder that are filled into hard gelatine capsules or a solution that is filled into soft capsules.” (Astra’s Resp. to Defs.’ Cl. Constr. Briefs, Ex. 64, Margare-ta Linderoth’s 11/26/90 Letter to EPO, at 3; Ex. 66, EP 247 983 Bl, at 4:19-20.) About a year later on October 11, 1991, Astra again communicated with the EPO in correspondence that states, “[flurther there is no subcoating according to Dl [the ’495 patent]. Thus the claimed invention is novel over Dl. The examiner also recognized inventiveness of the invention at the interview, but wanted to have a written explanation of the citations.” (As-tra’s Resp. to Defs.’ Cl. Constr. Briefs, Ex. 65.) Again, Astra informed the EPO that the ’495 patent did not disclose a subcoat, and this communication pointed out that the examiner agreed, as shown by the fact that the examiner recognized inventiveness at the interview. (Astra’s Resp. to Defs.’ Cl. Constr. Briefs, Ex. 67.) These facts, which Genpharm admitted in its claim construction briefing, show that all separating layers are not subcoatings and that the hard and soft gelatine capsules in the reference at issue were not subcoatings. Thus, Astra’s European prosecution is consistent with the ordinary meaning of the claim term “subcoating” and the plain language of the ’505 and ’230 patents.

Genpharm also refers to foreign patent proceedings in the Republic of South Africa during Astra’s prosecution of an ome-prazole formulation patent that corresponds to the ’505 and ’230 formulation patents. Genpharm relies upon the following language from an amendment discussing the ’495 patent:

EP-A-0 173 664 (A B Hassle) and EPA-0 124 495 (A B Hassle) are citable as prior art. The Applicant believes that these patent specifications do not destroy the novelty of claim 1 of the patent because gelatine capsules where the capsule serves as a subcoating, fall outside the scope of claim 1 when properly construed. In order to avoid a possible adverse finding based on these prior art documents, the Applicant seeks to delete reference to gelatine capsules at the passages cited, thereby ensuring that the patent specification is clear in this regard and is not vulnerable to an attack based on this prior art.

(11/5/01 Hovden Decl., Ex. 11, at 3.) Even the portion quoted by Genpharm acknowledges that gelatine capsules fall outside the scope of claims 1 of the ’505 and ’230 patents when properly construed. (See 11/5/01 Hovden Decl. Ex. 11, at 3.) Once again, a document from the South African *468 file expressly refutes Genpharm’s assertion that the claimed subcoating covered gelatine capsules. (Astra’s Resp. to Defs.’ Cl. Constr. Briefs Ex. 36, Application to Amend South Africa Specification, filed 9/17/97, at 7.)

Additional extrinsic evidence also supports .Astra’s construction. Dr. Langer testified that a subcoating was a substantially continuous film, distinguishing between subcoatings on one hand and separating layers or gelatine capsules on the other. (Langer Tr. 419:1-4, 421:8-16, 442:16-18, 5026:4-5027:9, 5029:3-16.) While a subcoating and gelatine capsules both separate, the subcoating conforms to and is in contact with the core. (Langer Tr. 5026:1-5027:3.) The inventors also distinguished between subcoatings and separating layers or gelatine capsules. (Pil-brant Tr. 1631:20-24, 1718:5-23, 1719:1-11; Lovgren Tr. 4520:14-24.) Prior to trial, others of at least ordinary skill, including Genpharm’s expert Dr. Story and Chemi-nor’s expert Dr. Porter, construed the term “subcoating” so that it did not include gelatine capsules and acknowledged that the subcoatings of claims 1 were missing from the prior art describing such gelatine capsule separating layers. (See Story Tr. 4798:9-4799:11, 4799:21-4801:8.) Dr. Porter stated categorically that the ’974 patent, 28 which refers to enteric-coated gelatine capsules, is missing the subcoating. (Astra’s Cl. Constr. Resp. of 11/12/01, Ex. 34, Porter Dep. Tr. 86:7-87:10.) In other words, Dr. Porter recognized that the gelatine capsules are not subcoatings as they are claimed in the ’505 and ’230 patents. Dr. Goldberg, Andrx’s expert, expressly noted the difference between coatings and capsules in a sworn affidavit:

The process of making capsules is substantially different than the process of microencapsulation. The process of mi-croencapsulation involves coating the individual particles of the material, while the manufacture of capsules involves placing multiple particles into a pre-ex-isting shell capsule. Capsules can also contain drugs that have been microen-capsulated.

(Astra’s Resp. to Defs.’ Cl. Constr. Briefs, Ex. 61, Deck of Dr. Arthur H. Goldberg dated 2/26/98, at 6.)

To sum up, based upon the ordinary meaning of the terms “subcoating” and “capsule,” the patent specifications and file histories, the foreign proceedings raised by Genpharm, and other extrinsic evidence, the court finds that the phrase “subcoating ... disposed on said core region” that appears in claims 1 of the ’505 and ’230 patents does not include gelatine capsules.

3. One Subcoating May Contain One “Material”

Cheminor asserts that under claim 1 of both the ’505 and the ’230 patents, the subcoating must be made up of two or more materials and that any subcoating consisting of only one material does not come within the scope of the claims. The court notes that this construction, like others adopted by Cheminor, is newly proposed. Cheminor conceded in a letter written two months after trial began that this was a new claim construction. (See Letter from Cheminor to court of 2/6/02; Trial Tr. 4037:16-4038:5.) Cheminor did not come forward with it until a month after Astra’s last witness with respect to infringement, Dr. Lovgren, left the stand on January 4, 2002. The prejudice to As-tra from this decidedly late claim construction argument is plain. Astra did not have a reasonable opportunity to present documentary evidence or to have its experts testify concerning this new construction. The court, therefore, sustains Astra’s objection to Cheminor’s change in position *469 and precludes Cheminor from asserting noninfringement on the basis of this argument. Nevertheless, for purposes of completeness, the court addresses this argument, which is at best superfluous and at worst specious. Before February of 2002, Cheminor apparently never noticed this new construction, and it can hardly be deemed the way one of ordinary skill in the art would construe the claims.

Turning to the claim language itself, the pertinent language is not merely “materials,” but rather claim 1 of the ’505 patent, which requires “one or more layers of materials,” (PI, col. 16:50-51), and claim 1 of the ’230 patent, which requires “one or more layers comprising materials.” (P2A, col. 13:12-13). When construing this claim language, the court must remain cognizant of the rules of grammar and syntax. In re Hyatt, 708 F.2d 712, 714 (Fed.Cir.1983). The court finds that even though the term “materials” in claims 1 of the ’505 and ’230 patents was clearly intended to include the singular, the plural form was used to comply with grammatical correctness. See Huntington Dry-Pulverizer Co. v. Whittaker Cement Co., 89 F. 323, 326 (D.N.J.1898) (construing the claim, which included the terms “rollers” and “shafts,” to include a roller and a shaft; explaining that “the use of the plural included the singular, if the singular could do the work marked out by the plural”). The phrases “one or more layers of materials” and “one or more layers comprising materials” require at least one material when there is one layer, and at least two materials when there is more than one layer. This is the only construction that makes sense for either the ’505 or the ’230 patent when one considers the substance of the inventions. There is no support in either patent for the exclusion of subcoatings made of only one material. Several examples listed in the patent use only one material in their subcoats: Examples 3 and 4 use only polyvinylpyrrolidone (“PVP”) in the subcoating (PI, col. 8:58, 9:27); and Examples 2, 5, 7, and 8 use only HPMC (PI, col. 8:10, 10:10, 11:23-24). Any construction of the claims that excludes 6 of the first 8 examples included in the patent cannot be the proper construction, absent some express intent or reason to exclude them, and Cheminor relies solely on attorney argument in support of this contention and has presented no testimony on the issue. Therefore, the court rejects Cheminor’s attempt to limit the claims of the ’505 and ’230 patent to cover only those formulations containing more than one “material” in the subcoating.

4. The Term “Disposed on” Does Not Require a Separate Processing Step

Andrx argues that the phrase “disposed on” requires that the subcoating be “physically applied to” the core, as opposed to forming spontaneously. Andrx’s definition attempts to import process limitations into a product claim. It is improper to limit product claims to a particular process. Vanguard Prods. Corp. v. Parker Hannifin Corp., 234 F.3d 1370, 1372-73 (Fed.Cir.2000) (holding scope of claim for electromagnetic shielding gasket not limited to method of manufacture set forth in specification). A novel product that meets the criteria for patentability is not limited by the process by which it is made, Vanguard Prods., 234 F.3d at 1372-73, and the specification need not describe every possible way of making the product, SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121-22 (Fed.Cir.1985). Andrx’s claim construction position ignores this basic principle and attempts to narrow the product claims of the ’505 and ’230 patents to cover only those formulations made by applying the subcoating in a particular way. However, the product claims are not limited in the manner in which the product is made and so would include products in which the subcoating *470 was formed in situ. See Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1581 (Fed.Cir.1984) (upholding the district court’s rejection of defendant’s argument that because its product is formed in situ it is different from the claimed product) (“It is the claimed product, ... not the process of forming it, that is involved.”).

The intrinsic evidence is crystal clear. The ’505 patent contains 8 asserted product claims and 1 asserted process claim. It is not surprising, therefore, that the specification contains disclosure about the process. Even if the patent contained only product claims, the law would require the patent to enable the making of the invention. See 35 U.S.C. § 112. For this reason, Defendants are wrong when they refer to the different methods disclosed in the specification as evidence that the product claims are limited. 29 The phrase “disposed on” only appears in the product claims, which provide a composition and structure for the claimed formulation. As such, the phrase “disposed on” as used is used in its conventional patent law sense— that is, to refer to the position or location of an element in a structure. See generally Moeller v. Ionetics, Inc., 794 F.2d 653, 655 (Fed.Cir.1986); Lawler Mfg. Co. v. Bradley Corp., No. IP98-1660, 2000 WL 33281119, at *21 (S.D.Ind. Nov. 30, 2000). Contrary to Andrx’s arguments, the court finds that the patentees did not act as their own lexicographers to define this commonly understood phrase with any special meaning. The ordinary meaning of the phrase “disposed on” in the context of these product claims refers to the position of the subcoating relative to the core and, as mentioned above, means that the sub-coating is in contact with the core region. The court finds that the term “disposed on” does not require that the subcoating be applied using any particular process and that the subcoating need not necessarily be “physically applied to” the core in a separate processing step. 30

5. The Claims Do Not Require Perfection

While the parties seem to agree that the subcoating, as a type of separating layer, has to separate the core and the enteric coating, (see PI, col. 5:29-33), Andrx’s claim construction arguments would also impose numerous additional requirements on the subcoating. Andrx would include in the definition of the term subcoating several components designed to ensure that the required separation is perfect and absolute. Andrx’s position, developed at trial through its expert Dr. Banakar, is that in 1985 a person of ordinary skill in the art of pharmaceutical formulation would have understood that a subcoating “has to separate something” such that “[w]hat is being separated cannot be in the separating layer,” “has to be 100% continuous,” “has to have defined boundaries,” and “has to have a defined thickness.” (Banakar Tr. 3217:1-5.) In other words, adoption of Andrx’s position would require that the subcoating have no imperfections. The *471 court finds that Andrx’s position is inconsistent with the intrinsic evidence and the real world.

Looking at the intrinsic evidence, the claims omit any words like continuous, separating, definite boundaries or specific thicknesses. If there were any doubt, Table 3 of the patent, (PI, col. 7:12-28), shows that even some subcoated formulations of the invention exhibited discoloration, and so were not perfect. What is important is that even though some of those formulations showed some discoloration, they were improved over those with no subcoat. (See PI, col. 7:12-28.) In other words, the formulation with a sub-coating discolored less than the formulation with no subcoat. Thus, the patent contemplates, and the court construes the claims to cover, subcoatings that are less than perfect, including subcoatings that contain inconsequential amounts of ome-prazole or permit inconsequential contact between portions of the core and the en-teric coat. The claims do not require a perfectly continuous, exactly uniform sub-coating. See Atmel Corp. v. Info. Storage Devices, Inc., 997 F.Supp. 1210, 1221 (N.D.Cal.1998) (rejecting defendant’s argument that a layer cannot have a varying thickness because there is “nothing in the meaning of the word ‘layer’ that so restricts the patent”); AFG Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1250 (Fed.Cir.2001) (stating that, with respect to a patent for which the parties generally agreed that a “layer” requires a “uniform” chemical composition, absent any specific statement in the patent of chemical uniformity as a characteristic of the layer, the layer must be understood as only “substantially” uniform). As the court has already noted, infringement need not be perfect to be infringement, Shamrock Techns., Inc. v. Medical Sterilization, Inc., 903 F.2d 789, 792 (Fed.Cir.1990) (inefficient infringement is still infringement), and the term “substantially,” unless expressly excluded, is understood as being incorporated into a patent claim. Contrary to Andrx’s assertions with respect to the meaning of “subcoating,” a subcoating can still be sufficiently continuous, despite the presence of an imperfection, to be considered a film. Whether perfect or not, a subcoating is still a subcoating.

Although the court need not look to extrinsic evidence to construe the claim term “subcoating,” the court notes that the extrinsic evidence supports rejection of Andrx’s perfectionistic claim construction. In the real world of pharmaceutical formulation, it is understood that coatings may have imperfections. For this reason, when asked whether the subcoating had to be continuous, Dr. Langer stated that the subcoating should be “substantially continuous.” (Langer Tr. 419:1-4; see Langer Tr. 424:2-8 (“The only thing I don’t want to imply is that something can be absolutely perfect because nothing in science is perfect. Anyone of ordinary skill would know that.’.’).) Thus, Andrx’s strained requirements of perfection are inconsistent with the understanding of those skilled in the art. 31 The court must construe the patent terms practically.

6. The Term “Inert”

Subparagraphs (b) of claims 1 of the ’505 and ’230 patents require that the subcoating be “inert.” (PI, col. 16:48; P2A, col. 13:10.) The inventors nowhere defined the term “inert” to have any specialized meaning; “inert” is not expressly *472 defined in the ’505 and ’230 patents, or in their file histories. That means that the ordinary meaning of the term controls, and the ordinary meaning of “inert” is very clear. At the time of the patents, a person of ordinary skill in the art of pharmaceutical formulation would have understood the term “inert” to mean pharmaceutically, chemically, and pharmacologically inactive. (Banakar Tr. 3220:24-3221:1.) This is consistent with the common understanding of the term set forth in dictionaries and technical treatises. See, e.g., Oxford University Press (1974) (defining “inert” as “without active chemical properties”); Oxford University Press (1973) (defining “inert” as “without active chemical, physiological or other properties; neutral”; Random House (defining “inert” as “having little or no ability to react”; “Pharm. having no pharmacological action, as the excipient of a pill”); A55 at 635 (Hawley’s Condensed Chemical Dictionary (12th ed.) (“Inert: A term used to indicate chemical inactivity in an element or compound.”)).) In Remington’s Pharmaceutical Sciences, for example, the term “inert” is used as follows: “[i]n addition to the active or therapeutic ingredient, tablets contain a number of inert materials. The latter are known as additives or excipients.” Remington’s Pharmaceutical Sciences, 17th ed. at 1605 (1985) (emphasis added) (Andrx Reply Mem. Regarding Cl. Constr. of 11/12/01, Ex. Q). These terms, which are widely used in pharmaceutical science, are terms of art meaning an inactive material in a pharmaceutical dosage form. Handbook of Pharmaceutical Excipients, Arthur H. Kibbe, Ph.D., Ed., Preface at xv, 3d ed. (2000) (Andrx Reply Mem. Regarding Cl. Constr. of 11/12/01, Ex. R). The Handbook of Pharmaceutical Excipients does not list any pharmaceutically active substance as an additive or excipient. Thus, the court adopts the construction proffered by Defendants, which is grounded entirely in the ordinary meaning of the term. See Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed.Cir.1999) (holding that the ordinary meaning of claim language is heavily presumed and that party seeking to use statements in the written description to affect a patent’s scope must at the very least identify a claim term that is susceptible to clarification); see also Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248-49 (Fed.Cir.1998).

Reliance on the ordinary meaning of the term, however, does not require blindfolding oneself to reality, as Defendants have done. Just as Defendant Andrx argued that the subcoating had to be 100% continuous, among other things, Defendants argue that the term “inert” requires the absolute absence of any pharmaceutically active or chemically reactive substances in any infringing subcoating. Under Defendants’ proposed construction, this absence of reactivity is to be determined in a vacuum, based solely upon the known characteristics of a particular substance found to be in a subcoating and without reference to the invention or consideration of the materials with which that particular substance interacts. Defendants’ construction would bar even a single molecule of ome-prazole from appearing in the subcoating of an infringing formulation. Once again Defendants’ claim construction theory attempts to read an unattainable “perfection” limitation into the claims. Indeed, since almost no substance is-totally inert under all conditions, Defendants’ construction would vitiate any possibility of proving infringement and thereby render the claims meaningless. The law is plain, infringement need not be perfect to be infringement. Shamrock Techns., Inc. v. Medical Sterilization, Inc., 903 F.2d 789, 792 (Fed.Cir.1990). Moreover, the term “substantially,” unless expressly excluded, is understood as being incorporated into a patent claim. See AFG Indus., Inc. v. Cardinal IG Co., Inc., 239 F.3d 1239, 1250 *473 (Fed.Cir.2001) (stating that, with respect to a patent for which the parties generally agreed that a ‘layer’ requires a “uniform” chemical composition, absent any specific statement in the patent of chemical uniformity as a characteristic of a layer, the layer must be understood as only “substantially” uniform.). A subcoat that is “substantially” inert will also meet the claim limitation of “inert subcoat.” Genp-harm’s Andrx’s and Cheminor’s contention that “inert” must mean totally and absolutely inert is simply wrong as a matter of law.

The claim language and other disclosures in the patent support the position that the use of the word “inert” to modify the term “subcoating” was not intended to cut off all possibility of reactivity. In fact, the claim language “said subcoating comprising ... materials selected from ...” permits the presence of additional components in the subcoating. See Crystal Semiconductor Corp. v. TriTech Microelectronics Int'l, Inc., 246 F.3d 1336, 1348 (Fed.Cir.2001). In addition, the patent claims and specifications themselves make it clear that the subcoating can contain chemically reactive substances, like alkaline reacting compounds. Defendant’s definition is inconsistent with claim 11 of the ’506 patent, which expressly requires that the subcoating of claim 1 include an ARC, (PI, col. 18:1-3), and the ’505 patent specification, which expressly permits ARCs in the subcoating, (PI, col. 4:14-27). Any doubt that the “inert subcoating” of claim 1 can include reactive compounds and pharmaceutically active compounds is directly addressed by reviewing claim 1 in the context of claim 11. Claim 11 expressly calls for “[a] preparation according to claim 1, wherein the subcoating further comprises an alkaline buffering compound.” (PI, Col. 18:1-3.) In other words, subcoats may include “alkaline buffering compounds,” like disodium hydrogen phosphate, which is not only an ARC but also a pharmaceutically active compound. (Astra’s Cl. Constr. Mem. Ex. 11, 1996 Merck Index 12th ed. at 1481 (DHP listed with therapeutic activity in humans).)

The patent prosecution histories also teach that the subcoating can contain phar-maceutically active substances, like ome-prazole. During the prosecution of the ’230 patent, the examiner rejected As-tra’s claims as indefinite, asserting that acid labile compounds and ARCs could be the same thing. (’230 Prosecution History, at 216 (“[T]he language ‘acid labile compound’ and ‘alkaline reacting compound’ read on the same compound whereas applicants specification specifically identifies precise and exact compounds that are not related.”).) In its response, Astra pointed out that the examiner was correct, that ARCs can also be acid-labile compounds. (’230 Prosecution History at 256 (“this is precisely what applicants intended”).) That part of the prosecution history shows that ARCs may be pharmaceutically active, acid labile compounds, and the specification expressly states that a subcoating may contain such compounds. (P2A, col. 9:23-25 (“The separating layer consists of one or more water soluble inert layers, optionally containing pH-buffering substances.”).)

Credible extrinsic evidence supports the court’s construction as well. For example, Defendants’ experts Dr. Auslander and Dr. Porter opined that formulators understand the term “inert” to mean not having an adverse affect on the formulation and to encompass situations where there is a small amount of interaction. {See Astra’s 11/12/01 Cl. Constr. Resp., Exs. 34, 70.) 32 Even the prior art relied on by Defendants *474 shows that the terra “inert” means substantially non-reactive. (See G31, GB 760 403 at 2, col. 2:67-70 (“By ‘inert mineral solid’ is meant a mineral solid which is substantially non-reactive with either the coating substance [enteric coating] or the medicament and is inert to acid medium.”).) For these additional reasons, the aspects of Defendants’ claim construction requiring that every molecule of every substance in the subcoating be utterly devoid of all reactivity are inconsistent with the patents’ claim language, specifications, and prosecution histories.

Defendants worry about the slippery slope; they ask, if the materials in the subcoating do not have to be completely inert, just how “inert” is enough to qualify as “inert?” Defendants’ fear is unwarranted. A person of ordinary skill reviewing the ’506 and ’230 patent specifications would understand that the invention is a stable formulation. That requires a sub-coating that protects the omeprazole and maintains the integrity of the enteric coating. (See, e.g., PI, col. 15:34-38; see also PI, col. 15:7-16.) The meaning of “inert” flows directly from the invention described in the specification — the subcoating layer cannot adversely affect the properties of the omeprazole or the enteric coating. The patent specification provides that “not adversely affecting ... the enteric coating” means that the formulation retains gastric acid resistance. (See, e.g., PI, col. 5:33-53 (“Without this separating layer the resistance towards gastric juice would be too short and/or the storage stability of the dosage form would be unacceptably short.”).) This construction of the term “inert” is also supported by the file histories of the two patents. For example, United States Patent 4,685,918 (“Ami-don”), a document referenced in the prosecution history for the ’505 patent, discusses “inert inorganic and organic solvents” that “do not adversely harm the core, wall, and the materials forming the final wall.” (As-tra’s Cl. Constr. Mem., Ex. 19, ’505 Pros. History at 295, Amidon, col. 10:4-8 (emphasis added).)

The patent specifications describe the properties the subcoating should have in terms of stability. The subcoating must provide increased gastric acid resistance and storage stability. (See, e.g., PI, col. 5:33-53.) Thus, the patent teaches that the subcoating must be inert under those conditions, which allows for the possibility that some inconsequential amounts of different components may react under some conditions or to such a limited extent that gastric acid resistance and storage stability remain uncompromised for practical purposes. Therefore, the court construes the term “inert” in claims 1 of the ’505 *475 and ’230' patents, when modifying “sub-coating,” to require that the subcoating be chemically, pharmaceutically, and pharma-cologically inactive such that the subcoat-ing does not adversely affect the properties of the active ingredient or the enteric coating material in the formulation.

7. The “Soluble or Rapidly Disintegrating in Water”

. Requirement

The phrase “which is soluble or rapidly disintegrating in water” is straightforward; it requires that the subcoating dissolves or breaks up quickly in water. The specification provides examples of water soluble compounds and polymers: “The material for the separating layer is chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications such as, for instance sugar, polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol, hydroxypropyl cellulose, methyl-cellulose, hydroxymethyl cellulose, hydrox-ypropyl methylcellulose, polyvinyl acetal diethylaminoacetate or the like.” (PI, col. 4:35-42 and ’505 Certificate of Correction; see also P2A, col. 8:43-55.) The “soluble or rapidly disintegrating in water” requirement affords omeprazole release in the very upper portion of the small intestine, also referred to as the “duodenum” or “proximal part” of the small intestine, the desired site for absorption. (PI, col. 1:45-47, col. 2:29-30, 53-55.)

E. Part “(c)” of Claims 1

Part “(c)” of claims 1 of both patents requires an enteric-coating layer and defines the required characteristics, of that layer. This portion of the claims is largely self-explanatory. On the subcoating layer is an enteric-coating material, a material that protects the medicinal preparation so that it will pass through the stomach unaltered. An enteric-coating material is a polymer that is insoluble in acid media but soluble in neutral to alkaline media; therefore, it resists breakdown in the stomach. Examples of enteric coatings may be found in the ’505 patent and include hydoxypro-pyl methylcellulose phthalate and Eudragit L-100 brand enteric coating, which is a methacrylic copolymer. (PI, col. 4:59 — col. 5:18.)

Unlike claim 1(c) of the ’505 patent, claim 1(c) of the ’230 patent contains additional language further characterizing the subcoating. (P2A, col. 13:16-20.) The claim language “wherein the subcoating layer isolates the alkaline reacting core from the enteric coating layer such that the stability of the preparation is enhanced” is self-explanatory in that it means that the subcoating layer isolates or separates the core from the enteric coating sufficiently to enhance the formulation’s stability. According to the specification of the ’230 patent, the subcoating of claim 1 isolates the core from the enteric coating through the creation of a “pH-buffering zone” between them. (See P2A, col. 9:4r8 (“The subcoating layer, (the separating layer), also serves as a pH-buffering zone in which hydrogen ions diffusing from the outside in towards the alkaline core can react with hydroxyl ions diffusing from the alkaline core towards the surface of the coated articles.”).) As claim 1 of the ’230 patent expressly states, the existence of this subcoating zone, in combination with the rest of the claimed formulation, enhances stability. As explained in the ’230 patent specification, (P2A, col. 8:67' — col. 9:4), the subcoating, in combination with the other claimed elements, enhances stability by protecting against the “degradation/discoloration of the acid labile compound during the coating process o[r] during storage.” (P2A, col. 9:2-4.) 33

*476 F. Claim 3 of the ’505 Patent

Claim 3 of the ’505 patent is dependent on claim 1: “A preparation according to claim 1 wherein the subcoating comprises two or more sub-layers.” (PI, col. 16:60-61.) This claim has been asserted only against Defendant Andrx, and no corresponding claim in the ’230 patent has been asserted. The claim unambiguously requires that the subcoating be made up of at least two sublayers and does not raise any additional claim construction disputes.

G. ’505 Patent Claim 5/’230 Patent Claim 6

Claim 5 of the ’505 patent and claim 6 of the ’230 patent also depend from claims 1:

A preparation according to claim 1 wherein the alkaline core comprises omeprazole and pH-buffering alkaline compound rendering to the micro-environment of omeprazole a pH of 7-12.

(PI, col. 16:65-68.)

A preparation according to claim 1, wherein an alkaline core comprises the acid labile compound and a pH-buffering alkaline reacting compound which renders to the micro-environment of the acid labile compound a pH of 7-12.

(P2A, col. 14:4-8.) Both of these claims contain three additional disputed terms— “alkaline core,” “pH-buffering compound” or “pH-buffering alkaline reacting compound,” and “microenvironment.”

1. The Term “Alkaline Core”

Claim 5 of the ’505 patent depends from claim 1 and includes a reference to “the alkaline core.” Unless claim 5 is invalid for lack of an antecedent basis for this claim element, the alkaline core must be the same as the core region in claim 1. Cf 35 U.S.C. § 112; Manual of Patent Examining Procedure 7th ed., § 2173(e). As the court previously held, one of ordinary skill would understand the term “alkaline core” in claim 5 of the ’505 patent to refer to any core containing an ARC or an alkaline salt of omeprazole. Such person would not understand that the entirety of the core must have a pH above 7. Similarly, one of ordinary skill would understand the term “alkaline core” in the ’230 patent to refer to any core that contains either an ARC or an alkaline salt of an acid labile archive compound.

2. The Terms “pH-Buffering Compound” and “pH-Buffering Alkaline Reacting Compound”

As apparent from the court’s discussion of the “alkaline reacting compound” claim limitation, one of the central disputes in this case has been the meaning of the phrase “alkaline reacting compound” as that phrase is used in the claims of the ’505 and ’230 patents. That dispute also extends to other variations of that term, such as “pH-buffering compound” and “pH-buffering alkaline reacting compound.” The term “alkaline reacting compound” appears in claims 1 and 14 of the ’505 patent and claims 1 and 12 of the ’230 patent. The terms “pH-buffering alkaline compound” and “alkaline buffering compound” appear in claims 5 and 11 of the ’505 patent, respectively. The terms “pH-buffering alkaline reacting compound” and “alkaline buffering compound” appear in claims 6 and 15 of the ’230 patent, respectively. Originally, the parties agreed that those variations of the term all have the same meaning as “alkaline reacting compound.” (See, e.g., Joint Mem. of Defs. KUDCo & Genpharm on Claim Construction of the Term “Alkaline Reacting Compound” at 1 n.2, 4-5; Mem. in Supp. *477 of Cheminor Defs.’ Construction of Certain Terms of the Claims of 11/5/01, at 13 n.ll.) Now the definitions of all those terms are disputed, and different definitions are proposed.

Until about a month after Astra’s last witness on infringement with respect to the ’505 and ’230 patents, Dr. Lóvgren, left the stand on January 4, 2002, no Defendant disputed Astra’s construction of the term “buffering,” which is used in the phrase “pH-buffering” in claim 5 of the ’505 patent and claim 6 of the ’230 patent, and in “alkaline buffering compound” in claim 11 of the ’505 patent and claim 15 of the ’230 patent. (See, e.g., Genpharm’s Cl. Constr. Br. of 11/5/01, at 20 (“Astra and Genpharm agree that, properly construed, alkaline reacting compounds are the same in the patents as alkaline buffering compounds.”).) Astra has consistently argued that those phrases have the same meaning as the phrase “alkaline reacting compound” in claims 1. In the middle of trial, three defendants— Genpharm, Cheminor, and KUDCo— changed their positions and began to urge that the narrower, “classical” definition of “buffer,” 34 which generally is not required of an ARC, should be used in construing the patents. (See Tr. 3754:6-3755:24 (Astra’s objection to the testimony of Dr. Story on this new theory of infringement); see also Letter from Che-minor to court of 2/6/02; Letter from KUDCo to court of 2/11/02.) At the time, the court expressed concern about new claim construction theories. (Tr. 3989:19-3991:1.) As Astra predicted, those new theories of claim construction ultimately led to additional noninfringement positions urged by Defendants. (See KUDCo FF 36, n.4; Cheminor PFF 4.6(b), n.6, 8.7.) In the interest of attempting to resolve the claim construction disputes as comprehensively as possible in this case, the court reserved ruling on Astra’s objection at the time. (Tr. 4045:19-22.) ■

Despite the utter tardiness with which they were raised, the court will address Defendants’ new claim construction arguments in the interest of ensuring that the court’s claim construction is as accurate as possible; the court has no interest in precluding any party from pursuing the correct claim construction. It is not the claim construction arguments, but rather the previously undisclosed, undiscovered noninfringement positions that result from them that present potential prejudice to Plaintiffs. At this time, the court finds that Defendants’ attempts to utilize these new claim construction arguments to assert novel noninfringement defenses after the close of Astra’s direct case severely prejudiced Plaintiffs. Astra had no reasonable opportunity to have its expert witnesses address these “buffer” theories or to question Defendants’ experts effectively on these new theories. Given the chance to develop the information during discovery, Astra surely would have introduced evidence specifically directed to those constructions and their implications for As-tra’s infringement claims. Therefore, the court precludes Defendants from arguing noninfringement of any of the patent claims at issue in this suit on the basis of their new construction that the phrases “pH-buffering compound” and “pH-buffering alkaline reacting compound” mean something different from the term “alkaline reacting compound.”

*478 Now Defendants argue that the terms “pH-buffering alkaline compound” recited in claim 5 of the ’505 patent and “pH-buffering alkaline reacting compound” recited in claim 6 of the ’230 patent require a compound that can maintain a constant pH in an aqueous solution when an acid or base is added to it within the buffering capacity of the compound. The reasons Defendants did not think to dispute As-tra’s initial construction until this time are evident in the patents. In both patents, the examples of alkaline reacting compounds largely overlap the substances described as “pH-buffering compounds.” (Compare PI, col. 3:47-59, with PI, col. 4:14r-27; compare also P2A, col. 8:43-55, with P2A, col. 9:9-23.) During the initial rounds of claim construction briefing, Che-minor even conceded that with respect to the categories of ARCs listed in the patent, “the patent makes clear that the specified ‘alkaline reacting compounds’ are all ‘conventional buffering substances.’ ” (Mem. in Supp. of Cheminor Defs.’ Constr. of Certain Terms of the Claims of 11/5/01, at 13 (emphasis added).) The patents also repeatedly describe substances that are not buffers in the traditional sense as compounds that have buffering characteristics or create buffering zones. For example, the patents provide a lengthy list of substances can be added to the subcoating to “strengthen” its “pH-buffering properties,” and those substances are referred to as “pH-buffering compounds.” (PI, col. 4:14-27 (emphasis added).) This disclosure indicates to a person of ordinary skill in the art that even a subcoating that does not contain the optional pH-buffering compound has “pH-buffering properties,” albeit properties capable of improvement. Additionally, magnesium hydroxide, which is not an acid-base pair but which is listed as an ARC, (PI, col. 3:53), is called a “buffering substance” in the ’505 patent, (PI, col. 15:28). The use in the patents of a broad definition of the term “buffer” as something that provides a barrier between the active ingredient and other potentially harmful substances or that helps to stabilize the active ingredient, like an ARC, is exemplified further by the use of the phrase “pH-buffering zone” in the patents to describe the subcoating as possessing “pH-buffering properties.” (PI, col. 4:10, 14; P2A, col. 9:5, 9.) KUDCo’s expert Dr. Auslander testified that the “pH-buffering zone” was “providing a barrier” and that the term “buffer” in that phrase was not used in the “classical sense of chemistry.” (Auslander Tr. 2703:19-2704:13.)

As discussed earlier in this opinion, the patentees acted as their own lexicographers and defined the term “alkaline reacting compound,” which would not be have been readily understood by someone of skill in the art at the time of the patents, in the specifications. Based on a detailed review of the intrinsic evidence, particularly the claims and the specifications, the court finds that a person of ordinary skill in the art of pharmaceutical formulation, who read the patents and understood the term “alkaline reacting compound” in light of the specifications, would realize that the terms “pH-buffering compound” and “pH-buffering alkaline reacting compound” are used interchangeably with the term “alkaline reacting compound” throughout the patent. (See Lovgren Tr. 4477:21-4478:5 (“I think an average skilled formulator reading this patent will see these terms used interchangeably so many times in the specifications.”).) The person of ordinary skill in the art would, therefore, understand that the term “pH-buffering” generally was not used in the patent to convey the traditional characteristics of a buffer in chemistry. Instead of relying on the ordinary meaning of the term “pH-buffering,” the patentees made it clear that they had something special in mind — an ARC. Thus, the paten- *479 tees assigned their own definition to the terms “pH-buffering compound” and “pH-buffering alkaline reacting compound” by equating them with an ARC, a concept the patentees clearly and specifically defined in the specifications. The court rejects Defendants’ late-raised claim construction as unsupported by the intrinsic evidence; therefore, the court construes the terms “pH-buffering alkaline compound” and “pH-buffering alkaline reacting compound” to mean the same thing as the term “alkaline reacting compound” in the patents.

3. The Term “Micro-environment”

The term “micro-environment” introduces a limitation relative to claims 1 concerning the core region. {See, e.g., PI, col. 16:67; P2A, col. 14:7.) Claim 5 requires that the core “comprises ome-prazole” and a “pH-buffering alkaline compound” that renders to the “microen-vironment” of omeprazole a pH of 7 to 12. The term “microenvironment” is construed to refer to the regions immediately around or in close proximity to the omeprazole particles. (-See Langer Tr. 318:16-23, 588:16-589:11; Auslander Tr. 2691:3-7; Seth Tr. 2057:12-15.) This definition is supported by the patent specifications, which state that the alkaline reacting compound should create a “micro-pH” around the omeprazole when water is adsorbed to the particles ... or when water is added in small amounts to the mixture.” (PI, col. 3:43-46.) The exact size of the microenvironment depends on the way the core is formulated, including the substances in it. (See Davies Tr. 1173:4-1177:2.) Defendant Genpharm argues that the term “microenvironment” is unclear and renders the claim invalid under 35 U.S.C. § 112. The court will address that argument in the section of this opinion devoted to invalidity defenses.

H. ’505 Patent Claim 6/’230 Patent Claim 7

Claim 6 of the ’505 patent in turn is dependent on claim 5:

A preparation according to claim 5 wherein the alkaline compound comprises one or more of magnesium oxide, hydroxide or carbonate, aluminium hydroxide, aluminium, calcium, sodium or potassium carbonate, phosphate or citrate, the composite aluminium/magnesi-um compounds Al203«6Mg0*C02*12H2 O or Mg0»Al203«2Si02«nH20 where n is not an integer and less than 2.

(PI, col. 17:1-8.) Similarly, claim 7 of the ’230 patent in turn is dependent on claim 6:

A preparation according to claim 6 wherein the alkaline reacting compound comprises one or more of magnesium oxide, hydroxide or carbonate, alumini-um hydroxide, aluminium, calcium, sodium or potassium carbonate, phosphate or citrate, the composite alumini-um/magnesium compounds A1203 •6Mg0«C02»12H20 or Mg0«Al203 •2Si02»nH20 where n is not an integer and less than 2.

(P2A, col. 14:9-16.) Again, “alkaline compound” in claim 6 of the ’505 patent has the same meaning as “alkaline reacting compound,” as used in the other claims of the ’505 and ’230 patents, including claim 7 of the ’230 patent. In order to fall within these claim limitations, the alkaline compound or ARC must be selected from one of the compound types listed in the claims.

I. ’505 Patent Claim 8/’230 Patent Claim 10

Claim 8 of the ’505 patent and claim 10 of the ’230 patent are dependent upon claims 1:

A preparation according to claim 1 wherein the enteric coating comprises hydroxypropyl methylcellulose phtha- *480 late, cellulose acetate phthalate, co-polymerized methacrylic acid/methacrylic acid methyl ester or polyvinyl acetate phthalate, optionally containing a plasti-cizer.

(PI, col. 17:13-18.)

A preparation according to claim 1 wherein the enteric coating comprises hydroxypropyl methylcellulose phtha-late, cellulose acetate phthalate, co-polymerized methacrylic acid/methacrylic acid methyl ester or polyvinyl acetate phthalate, optionally containing a plasti-cizer.

(P2A, col. 14:24-29.) The composition of the enteric coating materials in these claims is self-explanatory. “Plasticizer” means an additive that imparts flexibility, workability, or stretchability to an enteric-coating polymer. Examples of plasticizers are provided in the ’505 patent specification and include diethyl phthalate and cetyl alcohol. (PI, col. 9:53-55.)

J. ’505 Patent Claim 9/’230 Patent Claim 11

Claim 9 of the ’505 patent is also dependent upon claim 1: “A preparation according to claim 1 wherein the water content of the final dosage form containing omepra-zole does not exceed 1.5% by weight.” (PI, col. 17:19-21.) Claim 11 of the ’230 patent imposes the same water content requirement upon the “final dosage form” of the ’230 patent containing the “acid labile compound.” (P2A, col. 14:30-32.) Defendant Cheminor alone challenges As-tra’s proposed constructions with respect to these claims.

The court agrees with Cheminor that the term “water content” is not an ambiguous term. It simply means the amount of water in a given thing. Contrary to this plain and readily discernible meaning, Astra proposed that the term “water content” should incorporate concepts of molecular crystallinity and boiling temperatures. Astra proposes that the phrase “water content” refers to water that can be released from the formulation at elevated temperatures up to about the boiling point of water; it does not include bound water, or water of crystallization. 35 (See Astra Cl. Constr. Mem. of 11/5/01, at 33.) There is no reference in either patent to “bound water” or a test of water content that includes elevating temperatures to “about the boiling temperature.” These new concepts Astra seeks to inject into the patent claims are extrinsic to the claims and the specification and, of course, can only be proven by extrinsic evidence. Because this claim term can be construed solely from the intrinsic evidence, there is no need for the court to even consider such extrinsic evidence. Indeed, “if the meaning of the claim limitation is apparent from the intrinsic evidence alone, it is improper to rely on evidence other than that used to ascertain the ordinary meaning of the claim limitation.” Bell Atl. Network Servs., Inc. v. Covad Communications Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001); Vitronics, 90 F.3d at 1582. Accordingly, the court rejects Astra’s proposed definition and holds that the term “water content” simply refers to any water in the final dosage form. 36

*481 The specification defines the “final dosage form” as, for example, the enteric-coated pellets that are found inside the capsules. (PI, col. 5:60-63; P2A, col. 10:37-40.) Every example of the “final dosage form” listed in the specification refers to a formulation that has been en-teric coated, which does not include the capsule into which enteric-coated formulations are filled. Under the section titled “Final dosage form,” the ’230 patent specification states that “[i]t is essential for the long term stability during storage that the water content of the final dosage form containing acid labile compound (enteric coated tablets, capsules or pellets) is kept low, preferably not exceeding 1.5% by weight.” (P2A, col. 10:40-44 (emphasis added); see also PI col. 5:67 — col. 6:5 (“[a]s a consequence the final package containing hard gelatine capsules filled with enteric coated pellets preferably also contain a desiccant, which reduces the water content of the gelatine shell to a level where the water content of the enteric coated pellets filled in the capsules does not exceed 1.5% by weight.”) (emphasis added).) Only Cheminor challenges this definition, relying on extrinsic evidence and mischaracterization of quotes from the specifications to argue that the water content measurement must be construed to include both the capsule and the enteric coated pellets. This interpretation cannot stand, because the specification expressly states that the “final dosage form” is the formulation that has been enteric coated, before being filled into any capsule. (See PI, col. 5:60-63; P2A, col. 10:37-44.) In addition, the test results relating to water content in the patent specification refer to testing “pellets,” not the final package. (See PI, col. 14:46-61.) Since the “final dosage form” referenced in the claims is the enteric-coated pellets, and not pellets filled into a capsule, the term “1.5% by weight” refers to the water content of the enteric-coated pellets, calculated as a weight percentage.

K ’505 Patent Claim 10/’230 Patent Claim 13

Claim 10 of the ’505 patent and claim 13 of the ’230 patent cover a method of treatment utilizing the formulation claimed in claims 1:

A method of treatment of gastrointestinal disease comprising administering to a host in need of such treatment a therapeutically effective amount of a preparation according to claim 1.

(PI, col. 17:22-25.)

A method for the treatment of gastrointestinal disease characterized in that a preparation according to claim 1 is administered to a host in the need of such treatment in a therapeutically effective amount.

(P2A, col. 14:42-45.) “Gastrointestinal disease” refers to diseases related to gastric acid secretion. (PI, col. 6:12-15.) “Administering” refers to “give as a remedy to cure or relieve a disease or bodily disorder,” in this case via the oral route required by claim 1. In the ’230 patent, this claim language confirms that the acid labile pharmaceutically active substance of claim 1 must be useable to treat gastrointestinal disease. (P2A, col. 14:42-45.) This claim language unambiguously requires that the acid labile pharmaceutically active substance of all claims, including claims 1 and 13 of the ’230 patent, have an effect on gastrointestinal disease.

“Therapeutically effective amount” means an amount that is effective in therapy, or an amount sufficient to provide a therapeutic effect. An amount that is effective in therapy is an amount which produces a biological activity and will depend, among other things, on the individual. “The typical daily dose of the active substance varies and will depend on vari *482 ous factors such as the individual requirements of the patients, the mode of administration and disease. In general the daily dose will be in the range of 1-400 mg of omeprazole.” (PI, col. 6:15-20 and ’505 Certificate of Correction; see P2A, col. 10:59-61.) The preparations of the invention encompass a vast number of acid labile pharmaceutically active compounds. Each will have its own dosage particulars; as evidenced by the patents themselves, Astra’s proposed limitation of 1 to 400 mg is only applicable to omeprazole or to ben-zimidazoles, a subset of the substances claimed in claim 2 of the ’230 patent, a claim that is dependent from claim 1. Since omeprazole is the compound at issue, however, that portion of the specification is helpful in providing guidance on the appropriate range for this case.

L.’505 Patent Claim ll/’230 Patent Claim 15

Claim 11 of the ’505 and claim 15 of the ’230 patent are nearly identical claims that are dependent on their respective claims 1:

A preparation according to claim 1, wherein the subeoating further comprises an alkaline buffering compound.

(PI, col. 18:1-3; see also P2A, col. 14:50-52.) These claims narrow claims 1 to instances in which the subeoating contains an “alkaline buffering compound.” As discussed above, the phrase “alkaline buffering compound” has the same meaning as “alkaline reacting compound.” These two claims simply require that the subcoat contain an alkaline buffering compound or ARC. In contrast to suggestions by Defendants, the presence of an ARC in the “inert” subcoating does not necessarily create conflict with the term “inert.” It is possible to include ARCs in an inert sub-coating, so long as the ARC does not compromise the enteric coat or cause degradation of the omeprazole. (PI, col. 4:14-27 (demonstrating use of ARCs in subcoats); PI, Table 2, col. 6:54-65 (subcoating includes ARC magnesium hydroxide).)

M.’505 Patent Claim 12

Claim 12 of the ’505 patent is also dependent on claim 1 of the ’505 patent: “A preparation according to claim 1, wherein the core comprises omeprazole and disodi-um hydrogen phosphate, and the subcoat-ing comprises hydroxy propyl methyl cellulose.” (PI, col. 18:4-7.) Claim 12 is self-explanatory and does not appear to raise any additional claim construction disputes.

N.’505 Patent Claim 14/230 Patent Claim 12

Claim 14 of the ’505 patent covers a process for formulating an omeprazole dosage form:

A process for the preparation of an oral pharmaceutical preparation containing omeprazole, comprising:

(a) preparing a core comprising an effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline ome-prazole salt alone;

(b) coating the core with one or more layers of an inert subcoating material selected from among tablet excipients and polymeric film-forming compounds to form a subcoated core; and

(c) coating the subcoated core with an enteric coating.

(PI, col. 18:13-25.) Similarly, claim 12 of the ’230 patent covers a process for preparing a formulation containing an acid labile compound:

Process for the preparation of an oral pharmaceutical preparation containing an acid labile compound, in which cores containing the acid labile compound mixed with an alkaline reacting compound or compounds or an alkaline salt *483 of the acid labile compound optionally mixed with an alkaline reacting compound or compounds are coated with one or more inert reacting subcoating layers whereafter the subcoated cores are further coated with an enteric coating layer.

(P2A, col. 14:33-41.)- Terms common to these two claims and claims 1 of the ’505 and ’230 patents have the same meaning in both instances. “Coating” in claim 14 parts (b) and (c) and “coated” in claim 12 are both used as verbs and mean a process step wherein either the inert subcoating or enteric coating material is applied onto either the core or subcoated core, respectively, so that the inert subcoating or the enteric coating takes the form of the thing being coated.

While not expressly discussed in Genp-harm’s proposed findings of fact and conclusions of law, Genpharm apparently is construing the terms “coating” and “coated” in these two claims as covering encapsulation and filling capsules in connection with its invalidity arguments. Neither patent specification uses the term “coating” or “coated” as a verb in relation to gelatine capsules. Rather, the term “coating,” when used as a verb, is used in relation to fluidized bed or pan coating and dry coating techniques. (PI, col. 8:6-16, col. 12:1-4, 18-20; P2A, col. 11:29-31, col. 12:13-15.) As previously discussed, filling a capsule is not a coating step. There is no support for any construction of “coating” or “coated” that would bring capsules and encapsulation into the process claims 14 and 12, respectively, in the ’505 and ’230 patents.

O. Claim Construction Issues Limited to the ’230 patent

Two disputed claim limitations— “acid-labile pharmaceutically active substance” or “acid labile compound” and “the stability of the preparation is enhanced”— are peculiar to the ’230 patent in that the terms do not appear in the claims of the ’505 patent. As an initial matter, the court must address whether the ’230 patent covers any omeprazole-containing formulation, specifically whether the claim language “acid labile pharmaceutically active substance” includes omeprazole. After over three years of litigation, Defendants for the first time on October 29, 2001, suggested that the ’230 patent claims excluded omeprazole. However, the court finds that Defendants’ claim construction theory is inconsistent with the evidence intrinsic to the ’230 patent. The court determines that the terms “acid-labile pharmaceutically active substance” and “acid labile compound” in the ’230 patent include omeprazole. This definition is supported by both the intrinsic and extrinsic evidence.

Claims 1 and 12 of the ’230 patent concern pharmaceutical formulations comprising “an acid-labile, pharmaceutically active substance” and “an acid labile compound,” respectively. (P2A, col. 13:2-3, col. 14:34-35.) The parties do not distinguish between these two terms, and the court likewise sees no evidence in the intrinsic or extrinsic record that they are distinct. On its face, the language of the claims of the ’230 patent asserted against Defendants, claims 1, 6, 7, 10-13, and 15, unambiguously covers omeprazole. Claim 1, subpart (a) requires the presence of an “acid-labile pharmaceutically active substance” or an alkaline salt of such substance. (P2A, col. 13:2-9.) “Acid-labile pharmaceutically active substances” are those that are transformed into biologically active compounds by a rapid degradation or transformation in acid media. (P2A, col. 2:30-33 (“A common feature of these compounds are that they are transformed into the biologically active compounds via rapid degradation/transformation in acid media.”).) These compounds include compounds that are defined by the general *484 formula I, depicted in column 1 of the patent, (P2A, col. 1:30^40), and certain other compounds, such as 2-[ (2-dimethylami-no benzyl)sulfinyl]-benzimidazole. (P2A, col. 1:30 — col. 2:5.) It is undisputed that the general formula I includes omeprazole. There are other claims in the ’230 patent that expressly exclude omeprazole. (See, e.g., P2A, col. 13:42-45.) For instance, claim 2, depends from claim 1 and expressly limits the acid labile substance to those of formula I substituted benzimidazoles “except the compound omeprazole.” (P2, col. 13:21-46.) The claims that exclude omeprazole have not been asserted against any Defendant.

Where the claim language is clear and unambiguous on its face, the court need not consider any other intrinsic evidence. Johnson Worldwide Assocs. Inc. v. Zebco Corp., 175 F.3d 985, 989-90 (Fed.Cir.1999) (holding that the ordinary meaning of claim language is heavily presumed and that party seeking to use statements in the written description to affect a patent’s scope must at the very least identify a claim term that is susceptible to clarification); Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248-49 (Fed.Cir.1998) (holding that a party seeking to use the written description to affect a patent’s scope must at the very least identify a term requiring clarification). Indeed, “a court must presume that the terms in the claim mean what they say .... ” Johnson Worldwide Assocs., 175 F.3d at 989. Thus, on the basis of the language of the asserted claims alone, the court finds that the asserted claims of the ’230 patent cover the use of omeprazole as the acid labile active ingredient.

Even if the court were to resort to the intrinsic evidence beyond the language of the claims themselves, the court would reach the same conclusion. Claim 1 of the ’230 patent covers a very broad group of active ingredients referred to as “acid-labile pharmaceutically active substance[s].” (P2A, col. 13:2-3.) The ’230 patent specification states that acid labile compounds are those “substances that are labile in acid media.” (P2, col. 1:14-27.) Claim 2, on the other hand, claims a narrower group of active ingredients that have the “general formula I,” which is described in the claim. (P2A, col. 13:21-46.) The specification also describes this subset of acid-labile compounds, benzimi-dazoles according to “formula I,” which “are virtually biologically inactive as such, but degrade/transform to active inhibitors of certain enzyme systems in acid media.” (P2A, col. 2:6-9.) In support of their construction that the ’230 patent claims do not include the compound omeprazole, Defendants point to a single passage in the specification. (P2A, col. 7:51-55.). The specification states that “[t]he object of the present invention is thus an enteric coated dosage form of acid labile compounds with the general formula I defined above except the compound omeprazole.” (P2A, col. 7:51-54.) This statement, which is discussing compounds of the general formula I, clearly relates to claim 2 and does not limit the scope of claim 1. The formula I compounds in the ’230 patent specification, claimed in claim 2, are a subset of the general acid labile compounds found in claim 1; there is no limitation in claim 1 that requires the acid labile substances to be benzimidazoles according to formula I. Moreover, even if the phrase cited by Defendants were applicable to claim 1, a single passage in the specification in apparent conflict with the language of the claims and the written specification as a whole must be ignored when interpreting a claim. See Digital Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335, 1345 (Fed.Cir.1998).

. Defendants’ proposed construction also ignores key portions of the prosecution history that clearly refute Defendants’ arguments on this point. See Burke, Inc. v. *485 Bruno Indep. Living Aids, Inc., 188 F.3d 1884, 1341 (Fed.Cir.1999) (looking not only to the specification, but also to the prosecution history). The ’230 patent prosecution history resolves any question about whether claim 1 of the ’230 patent includes omeprazole. During prosecution of the application that matured into the ’230 patent, Astra realized that it might be necessary for Astra to file a terminal disclaimer in view of the issuance of the ’505 patent. (See Astra Resp. to the First Office Action of 12/19/88, Ex. 28 to Astra’s Cl. Constr. Mem.) Thereafter, the patent examiner rejected the claims, including what is now claim 1, over the ’505 patent. The examiner stated that “[although the conflicting claims are not identical, they are not pat-entably distinct from each other because the pharmaceutically active substance of the instant application could be omepra-zole as in U.S. 1,786,505.” (P8A, Office Action 9/2/88, at pg. 2 (emphasis added).) In other words, the patent examiner rejected what is now claim 1 of the ’230 patent, as well as the other asserted claims of the ’230 patent, because those claims include omeprazole. In response to this rejection, Astra did not amend the claims but instead overcame the rejection by filing a terminal disclaimer, in which Astra agreed that any resulting patent would expire on the same date that the ’505 patent expired. (P8A, ’230 Prosecution History at 311, Terminal Disclaimer of 1/19/89.) Astra thus acknowledged that its ’230 patent claims covered omeprazole and forfeited part of the life of the ’230 patent rather than amend its claims to exclude omeprazole. As a result, the patent examiner allowed the claims. (P8A, Notice of Allowability of 3/28/89.) The patent examiner’s interpretation of the claim at issue, and Astra’s decision not to amend the claims, confirm that claim 1 of the ’230 patent covers omeprazole.

Defendants rely on two recent cases from the Federal Circuit for the proposition that a feature of an invention that has been disclaimed cannot be included in the scope of the claims. See SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed.Cir.2001) (“Where the specification makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question.”); Cultor Corp. v. A.E. Staley Mfg. Co., 224 F.3d 1328, 1331 (Fed.Cir.2000). Defendants’ reliance on these cases is misplaced, however, for they failed to take into account the relevant portions of the prosecution history. For example, in Cultor, the court expressly stated that “[wjhether a claim must, in any particular case, be limited to the specific embodiment presented in the specification depends on each case on the specificity of the description of the invention and on the prosecution histoi^y. ” Cultor, 224 F.3d at 1331 (emphasis added). In Cultor, the prosecution history repeatedly distinguished the prior art based on a narrow disclosure of the invention. In contrast, here, the patent examiner said the claims covered omeprazole, and Astra agreed. Similarly, in SciMed, the court found “nothing pertinent” in the prosecution history to consider. 242 F.3d at 1340. Clearly that is not the case here. The analysis in these two cases is inapplicable because Defendants’ failed to consider the prosecution history.

III. Defendants’ Daubert Motions

All Defendants move to exclude various portions of the testimony of both Dr. Davies and Dr. Langer, two of Plaintiffs’ expert witnesses who testified at the trial. Defendants initially made timely motions in limine, pursuant to Federal Rules of Evidence 104, 402, 702, and 703 to exclude *486 the challenged testimony under Daubert. Because Defendants’ Daubert challenges were raised just prior to trial and this trial was conducted as a bench trial, the court elected to hear the Daubert proof during the trial itself. (See Mem. of Law in Supp. of Andrx’s Mot. to Exclude Expert Testimony of Martyn C. Davies under Daubert at 1 (“Andrx believes that-it would be most efficient for the Court to determine the overlapping and related issues of admissibility and weight in the context of overall post-trial determinations.”).) Although courts often hold pretrial evidentiary hearings in the context of Rule 104(a) rulings on the admissibility of expert testimony, “[njothing in Daubert, or any other Supreme Court or Second Circuit case, mandates that the district court hold a Daubert hearing before ruling on the admissibility of expert testimony.” Colon v. Bic USA, Inc., 199 F.Supp.2d 53, 71 (S.D.N.Y.2001); see also Stone v. 866 3rd Next Generation Hotel, LLC, No. 99 Civ. 4780, 2002 WL 1046706, at *4 (S.D.N.Y. May 22, 2002).

At the conclusion of the trial, Defendants renewed their motions. The court has now considered thoroughly all submissions and arguments relating to the motions of all Defendants. The court has considered all of the testimony of the experts, as well as the other evidence offered at trial. For the following reasons, Defendants’ motions to exclude or strike portions of the testimony of Dr. Davies and Dr. Langer and exhibits offered through those two witnesses are denied in their entirety.

A. Choice of Law

When deciding issues in a patent case, a district court applies the law of the circuit in which it sits to nonpatent issues and the law of the Federal Circuit to issues of substantive patent law. In re Cambridge Biotech Corp., 186 F.3d 1356, 1368 (Fed.Cir.1999). An issue “that is not itself a substantive patent law issue is nonetheless governed by Federal Circuit law if the issue pertains to patent law, if it bears an essential relationship to matters committed to [the] exclusive control [of the Federal Circuit] by statute, or if it clearly implicates the jurisprudential responsibilities of [the Federal Circuit] in a field within its exclusive jurisdiction.” Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359 (Fed.Cir.1999) (en banc in relevant part) (internal citations and quotations omitted). Under these rules, evidentiary rulings concerning the admissibility of expert testimony are generally governed by regional circuit law. Odetics, Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1276 (Fed.Cir.1999) (“Because these evidentiary rulings raise procedural issues not unique to patent law, this court applies the law of the regional circuit where appeals from the district court would normally lie.”); WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1361 (Fed.Cir.1999). However, the determination of whether material is relevant in a patent case is governed by Federal Circuit law when the material relates to an issue of substantive patent law. See Midwest Indus., Inc., 175 F.3d at 1359 (citing Truswal Sys. Corp. v. Hydro-Air Eng’g, Inc., 813 F.2d 1207, 1212 (Fed.Cir.1987)). Thus, this court is governed by the law of the Federal Circuit as to relevance and the law of the Second Circuit as to the other issues raised by Defendants’ challenges to the testimony of Dr. Davies and Dr. Langer.

B. Legal Requirements Under Daubert and Rule 702

The admissibility of expert testimony is governed by Federal Rule of Evidence 702, which has been amended to codify the holdings of Daubert v. Merrell Dow Pharms., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), and its progeny. See Colon v. Bic USA, Inc., 199 *487 F.Supp.2d 53, 69 (S.D.N.Y.2001). Rule 702 provides:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

The admissibility of all expert testimony under Rule 702 is a preliminary question of law for the district court to determine pursuant to Federal Rule of Evidence 104(a), see Daubert, 509 U.S. at 592, 113 S.Ct. 2786, and district courts have broad discretion when determining whether or not to admit expert testimony, Fiataruolo v. United States, 8 F.3d 930, 941 (2d Cir.1993). The proponent of the evidence, in this case Astra, must establish admissibility under Rule 104(a) by a preponderance of the evidence. See Bourjaily v. United States, 483 U.S. 171, 175-76, 107 S.Ct. 2775, 97 L.Ed.2d 144 (1987); see also Colon v. Bic USA, Inc., 199 F.Supp.2d 53, 69 (S.D.N.Y.2001). However, when interpreting the requirements under Daubert and its progeny, the Second Circuit has noted that “[although expert testimony should be excluded if it is speculative or conjectural, or if it is based on assumptions that are so unrealistic and contradictory as to suggest bad faith or to be in essence an apples and oranges comparison, other contentions that the assumptions are unfounded go to the weight, not the admissibility, of the testimony.” Boucher v. United States Suzuki Motor Corp., 73 F.3d 18, 21 (2d Cir.1996) (internal quotations and citations omitted).

In determining admissibility under Daubert, trial judges are charged with a gate-keeping function pursuant to Rule 702 whereby they must determine (1) whether the theory or methodology underlying the testimony is reliable and (2) whether the expert’s theory or methodology is relevant in that it “fits” the facts of the case. See Daubert, 509 U.S. at 590-91, 113 S.Ct. 2786; Kumho Tire Co. v. Carmichael, 526 U.S. 137, 149-50, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999); Campbell v. Metro. Prop. & Cas. Ins. Co., 239 F.3d 179, 184-85 (2d Cir.2001). For consideration by district courts in determining the reliability of expert testimony, the Supreme Court set forth the following non-disposi-tive, non-exclusive factors as “flexible” guidelines in Daubert: (1) whether the theory or technique can be or has been tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) the known or potential rate of error associated with the technique along with the existence and maintenance of standards controlling the technique’s operation; and (4) whether the technique or theory has been generally accepted in the scientific community. Daubert, 509 U.S. at 592-95, 113 S.Ct. 2786. In addition to the five factors explicitly discussed in Dau-bert, a variety of other factors have been considered by district courts in the Second Circuit when determining the admissibility of expert testimony. Some of the more commonly used factors include consideration of the foundation for the opinion, its subjectivity, any failure to test, the expert’s consideration of alternative causes, and a comparison of the methodology to the expert’s regular professional work. See, e.g., Franklin v. Consolidated Edison Co., 37 Fed.Appx. 12, 15, No. 01-7559, 2002 U.S.App. LEXIS 6518, at *5 (2d Cir. Apr. 9, 2002); Brooks v. Outboard Marine Corp., 234 F.3d 89, 92 (2d Cir.2000); United States v. Mazzeo, 205 F.3d 1326, 2000 *488 WL 232032, at *2, No. 99-1223, 2000 U.S.App. LEXIS 818, at *6 (2d Cir. Jan. 21, 2000); Washburn v. Merck & Co., 213 F.3d 627, 2000 WL 528649, at *2, No. 99-9121, 2000 U.S.App. LEXIS 8601, at *5 (2d Cir. May 1, 2000); B.F. Goodrich v. Betkoski, 99 F.3d 505, 524-27 (2d Cir.1996).

The “fit” or relevance requirement enunciated in Daubert has been interpreted to encompass several concepts. In order for scientific evidence to be admissible it must be relevant, which means the evidence must have the “tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.” Fed.R.Evid. 401; Daubert, 509 U.S. at 587, 113 S.Ct. 2786. Thus, even if the methodology used by the expert is considered to be reliable, the expert’s testimony will nevertheless fail to meet the “fit” requirement and should be excluded if the data relied upon by the expert is materially different from the data relevant to the facts of the case. See Raskin v. Wyatt Co., 125 F.3d 55, 67-68 (2d Cir.1997). If the expert has failed to consider the necessary factors or if the analysis is premised upon a faulty assumption, his testimony may be excluded for lack of probative value. See Lightfoot v. Union Carbide Corp., 175 F.3d 1008, 1999 WL 110424, at *2, No. 98-7166, 1999 U.S.App. LEXIS 3329, at *7 (2d Cir. Mar. 1, 1999). Likewise, where the proffered testimony is based on a methodology transposed from one area to a completely different context, and there is no independent research supporting the transposition, the “fit” requirement may not be satisfied. To the extent that Dr. Davies and Dr. Langer have based their opinions on studies, models, or experiments, therefore, it is Astra’s burden to connect those analyses to the facts of this case. See General Electric Co. v. Joiner, 522 U.S. 136, 144, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997).

Even if an expert’s methodologies satisfy the Daubert standard for admissibility, the court must still determine whether that evidence actually supports the expert’s conclusions. Joiner, 522 U.S. at 146, 118 S.Ct. 512. The court must reject expert testimony where “there is simply too great an analytical gap between the data and the opinion proffered.” Joiner, 522 U.S. at 146, 118 S.Ct. 512; Graham v. Playtex Prods., 993 F.Supp. 127, 132 (N.D.N.Y.1998) (noting that Joiner applies Daubert gate-keeping to conclusions as well as methodology). Failure to test for alternative causes or the use of control experiments may provide a basis for exclusion. See In re Executive Telecard Ltd., Sec. Litig., 979 F.Supp. 1021, 1026 (S.D.N.Y.1997); Valentine v. Pioneer Chlor Alkali Co., 921 F.Supp. 666, 677 (D.Nev.1996). It is not required, however, that an expert categorically exclude each and every possible alternative cause in order to render the proffered testimony admissible. See, e.g., Zuchowicz v. United States, 140 F.3d 381, 385-87 (2d Cir.1998).

C. Expert Qualifications

Before determining whether the testimony and evidence offered by Dr. Davies and Dr. Langer meets the Daubert standards, the court must first determine whether each expert is qualified to testify. 37 See In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir.1994); Mancuso v. Consol. Edison, 56 F.Supp.2d 391 (S.D.N.Y.1999), aff'd in relevant part, *489 vacated in part, 216 F.3d 1072 (2d Cir.2000). The ultimate issue for the court to determine is whether the witness has “specialized knowledge” through “experience, training or education” as to the contents of his proposed expert testimony. Fed.R.Evid. 702. The court considered each expert’s background and experience in order to determine whether each witness was qualified to render the opinion testimony he offered at trial. See McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1043 (2d Cir.1995) (cited in Johnson Elec. N. Am., Inc. v. Mabuchi Motor Am. Corp., 103 F.Supp.2d 268, 279 (S.D.N.Y.2000)). Pursuant to those standards, Dr. Davies was accepted by the court as an expert in the testing and characterization of pharmaceutical dosage forms. (Tr. 798:10-11.) Dr. Langer was accepted by the court as an expert in drug delivery systems and pharmaceutical dosage forms. (Tr. 291:10-12.)

D. Genpharm’s Motions

Defendant Genpharm filed a motion to strike the testimony of Dr. Davies concerning certain pH tests he conducted on Genpharm’s ANDA products. Genpharm also moved to strike the testimony of Dr. Langer as unreliable and irrelevant to the extent that Dr. Langer’s opinions were based on Dr. Davies’ tests. First, Genp-harm argues that Dr. Davies’ tests regarding the pH of the HPMC used in Genp-harm’s subeoating are irrelevant because they do not test for buffering capacity. However, as this court’s claim construction makes clear, the pH of the HPMC used in the subcoating is undeniably relevant to the issue of whether the HPMC is alkaline, which is a requirement for all ARCs and “alkaline buffering” compounds. Second, Genpharm argues that Dr. Davies’ acetone-washing procedure is unreliable because it has not been subjected to peer review or gained general acceptance within the scientific community. Finally, Genp-harm argues that the court should exclude Dr. Davies’ tests on the microenvironment of the active layer of Genpharm’s ANDA products as unreliable and irrelevant. Specifically, Genpharm argues that Dr. Davies failed to account for the effects of degradation products of omeprazole and dissolved HPMC in the acetone bath he used to remove the enteric coating and the subcoating from the pellets before testing their pH. (See Davies Tr. 1145:21-25, 1146:1-3, 1182:14-1186:19.) Genpharm also objects to the type of electrode Dr. Davies employed to conduct the test.

The court finds that Dr. Davies’ acetone-washing technique is reliable and his testimony concerning the technique and results obtained thereby are admissible. Genpharm emphasizes the lack of peer review or publication of Dr. Davies’ acetone-washing procedure. Although peer review and publication of an expert’s technique enhance its reliability, see generally, Campbell v. Metro. Prop. and Cas. Ins. Co., 239 F.3d 179, 186 (2d Cir. 2001), the mere fact that an expert’s findings have not been peer-reviewed or published is not a sufficient reason to exclude it, see, e.g., Jarvis v. Ford Motor Co., 92 Civ. 2900, 1999 WL 461813, at *6, 1999 U.S. Dist. LEXIS 10041, at *19 (S.D.N.Y. Jul. 6, 1999), aff'd in part, vacated in part, 283 F.3d 33 (2d Cir.2002). Particularly in areas raising issues that may never have interested any scientist, the absence of peer review may not be surprising. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 151, 119 S.Ct. 1167, 143 L.Ed.2d 238 (1999). Dr. Davies employed the acetone-washing procedure to accommodate the different types of product samples provided to Astra by Defendants during discovery. Dr. Davies’ acetone-washing techniques were necessary and carefully developed to isolate the particular layers of each Defendant’s products for further testing. Dr. Davies developed the procedure to handle a new *490 problem unique to this litigation; therefore, the court does not find a lack of prior publication to be either noteworthy or indicative of a lack of reliability.

Dr. Davies described his acetone-washing procedure as follows:

What we did was, again, we took a capsule and we emptied the contents of the capsule into some acetone. We then— acetone is a very good solvent for the enteric coating. Also, these particles are in this liquid and they are rolling over each other, so they are washing each other, they are rubbing each other. So that helps rub away the enteric coating. Using this process, it also helped rub away the subcoating and the drug layer was remaining.

(Davies Tr. 804:10-17.) Dr. Davies used a well known and widely accepted technique, attenuated total reflectance fourier transform . infrared spectroscopy (“ATR-FTIR”), to monitor the progress of the acetone washing. (See, e.g., Davies Tr. 804:8-805:18, 1158:23-1159:10, 1159:23-1160:4, 1181:19-1182:1, 1183:4-7.) Dr. Davies ran numerous ATR-FTIR spectra to confirm that his acetone-washing procedures were accurate and that the active layer was at the surface of the Genpharm products for further testing. (Davies Tr. 804:8-805:18, 1158:23-1159:10, 1159:23-1160:4, 1181:19-1182:1, 1183:4-7.)

Once the acetone washing was completed, Dr. Davies tested the pH of the active layer of the Genpharm products. Genp-harm challenges the techniques used by Dr. Davies for his pH tests. Obtaining pH measurements using an electrode and a pH meter, as Dr. Davies did, however, is a standard, reliable method for determining whether a material has alkaline characteristics. (Langer Tr. 321:3-5.) Every witness who testified on this subject, and the manufacturers of the substances like HPMC that were tested, acknowledged that pH-electrode testing is a standard analytical tool. {See, e.g., Carr Tr. 2402:8-11; Schmitt Tr. 3602:15-20; Davies Tr. 1194:3-^1.) 38 Dr. Davies conducted his pH tests with a Beetrode micro-pH electrode and a pH meter and used standard buffer solutions for calibration. (Davies Tr. 809:18-811:19.) Several Defendants, including Genpharm, criticize Dr. Davies for his choice of electrode. The Beetrode electrode is, however, not some previously unheard-of device. It is a commercial piece of equipment, in use since at least the mid 1980s. (Davies Tr. 4343:12-13.) Dr. Davies cited references that showed the use of microelectrodes and Beetrode-type electrodes for over 20 years. (P1271; P1275; Davies Tr. 4218:18-4220:6, 4220:23-4221:2.) Dr. Davies also pointed out references that measured the microenvironment pH using microelectrodes. (P768A; Davies Tr. 793:1-10.) Astra presented numerous references during trial that evidenced the general scientific acceptance of microenvi-ronment and micro-pH, (P1303; P1304; P1305; P1309; P1310); moreover, Dr. Davies checked the accuracy of his specific instrument by measuring standard buffer solutions with established pHs of 4, 7, and 10 and got precisely accurate readings of each. (P1270; Davies Tr. 4215:15^216:7.)

As described above, Dr. Davies’ analysis of the Genpharm products involved a pro *491 cess by which he washed the enteric coat and HPMC subcoat from the Genpharm products by subjecting the pellets to an acetone-washing procedure. (See Davies Tr. 1181-83.) Genpharm argues that Dr. Davies’ pH test results are unreliable because he allegedly failed to account for what happens to the HPMC during the acetone-washing process, (Davies Tr. 1181-83), and he allegedly failed to account for any degradation of the active omepra-zole layer during his protocol, (Davies Tr. 1182-87). The court finds, however, that there is no evidence that degradation occurs during acetone washing. Dr. Davies expressly refuted the hypothesis that degradation would occur during his acetone-washing procedure because the pellets were exposed for a very short period of time. (Davies Tr. 1185:9-24.) In fact, Dr. Davies’ ATR-FTIR analyses demonstrated that no degraded omeprazole was present at the surface of Genpharm’s active pellets when they were tested after the acetone-washing procedure. (Davies Tr. 1185:19— 24,1186:22-1187:1.)

For the foregoing reasons, the court denies Genpharm’s motion to strike the testimony of Dr. Davies. In light of the court’s rulings concerning the admissibility of the pH tests performed on Genp-harm’s ANDA products by Dr. Davies, the court also denies Genpharm’s motion to strike portions of Dr. Langer’s testimony and reports. Pursuant to Rule 703, an expert may rely on any facts or data “of a type reasonably relied upon by experts in the particular field,” including facts, data, and opinions that are otherwise inadmissible. There is no requirement that an expert must run his own tests. Gussack Realty Co. v. Xerox Corp., 224 F.3d 85, 94-95 (2d Cir.2000) (“[A]n expert may rely on data that she did not personally collect.”). The court has admitted the testimony and test results by Dr. Davies upon which Dr. Langer relied, and the court finds that Dr. Langer’s rebanee on that information was reasonable.

E. Cheminor’s Motions

Defendants Cheminor filed a motion pursuant to Federal Rules of Evidence 104, 402, 702, and 703 to strike portions of the trial testimony of Dr. Davies relating to the water content and pH of Cheminor’s ANDA products. Cheminor also filed a motion to strike selected portions of the trial testimony of Dr. Langer concerning the water content of Cheminor’s “final dosage form” and the pH of the microenvironment of Cheminor’s core. Cheminor attacks those opinions of Dr. Langer because Cheminor believes they rely solely upon inadmissible portions of Dr. Davies’ opinions and testing.

As an initial matter, Cheminor objects to the identity of the individuals who performed the testing and the manner in which Defendants’ samples were handled at Dr. Davies’ laboratory. The court finds these criticisms to be without merit. Dr. Davies received bottles marked with labels containing samples of Cheminor’s products. (Davies Tr. 1056:10-16, 1061:7-19.) When performing the tests, Dr. Davies and his colleagues identified the samples they tested by looking at the label on the bottle from which the sample came. (Davies Tr. 1055:8-14, 1060:6-14.) Dr. Davies appropriately stored the sealed bottles of Cheminor’s samples in a climate-controlled environment. (Davies Tr. 1063:25-1065:1, 1057:21-1058:2.) Dr. Davies testified that the storage of the product samples was important and that the products remained stable in the lab. (Davies Tr. 1058:24-1059:3.) There is no real question with record keeping or procedure with respect to Dr. Davies’ pH testing. All of the tests were performed under Dr. Davies’ direction and by appropriate personnel. The scientists under Dr. Davies’ direction who performed the tests on Cheminor’s *492 product include an analytical chemist and a pharmacist. (Davies Tr. 1047:23-1048:15-16.) Dr. Davies relies on his laboratory and competent scientist for academic and other professional endeavors, (Davies Tr. 1046:19-1047:2), and he is entitled to rely upon the work of his colleagues on experiments that he designed. See Ecolab Inc. v. Amerikem Lab., Inc., 98 F.Supp.2d 569, 574 (D.N.J.2000)(rejecting the notion that expert must personally conduct each experiment, finding no legal authority for the proposition), affd in fart, vacated in fart, 264 F.3d 1358 (Fed.Cir.2001). This notion is consistent with Federal Rule of Evidence 703, which specifically provides that an expert may rely on facts or data “perceived by or made known to the expert at or before the hearing.” Fed.R.Evid. 703.

The court has already addressed the admissibility of Dr. Davies’ pH testing with respect to the Genpharm products. The court incorporates that discussion to the extent it is relevant to the testing conducted on the Cheminor products. In addition, the court notes a detailed data sheet was used to record the pH measurements. (See P591 I.) The operating procedure, sample size, sample description, sample temperature, calibration details for the Beetrode probe, and actual sample measurements were recorded for each experiment. (See P5911.) A simple review of the data sheets refutes Cheminor’s argument that there were no standards in Dr. Davies’ pH testing. Dr. Davies’ detailed calibration procedures ensured that the data was accurate and reproducible. (Davies Tr. 809:18-810:25.) Although Cheminor claims that Dr. Davies failed to test the micro-pH when he tested the bulk core of Cheminor’s product, the court finds that Dr. Davies’ pH test was conducted on the appropriate substance. Just as the pH of the core is a result of the pH from the combination of all excipients present in the core region, (Ravinder Dep. Tr. 47:25-48:7), the pH of the microenvironment around the omeprazole results from the combination of all the excipients present in the core, (Ravinder Dep. Tr. 227:12-228:3). Testing the pH of the core in its entirety reveals the pH of the microenvironment of the omeprazole in the core of Cheminor’s products, which is exposed to all of the other excipients present in the core.

Dr. Davies’ pH testing is completely unchallenged by any expert on behalf of Che-minor. While it is true that Cheminor need not offer expert testimony to challenge the reliability of Dr. Davies’ testing, see Brooks v. Outboard Marine Corp., 234 F.3d 89, 92 (2d Cir.2000), Cheminor must, at a minimum, present a cogent, reasonable argument in support of its motion. Instead, Cheminor selectively quotes from the testimony of Dr. Carr, an expert who testified on behalf of KUDCo, and implies that there are numerous potential sources of error in Dr. Davies’ pH testing. The bulk of Cheminor’s complaints, in fact, are drawn directly from Dr. Carr’s testimony concerning the potential for errors when testing the pH of HPMC at very high concentrations. These include errors associated with liquid junction potential and colloidal and non-aqueous solutions. There is no question that the pH tests Dr. Davies conducted on Cheminor’s products differ dramatically from those Dr. Davies performed on the HPMC used in KUDCo’s products. Those differences in testing technique stem from actual differences in the two Defendants’ ANDA products. Aside from implausible attorney argument, Cheminor has presented no evidence linking Dr. Carr’s criticisms of Dr. Davies’ high-concentration HPMC pH tests to the pH tests conducted on the core of Chemi-nor’s products. As such, Cheminor’s unsupported argument that the pH-testing technique used by Dr. Davies to test Che-minor’s core did not result in reliable results is wholly without merit. The court finds that Plaintiffs have established the admissibility of Dr. Davies’ pH testing of *493 Cheminor’s products and denies Chemi-nor’s motion to strike the portions of Dr. Davies’ testimony discussing those tests.

The court also finds that Dr. Davies’ Coulometrie Karl Fischer titration tests will assist the court by providing relevant information necessary on infringement issues. Claim 9 of the ’505 patent and claim 11 of the ’230 patent require that the water content of the “final dosage form” does not exceed 1.5% by weight. This court construes the term “final dosage form” to refer to enteric-coated pellets. Therefore, Dr. Davies’ water content tests on Cheminor’s enteric-coated pellets are directly relevant to the issue of Chemi-nor’s infringement of claim 9 of the ’505 patent and claim 11 of the ’230 patent. Dr. Davies used a reliable method for testing Cheminor’s water content that is approved in the United States Pharmacopoeia (“USP”). (P1134 at 2705; Davies Tr. 900:4-901:2, 1042:23-1043:11; Langer Tr. 639:3-6, 639:14-640:4; P590A; P1038 (Dem.Ex.) at 6.) The methods Dr. Davies used for water content testing are standard and well known in the field of testing and characterizing pharmaceutical dosage forms. (Davies Tr. 900:17-901:2, 1042:23-1043:11; Langer Tr. 639:14-640:6.) Even Cheminor admits that “there are many articles and published tests on the Karl Fischer Titration method.” (Cheminor’s Davies Daubert Motion at 21; Thiex Aff. ¶ 1.3 (“The oven technique of Karl Fischer analysis ... can provide valid and reliable information about the water content of many different kinds of materials.”).) Any criticism about the technique exclusively being put to judicial use is nonsense. Che-minor admits that “the technique of determining water content by Karl Fischer Titration is accepted by science, and thus put to nonjudicial use.” (Cheminor’s Davies Daubert Motion at 24.) When implementing his Karl Fischer titration method, Dr. Davies followed the guidance of the USP, (Davies Tr. 899:17-900:2), and he selected the appropriate parameters and conditions for the test to ensure accurate results, (Davies Tr. 1078:1-8; Davies Supp. Dep. Tr. 185:4-186:9, 186:17-25, 189:20-190:9, 206:4-13, 207:7-20). Dr. Davies also ensured that those working in his laboratory used appropriate operating procedures for the titrator. (Davies Supp. Dep. 207:7-20, 208:15-209:13.)

The court agrees with Cheminor that Dr. Davies’ water content tests are by no means flawless. For instance, Dr. Davies’ test results had a very high standard deviation. 39 The court will address those po *494 tential problems carefully when determining the appropriate weight to be given Dr. Davies’ water content tests on the issue of Cheminor’s alleged infringement of the ’505 and ’230 patents. See McCullock, 61 F.3d at 1043 (“Disputes as to the strength of his credentials, faults in his use of differential etiology as a methodology, or lack of textual authority for his opinion, go to the weight, not the admissibility, of his testimony.”) Nevertheless, the court finds that Plaintiffs demonstrated sufficient relevance and reliability to surpass the Daubert requirements as implemented by Rule 104 in conjunction with Rules 702 and 703. The court denies Cheminor’s motion to strike the portions of Dr. Davies’ testimony addressing his water content testing.

In light of the court’s rulings concerning the pH and water content tests performed on Cheminor’s ANDA products by Dr. Davies, the court denies Cheminor’s motion to strike portions of Dr. Langer’s testimony and reports. See Fed.R.Evid. 703; Gussack Realty Co. v. Xerox Corp., 224 F.3d 85, 94-95 (2d Cir.2000) (“[A]n expert may rely on data he or she did not personally collect.”). The court has admitted the testimony and test results by Dr. Davies upon which Dr. Langer relied, and the court finds that Dr. Langer’s reliance on that information was reasonable.

F. Andrx’s Motions

Defendant Andrx filed a motion to exclude portions of the expert testimony of Dr. Davies under Daubert. Andrx objects to nearly every technique employed by Dr. Davies to analyze its ANDA products. Specifically, Andrx attacks Dr. Davies’ ultraviolet (“UV”) fluorescence microscopy, sample preparation techniques, film and water solubility experiments, and ATR-FTIR analyses. Each of these objections to Dr. Davies’ testing fails for the same reason'—every single one represents conjecture based upon theoretically possible sources of error, fails to account for the totality of Dr. Davies’ testing, and is divorced from the facts of this case. The court finds that Dr. Davies conclusively established the reproducibility and reliability of his results not only by obtaining the same results using multiple trials for each type of experiment, but also by utilizing numerous testing techniques to verify the results using different types of equipment, testing methods, and sampling techniques. The court concludes that Plaintiffs have established the relevance and reliability of the testing performed on the Andrx products by Dr. Davies. 40

As an initial matter, Andrx objects to Dr. Davies’ microtoming technique, which he used to slice off the top portion of the Andrx pellets so that he could examine a cross-section of the pellets using UV fluorescence microscopy. Confirmation of the validity of Dr. Davies’ sectioning technique was undertaken using confocal laser scanning microscopy (“CLSM”) of sectioned active beads to reveal the cross-section of the area of the microtomed surfaces. (Davies Tr. 4162:21-24.) Using the microtome technique, Dr. Davies was attempting to remove the top 10 microns of the Andrx pellets. CLSM performed on microtomed pellets indicated that the average diameter of the section was 172 microns, which confirms an average sampling depth of 10.1 microns assuming spherical shape of the beads. (Davies Tr. 4163:5- *495 11.) The methodology used to microtome the top of Andrx’s active pellet to expose the interior of the active layer 10 microns down was done three separate times prior to November 2000, revealing consistent and reproducible ATR-FTIR data on the chemical composition of the interior of the pellets. (Davies Tr. 4162:12-13; P227; P1265 at 1.) The ATR-FTIR microprobe crystal was precisely positioned in the center of the sectioned area using the cross-hairs of the CCD camera on the microscope, allowing the collection of the ATR-FTIR data from only the middle 50 pm of the microtomed region. (Davies Tr. 4163:12-25.) This careful placement of the probe avoids collection of data from the edge of the section region. Evidence obtained from the microtoming procedure is clearly relevant to the issues in this case, since it permitted Dr. Davies to test the interior of Andrx’s active pellets for the existence of a subcoating. The court also finds this evidence to be reliable since Dr. Davies’ use of CLSM and ATR-FTIR verified the reproducibility and accuracy of the microtome procedure. Therefore, the court rejects Andrx’s Daubert challenge to Dr. Davies’ microtome technique.

Andrx also challenges the UV fluorescence microscopy techniques used by Dr. Davies to test the microtomed pellets. The court finds that Dr. Davies’ UV fluorescence microscopy tests are relevant to the issue of Andrx’s infringement — they address the questions of whether Andrx’s product has a subcoating and whether that subcoating meets the limitations of the claims. UV fluorescence microscopy is a microscopic technique for obtaining spatial analytical information about a sample. (A626 (Dem.Ex.); Davies Tr. 937:24-938:2.) Fluorescence is a physical phenomenon in which a material absorbs light, called the “excitation” light, and then emits light at a higher (longer) wavelength, called the “emitted” light. (Salzberg Tr. 3459:4-22.) The excitation light is in the ultraviolet range with a wavelength shorter than about 390 nanometers, and a material that does not absorb the excitation light will not fluoresce. (Salzberg Tr, 3459:22-24, 3460:5-18.) In fluorescence microscopy, the sample to be examined is illuminated with a given excitation wavelength, and the microscope collects the light emitted by the sample, which will include any light emitted due to fluorescence, as well as light due to other optical phenomena. (Salzberg Tr. 3459:12-3460:4, 3484:9-14; Davies Tr. 800:4-15.) With this type of microscopy, differences in col- or in an image indicate a different chemical environment that may be due to a different chemical composition. , (Davies Tr. 800:16-24; see also P1286 (Dem.Ex.) at 3; P1036 (Dem.Ex.) at 2.)

The UV fluorescence testing Dr. Davies conducted shows the presence of a brightly fluorescing, continuous layer that appears with a different intensity and color than the surrounding regions. (Davies Tr. 821:19-824:2, 824:8-15.) The different intensity and color of the fluorescence indicate a physical and chemical environment different from the enteric coat and the active layer. (Davies Tr. 799:18-800:15, 827:23-828:19, 4088:14-22.) That evidence is unquestionably relevant to the issue of whether a subcoating, later determined to be an HPMCP-salt 'subcoating, exists at all. Dr. Davies also analyzed the intense, fluorescing layer for continuity and thickness. (Davies Tr. 799:18-800:15, 821:10— 15, 827:23-828:19, 926:13-16, 941:2-7.) Dr. Davies’ use of UV fluorescence microscopy on Andrx’s product is directly relevant to the issues in this case and assists the court in determining whether or not the Andrx product meets the subcoating claim limitation of the ’505 and ’230 patents.

The court also finds that Dr. Davies’ UV fluorescence microscopy testing is reliable. There is no question that UV *496 fluorescence microscopy is an accepted, reliable methodology. (See, e.g., Davies Tr. 4088:19-22; Banakar Tr. 3318:18-3319:4.) UV fluorescence microscopy is an appropriate technique for studying the structure of a bisected pharmaceutical formulation. (Davies Tr. 4088:14-17.) Publications put forth by Dr. Davies, (see, e.g., P997A, P1003A), and by Dr. Salz-berg, (see, e.g., A542), demonstrate that UV fluorescence microscopy can be effectively and reliably used to detect the presence or absence of different environments. All three articles confirm that a scientist can analyze UV fluorescence microscopy tests by visually inspecting the image. Dr. Davies used the same peer reviewed methodology when testing Andrx’s product. (Davies Tr. 4088:14-22.) Andrx wrongly alleges that visual inspection is inappropriate to detect color change in UV fluorescence microscopy images. Dr. Davies directly addressed that criticism: “We must always remember that visual inspection is one accepted method of evaluating changes in color. That’s why they put eyepiece, binocular eyepieces on microscopes, so you can look down the microscope and see the color, see the features. You use the eye to do that.” (Davies Tr. 4149:25-4150:1-6.) Dr. Davies visually inspected the UV fluorescence microscopy images and concluded that the intense fluorescing layer fluoresced a different color, (Davies Tr. 817:5-820:2, 822:24-823:17.); however, Dr. Davies did not rely purely upon his eye to detect the different chemical layer. He confirmed the color change in the intense band by using spectroscopic confocal laser scanning microscopy (“CLSM”), a dispersive technique. 41 An image of the areas studied and the resulting light emission spectra from 475 to 650 nanometers (“nm”) are depicted in Exhibit P1263. This test shows that the fluorescing region of the HPMCP salt is both more intense and of a different color than the adjacent regions. For example, compare region “B,” the active layer, with region “G,” the intense, fluorescing layer, in the normalized intensity graph. The G curve has a peak intensity that is shifted to longer wavelengths, which means that it is less blue and more yellow-green than the active layer. (Davies Tr. 4146:4-4150:20; P1263; P1263A.) Thus, regardless of whether a color change is observable by visual inspection, the existence of a different chemical was verified by two independent techniques, ATR-FTIR and CLSM color dispersive testing.

Andrx’s argument that chemical identification by UV fluorescence microscopy requires that the sample’s chemistry be known is a misdirection. Dr. Davies found time and time again that a brightly fluorescing layer occurred “right all the way around” each and every Andrx pellet he examined. (Davies Tr. 817:5-818:6, 821:19-24.) Dr. Davies did not use UV fluorescence microscopy to determine the identity of the chemicals present in the bright fluorescing layer. The presence of the intense, fluorescing layer led to further relevant testing to isolate that layer by acetone washing, (Davies Tr. 822:2-824:15), and to identify its chemical composition by ATR-FTIR, (Davies Tr. 831:22-833:6). Dr. Davies performed ATR-FTIR to determine that the brightly fluorescing layer corresponded to an HPMCP salt. (Davies Tr. 831:22-833:16, 924:2-12.)

At trial, Andrx’s expert Dr. Salzberg suggested that the HPMCP salt did not absorb light in the wavelengths used for *497 Dr. Davies’ UV fluorescence microscopy so it could not be the bright fluorescing layer. To determine whether Dr. Salzberg’s suggestion was accurate, Dr. Davies conducted UV absorbance testing on an HPMCP-salt sample and showed that it did absorb light in the 340 to 360 nm range. (P1261.) In addition, Dr. Davies showed that the HPMCP salt fluoresced when excited with light in the 340 to 360 range. (P1262 at 1-6.) Dr. Davies also conducted a test to demonstrate that an HPMCP-salt solution absorbs and fluoresces when excited by the wavelengths used in his UV fluorescence microscopy. (Davies Tr. 4143:12-4145:20; P1262.) The tests showed that the HPMCP-salt solution does fluoresce under the conditions used in Dr. Davies’ UV fluorescence microscopy tests. 42 (Davies Tr. 4144:2-6.) A similar analysis was done using 458 nm excitation, the same wavelength used for Dr. Davies’ CLSM tests, and monitoring 475-650 nm emission confirming the fluorescence. (Davies Tr. 4145:21-^1146:3; P1262 at 11,12.)

Through its expert Dr. Salzberg, Andrx also argues that Dr. Davies failed to account for artifacts that could result in potential errors in his UV fluorescence microscopy testing. These criticisms ignore all of the confirmatory testing conducted by Dr. Davies; 43 moreover, Dr. Davies demonstrated that the artifacts described by Dr. Salzberg are not distorting the presence of the fluorescing ring as it appears in the UV images. On cross-examination, Dr. Davies addressed issues of refraction, (Davies Tr. 965:18-966:3), interference, (Davies Tr. 966:13-23), and out-of-focus fluorescent flare (Davies Tr. 976:18-977:12), issues that were later raised again by Dr. Salzberg. To some extent, Dr. Salzberg’s criticisms are irrelevant due to his lack of expertise in the relevant field of testing and characterizing pharmaceutical dosage forms. See, *498 e.g., In re Unisys Savs. Plan Litig., 173 F.3d 145, 156-57 (3d Cir.1999), Dr. Salz-berg is experienced in the study of biological samples. (Salzberg Tr. 3446:14-17.) Dr. Salzberg has no experience applying UV fluorescence microscopy to pharmaceutical dosage formulations, and he never tested an Andrx sample or any other pharmaceutical. (Salzberg Tr. 3495:9-14, 3496:13-16.) Moreover, Dr. Salzberg admitted that he was not aware of the nature of the Andrx sample. (Id.) Instead of focusing his criticisms on the nature of the problem at issue, Dr. Salz-berg listed every remotely possible error he could imagine and then admitted on cross-examination that he had no way of knowing whether any of the errors he identified were actually present in Dr. Davies’ images. (Salzberg Tr. 3521:14-3522:16, 3523:2-19.) A comparison of Exhibit P1206, Dr. Salzberg’s copy of a UV image, with P220, the copy of the same image from Dr. Davies’ original report, shows that the images that Dr. Salzberg examined are inadequate to make judgments concerning focus or resolution. (Davies Tr. 4122:7-4124:6.) Dr. Salzberg never visually inspected a good copy of the original, UV fluorescent images to assess color change, or any other issue related to blurriness or resolution. Based on the poor quality pictures Dr. Salzberg was provided by Andrx, he could not distinguish the differences, or color, between the active layer and the sugar seed. (Salzberg Tr. 3515:9-3516:19; see also Salzberg Tr. 3517:6-3518:3.) While the delineation between the active layer and the sugar seed is fully obscured in P1206, it is sharp in P220. (Davies Tr. 4124:4-20.) Moreover, the effects that Dr. Salz-berg' speculated about are more pronounced in the biological samples and translucent samples with which he is familiar based on his biology background. (Davies Tr. 4099:14^101:23.) Under these circumstances, Dr. Davies is not obligated to conduct every experiment Dr. Salzberg might imagine, and ultimately, Dr. Salzberg acknowledged that the intense, fluorescing ring in the Andrx product may be due to the existence of a layer. (Salzberg Tr. 3536:9-12.)

Nevertheless, to confirm the reproducibility and reliability of his UV fluorescence microscopy results, and to show that the theoretical possibility of out of focus, edge effects, and other potential problems described by Dr. Salzberg are not the cause of the brightly fluorescing band present in the UV fluorescence testing, Dr. Davies conducted a battery of confirmatory testing using CLSM. (Davies Tr. 4088:23-4089:21.) Those additional tests confirmed that the UV fluorescence microscopy results that Dr. Davies relied on initially were accurate, reliable, representative of the Andrx product, and showed true structural features, not artifacts. (Davies Tr. 4139:22-4140:13.) The CLSM and the UV fluorescence microscopy images all show the same intense, fluorescing region. To confirm the correlation between CLSM and UV fluorescence microscopy when viewing Andrx’s enteric-coated pellets, Dr. Davies examined the same pellets using both techniques. Exhibit P1250 is a side by side comparison of the same pellet studied by both UV fluorescence microscopy and CLSM. An additional two pellets were studied in a similar manner. (P1251; P1252.) The brightly fluorescing region appears in both the UV fluorescence microscopy and the CLSM, confirming that the features observed in the UV fluorescence microscopy images are true representations of the sample and are not due to out of focus, scattering, edge or interface effects. (Davies Tr. 4090:8-4091:5.) For example, the two portions of Exhibit P1253 circled on the side-by-side comparison contain two parallel high intensity bands. Based on the CLSM image, the left-hand side, the thinner left-hand band is about 3.2 microns thick, and the right-hand band *499 is about 7.3 microns. For the UV fluorescence microscopy image, the right-hand side, the thinner left-hand band is about 2.2 microns and the right-hand band is about 6.8 microns. 44 (P1286 (Dem.Ex.) at 1; Davies Tr. 4096:19^098:16.) These results confirm the validity and reliability of Dr. Davies’ earlier UV fluorescence microscopy work represented by Exhibit P220. (See also P1254; P1255; P1256; Davies Tr. 4115:11-4120:17.) Additional CLSM images confirm that the presence of an intense, fluorescing region shown in the UV images is representative of Andrx’s product. (See P1254; P1255; P1256; Davies Tr. 4115:11-4120:17.)

In response to Dr. Salzberg’s criticisms, Dr. Davies also recorded the excitation light reflected back from CLSM samples. (P1254 at 6; P1255 at 5.) The images show the texture of the bisected pellets. The reflectance images do not exhibit evidence of light scattering, which means that the features in the fluorescence microscopy images are not. due to scattering of light. (Davies Tr. 4117:21-4118:13, 4131:19-4132:8.) The intense ring also is not an edge effect or “mirage.” The intense ring does not appear in any of the other Defendants’ products, which were examined using the same procedure; it only appears in Andrx’s enteric-coated omeprazole products. (Compare P82, P387, and P554, with P220.) CLSM data also show that the intense, fluorescing ring is not due to an interface effect. CLSM confirms the ATR-FTIR results and shows that the intense region is located above the active layer. A reflectance image of the acetone-washed pellet with fluorescence overlayed, P1260, shows that the morphology or texture of the intense region is different from the active layer and confirms that the intense, fluorescing region is a distinct layer that forms where the enteric coat was applied. (Davies Tr. 4134:14-4137:15.)

Andrx would prefer that Dr. Davies performed all his testing using CLSM; nevertheless, the court finds that the use of CLSM is not necessarily the preferred method in this case. In fact, while CLSM. may provide an improved image for certain samples, like improved focus in translucent or biological samples, those benefits are diminished when a sample is flat and does not permit deep penetration of significant amounts of light. (Davies Tr. 4099:21-4101:23; see, e.g., P1286 (Dem.Ex.) at 2; A542 at 358-59.) When the sample is flat and nontranslucent and there is nothing in front of the plane of interest, differences in contrast and focus between UV fluorescence microscopy and CLSM are reduced. (Davies Tr. 4100:18-4105:14, 4113:15-4114:16; A543 at 121.) Now faced with the validation of Dr. Davies’ UV data by his CLSM data, Andrx next asserts that the CLSM images obtained by Dr. Davies are somehow misleading or erroneous due to “stacking.” 45

*500 As Dr. Davies explained at trial, maximum intensity projection is a standard approach used to present an accurate image of CLSM data of the surface of a sample by combining Z-sliees that may only contain CLSM data for a portion of the surface. (Davies Tr. 4111:2-16.) CLSM collects data for one optical image slice (Z-slice) at a time. (Davies Tr. 4104:18-19.) The data for each Z-slice is collected by three detectors. (Davies Tr. 4104:6-9; P1286-3 (Dem. Ex.).) The first Z-slice is collected beginning above the sample. Then the microscope moves down one step, the distance between the middle of consecutive Z-slices, and takes a second Z-slice that overlaps with the first. This progression of obtaining Z-slices continues until all of the Z-slices are obtained. (Davies Tr. 4108:11-17, 4109:25-4110:3, 4111:23-4112:4; P1286 (Dem.Ex.) at 4, 5.) The Z-slices were only 1.28 microns apart, and Dr. Davies gave a detailed explanation of how the 1.28 micron measurement was determined. (Davies Tr. 4296:6-16.) The only portion of the pellets that could fluoresce and therefore be detected is the top 5 microns because the Argon laser used for CLSM penetrates the sample about 5 microns. (Davies 4109:8-13, 4109:25-4110:3, 4111:23 — 4112:4; P1286 (Dem.Ex.) at 5.) Since each Z-slice only collects fluorescence in a limited depth of field and the relatively flat surface of the bisected pellet may be on a tilt, all of the Z-slices are considered when evaluating the surface of the bisected pellet. (Davies Tr. 4292:19-4293:5.) Considering only one or two Z-slices does not give an accurate representation of the complete surface of the tilted sample. (Davies Tr. 4292:19-4293:5.) The court finds that Dr. Davies properly used maximum intensity projection to present his CLSM images.

*501 As mentioned previously, Dr. Davies employed two techniques to confirm that the presence of the bright fluorescing ring in the UV images represented a layer with a distinct chemical composition as compared to those neighboring it and to identify the substances in that layer — acetone washing and ATR-FTIR. Andrx objects to both of those procedures as well. The court has already addressed the admissibility of Dr. Davies’ acetone-washing procedure with respect to the Genpharm products. The court incorporates that discussion to the extent it is relevant to the testing conducted on the Andrx products. Contrary to Andrx’s assertions, Dr. Davies’ acetone-washing technique did not result in a wide range of results. The original 5 acetone-washed results and the newly-conducted ATR-FTIR analyses show that the HPMCP salt forms and is detected clearly in every sample where the enteric coating has been removed. (Davies Tr. 4165:16^4166:2.) If a washing was incomplete, thé ATR-FTIR spectrum matched the spectrum for the enteric coating. (Davies Tr. 986:10-14, 994:3-7.) However, the presence of talc peaks in the ATR-FTIR spectrum does not indicate that the enteric coat was removed incompletely because talc is co-deposited on the Andrx pellets with HPMCP during the enteric-coating process. (Davies Tr. 4298:7-10.) Andrx’s suggestion that there is no possibility of obtaining a negative result is incorrect. If a salt layer was not present, Dr. Davies would never detect the salt. In that case, Dr. Davies would have first detected the enteric coating and then, upon removing the enteric coating, the active layer. That is not what happened. Upon washing, Dr. Davies detected an HPMCP-salt layer. (Davies Tr. 822:17-823:11.) Andrx’s complaint that HPMCP is only slightly soluble in acetone fails to take into account that Dr. Davies relied on the difference in the solubility of the HPMCP in the enteric coating and the HPMCP-salt subcoating for the washing process. (See Davies Tr. 4300:11-16.) Dr. Davies explained that in the acetone wash the HPMCP washed away in a matter of minutes. (Davies Tr. 4299:22-24.) The wash technique includes washing multiple pellets at the same time; when they rub together, the rubbing facilitates the erosion of the enteric coating. {See, e.g., Davies Tr. 804:19-24, 1158:23-1159:10.) In addition, the peak shapes and positions of the ATR-FTIR spectra are consistent, showing reproducibility and reliability of the results. (Id.)

Attenuated total reflectance fourier transform infrared spectroscopy (“ATR-FTIR”) is an analytical technique that is commonly used to analyze the chemical composition of a sample. (Davies Tr. 805:20-806:2; Gardella Tr. 3853:18-24.) 46 ATR-FTIR analysis is based on the wavelengths of infrared light that are absorbed by a sample. (Davies Tr. 828:25-829:11.) With this technique, infrared light is projected into a sample to a depth of approximately 1 micron. (Davies Tr. 937:22-23, 938:9-10, 939:12-13; see also Davies (Dau- bert) Tr. 4304:24-4305:1.) Some of the light is absorbed and some is reflected. The difference between the projected light and the reflected light yields a “fingerprint” of the chemical contents of the material being tested. (Davies Tr. 828:25-830:11.) In order to identify a particular chemical compound in an unknown sample with ATR-FTIR, a “reference” spectrum is compared against the spectrum of the *502 unknown sample. (Davies Tr. 832:20-23; P773; P774.) The ATR-FTIR showed that the brightly fluorescing layer in the Andrx products corresponds to an HPMCP salt. (Davies Tr. 832:2-833:16, 924:2-12.) The ATR-FTIR data, in conjunction with the UV microscopy pictures, (P220; P221), show that the HPMCP-salt layer corresponds to the intense, fluorescing region. (Davies Tr. 835:19-836:7.) This was reconfirmed by partial acetone-wash tests reported as part of the reliability proofs. (See, e.g., P1266.) The peak assignments that Dr. Davies focused on are similar to those discussed in a recent ATR-FTIR publication relating to phthalic acid .and identifying its peaks for the acid form and salt form. (Davies Tr. 4167:19-4169:1; P769 at 1639-41, figure 1, Table 3.) The court concludes that Dr. Davies’ ATR-FTIR testing produced accurate and reliable results that are admissible at trial. Those ATR-FTIR results are also clearly relevant to the issue of what chemical substances exist in the brightly fluorescing layer visually apparent in the Andrx products.

Like the other Defendants, Andrx also moves to exclude the testimony of Dr. Langer. In light of the court’s rulings concerning the tests performed on Andrx’s ANDA products by Dr. Davies, the court denies Andrx’s motion to exclude portions of Dr. Langer’s testimony and reports under Daubert. See Fed.R.Evid. 703; Gussack Realty Co. v. Xerox Corp., 224 F.3d 85, 94-95 (2d Cir.2000) (“[A]n expert may rely on data that she did not personally collect.”). The court has admitted the testimony and test results by Dr. Davies upon which Dr. Langer relied, and the court finds that Dr. Langer’s rebanee on that information was reasonable. It is also clear that an expert in a case like this one may comment upon and rely on the testimony of the scientists who developed an allegedly infringing formulation; accordingly, the court concludes that it was reasonable for Dr. Langer to rely upon the testimony of Drs. Timothy Weng and Joseph Chou. 47 Therefore, the court denies Andrx’s motion to exclude Dr. Langer’s testimony under Rule 702 as interpreted by Daubert and its progeny.

G. KUDCo’s Motions

Defendants KUDCo filed a motion pursuant to Federal Rule of Evidence 702 and Daubert to exclude evidence relating to the high-concentration pH meter testing of HPMC conducted by Dr. Davies. All of the arguments made by KUDCo in that motion were directed to the relevancy and reliability of the high-concentration tests Dr. Davies performed on the HPMC used in the KUDCo formulation. Defendants KUDCo also filed a motion to exclude the expert testimony of Dr. Langer pursuant to Rule 702, Rule 703 and Daubert. That motion attacked the opinions Dr. Langer testified to at trial that relied upon Dr. Davies’ high-concentration HPMC pH test results. In light of the analysis contained in the portion of this opinion concerning KUDCo’s noninfringement of the ’505 and ’230 patents, the court finds that KUDCo’s motions to exclude portions of the testimony of Dr. Davies and Dr. Lan-ger are moot.

H. Daubert Analysis Applies to Weight and Credibility Determinations

Of course, many of the Daubert factors go not only to the admissibility of the evidence, but also to the weight that evi *503 dence is to be given and the credibility of the expert witness. See Libas, Ltd. v. United States, 193 F.3d 1361, 1366 (Fed.Cir.1999) (“[T]he proposition for which [.DaubeH and Kumho] stand, that expert testimony must be reliable, goes to the weight that [the] evidence is to be accorded as well as to its admissibility.”); McCulloch, 61 F.3d at 1044 (“Disputes as to ... faults in his use of ... a methodology, or lack of textual authority for his opinion, go to the weight ... of his testimony.”). The court must take a “hard look” at the expert scientific testimony offered to prove infringement, even the evidence admitted under the Daubert standard, and the court must reject an expert’s conclusions where there is “too great an analytical gap between the data and the opinion proffered.” General Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S.Ct. 512, 139 L.Ed.2d 508 (1997). Therefore, the court will reconsider the issues raised by Defendants’ Daubert motions in the context of its infringement analyses.

IV. Infringement of the ’505 & ’230 Patents

A. General Principles

Section 271(e)(2) provides, in relevant part, that “[i]t shall be an act of infringement to submit ... an application under [21 U.S.C. § 355(j)] for a drug claimed in a patent or the use of which is claimed in a patent.” As described above, this is an artificial act of infringement based on the filing of an ANDA and challenging existing patents through a Paragraph IV certification. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 676, 110 S.Ct. 2683 (1990); 21 U.S.C. § 355(j)(2)(A)(VU)(iv). A claim of infringement brought under section 271(e)(2) focuses on the hypothetical product described in the ANDA. Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241, 1248 (Fed.Cir.2000), cert. denied, 531 U.S. 993, 121 S.Ct. 484, 148 L.Ed.2d 457 (2000). “[I]t is proper for the court to consider the ANDA itself, materials submitted by the ANDA applicant in support of the ANDA, and any other relevant evidence submitted by the applicant or patent holder.” Bayer AG, 212 F.3d at 1249, cert. denied, 531 U.S. 993, 121 S.Ct. 484, 148 L.Ed.2d 457 (2000). “When a patentee seeks to block FDA approval of an NDA under 35 U.S.C. § 271(e)(2)(A), the infringement inquiry focuses on the hypothetical infringement that would occur if the defendant’s NDA were approved and the defendant began to make and sell the drug.” Novartis Corp. v. Ben Venue Labs., Inc., 271 F.3d 1043, 1047 (Fed.Cir.2001).

Comparing the accused product to the asserted claims, for analysis of either literal infringement or infringement under the doctrine of equivalents, is a question of fact. Glaxo Group, Ltd. v. Ranbaxy Pharms., Inc., 262 F.3d 1333, 1335 (Fed.Cir.2001); Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d 1512, 1520, 1522 (Fed.Cir.1995), rev’d on other grounds, 520 U.S. 17, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). Plaintiffs bear the burden to prove their claims of infringement by a preponderance of the evidence. Wilson Sporting Goods Co. v. David Geoffrey & Assocs., 904 F.2d 677, 685 (Fed.Cir.1990). This standard applies to both literal infringement and infringement under the doctrine of equivalents. Lemelson v. United States, 752 F.2d 1538, 1547 (Fed.Cir.1985). The fact that section 271(e)(2) creates an artificial act of infringement does not lessen that burden. Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1567 (Fed.Cir.1997). The burden rests at all times on Astra to prove through an accurate, scientific method that the claimed invention is actually present in the allegedly infringing ANDA product. See Novartis Corp., 271 F.3d at 1050.

*504 1. Literal Infringement

Proof of infringement is a two-step process. The court has already construed each claim to determine its proper scope and meaning. See Markman v. Westview Instruments, Inc., 517 U.S. 370, 384, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Now, the court must determine whether Astra has proven by a preponderance of the evidence that Defendants’ products meet each and every element or limitation recited in the properly construed claims. See Southwall Techs., Inc. v. Cardinal IG Co., 54 F.3d 1570, 1575 (Fed.Cir.1995); Morton Int’l v. Cardinal Chem. Co., 5 F.3d 1464, 1468 (Fed.Cir.1993). There can be no infringement as a matter of law — even under the doctrine of equivalents — if a claim limitation is not found in the accused device. Phonometrics Inc. v. Northern Telecom Inc., 133 F.3d 1459, 1467 (Fed.Cir.1998); Gen. Am. Transp. Corp. v. Cryo-Trans, Inc., 93 F.3d 766, 771 (Fed.Cir.1996).

2. Infringement Under the Doctrine of Equivalents

The doctrine of equivalents prevents an accused infringer from avoiding liability for infringement by changing only minor or insubstantial details of a claimed invention while retaining the invention’s essential identity. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 234 F.3d 558, 564 (Fed.Cir.2000). “If an asserted claim does not literally read on an accused product, infringement may still occur under the doctrine of equivalents if there is not a substantial difference between the limitations of the claim and the accused product.” Bayer AG, 212 F.3d at 1250-51; see also Warner-Jenkinson, Inc. v. Hilton Davis Chem. Co., 520 U.S. 17, 21, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). The doctrine of equivalents is used to “temper unsparing logic and prevent an infringer from stealing the benefit of the invention.” Festo Corp., 234 F.3d at 564. In pursuing these goals, the doctrine attempts to strike a balance between ensuring that the paten-tee enjoys the full benefit of his patent and ensuring that the claims give “fair notice” of the patent’s scope. Id. However, as the Federal Circuit recognized, “it is impermissible to erase under the doctrine of equivalents ‘meaningful limitations of the claim on which the public is entitled to rely in avoiding infringement.’ ” Genentech Inc. v. Wellcome Found., 29 F.3d 1555, 1568 n. 41 (Fed.Cir.1994) (citation omitted). In other words, because each element of a claim is material and essential, equivalency requires the accused product to have an equivalent of every element of the claim. Warner-Jenkinson, 520 U.S. 17, 30-31, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997).

Equivalence is a question of fact. Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). To determine whether the accused device includes equivalents for a claimed limitation, the court applies an “insubstantial difference” test. Toro Co. v. White Consol. Indus., Inc., 266 F.3d 1367, 1370 (Fed.Cir.2001). Quoting the Supreme Court in Graver Tank, 339 U.S. at 607, 70 S.Ct. 854, the Federal Circuit stated:

courts have ... recognized that to permit imitation of a patented invention which does not copy every literal detail would be to convert the protection of the patent grant into a hollow and useless thing. Such a limitation would leave room for- — -indeed encourage — the unscrupulous copyist to make unimportant and insubstantial changes and substitutions in the patent which, though adding nothing, would be enough to take the copied matter outside the claim, and hence outside the reach of law.

Toro, 266 F.3d at 1370. The test for whether an element in the infringer’s *505 product or process is equivalent to a claimed element is whether the differences between the two are insubstantial to one of ordinary skill in the art. KCJ Corp. v. Kinetic Concepts, Inc., 223 F.3d 1351, 1359 (Fed.Cir.2000).

The use of a substitute with “known interchangeability” with a literally claimed element is an objective factor to be considered in determining whether the substitute meets the claim limitation under the doctrine of equivalents. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 36, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). The “known interchangeability” test looks to the knowledge of the skilled artisan to see whether the artisan would “contemplate the interchange as a design choice.” Interactive Pictures Corp. v. Infinite Pictures, Inc., 274 F.3d 1371, 1383 (Fed.Cir.2001). Where skilled artisans would contemplate an interchange as a design choice, this is “substantial evidence” of equivalence. Id. Proof can be made in any form, “through testimony of experts or others versed in the technology; by documents, including texts and treatises; and, of course, by the disclosures of the prior art.” Graver Tank, 339 U.S. at 609, 70 S.Ct. 854. Courts have sometimes employed a tripartite funetion-way-result test in determining whether a change is “insubstantial.” The function-way-result test inquires into whether the accused structure performs substantially the same function in substantially the same way to achieve substantially the same result. Warner-Jenkinson, 520 U.S. at 39-40, 117 S.Ct. 1040. The doctrine is not applied to the invention as a whole, but to individual elements of the claimed invention. Id. at 29, 117 S.Ct. 1040.

B. Genpharm

Plaintiffs assert that Genpharm’s omeprazole formulations will infringe claims 1, 5, 6, 8-12, and 14 of the ’505 patent and claims 1, 6, 7, 10-13, and 15 of the ’230 patent either literally or under the doctrine of equivalents. Genpharm’s ANDA describes two proposed omeprazole products. The first is a 10 mg delayed-release capsule, and the second is a 20 mg delayed-release capsule (hereinafter sometimes referred to as “Genpharm’s ANDA products” or “Genpharm’s products”). The pellets that make up the 10 mg and 20 mg capsules are the same. The only difference between the two dosage forms is the number of pellets contained in the capsules. (Langer Tr. 308:6-8; Genpharm by Judy 30(b)(6) Dep. Tr. 235:21-237:14.) Genpharm’s omeprazole formulation and the detailed manufacturing process for Genpharm’s pellets is set forth in Exhibit P85. Genpharm’s products are to be administered orally as delayed-release capsules. (Langer Tr. 310:6-21; P87 at G46-47; Genpharm by Judy 30(b)(6) Dep. Tr. 246:24-247:16.) Therefore, Genpharm’s omeprazole capsules, both 10 mg and 20 mg, are “oral pharmaceutical preparations” as that phrase is used in claims 1 of both the ’505 and ’230 patents.

Genpharm raises two principal non-infringement arguments: (1) that its ANDA products do not include the claimed “core region” and (2) that its ANDA products do not include the claimed “subcoating.” Genpharm argues that its ANDA products do not infringe claims 1 of the patents because Genpharm’s core is an inert neutral pellet; therefore, the first layer in Genpharm’s products is the active drug layer, not the inert subcoating. Genp-harm’s contentions as to the core region and subcoating limitations are based solely on its proposed claim construction, which would graft onto claims 1(a) a requirement of homogeneity in order to exclude a core built on a sugar seed. Despite Genp-harm’s arguments, the court has not adopted Genpharm’s proposed claim construction for the terms “core” and “core region;” therefore, the court finds that *506 Genpharm’s omeprazole products meet every limitation of claims 1 of the ’505 and ’230 patents.

In March of 1997, Mr. Craig Judy, Genpharm’s Manager of Formulation Development, began working on the development of an ANDA omeprazole product for Genpharm. (Judy Dep Tr. 5:16-19, 124:21-24, 125:3-11.) Ultimately Genp-harm decided to use a formulation developed by Usan litas. (Judy Dep. Tr. 146:23-147:2, 147:5, 149:4-22.) Now Genp-harm’s ANDA product is manufactured by Usan Utas, a generic pharmaceutical company located in Istanbul, Turkey. (Pike Tr. 3630:17-21; Ugurlu Tr. 3649:14-16.) Genpharm begins its pellet manufacturing process with a sugar seed. (Langer Tr. 309:10-15.) Genpharm then sprays an active coating solution containing micronized omeprazole, lactose, sodium lauryl sulphate, disodium hydrogen phosphate (“DHP”), HPMC, and low substituted hy-droxypropyl cellulose onto the sugar seed. (Langer Tr. at 308:21-309:21; P85 at G4133; Pike Tr. at 3638:20-3639:8; G17B.) A protective coating layer of HPMC is then sprayed onto the active drug layer. (Langer Tr. 309:21-24; P85 at G4143-44; Pike Tr. 3638:20-3639:8; G17B.) Finally, an enteric coating containing HPMCP and diethyl phthalate is sprayed onto the protective coating layer. (Langer Tr. 309:25-310:5; P85 at G4152-53; Pike Tr. 3638:20-3639:8; G17B.)

Claim 1(a) of the ’505 describes “a core region comprising an effective amount of material selected from the group consisting of omeprazole plus an alkaline reacting compound.” (PI, col. 16:43-45.) Claim 1(a) of the ’230 further describes “an alkaline reacting core comprising an acid-labile pharmaceutically active substance and an alkaline reacting compound different from said active substance.” (P2A, col. 13:2-5.) In preparing Genpharm’s draft Development Report, Mr. Judy himself defined the sugar seed together with the active drag layer of omeprazole and disodium hydrogen phosphate as the “core” of Genp-harm’s product. (Judy Dep. Tr. 340:3-25; P19 at G13038.) Even in the final Development Report prepared in connection with Genpharm’s ANDA, Mr. Judy again defined a sugar seed together with the omeprazole active drug layer in Genp-harm’s generic product as a “core.” (Judy Dep. Tr. 362:9-12; P20 at G13549.) This court has construed the terms “core” and “core region” to mean the portion of the patented preparation that lies beneath the subcoating and contains the active ingredient and, in the case of omeprazole as the active ingredient, an ARC. Spraying layers onto a sugar seed is a conventional way of making cores or pellets in the pharmaceutical industry. (Langer Tr. 312:7-313:10; PI, col. 3:1-2; Judy Dep. Tr. 307:20-22, 308:4-17, 309:4; P921 at 12; P20 at G13549; P85 at G4133.) The court finds, therefore, that Genpharm’s ANDA products have a core that includes a sugar sphere, micronized omeprazole, lactose, DHP, and sodium lauryl sulphate. (Lan-ger Tr. 308:6-309:24, 312:3-313:10; Davies Tr. 802:21-803:4; Genpharm by Judy 30(b)(6) Dep. Tr. 236:3-237:7, 237:10-19, 248:3-24, 254:22-25, 255:4-18, 255:23-256:2; P51, at G24635; P82; P85; P87; P1039.) There is no dispute that omepra-zole is an acid labile pharmaceutically active substance. (Langer Tr. 313:20-314:2; Genpharm by Judy 30(b)(6) Dep. Tr. at 352:4-5,8.) The active drag layer, which is part of the core in Genpharm’s product, includes DHP, (Langer Tr. 308:15-309:2; Ugurlu Tr. 3680:17-24), and DHP is undeniably an ARC, (Langer Tr. 311:5-15; Genpharm by Judy 30(b)(6) at 279:15-18, 21; P20 at G13546). In fact, DHP is expressly listed in the ’505 and ’230 patents as an ARC. (PI, col. 7:64; P2, col. 11:10.)

*507 The DHP-in Genpharm’s ANDA products is used as a pH-adjuster to stabilize the omeprazole while it is in the active-coating suspension, and it accomplishes that objective by maintaining the solution of the active-coating suspension at an appropriate pH. (Genpharm by Judy 30(b)(6) Dep. Tr. 285:10-15, 353:11-24.) DHP itself is an alkaline material, (Ugurlu 3680:25-3681:6), and the purpose of including it in Genpharm’s product is to adjust the pH of the active drug layer so that the omeprazole does not degrade and to create a more stable product. (Langer Tr. 311:16-22; Genpharm by Judy 30(b)(6) Dep. Tr. 258:9-25, 353:11-22, 353:24; P51 at G24635.) Genpharm carefully calculated the amount of DHP to include in order to provide the proper pH range for stabilizing omeprazole in its formulation, (Judy Dep. Tr. 305:3-306:10), and the DHP does, in fact, prevent the degradation of omepra-zole from occurring, (Genpharm by Judy 30(b)(6) Dep. Tr. 285:16-25, 288:19-289:6).

The evidence introduced at trial dearly shows that the pH of the microenvironment of the omeprazole in Genpharm’s core is at least 7. In fact, Dr. Davies testified and submitted data that show that the pH of the microenvironment of the omeprazole in Genpharm’s formulation is between 7 and 12, as required by claim 5 of the ’505 patent and claim 6 of the ’230 patent. The active drug layer in Genp-harm’s products is homogenous. (Ugurlu Tr. 3679:11-3680:16; G17C at G50205.) Because of that homogeneity, Dr. Davies could measure the pH of the microenvironment of the omeprazole in the core by washing off the enteric coating with an acetone wash, cracking off a piece of the exposed active drug layer, adding a small amount of water, and measuring the pH. (Davies Tr. 804:9-808:13.) Dr. Davies conducted pH testing to determine the pH of the omeprazole microenvironment in Genp-harm’s product. (Davies Tr. 803:22-808:2; P83.) As measured by Dr. Davies, Genp-harm’s active drug layer has a microenvi-ronment pH of about 7.39 and 7.29, within the 7 to 12 range. (Davies Tr. 808:6-13, 814:7-15; P591A; P83; Langer Tr. 322:8-12; Genpharm by Judy 30(b)(6) Dep. Tr. 392:5-17.) Even if the court did not rely on Dr. Davies’ pH tests on the microenvi-ronment of Genpharm’s product, Genp-harm itself has admitted on several occasions that its product meets this limitation. Genpharm’s own documents and witnesses establish beyond any doubt that the active drug layer in its product not only is homogenous but also has a pH between 7 and 12. Genpharm’s Development Reports state that the pH of the active coating solution in its product is 8.4. (Judy Dep. Tr. 342:7-343:8; P19 at G13038; Genpharm by Judy 30(b)(6) Dep. Tr. 291:12-292:5; P20 at G13550.) Mr. Judy testified that even taking into account normal variation, the pH of the active coating solution does not fall below 7.5. (Judy Dep Tr. 343:16-344:6, 344:21-24.) Moreover, Genpharm realized that the use of DHP in its product would meet the ’505 patent claim limitation for an ARC. (Genp-harm by Judy 30(b)(6) Dep. Tr. 339:19-23, 340:5-22, 341:4-5.) Since Genpharm’s ANDA products are composed of enteric-coated pellets that have cores that contain either 10 mg or 20 mg of omeprazole, which is an acid labile pharmaceutically active substance, in the presence of disodi-um hydrogen phosphate, an ARC, Genp-harm’s ANDA products meet all limitations of claims 1(a).

Claim 1 of the ’505 patent also requires “(b) an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said subcoating .comprising one or more layers of materials selected from among tablet excipients and polymeric film-forming compounds.” Similarly, claim 1 of the ’230 patent requires “(b) an inert subcoating which rapidly dissolves or disintegrates in water disposed *508 on said core region, said subcoating comprising one or more layers comprising materials selected from the group of tablet excipients, film forming compounds and alkaline compounds.” The structure of Genpharm’s ANDA products is such that the core, comprised of the active drug layer and the sugar seed, is underneath a protective layer of hydroxypropyl methyl-cellulose (“HPMC”). (Langer Tr. 308:15-309:24, 311:23-312:6; Davies Tr. at 799:7-803:21; P82; Ugurlu Tr. 3655:18-3656:24, 3680:17-24, 3681:16-20.) The HPMC protective coating is on top of and in intimate contact with the active coating layer. (Genpharm by Judy 30(b)(6) Dep. Tr. 312:20-313:24, 314:2-9.) The HPMC used in Genpharm’s product is a tablet excipi-ent and a polymeric film forming compound, and the HPMC protective layer in Genpharm’s product is inert and soluble in water. (Langer Tr. 314:3-315:5; Genp-harm by Judy 30(b)(6) Dep. Tr. 310:19-25, 311:2-312:5; P77 at G3672.) Not only does the HPMC used in Genpharm’s ANDA products possess the qualities required by the patent for subcoating materials, HPMC is expressly identified as one choice for the subcoating in the ’505 patent. (PI, col. 4:35-42.) The court finds that Genpharm’s ANDA products contain a subcoating of HPMC disposed on the core and between the core and the enteric coating. (See Story Tr. 3784:9-16 (testifying that the subcoat in -the Genpharm product provides the same function as the subcoat in the ’505 patent).)

Genpharm argues that the “subcoating” must be the “first layer” in the formulation. Genpharm then reasons that the HPMC protective layer in its products is not the “first layer” in the formulation because the active layer is applied to the sugar seed first. In this regard, Genp-harm relies on the disclosure in the patent specifications. (See PI, col. 3:26-28.) Genpharm’s argument fails for several reasons. Initially, the term “first” appears nowhere in any of the asserted claims. There is no requirement that the subcoat-ing be the “first” layer in the formulation. (PI, col. 16:42-54.) Even if it were appropriate to read into the asserted claims the disclosure cited by Genpharm, (see PI, col. 3:20-28), at best that disclosure indicates that the subcoating is the first layer on the core, not the first layer in the whole formulation. When the term “core region” is construed properly to include both the sugar sphere and the active drug coating, the HPMC protective layer in Genpharm’s products is the “first” layer on top of the core. Because there is no dispute that Genpharm’s products have an inert, water-soluble subcoating, (see Genpharm PFF 477 (citing Ugurlu Tr. 3656:18-24); Lan-ger Tr. 314:3-315:9; P85 at G4143), the court finds that Genpharm’s ANDA products meet the requirements of claims 1(b) of the ’505 and ’230 patents. The subcoat-ing in Genpharm’s products also meets claim 1(c) of the ’230 patent because it enhances the stability of Genpharm’s products. (Langer Tr. 316:1-9; Judy Dep. Tr. 79:12-23.)

Finally, claim 1 of the ’505 patent requires “(c) an outer layer disposed on said subcoating comprising an enteric coating.” Claim 1 of the ’230 patent also requires “(c) an enteric coating layer surrounding said subcoating layer, wherein the subcoat-ing layer isolates the alkaline reacting core from the enteric coating layer such that the stability of the preparation is enhanced.” There is no dispute that Genp-harm’s ANDA products have an enteric coating layer containing hydroxypropyl methylcellulose phthalate (“HPMCP”) and diethyl phthalate disposed on the HPMC subcoating and that claims 1(c) of the ’505 and ’230 patents are met by the Genpharm product. (Langer Tr. 315:10-316:9; Genp-harm by Judy 30(b)(6) Tr. 314:10-15; Judy Dep. Tr. 79:12-23; PI, col. 4:65-67.) Since Genpharm’s ANDA products meet every *509 limitation of claims 1 of the ’505 and ’230 patents, the court concludes that Genp-harm literally infringes claims 1 of both the ’505 and ’230 patents.

Claim 5 of the ’505 patent calls for “[a] preparation according to claim 1 wherein the alkaline core comprises omeprazole and pH-buffering alkaline compound rendering to the micro-environment of ome-prazole a pH of 7-12.” (PI, col. 16:65-68.) Claim 6 imposes a similar requirement with respect to a core comprising an acid labile compound and a pH-buffering alkaline reacting compound. The only new requirement beyond claims 1 is that the micro-pH fall between 7 and 12. As discussed in relation to claims 1, Dr. Davies’ tests clearly show that this claim limitation is met by Genpharm’s ANDA products. Genpharm repeats the noninfringement arguments made with respect to claims 1, but Genpharm also raises an additional argument concerning the requirement for a “pH-buffering alkaline compound.” Essentially, Genpharm argues that Astra failed to demonstrate that the DHP in Genpharm’s core demonstrates pH-buffering capacity; this argument depends entirely on an assumption of Genpharm’s claim construction. The court has already precluded Defendants from asserting non-infringement positions on the basis of their belated claim construction arguments for the term “pH-buffering alkaline compound;” moreover, the court declined to adopt the claim construction upon which Genpharm relies. Therefore, Genpharm’s noninfringement positions with respect to these claims fail, and the court concludes that Genpharm literally infringes claim 5 of the ’505 patent and claim 6 of the ’230 patent. 48

Claim 6 of the ’505 and claim 7 of the ’230 patent call for “[a] preparation ... wherein the alkaline compound comprises one or more of ... sodium ... phosphate.” (PI, col. 17:1-8; P2A, col. 14:9-16.) Genp-harm uses disodium hydrogen phosphate, which is a kind of sodium phosphate, in the core of its ANDA products. (Langer Tr. 322:17-323:6; P85 at G4133; Pike Tr. 3638:20-3639:8; G17B.) Claim 6 of the ’505 patent depends from claim 5, and Genp-harm raises no additional arguments as to noninfringement. The same holds true for claim 7 of the ’230 patent, which depends from claim 6. Therefore, the court concludes that Genpharm literally infringes claim 6 of the ’505 patent and claim 7 of the ’230 patent.

Claim 8 of the ’505 patent and claim 10 of the ’230 patent require “[a] preparation according to claim 1, wherein the enteric coating comprises [HPMCP] ..., optionally containing a plasticizer.” (PI, col. 9:50-54.) Genpharm’s ANDA products contain HPMCP in the enteric coating layer. (Genpharm by Judy 30(b)(6) Dep. Tr. 314:10-15; P56.) Genpharm also adds die-thyl phthalate to the enteric coating as a plasticizer. (P93 at Response Nos. 35, 36; Langer Tr. 309:3-7, 323:7-324:7.) Claim 8 of the ’505 patent and claim 10 of the ’230 patent depend from claims 1 of the patents, and Genpharm raises no additional arguments of noninfringement as to these claims. For the reasons given above, and in light of this court’s findings concerning the enteric coating layer in Genpharm’s *510 ANDA products, the court concludes that Genpharm literally infringes claim 8 of the ’505 patent and claim 10 of the ’230 patent.

Claim 9 of the ’505 patent calls for “[a] preparation according to claim 1 wherein the water content of the final dosage form containing omeprazole does not exceed 1.5% by weight.” (PI, col. 17:20-22.) Claim 11 of the ’230 patent imposes the same requirements for the formulation containing the acid labile compound. (P2A, col. 14:30-32.) Both claim 9 of the ’505 patent and claim 11 of the ’230 patent depend from claims 1, and Genp-harm raises no additional arguments of noninfringement as to these claims. In fact, Genpharm has admitted that “[t]he water content of the enteric coated pellets in Genpharm’s ANDA products does not exceed 1.5% by weight.” (P93 at Response No. 37; Genpharm by Judy 30(b)(6) Dep. Tr. 332:24-333:10, 334:11-335:4, 336:9-25; P68.) On the basis of these facts, the court concludes that Genp-harm literally infringes claim 9 of the ’505 patent and claim 11 of the ’230 patent.

Claim 10 of the ’505 patent is directed to “[a] method for the treatment of gastrointestinal disease comprising administering to a host in need of such treatment a therapeutically effective amount of a preparation according to claim 1.” (PI, col. 17:23-26.) Similarly, claim 13 of the ’230 patent is directed to “[a] method for the treatment of gastrointestinal disease characterized in that a preparation according to claim 1 is administered to a host in need of such treatment in a therapeutically effective amount.” (P2A, col. 14:42-45.) The court finds that Genpharm’s 10 mg and 20 mg capsules contain a therapeutically effective amount of omeprazole, and Genpharm’s products are designed for use in treating gastrointestinal disease. (Lan-ger Tr. 325:5-14; P737 at G24437-38.) Because these two claims depend from claims 1 of both patents, Genpharm raises the same non-infringement arguments, which fail for the same reasons. Genp-harm also argues that Astra failed to prove inducement because Astra failed to offer evidence of actual infringement by third parties or of affirmative acts of inducement by Genpharm, but the court has already found such proof unnecessary. First, Genpharm submitted its ANDA seeking approval to market its product for use in the method patented in these claims. (P737 at G24438.) That submission constitutes an act of direct infringement under 35 U.S.C. § 271(e)(2). Thus, the court finds that Genpharm literally infringes claim 10 of the ’505 patent and claim 13 of the ’230 patent.

Claim 11 of the ’505 patent and claim 15 of the ’230 patent call for “[a] preparation according to claim 1, wherein the subcoating further comprises an alkaline buffering compound.” Genpharm’s subcoating is made of HPMC. (Ugurlu Tr. 3656:18-24; G17B; Davies Tr. 814:13-14; Langer Tr. 326:22; Genpharm by Judy 30(b)(6) Dep. Tr. 308:22-309:3.) The HPMC Genpharm uses is from Colorcon. (Genpharm by Judy 30(b)(6) 309:4-8, 310:8-18; P55 at G3698; P77 at G3672; G17D at G3699.) The court finds by a preponderance of the evidence that Genp-harm uses concentrations of HPMC in its subcoating that are alkaline. According to Genpharm’s own specifications, HPMC with a pH up to 8 is acceptable for use in Genpharm’s products. (Ugurlu Tr. 3682:24-3683:3, 20-22; G17D at G3698.) Genpharm points out that Usan tested and found the pH of Colorcon’s HPMC to be 6.8; .however, that testing was performed on a 1% solution. (Ugurlu Tr. 3684:19-21; G17D at G3698.) The concentration of HPMC in the protective-coating solution used in Ilsan’s manufacturing process for preparing Genpharm’s products is greater *511 than 1%. (Ugurlu Tr. 3684:22-3687:8.) As determined by Dr. Davies, the HPMC used in Genpharm’s subcoat has a pH of 7.93 to 8, with a mean value of 7.97, in a 10% solution. (Davies Tr. 811:19-22, 812:24-25; P591B; P84.) The mean pH value of Genpharm’s HPMC increases from 7.97 to 8.51 to 8.75 to 9.12 with increasing concentrations from 10% to 20% to 40% to 60%; the more HPMC added, the higher the pH. (Davies Tr. 812:24-813:6; P591B; P84.) Thus, Astra has shown that the HPMC used in Genpharm’s subcoat is alkaline.

However, proving that a substance is alkaline is not sufficient to demonstrate that it is an ARC. The ’505 and ’230 patents list HPMC as an example of a material that can be used as an inert subcoating. (PI, col. 4:35-41; P2A, col. 9:30-36.) HPMC is inert and has not been shown by a preponderance of the evidence to be an ARC. (Story Tr. 3760:7-8.) See supra Part IV. E. The Genpharm formulation does not have an alkaline buffering compound or ARC in the subcoat. (Story Tr. 3756:10-13, 3757:23-25.) The sole basis for Dr. Langer’s conclusion that HPMC contains alkaline buffering compound are the tests Dr. Davies conducted that demonstrated that when HPMC is added to water the pH increases. (Langer Tr. 697:25-698:14.) All additional documents and testimony Astra cites, including P591B, Dr. Davies’ lab notebook, and P84, summary of pH measurements from Dr. Davies’ report, show at most alkaline pH values for components of Genpharm’s proposed product. Astra has presented no additional evidence or argument on this issue. Plaintiffs have failed to prove by a preponderance of the evidence that Genp-harm’s HPMC either is itself or contains an alkaline buffering, or alkaline reacting compound. Therefore, the court concludes Plaintiffs have failed to prove that Genp-harm infringes claim 11 of the ’505 patent or claim 15 of the ’230 patent either literally or under the doctrine of equivalents. 49

Claim 12 of the ’505 patent depends from claim 1 and requires that “the core comprises omeprazole and disodium hydrogen phosphate, and the subcoating comprises hydroxy propyl methyl cellulose.” (PI, col. 18:4-7.) Genpharm raises no additional arguments for claim 12, and indeed, claim 12 of the ’505 patent claims precisely the ingredients used in the core and subcoating of Genpharm’s ANDA products. That is, Genpharm’s ANDA products use omeprazole and disodium hydrogen phosphate in the core and HPMC in the subcoating. (Langer 327:20-329:1; P85 at G4133, G4143-44.) Thus, Genp-harm literally infringes claim 12 of the ’505 patent.

Claim 14 of the ’505 patent and claim 12 of the ’230 patent are directed to “[a] process for the preparation of an oral pharmaceutical preparation,” (PI, col. 18:13-14), or “formulation,” (P2A, col. 14:33-34.) Genpharm’s ANDA describes its method for preparing its omeprazole capsules. Genpharm will practice a method for preparing an “oral pharmaceutical preparation” or formulation as that phrase is used in the patents. (Langer Tr. 328:22-329:2; P87 at G46-47.) Claim 14 further involves “preparing a core comprising an effective amount of material selected from the group consisting of orne- *512 prazole plus an alkaline reacting compound.” (PI, col. 18:15-17.) Similarly, claim 12 of the ’230 patent involves a process for preparing a formulation that has “cores containing the acid labile compound mixed with an alkaline reacting compound.” (P2, col. 14:35-36.) Under the process described in its ANDA, Genpharm first prepares cores, containing, amongst other things, omeprazole, which is an acid labile compound, and DHP, which is an ARC. Genpharm’s process includes steps for preparing a core with an effective amount of omeprazole and an alkaline reacting compound. (Langer Tr. 329:3-15; P85 at G4133.) Claim 14 also requires “coating the core with one or more layers of an inert subcoating material selected from among tablet excipients and polymeric film-forming compounds to form a sub-coated core.” (PI, col:18:20-23.) Similarly, claim 12 of the ’230 patent requires that the foregoing cores “are coated with one or more inert reacting subcoating layers.” (P2A, col. 14:39^10.) Genpharm’s manufacturing process includes a step for coating the core with an inert subcoating comprising HPMC. (Langer Tr. 329:16-330:2; P85 at G4143, G4144.) HPMC is water soluble and is a polymer used for film-coating applications. Finally, claim 14 of the ’505 patent requires “coating the sub-coated core with an enteric coating.” (PI, col. 18:24-25.) Likewise, claim 12 of the ’230 patent requires that “the subcoat-ed cores are further coated with an enteric coating layer.” (P2A, col. 14:40^1.) Genpharm’s manufacturing process includes this step, which involves spraying its subcoated pellets with a coating that includes HPMCP. (Langer Tr. 330:3-16; P85 at G4152.)

Genpharm raises two arguments in support of its noninfringement defenses to the process claims, which focus on the first two steps of claim 14. Specifically, and in a manner similar to its approach to claim 1, Genpharm argues (1) that it does not prepare a “core” as required by the claim and (2) that the HPMC protective layer in its product is not the “first” coating. Both arguments fail for much the same reason as explained above with respect to claim 1 — they are predicated entirely on an erroneous claim construction. First, the term “core” does not exclude nonpareil technology, which was conventional at the time the ’505 patent was filed. In fact, Genp-harm’s own expert, Dr. Story, testified that a person who was working in this field prior to 1986 knew that pellets could be made by various conventional methods, including extrusion and spheronization, coating an inert sugar seed in a fluidized bed and pan coating an inert sugar seed. (Story Tr. 3792:11-3793:6.) The fact that claim 14 is a process claim and requires “preparing a core” does not change the analysis. Nowhere in the claim is there any requirement that the “preparing” be accomplished in any particular way, such as by extrusion and spheronization. On its face, claim 14 covers any method used to “prepare” a core. Moreover, the fact that Genpharm “purchases” its sugar sphere from a third party, (Ugurlu Tr. 3668:23-3669:3, 3671:20-3672:7), is irrelevant. The claim does not foreclose the purchase of raw materials from a third party to be used in “preparing a core.” The claim also does not require that the step of “coating the core with ... a subcoating material” be the “first” coating or layer in the formulation. As with claim 1, the word “first” appears nowhere in claim 14, and the specification merely describes the sub-coating as the first layer added after the core is complete. For the foregoing reasons, the court concludes that Genpharm literally infringes claim 14 of the ’505 patent. Claim 12 of the ’230 patent does not differ materially from claim 14 of the ’505 patent, and Genpharm repeats the same noninfringement arguments. For the same reasons as given for claim 14 of *513 the ’505 patent, the court finds that Genp-harm literally infringes claim 12 of the ’230 patent.

Any argument that Genpharm manufactures its ANDA products outside the United States does not avoid infringement of these process claims. Infringement under § 271(g) includes the importation, offer to sell, sale, or use of a product made by a process patented in the United States. Bio-Tech. Gen. Corp. v. Genentech, Inc., 80 F.3d 1553, 1560 (Fed.Cir.1996); see 35 U.S.C. § 271(g) (“Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent”) (emphasis added). A patentee may seek a declaration that a person will infringe a patent under 35 U.S.C. § 271(g) in the future, but there must be an actual controversy for a district court to have jurisdiction. “To demonstrate that an actual controversy exists, a patentee must show that ‘(1) the defendant must be engaged in an activity directed toward ... an infringement charge ... or be making meaningful preparation for such activity; and (2) acts of the defendant must indicate a refusal to change the course of its actions in the face of acts by the patentee sufficient to create a reasonable apprehension that a suit will be forthcoming.’ ” Glaxo, Inc. v. TorPharm, Inc., No. 95 C 4686, 1997 WL 282742, at *3 (N.D.Ill. May 18, 1997) (citations omitted). Here there is no question that all Defendants seek or have obtained FDA approval to sell the proposed ANDA product within the near future; therefore, the actual controversy requirement is met and the declaratory judgment action will be entertained. Id. Astra is entitled to declaratory judgment concerning claim 14 of the ’505 patent and claim 12 of the ’230 patent.

C. Cheminor

Plaintiffs assert that Cheminor’s ome-prazole formulations will infringe claims 1, 5, 9, 10, and 14 of the ’505 patent and claims 1, 6, and 11-13 of the ’230 patent either literally or under the doctrine of equivalents. Cheminor’s ANDA describes three proposed omeprazole products — 10 mg, 20 mg, and 40 mg omeprazole capsule shells containing enteric-coated pellets (hereinafter sometimes referred to as “Cheminor’s ANDA products” or “Chemi-nor’s products”). All the pellets that fill the 10 mg, 20 mg, and 40 mg capsules are the same — they have the same composition. (Prasad Tr. 2986:1-5, 2953:8-25.) The only difference is the number of pellets contained in each type of capsule. Cheminor’s omeprazole formulations and the detailed manufacturing process for making Cheminor’s products is described in Cheminor’s ANDA. (Langer Tr. 378:17-379:15; P446 at OME3321-26, OME3331; P445 at OME60711; see also P446 at OME3338.) Cheminor’s products are “oral pharmaceutical preparations” or formulations as those terms are used in claim 1 of both the ’505 and ’230 patents.

WTien this litigation began, Che-minor did not have a good faith basis for asserting that its product did not infringe claims 1, 4, 5, 8, 10, and 14 of the ’505 patent and at least claim 1 of the ’230 patent. (Cheminor by Koprowski 30(b)(6) Dep. Tr. 51:4-6, 12-16, 19-23, 52:4-12, 58:4-7, 13.) Even though the facts necessary to assess infringement, including knowledge of its own product and the patent claims, specification, and file history, were available to Cheminor long ago, Che-minor has only now raised two infringement issues: (1) whether the meglumine in its products is an ARC or an alkaline buffering compound as required by the claims, and (2) whether its product includes the subcoat of claim 1(b) of the ’505 patent and claim 1(b) and (c) of the ’230 *514 patent. Cheminor also asserts that the ’230 patent does not cover omepra-zole. 50 The court finds that Cheminor literally infringes claims 1, 5, 10, and 14 of the ’505 patent and claims 1, 6, 12, and 13 of the ’230 patent. 51

Cheminor tried several formulation approaches during its omeprazole development efforts. (Cheminor by Ravinder 30(b)(6) Dep. Tr. 40:4-8; Ravinder Dep. Tr. 53:24-54:7.) These efforts included a surfactant approach and a buffer approach. (Ravinder Dep. Tr. 54:11-22, 64:15-17.) The surfactant approach involved the use of a surfactant without using any stabilizers, (Ravinder Dep. Tr. 64:18-20), but the results indicated that a stabilizer was needed in the formulation, and the surfactant approach was discontinued, (Ravinder Dep. Tr. 65:1-24). Cheminor also evaluated the use of a number of buffers as stabilizers in another approach, including phosphate, citrophosphate, and carbonate buffers. (Cheminor by Ravinder 30(b)(6) Dep. Tr. 40:9-41:3; Seetaraju Dep. Tr. 91:5-92:7, 104:3-8; Ravinder Dep. Tr. 56:11-21.) These ingredients were not selected because of the potential for salt formation, which would inn afoul of U.S. Patent No. 4,738,974, an Astra patent covering omeprazole salts. (Prasad Tr. 2926:23-2927:8, 2940:15-22, 2941:16-21, 2942:17-24.) Cheminor wanted to have a formulation with an alkaline core for the omeprazole. (Ravinder Dep. Tr. 225:4-7, 15-25.) Ultimately, Cheminor selected meglumine, which has an alkaline pH. (Langer Tr. 381:19-382:9, 383:25-384:8; P767 at 870-71; P763 at 378.)

Cheminor makes its core pellets by extrusion and spheronization. Cheminor’s core pellet contains omeprazole, mannitol (an excipient), crospovidone (a disinteg-rant), meglumine (an alkaline compound), poloxamer and HPMC (binders). (Prasad Tr. 2889:8-10; Langer Tr. 378:17-25; P446 at OME3321-26; see C174 (Chemi-nor Development Report); C217 (Batch Production Record).) The 3.0 mg of me-glumine used by Cheminor constitutes 1% *515 of the core of Cheminor’s ANDA products. (Prasad Tr. 2889:8-10, 2890:5-21; see C174; C217.) That meglumine stabilizes the omeprazole by providing an alkaline environment around the omeprazole in the core region of Cheminor’s products. (Che-minor by Ravinder 30(b)(6) Dep. Tr. 48:15-19; Ravinder Dep. Tr. 48:17-49:7; Seeta-raju Dep. Tr. 56:15-57:4, 58:16-18, 64:23-65:2, 65:12-19; Prasad Tr. 2963:2-2964:9; P489 at OME11562A; Langer Tr. 381:7-18; P489 at OME11562A; P767 at 870-71; P998 at 332-33.)

Cheminor spray coats its core pellets with a coating solution of polyvinylpyrroli-done (“PVP”). (Langer Tr. 379:1-9; P446 at 3331-34; Cheminor by Ravinder 30(b)(6) Dep. Tr. 77:11-16.) Cheminor chose to use Povidone K-30 PVP as the layer or barrier coat between the enteric coat and the core pellet. (Seetaraju Dep. Tr. 118:5-8; P489 at OME11553A.) Che-minor’s barrier layer contains 26.8 mg of PVP, which is the only material in the intermediate layer between the core and the enteric coating. (Prasad Tr. 2889:24-2890:1, 2917:22-24, 2890:15-21.) PVP is soluble in water. (Prasad Tr. 2915:22-2916:1.) The PVP coating provides an inert barrier between the enteric coat and the core region. (Langer Tr. 390:4-9; P446 at OME3331; P489 at OME11553A; Seetaraju Dep. Tr. 70:18-23; P543 at CDV-00073.) The purpose of the PVP coat in Cheminor’s products is to protect the core materials from the enteric coat, (Prasad 2978:23-25; Langer Tr. 389:16-390:11; P489 at OME11553A), and the PVP coating helps to enhance the stability of Che-minor’s product, (Langer Tr. 391:13-21; Cheminor by Ravinder 30(b)(6) Dep. Tr. 79:2-4). Cheminor’s final step in making its Enteric-coated Pellets will involve pan-coating its PVP-Coated Pellets with a solution of Eudragit L 100-55, triethyl citrate and magnesium stearate in isopropyl alcohol to form an outer enteric coating layer containing Eudragit L 100-55, trie-thyl citrate and magnesium stearate disposed on the PVP-Coated Pellets. (C217, at OME03338-41.) Eudragit L 100-55 is an enteric-coating material; thus, the outer layer on Cheminor’s pellets is an enteric coating. (Prasad Tr. 2979:1-3.)

Claim 1(a) of the ’505 patent describes “a core region comprising an effective amount of material selected from the group consisting of omeprazole plus an alkaline reacting compound.” (PI, col. 16:43-45.) Claim 1(a) of the ’230 patent further describes “an alkaline reacting core comprising an acid-labile pharmaceu-tically active substance and an alkaline reacting compound different from said active substance.” (P2A, col. 13:2-5.) There is no dispute that the core region of Che-minor’s products contains omeprazole and meglumine, (Langer Tr. 378:17-22; P446 at OME3321-26; P489 at OME11553A; Prasad Tr. 2962:24-2964:12, 2976:17-24; Seetaraju Dep. 45:20-22), and the court finds by a preponderance of the evidence that meglumine is an ARC. {See Langer Tr. 389:13-15; see also Langer Tr. 381:3-384:8; P998 at 332-33; P767 at 870-71.) 52 The Merck Index specifies that meglumine has an alkaline pH — the pH of meglumine is 10.5 in a 1% solution, (Langer Tr. 382:6- *516 9; see P767 at 870-71); moreover, Chemi-nor’s witnesses admit that meglumine is an alkaline compound with a pH of about 10.5, (Prasad Tr. 2962:18-23; Ravinder Dep. Tr. 283:9-11; Seetaraju Dep. Tr. 65:12-14).

The ARC claimed in the ’505 and ’230 patents must stabilize the omeprazole by providing a micro-pH of not less than 7 around the omeprazole particles in the core, and the meglumine in Cheminor’s products has that very same function. (Prasad Tr. 2966:14-2968:2; P489 at OME11562A.) Dr. Davies tested the pH of the microenvironment around the ome-prazole particles in the Cheminor product. 53 (Davies Tr. 895:12-896:16; see P1038 at 4-6; P5911.) The microenvironment around the omeprazole particles in Cheminor’s product has a pH of about 9.17, which is within the 7 to 12 range. (Langer Tr. 391:22-392:15; Davies Tr. 896:2-897:19; P5911.) Cheminor argues that Dr. Davies’ measurement of the pH of the core of Cheminor’s ANDA products is irrelevant to the pH in the microenvironment. Cheminor bases this argument on testimony by Dr. Pilbrant. (See Pilbrant Tr. 1498:21-23 (“The entire core doesn’t say anything about the micro-pH, and the pH of the immediate surrounding is what controls the stability of omeprazole.”).) The portion of Dr. Pilbrant’s testimony upon which Cheminor attempts to rely was elicited by counsel for Astra and demonstrates that it is possible to maintain a micro-pH above 7 even though the pH of the entire core is less than 7. The testimony says nothing about the validity of using particular testing methods on particular cores.

Cheminor’s argument ignores the significant structural differences that can exist *517 among different omeprazole formulations, which imply that different testing procedures are appropriate to determine the micro-pH of the omeprazole present in different types of cores. The ’505 and ’230 patents specifically discuss the measurement of micro-pH in the context of the “mixture” of omeprazole, an ARC, and the “conventional pharmaceutical constituents” found in the core. (PI, col. 3:36-46; P2A, col. 8:32-42.) The patents themselves provide explicit directions for completion of an appropriate micro-pH test. Specifically, the experimenter is to test a small amount of the omeprazole-containing region with a small amount of water — like milligrams of material with microliters of water. (PI, col. 3:45-47 (“when water is adsorbed to the particles of the mixture or when water is added in small amounts to the mixture”); P2A, col. 8:40-42; Davies Tr. 806:15-807:11, 896:2-16.) This is precisely what Dr. Davies did to test the micro-pH of the omeprazole in the core of Cheminor’s products. Dr. Davies conducted tests on three samples of Cheminor’s ANDA products by taking a 2 mg sample of the core region and placing it in 2 to 4 microliters of water. 54 (Davies Tr. 1094:20-1095:2.) For Cheminor’s products, Dr. Davies found that it was sufficient to conduct the pH test on the bulk contents of the ome-prazole-containing core. (Davies Tr. 895:12-896:16.) This is because Cheminor makes its cores by mixing all of its core excipients together, (P446; Langer Tr. 395:7-22), which means that the omepra-zole resides throughout the core, the ome-prazole comes into contact with all of the other excipients in the core, and the core itself is the omeprazole-containing region of the pellets, (Davies Tr. 895:12 — 896:1). 55 The court finds that Dr. Davies designed the pH test most suitable for the type of core used by Cheminor. Because the ingredients in Cheminor’s core are mixed together, the micro environment of the omeprazole contains all the excipients present in the core itself. Just as the pH of the core is a result of the pH from the combination of all excipients present in the core region, (Ravinder Dep. Tr. 47:25-48:7), the pH of the microenvironment around the omeprazole results from the combination of all the excipients present in the core, (Ravinder Dep. Tr. 227:12-228:3). Therefore, the court finds that a pH value for the core as a whole, when tested in keeping with the method required by the patents, represents the pH value for the microenvironment of the omeprazole in the Cheminor formulation.

Dr. Davies’ test results are confirmed by Cheminor’s own witnesses and documents. Cheminor’s internal tests demonstrate that meglumine provides an alkaline environment when mixed with omeprazole; therefore, Cheminor’s internal data provides an independent basis for concluding that me-glumine renders to the microenvironment of omeprazole a pH of 7-12. 56 (C222A at CDL 595.) 57 In fact, they demonstrate *518 that the core region of Cheminor’s product has a pH of around 9. 58 (C226 at CDL 841; Ravinder Dep. Tr. 267:22-269:20, 270:11-18.) Cheminor tested the pH of its core pellets by crushing and dissolving them in water. (C226 at CDL 841 (“8.1 omepra-zole pellets ... were crushed and powdered. .. 3.2 each sample ... transferred to 100 ml beaker having 100 ml purified water and stirred”).) Cheminor’s scientists also verified that the purpose of the meglumine in Cheminor’s products is to provide an alkaline environment around the omeprazole in the core and thereby stabilize the omeprazole. (Prasad Tr. 2963:2-2964:9; Seetaraju Dep. Tr. 56:15-57:4; 58:16-18, 64:23-65:2, 65:12-19; see also P489 at OME11562A.) Finally, Che-minor’s Development Report, which was made available to the FDA for review, states, “[mjeglumine provides alkaline environment around omeprazole particles and thus improves stability of omepra-zole.” (P489 at OME11562A; Prasad 2964:10-2965:13; C174 at OME11562A.) On the basis of these facts, the court finds that Cheminor’s ANDA products meet all the limitations of claims 1(a).

Cheminor’s primary argument for non-infringement rests on the position that meglumine is not an ARC as required by subpart (a) of claims 1 of the ’505 and ’230 patents. All of the credible evidence submitted at the trial, however, demonstrates that meglumine is alkaline, it provides an alkaline environment for the omeprazole in Cheminor’s formulation, and it improves the stability of the omeprazole in Cheminor’s product. Cheminor’s Development Report for its product leaves little doubt: “Meglumine is used as a stabilizer for Omeprazole. It is included in FDA Inactive Ingredients guide. Meglumine provides alkaline environment around Omeprazole particles and thus improves stability of Omeprazole.” (P489 at OME11562A.) In addition, Cheminor’s internal pH tests of meglumine in solution demonstrate that meglumine is an alkaline substance. 59 (C224 at CDL 794.) Chemi-nor cites no evidence to contradict its witnesses, internal tests, development report, learned treatises, or tests by Dr. Davies. Cheminor did not cite to any admissible evidence indicating that meglumine is not an ARC, but instead relies on hearsay and attorney argument for its defense.

One position taken by Cheminor addresses an alleged lack of similarity between meglumine and Tris-Buffer, a compound listed in the patents as an ARC. In order to exclude meglumine from the definition of an ARC, Cheminor propounds a new definition of ARC that seeks to read additional limitations into the claims and contains a logical disconnect. Cheminor’s argument is that the patent refers to a specific organic compound, “TRIS Buffer,” as an example of an ARC, and meglumine is not such a buffer, so meglumine is not an ARC. Cheminor’s argument is analogous to saying that New York City includes the Bronx; Brooklyn is not the Bronx; and, therefore, New York City does not include Brooklyn. Whether me-glumine is or is not like Tris-Buffer is irrelevant to the determination of whether meglumine is an ARC. The term “alkaline reacting compound” is broader than the *519 subset of organic pH buffering substances that is listed in the patents, and the patent expressly states that the list of ARCs provided was not meant to be limiting. 6See PI, col. 3:47-48.)

Cheminor also argues that meglumine cannot be an ARC because it contains no acid-base pair and is not a “buffer” as that term is used in classical chemistry. The court has already held that the patents use the term “buffer” more broadly than the limited technical meaning Cheminor proposes. Even Cheminor itself used that broader definition when it described its use of meglumine as a “buffer” during the development of its product. The Chemi-nor/Schein development meeting minutes concerning the development of omeprazole products expressly refer to meglumine as a buffer. (P760 at OME59614 (“[T]he initial data for the formula based on Meglu-mine as a buffer and Poloxamer as a surfactant looks encouraging.”); 60 Prasad Tr. 2969:22-24, 2971:11-23; Cheminor by Ra-vinder 30(b)(6) Dep. Tr. 106:3-14, 106:25-107:3; see also Prasad Tr. 2968:21-2970:6; Cheminor by Ravinder 30(b)(6) Dep. Tr. 103:16-104:5,104:9-105:2.)

A second Cheminor position is that me-glumine was not known in the art as an excipient for pharmaceuticals in 1986, and therefore could not come within the claims of the ’505 or ’230 patents. Specifically, Cheminor argues that meglumine was not known to be a buffer in 1986, so it could not have been considered or claimed as an “organic pH-buffering substanee[ ] such as Tris-Buffer.” As an initial matter, the court notes that this assessment of the state of the art is irrelevant because it is infected by Cheminor’s mistaken claim construction argument that in order to be an ARC meglumine must be an organic buffer like Tris-Buffer. Meglumine need not have been known as a buffer to be an ARC; it simply needs to function as an ARC in the omeprazole formulation. See Specialty Composites v. Cabot Corp., 845 F.2d 981, 989 (Fed.Cir.1988) (holding plasticizers not listed in the specification still within scope of claims) (“The emphasis is on the suitability of any plasticizer that will achieve the specified properties, not on the particular class of plasticizer.”). Thus, under a proper construction of the claim terms, Cheminor’s ANDA products meet all the limitations of claims 1(a) of the patents. 61

*520 Claim 1(b) of the ’505 patent requires “an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said subcoating comprising one or more layers of materials selected from among tablet excipients and polymeric film-forming compounds.” Similarly, claim 1(b) of the ’230 patent requires “an inert subcoating which rapidly dissolves or disintegrates in water disposed on said core region, said subcoating comprising one or more layers comprising materials selected from the group of tablet excipients, film-forming compounds and alkaline compounds.” The ’505 and ’230 patents specifically describe PVP as an inert subcoating material. (PI, col. 3:35-39 and Certificate of Correction at 1 (“The material for the separating layer is chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications such as, for instance, ... polyvinyl-pyrrolidone.”); P2A, col. 9:30-36.) Invention examples 3 and 4 of the ’505 patent employ PVP as the only subcoating material in the formulation. (PI, col. 8:52-60, col. 9:25-30.) Cheminor’s PVP subcoating serves as an inert barrier between the enteric coat and the alkaline core region and helps to enhance the stability of the product. (Langer Tr. 389:16-390:15; P489 at OME11553A; Seetaraju Dep. Tr. 70:18-25; P543 at CD-V-00073; Chemi-nor by Ravinder 30(b)(6) Dep. Tr. 79:2-4.) Despite its argument to the contrary, Cheminor fails to set forth any credible position through evidence, expert testimony, or opinion that would support a nonin-fringement position based on its subcoat-ing not being inert. The only evidence cited by Cheminor is a pH test of Povi-done (PVP) that indicated an acidic pH of 3.6. (Prasad Tr. 2916:21-2917:8.) The patent does not indicate any pH requirement for the materials in the subcoating, and this testimony fails to provide any indication of the effect of PVP in the sub-coating on either the core or the enteric coating of Cheminor’s ANDA products. Although counsel for Cheminor would like the court to assume that this pH value means that “it [PVP] is unlikely to be inert with respect to omeprazole,” (Chemi-nor’s Rebuttal Proposed Findings of Fact Concerning Phase I, ¶ 13.3), Cheminor presented no evidence in support of that logical leap. Indeed, the evidence actually presented at trial is to the contrary. Both Mr. Prasad and Mr. Seetaraju, Chemi-nor’s formulator, testified that the PVP coating in Cheminor’s product is inert, (Prasad Tr. 2977:10-11; Seetaraju Dep. Tr. 70:18-23). As to the “enhanced stability” required by claim 1(c) of the ’230 patent, the court finds by a preponderance of the evidence that Cheminor’s PVP coating enhances the stability of its ANDA products. (Langer Tr. 391:13-21; Chemi-nor by Ravinder 30(b)(6) Dep. Tr. 79:2-4.) The court concludes that Cheminor’s PVP subcoating meets the limitations of claim 1(b) of the ’505 patent and claim 1(b) and (c) of the ’230 patent.

*521 Cheminor belatedly has contrived a non-infringement position based on an incorrect construction of subpart 1(b) as requiring that the subcoating contain a plurality of “materials,” an argument no other Defendant espouses. As the court has already noted, PVP is specifically listed in the patent specification as one example of an inert subcoating, (PI, col. 4:39 and Certificate of Correction), and the patent contains several examples of formulations in which the inert subeoat contains only one polymer film-forming material, (see PI, Ex. 2, col. 8:8-11, Ex. 3, col. 8:56-58, Ex. 4, col. 9:25-28, Exs. 7-8, col. 11:21-24). This is another Cheminor position without support in the record. There is no doubt that a person of ordinary skill in the art reading these patents would understand that claims 1(b) cover a subcoating containing only PVP. Under a proper construction of the claim terms, Cheminor’s PVP coat meets the limitations of subpart (b) of claims 1 of the ’505 and ’230 patents.

Finally, claim 1(c) of the ’505 patent requires “an outer layer disposed on said subcoating comprising an enteric coating.” Claim 1(c) of the ’230 patent also requires “an enteric coating layer surrounding said subcoating layer, wherein the subcoating layer isolates the alkaline reacting core from the enteric coating layer such that the stability of the preparation is enhanced.” There is no question that Che-minor’s product contains an enteric coating as required by claims 1(c) of the ’505 and ’230 patents. (Langer Tr. 390:20-391:12; P489 at OME11553A.) In light of the court’s findings that all elements of claims 1 are satisfied by Cheminor’s ANDA products, the court concludes that Cheminor literally infringes claims 1 of the ’505 and ’230 patents.

Claim 5 of the ’505 patent calls for “[a] preparation according to claim 1 wherein the alkaline core comprises omeprazole and pH-buffering alkaline compound rendering to the microenvironment of ome-prazole a pH of 7-12.” (PI, col. 16:65-68.) Claim 6 imposes a similar requirement with respect to a core comprising an acid labile compound and a pH-buffering alkaline reacting compound. The only new requirement beyond claims 1 is that the micro-pH fall between 7 and 12. In connection with its analysis as to claims 1, the court has already determined by a preponderance of the evidence that the micro-pH of the omeprazole particles in Cheminor’s core falls in the range of pH 7 to pH 12. Therefore, the court concludes that Chemi-nor literally infringes claim 5 of the ’505 patent and claim 6 of the ’230 patent.

Claim 9 of the ’505 patent calls for “[a] preparation according to claim 1 wherein the water content of the final dosage form containing omeprazole does not exceed 1.5% by weight.” (PI, col. 17:20-22.) Claim 11 of the ’230 patent imposes the same requirements for the formulation containing the acid labile compound. (P2A, col. 14:30-32.) The court finds that Astra has failed to prove by a preponderance of the evidence that Cheminor’s en-teric-coated pellets have a water content that does not exceed 1.5% by weight. Dr. Davies tested Cheminor’s products for water content. (Davies Tr. 899:8-900:11; P590A; 62 see P1038 at 6.) Dr. Davies test *522 ed the enteric-coated pellets in Cheminor’s products by using the coulometric method of Karl Fischer titration, and he found that the water content results for six samples were 1.76, 0.8B, 1.15, 1.89, 1.38, and 1.46% and that the water content in Cheminor’s products averaged 1.42%. 63 (Davies Tr. 900:12-903:13, 902:3-13; P590A; P1024; P556; see P1031 at 6-7.) Dr. Davies based his findings on that average; however, Dr. Davies’ data alone does not support an infringement finding. Dr. Langer testified that the standard deviation of the data was 0.2 at a minimum, meaning that, in his view, the data is, at best, accurate within a range of 1.22% to 1.62%. 64 (Langer Tr. *523 640:21-641:2; Davies Tr. 891:13-17.) Therefore, the court finds that Dr. Davies test results, even assuming their accuracy, do not demonstrate by a preponderance of the evidence that Cheminor’s ANDA products have a water content of less than 1.5%.

Astra argues that infringement exists even when some, though not all, products fall within the claims of a patent. Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 622-23 (Fed.Cir.1995) (“[A]n accused product that sometimes, but not always, embodies a claimed method nonetheless infringes.”); Paper Converting Mach. Co. v. Magna-Graphics Corp., 745 F.2d 11, 20 (Fed.Cir.1984) (“[I]mperfect practice of an invention does not avoid infringement.”). However, based upon the evidence submitted at trial, the court is unable to find by a preponderance of the evidence that any of the enteric-coated pellets manufactured by Cheminor infringes these claims. Proof of infringement of claim 9 of the ’505 patent and claim 11 of the ’230 patent requires physical testing of the water content of the final dosage form. (Langer Tr. 393:4-15.) Given the nature of Cheminor’s manufacturing process, which takes a mass of material and reduces the material to tiny spheres, the court does not agree with Astra that variations in water content test results from 0.83% to 1.76% are adequately explained by Astra’s conclusion that there is that much actual water content variation in the samples.

In addition to the failure of proof indicated by Dr. Davies’ numerical results, problems with the testing methods used cause the court to question further the reliability of Dr. Davies’ results. Dr. Davies’ Karl Fischer machine was purchased only two days before the water content tests were conducted on Cheminor’s product, (Davies Tr. 1037:12-15; 1073:23-25), and Dr. Davies was unfamiliar with the Karl Fischer testing method and equipment, (Davies Tr. 1071:8-12). Dr. Davies did not run the Karl Fischer tests himself, and no evidence was presented as to the qualifications or knowledge of the individual who did. (See, e.g., Carr Tr. 2328:22-2329:2.) Dr. Davies used the coulometric method of Karl Fischer water content titration. (Davies Tr. 1087:1-2). The coulo-metric method is particularly suited for substances with low water content that are chemically inert, unlike omeprazole, but including hydrocarbons, alcohols, and ethers, (Reddy Tr. 2867:6-2868:8; P1134; C508), and the method is to be avoided where the ingredients react, (C508). When conducting the testing, Dr. Davies did not account for factors like desiccants, which minimize the water content of a material when present in the container with the material, (Davies Tr. 1063:8-24), and neither Dr. Davies nor his laboratory assistants heated any sample above 100 degrees Celsius to determine if all of the critical water was removed from the sample, (Davies Tr. 1074:18-25). Finally, the lab notebook in which the water content data pertaining to Cheminor’s omeprazole product was recorded omits one of the experiments that is nonetheless reflected in Dr. Davies’ expert report and in his *524 testimony. (Davies Tr. 901:8-15.) In light of these circumstances, which indicate a lack of reliability of testing methods, and the significant potential for error illustrated by the test results themselves, the court finds that Plaintiffs failed to prove by a preponderance of the evidence that Chemi-nor infringes claim 9 of the ’505 patent and claim 11 of the ’280 patent. Therefore, the court concludes that Cheminor does not literally infringe either claim 9 of the ’505 patent or claim 11 of the ’230 patent.

Claim 10 of the ’505 patent is directed to “[a] method for the treatment of gastrointestinal disease comprising administering to a host in need of such treatment a therapeutically effective amount of a preparation according to claim 1.” (PI, col. 17:23-26.) Similarly, claim 13 of the ’230 patent is directed to “[a] method for the treatment of gastrointestinal disease characterized in that a preparation according to claim 1 is administered to a host in need of such treatment in a therapeutically effective amount.” (P2A, col. 14:42^15.) Cheminor’s proposed package insert for its omeprazole capsules instructs the user to swallow the capsules whole and states under the Indication and Usage section that its products can be used for duodenal ulcer, gastric ulcer, gastroesophageal reflux disease (GERD), erosive esophagitis and pathological hypersecretory conditions. (Langer Tr. 394:3-17; P525 at OME60096; see also C207 at OME79.) Thus, Chemi-nor’s package insert instructions for using its omeprazole products direct the treatment of gastrointestinal disease by having patients in need of such treatment swallow a 10 mg, 20 mg, or 40 mg capsule, all of which are therapeutically effective amounts. Cheminor’s only argument in support of noninfringement of claim 10 and claim 13 is that Cheminor has not yet sold, offered to sell or administered to patients its products. That argument is irrelevant because no actual sale or use is required to show infringement under 35 U.S.C. § 271(e)(2). Thus, the court finds that Cheminor literally infringes claim 10 of the ’505 patent and claim 13 of the ’230 patent.

Claim 14 of the ’505 patent and claim 12 of the ’230 patent are directed to “[a] process for the preparation of an oral pharmaceutical preparation,” (PI, col. 18:13-14), or “formulation,” (P2A, col. 14:33-34.) Cheminor’s manufacturing process for its ANDA products is a process for preparation of an oral pharmaceutical preparation. (Langer Tr. 380:1-12, 395:1-5; P569 at OME60011; see also C207 at OME79.) The process includes steps for preparing a core containing an effective amount of omeprazole and an ARC. (Lan-ger Tr. 395:7-22; P446 at OME3322; see also Langer Tr. 380:13-25; P752 at OME2.) The process also includes a step for coating the core with a layer of an inert subcoating comprising PVP. (Langer Tr. 395:23-396:5; P446 at OME3333.) Finally, Cheminor’s manufacturing process includes a step for coating the subcoated core with an enteric coat. (Langer Tr. 396:6-12; P445 at OME60713; see also P446 at OME3338.)

Cheminor only asserts noninfringement of this claim because Cheminor uses the infringing process outside the United States. Cheminor, however, infringes claim 14 of the ’505 patent and claim 12 of the ’230 patent pursuant to 35 U.S.C. § 271(g), which includes the importation, offer to sell, sale, or use of a product made by a process patented in the United States. Bio-Tech. Gen. Corp. v. Genen-tech, Inc., 80 F.3d 1553, 1560 (Fed.Cir. 1996); see 35 U.S.C. § 271(g) (‘Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the *525 product occurs during the term of such process patent.”) (emphasis added). A patentee may seek a declaration that a person will infringe a patent under § 271(g) in the future, but there must be an actual controversy for a district court to have jurisdiction. “To demonstrate that an actual controversy exists, a patentee must show that ‘(1) the defendant must be engaged in an activity directed toward ... an infringement charge ... or be making meaningful preparation for such activity; and (2) acts of the defendant must indicate a refusal to change the course of its actions in the face of acts by the patentee sufficient to create a reasonable apprehension that a suit will be forthcoming.’” Glaxo, Inc. v. TorPharm, Inc., No. 95 C 4686, 1997 WL 282742, at ;::3 (N.D.Ill. May 18, 1997) (citations omitted). Where there is no question that the defendant seeks imminent FDA approval to sell the proposed ANDA product within the near future, the actual controversy requirement is met and the declaratory judgment action will be entertained. Glaxo, Inc., 1997 WL 282742, at *3. Here there is no question that all Defendants seek or have obtained FDA approval to sell the proposed ANDA product within the near future; therefore, the actual controversy requirement is met and the declaratory judgment action will be entertained. Id. The court finds that Astra is entitled to a declaratory judgment that the importation, use, and sale of Che-minor’s ANDA product will literally infringe claim 14 of the ’505 patent and claim 12 of the ’230 patent under 35 U.S.C. § 271(g).

D. Andrx

Plaintiffs assert that Andrx’s omeprazole formulations will infringe claims 1, 3, 5, 6, 8, 10, and 11 of the ’505 patent and claims 1, 6, 7, 10, 13, and 15 of the ’230 patent either literally or under the doctrine of equivalents. Andrx’s ANDA describes its omeprazole formulations and the process for making that formulation. (Langer Tr. 333:10; P116 at 2888-93, 2919-24.) Andrx’s ANDA describes three proposed omeprazole products — 10 mg, 20 mg, and 40 mg capsules (hereinafter sometimes referred to as “Andrx’s ANDA products” or “Andrx’s products”). The pellets that make up the 10 mg, 20 mg, and 40 mg capsules are the same, and the three dosage forms are proportional in their active and inactive ingredients. (Langer Tr. 332:10-17; P253; P254; Andrx Stipulated Statements of Fact No. 9.) The process for making Andrx’s omeprazole products is described in detail in Exhibits P116 and P153. Each strength of capsule will be for an oral route of administration. Therefore, Andrx’s ANDA products, 10 mg, 20 mg, and 40 mg, are “oral pharmaceutical preparations” as those terms are used in the ’505 and ’230 patents.

The first step of the manufacturing process required in Andrx’s ANDA is the creation of an active, omeprazole-contain-ing pellet. (Jan Tr. 3077:18-3078:8.) Andrx’s ANDA requires that a homogenized suspension of micronized omepra-zole; sodium lauryl sulphate, which helps disperse the omeprazole in the suspension; disodium hydrogen phosphate, which helps stabilize the omeprazole; lactose anhydrous, a filler; Povidone, a binder; and water, the solvent, be sprayed onto sugar seeds that carry the active coat for 12 hours in a conventional coating and drying device, known as a fluidized-bed coater. (Jan Tr. 3077:18-3078:8, 3081:11-3082:10; see Langer Tr. 333:4-11, 405:4-8.) A key element of the manufacturing process required in Andrx’s ANDA is homogenization. (A390 at 2477-78 (Add ingredients while “homogenizing;” “dissolve completely;” “[cjontinuously stir the drug suspension throughout the coating process.”).) The homogenization process ensures that the lactose is fully dissolved, and stirring during the coating process “makefs] sure omeprazole is uniformly dispersed.” *526 (A554, Weng 5/15/00 Dep. Tr. 128:9-22.) In the fluidized-bed coater, the pellets pass through an extremely fine mist of the ome-prazole suspension and then continue circulating through the air, which is heated to 104 degrees Fahrenheit. (Jan Tr. 3085:3-16, 3087:19-3088:17.) These active pellets are then further dried in an oven for hours. (Jan Tr. 3089:11-19.)

The second step of the manufacturing process required in Andrx’s ANDA is the creation of the enteric-coated pellet. (Jan Tr. 3078:15-3079:6.) Andrx’s ANDA requires that a homogenized solution of hy-droxypropyl methylcellulose phthalate (“HPMCP”), cetyl alcohol, talc, acetone, and isopropyl alcohol be sprayed onto the active pellets for 12 hours in the fluidized-bed coater. (Jan Tr. 3078:15-3079:6; Lan-ger Tr. 334:21-23; P153 at 2919-2924.) The enteric coating ingredients are extensively homogenized. (A390 at 002492-93 (Add ingredients “while homogenizing;” “[a]llow all materials to dissolve completely;” “[k]eep mixing throughout the entire coating process.”).) Andrx refers to the formulation at this stage as enteric-coated pellets. (P153 at 2919.) Ultimately, the enteric-coated pellets are encapsulated in gelatin capsules of various sizes. (Jan Tr. 3079:8-11; Banakar Tr. 3280:12-19.)

Claim 1(a) of the ’505 patent describes “a core region comprising an effective amount of material selected from the group consisting of omeprazole plus an alkaline reacting compound.” (PI, col. 16:43-45.) Claim 1(a) of the ’230 patent further describes “an alkaline reacting core comprising an acid-labile pharmaceu-tically active substance and an alkaline reacting compound different from said active substance.” (P2A, col. 13:2-5.) Andrx admits that its formulation meets claim 1(a) of the ’505 patent. (P273, Request to Admit No. 15; Langer Tr. 333:12-17; see also Weng Dep. Tr. 61:18-62:10; Davies Tr. 856:13-85711, 929:23-930:3; Langer Tr. 350:20-351:6.) The alkaline reacting compound in Andrx’s product is disodium hydrogen phosphate. (Id.; Andrx Stipulated Statements of Fact No. 15 (“Disodium phosphate is an alkaline reacting compound.”).) Before trial, Andrx also admitted that its ANDA products met the limitations of claim 1(a) of the ’230 patent. (See Langer Tr. 334:1-5; P273 at 5 (Response to Request for Admission No. 16) (“Each of Andrx’s ANDA omeprazole products include the elements of part (a) of claim 1 of the ’230 patent.”).) Nevertheless, in the Joint Pre-trial Order, Andrx asserted that the ’230 patent does not cover omeprazole. Since the court has construed claim 1 of the ’230 patent to include omeprazole, the court rejects Andrx’s argument.

Andrx’s ANDA products contain ome-prazole as the active ingredient and have a microenvironment pH of between 7 and 12. (Langer Tr. 349:12-350:17.) Fashioning the proper test for the microenvironment around the omeprazole depends on the product being tested. (Langer Tr. 619:1— 19.) Because of the way Andrx makes its active layer, the pH of the microenvironment of the omeprazole is the pH of the active layer itself. (Davies Tr. 856:13-857:11.) Dr. Davies measured the pH of the microenvironment by washing off the enteric coat of Andrx’s pellets with an acetone wash, cracking off a piece of the exposed active drug layer, adding a small amount of water and measuring the pH. (Davies Tr. 804:9-808:16; 854:23-555:17; P591C.) The pH testing conducted on the omeprazole-containing region of Andrx’s ANDA products, the active layer, shows that the region has a pH of about 8.15 to 8.3, based on eight separate readings. (Davies Tr. 856:13-23; P591C; P233; see also P1036 (Dem.Ex.) at 20.) Andrx uses DHP in its active layer. (P116 at 2888.) Disodium hydrogen phosphate is an ARC and a pH buffering alkaline compound. *527 (See, e.g., PI, col. 4:14-27; P2A, col. 9:9-22 (“The pH buffering properties ... can be further strengthened by introducing ... the sodium ... salt[ ] of phosphoric” acid.); see also Langer Tr. 353:2-5.) As demonstrated above, the omeprazole-containing region of Andrx’s ANDA products contains DHP, an alkaline reacting compound that stabilizes the omeprazole by creating a micro-pH between pH 7 and pH 12 around the particles. Therefore, the court finds that Andrx’s ANDA products meet all the limitations of claims 1(a) of both the ’505 and ’230 patents.

Andrx’s noninfringement defense centers around the argument that Andrx practices the prior art. Andrx makes three uses of the prior art and the comparative examples in the ’505 patent in its post-trial briefing. First, Andrx claims that it practices the prior art that was disclaimed in the patent and, therefore, cannot be infringing. A claim is literally infringed if the elements of the asserted claim are present in the allegedly infringing product, process or method of use. Enercon v. Int’l Trade Comm’n, 151 F.3d 1376, 1384 (Fed.Cir.1998). The Federal Circuit has “made unequivocally clear ... that there is no ‘practicing the prior art’ defense to literal infringement.” Tate Access Floors, Inc. v. Interface Architectural Resources, Inc., 279 F.3d 1357, 1365 (Fed.Cir.2002). The Federal Circuit rejected the “practicing the prior art” defense to literal infringement, in part, because such a defense impermissibly skews the burdens of proof by letting an infringer avoid the “clear and convincing evidence” standard required to prove invalidity. Tate, 279 F.3d at 1367. Literal infringement analysis is determined by comparing claims to the accused device, “not by comparing the accused device to the prior art.” Tate, 279 F.3d at 1365 (citing Baxter Healthcare Corp. v. Spectramed, Inc., 49 F.3d 1575, 1583 (Fed.Cir.1995)); Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834, 846 (Fed.Cir.1992). Thus, Andrx’s comparison of its ANDA products to the Pilbrant and Cederberg reference and other alleged prior art as part of an infringement analysis impermissibly flips the burdens of proof. The court has already addressed some of these arguments in connection with claim construction, and the court will reconsider them later only in so far as they relate to Andrx’s invalidity defenses.

Second, Andrx asserts the related argument that its ANDA products represent formulations that were disclaimed as part of the comparative examples in the ’505 patent. Andrx is correct that the formulations described in the comparative examples are not claimed by the patents. (See PI, col. 12:40-42, col. 15:11-12; Pil-brant Tr. 1390:1-13, 1390:23-25; Lóvgren Tr. 1834:22-24.) Therefore, the information contained in those Comparative Examples is in the public domain and not covered by the patents. The law is clear that claims of infringement cannot encompass that which has been affirmatively disclaimed and dedicated to the public. See Rheox, Inc. v. Entact, Inc., 276 F.3d 1319, 1325 (Fed.Cir.2002); see Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046, 1054 (Fed.Cir.2002)(holding matters disclosed but not claimed are not within the claims of the patent and may not be recaptured under the doctrine of equivalents). However, the court finds that Andrx’s formulations do not represent any of the comparative examples. Andrx’s comparison of its products to Comparative Example III (“CE III”) is flawed. Andrx’s product composition and process parameters differ significantly from CE III. Andrx’s Dr. Chen admits that Andrx’s products have significantly more ARC than the comparative examples. (Chen Tr. 3057:3-6.) The amount of DHP on a weight/weight basis in the omeprazole- *528 containing region in CE III is 1.19%, whereas for Andrx’s product the amount is 5.51%. (Compare PI, col. 12:52-59, with P116 at 2888.) Dr. Chen also admits that Andrx uses significantly more lactose than the comparative examples. (Chen Tr. 3058:3-6.) Mannitol is the major component in CE III, while lactose is the major excipient component in Andrx’s products. (Compare PI, col. 12:52, with A207 at G5133.) CE III does not disclose detailed process information concerning the preparation of the core region or the enteric coating, but sufficiently detailed process information is available for Andrx’s process to demonstrate that it is not the same as CE III. (Compare PI, col. 12:40-60, with P116, P198.) Dr. Chen admits that in the Andrx process the lactose is completely dissolved, while in the ’505 patent comparative examples the lactose is not dissolved. (Chen Tr. 3058:7-25.) The formulation of CE III has gastric acid resistance of 58%, a poor result, but good storage stability, while the formulation used by Andrx has both good gastric acid resistance and good stability. (PI, col. 14:31.)

Andrx also erroneously asserts that it is practicing one of the non-subcoat formulations of Example 1 in the ’505 patent. Example 1 discloses a tablet formulation. (PI, col. 6:28-29.) Andrx’s products are not tablets. The process for making a tablet can involve different processing steps and different processing parameters from formulating a pellet. (Langer Tr. 502:7-503:12, 528:11-16; Davies Tr. 934:21-935:18.) The ’505 patent does not provide details on the process conditions of Example 1, including tabletting techniques employed for the core and the order of addition of ingredients. As previously explained, Andrx includes a process step to completely dissolve lactose and Dr. Chen admits that the lactose in the example is not completely dissolved. (Chen Tr. 3058:18-22.) The final product characteristics are also different. For example, a review of the stability data in Table 3 shows that the unsubcoated tablet from Example 1 (Roman I, core material 2) degrades over time — starting white and turning brownish white to deep brown under accelerated testing conditions. (PI, col. 7:17-19.) Those data show that discoloration was present on bisected pellets. (PI, col. 7:33-37.) Andrx’s product does not exhibit the same type of degradation over time. Therefore, the court finds that Andrx does not practice the non-subcoated Example 1 formulations.

Third, Andrx relies on the prior art as a defense to Astra’s claims under the doctrine of equivalents. While there is no question Andrx may do so, see We Care Inc. v. Ultra-Mark Int’l Corp., 930 F.2d 1567, 1571 (Fed.Cir.1991) (holding that the range of equivalents may not extend to what the prior art anticipates under 35 U.S.C. § 102 or to what the prior art makes obvious under 35 U.S.C. § 103), the court need not address these arguments because the court finds that Andrx literally infringes all of the asserted claims with the exception of claims 3 and 11 of the ’505 patent and claim 15 of the ’230 patent. Moreover, as to those three remaining claims, the court finds that Astra has failed to carry its burden of demonstrating infringement under the doctrine of equivalents, without reaching the argument of whether Andrx’s products are covered by the prior art.

The infringement issue, then, depends upon whether Andrx’s ANDA products include the subcoat required by claims 1(b) of the ’505 and ’230 patents. Claim 1(b) of the ’505 patent requires “an inert subcoat-ing which is soluble or rapidly disintegrating in water disposed on said core region, said subcoating comprising one or more layers of materials selected from among tablet excipients and polymeric film-form *529 ing compounds.” Similarly, claim 1(b) of the ’230 patent requires “an inert subcoat-ing which rapidly dissolves or disintegrates in water disposed on said core region, said subcoating comprising one or more layers comprising materials selected from the group of tablet excipients, film-forming compounds and alkaline compounds.” Andrx asserts that it does not infringe any of the asserted claims because its ANDA products have no subcoating. Astra argues that Andrx’s enteric-coated pellets have an inert subcoating containing two sublayers that form a barrier between the omeprazole-rich region and the enteric coating as described by claims 1(b) of the ’505 and ’230 patents. According to Astra, one sublayer is made of HPMCP salt, a film-forming compound, and the other is made'of lactose, a tablet excipient. The court finds that Andrx’s ANDA products have an inert subcoating that is disposed on the core region; that subcoating is composed of an HPMCP salt that is rapidly soluble in water and is a polymeric film-forming compound. (See Langer Tr. 346:14-347:5; Davies Tr. 846:20-847:11.) The HPMCP-salt subcoating forms a barrier between the omeprazole and the en-teric coating and enhances the stability of Andrx’s preparations. However, the court finds that Plaintiffs have not proven the existence of a lactose-enriched layer that meets the limitations of claims 1 by a preponderance of the evidence.

Numerous scientific tests were conducted on Andrx’s ANDA products; however, Dr. Davies was the only expert in this case who analyzed Andrx’s enteric-coated products. Among other testing, Dr. Davies examined the structure and chemical make-up of Andrx’s enteric-coated pellets using ultraviolet fluorescence (“UV”) microscopy, attenuated total reflectance-four-ier transform infrared spectrometry (“ATR-FTIR”), time of flight ion mass spectrometry (“ToF-SIMS”), scanning electron microscopy (“SEM”), x-ray photo-electron microscopy (“XPS”), confocal laser scanning microscopy (“CLSM”), solubility testing, pH testing, and visual inspection. 65 (Davies Tr. 790:12-791:6, 816:11-14, 828:20-22, 854:17-22, 939:23-940:16, 968:23-969:9.) The court previously has discussed many of these techniques in connection with its Daubert analysis. One of the first tests Dr. Davies performed on the Andrx ANDA products was to view the Andrx samples 66 using ultraviolet (“UV”) fluorescence microscopy. *530 During the summer of 2000, Dr. Davies bisected over 20 Andrx enteric-coated pellets and observed the cross-section using UV fluorescence microscopy. (Davies Tr. 817:16-21.) A representative UV fluorescence microscopy picture of Andrx’s ANDA products, Exhibit P220, shows a continuous, very bright, intense ring all the way around the bead. (Davies Tr. 816:21-817:22, 821:19-24; see also Davies Tr. 817:23-818:6; P1040 (Dem.Ex.) (pointing out the intense, fluorescing region in P220).) Without exception, every Andrx pellet has this bright ring, (Davies Tr. 817:23-818:6), which is below the enteric coating, but on top of the region of the lactose-containing core region, (Davies Tr. 815:13-23; Langer Tr. 335:18-336:5, 342:16-344:8). The dark blue region all the way to the left of P220 is the sugar seed; the lighter region next to the sugar seed is the active drug layer, and the dark blue region on the outer surface is the enteric coating. (Davies-Tr. 818:22-819:7, P220.) The intense, fluorescing layer underneath the enteric coating ranges in thickness between 3 and 7 microns, (Davies Tr. 827:23-828:10; P220), and is composed of an HPMCP salt that results from the reaction of HPMCP and DHP. (Davies Tr. 815:18-816:3, 837:4-20, 839:9-840:14, 840:22-841:5; Langer Tr. 344:8-345:4). The more intense, more yellow-green layer was shown to have chemical characteristics different from the enteric coating layer; it fluoresces a different color, (Davies Tr. 817:24-818:7), and it is not as soluble in acetone as the enteric coating layer, (Davies Tr. 822:7-823:11, 824:8-23).

Dr. Davies isolated the bright ring visible in the UV images of the Andrx ANDA products by washing the enteric-coated pellets in acetone. (Davies Tr. 822:7-823:11; 824:8-23.) The court does not agree with Andrx’s criticisms of the acetone-washing method Dr. Davies developed to isolate the intense, fluorescing layer. Dr. Davies’ acetone washing was designed to remove the enteric coating of the Andrx products. (Davies Tr. 985:24-986:3.) Dr. Davies used ATR-FTIR to test the pellets at intervals as he washed them to confirm where he was in the washing process. (Davies Tr. 804:17-805:18.) If he detected the HPMCP en-teric coating using the ATR-FTIR testing, Dr. Davies knew he had not yet reached the active or any other layer. (Davies Tr. 986:4-14.) Andrx claims that by defining the washing procedure in terms of finding particular substances, Dr. Davies was able to discard every result in which he was unable to detect any HPMCP salt by claiming he just had not washed those samples enough. Andrx’s suggestion is ludicrous. Dr. Davies was able to tell he had not washed the sample enough because the ATR-FTIR detected the ingredients of the enteric coating, including unreacted HPMCP. Dr. Davies only discovered and identified the HPMCP salt upon ATR-FTIR testing. (Davies Tr. 991:14-21.)

Andrx also argues that the presence of talc in Dr. Davies’ ATR-FTIR analysis indicates that the enteric coating was not fully removed by the acetone-washing procedure. This argument distorts the facts. Dr. Davies explained that the salt layer is the result of a reaction between the HPMCP in the enteric-coating material and the DHP in the active layer. The talc from the enteric-coating spray remains in the HPMCP-salt layer when the HPMCP converts to the salt. (Davies Tr. 992:16-993:4 (“Talc is placed on the product in the enteric coating layer. It is still present during the formation of the HPMCP salt layer .... [The] salt layer [and] the enteric coating layer both contain talc.”).) As can be seen by a comparison of Exhibits P220 and P221, the intense, fluorescing layer remains after washing Andrx’s enteric-coated pellets in acetone to remove the enteric coating. (Davies Tr. 821:19-824:7; *531 compare P220 (enteric-coated pellet before acetone wash); with P221 (enteric-coated pellet after acetone wash).) . Dr. Davies then viewed the acetone-washed pellet using UV fluorescence microscopy. (Davies Tr. 822:17-823:3.) By comparing an active pellet (no bright fluorescing layer) with an enteric-coated pellet (bright fluorescing layer under enteric coating) and an acetone washed pellet (bright layer on the surface), Dr. Davies determined that the bright layer resulted from the enteric-coat-ing process. (Davies Tr. 823:7-824:2.) The absence of the intense, fluorescing layer in the active-coated pellet, which has not been enteric coated, shows that the active-coating process is not the cause of the fluorescence. Its appearance in the enteric-coated pellet shows that the intense, fluorescing layer is created during or after the enteric-coating process. (Davies Tr. 823:24-824:2.) Dr. Davies recognized that the intense, fluorescing layer may be different chemically from the en-teric coating because the acetone washing did not remove the fluorescing layer, which means that the two layers have different solubility characteristics. (Davies Tr. 824:16-23.)

Without any support, Andrx suggests that an Astra-developed acetone-wash methodology, designed to examine a single tablet, is superior to the test used by Dr. Davies. Astra’s methodology and Dr. Davies’ washing techniques were designed for different types of products. The court finds that Dr. Davies’ procedure was appropriate for Andrx’s samples. (See Davies Tr. 1032:10-1033:12.) The Astra procedure related to washing a large tablet with a thicker coating for a much longer time than appropriate for Andrx’s enteric-coated smaller pellets with a much thinner enteric coating. (Davies Tr. 1032:20-1033:12.) Both Dr. Davies’ and Astra’s methodologies included monitoring the wash. Dr. Davies monitored the wash using ATR-FTIR. (Id.; see also Davies Tr. 991:18-21; Davies Tr. 993:20-25 (“[W]hen you undertake a series of washings, you watch for the presence of the HPMCP, distinctive peaks, and you would see those change into the salt peaks. That’s how you know you got to the salt layer.”).) Dr. Davies explained that if the washing is not complete, the ATR-FTIR spectrum matches the spectrum for the enteric coating. (Davies Tr. 994:3-7 (“When you’re acetone washing and you don’t go far enough, you just see the same spectrum as you see from the outside of the enteric coating. You haven’t gone far enough. When you continué to wash, you see those peaks change. You see the ester peaks stay, the acid peaks change into the salt.”).)

Intrigued by the appearance of the unexpected bright layer in the UV images, Dr. Davies decided to identify the chemical composition of the layer using ATR-FTIR. (.See Davies Tr. 827:23-828:22.) ATR-FTIR spectra were obtained from (1) the surface of Andrx’s enteric-coated pellet, (P222); (2) the intense, fluorescing layer that remains after removing the enteric coat, (P228); (3) an HPMCP reference film, (P223); and (4) an in situ HPMCP-salt reference film made by placing a drop of disodium hydrogen phosphate on an HPMCP film, (P229). The enteric coating has a unique ATR-FTIR spectrum, like a fingerprint. (Davies Tr. 829:22-833:16.) A comparison of the ATR-FTIR spectra for the enteric coating and the intense, fluorescing layer shows that the bright layer has a different ATR-FTIR spectrum than the enteric-coating material and, therefore, is different chemically. (Davies Tr. 831:15-833:16, 836:3-16; compare P228; with P222.)

After analyzing the ATR-FTIR test results, Dr. Davies determined that the intense, fluorescing region is a layer of the carboxylic acid salt of HPMCP (“HPMCP salt”). (Davies Tr. 832:12-833:16.) Dr. *532 Davies determined that the ATR-FTIR spectrum for the HPMCP enteric-coating material exhibits absorption peaks at about 1725 cm-1 and 1283 cm-1. (Davies Tr. 833:21-834:22; P222.) Relying on authoritative treatises as well as his own experience, Dr. Davies determined that these peaks reflected the acid-ester in HPMCP. (Davies Tr. 831:19-832:11.) For example, the Aldrich Library of Infrared Spectra, an authoritative treatise, (P774 at 92), shows two peaks associated with an acid-ester, (C-0 at about 1725 cm _1 and C-0 at about 1283 cm _1). (Davies Tr. 833:21-834:22; ° see also P774, at 1017 (showing characteristic absorption peaks for aromatic esters like those found in HPMCP).) On the other hand, the ATR-FTIR spectra for the intense, fluorescing layer exhibits absorption peaks at 1725 cm- and between 1640 cm-1 and 1540 cm-1. (Davies Tr. 834:19-835:11.) Again, relying on authoritative treatises as well as his own experience, Dr. Davies determined that these peaks reflect the presence of an aromatic salt and indicate that the intense, fluorescing region is a layer of HPMCP salt. (Davies Tr. 833:21-836:2.) A comparison of the spectra for the enteric coating and the intense, fluorescing layer shows that salt peaks are present in the bright layer that are not present in the enteric coat. (Compare P228, with P222.) This indicates that the intense, fluorescing region is an HPMCP-salt layer that is chemically distinct from the enteric coating. (Davies Tr. 831:12-833:16; see P1036 (Dem.Ex.) (comparing P228 with P222).)

Dr. Davies confirmed the identity of the salt in the bright layer by comparing ATR-FTIR spectra from a separately prepared HPMCP-salt film with ATR-FTIR spectra from the intense, fluorescing layer. (Davies Tr. 841:22-844:23; compare P231; with P228; see also P1036 at 9 (comparing P223 with P229); P1036 at 10 (comparing P229 with P228).) The existence of the salt peaks in both Exhibits P228 and P231 and the similarity in the spectra confirm that the intense, fluorescing layer is composed of an HPMCP-salt. (Davies Tr. 844:24-845:9; P228; P231.) Dr. Davies examined the composition of Andrx’s active-coated pellet, (Davies Tr. 837:4-14), and based on his ATR-FTIR test results for (1) the Andrx enteric coat compared with an HPMCP reference sample, (Davies Tr. 838:1-24; P1036 (Dem. Ex.) at 8; P223; P222); (2). the Andrx bright layer compared with an HPMCP-salt reference sample, (Davies Tr. 839:9-840:14, 841:6-842:3); and (3) the salt reference and Andrx bright layer compared with the enteric coat and HPMCP reference samples, (Davies Tr. 831:15-833:16; P1036 (Dem.Ex.) at 6; P1036 (Dem Ex.) at 10; P229; P228; P1036 (Dem.Ex.) at 10; P222; P223), Dr. Davies determined that the HPMCP-salt layer forms as a result of the interaction between the enteric coating and the DHP in the active-coated pellet. (Davies Tr. 815:24-816:3, 837:4-20; Langer Tr. 344:7-345:5.) Thus, the court finds that an HPMCP-salt layer forms in the Andrx products as a result of a reaction between the DHP in the core and the HPMCP in the enteric coating. 67 (See Davies Tr. *533 815:24-816:3, 837:11-20, 839:9-840:14, 841:10-842:11; Langer Tr. 344:7-345:5.)

Andrx relies on the testing completed by its expert Dr. Gardella to rebut Astra’s infringement proofs. 68 The only affirmative evidence Dr. Gardella relied on to disprove the existence of an HPMCP-salt layer was his own Time of Flight-Secondary Ion Mass Speetometry (“ToF-SIMS”) analysis for phosphate on the surface of Andrx’s active pellets. 69 (Gardella Tr. 3900:3-6.) Secondary Ion Mass Spectome-try (“SIMS”) is a type of mass spectrometry that uses a beam of “primary” ions, which are charged particles, to cause other “secondary” ions to be ejected from the surface of the sample. (Gardella Tr. 3855:24-3856:6.) In the case of ToF-SIMS, the mass of the secondary ions is calculated by measuring the time it takes for them to travel a known distance. (Gar-della Tr. 3856:7-14.) ToF-SIMS is a form of mass spectrometry that is commonly used to analyze the surface of a sample. (Davies Tr. 937:20-23; Gardella Tr. 3855:14-3856:20.) The technique provides very precise and specific information on the particular molecular’ structures present on the topmost molecular surface of a sample. (Gardella Tr. 3853:22-23, 3857:19-3858:7; Davies Tr. 1023:20-1024:3.) ToF-SIMS is a recognized technique that has been developed over the past fifty years and the use of which is described in published and peer-reviewed scientific literature. (Gardella Tr. 3855:24-3857:16; P771.)

Dr. Gardella conducted two negative ToF-SIMS analyses to detect phosphate and commented on only one of those tests. (Gardella Tr. 3948:4-10.) The only source of phosphate in Andrx’s products is the DHP in the core. (Gardella Tr. 3957:2-11.) Dr. Gardella’s theory was that the ToF-SIMS analysis showed no detectable amount of phosphate on the surface of the active pellet, which meant that there was insufficient DHP present to permit the HPMCP-salt layer to form. (Gardella Tr. 3869:18-3870:1.) Ultimately, Dr. Gardella opined that phosphate was not present above the detection limit of the ToF-SIMS instrument because he did not detect a peak at 95 m/z. (Gardella Tr. 3866:11-18; see generally Gardella Tr. 3865:20-3867:7.) However, Dr. Gardella ignored authoritative treatises that disclose that distinctive peaks for the presence of phosphate appear at 63 m/z and 79 m/z when a sample of DHP is tested. (Gardella Tr. 3953:2-20, 3954:22-25; Davies Tr. 4179:22-4180:4; 4180:8-4182:3.) For example, the Munster *534 High Mass Resolution Static SIMS Library shows the expected spectrum for negative ToF-SIMS analysis of DHP. (Gardella Tr. 3953:2-20.) According to this reference, distinctive peaks appear at 63 m/z and 79 m/z, and both have about the same intensity of approximately 40%. (Gardella Tr. 3955:21-23; P1195.) The peak for phosphate at 95 m/z, on the other hand, has a listed intensity of 0.05%. (Gar-della Tr. 3955:24-3956:1.) That means that the 63 m/z and 79 m/z peaks are about 1000 times more prominent than the 95 m/z peak. Looking at the mass units above 95 in the Library, there is no peak above 95 mass units that has a higher intensity than about 0.5%. (Gardella Tr. 3955:4-3956:7.) Likewise, according to the Static SIMS Library, DHP exhibits peaks at 63 m/z and 79 m/z — the same places the Munster reference shows peaks. (Gardel-la Tr. 3960:17-3961:17.)

Without consulting any reference, Dr. Gardella focused on 95 m/z as the place where he thought phosphate was going to be and looked for masses above that location. (Gardella Tr. 3958:21-3959:3.) Dr. Gardella amplified the region of his spectrum from 94 to 99 mass units, but did not amplify the region below 94, (Gardella Tr. 3963:1-6); this caused his spectrum to distort the scale of the various peaks that were amplified in comparison with those that were not. On cross-examination, Dr. Gardella admitted that his negative ToF-SIMS spectrum does show peaks at 63 m/z and 79 m/z and that these two peaks are a positive indication for phosphate in that spectrum. (Gardella Tr. 3963:7-20.) Dr. Gardella also acknowledged that ToF-SIMS analysis conducted by Dr. Davies showed detectable peaks at 63 m/z and 79 m/z, (Gardella Tr. 3979:23-3980:9), and that Dr. Davies’ peaks at 63 m/z and 79 m/z are consistent with Dr. Gardella’s negative ToF-SIMS. (Gardella Tr. 3980:10-13.) The court finds that it is unable to credit Dr. Gardella’s opinions concerning the amount of phosphate on the surface of the Andrx product for the formation of an HPMCP-salt layer. 70 Unlike Dr. Gardel-la’s results, which appear noisier, Dr. Davies’ ToF-SIMS analysis also exhibits the comparatively weak peak at 95 m/z. (Davies Tr. 4183:23-4185:12; P1276 at 7; P1286 (Dem.Ex.) at 14.) 71 Because ToF- *535 SIMS is not quantitative, even that small peak for phosphate may correlate with the presence of a large amount of DHP. (Gar-della Tr. 3964:17-20; Davies Tr. 4184:24-4185:12.) Dr. Gardella himself testified that peaks at 63 m/z, 79 m/z, and 95 m/z would indicate phosphate concentrations greater than 1%, (Gardella Tr. 3975:19-24), and Dr. Davies found all three of those peaks.

As noted earlier, none of Andrx’s experts conducted testing on Andrx’s enteric-coated product. Since Andrx has no direct evidence to present in support of its argument that there is no subcoating present in its final product, Andrx resorts to attacking the reliability of Dr. Davies’ testing. The court has addressed some of those objections in conjunction with its decision to deny Andrx’s motion to exclude Dr. Davies’ testimony under Daubert. The court will address the remainder of those objections at this time. Dr. Davies consulted a series of tests to gain a basic understanding of Andrx’s product, to determine appropriate testing methodology, and to assure that his testing accurately characterized Andrx’s ANDA product. {See, e.g., Davies Tr. 822:13-25, 940:6-16.) The court finds that the evidence demonstrates that Dr. Davies’ tests are reliable and that Dr. Davies’ tests provide compelling evidence that Andrx’s product has an HPMCP-salt subcoating.

One test performed by Dr. Davies that Andrx attacks is the UV fluorescence microscopy. Dr. Davies used UV fluorescence microscopy to verify the structure of the products for all Defendants in this litigation. (Davies Tr. 790:12-23; see also P82 (Genpharm), P220 (Andrx), P387 (KUDCo), P554 (Cheminor).) Using UV fluorescence microscopy, Dr. Davies found a subcoating layer in the Andrx ANDA products; other testing later confirmed that layer was composed of an HPMCP salt. (Davies Tr. 816:11-14.) After viewing the whole pellet under the microscope, Dr. Davies zoomed in on the portions of Andrx’s products that showed the presence of different coatings. (Davies Tr. 801:6-802:4, 816:6-8.) Dr. Davies noticed an intense, fluorescing ring all the way around the Andrx pellet. (Davies Tr. 817:5-818:6; P220; P221; see also P249-P251.) Dr. Davies viewed over twenty Andrx pellets. (Davies Tr. 817:23-818:6.) As a result of the number of pellets studied, the court is confident that P220 is representative of Andrx’s product. (Davies Tr. 821:19-24.) There is no dispute that a change in the intensity of fluorescence, like that seen in Exhibit P220, indicates a different environment, (Salzberg Tr. 3504:18-21); moreover, color change may indicate a different chemical environment that can be due to a different chemical substance being present, (Salzberg Tr. 3503:10-15; Davies Tr. 800:16-24). According to Dr. Davies, the intense, fluorescing layer appeared to be a different color from the area on either side of it, indicating the presence of a different chemical environment. (Davies Tr. 800:16-24; see also Davies Tr. 818:24-819:18.)

*536 Andrx criticizes Dr. Davies because he relied on a visual inspection to determine that a color change existed in the first instance. (See Davies Tr. 951:2-4.) The court notes that Dr. Davies has the trained eye of a scientist who has interpreted many UV fluorescence microscopy images of drug formulations. (See, e.g., Davies Tr. 784:5-14.) More importantly, the difference in the chemical nature of the intensely fluorescent layer, and, therefore, the presence of the HPMCP-salt layer, was confirmed by ATR-FTIR testing. Andrx’s suggestion that Dr. Davies needed to bolster his opinion that the UV fluorescence image exhibited a color change ignores the confirmatory ATR-FTIR testing that proves that the intense, fluorescing region corresponds to the chemically distinct HPMCP salt. On behalf of Andrx, Dr. Salzberg asserted that independent color-change tests of the intense, fluorescing region were a necessity. This assertion demonstrates that Dr. Salzberg does not understand the objective of the testing. Dr. Davies’ study was not designed to find a “color change.” The study was designed to learn more about the bright region. (Davies Tr. 821:25-822:6.) Dr. Davies accomplished this task using a different, but scientifically appropriate, method that provided more information than a test for color change — the ATR-FTIR identified the chemical substance. (Davies Tr. 828:20-830:16.) Dr. Salzberg wrongly believed that Dr. Davies was basing his determination that the fluorescing layer was chemically distinct solely on visual inspection of the UV fluorescence microscopy image and not on ATR-FTIR testing. (Salzberg Tr. 3498:25-3499:15.) Dr. Salz-berg is not an expert in ATR-FTIR, has never used ATR-FTIR, and did not pay attention to Dr. Davies’ use of ATR-FTIR. (Salzberg Tr. 3497:6-18, 3498:21-24.) Dr. Davies’ ATR-FTIR testing confirmed that the HPMCP-salt layer corresponded to the intense, fluorescing layer observed with the UV fluorescence microscopy.

Andrx suggests that the presence of omeprazole in the core might have affected Dr. Davies’ results in two ways. First, Andrx implies that the ring-like fluorescence is the result of the effect of acetone on omeprazole during the washing procedure. If the salt did not exist, however, Dr. Davies would not have detected any salt peaks using the ATR-FTIR testing. Moreover, Dr. Lovgren testified that he personally examined a number of in situ formed subcoats made using a placebo — no omeprazole — that exhibited fluorescence. (Lovgren Tr. 1810:24-1811:7.) If the fluorescence were caused by an interaction with omeprazole, placebo pellets would not fluoresce. In addition, Dr. Davies’ ATR-FTIR testing of the salt layer did not detect omeprazole or degraded omepra-zole. (Davies Tr. 968:23-970:9, 971:7-22; Gardella Tr. 3978:20-25.)

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