Celgene Corporation v. Mylan Pharmaceuticals Inc.

Case: 21-1154    Document: 50    Page: 1     Filed: 11/05/2021




   United States Court of Appeals
       for the Federal Circuit
                  ______________________

                CELGENE CORPORATION,
                    Plaintiff-Appellant

                            v.

  MYLAN PHARMACEUTICALS INC., MYLAN INC.,
                MYLAN N.V.,
             Defendants-Appellees
            ______________________

                        2021-1154
                  ______________________

     Appeal from the United States District Court for the
 District of New Jersey in No. 2:19-cv-05802-ES-MAH,
 Judge Esther Salas.
                 ______________________

                 Decided: November 5, 2021
                  ______________________

     ELLYDE R. THOMPSON, Quinn Emanuel Urquhart &
 Sullivan, LLP, New York, NY, argued for plaintiff-appel-
 lant. Also represented by FRANCIS DOMINIC CERRITO,
 FRANK CHARLES CALVOSA, ERIC C. STOPS; MATTHEW J.
 HERTKO, Jones Day, Chicago, IL; JENNIFER L. SWIZE,
 Washington, DC.

     TUNG ON KONG, Wilson, Sonsini, Goodrich & Rosati,
 PC, San Francisco, CA, argued for defendants-appellees.
 Also represented by KRISTINA M. HANSON; STEFFEN
Case: 21-1154    Document: 50     Page: 2    Filed: 11/05/2021




 2     CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 NATHANAEL JOHNSON, GEORGE E. POWELL, III, Washing-
 ton, DC; ELHAM FIROUZI San Diego, CA.
                 ______________________

     Before PROST, CHEN, and HUGHES, Circuit Judges.
 PROST, Circuit Judge.
    This is a case about venue and pleading under the
 Hatch-Waxman Act.
     Celgene Corporation (“Celgene”) markets pomalido-
 mide as a multiple-myeloma drug under the brand name
 Pomalyst. It has patents related to that drug, but many
 drug companies viewed the validity or applicability of those
 patents with skepticism and sought to bring generic poma-
 lidomide to market. They applied to the FDA to do so;
 Celgene sued. This appeal concerns Celgene’s suit sur-
 rounding the abbreviated new drug application (“ANDA”)
 submitted by Mylan Pharmaceuticals Inc. (“MPI”).
     Celgene filed that suit in New Jersey. Celgene is head-
 quartered there, but none of the defendants are. Rather,
 MPI is based in West Virginia, Mylan Inc. in Pennsylvania,
 and Mylan N.V. in Pennsylvania and the Netherlands. The
 district court ultimately dismissed this case for improper
 venue (as to MPI and Mylan Inc.) and for failure to state a
 claim (as to Mylan N.V.). Celgene appeals.
      For the reasons below, we agree with the district court
 that venue was improper in New Jersey for the domestic-
 corporation defendants, MPI and Mylan Inc. That is,
 Celgene did not show that those defendants committed acts
 of infringement in New Jersey and have a regular and es-
 tablished place of business there. We also agree that, as to
 the foreign-corporation defendant, Mylan N.V., Celgene’s
 pleadings failed to state a claim upon which relief could be
 granted. We therefore affirm.
Case: 21-1154    Document: 50     Page: 3    Filed: 11/05/2021




 CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.       3



                              I
                              A
     In 1984, Congress enacted the Hatch-Waxman Act, a
 complex statutory framework that tries to balance generic
 and brand interests within the pharmaceutical industry.
 See Drug Price Competition and Patent Term Restoration
 Act of 1984, 

Pub. L. No. 98-417, 98

 Stat. 1585. One aim of
 Hatch-Waxman was to “speed the introduction of low-cost
 generic drugs to the market.” Caraco Pharm. Labs., Ltd.
 v. Novo Nordisk A/S, 

566 U.S. 399, 405

 (2012); see also Eli
 Lilly & Co. v. Medtronic, Inc., 

496 U.S. 661, 676

 (1990).
      To market a new drug, a sponsor submits to the FDA a
 new drug application (“NDA”). See Caraco, 

566 U.S. at 404

. An NDA must contain the drug’s proposed labeling
 and directions for use but also must contain extensive in-
 formation on clinical trials showing that the drug is safe
 and effective for its labeled use. See 

id.

 Brand-drug spon-
 sors are also required to inform the FDA of all its patents
 covering the drug or its labeled methods of use. See
 

21 U.S.C. § 355

(b)(1), (c)(2). These patents are publicly
 listed in what is known as the Orange Book. Caraco,
 566 U.S. at 405–06.
      To speed the introduction of low-cost generics, Hatch-
 Waxman includes the option for generic-drug sponsors to
 submit an abbreviated new drug application, or ANDA.
 With an ANDA, a generic-drug sponsor need not repeat a
 brand drug’s safety-and-efficacy trials at great (and scien-
 tifically redundant) expense. Instead, a generic-drug spon-
 sor must show that its product is bioequivalent to the
 reference brand drug. See 

id.

 If so, the sponsor can market
 that generic drug with a label matching that of brand drug.
 See 

id. at 415, 425

.
     A generic-drug sponsor may not market a drug in a way
 that infringes a brand-drug sponsor’s patents. See 

id.

 at 405–06; FTC v. Actavis, Inc., 

570 U.S. 136, 143

 (2013).
Case: 21-1154     Document: 50     Page: 4    Filed: 11/05/2021




 4       CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 The generic must therefore “assure the FDA” that market-
 ing the generic “will not infringe.” Actavis, 

570 U.S. at 143

.
 It does so through certifications to the FDA.
     An ANDA applicant might choose to avoid infringe-
 ment by waiting out a patent’s term. If so, the applicant
 includes with its ANDA a so-called paragraph III certifica-
 tion for that patent. See 

21 U.S.C. § 355

(j)(2)(A)(vii)(III).
 It might also omit a patented method of use from its drug
 label and therefore not seek approval in a way that impli-
 cates the patent. See 

21 U.S.C. § 355

(j)(2)(A)(viii); Caraco,
 566 U.S. at 406–07, 425; United Food & Com. Workers Lo-
 cal 1776 & Participating Emps. Health & Welfare Fund
 v. Takeda Pharm. Co., 

11 F.4th 118

, 124–27 (2d Cir. 2021).
 But an applicant might also think that a patent is invalid,
 unenforceable, or not infringed, notwithstanding its ANDA
 encompassing the same methods of use as the brand drug’s
 NDA. If so, the applicant can ask for full approval (without
 omitting any methods of use from its drug label) during the
 patent’s term and include with its ANDA a paragraph IV
 certification. See 

21 U.S.C. § 355

(j)(2)(A)(vii)(IV).
     Submitting an ANDA that seeks approval to market a
 drug while that drug is on-patent (e.g., an ANDA contain-
 ing a paragraph IV certification) is patent infringement.
 

35 U.S.C. § 271

(e)(2); see also Valeant Pharms. N. Am. LLC
 v. Mylan Pharms. Inc., 

978 F.3d 1374

, 1381–82 (Fed. Cir.
 2020). 1 If a generic goes the paragraph IV route, the brand
 can sue under a set of rules particular to this kind of in-
 fringement. The way this works is that the generic must


     1    That is not to say that a generic’s failure to comply
 with some procedural rule surrounding the paragraph IV
 certification renders an ANDA noninfringing. The statu-
 tory infringement question is whether the “purpose” of the
 submitted ANDA “is to obtain approval” to market the drug
 “before the expiration of [the relevant] patent.” 

35 U.S.C. § 271

(e)(2).
Case: 21-1154      Document: 50      Page: 5     Filed: 11/05/2021




 CELGENE CORPORATION     v. MYLAN PHARMACEUTICALS INC.          5



 provide a so-called paragraph IV notice to the patentee
 brand-drug sponsor after it submits its ANDA and the FDA
 confirms receipt of the submission.              See 

21 U.S.C. § 355

(j)(2)(B); see also 

id.

 § 355(j)(2)(B)(ii)(I). That notice
 must include “a detailed statement of the factual and legal
 basis of the opinion of the applicant that the patent is in-
 valid or will not be infringed.”                     

21 U.S.C. § 355

(j)(2)(B)(iv)(II). The notice and accompanying de-
 tailed statement, however, are not part of the ANDA and
 need not be submitted to the FDA. See id.; 

21 C.F.R. § 314.95

(e). Indeed, the substance of the notice letter (i.e.,
 the generic’s legal opinion) is immaterial to the FDA, which
 professes to lack “expertise” and “authority” on patent mat-
 ters.    See Caraco, 566 U.S. at 406–07; United Food,
 

2021 WL 3744899

, at *3; Applications for FDA Approval to
 Market a New Drug, 

68 Fed. Reg. 36,676

, 36,683 (June 18,
 2003) (“[W]e have long observed that we lack expertise in
 patent matters.”).
      A brand-drug sponsor that sues within 45 days of re-
 ceiving notice of a generic’s paragraph IV certification is
 entitled to an automatic thirty-month stay of FDA approval
 so the infringement and validity questions can be worked
 out in court. 

21 U.S.C. § 355

(j)(5)(B)(iii); Actavis, 

570 U.S. at 143

. If a brand-drug sponsor waits more than 45 days
 after it receives notice, it isn’t entitled to that stay but also
 isn’t precluded from suing later for infringement. See, e.g.,
 GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 

7 F.4th 1320

, 1325 (Fed. Cir. 2021); Dey Pharma, LP v. Sunovion
 Pharms. Inc., 

677 F.3d 1158, 1160

 (Fed. Cir. 2012); Teva
 Pharms. USA, Inc. v. Novartis Pharms. Corp., 

482 F.3d 1330, 1341

 (Fed. Cir. 2007); Valley Drug Co. v. Geneva
 Pharms., Inc., 

344 F.3d 1294

, 1297 n.5 (11th Cir. 2003). If
 the brand-drug sponsor doesn’t sue within the 45 days, the
 generic can instead bring a declaratory-judgment action “to
 obtain patent certainty.”           

21 U.S.C. § 355

(j)(5)(C)(i);
 

35 U.S.C. § 271

(e)(5); see Dey Pharma, 677 F.3d at 1160–
 61; Teva, 

482 F.3d at 1335

. The upshot is that the timing
Case: 21-1154     Document: 50     Page: 6    Filed: 11/05/2021




 6       CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 of receipt of the notice letter governs the timing of the
 availability of particular forms of relief.
                               B
     In early 2017, MPI submitted an ANDA seeking ap-
 proval to market a generic version of Pomalyst before the
 expiration of four Orange-Book-listed patents. MPI in-
 cluded a paragraph IV certification as to those patents. In
 turn, Celgene sued the defendants under the Hatch-Wax-
 man Act, asserting the four listed patents.
     Celgene later obtained (and asserted) five more related
 patents. It sued the same defendants again twice—once in
 2018, asserting one of the later-issued patents, and once in
 2020, asserting another. Those cases were consolidated
 with the 2017 one. For the sake of simplicity, we call that
 consolidated six-patent action “the first case.” 2 In 2019,
 Celgene asserted the remaining three of the later-issued
 patents (again against these defendants, again in New Jer-
 sey) through a largely identical complaint. That’s this
 case. 3 This procedural bookkeeping matters because this
 case, though not consolidated with the first, shared Rule 12
 briefing with it. That is, the parties stipulated that the
 resolution of motions to dismiss in the first case would gov-
 ern this one too. See J.A. 220–23.
     Celgene filed its first case in May 2017. The defend-
 ants-appellees moved to dismiss for improper venue and
 failure to state a claim in August 2017. That motion was
 denied in March 2018 without prejudice so that the parties
 could engage in venue-related discovery.




     2   Celgene Corp. v. Hetero Labs Ltd., No. 17-cv-3387
 (D.N.J.).
    3    Celgene Corp. v. Mylan Pharms., No. 19-cv-5802
 (D.N.J.).
Case: 21-1154    Document: 50      Page: 7    Filed: 11/05/2021




 CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.        7



     After two years of that discovery, the defendants re-
 newed their motion to dismiss. The district court reviewed
 the motion under In re Cray Inc., 

871 F.3d 1355

 (Fed. Cir.
 2017), and concluded that venue was improper. Namely,
 the thin set of facts that Celgene had gathered after those
 two years—the presence of affiliated entities and employ-
 ees in New Jersey—failed to show a “regular and estab-
 lished place of business” of the defendants in the district
 under 

28 U.S.C. § 1400

(b).
     The district court also concluded that, for Mylan N.V.,
 Celgene had failed to state a claim upon which relief could
 be granted. That is, the ANDA that Celgene itself included
 with its complaint sought approval only on behalf of MPI.
 And Celgene’s pleadings with respect to the involvement of
 Mylan N.V. in that submission were simply too speculative
 and conclusory. In doing so, the district court also rejected
 Celgene’s request in the alternative for leave to amend its
 pleadings.
     Celgene appeals. We have jurisdiction under 

28 U.S.C. § 1295

(a)(1).
                              II
    First we turn to the district court’s dismissal of MPI
 and Mylan Inc. for improper venue.
     We review de novo whether venue under § 1400(b) is
 proper. 4 Valeant, 

978 F.3d at 1381

. The plaintiff has the
 burden of establishing proper venue under that provision.
 Andra Grp., LP v. Victoria’s Secret Stores, L.L.C., 

6 F.4th 1283, 1287

 (Fed. Cir. 2021).
     To establish venue, a plaintiff may show either that the
 defendant “resides” in a particular district or that it “has
 committed acts of infringement and has a regular and


     4  Federal Circuit law applies to this issue, which is
 unique to patent law. Valeant, 

978 F.3d at 1381

.
Case: 21-1154     Document: 50     Page: 8    Filed: 11/05/2021




 8       CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 established place of business” there. 

28 U.S.C. § 1400

(b).5
 No one argues that the defendants-appellees reside in New
 Jersey. And so Celgene has the burden of meeting both
 portions of the other prong of § 1400(b)—that is, showing
 both the defendants’ acts of infringement in the district and
 their regular and established place of business there. The
 district court concluded that it had not met that burden
 with respect to MPI and Mylan Inc. For the reasons below,
 the district court was correct.
                               A
     First, we address whether MPI and Mylan Inc. “com-
 mitted acts of infringement” in New Jersey. We conclude
 that they did not.
                               1
     As we have repeatedly observed, “the Supreme Court
 has instructed that the requirement of venue is specific and
 unambiguous; it is not one of those vague principles [that],
 in the interests of some overriding policy, is to be given a
 liberal construction.” Andra, 

6 F.4th at 1287

 (cleaned up)


     5   Celgene also argues—largely on policy grounds—
 that venue in Hatch-Waxman cases should be governed by
 

28 U.S.C. § 1391

(c), the general venue provision. But TC
 Heartland and Valeant say otherwise. The Supreme Court
 in TC Heartland reaffirmed that § 1400(b) is the sole and
 exclusive provision controlling venue in patent infringe-
 ment actions. TC Heartland LLC v. Kraft Foods Grp.
 Brands LLC, 

137 S. Ct. 1514, 1519

 (2017). And this court
 in Valeant reiterated that submitting an ANDA is an act of
 infringement for purposes of § 1400(b).             978 F.3d
 at 1381–82. It follows that § 1400(b) is the sole venue pro-
 vision with respect to domestic defendants in Hatch-Wax-
 man actions. See also Valeant, 

978 F.3d at 1382

 (“Congress
 enacted § 1400(b) in 1948 to be a standalone venue statute
 for patent cases.”).
Case: 21-1154     Document: 50      Page: 9    Filed: 11/05/2021




 CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.         9



 (citing Schnell v. Peter Eckrich & Sons, Inc., 

365 U.S. 260, 264

 (1961)); see also In re Google LLC, 

949 F.3d 1338, 1346

 (Fed. Cir. 2020) (“[T]he Supreme Court has cautioned
 against a broad reading of the venue statute.”). Time and
 again “we have narrowly construed the requirements of
 venue in patent cases.” Valeant, 

978 F.3d at 1379

.
     This court in Valeant recently addressed venue under
 Hatch-Waxman. We reiterated that “venue in Hatch-Wax-
 man cases must be predicated on past acts of infringe-
 ment.” Valeant, 

978 F.3d at 1381

. And for the purposes of
 the Hatch-Waxman Act, “it is the submission of the ANDA,
 and only the submission, that constitutes an act of infringe-
 ment in this context.” 

Id.

 In so holding, we expressly re-
 jected relying on the contemplated future conduct of the
 generic-drug sponsor. 

Id.

 at 1381–83.
                               2
     Celgene argues that the defendants have committed
 acts of infringement in New Jersey. Here, the alleged in-
 fringing act is the submission of the ANDA. See 

35 U.S.C. § 271

(e)(2); Valeant, 

978 F.3d at 1381

. The question is
 where the submission occurred and what acts it includes.
     First, Celgene argues that the “artificial act of infringe-
 ment stemming from the ANDA submission extends na-
 tionwide” (i.e., wherever the generic drug will be marketed
 and sold). Relatedly, it contends that the effects of the
 ANDA submission will be “felt” in New Jersey. But Vale-
 ant squarely forecloses Celgene’s position. Venue must be
 “predicated on past acts of infringement.”            Valeant,
 

978 F.3d at 1381

. For Hatch-Waxman cases, this means
 venue is proper “where an ANDA-filer submits its ANDA
 to the FDA,” not “wherever future distribution of the ge-
 neric is contemplated.” 

Id.

 at 1378–79; see also 

id. at 1384

.
    Second, Celgene argues that, because MPI sent a par-
 agraph IV notice letter from West Virginia to Celgene’s
 headquarters in New Jersey, acts of infringement occurred
Case: 21-1154    Document: 50      Page: 10    Filed: 11/05/2021




 10    CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.



 in New Jersey. The notice letter is mandatory and the
 ANDA must be amended later to include proof that it was
 delivered. See 

21 C.F.R. § 314.95

(a), (e). So, says Celgene,
 receipt of the letter by the brand sponsor is part of the “act
 of infringement” for venue purposes. We disagree.
      This court in Valeant stated that “[u]nder the plain lan-
 guage of the statute, the only past infringing act is the
 ANDA submission, which creates the right to bring suit in
 the first instance.” 

978 F.3d at 1382

. Celgene argues that
 infringement for venue purposes includes all “acts that are
 ‘sufficiently related to the ANDA submission.’” See, e.g.,
 Appellant’s Br. 48, 50, 51 (quoting Valeant, 

978 F.3d at 1384

). Celgene is incorrect. While the court took care
 not to prematurely “define what all relevant acts involved
 in the preparation and submission of an ANDA might be,”
 Valeant, 

978 F.3d at 1384

 n.8, it did make clear that it is
 the submission that infringes, 

id.

 at 1381–82. Valeant’s fo-
 cus on the submission itself (along with acts involved in its
 “preparation”) indicates that the relevant infringing acts
 must, at a minimum, fairly be part of the submission—not
 merely “related to” it in some broader sense. See 

id. at 1384

 (considering whether “acts occurred” in the district
 “that would suffice to categorize those taking them as a
 ‘submitter’ under § 271(e)”). After all, the relevant prong
 of § 1400(b) restricts venue to “where the defendant has
 committed acts of infringement”—not where the defendant
 has committed acts related to (but not part of) acts of in-
 fringement. See Valeant, 

978 F.3d at 1381

 (“[I]t is the sub-
 mission of the ANDA, and only the submission, that
 constitutes an act of infringement in this context.”).
     With this in mind, we turn to Celgene’s argument that
 receipt of the notice letter is an infringing act in New Jer-
 sey. Celgene says that the notice letter is an “essential part
 of the ANDA submission” itself, Appellant’s Br. 50, and
 that the defendants “had to undertake an act in New Jer-
 sey to fulfill its requirements for its ANDA submission,”
 Reply Br. 25. But the statute and regulations treat the
Case: 21-1154     Document: 50      Page: 11    Filed: 11/05/2021




 CELGENE CORPORATION     v. MYLAN PHARMACEUTICALS INC.        11



 infringing ANDA submission and the notice letter as dif-
 ferent things. For example, the initial ANDA submission
 to the FDA requires the applicant to state that it “will give
 notice”—and such notice “shall” be given “not later than
 20 days after” the date that the FDA confirms that the
 ANDA has been filed. 

21 U.S.C. § 355

(j)(2)(B)(i), (ii)(I);
 

21 C.F.R. § 314.95

(b)(1). Indeed, the ANDA applicant can-
 not send the notice letter before the FDA has confirmed re-
 ceipt of the ANDA. 

21 C.F.R. § 314.95

(b)(2). The notice
 letter itself is even required to state that an ANDA “has
 been submitted.” 

21 U.S.C. § 355

(j)(2)(B)(iv); 

21 C.F.R. § 314.95

(c)(1) (specifying that “the notice must include,”
 among other things, “[a] statement that [the] FDA has re-
 ceived an ANDA submitted by the applicant”). And the ap-
 plicant is under no obligation to send a copy of the notice
 letter itself to the FDA. 

21 C.F.R. § 314.95

(e) (“A copy of
 the notice itself need not be submitted to the Agency.”); 

id.

 § 314.95(b)(3) (similar). Further, one statutory provision
 separately references “the date on which the [para-
 graph IV] notice is received” and “the date on which the ap-
 plication . . . was submitted.” 

21 U.S.C. § 355

(j)(5)(B)(iii).
 Under the statute and regulations, then, receipt of the no-
 tice letter occurs after and apart from the submission of the
 ANDA.
     Celgene argues that infringement under 

35 U.S.C. § 271

(e)(2) occurs only once the ANDA filing contains a par-
 agraph IV certification—and therefore that receiving the
 notice letter is part of the infringing act because it “triggers
 the patent owner’s infringement claim.”            Appellant’s
 Br. 49–50. We disagree. First, as we explained above, the
 paragraph IV certification in the ANDA precedes the notice
 letter. And although receipt of the letter influences the
 timing of the lawsuit by setting a 45-day cutoff after which
 the patentee cannot get an automatic 30-month stay of fi-
 nal approval, the letter itself does not establish the cause
 of action. The ANDA submission does. The statute itself
 says that it is an act of infringement to “submit . . . an
Case: 21-1154    Document: 50      Page: 12     Filed: 11/05/2021




 12    CELGENE CORPORATION     v. MYLAN PHARMACEUTICALS INC.



 [ANDA] application” “if the purpose . . . is to obtain ap-
 proval” to market the drug “before the expiration of” a rel-
 evant patent. 

35 U.S.C. § 271

(e)(2). Celgene points to no
 authority suggesting either that an ANDA with noncompli-
 ant notice doesn’t infringe or that it can never sue for in-
 fringement if the generic doesn’t comply with the
 formalities of the notice provision.
     Under § 271(e)(2), submitting an ANDA is the act of in-
 fringement. And although the ANDA applicant must later
 send a notice letter and inform the FDA of the letter’s re-
 ceipt, that all happens after the infringing submission.
 Sending a paragraph IV notice letter does not fall within
 “submitting” the ANDA under the meaning of Valeant. Ac-
 cordingly, we conclude that Celgene did not establish that
 the defendants-appellees committed an act of infringement
 in New Jersey.
                               B
     Next we address whether MPI and Mylan Inc. had a
 “regular and established place of business” in New Jersey.
 We conclude that they did not.
                               1
     To show that a defendant has a regular and established
 place of business, there are three requirements: “(1) there
 must be a physical place in the district; (2) it must be a reg-
 ular and established place of business; and (3) it must be
 the place of the defendant.” Cray, 

871 F.3d at 1360

. Venue
 is improper if any of those three is not satisfied. See 

id.

     The third requirement is particularly relevant here.
 The place must be “of the defendant, not solely . . . of the
 defendant’s employee.” 

Id.

 at 1362–63. Accordingly, “the
 defendant must establish or ratify the place of business,”
 and it is “not enough that the employee does so on his or
 her own.” 

Id.

Case: 21-1154    Document: 50      Page: 13    Filed: 11/05/2021




 CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.       13



      We have observed that in the venue inquiry “no precise
 rule has been laid down and each case depends on its own
 facts.” 

Id. at 1362

. But as to the third requirement, we
 have discussed non-exhaustive relevant factors, including
 (1) “whether the defendant owns or leases the place, or ex-
 ercises other attributes of possession or control over the
 place”; (2) “whether the defendant conditioned employ-
 ment on” “an employee’s continued residence in the dis-
 trict” or “the storing of materials at a place in the district
 so that they can be distributed or sold from that place”;
 (3) “a defendant’s representations” about that place, in-
 cluding advertisements; and (4) “the nature and activity of
 the alleged place of business of the defendant in the district
 in comparison with that of other places of business of the
 defendant in other venues.” 

Id.

 at 1363–64.
                               2
      No one argues that either MPI or Mylan Inc. itself has
 any fixed, physical presence in New Jersey. Instead,
 Celgene offers two theories to impute venue to those de-
 fendants: first, through places associated with Mylan em-
 ployees, and second, through places associated with Mylan
 affiliates. We discuss each in turn.
                               i
     First, Celgene contends that certain employee-associ-
 ated locations should be imputed to MPI and Mylan Inc.
      Celgene first points to a handful of homes in New Jer-
 sey. Those homes belong to MPI or Mylan Inc. employees.
 In total, MPI and Mylan Inc. have tens of thousands of em-
 ployees. Seventeen live in New Jersey. J.A. 2311 The de-
 fendants-appellees also presented evidence that neither
 MPI nor Mylan Inc. (1) required or instructed those em-
 ployees to live in New Jersey, (2) pays for their homes,
 (3) requires the employees to store materials in the homes
 or in New Jersey, or (4) pays for secretarial or support staff
Case: 21-1154     Document: 50     Page: 14    Filed: 11/05/2021




 14       CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 to work at the homes. J.A. 2311. These specific facts went
 undisputed. J.A. 57–58.
     Celgene argues that MPI and Mylan Inc.’s representa-
 tions to the public show that the homes are places of the
 defendants. But Celgene doesn’t point to advertising or
 marketing identifying the personal homes as places of busi-
 ness. And even if it had, the fact “that a defendant has
 advertised that it has a place of business or has even set up
 an office is not sufficient; the defendant must actually en-
 gage in business from that location.” Cray, 

871 F.3d at 1364

.
      Celgene instead points to a roster of employees who live
 in the state, a handful of business cards with employee
 names and New Jersey home addresses, and two LinkedIn
 profiles mentioning New Jersey. Without more, this is all
 too speculative to show ratification of those addresses as
 MPI’s or Mylan Inc.’s places of business (much less that the
 employees themselves regularly conducted business specif-
 ically at their homes). Indeed, it is not enough “that there
 exists within the district a physical location where an em-
 ployee of the defendant carries on certain work for his em-
 ployer.” 

Id. at 1366

.
     Celgene also identifies a job posting (listing no specific
 Mylan entity) asking that candidates live in New Jersey or
 “within reasonable driving distance.” 6            See, e.g.,
 J.A. 2549–51. The undated posting does little to illuminate
 MPI’s or Mylan Inc.’s employment requirements in 2017.
 Indeed, we agree with the district court that the record
 shows no requirement to actually live in New Jersey or any
 restriction on moving out of state once there.            See
 J.A. 60–61. And we have observed that an employee’s



      6  The district court properly disregarded several
 other job postings as being insufficiently relevant, being
 unrelated to New Jersey in 2017. See J.A. 60 n.5.
Case: 21-1154    Document: 50      Page: 15     Filed: 11/05/2021




 CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.        15



 ability to move “out of the district at his or her own insti-
 gation, without the approval of the defendant . . . cut[s]
 against the employee’s home being considered a place of
 business of the defendant.” Cray, 

871 F.3d at 1363

.
      At bottom, this case is like Cray. There, the defendant
 did not rent or own an office or any property in the district,
 but it allowed two employees to work remotely from their
 homes there. Cray, 

871 F.3d at 1357

. The company iden-
 tified the employees’ home numbers in business communi-
 cations, and they worked as local territory managers and
 sales executives in the region. See 

id.

 But the company did
 not maintain products at their homes, the company did not
 pay for their homes, and no one advertised their homes as
 the company’s place of business. 

Id.

 Similarly, MPI and
 Mylan Inc. “allowed” its employees to work from the dis-
 trict. But there was “no indication” that MPI or Mylan Inc.
 “own[], lease[], or rent[]” their homes, that they “played a
 part in selecting the [homes’] location, stored inventory or
 conducted demonstrations there, or conditioned . . . em-
 ployment or support on the maintaining of” a home in New
 Jersey. See 

id. at 1365

. And even if evidence here might
 suggest that MPI or Mylan “believed a location within
 [New Jersey] to be important to the business performed,”
 there is no evidence that MPI or Mylan Inc. “had any in-
 tention to maintain some place of business in that district”
 if the employees were to “decide[] to terminate their resi-
 dences.” 

Id.

 In view of the specific evidence here, the em-
 ployee homes here are not places “of the defendant.” 7



     7   Celgene argues for the first time on appeal that
 “the fact that service of process could be effectuated on MPI
 and Mylan Inc. at their employees’ homes” confirms that
 § 1400(b) is satisfied. See Appellant’s Br. 38. Celgene
 doesn’t dispute that it didn’t raise this point at the district
 court. Reply Br. 17. The underlying record on this point
 is, accordingly, underdeveloped, and the appellees
Case: 21-1154    Document: 50     Page: 16    Filed: 11/05/2021




 16    CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.



      Beyond the homes, Celgene also points to two small
 storage lockers rented by MPI sales or marketing employ-
 ees to store product samples. Those lockers are rented in
 the employees’ own names. They are used to intermittently
 store and access product samples. There is no evidence, in
 contrast, that they are used like warehouses—for order ful-
 fillment, wholesaling, retail, or the like. As the appellees
 point out, Celgene offered no evidence that MPI or Mylan


 maintain that Celgene has forfeited this argument. See In
 re Google Tech. Holdings LLC, 

980 F.3d 858

, 862–63
 (Fed. Cir. 2020). We agree, and we are also skeptical on
 the merits. Even if we accepted Celgene’s argument that
 some employees could accept service of process on behalf of
 the defendants at their homes, Celgene has not demon-
 strated that this would make the employees’ homes the de-
 fendant’s place of business. The patent service provision,
 

28 U.S.C. § 1694

, states that an agent “conducting” the de-
 fendant’s business can accept service in a district in which
 the defendant “has a regular and established place of busi-
 ness.” But courts considering the question have held that
 § 1694 is not the exclusive basis for service of process in a
 patent-infringement action. Rule 4 of the Federal Rules of
 Civil Procedure provides for service of process not neces-
 sarily predicated on a regular and established place of busi-
 ness of the defendant. See, e.g., Welch Sci. Co. v. Human
 Eng’g Inst., Inc., 

416 F.2d 32, 34

 (7th Cir. 1969);
 14D Wright & Miller, Federal Practice & Procedure § 3823
 (4th ed., Apr. 2021 update). We therefore tend to agree
 with the appellees that, although the presence of a defend-
 ant’s regular and established place of business in a district
 implies that service is proper on agents there, the presence
 of employees who can accept service does not by itself es-
 tablish the existence of the defendant’s regular and estab-
 lished place of business at those employees’ location.
 Regardless, given Celgene’s argument forfeiture and evi-
 dentiary failures, we need not decide the issue.
Case: 21-1154    Document: 50       Page: 17   Filed: 11/05/2021




 CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.       17



 Inc. requires its employees to store materials anywhere in
 New Jersey or that renting lockers in New Jersey was an-
 ything but the employees’ choice. Nor did Celgene offer any
 evidence that either MPI or Mylan Inc. owns, leases, pos-
 sesses, or controls the lockers. And Celgene hasn’t pointed
 to any advertisements or other representations holding
 them out as places of MPI or Mylan Inc.
     Celgene mainly points to testimony that some employ-
 ees needed to access the lockers “as part of [their] job.” But
 even if MPI or Mylan Inc. required employees to have ac-
 cess to pharmaceutical samples (wherever they ended up
 being stored), no evidence suggests that they were required
 to specifically use lockers in New Jersey in the first place.
 Accordingly, the testimony cites does not support a reason-
 able inference that MPI or Mylan Inc. established or rati-
 fied New Jersey–based lockers as a place of business. In
 our view, then, the lockers are not places “of the defend-
 ant.” Nor do they bolster that the employees’ homes were
 such places, as Celgene suggests in the alternative.
     Celgene finally argues that even if the homes or lockers
 cannot individually be considered regular and established
 places of business, they should together be deemed as
 much. But even setting aside that Celgene points to no
 case endorsing its aggregate-place theory—one in which we
 would “assess[] venue on a district-by-district rather than
 address-by-address basis,” Appellant’s Br. 41—we are un-
 convinced that the homes and lockers even lumped to-
 gether would be “of the defendant” under the facts of this
 case.
     In summary, the employee-associated locations are not
 a regular and established place of business of the defend-
 ants under § 1400(b).
                               ii
     In the alternative, Celgene emphasizes that a now-de-
 funct entity—Mylan Laboratories Inc. (“MLI”)—had a
Case: 21-1154    Document: 50      Page: 18    Filed: 11/05/2021




 18    CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.



 physical office in New Jersey. In its view, that office should
 be imputed to MPI and Mylan Inc. for venue purposes. We
 disagree.
     MLI, before it dissolved in 2017, was a Delaware cor-
 poration with an office in New Jersey. J.A. 68. Through a
 chain of ownership, it was indirectly wholly owned by MPI.
 J.A. 68.
     At the district court, Celgene argued an alter-ego the-
 ory predicated on the defendants’ disregard of corporate
 formalities, contending that all the Mylan entities were ef-
 fectively operating as a single company. J.A. 62, 3154. In
 the alternative, it argued that a showing of alter ego or
 abuse of the corporate form wasn’t required. J.A. 62.
     The district court was not convinced. It surveyed vari-
 ous cases, concluding that the majority view is that a sub-
 sidiary’s presence isn’t imputed to a parent for venue
 unless the parties “disregarded the corporate form in their
 dealings with their respective subsidiaries and affiliates.”
 J.A. 66. And that wasn’t shown, the district court con-
 cluded. We agree.
     Venue may be imputed under an alter-ego or veil-pierc-
 ing theory. See Andra, 

6 F.4th at 1289

; Minn. Min. & Mfg.
 Co. v. Eco Chem, Inc., 

757 F.2d 1256, 1265

 (Fed. Cir. 1985)
 (“3M”). But “where related companies have maintained
 corporate separateness, the place of business of one corpo-
 ration is not imputed to the other for venue purposes.” An-
 dra, 

6 F.4th at 1289

. Corporate separateness is an issue of
 regional-circuit law. See Wechsler v. Macke Int’l Trade,
 Inc., 

486 F.3d 1286, 1295

 (Fed. Cir. 2007). The relevant
 veil-piercing theory in the Third Circuit is called the “alter
 ego” doctrine, among other names. See Pearson v. Compo-
 nent Tech. Corp., 

247 F.3d 471

, 484 & n.2 (3d Cir. 2001).
 Under that doctrine, courts will disregard the corporate
 form to “prevent fraud, illegality, or injustice,” “when
 recognition of the corporate entity would defeat public pol-
 icy or shield someone from liability for a crime,” or “when
Case: 21-1154    Document: 50      Page: 19    Filed: 11/05/2021




 CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.       19



 the parent so dominated the subsidiary that it had no sep-
 arate existence.” Id. at 484 (first quoting Zubik v. Zubik,
 

384 F.2d 267, 272

 (3d Cir. 1967); and then quoting N.J.
 Dep’t of Env’t Prot. v. Ventron Corp., 

468 A.2d 150, 164

 (N.J. 1983)). 8 Among other possible considerations, the
 Third Circuit looks at “gross undercapitalization, failure to
 observe corporate formalities, nonpayment of dividends,
 insolvency of the [subsidiary] corporation, siphoning of
 funds from the [subsidiary] corporation by the dominant
 stockholder, nonfunctioning of officers and directors, ab-
 sence of corporate records, and whether the corporation is
 merely a facade for the operations of the dominant stock-
 holder.” 

Id.

 at 484–85 & n.2; see also Trinity Indus., Inc.
 v. Greenlease Holding Co., 

903 F.3d 333, 365

 (3d Cir. 2018).
 In the end, this is an inquiry into whether the entities’ sep-
 arateness “is little more than a legal fiction”—a “notori-
 ously difficult” burden.        Pearson, 247 F.3d at 485.
 Plaintiffs “must essentially demonstrate that in all aspects
 of the business, the two corporations actually functioned as
 a single entity.” Id. A court “consider[s] whether veil pierc-
 ing is appropriate in light of the totality of the circum-
 stances.” Trinity Indus., 

903 F.3d at 365

.
     Against this standard, Celgene’s factual offerings come
 up short. Namely, Celgene pointed to shared marketing,
 branding, and trade names, as well as MLI’s involvement
 in procuring pomalidomide for ANDA preparation (as well
 as other unspecified preparatory aspects). Appellant’s



     8   The appellees argued and the district court con-
 cluded that there must also be a showing of “extraordinary
 circumstances, such as fraud or injustice.” Appellees’
 Br. 32 (citing Linus Holding Corp. v. Mark Line Indus.,
 LLC, 

376 F. Supp. 3d 417

, 425 & n.4 (D.N.J. 2019)); J.A. 67,
 75 (similar). Because Celgene fails to show a disregard of
 corporate separateness, we need not reach that issue of
 Third Circuit law.
Case: 21-1154     Document: 50     Page: 20    Filed: 11/05/2021




 20       CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 Br. 44 (citing J.A. 2487–88, 2494–96, 2499, 2534); J.A. 69–
 70. It also pointed to a Mylan Inc. employee signing MLI’s
 lease termination when it dissolved and directing future
 correspondence to it. Appellant’s Br. 44 (citing J.A. 2410,
 2517, 2528); J.A. 69–70. But “courts have refused to pierce
 the veil even when subsidiary corporations use the trade
 name of the parent, accept administrative support from the
 parent, and have a significant economic relationship with
 the parent.” Pearson, 247 F.3d at 485. Celgene also points
 out that MLI’s sole officer was also an officer of Mylan Inc.
 and that the corporations all sit in a common web of own-
 ership. Appellant’s Br. 43–44 & n.7 (citing J.A. 2405–06,
 2408, 2531–32). But it is a “well established principle” of
 corporate law “that directors and officers holding positions
 with a parent and its subsidiary can and do ‘change hats’
 to represent the two corporations separately, despite their
 common ownership.” United States v. Bestfoods, 

524 U.S. 51, 69

 (1998); Trinity Indus., 

903 F.3d at 367

 (“[D]uplica-
 tion of some or all of the directors or executive officers is
 not fatal to maintaining legally distinct corporate forms.”
 (cleaned up)). And as the district court observed, there is
 no evidence showing, for instance, dominion of MLI’s fi-
 nances, policy, or business practices. See J.A. 67. Nor did
 Celgene show that MLI is “undercapitalized or insolvent,
 that its officers and directors are strawmen, or that MLI
 lacks its own books and records.” See J.A. 70–71.
     At most, the evidence shows collaboration, not com-
 monality. Celgene has not met its burden of showing that
 corporate separateness has not been maintained with re-
 spect to MLI. 9



      9  Celgene points to various instances of possible
 form-blurring between MPI, Mylan Inc., and Mylan N.V.
 E.g., Appellant’s Br. 46–47 (discussing mutual review of
 ANDA filing and instance of reporting of single employee
 of one entity to employee of another). In our view, however,
Case: 21-1154    Document: 50     Page: 21    Filed: 11/05/2021




 CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.       21



     Celgene alternatively argues that there is enough in-
 terrelatedness here, even absent a showing of alter ego, to
 impute venue wholesale from a subsidiary to its parent.
 See Appellant’s Br. 43. But Celgene’s cited cases do not
 support this view.
     First, Celgene argues that this court in 3M said that
 “the acts of another, intimately connected, corporation”
 could be enough to import venue across the board, “even
 absent a showing of alter ego.” See Appellant’s Br. 43. But
 that misreads 3M. That case remarked that a “piercing the
 corporate veil” theory could be appropriate to impute
 venue. 3M, 

757 F.2d at 1265

. It also commented that “in-
 fringement within the district by a wholly owned subsidi-
 ary can be considered infringement by the parent
 corporation for the purposes of [venue if] fraud upon or in-
 justice to the plaintiff are present.” 

Id. at 1265

. It ex-
 plained that the “corporate form is not readily brushed
 aside” and that “alter ego” is applied only if the record
 “clearly support[s] disregard of the corporate fiction on
 grounds of fundamental equity and fairness.” 

Id. at 1264

.
 And, importantly, in that case this court did find alter ego.
 See 

id.

 at 1264–65 (basing alter-ego finding on lack of cor-
 porate formalities and manipulation of form to thwart re-
 covery of judgment).
     Second, Celgene relies on Leach. See Leach Co. v. Gen.
 Sani-Can Mfg. Corp., 

393 F.2d 183, 184

 (7th Cir. 1968).
 But the Leach court also found alter ego. See 

id.

 And there,
 the entities in question “did not observe even the form of
 corporate separation,” and “freely disregarded their sepa-
 rateness” in practice, under the specific facts of that case.
 

Id. at 186

. And so Leach too provides no support for
 Celgene’s alter-ego-free venue-imputation argument.




 this evidence does not move the needle on whether the cor-
 porate form was disregarded as to those firms and MLI.
Case: 21-1154      Document: 50     Page: 22    Filed: 11/05/2021




 22        CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



     Third, Celgene cites a handful of district-court cases for
 the proposition that showing alter ego or veil-piercing isn’t
 necessary. E.g., Appellant’s Br. 43 (citing Javelin Pharm.,
 Inc. v. Mylan Labs. Ltd., No. 16-cv-224, 

2017 WL 5953296

,
 at *3–4 (D. Del. Dec. 1, 2017)); J.A. 65. We agree with the
 district court, however, that these cases answered a differ-
 ent question: whether the patentee stated a “non-frivolous
 basis to warrant venue-based discovery.” See J.A. 65.
     In all, Celgene’s cited cases don’t support the wholesale
 imputation of venue here. And Celgene has identified no
 authority showing that affiliation or shared activities alone
 are enough.
     Of course, it might be that a parent corporation might
 specifically ratify a subsidiary’s place of business, even if
 the two do maintain corporate separateness. See, e.g., An-
 dra, 

6 F.4th at 1289

. But Celgene hasn’t argued that MPI
 or Mylan Inc. ratified MLI’s New Jersey office. 10 Nor has
 Celgene argued that MLI’s office was MPI’s or Mylan Inc.’s
 under an agency theory. See J.A. 63; Andra, 6 F.4th
 at 1287–89.
     In conclusion, Celgene has not met its burden to show
 a lack of corporate separateness such that MLI’s place of
 business should be imputed to the defendants—nor pro-
 vided any other reason to disregard the corporate distinc-
 tion between them. And Celgene has not otherwise shown
 that MPI and Mylan Inc. established or ratified MLI’s New
 Jersey office. Accordingly, that office is not a regular and



      10  Celgene appears to have broadly argued that
 Mylan N.V. (for which venue would be proper) ratified the
 “collective business of Mylan entities conducted at physical
 places in the district.” See Appellant’s Br. 45. But it didn’t
 argue this as to MPI or Mylan Inc., and, as discussed later,
 Celgene didn’t adequately state a claim against Mylan N.V.
 anyway.
Case: 21-1154    Document: 50        Page: 23   Filed: 11/05/2021




 CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.        23



 established place of business of the defendants under
 § 1400(b).
                              ***
     As in Cray, we stress that “each case depends on its
 own facts” and that, here, “no one fact is controlling.”
 

871 F.3d at 1362, 1366

. “But taken together, the facts can-
 not support a finding that” the defendants “established a
 place of business in” New Jersey. See 

id.

 Venue is there-
 fore not proper as to MPI and Mylan Inc. under § 1400(b).
                               III
      We move next from the propriety of venue to the ade-
 quacy of the pleadings. The district court dismissed
 Celgene’s complaint against Mylan N.V. for failure to state
 a claim. It also denied Celgene’s request in the alternative
 for leave to amend that complaint. We agree on the first
 point and conclude that the district court did not abuse its
 discretion on the second.
                               A
     The district court dismissed Celgene’s complaint
 against Mylan N.V. for failure to state a claim under
 Rule 12(b)(6), holding that Celgene hadn’t made any non-
 conclusory allegations that Mylan N.V. “submitted” the
 ANDA under the meaning of 

35 U.S.C. § 271

(e)(2).
     We review a dismissal under Rule 12(b)(6) de novo. 11
 Tatis v. Allied Interstate, LLC, 

882 F.3d 422, 426

 (3d Cir.
 2018). A complaint “must contain sufficient factual matter,
 accepted as true, to ‘state a claim to relief that is plausible
 on its face.’” 

Id.

 (quoting Ashcroft v. Iqbal, 

556 U.S. 662, 678

 (2009)); see also Bell Atl. Corp. v. Twombly, 

550 U.S. 11

  Regional-circuit law applies to this issue. Intell.
 Ventures I LLC v. Erie Indemnity Co., 

850 F.3d 1315, 1325

 (Fed. Cir. 2017).
Case: 21-1154      Document: 50     Page: 24    Filed: 11/05/2021




 24        CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 544, 570 (2007). “Plausibility means ‘more than a sheer
 possibility that a defendant has acted unlawfully.’” Tatis,
 

882 F.3d at 426

 (quoting Iqbal, 

556 U.S. at 678

). “A claim
 has facial plausibility when the plaintiff pleads factual con-
 tent that allows the court to draw the reasonable inference
 that the defendant is liable for the misconduct alleged.” Iq-
 bal, 

556 U.S. at 678

. At bottom, the pleading standard
 “does not unlock the doors of discovery for a plaintiff armed
 with nothing more than conclusions.” 

Id.

 at 678–79. Ac-
 cordingly, we accept as true factual allegations in the plain-
 tiff’s complaint and all reasonable inferences that can be
 drawn from them, and we construe them in the light most
 favorable to the nonmovant. Tatis, 

882 F.3d at 426

. That
 said, we “disregard rote recitals of the elements of a cause
 of action, legal conclusions, and mere conclusory state-
 ments.” James v. City of Wilkes-Barre, 

700 F.3d 675, 679

 (3d Cir. 2012). “[A] document integral to or explicitly relied
 upon in the complaint may be considered without convert-
 ing the motion to dismiss into one for summary judgment.”
 In re Burlington Coat Factory Sec. Litig., 

114 F.3d 1410, 1426

 (3d Cir. 1997) (cleaned up).
     As an initial matter, it is undisputed that MPI, not
 Mylan N.V., was the entity that signed and physically sub-
 mitted the ANDA. 12 The question, then, is whether
 Celgene pled sufficient facts that either (1) Mylan N.V. was
 actively involved in and directly benefited from the ANDA
 (including in the agent–principal sense) or (2) MPI acted as



      12 Celgene argues that the district court erroneously
 made formal signatory status dispositive. We disagree.
 The district court simply noted that Mylan N.V. hadn’t
 signed the ANDA, as evidenced by the documents that
 Celgene itself included with the complaint. J.A. 80. Ac-
 cordingly, Celgene cannot argue that Mylan N.V. filed the
 ANDA, despite its broad allegation that the Mylan defend-
 ants collectively “filed” the ANDA. J.A. 79–80.
Case: 21-1154    Document: 50     Page: 25    Filed: 11/05/2021




 CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.       25



 Mylan N.V.’s alter ego in derogation of the corporate form.
 Celgene’s pleadings fail under either theory.
     Celgene alleged that MPI was wholly owned by Mylan
 Inc., and Mylan Inc. by Mylan N.V. J.A. 116–17 ¶¶ 6–7,
 3057 ¶¶ 23–24. This chain of ownership alone, however, is
 insufficient to state a claim against Mylan N.V. based on
 MPI’s ANDA submission. See Pearson, 247 F.3d at 484
 (“[M]ere ownership of a subsidiary does not justify the im-
 position of liability on the parent.”). And Celgene’s remain-
 ing relevant allegations are, as the district court observed,
 too conclusory. Celgene alleged that the defendants “work
 in concert with respect to the regulatory approval, manu-
 facturing, marketing, sale, and distribution of generic
 pharmaceutical products.” J.A. 120 ¶ 23 (present-case
 complaint), 3069 ¶ 76 (first-case complaint). It alleged that
 MPI “acts at the direction, and for the benefit, of Mylan
 N.V. and Mylan Inc., and is controlled and/or dominated by
 Mylan N.V. and Mylan Inc.” J.A. 120 ¶ 24, 3069 ¶ 77. It
 alleged that unspecified “members of the Mylan corporate
 family” are “alter egos” of Mylan N.V. J.A. 121 ¶ 25. It also
 alleged that MPI was an “alter ego[]” of Mylan N.V.
 J.A. 119 ¶ 18. And it alleged that “Mylan” (defined collec-
 tively to include all three defendants) “filed Mylan’s
 ANDA” at issue. J.A. 115–16 ¶ 1, 121–22 ¶ 30; see also
 J.A. 3074 ¶ 98. It also included with its complaint docu-
 ments from the ANDA in question, which were filed and
 signed by MPI.
      That just isn’t enough. At most, Celgene’s allegations
 amount to legal conclusions as to the defendants as a
 group—not to facts showing a plausible inference of liabil-
 ity as to Mylan N.V. For instance, nothing in the complaint
 suggests how Mylan N.V. is involved in the ANDA process,
 how it bypassed the corporate form to make MPI its alter
 ego, or the like.
    Celgene points to the Rosuvastatin line of cases and ar-
 gues both that signatory status does not matter and that
Case: 21-1154    Document: 50     Page: 26    Filed: 11/05/2021




 26    CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.



 its allegations that Mylan N.V. will benefit should be
 enough. We disagree. As an initial matter, Celgene grossly
 overreads Rosuvastatin. See In re Rosuvastatin Calcium
 Pat. Litig., 

703 F.3d 511

 (Fed. Cir. 2012). That case did not
 hold a non-signer liable or provide that benefiting from the
 ANDA was enough to be deemed to have “submitted” it.
 Instead, the entity that signed the ANDA sought to escape
 liability because it claimed that it was only filing the ANDA
 as the agent of a Canadian company. 

Id. at 527

. And there,
 the entity in question not only signed the ANDA but was
 found to have participated in its preparation and repre-
 sented that it would sell the product. 

Id. at 529

. Accord-
 ingly, Rosuvastatin held that an entity that is actively
 involved in filing the ANDA and stands to benefit from its
 approval is a “submitter”—not that benefiting from it is
 enough alone. Against the backdrop of the ANDA itself—
 which names only MPI—Celgene provides no nonconclu-
 sory allegations that Mylan N.V. was actively involved in
 and would benefit from the ANDA’s submission. Instead,
 it offers only “unadorned supposition” that the defendants
 “work in concert,” see J.A. 79, and allegations that Mylan
 N.V. “filed” the ANDA that are contradicted by the ANDA
 itself.
     Celgene further suggests that its allegations that
 Mylan N.V. directs and controls MPI (or that MPI is Mylan
 N.V.’s alter ego) should be enough, especially in view of the
 Mylan corporate structure. On these conclusory pleadings,
 we are unconvinced. As the district court observed, the
 complaint doesn’t contain “specific facts with respect to
 how” this control occurs. J.A. 79; cf. Twombly, 550 U.S.
 at 556–57 (finding insufficient “conclusory allegation of
 agreement” and “bare assertion of conspiracy”). Again, the
 complaint in this case is too conclusory to establish a plau-
 sible claim of liability as to Mylan N.V. Were it otherwise,
 an allegation that one corporation filed an ANDA coupled
 with a bare assertion of cooperation or control by another
Case: 21-1154    Document: 50      Page: 27    Filed: 11/05/2021




 CELGENE CORPORATION    v. MYLAN PHARMACEUTICALS INC.       27



 would open the door to discovery for the entire parent-sub-
 sidiary chain in any Hatch-Waxman case.
      Finally, Celgene points to Valeant, in which the court
 remanded for a district court to consider the sufficiency of
 seemingly similar allegations, rather than dismissing the
 case outright. But the district court in Valeant hadn’t de-
 cided the sufficiency of those allegations on the merits.
 There had been no adjudication at all on failure to state a
 claim. And so, rather than decide that issue, this court re-
 manded to the district court to consider the allegations’ suf-
 ficiency in the first instance, to resolve internally
 contradictory aspects of those allegations, and to consider
 whether leave to amend would be appropriate to clarify the
 confusion caused by those internally contradictory asser-
 tions. Valeant, 978 F.3d at 1384–85. Here, there has al-
 ready been an initial adjudication and the issue is ready for
 appellate review.
     We agree with the district court that Celgene did not
 state a claim against Mylan N.V.
                               B
      At the district court, Celgene asked in the alternative
 for leave to amend to “add additional allegations regarding
 the interconnectedness of [the defendants], including with
 respect to their involvement in Mylan’s ANDA.” See
 J.A. 81 n.12. The district court denied Celgene’s request.
      We review the denial of leave to amend for abuse of dis-
 cretion. 13 Premier Comp Sols., LLC v. UPMC, 

970 F.3d 316

, 318–19 (3d Cir. 2020). “Ultimately, a motion to amend
 is committed to the ‘sound discretion of the district court.’”
 In re Allergan ERISA Litig., 

975 F.3d 348

, 356 n.13 (3d Cir.



     13  Regional-circuit law applies. See Simio, LLC v.
 FlexSim Software Prods., Inc., 

983 F.3d 1353, 1358

 (Fed. Cir. 2020).
Case: 21-1154      Document: 50     Page: 28    Filed: 11/05/2021




 28        CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.



 2020) (quoting Cureton v. NCAA, 

252 F.3d 267

, 272 (3d Cir.
 2001)).
     Ordinarily, Rule 15 of the Federal Rules of Civil Proce-
 dure sets a liberal standard that a court “should freely give
 leave” to amend “when justice so requires.” But once the
 district court’s scheduling-order deadline has passed,
 Rule 16(b)(4) kicks in and a party must first show good
 cause. Premier Comp Sols., 

970 F.3d at 319

. No good
 cause, no leave to amend.
     Celgene did not make its request in a way that was
 compliant with the district court’s local rules. The district
 court also observed that the relevant amendment deadline
 had long since expired. And it noted that Celgene had been
 on notice of Mylan N.V.’s challenge to the adequacy of its
 pleading since August 2017 when the original motion to
 dismiss was filed. 14 Yet Celgene had not offered any
 grounds that demonstrated good cause for modification of
 the deadline. It denied Celgene’s request.
     On appeal, Celgene does not argue that it demon-
 strated good cause at the district court. Instead, it mainly
 (and incorrectly) argues that the district court considered
 the wrong deadline and didn’t properly apply the Rule 15
 standard. Recall that this was the second of two similar
 cases, as we explained above. See supra Section I.B. And



      14 Celgene suggests that it wasn’t on notice of this in-
 sufficiency because the district court initially denied the
 motion to dismiss. Appellant’s Br. 27. But as to failure to
 state a claim, the district court simply didn’t reach that
 ground on the merits—having allowed the parties to pro-
 ceed on venue-related discovery instead. See Celgene Corp.
 v. Hetero Labs Ltd., No. 17-cv-3387, ECF No. 150, at 8
 (D.N.J. Mar. 2, 2018). It should have been no surprise that
 the ground was included when the defendants renewed
 their motion to dismiss.
Case: 21-1154    Document: 50      Page: 29   Filed: 11/05/2021




 CELGENE CORPORATION   v. MYLAN PHARMACEUTICALS INC.       29



 recall that the parties stipulated that the resolution of
 Rule 12 motions in the first case would govern this one. See
 id. Celgene now argues that the second case’s scheduling
 order (which had not expired when it made this leave-to-
 amend request in the first case) should apply. But the par-
 ties agreed that the resolution of the motion in the first
 case would govern this one. It would make little sense to
 apply the scheduling order in the second case when all the
 briefing occurred under the first case’s schedule (and, in-
 deed, the opinion that we’re reviewing was issued in the
 first case). We also note that Celgene did not argue at the
 district court that the second case’s scheduling order
 should apply—this argument is new on appeal. We con-
 clude that the district court applied the correct deadline.
     Celgene’s allegations in its complaint were conclusory
 and insufficient. It knew the basis for their deficiency for
 years, as the district court correctly concluded, yet made no
 attempt to amend them in a timely manner. Nor has
 Celgene argued on appeal that it showed good cause. In
 our view, then, the district court did not abuse its discre-
 tion in denying Celgene’s request for leave to amend its
 complaint.
                              IV
     We have considered Celgene’s remaining arguments
 but find them unpersuasive. For the reasons we discussed,
 the district court’s judgment is affirmed.
                        AFFIRMED