Celgene Corporation v. Mylan Pharmaceuticals Inc. ( 2021 )

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
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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.
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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).
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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).
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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
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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.).
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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.
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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.”).
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(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
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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
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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
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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.
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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
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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.
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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
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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.
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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.
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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.
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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.
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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
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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