Petition for Writ of Certiorari — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.

No. __-____

In the Supreme Court of the United States

__________

HIKMA PHARMACEUTICALS USA INC. AND

HIKMA PHARMACEUTICALS PLC, PETITIONERS

v.

AMARIN PHARMA, INC., ET AL.

__________

ON PETITION FOR A WRIT OF CERTIORARI TO THE UNITED

STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

__________

PETITION FOR A WRIT OF CERTIORARI

__________

EIMERIC REIG-PLESSIS

Winston & Strawn LLP

101 California Street

San Francisco, CA 94111

(415) 591-1000

ALISON M. KING

Winston & Strawn LLP

35 W. Wacker Drive

Chicago, IL 60601

(312) 558-5600

CHARLES B. KLEIN

Counsel of Record

CLAIRE A. FUNDAKOWSKI

Winston & Strawn LLP

1901 L Street NW

Washington, DC 20036

(202) 282-5000

cklein@winston.com

Counsel for Petitioners

QUESTIONS PRESENTED

Congress passed the Hatch-Waxman Act “[t]o facilitate the approval of generic drugs as soon as patents

allow.” Caraco Pharm. Labs., Ltd. v. Novo Nordisk

A/S, 566 U.S. 399, 405 (2012). Recognizing that many

drugs are approved for both patented and unpatented

uses, Congress sought to ensure “that one patented

use will not foreclose marketing a generic drug for

other unpatented ones.” Id. at 415. The statutory

mechanism is a “skinny label”: Generic drugmakers

“carve out” patented uses from their labels, leaving

only instructions to use generic drugs for their unpatented uses. See 21 U.S.C. § 355(j)(2)(A)(viii).

Congress designed this carve-out mechanism to encourage competition and to protect generic drugmakers from allegations that marketing a generic drug for

an unpatented use “actively induces infringement.” 35

U.S.C. § 271(b). After all, active inducement requires

“clear expression or other affirmative steps taken to

foster infringement”—there is no “liability when a defendant merely sells a commercial product suitable for

some lawful use.” Metro-Goldwyn-Mayer Studios Inc.

v. Grokster, Ltd., 545 U.S. 913, 936–937 & n.11 (2005).

The questions presented are:

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker

calls its product a “generic version” and cites public information about the branded drug (e.g., sales) enough

to plead induced infringement of the patented use?

2. Does a complaint state a claim for induced infringement of a patented method if it does not allege

any instruction or other statement by the defendant

that encourages, or even mentions, the patented use?

ii

PARTIES TO THE PROCEEDING

Petitioners (defendants-appellees below) are Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (collectively, “Hikma”).

Respondents (plaintiffs-appellants below) are Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland

Limited, and Mochida Pharmaceutical Co., Ltd. (collectively, “Amarin”).

RULE 29.6 STATEMENT

Hikma Pharmaceuticals USA Inc. is an indirect,

wholly owned subsidiary of Hikma Pharmaceuticals

PLC, which is a publicly held corporation.

Hikma Pharmaceuticals PLC does not have a parent corporation, and no publicly held corporation owns

10% or more of its stock.

RELATED PROCEEDINGS

U.S. District Court for the District of Delaware:

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 20-cv-1630 (Oct. 13, 2022).

U.S. Court of Appeals for the Federal Circuit:

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 2023-1169 (June 25, 2024).

iii

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED ....................................... i

PARTIES TO THE PROCEEDING .......................... ii

RULE 29.6 STATEMENT ......................................... ii

RELATED PROCEEDINGS...................................... ii

TABLE OF AUTHORITIES ..................................... vi

INTRODUCTION ...................................................... 1

OPINIONS BELOW .................................................. 7

JURISDICTION......................................................... 7

STATUTORY PROVISIONS INVOLVED ................ 7

STATEMENT............................................................. 7

A. Congress enacts § 271(b), limiting

inducement liability to one who “actively

induces infringement of a patent.” ................. 7

B. Congress enacts the Hatch-Waxman Act,

including section viii, allowing generic drugs

to avoid any potential inducement liability by

“carving out” patented uses. ........................... 9

C. Hikma follows the section viii pathway and

fully carves out the sole patented use. ......... 11

D. The district court dismisses Amarin’s suit for

failure to state a claim. ................................. 14

E. The Federal Circuit resurrects Amarin’s

suit—despite agreeing that Hikma fully

carved out Amarin’s patented use. ............... 15

iv

REASONS FOR GRANTING THE PETITION ...... 16

I. The decision below warrants review because it

creates a “very permissive pleading standard for

induced infringement” that conflicts with

multiple lines of precedent. ............................... 16

A. The decision conflicts with precedent

interpreting § 271(b), which requires active

inducement of all method steps. ................... 17

B. The decision conflicts with this Court’s

pleading standard. ........................................ 21

C. The decision creates a circuit split over

whether inducement can be decided on the

pleadings as a matter of law. ........................ 24

II. Review is urgently needed because the decision

below effectively nullifies labeling carve-outs

under section viii, threatening severe harm to

generic-drug competition. .................................. 26

A. The allegations deemed sufficient to plead

induced infringement here apply to every

generic drug with a skinny label. ................. 27

B. The decision below will deter generics from

using labeling carve-outs, which will delay

market entry and raise drug prices.............. 30

CONCLUSION ........................................................ 35

v

APPENDIX A: Opinion of the U.S. Court

of Appeals for the Federal Circuit

(June 25, 2024) ................................................... 1a

APPENDIX B: Order of the U.S. District

Court for the District of Delaware

(Jan. 4, 2022) .................................................... 23a

APPENDIX C: Opinion of the U.S. District

Court for the District of Delaware

(Jan. 4, 2022) .................................................... 25a

APPENDIX D: Order of the U.S. Court

of Appeals for the Federal Circuit on

Petition for Rehearing En Banc

(Oct. 17, 2024) ................................................... 39a

APPENDIX E: Statutory Provisions

Involved ............................................................ 42a

vi

TABLE OF AUTHORITIES

Page(s)

CASES

Ashcroft v. Iqbal,

556 U.S. 662 (2009) ............................ 14, 21–23, 25

AstraZeneca Pharms. LP v. Apotex

Corp.,

669 F.3d 1370 (Fed. Cir. 2012)................... 7, 29, 30

In re Barr Labs., Inc.,

930 F.2d 72 (D.C. Cir. 1991) ................................ 35

Bell Atl. Corp. v. Twombly,

550 U.S. 544 (2007) ........................ 4, 14, 21–23, 32

Blonder-Tongue Labs., Inc. v. Univ. of

Ill. Found.,

402 U.S. 313 (1971) .............................................. 32

Caraco Pharm. Labs., Ltd. v. Novo

Nordisk A/S,

566 U.S. 399 (2012) .... 1, 3, 9–11, 27, 28, 30, 31, 33

Conley v. Gibson,

355 U.S. 41 (1957) .......................................... 21, 23

Eli Lilly & Co. v. Medtronic, Inc.,

496 U.S. 661 (1990) .............................................. 31

F.T.C. v. Actavis, Inc.,

570 U.S. 136 (2013) .............................................. 31

GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc.,

7 F.4th 1320 (Fed. Cir. 2021) ... 5, 25–28, 31–33, 35

GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc.,

25 F.4th 949 (Fed. Cir. 2022) ......................... 31, 32

vii

Glob.-Tech Appliances, Inc. v. SEB S.A.,

563 U.S. 754 (2011) ...................................... 3, 8, 17

Limelight Networks, Inc. v. Akamai

Techs., Inc.,

572 U.S. 915 (2014) .................................. 17, 18, 20

Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd.,

545 U.S. 913 (2005) .............. 3, 8, 17, 18, 20, 24, 25

Perfect 10, Inc. v. Visa Int’l Serv. Ass’n,

494 F.3d 788 (9th Cir. 2007) .................. 4, 5, 24, 25

Sony Corp. of Am. v. Universal City

Studios, Inc.,

464 U.S. 417 (1984) .............................................. 25

Takeda Pharms. U.S.A., Inc. v. W.-Ward

Pharm. Corp.,

785 F.3d 625 (Fed. Cir. 2015)................... 19, 21, 30

Teva Pharms. USA, Inc. v. Sebelius,

595 F.3d 1303 (D.C. Cir. 2010) ............................ 30

Twitter, Inc. v. Taamneh,

598 U.S. 471 (2023) ........................................ 21, 22

Wallace v. Holmes,

29 F. Cas. 74 (D. Conn. 1871) .............................. 26

Warden v. McLelland,

288 F.3d 105 (3d Cir. 2002) .............................. 4, 22

Warner-Jenkinson Co. v. Hilton Davis

Chem. Co.,

520 U.S. 17 (1997) ................................................ 18

STATUTES

21 U.S.C. § 353d(a)(3) ................................................ 27

21 U.S.C. § 355(b)(1) .................................................... 9

viii

21 U.S.C. § 355(d) ........................................................ 9

21 U.S.C. § 355(j)(2)(A)(ii) ........................................... 9

21 U.S.C. § 355(j)(2)(A)(iv) .................................... 9, 27

21 U.S.C. § 355(j)(2)(A)(vii)(IV) ................................. 10

21 U.S.C. § 355(j)(2)(A)(viii) ........ 1–7, 9–12, 16, 26–35

21 U.S.C. § 355(j)(4)(F) .............................................. 27

21 U.S.C. § 355(j)(5)(B)(iii) ........................................ 10

28 U.S.C. § 1254(1) ...................................................... 7

28 U.S.C. § 1331........................................................... 7

28 U.S.C. § 1338(a) ...................................................... 7

35 U.S.C. § 103........................................................... 11

35 U.S.C. § 271(b) .................... 2–4, 7, 8, 11, 16–18, 20

35 U.S.C. § 271(e)(2)(A) ............................................. 10

35 U.S.C. § 271(e)(4)(C) ............................................. 31

Drug Price Competition and Patent

Term Restoration Act of 1984,

Pub. L. No. 98-417, 98 Stat. 1585 .......................... 9

OTHER AUTHORITIES

21 C.F.R. § 314.94(a)(7)(i).......................................... 27

42 C.F.R. § 423.132(a) ............................................... 28

Abbreviated New Drug Application

(ANDA), FDA,

https://www.fda.gov/drugs/typesapplications/abbreviated-new-drugapplication-anda ................................................... 28

ix

Brief for the United States as Amicus

Curiae, Teva Pharms. USA, Inc. v.

GlaxoSmithKline LLC,

143 S. Ct. 2483 (2023),

2023 WL 2717391 ............................................. 5, 33

Bryan S. Walsh et al., Frequency of First

Generic Drug Approvals With

“Skinny Labels” in the United States,

181 J. AM. MED. ASS’N INTERNAL

MED. 995 (2021) .................................................... 34

Christopher Bruno, Is Pleading

“Generic” Enough to Plead

Inducement?,

IP UPDATE (July 11, 2024),

https://www.ipupdate.com/2024/07/ispleading-generic-enough-to-pleadinducement/ ............................................................ 6

DUANE MORRIS LLP, Federal Circuit

Revives Induced Infringement Suit

Against Generic Pharma When Its

Skinny Label Is Skinny Enough

(July 15, 2024),

https://www.duanemorris.com/alerts/f

ederal_circuit_revives_induced_infrin

gement_suit_against_generic_pharm

a_when_skinny_label_0724.html ........................... 6

Garrett T. Potter, Beefing Up Skinny

Labels: Induced Infringement as a

Question of Law,

97 NOTRE DAME L. REV. 1707 (2022) ................... 26

Gregory Day & Steven Udick, Patent

Law and the Emigration of

Innovation,

94 WASH. L. REV. 119 (2019) ................................ 32

x

Jeremiah Helm & Sean Murray, The

Fed. Circ. In June: More Liability For

Generic-Drug Makers,

LAW360 (Aug. 2, 2024),

https://www.law360.com/ip/articles/1

863857/the-fed-circ-in-june-moreliability-for-generic-drug-makers ...................... 6, 7

Mark A. Lemley, Inducing Patent

Infringement,

39 U.C. DAVIS L. REV. 225 (2005)......................... 19

Ryan Davis, The Biggest Patent

Decisions of 2024 (Dec. 16, 2024),

https://www.law360.com/trials/article

s/2262517/ ............................................................... 6

S. Sean Tu & Charles Duan,

Pharmaceutical Patent Two-Step:

The Adverse Advent of Amarin v.

Hikma Type Litigation, 12 NYU J.

INTELL. PROP. & ENT. L. 1 (2022) ........................... 6

U.S. Dep’t of Health & Human Servs.,

Comprehensive Plan for Addressing

High Drug Prices (Sept. 2021),

https://aspe.hhs.gov/sites/default/files

/2021-09/Drug_Pricing_Plan_9-92021.pdf ................................................................ 34

xi

U.S. Dept. Health & Human Services,

Policy Considerations to Prevent

Drug Shortages and Mitigate Supply

Chain Vulnerabilities in the United

States (2024),

https://aspe.hhs.gov/sites/default/files

/documents/3a9df8acf50e7fda2e443f0

25d51d038/HHS-White-PaperPreventing-Shortages-Supply-ChainVulnerabilities.pdf ................................................ 33

U.S. Generic & Biosimilar Medicines

Savings Report (Sept. 2023),

https://accessiblemeds.org/sites/defau

lt/files/2023-09/AAM-2023-GenericBiosimilar-Medicines-SavingsReport-web.pdf ..................................................... 34

WEBSTER’S NEW INT’L DICTIONARY

(2d ed. 1945) ........................................................... 8

INTRODUCTION

Under the Federal Circuit’s decision in this case,

accurately calling a generic drug the “generic version”

of a branded drug and citing public information about

the brand (e.g., annual sales) now exposes a generic

drugmaker to potential damages for inducing infringement of patents on “any of the [brand’s] approved

uses”—even when, as here, the generic drug is labeled

only for an unpatented use. App. 19a, 17a. The decision effectively nullifies a statutory mechanism for expediting access to generic drugs and breaks sharply

with precedent on inducement.

Forty years ago, Congress passed the Hatch-Waxman Act “to speed the introduction of low-cost generic

drugs to market.” Caraco Pharm. Labs., Ltd. v. Novo

Nordisk A/S, 566 U.S. 399, 405 (2012). Among the

Act’s innovations is the “so-called section viii statement,” which authorizes the Food and Drug Administration (“FDA”) to approve generic versions of

branded drugs when “the brand holds patents on only

some approved methods of using the drug,” provided

that the “labeling for the generic drug [ ] ‘carves out’

from the brand’s approved label the still-patented

methods of use.” Id. at 406 (citing 21 U.S.C. § 355(j)

(2)(A)(viii)). The resulting carve-out, or “skinny label,”

App. 4a–5a, ensures “that one patented use will not

foreclose marketing a generic drug for other unpatented ones,” Caraco, 566 U.S. at 415.

The decision below changes all that. It is undisputed that petitioners (“Hikma”) complied with section

viii and fully carved out of their generic drug label the

allegedly patented uses of respondents’ (“Amarin”)

branded drug, Vascepa. App. 4a–5a, 17a. Amarin’s

patents require using the active ingredient, icosapent,

2

for “reducing risk of cardiovascular death” or (when

taken with a second drug) “reducing occurrence of a

cardiovascular event.” App. 8a–9a. Amarin alleges

these patents cover one of Vascepa’s two approved

uses: reducing cardiovascular (“CV”) risk in specific

populations. Hikma’s generic product, however, is labeled only for the other, off-patent use: treating severe

hypertriglyceridemia (“SH”). Nothing in Hikma’s label or in any alleged statements about its generic product even mentions reducing CV risk.

The district court, therefore, dismissed Amarin’s

complaint alleging induced patent infringement for

failure to state a claim under 35 U.S.C. § 271(b). App.

11a. But the Federal Circuit reversed. Despite agreeing that Hikma’s skinny label fully carves out the patented uses of reducing CV risk, App. 17a, the decision

holds that Amarin plausibly alleged induced infringement because Hikma called its product a “generic version” of Vascepa and quoted Vascepa’s publicly available “sales figures,” App. 18a–20a.

That result is extraordinary, and it effectively nullifies section viii of the Hatch-Waxman Act by allowing

inducement claims against every generic drug with a

skinny label. All generic drugs, by definition, are “generic versions” of branded drugs. And market-size discussions are inevitable in a for-profit industry. Under

the ruling below, an earnings call with investors announcing a new “generic” product would invite a lawsuit for inducing infringement of any patent on any use

of the branded drug, even if the generic label carves

out all patented uses. As a practical matter, any

branded pharmaceutical company can now point to

some public statement by the generic-drug manufacturer to justify a post-launch suit alleging induced

3

infringement, even when the generic product is labeled

only for unpatented uses—and that lawsuit could survive a motion to dismiss. This entirely defeats the

point of section viii, which Congress enacted so that

generics could avoid litigation and “quickly come to

market.” Caraco, 566 U.S. at 415.

But there is a more fundamental problem with the

decision: It allows, for the first time, inducement

claims against a defendant for marketing a product

that undisputedly lacks any instruction to perform the

patented use. That result conflicts with this Court’s

precedent and the Patent Act itself, which limits liability to “[w]hoever actively induces infringement.” 35

U.S.C. § 271(b) (emphasis added). As this Court has

recognized, the statutory language requires “the taking of affirmative steps to bring about” infringement.

Glob.-Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754,

760 (2011). Absent “clear expression or other affirmative steps taken to foster infringement,” there is no liability “when a defendant merely sells a commercial

product suitable for some lawful use.” Metro-GoldwynMayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913,

936–937 (2005).

The decision below contravenes these precedents.

It is undisputed that Hikma’s generic product is “suitable for some lawful use”—i.e., its sole approved use

for treating SH. Ibid. And there is no alleged “clear

expression or other affirmative steps [by Hikma] to

foster infringement.” Ibid. Instead, the inducement

theory below speculates that physicians will infer they

can use Hikma’s “generic version” for all approved

uses of Vascepa and then consult Amarin’s Vascepa label—not Hikma’s own label—to determine those uses.

At best, this is a theory of passive inducement: There

4

is no plausible allegation that Hikma itself “actively”

encourages anyone to practice the patented uses. See

35 U.S.C. § 271(b).

The Federal Circuit brushed aside this glaring defect in Amarin’s complaint because the case is “at its

most nascent stage: on a motion to dismiss,” and thus

lacks “the benefit of discovery.” App. 14a. Citing preTwombly caselaw, the decision holds that courts may

dismiss a claim “only if it is certain no relief could be

granted under any set of facts that could be proven.”

App. 12a (quoting Warden v. McLelland, 288 F.3d 105,

110 (3d Cir. 2002)) (emphasis added). That holding

contradicts this Court’s decision in Twombly, which

“retir[ed]” the same “no set of facts” standard as “best

forgotten,” and rejected the same reasoning that courts

should wait for the “discovery process” to throw out defective claims. Bell Atl. Corp. v. Twombly, 550 U.S.

544, 563, 559 (2007). Under the outdated pleading

standard below, “the threat of discovery expense will

push cost-conscious defendants to settle even anemic

cases,” id. at 559—a concern that is especially vital in

the generic drug industry.

Beyond reviving an abrogated pleading standard,

the decision below categorically excludes inducement

claims from dismissal: It holds that inducement is a

pure “question of fact—not law—and is therefore not

proper for resolution on a motion to dismiss.” App.

18a–19a (emphasis added).

That holding splits

sharply with the Ninth Circuit’s precedent in the analogous copyright context that “‘[i]nducement’ is a legal

determination, and dismissal may not be avoided by

characterizing a legal determination as a factual one.”

Perfect 10, Inc. v. Visa Int’l Serv. Ass’n, 494 F.3d 788,

802 (9th Cir. 2007) (emphasis added). The Ninth

5

Circuit thus requires courts to “determine whether the

facts as pled constitute a ‘clear expression’ of a specific

intent to foster infringement.” Ibid. (dismissing inducement claim). The Ninth and Federal Circuits disagree fundamentally on whether inducement claims

are subject to dismissal as a matter of law—a split that

only this Court can resolve.

Notably, the only precedent the Federal Circuit

cited for its holdings that a skinny-label generic may

induce infringement and that inducement is a pure

factual issue is its own controversial ruling in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th

1320 (Fed. Cir. 2021) (“GSK”). There, the Solicitor

General urged this Court to grant certiorari because

even “potential for inducement liability * * * may significantly deter use of the section viii pathway.” Brief

for the United States as Amicus Curiae, Teva Pharms.

USA, Inc. v. GlaxoSmithKline LLC, 143 S. Ct. 2483

(2023) (No. 22-37), 2023 WL 2717391, at *22.

This case offers another chance to review the Federal Circuit’s erosion of section viii and § 271(b)—with

a much better vehicle than GSK, where the Federal

Circuit credited alleged evidence that the generic

drugmaker’s “partial label instructed the method of

use claimed.” 7 F.4th at 1328. Here, it is undisputed

that Hikma’s label is “skinny enough.” App. 13a, 17a.

This case thus confirms what the dissent in GSK predicted: “a generic can be deemed liable for inducement

for saying that its product is a ‘generic version’”—“a

drastic holding” that “makes little sense.” 7 F.4th at

1353 (Prost, J., dissenting).

Commentators are raising alarms that this case is

“a prototype for future litigation” that “may delay or

6

deter generics from entering the market,”1 “diminish

hope and add uncertainty to the statutory skinny label

practices,”2 “create[ ] uncertainty in the sale and marketing of generic drugs,”3 and “embolden[ ]” branded

drugmakers “to sue after [generic] launch based on

theories of inducement where section viii carveouts

were employed.”4 Because the decision “opens the door

for post-launch lawsuits against generics that do have

adequate carve-outs,” this is one of the “biggest patent

decisions of 2024.”5

In short, the decision below is an imminent threat

to generic competition, which is critically important to

the U.S. healthcare system. And the “very permissive

1 S. Sean Tu & Charles Duan, Pharmaceutical Patent Two-

Step: The Adverse Advent of Amarin v. Hikma Type Litigation, 12 NYU J. INTELL. PROP. & ENT. L. 1, 17–18 (2022).

2 DUANE MORRIS LLP, Federal Circuit Revives Induced In-

fringement Suit Against Generic Pharma When Its Skinny

Label Is Skinny Enough (July 15, 2024),

https://www.duanemorris.com/alerts/federal_circuit_revives_induced_infringement_suit_against_generic_pharma_when_skinny_label_0724.html.

3 Jeremiah Helm & Sean Murray, The Fed. Circ. In June:

More Liability For Generic-Drug Makers, LAW360 (Aug. 2,

2024), https://www.law360.com/ip/articles/1863857/thefed-circ-in-june-more-liability-for-generic-drug-makers.

4 Christopher Bruno, Is Pleading “Generic” Enough to

Plead Inducement?, IP UPDATE (July 11, 2024),

https://www.ipupdate.com/2024/07/is-pleading-genericenough-to-plead-inducement/.

5 Ryan Davis, The Biggest Patent Decisions of 2024,

LAW360 (Dec. 16, 2024), https://www.law360.com/trials/articles/2262517/.

7

pleading standard for induced infringement” that the

decision creates will dramatically expand the risk of

inducement liability, even “outside of just the pharmaceutical context.” Helm, supra note 3.

The Court should grant certiorari.

OPINIONS BELOW

The decision below (App. 1a–22a) is reported at 104

F.4th 1370 (Fed. Cir. 2024). The order denying rehearing (App. 39a–41a) is unpublished. The district court’s

decision (App. 25a–38a) is reported at 578 F. Supp. 3d

642 (D. Del. 2022).

JURISDICTION

The district court had jurisdiction under 28 U.S.C.

§§ 1331 and 1338(a). The Federal Circuit entered

judgment on June 25, 2024, and denied rehearing on

October 17, 2024. On January 3, 2025, the Chief Justice extended the time to file a petition for a writ of

certiorari until February 14, 2025. This Court has jurisdiction under 28 U.S.C. § 1254(1).

STATUTORY PROVISIONS INVOLVED

This case involves the intersection of 35 U.S.C.

§ 271(b) and 21 U.S.C. § 355(j)(2)(A)(viii). The relevant statutory provisions are reproduced in the petition appendix, infra, at 42a–43a.

STATEMENT

A. Congress enacts § 271(b), limiting inducement liability to one who “actively induces

infringement of a patent.”

Although direct patent infringement is a strict-liability tort, Congress limited liability for inducing another’s infringement to “[w]hoever actively induces

8

infringement of a patent….” 35 U.S.C. § 271(b). “The

term ‘induce’ means ‘[t]o lead on; to influence; to prevail on; to move by persuasion or influence,’” whereas

“‘actively’ suggests that the inducement must involve

the taking of affirmative steps to bring about the desired result.” Glob.-Tech, 563 U.S. at 760 (alteration

in original) (quoting WEBSTER’S NEW INT’L DICTIONARY

1269, 27 (2d ed. 1945)).

Added by the 1952 Patent Act, § 271(b) codifies an

inducement standard that governs both patent and

copyright law, and which originates in aiding-andabetting liability at common law. See id. at 764; Grokster, 545 U.S. at 935–936 & nn.10–11. In both patent

and copyright cases, inducement requires “active steps

taken to encourage direct infringement, such as advertising an infringing use or instructing how to engage

in an infringing use”—i.e., “clear expression or other

affirmative steps taken to foster infringement.” Grokster, 545 U.S. at 936–937 (cleaned up).

Only “a showing that infringement was encouraged

overcomes the law’s reluctance to find liability when a

defendant merely sells a commercial product suitable

for some lawful use.” Id. at 936. In contrast, “mere

knowledge of infringing potential or of actual infringing uses would not be enough [ ] to subject a distributor

to liability.” Id. at 937. “The inducement rule, instead,

premises liability on purposeful, culpable expression

and conduct, and thus does nothing to compromise legitimate commerce or discourage innovation having a

lawful promise.” Ibid.

9

B. Congress enacts the Hatch-Waxman Act,

including section viii, allowing generic

drugs to avoid any potential inducement

liability by “carving out” patented uses.

The Hatch-Waxman Act—formally, the Drug Price

Competition and Patent Term Restoration Act of

1984—provides the regulatory foundation for today’s

generic drug industry. See 98 Stat. 1585.

1. A manufacturer seeking FDA approval to market a new drug must submit a new drug application

(“NDA”), which includes “scientific data showing that

the drug is safe and effective, and proposed labeling

describing the uses for which the drug may be marketed.” Caraco, 566 U.S. at 404 (citing 21 U.S.C.

§ 355(b)(1), (d)). After FDA approves an NDA, other

companies can seek approval for a generic version of

the drug by filing an abbreviated new drug application

(“ANDA”) that refers to the NDA. Id. at 404–405. Instead of recreating “independent evidence of safety

and efficacy, the typical ANDA shows that the generic

drug has the same active ingredients as, and is biologically equivalent to, the brand-name drug”—an expedited process “designed to speed the introduction of

low-cost generic drugs to market.” Id. at 405 (citing 21

U.S.C. §§ 355(j)(2)(A)(ii), (iv)).

“Because the FDA cannot authorize a generic drug

that would infringe a patent, the timing of an ANDA’s

approval depends on the scope and duration of the patents covering the brand-name drug,” which “come in

different varieties.” Ibid. Some patents cover “the

drug compound itself.” Ibid. Others cover only “a particular method of using the drug.” Ibid. Importantly,

“FDA may approve a brand-name drug for multiple

methods of use—either to treat different conditions or

10

to treat the same condition in different ways”—and, oftentimes, “the brand holds patents on only some approved methods of using the drug.” Id. at 404, 406.

“To facilitate the approval of generic drugs as soon as

patents allow,” the brand must publicly identify any

patents that allegedly cover the drug or its approved

methods of use, which FDA lists in “the Orange Book.”

Id. at 405–406.

2. An ANDA filer (i.e., generic company) seeking to

market a generic version of a drug with unexpired patents in the Orange Book has two options.

One option is to file a “paragraph IV certification”

that the listed patent is invalid or not infringed by the

proposed generic drug. Id. at 407 (citing 21 U.S.C.

§ 355(j)(2)(A)(vii)(IV)). “Filing a paragraph IV certification means provoking litigation” because it “gives

the brand an immediate right to sue.” Ibid. (citing 35

U.S.C. § 271(e)(2)(A)). “Assuming the brand does so,

the FDA generally may not approve the ANDA until

30 months pass or the court finds the patent invalid or

not infringed,” which may “keep the generic drug off

the market for a lengthy period.” Id. at 407–408 (citing

21 U.S.C. § 355(j)(5)(B)(iii)).

For Orange-Book patents that cover fewer than all

approved uses of a drug, ANDA filers have another option. To avoid the burdens and delays of patent litigation, the ANDA filer may submit a section viii statement, which “asserts that the generic manufacturer

will market the drug for one or more methods of use

not covered by the brand’s patents.” Id. at 406 (citing

21 U.S.C. § 355(j)(2)(A)(viii)).

Under section viii, an ANDA filer can market its

generic drug with a skinny label “that ‘carves out’ from

11

the brand’s approved label the still-patented methods

of use.” Ibid. By omitting any instructions in the label

that might otherwise encourage physicians to prescribe the drug for patented uses, the generic drugmaker avoids any potential claim for “actively induc[ing]” infringement under § 271(b). This ensures

that generic drugs “can quickly come to market”—and

avoid litigation altogether—because “one patented use

will not foreclose marketing a generic drug for other

unpatented ones.” Id. at 415.

C. Hikma follows the section viii pathway

and fully carves out the sole patented use.

This case is Amarin’s second attempt to block competition by Hikma to Amarin’s brand-name Vascepa,

which contains icosapent—a purified omega-3 fatty

acid found naturally in fish oil. App. 2a.

1. In 2012, FDA originally approved Vascepa for a

single use: treating SH, which is characterized by a

blood triglyceride level of at least 500 mg/dL. App. 2a–

3a. In 2016, Hikma filed an ANDA for generic icosapent with paragraph IV certifications challenging Amarin’s then-existing patents on using icosapent to treat

SH. App. 4a n.4. Amarin sued Hikma on those patents, but Hikma prevailed, invalidating the SH patents as obvious under 35 U.S.C. § 103. Ibid.

In 2019, while that first lawsuit was pending, FDA

approved a second indication for Vascepa to reduce

certain types of CV risk in certain patients. App. 3a.

Specifically, Vascepa was approved “as an adjunct to

maximally tolerated statin therapy to reduce the risk

of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization

in adult patients with elevated triglyceride (TG) levels

12

(≥150 mg/dL) and established cardiovascular disease

or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.” C.A. App. 636.

Amarin obtained patents, including the two asserted here, claiming icosapent’s use for “reducing risk

of cardiovascular death” or (when combined with a second drug, a statin) “reducing occurrence of a cardiovascular event” in patient populations with triglycerides

of at least 150 mg/dL. App. 8a–9a. Amarin alleges

both patents cover Vascepa’s CV indication, even

though Vascepa is not approved for “reducing risk of

cardiovascular death.” See App. 9a; C.A. App. 636.

Unlike for the earlier SH patents, Hikma did not

file paragraph IV certifications challenging Amarin’s

CV patents. Instead, Hikma filed a section viii statement “seeking FDA approval only for uses not covered

by Amarin’s newly listed CV indication patents.” App.

4a. Hikma therefore sought FDA “approval of a

‘skinny label’ for its generic product that would include

only the SH indication and not the CV indication,”

which FDA approved. App. 4a–5a.

2. In 2020, with the SH patents invalidated and

the CV indication fully carved out, Hikma finally

launched its generic icosapent product. App. 7a.

Within a month, however, Amarin sued Hikma again,

this time for allegedly inducing infringement of the CV

patents and seeking “damages, including lost profits.”

C.A. App. 545, 546, 548.

Amarin’s complaint admits that Hikma’s product

“is not FDA-approved for the CV Indication” and approved for “only the [SH] Indication.” C.A. App. 521–

522. Nevertheless, Amarin alleges that statements in

three pre-launch press releases and Hikma’s website

13

induce infringement of the CV patents.6 App. 5a–7a;

C.A. App. 709–713, 613, 820. The press releases are

not directed to physicians but instead report on

Hikma’s litigation victories involving Amarin’s SH patents (C.A. App. 709, 712) and the regulatory approval

of Hikma’s generic product (C.A. App. 613). These

press releases refer to Hikma’s product as a “generic

version” of Vascepa. Ibid. Two press releases quote

Vascepa’s annual sales. Ibid. A fourth press release

announcing Hikma’s launch, however, quotes the SH

indication and warns that “Hikma’s product is not approved for any other indication for the reference listed

drug VASCEPA®.” App. 7a; C.A. App. 715–717.

Hikma’s website states that Hikma’s generic icosapent product is in the “Therapeutic Category: Hypertriglyceridemia” and “AB” rated (i.e., therapeutically

equivalent to a branded drug). App. 7a. The website

does not mention Vascepa, and it explicitly warns that

Hikma’s generic icosapent product “is indicated for

fewer than all approved indications of the Reference

Listed Drug.” Ibid.; C.A. App. 820.

None of Hikma’s alleged statements mention

Vascepa’s CV indication or CV risk, let alone using

icosapent (with or without a statin) to reduce CV risk.

6 Amarin’s complaint also alleged that Hikma’s skinny label

induced infringement of the CV patents, but both the district court and the Federal Circuit rejected that theory.

App. 17a, 31a–32a. Tellingly, Amarin has not asserted its

CV patents against any other drugmaker with a generic

icosapent product (which all have the same skinny label),

confirming that Amarin’s lawsuit here depends on statements outside of the label.

14

Indeed, the statements do not even mention the term

“cardiovascular,” or make any reference to statins.

D. The district court dismisses Amarin’s suit

for failure to state a claim.

The district court granted Hikma’s motion to dismiss Amarin’s complaint for failure to state a claim.

App. 11a, 25a–35a.

Applying this Court’s pleading standard in

Twombly and Iqbal, App. 28a, the district court found

that Hikma’s “label does not instruct CV risk reduction,” as required by Amarin’s patents, App. 32a.

Turning to the press releases, the court found that

statements in “Hikma’s advertising of icosapent ethyl

as the ‘generic equivalent’ of Vascepa do[ ] not expose

Hikma to liability” because they too fail to instruct CVrisk reduction. App. 33a. The court found that, at

most, statements about Vascepa’s sales “might be relevant to intent,” but “[i]ntent alone is not enough; Amarin must plead an inducing act.” Ibid.

For purposes of Hikma’s motion, the court accepted

Amarin’s theory that the reference to “Hypertriglyceridemia” on Hikma’s website is broader than SH and

overlaps with the patient population for the CV indication. App. 32a–33a. But the court found that this

alleged overlap “does not rise to the level of encouraging, recommending, or promoting taking Hikma’s generic for the reduction of CV risk.” App. 33a. The

court explained that, both in Hikma’s press releases

and website, “Hikma has not pointed to Vascepa’s patented uses in describing [Hikma’s product] as

Vascepa’s generic equivalent.” App. 35a.

15

E. The Federal Circuit resurrects Amarin’s

suit—despite agreeing that Hikma fully

carved out Amarin’s patented use.

The Federal Circuit reversed. It began by holding

that appellate courts “may affirm [a dismissal] only if

it is certain no relief could be granted under any set of

facts that could be proven.” App. 12a. Even under this

permissive standard, the Federal Circuit agreed that

Hikma’s “label does not, as a matter of law, recommend, encourage, or promote an infringing use.” App.

17a (cleaned up). As the decision notes, “even Amarin

seems to agree that the label alone does not instruct

infringement.” App. 21a.

Nevertheless, the Federal Circuit found “it at least

plausible that a physician could read Hikma’s press releases—touting sales figures attributable largely to an

infringing use, and calling Hikma’s product the ‘generic version’ of a drug that is indicated ‘in part’ for the

SH indication—as an instruction or encouragement to

prescribe that drug for any of the approved uses of

icosapent ethyl, particularly where the label suggests

that the drug may be effective for an overlapping patient population.” App. 19a.

The Federal Circuit also relied on the word “Hypertriglyceridemia” on Hikma’s website to find plausible

induced infringement of Amarin’s asserted CV patents, despite the website’s “express disclaimer that

Hikma’s product is FDA-approved for fewer than all

uses of Vascepa.” App. 19a–20a & n.6.

The Federal Circuit did not identify a single alleged

statement by Hikma that even mentions, much less

encourages, administering icosapent for “reducing risk

of cardiovascular death” or “reducing occurrence of a

16

cardiovascular event” when taken with a statin, as

Amarin’s patents require. App. 8a–9a. Yet the Federal Circuit held that it could not dismiss Amarin’s

complaint without “the benefit of discovery” because,

in its view, induced infringement is purely a “question

of fact” that is “not proper for resolution on a motion to

dismiss.” App. 14a, 18a–19a.

REASONS FOR GRANTING THE PETITION

Under the decision below, a defendant that distributes a product with noninfringing instructions may

face liability for induced infringement merely for marketing its product as the “generic version” of a branded

product with patented uses and citing publicly available information about the brand—even if the defendant never mentions the patented uses, let alone instructs anyone to practice them.

The decision creates a new, “very permissive pleading standard for induced infringement” (Helm, supra

note 3), which conflicts with multiple lines of precedent (infra, Part I) and effectively nullifies section viii

of the Hatch-Waxman Act—a result that will deter generic competition and raise drug prices, contrary to

congressional intent (infra, Part II).

I. The decision below warrants review because

it creates a “very permissive pleading standard for induced infringement” that conflicts

with multiple lines of precedent.

The Federal Circuit’s decision here creates three

related conflicts, and each warrants this Court’s review. First, in holding that vague marketing statements about a competitor’s product can induce infringement of specific method steps, the decision conflicts with precedent on 35 U.S.C. § 271(b), which

17

limits liability to “active[ ]” inducement. Infra, Part A.

Second, in precluding dismissal so long as “any set of

facts” could reveal inducement with “the benefit of discovery,” App. 12a, 14a, the decision conflicts with precedent requiring the complaint itself to recite sufficient

allegations to state a claim for relief. Infra, Part B.

Third, in categorically holding that inducement is a

“question of fact * * * not proper for resolution on a motion to dismiss,” App. 18a–19a, the decision creates a

circuit split with the Ninth Circuit, which holds exactly the opposite. Infra, Part C.

A. The decision conflicts with precedent interpreting § 271(b), which requires active

inducement of all method steps.

1. Neither Congress nor this Court has ever recognized a cause of action for passive inducement. Instead, Congress conditioned liability on “actively induc[ing]” infringement. 35 U.S.C. § 271(b) (emphasis

added). This statutory language requires “affirmative

steps to bring about the desired result” of infringement

by “lead[ing] on,” “influenc[ing],” “prevail[ing] on,” or

“mov[ing] by persuasion or influence” a third party to

infringe. Glob.-Tech Appliances, 563 U.S. at 760.

Thus, defendants cannot be liable for inducement

without taking “active steps [ ] to encourage direct infringement, such as advertising an infringing use or

instructing how to engage in an infringing use,” “as

shown by clear expression or other affirmative steps.”

Grokster, 545 U.S. at 936–937 (cleaned up).

Importantly, “[a] method patent claims a number

of steps; under this Court’s case law, the patent is not

infringed unless all the steps are carried out.” Limelight Networks, Inc. v. Akamai Techs., Inc., 572 U.S.

915, 921 (2014). “This principle follows ineluctably

18

from what a patent is: the conferral of rights in a particular claimed set of elements,” each of which “‘is

deemed material to defining the scope of the patented

invention.’” Ibid. (quoting Warner-Jenkinson Co. v.

Hilton Davis Chem. Co., 520 U.S. 17, 29 (1997)). “[A]

patentee’s rights extend only to the claimed combination of elements, and no further.” Ibid.

That principle is critical in inducement cases to

avoid “depriv[ing] § 271(b) of ascertainable standards.

If a defendant can be held liable under § 271(b) for inducing conduct that does not constitute infringement,

then how can a court assess when a patent holder’s

rights have been invaded?” Id. at 922. A claim for inducement thus lies only against a defendant that actively induces another to perform “all the steps” of the

patented method. Id. at 921.

2. The decision below cannot be reconciled with

these precedents. The patents here recite specific

methods of administering icosapent to patients for “reducing risk of cardiovascular death” or (when taken

with a statin) “reducing occurrence of a cardiovascular

event.” App. 8a–9a. It is undisputed that these patented steps are “limiting, such that infringement of

the claims requires use of icosapent ethyl to reduce cardiovascular risk.” App. 9a n.5. Yet neither the decision below nor Amarin’s complaint identifies any alleged statement by Hikma that actively induces—i.e.,

“encourage[s]” “by clear expression or other affirmative steps,” Grokster, 545 U.S. at 936–937—using

icosapent to reduce CV risk, much less with a statin.

Amarin pleaded no such statement by Hikma, whose

generic product is undisputedly labeled only for the

noninfringing use of treating SH. App. 17a.

19

Nevertheless, the decision below holds that vague

statements in Hikma’s pre-launch press releases calling its product a “generic version” and quoting “sales

figures” plausibly amount to “an instruction or encouragement to prescribe [Hikma]’s drug for any of the approved uses of icosapent,” App. 19a—including the CV

use that appears only in Amarin’s Vascepa label—even

though “Hikma’s approved label refers only to the SH

indication,” App. 5a.

At most, this is a theory of passive inducement. It

requires speculating that physicians will: (1) read

Hikma’s pre-launch press releases (which are not directed to physicians but instead report on litigation

and regulatory developments); (2) infer that they can

use Hikma’s “generic version” for all approved uses of

Vascepa (including uses that Hikma does not promote); (3) consult Amarin’s Vascepa label—instead of

Hikma’s label—to determine those uses; and (4) prescribe Hikma’s generic product for Vascepa’s CV use,

which is never mentioned in Hikma’s label or in any of

Hikma’s statements outside the label.

This expansive theory of liability is unprecedented.

Until now, it was settled that “[p]ublication of information about a patented product is not itself inducement.” Mark A. Lemley, Inducing Patent Infringement, 39 U.C. DAVIS L. REV. 225, 231 (2005). The Federal Circuit previously held that “vague” statements

“cannot be combined with speculation about how physicians may act to find inducement.” Takeda Pharms.

U.S.A., Inc. v. W.-Ward Pharm. Corp., 785 F.3d 625,

632 (Fed. Cir. 2015). Yet the decision below depends

upon speculation that third parties will independently

research the uses of a competitor’s product, based on

external sources of knowledge that Hikma does not

20

control. This cannot be what Congress meant by “actively induc[ing] infringement of a patent.” 35 U.S.C.

§ 271(b).

Notably, the holding below is “not limited” to generic drugs; it expands potential inducement “outside

of just the pharmaceutical context.” Helm, supra note

3. Now, for example, merely calling a computer product “compatible” with a patented system, or comparing

a product to “the leading brand,” may invite a lawsuit

for induced patent infringement. Even “citing sales

data related to a patented method might be enough.”

Ibid. There are no “ascertainable standards” to limit

the reasoning in the decision below, Limelight, 572

U.S. at 922, which will create uncertainty and risk

across all industries.

3. Equally disturbing are the decision’s repeated

admonishments that Hikma should have done more to

discourage infringement. The decision acknowledges

that Hikma’s “website includes an express disclaimer

that Hikma’s product is FDA-approved for fewer than

all uses of Vascepa” and “clearly labels the drug as ABrated, indicating generic equivalence for only labeled

uses.” App. 19a–20a & n.6. Yet the decision criticizes

Hikma for including these disclaimers only on its website “and nowhere else,” ibid., warning that greater

“clarity and consistency” in public statements “may be

essential in avoiding liability for induced infringement,” App. 22a (emphasis added).

This flips the burden of proof—and the meaning of

“inducement”—on its head. As Grokster makes clear,

“a failure to take affirmative steps to prevent infringement” is not inducement. 545 U.S. at 939 n.12 (emphasis added). “[O]ur legal system generally does not

impose liability for mere omissions, inactions, or

21

nonfeasance,” and all forms of aiding-and-abetting liability (inducement is one) require “culpable participation in another’s wrongdoing”—not inaction. Twitter,

Inc. v. Taamneh, 598 U.S. 471, 489, 493 (2023) (emphasis added); see also Takeda, 785 F.3d at 632 n.4

(recognizing that inducement requires “affirmative

steps to induce, not affirmative steps to make sure others avoid infringement”).

Making matters worse, the Federal Circuit here

“provided little guidance” on what defendants can do

“to help avoid inducement, and generally left that

question unresolved,” which “creates uncertainty.”

Helm, supra note 3. This Court’s review is needed to

clarify the standard for inducement and dispel the confusion that the decision below creates.

B. The decision conflicts with this Court’s

pleading standard.

Beyond conflicting with the substantive law of inducement, the decision below conflicts with this

Court’s precedent in Twombly and Ashcroft v. Iqbal,

556 U.S. 662 (2009), which govern the allegations a

complaint must recite to avoid dismissal.

1. Twombly reached this Court in the same posture

as this case: The district court dismissed the complaint

for failure to state a claim (there, for antitrust conspiracy), but the court of appeals reversed, holding “a court

would have to conclude that there is no set of facts that

would permit a plaintiff to demonstrate” its entitlement to relief. 550 U.S. at 553. The court of appeals

relied on Conley v. Gibson, which articulated the same

“no set of facts” test. 355 U.S. 41, 45–46 (1957). That

test effectively led the court of appeals in Twombly to

deem “the prospect of unearthing direct evidence of

22

conspiracy sufficient to preclude dismissal, even

though the complaint does not set forth a single fact in

a context that suggests an agreement.” Twombly, 550

U.S. at 561–562.

This Court reversed, announcing that Conley’s “no

set of facts” standard “has earned its retirement” and

is “best forgotten.” Id. at 562–563. Two years later, in

Iqbal, the Court confirmed that “Twombly retired the

Conley no-set-of-facts test” and that Twombly’s holding was not limited to antitrust cases but “expounded

the pleading standard for ‘all civil actions.’” Iqbal, 556

U.S. at 670, 684 (emphasis added).

“To survive a motion to dismiss [under the nowgoverning standard], a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim

to relief that is plausible on its face.’” Id. at 678 (quoting Twombly, 550 U.S. at 570). The “sheer possibility”

that discovery might uncover wrongdoing is not

enough; the complaint itself must allege sufficient “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. at 678. Recently, this Court applied the same plausibility standard in dismissing aiding-and-abetting claims where the complaint failed to

recite sufficient allegations to conclude that the defendants “culpably participated in the tort at issue.”

Twitter, 598 U.S. at 506.

2. The decision below contradicts these precedents.

Most glaringly, the decision recites pre-Twombly

caselaw to hold that “[w]e may affirm [a dismissal]

only if it is certain no relief could be granted under any

set of facts that could be proven.” App. 12a (quoting

Warden, 288 F.3d at 110) (emphasis added). This is

the same “no-set-of-facts test” that Twombly “retired,”

23

Iqbal, 556 U.S. at 670, which “left open the possibility

that a plaintiff might later establish some ‘set of [undisclosed] facts’ to support recovery,” Twombly, 550

U.S. at 561 (alteration in original) (quoting Conley, 355

U.S. at 45–46).

As in Twombly, the complaint here “does not set

forth a single fact,” id. at 561–562, suggesting that

Hikma actively encourages the patented uses, which

require reducing CV risk, App. 9a n.5. Again, it is undisputed that none of Hikma’s alleged statements even

mention CV risk. Nor does the complaint allege that a

single physician has even read Hikma’s press releases

or website, much less been induced by those materials

to infringe Amarin’s patents.

Despite this fatal flaw in Amarin’s complaint, the

decision below invokes the “benefit of discovery,” including both “fact discovery and expert testimony,” because it could possibly lead to evidence of inducement.

App. 14a, 19a. This Court rejected identical logic in

Iqbal and Twombly: A complaint that facially lacks

sufficient allegations to state a claim for relief “does

not unlock the doors of discovery.” Iqbal, 556 U.S. at

678–679. “It is no answer to say that a claim just shy

of a plausible entitlement to relief can, if groundless,

be weeded out early in the discovery process,” or at

summary judgment. Twombly, 550 U.S. at 559. If that

were enough, “the threat of discovery expense w[ould]

push cost-conscious defendants to settle even anemic

cases.” Ibid. The result here will be even more drastic—“the potentially enormous expense of discovery,”

ibid., may deter generics from entering the market at

all, infra, Part II.

24

C. The decision creates a circuit split over

whether inducement can be decided on

the pleadings as a matter of law.

Apart from conflicting with this Court’s precedent,

the Federal Circuit’s decision here conflicts with the

Ninth Circuit’s approach to inducement claims in the

analogous context of copyright law, creating a circuit

split that only this Court can reconcile.

1. In Perfect 10, the Ninth Circuit recognized that

this Court has “applied the patent law concept of ‘inducement’” to claims for contributory copyright infringement and that inducement (in either context) requires “‘clear expression or other affirmative steps

taken to foster infringement.’” 494 F.3d at 800 (quoting Grokster, 545 U.S. at 936–937). The Ninth Circuit

then dismissed a complaint that alleged induced copyright infringement for failure to state a claim because,

as here, the complaint “point[ed] to no ‘clear expression’ or ‘affirmative acts’ with any specific intent to foster infringement.” Id. at 801.

As the Ninth Circuit explained, upholding an inducement complaint that alleges “no facts suggesting

that Defendants promoted their [product] as a means

to infringe * * * would render the concept of ‘inducement’ virtually meaningless.” Id. at 800–801 (emphasis added). Because the plaintiff had “not alleged any

‘specific acts’ intended to encourage or induce infringement,” the Ninth Circuit affirmed the dismissal for

failure to state a claim. Id. at 802.

Importantly, the Ninth Circuit held that it “need

not * * * take as true that Defendants ‘induce’ consumers” to infringe because “‘[i]nducement’ is a legal determination, and dismissal may not be avoided by

25

characterizing a legal determination as a factual one.”

Ibid. (emphasis added). After all, courts “are not

bound to accept as true a legal conclusion couched as a

factual allegation.” Iqbal, 556 U.S. at 678 (citation

omitted). In the Ninth Circuit, therefore, courts considering motions to dismiss induced copyright infringement claims “must determine whether the facts

as pled constitute a ‘clear expression’ of a specific intent to foster infringement” as a matter of law. Perfect

10, 494 F.3d at 802.

2. The decision below reaches exactly the opposite

result. It rejects Hikma’s “argu[ment] that the factual

contents of Hikma’s label and public statements are

undisputed, such that [the court] can resolve this case

as a matter of law.” App. 19a. Instead, the decision

holds that whether an undisputed statement induces

infringement “is a question of fact—not law—and is

therefore not proper for resolution on a motion to dismiss.” Ibid. (emphasis added). The only citation supporting this holding is the Federal Circuit’s own decision in GSK, which reversed a district judge (now-Federal Circuit Judge Stark) for treating the “fact question” of inducement “as though it were a legal one,”

App. 19a—a result that would be entirely proper under

Ninth Circuit law.

There is no principled reason for this divergent approach. In Grokster, this Court adopted the same “inducement rule” for copyrights that Congress codified

for patents, 545 U.S. at 936 & n.11, reaffirming “the

historic kinship between patent law and copyright

law,” Sony Corp. of Am. v. Universal City Studios, Inc.,

464 U.S. 417, 439 (1984). Now, however, the same district courts in the Ninth Circuit will arbitrarily apply

different pleading standards depending on whether a

26

plaintiff alleges induced infringement of a patent (controlled by Federal Circuit law) or copyright (controlled

by regional circuit law).

This conflict requires the Court’s guidance. As

commentators observe, there is “no statutory requirement or instruction from the Supreme Court indicating that the determination of all elements of inducement are actually questions of fact.” Garrett T. Potter,

Beefing Up Skinny Labels: Induced Infringement as a

Question of Law, 97 NOTRE DAME L. REV. 1707, 1711

(2022). History suggests, however, that inducement is

at least partly a legal issue: “There is no suggestion

that juries had the responsibility during the 18th century of analyzing inducement of infringement, and the

first example of any indirect infringement was assessed unilaterally by the judge, not a jury.” Id. at

1730 (citing Wallace v. Holmes, 29 F. Cas. 74, 79–80

(D. Conn. 1871)).

Given the uncertainty and split in authority over

whether inducement is a question of law or fact, and

whether courts may dismiss inducement claims on the

pleadings, this Court should grant review.

II. Review is urgently needed because the decision below effectively nullifies labeling carveouts under section viii, threatening severe

harm to generic-drug competition.

The questions presented are exceptionally important and warrant immediate review because the

decision below effectively vitiates section viii—a critical statutory mechanism for expediting access to lowcost, generic versions of branded drugs.

Although generics can still seek FDA approval for

skinny labels carving out patented uses, it no longer

27

makes sense to do so because the brand can sue anyway—including for patented uses the skinny label undisputedly omits. Indeed, the facts deemed sufficient

to state a claim for inducement here exist in every

skinny-label case. Infra, Part A. The decision thus

defeats section viii’s core purpose: ensuring that patents on carved-out uses do not “delay or block approval of a generic drug that infringes no patent.” Caraco, 566 U.S. at 424. Absent review, the decision will

deter drugmakers from invoking section viii, delaying

access to generic drugs until all patents covering all

approved uses expire, which will drive up healthcare

costs significantly. Infra, Part B.

A. The allegations deemed sufficient to plead

induced infringement here apply to every

generic drug with a skinny label.

Under the decision below, no skinny label is safe.

Brands will always find ways to allege induced infringement of uses that a skinny label carves out.

1. Consider the phrases “generic version” and “generic equivalent,” which the decision repeatedly relies

on to find plausible inducement of uses that Hikma undisputedly carved out of its label. App. 5a–7a, 18a–

20a. As the dissent in GSK recognized: “Essentially

all ANDA generics are the ‘generic version’ or ‘generic

equivalent’ of a brand drug; the law requires them to

be.” GSK, 7 F.4th at 1353 (Prost, J., dissenting) (citing

21 U.S.C. § 355(j)(2)(A)(iv), (j)(4)(F) (requiring ANDA

applicants to establish “bioequivalence”) and 21 C.F.R.

§ 314.94(a)(7)(i)).

Congress itself refers to generic drugs as the “‘generic version’ * * * [of a] reference listed drug.” 21

U.S.C. § 353d(a)(3) (emphasis added). This Court has

28

used the same phrase when interpreting section viii.

See Caraco, 566 U.S. at 415 (“Caraco wishes to market

a generic version of repaglinide for two (and only two)

uses.”) (emphasis added). So has the Department of

Health and Human Services, which includes FDA. See

42 C.F.R. § 423.132(a) (referring to the “lowest priced

generic version of [a] covered [Medicare] Part D drug”)

(emphasis added). As FDA explains, the Hatch-Waxman Act allows it “to approve applications to market

generic versions of brand-name drugs without repeating costly and duplicative clinical trials to establish

safety and efficacy.”7

If accurately calling a generic drug a “generic version” or “generic equivalent” were enough to induce infringement, every generic drug with a skinny label

would induce infringement of every patent on its

branded equivalent—rendering section viii useless.

As commentary on the decision below warns, Hikma’s

statement that its product is “a generic equivalent of

Vascepa * * * * accurately reflects [its] FDA approval,”

yet the decision “suggests that such accurate statements regarding regulatory approval may constitute

inducement.” Helm, supra note 3. It is “highly unlikely that Congress intended to make generics liable

for simply stating what the law requires.” GSK, 7

F.4th at 1353 (Prost, J., dissenting). Nor is it plausible

that Congress intended for generics to be held liable

for inducing patent infringement, despite a section viii

carve-out, merely for characterizing a product as a

Abbreviated New Drug Application (ANDA), FDA,

https://www.fda.gov/drugs/types-applications/abbreviatednew-drug-application-anda (emphasis added).

7

29

“generic version” consistent with the Hatch-Waxman

Act’s statutory scheme.

2. To be sure, the decision adds that “Hikma did

much more than call its product a ‘generic version.’”

App. 21a. But the “much more” here amounts to “touting sales figures” for the branded drug—without even

mentioning, much less encouraging, its patented uses.

App. 19a–20a. Again, patentees can allege similar

facts in nearly every skinny-label case. Market size is

a basic consideration for any competitive product

launch, and the pharmaceutical industry is no exception. Under the panel’s logic, a generic company’s CEO

announcing a new “generic” product and estimating

the market size for the relevant drug compound to

shareholders on an earnings call would invite a lawsuit for induced infringement.

It is no answer that the “touted sales figures for

Vascepa” are “largely attributable to the off-label CV

indication.” App. 18a–19a. Sales of a branded drug

will always include uses that are “off-label” for a

skinny-label generic; by definition, the skinny label

does not include all uses of the branded drug.

Likewise, every skinny-label generic can be accused of competing for the brand’s sales, including

carved-out uses, due to “market realities” of generic

substitution—i.e., brands can always allege that “even

if a generic drug is formally approved only for unpatented uses, pharmacists and doctors will nonetheless

substitute the generic for all indications once it becomes available.” AstraZeneca Pharms. LP v. Apotex

Corp., 669 F.3d 1370, 1380 (Fed. Cir. 2012). If this

were enough to induce infringement, it “would, in

practice, vitiate” section viii and “allow a pioneer drug

manufacturer to maintain de facto indefinite

30

exclusivity over a pharmaceutical compound by obtaining serial patents for approved methods of using

the compound,” “contrary to the statutory scheme.”

Ibid.

That is why the “requirement of inducing acts is

particularly important in the Hatch-Waxman Act context”—“the statute was designed to enable the sale of

drugs for non-patented uses even though this would result in some off-label infringing uses.” Takeda, 785

F.3d at 631 (emphasis added). Instead of requiring

“inducing acts,” however, the decision below finds

plausible inducement based on accurately reporting

publicly available sales figures that allegedly include

“off-label infringing uses.” Ibid. Because patentees

can always allege that a skinny-label generic will effectively compete for sales attributable to off-label

uses, the decision below will, “in practice, vitiate” section viii. AstraZeneca, 669 F.3d at 1380.

B. The decision below will deter generics

from using labeling carve-outs, which will

delay market entry and raise drug prices.

Left undisturbed, the decision will “delay or deter

generics from entering the market.” Tu, supra note 1,

at 18. Indeed, there will be no incentive for generic

drugmakers to use section viii at all.

1. Recall, Congress created section viii as an alternative to paragraph IV certifications, which “provok[e]

litigation” that “is likely to keep the generic drug off

the market for a lengthy period.” Caraco, 566 U.S. at

407–408. The “hazard of sparking costly litigation,” in

turn, can deter generic drugmakers from challenging

unexpired patents on branded drugs. Teva Pharms.

USA, Inc. v. Sebelius, 595 F.3d 1303, 1305 (D.C. Cir.

31

2010). By enacting section viii, Congress allowed generic drugmakers to avoid the costs and risks of paragraph IV litigation with a skinny label, which ensures

that “one patented use will not foreclose marketing a

generic drug for other unpatented ones.” Caraco, 566

U.S. at 415.

Absurdly, the decision below makes skinny labels

riskier than paragraph IV certifications. At least with

a paragraph IV certification, the generic drugmaker is

unlikely to pay damages: Any litigation begins before

FDA can approve the generic drug, id. at 407, and

“[m]onetary damages are permitted only if there has

been ‘commercial manufacture, use, or sale,’” Eli Lilly

& Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990)

(quoting 35 U.S.C. § 271(e)(4)(C)). As a result, it “is

usually true of a paragraph IV litigation” that there is

“no claim for damages.” F.T.C. v. Actavis, Inc., 570

U.S. 136, 152 (2013).

In contrast, the decision below allows brands to assert patents against skinny-label generics after

launch—when the generic can be on the hook for the

brand’s lost profits. In GSK, for example, a jury

awarded more than $234 million in lost profits. 7

F.4th at 1340–1341. As the dissent foresaw, “generics

simply won’t play” with section viii if complying with

it can lead to massive damages. GlaxoSmithKline LLC

v. Teva Pharms. USA, Inc., 25 F.4th 949, 955 (Fed. Cir.

2022) (“GSK Rehearing”) (Prost, J., dissenting). “The

risk is too great. Generics sell their products for considerably less than brands, so a jury’s award of lost

profits to the brand can dwarf whatever profits a generic could make.” Ibid.

“It seems implausible that Congress, when enacting the skinny-label provisions against the backdrop of

32

the inducement statute, intended to put generics in

this position.” Ibid. Yet that is the practical result of

the Federal Circuit’s decisions in GSK and below,

which will deter, rather than encourage, drugmakers

from seeking approval for unpatented uses until all patents on a branded drug have expired.

2. Beyond the risk of damages, the cost of litigation

alone will deter generic drugmakers from invoking section viii. This Court has long recognized that “patent

litigation is a very costly process,” and “prospective defendants will often decide that paying royalties under

a license or other settlement is preferable to the costly

burden of challenging the patent.” Blonder-Tongue

Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 334,

338 (1971). By one estimate, “the average cost to defend an infringement lawsuit in the United States is

roughly $3.5 million.” Gregory Day & Steven Udick,

Patent Law and the Emigration of Innovation, 94

WASH. L. REV. 119, 125 (2019). Thus, even unsuccessful “lawsuits increase the potential costs for competitors to enter the market or delay the entry of” generic

drugs. Tu, supra note 1, at 18. Again, this Court

raised a similar concern in Twombly that “the potentially enormous expense of discovery” often “will push

cost-conscious defendants to settle even anemic cases.”

550 U.S. at 559.8

8 This case is a prime example of that risk.

In addition to

suing Hikma, Amarin sued a health insurer (Health Net

LLC) for providing coverage and reimbursement for prescriptions filled with Hikma’s generic product. App. 35a.

The insurer has since settled. App. 2a n.2. Although

Hikma continues to litigate this case on remand, Amarin is

33

As the federal government has recently warned, generic drugmakers “face difficult economic conditions

that stem from low and/or unpredictable sales volumes, prices, and profit margins for many generic

drugs.”9 Adding litigation costs and the risk of lostprofits damages will “deter potential market entrants.”10 That is why the Solicitor General in GSK

warned that even “potential for inducement liability in

these circumstances may significantly deter use of the

section viii pathway, even if such liability is rarely imposed.” Teva, 2023 WL 2717391, at *22.

3. By deterring generic companies from using section viii, the decision below will delay generic market

entry and increase drug prices, defeating Congress’s

intent “to speed the introduction of low-cost generic

drugs to market.” Caraco, 566 U.S. at 405.

“The cost of pharmaceuticals has a massive influence on the healthcare system.” Potter, supra, at 1707.

The U.S. pharmaceutical industry accounts for nearly

a trillion dollars in annual revenue, ibid., and generic

aggressively pursuing costly discovery—even on its labelbased inducement theory that the Federal Circuit rejected

(see App. 17a–18a)—in a clear attempt to force Hikma off

the market.

9 U.S. Dept. Health & Human Services, Policy Considera-

tions to Prevent Drug Shortages and Mitigate Supply Chain

Vulnerabilities in the United States 3 (2024),

https://aspe.hhs.gov/sites/default/files/documents/3a9df8acf50e7fda2e443f025d51d038/HHS-WhitePaper-Preventing-Shortages-Supply-Chain-Vulnerabilities.pdf.

10 Ibid.

34

drugs have saved patients and payors an estimated

$2.9 trillion in the last decade alone.11

Section viii plays a critical role in achieving these

savings. Nearly half of all generics for drugs with multiple approved uses launch with skinny labels, providing low-cost alternatives years before patents on

carved-out uses expire. Tu, supra note 1, at 15.12 In a

five-year period, for example, skinny labels saved Medicare an estimated $1.5 billion. Ibid. The federal government has echoed that skinny labeling is a “critical

practice[ ]” that “may result in decreased costs to patients and to the federal government, including reducing spending on Medicare and Medicaid.”13 As the decision below illustrates, however, “[r]ecent litigation

* * * may discourage the use of carve-outs and thus delay the approval of some generic drugs,” threatening

these important cost-savings.14

*****

In passing the Hatch-Waxman Act, “Congress

sought to get generic drugs into the hands of patients

11 Ass’n for Accessible Meds., 2023 The U.S. Generic & Bio-

similar Medicines Savings Report 7 (Sept. 2023), https://accessiblemeds.org/sites/default/files/2023-09/AAM-2023Generic-Biosimilar-Medicines-Savings-Report-web.pdf .

12 See also Bryan S. Walsh et al., Frequency of First Generic

Drug Approvals With “Skinny Labels” in the United States,

181 J. AM. MED. ASS’N INTERNAL MED. 995 (2021).

U.S. Dep’t of Health & Human Servs., Comprehensive

Plan for Addressing High Drug Prices 21 (Sept. 2021),

https://aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_Plan_9-9-2021.pdf.

13

14 Ibid.

35

at reasonable prices—fast.” In re Barr Labs., Inc., 930

F.2d 72, 76 (D.C. Cir. 1991). The decision below derails that objective. It transforms section viii from a

virtual guarantee against patent-infringement liability to an invitation for exorbitant damages claims.

Even with long odds of ultimate success, patentees will

reflexively file suit if they can dodge motions to dismiss with vague and practically unavoidable statements that their generic competitors sell “generic versions” competing for the branded drug’s sales. Without this Court’s review, patients, doctors, and payors

(including the government) will pay the price.

CONCLUSION

For the foregoing reasons, the petition for certiorari

should be granted. At a minimum, given the importance of the question presented to the U.S.

healthcare system and the federal government’s support for certiorari in GSK, the Court should call for the

views of the Solicitor General.

Respectfully submitted.

EIMERIC REIG-PLESSIS

Winston & Strawn LLP

101 California Street

San Francisco, CA 94111

(415) 591-1000

ALISON M. KING

Winston & Strawn LLP

35 W. Wacker Drive

Chicago, IL 60601

(312) 558-5600

CHARLES B. KLEIN

Counsel of Record

CLAIRE A. FUNDAKOWSKI

Winston & Strawn LLP

1901 L Street NW

Washington, DC 20036

(202) 282-5000

cklein@winston.com

Counsel for Petitioners

FEBRUARY 2025