Reply Brief — Hikma Pharmaceuticals USA Inc., et al., Petitioners v. Amarin Pharma, Inc., et al.

No. 24-889

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

__________

REPLY TO BRIEF IN OPPOSITION

__________

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

SAMUEL S. PARK

Hikma Pharmaceuticals

200 Connell Drive

Berkeley Heights,

NJ 07922

Counsel for Petitioners

RULE 29.6 STATEMENT

The corporate disclosure statement included in the

petition remains accurate.

ii

TABLE OF CONTENTS

Page

RULE 29.6 STATEMENT .......................................... i

TABLE OF AUTHORITIES ..................................... iii

REPLY TO BRIEF IN OPPOSITION ....................... 1

I. The decision below conflicts with precedent and

urgently warrants this Court’s review. ............... 3

A. By broadly exposing every skinny-label

generic to potential inducement liability, the

decision eviscerates the requirement for

active inducement of all claim steps. ............. 3

B. The decision flouts this Court’s pleading

standard, deterring generic competition. ....... 7

C. The decision creates a circuit split and

aggravates uncertainty over whether

inducement is a legal or factual question. ..... 8

II. This case is an excellent vehicle to address the

critically important questions presented. ......... 11

CONCLUSION ........................................................ 12

iii

TABLE OF AUTHORITIES

Page(s)

CASES

Bell Atlantic Corp. v. Twombly,

550 U.S. 544 (2007) .................................. 3, 7, 8, 11

Caraco Pharm. Labs., Ltd. v. Novo

Nordisk A/S,

566 U.S. 399 (2012) .......................................... 1, 12

Glaxo-SmithKline LLC v. Teva Pharms.

USA, Inc.,

7 F.4th 1320 (Fed. Cir. 2021) ................................ 4

Grunenthal GmbH v. Alkem Labs. Ltd.,

919 F.3d 1333 (Fed. Cir. 2019)............................... 5

Limelight Networks, Inc. v. Akamai

Techs., Inc.,

572 U.S. 915 (2014) ............................................ 5, 7

Markman v. Westview Instruments, Inc.,

517 U.S. 370 (1996) ................................................ 8

Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd.,

545 U.S. 913 (2005) ........................................ 6, 7, 9

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

494 F.3d 788 (9th Cir. 2007) ............................ 8, 10

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

Pharm. Corp.,

785 F.3d 625 (Fed. Cir. 2015)................................. 7

Twitter, Inc. v. Taamneh,

598 U.S. 471 (2023) .............................................. 11

STATUTES

21 U.S.C. § 355(j)(2)(A)(iv) .................................... 2, 12

iv

21 U.S.C. § 355(j)(4)(F) ................................................ 2

35 U.S.C. § 271(b) ...................................... 2, 3, 4, 6, 11

OTHER AUTHORITIES

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 ............................................. 3, 11

Garrett T. Potter, Beefing Up Skinny

Labels: Induced Infringement as a

Question of Law,

97 NOTRE DAME L. REV. 1707 (2022) ..................... 9

Jacob S. Sherkow & Paul R. Gugliuzza,

Infringement by Drug Label,

78 STAN. L. REV. —, 48 (2026)

(rev. May 20, 2025), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=5145419 ............................................ 9, 10

REPLY TO BRIEF IN OPPOSITION

The decision below urgently warrants review because it exposes every generic drugmaker marketing

the “generic version” of a branded drug to potentially

catastrophic damages, even if the generic omits all patented uses from its label. As the government and

myriad commentators warn, Pet. 5–6, that will deter

drugmakers from invoking Hatch-Waxman’s skinnylabel pathway, which Congress enacted so that lowcost generics could avoid litigation risk and “quickly

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

Nordisk A/S, 566 U.S. 399, 415 (2012).

Amarin’s opposition rests on the false premise that

the decision is “intensely fact-bound.” Opp. 2. The

facts deemed sufficient to plead inducement—calling a

drug the “generic version” of another and citing market data, App. 19a—are ubiquitous. Whether such

bare allegations suffice to plead induced infringement

affects not just the pharmaceutical industry, but all

competitive markets. Pet. 27–30; Scholars’ Br. 13–18.

Unable to refute this, Amarin resorts to outright

fabrication. Without any citation, Amarin falsely declares that Hikma “began marketing [its generic drug]

broadly for both the unpatented and patented uses”

and “actively encouraged physicians to prescribe

Hikma’s generic drug so as to infringe Amarin’s patents.” Opp. 2 (emphasis added). None of that is remotely true—or even alleged. Amarin’s patents undisputedly require (i) administering icosapent for “reducing risk of cardiovascular death” or (ii) co-administering icosapent and another drug (a statin) for “reducing

occurrence of a cardiovascular event.” App. 8a–9a &

n.5. No alleged statement by Hikma even mentions,

much less encourages, either patented use.

2

When Amarin finally gets around to citing the record, it becomes clear that the only allegations here are

the same that any branded drug company could level

against any skinny-label generic, which have nothing

to do with any patented use: Hikma (correctly) called

its product “generic”; Hikma said Vascepa is indicated

“in part” for off-patent use (as it must be, for a skinny

label to be possible); and Hikma cited “domestic sales”

(as competitors routinely do). Opp. 12. Amarin even

relies on Hikma announcing it “received FDA approval,” ibid., which is true of any legally marketed

drug. Amarin’s other allegations either concern the

general population of “hypertriglyceridemia” patients—not the disputed claim steps—or rehash labelbased theories that even the Federal Circuit rejected.

Opp. 12–13; App. 16a–17a (summarizing Amarin’s label-based allegations, then agreeing with Hikma they

fail “as a matter of law”).

As Amarin ultimately admits, “the only approved

indication for Hikma’s generic” is undisputedly off-patent—and, thus, “the thrust of the complaint is not

that Hikma’s label was ‘not skinny enough.’” Opp. 27,

14. This case is about routine statements of therapeutic equivalence required for all generic drugs. See 21

U.S.C. § 355(j)(2)(A)(iv), (j)(4)(F). If this were enough

to assert inducement, Hatch-Waxman’s section viii

would be a dead letter—as well as the Patent Act’s requirement for “actively induc[ing]” all claimed method

steps. 35 U.S.C. § 271(b) (emphasis added).

It is no answer that this case is at the pleadings

stage. Opp. 2–3. That has never precluded this

Court’s review, and it misses the point. As the Solicitor General made clear in urging certiorari for the similar GSK case (which Amarin ignores), even “the

3

potential for inducement liability in these circumstances may significantly deter use of the section viii

pathway even if such liability is rarely imposed.” 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. And “the

threat of discovery expense will push cost-conscious

defendants to settle even anemic cases.” Bell Atlantic

Corp. v. Twombly, 550 U.S. 544, 559 (2007). Given

Hikma’s “skinny enough” label, Opp. 14, this is an

even better vehicle than GSK to prevent that result.

I. The decision below conflicts with precedent

and urgently warrants this Court’s review.

The Federal Circuit now allows inducement claims

to proceed to discovery even if plaintiffs allege no affirmative steps that “actively” encourage infringement. The decision conflicts with the plain language

of 35 U.S.C. § 271(b) and creates multiple conflicts

meriting review.

A. By broadly exposing every skinny-label generic to potential inducement liability, the

decision eviscerates the requirement for

active inducement of all claim steps.

1. Amarin concedes this Court’s precedents and

§ 271(b) require “‘active’ inducement” by “clear expression or other affirmative steps.” Opp. 21–22. For

method patents, that requires actively “inducing performance of all the claimed steps.” Opp. 22. Here the

claimed steps require, among other things, reducing

risk of cardiovascular (“CV”) death or co-administering

a statin to reduce CV events. App. 8a–9a & n.5. Amarin alleges no “clear expression or other affirmative

steps” by Hikma that actively induce others to perform

4

such steps. Hikma’s alleged conduct is no different

than any skinny-label generic’s.

First, Hikma called its product a “generic version”

or “generic equivalent” of Vascepa. Opp. 12, 22; App.

18a. That cannot actively induce infringement of specific treatment steps, or else calling any drug “generic”

would induce infringement of every patented method

for using the generic drug’s branded equivalent. Amarin does not dispute that this Court, Congress, FDA,

and the pharmaceutical industry routinely call generic

drugs “generic versions.” Pet. 27–29. That cannot be

what Congress meant by “actively induc[ing] infringement.” 35 U.S.C. § 271(b). As the GSK dissent foresaw, “a generic can be deemed liable for inducement

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

drastic holding” that “makes little sense.” GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., 7 F.4th

1320, 1353 (Fed. Cir. 2021) (Prost, J., dissenting).

Second, Hikma correctly stated Vascepa is indicated “in part” for the noninfringing severe hypertriglyceridemia (“SH”) indication. Opp. 12, 22; App. 18a.

Again, that cannot actively induce method steps for reducing CV-death risk or (with a statin) CV events.

Amarin admits the SH indication is “off-patent,” Opp.

22, and the branded equivalent for every skinny-label

generic is indicated “in part” for the generic’s approved

indication. That is the premise of a carve-out.

Third, Hikma quoted Vascepa’s “sales figures.”

Opp. 22; App. 18a. But those are numbers. The statement that, “[a]ccording to IQVIA, US sales of

Vascepa® were approximately $919 million in the 12

months ending February 2020,” App. 32a, says nothing about patented uses—and it is not materially different from financial reporting in any industry.

5

Fourth, Hikma’s website included the word

“[h]ypertriglyceridemia,” Opp. 12, 22, coupled with “an

express disclaimer that Hikma’s product is FDAapproved for fewer than all uses of Vascepa,” App. 20a

n.6. The accurate statement that Hikma’s product

falls under the general category for treating “hypertriglyceridemia,” especially combined with the disclaimer, cannot actively encourage the specific, patented treatment steps for reducing CV-death risk or

(with a statin) CV events. Although one asserted patent includes a triglyceride limitation, App. 8a, “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) (emphasis added).1 Until

now, reciting a general category that could include

both patented and unpatented uses was not enough to

induce infringement. See Grunenthal GmbH v. Alkem

Labs. Ltd., 919 F.3d 1333, 1339 (Fed. Cir. 2019) (no

inducement by generic labeled for “severe chronic

pain,” which covered both patented “polyneuropathic

pain” relief and off-patent pain relief, because it did

“not specifically encourage” the patented use).2

1 Amarin conflates triglycerides with CV risk, Opp. 4, but it

admits “lowered triglycerides” do not “prove[] a reduction in

cardiovascular risk,” Opp. 6, and “other omega-3 based

therapies[] lowered triglyceride levels in this patient population but did not show an actual reduction in cardiovascular risk,” S.App. 7a.

2 Amarin incorrectly states “[t]he court of appeals reasoned

that * * * portions of [Hikma’s] label” induced infringement.

Opp. 14 (citing App. 16a). The decision summarizes Amarin’s label-based allegations before rejecting them,

6

2. That the decision quotes the general standard

for “clear expression or other affirmative steps,” Opp.

22, does not preclude review. By holding that “generic

version” and sales figures suffice to plead inducement—without any alleged instruction to perform the

patented steps—the Federal Circuit eviscerated the

statutory requirement for “actively induc[ing] infringement.” 35 U.S.C. § 271(b). This is not mere “disagreement with the application of settled law to specific facts.” Opp. 16. The same facts apply to any patented method and any generic drug.

Amarin’s opposition confirms that its inducement

theory is passive—not active, as § 271(b) demands.

Amarin denies physicians must “research Amarin’s

brand-name label” to infringe, but only because it assumes Vascepa’s CV indication is already “known” to

them. Opp. 24, 33. Any such knowledge does not result from Hikma’s actions; it results from Amarin promoting its own product. If accepted, Amarin’s theory

would eliminate the need for active inducement in

every case. Nothing would stop any patentee from alleging its patented method is so “common” that it

needs no instruction. Opp. 24–25.

By endorsing Amarin’s passive inducement theory,

the decision not only departs from this Court’s precedent demanding “active steps,” Metro-Goldwyn-Mayer

Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936–937

(2005), but also departs from the Federal Circuit’s own

precedent that “vague” language “cannot be combined

with speculation about how physicians may act to find

“agree[ing] with the district court (and Hikma) that the label does not, as a matter of law, recommend, encourage, or

promote an infringing use.” App. 17a (cleaned up).

7

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

Pharm. Corp., 785 F.3d 625, 632 (Fed. Cir. 2015).

This case is unlike Grokster, where “[i]t was enough

for a defendant to promote a device’s use to infringe

copyright generally, without any reference to specific

copyrighted works.” Opp. 23. Amarin cites no alleged

promotion by Hikma “to infringe [patents] generally,”

ibid., and it ignores that a method “patent is not infringed unless all [claim] steps are carried out,” Limelight, 572 U.S. at 921. This may not require “recit[ing]

all the claim limitations” verbatim, Opp. 23, but it requires actively inducing each step. The Federal Circuit found plausible inducement without any alleged

instruction that promotes Hikma’s generic product for

reducing CV-death risk or for co-administration with

a statin to reduce CV events—breaking sharply with

precedent.

B. The decision flouts this Court’s pleading

standard, deterring generic competition.

Amarin admits the decision “quote[s] the preTwombly no-set-of-facts standard,” Opp. 20, which this

Court rejected. Twombly, 550 U.S. at 562–563; App.

12a. Amarin brushes aside this undisputable conflict

because the decision uses the word “plausibility.” Opp.

20. The problem is the decision never identifies any

instruction—plausible or not—to perform the patented

steps. The decision deems it sufficient that Amarin

presented a “theory” for how doctors might interpret

“generic version” and “sales figures” based on allegedly

preexisting knowledge of the patented uses. App. 17a–

18a. And the decision invokes a need for “discovery,”

both “fact discovery and expert testimony,” to explore

whether inducement exists. App. 14a, 19a.

8

Twombly rejected identical logic that “revealing the

theory of the claim will suffice” and that “the prospect

of unearthing direct evidence * * * preclude[s] dismissal.” 550 U.S. at 561–562. “It is no answer” that a

claim can “be weeded out early in the discovery process”—“the threat of discovery expense will push costconscious defendants to settle even anemic cases.” Id.

at 559. Amarin is thus wrong to call the decision’s reliance on the pre-Twombly standard “fact-bound” error. Opp. 20. As in Twombly, 550 U.S. at 559, “the

potentially enormous expense of discovery” will have

far-reaching effects—deterring generic market entry.

C. The decision creates a circuit split and aggravates uncertainty over whether inducement is a legal or factual question.

1. Amarin does not dispute the importance of

maintaining uniform pleading standards for inducement across patent and copyright law. Pet. 25–26.

The Federal Circuit’s holding cannot be reconciled

with the Ninth Circuit’s opposite approach: The decision below holds inducement is a “question of fact—not

law—and is therefore not proper for resolution on a

motion to dismiss.” App. 18a–19a (emphasis added).

In contrast, the Ninth Circuit holds “‘[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).

Amarin invokes an older case where the Federal

Circuit dismissed inducement claims, Opp. 17–18, but

that only confirms the departure from precedent. Amarin also cites this Court’s holding that direct infringement “is a question of fact,” Markman v. Westview Instruments, Inc., 517 U.S. 370, 384 (1996), but it admits

9

this case is not about direct infringement, Opp. 11,

which is a strict-liability tort. By contrast, inducement

is a form of “secondary liability”—a limited exception

to “the law’s reluctance to find liability when a defendant merely sells a commercial product suitable for

some lawful use.” Grokster, 545 U.S at 934, 936. Only

“clear expression or other affirmative steps taken to

foster infringement” render a defendant “liable for the

resulting acts of infringement by third parties.” Id. at

937. That is a legal inquiry distinct from the underlying factual question of direct infringement.

2. There is “no statutory requirement or instruction from th[is] 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). Amarin dismisses this commentary as “one student note,” Opp. 18

n.6, but it ignores more recent commentary (published

after the petition) confirming that the decision below

raises the same uncertainty:

[D]ecisions like GSK and Amarin, which purport to hinge on factual questions, could just as

easily be understood as hinging on questions

about inducement law. * * * In Amarin: is a

warning about the patented use, coupled again

with statements about ‘equivalence’ and

knowledge of prescribing practices, legally sufficient to state a claim of inducement? These

assessments of legal sufficiency sound much

more like issues of law than fact.

Jacob S. Sherkow & Paul R. Gugliuzza, Infringement

by Drug Label, 78 STAN. L. REV. —, 48 (2026) (rev. May

20, 2025), https://papers.ssrn.com/sol3/papers.cfm?

10

abstract_id=5145419. These scholars propose treating

inducement “as ultimately a legal question that can be

based on underlying factfinding.” Ibid. Amarin disagrees, but that is a merits-stage dispute. Either way,

this Court’s guidance is needed.

3. Amarin’s efforts to distinguish Perfect 10 confirm that the conflict is real—and the law-or-fact divide affects the outcome. Contra Opp. 18. As Amarin

acknowledges, the Ninth Circuit dismissed inducement claims because the plaintiff “alleged no ‘affirmative steps taken to foster infringement’” and “asserted

merely that the defendants marketed their credit

cards generally but provided no allegations that the

defendants affirmatively promoted the infringing

products.” Opp. 19 (citing Perfect 10, 494 F.3d at 800–

801). So too here: Amarin asserts Hikma generally

marketed its “generic version,” but it provides no allegation that Hikma affirmatively promoted the infringing methods—reducing risk of CV death and co-administering a statin to reduce CV events.

Under the Ninth Circuit’s standard, Amarin’s complaint is deficient: While courts “must take as true the

allegations” of factual statements, “‘[i]nducement’ is a

legal determination,” and courts “must determine

whether the facts as pled constitute a ‘clear expression’

of a specific intent to foster infringement.” Perfect 10,

494 F.3d at 802. The Federal Circuit rejected this exact approach—urged by Hikma below, contra Opp.

18—that “the factual contents of Hikma’s label and

public statements are undisputed, such that we can resolve this case as a matter of law,” App. 19a.

Amarin falsely declares without citation that

“Hikma is alleged to have courted prescribers of the

CV indication to use their generic rather than

11

Amarin’s product.” Opp. 19. But there is no allegation

that Hikma—a generic drug manufacturer—“courted”

anyone. This case is about vague statements in press

releases that are not directed to doctors and do not describe any treatment steps. That would never pass

muster in the Ninth Circuit; in the Federal Circuit, it

does. The split is undeniable.

II. This case is an excellent vehicle to address

the critically important questions presented.

Amarin raises no real vehicular obstacle. Its refrain that this case is “about the pleadings,” Opp. 25,

supports review. The pleadings-stage posture is ideal

for considering the legal sufficiency of inducement allegations—not post-trial disputes over facts—and this

Court commonly reviews cases in the same posture.

See, e.g., Twitter, Inc. v. Taamneh, 598 U.S. 471, 482

(2023) (reinstating district court’s dismissal of aidingand-abetting allegations that court of appeals had reversed); Twombly, 550 U.S. at 552–553.

It is no answer that Amarin must still prove liability and remedies. Opp. 31. This is a test case; the industry is watching. See Pet. 5–7. If lawsuits like these

survive the pleadings, the harm will already be done:

The risks and costs of litigating will chill generic competition. Pet. 31–34. As the Solicitor General warned

(and Amarin ignores), even “the potential for inducement liability * * * may significantly deter use of the

section viii pathway.” Teva, 2023 WL 2717391, at *22.

These are not “concerns [ ] properly addressed by

Congress.” Opp. 25. Congress has already spoken—

requiring “active” inducement in § 271(b) and enacting

section viii to ensure “patented use[s] will not foreclose

marketing a generic drug for other unpatented ones.”

12

Caraco, 566 U.S. at 415. Enforcing these statutory

mandates creates no “safe harbor” for drugmakers

that illegally promote unapproved, infringing method

steps. Opp. 26. Amarin pleads no such misconduct.

Absent this Court’s review, accurately calling a drug

“generic” and citing public market data will suffice to

plead inducement of any patented method—opening

floodgates to post-launch litigation and rendering both

§ 271(b) and section viii meaningless. As in Caraco,

this Court need not wait for widespread abuse of a Federal Circuit ruling that misinterprets the Hatch-Waxman Act; the Court should grant review now.

CONCLUSION

The petition should be granted. Alternatively, 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

JUNE 2025

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

SAMUEL S. PARK

Hikma Pharmaceuticals

200 Connell Drive

Berkeley Heights,

NJ 07922

Counsel for Petitioners