Supplemental 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

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HIKMA PHARMACEUTICALS USA INC. AND

HIKMA PHARMACEUTICALS PLC,

Petitioners,

v.

AMARIN PHARMA, INC., ET AL.,

Respondents

___________________

On Petition for a Writ of Certiorari to the

United States Court of Appeals for the Federal Circuit

___________________

SUPPLEMENTAL BRIEF FOR RESPONDENTS

___________________

Nathan K. Kelley

Nicholas S. Crown

Jonathan I. Tietz

PERKINS COIE LLP

700 Thirteenth Street N.W.

Suite 800

Washington, DC 20005-3960

Michael R. Huston

Counsel of Record

PERKINS COIE LLP

2525 E. Camelback Road,

Suite 500

Phoenix, AZ 85016-4227

(202) 434-1630

mhuston@perkinscoie.com

CORPORATE DISCLOSURE STATEMENT

The statement in respondents’ brief in opposition to

certiorari remains accurate.

ii

TABLE OF CONTENTS

A. The government identifies no legal question or

error warranting this Court’s review.......................... 3

B. The government’s retreaded policy arguments

remain unpersuasive ..................................................... 8

C. The government’s brief confirms that the

petition presents a poor vehicle ................................. 10

Conclusion .......................................................................... 13

iii

TABLE OF AUTHORITIES

Pages

CASES

American Wood-Paper Co. v. Fibre Disintegrating,

90 U.S. 566 (1874) ........................................................... 5

Ashcroft v. Iqbal,

556 U.S. 662 (2009) ..................................................... 5, 6

Brumfield v. IBG LLC,

97 F.4th 854 (2024) ....................................................... 11

Caraco Pharm. Lab’ys, Ltd. v. Novo Nordisk A/S,

566 U.S. 399 (2012) ................................................. 4, 6, 9

City & County of San Francisco v. Sheehan,

575 U.S. 600 (2015) ....................................................... 10

Cutter v. Wilkinson,

544 U.S. 709 (2005) ....................................................... 10

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.,

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

cert. denied, 143 S.Ct. 2483 (2023) ................................ 7

Kyles v. Whitley,

514 U.S. 419 (1995) ......................................................... 4

Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd.,

545 U.S. 913 (2005) ..................................................... 2, 4

Teva Pharmaceuticals USA, Inc.

v. GlaxoSmithKline LLC,

143 S.Ct. 2483 (2023) .......................................... 2, 3, 8, 9

The Monrosa v. Carbon Black Export, Inc.,

359 U.S. 180 (1959) ....................................................... 12

Ticor Title Ins. Co. v. Brown,

511 U.S. 117 (1994) ....................................................... 12

iv

United States v. Johnston,

268 U.S. 220 (1925) ......................................................... 3

RULES

Fed. R. Civ. P. 15(a)(2) ...................................................... 12

Sup. Ct. R. 10 ........................................................................ 3

REGULATIONS

68 Fed. Reg. 36,676 (2003)................................................... 8

OTHER AUTHORITIES

John D. Garretson, Litigating Patent Cases:

Industry-Specific Developments, Issues, and

Strategies, Aspatore, 2013 WL 574399 (Jan. 2013) .. 12

Lex Machina, Patent Litigation Report 2023 (2023) ...... 12

In the Supreme Court of the United States

_______________

No. 24-889

HIKMA PHARMACEUTICALS USA INC. AND

HIKMA PHARMACEUTICALS PLC,

Petitioners,

v.

AMARIN PHARMA, INC., ET AL.,

Respondents.

___________________

On Petition for a Writ of Certiorari to the

United States Court of Appeals for the Federal Circuit

___________________

SUPPLEMENTAL BRIEF FOR RESPONDENTS

____________

The court of appeals’ decision was a narrow, casespecific application of the settled legal standard for pleading induced patent infringement. That decision does not

affect the section viii pathway for generic drugs under the

Hatch-Waxman Act because Amarin pleaded in detail

how petitioners intentionally encouraged infringing uses

of Amarin’s ground-breaking pharmaceutical product.

The government’s invitation brief agrees with the Federal

Circuit that Congress imposed liability when a generic

actively encourages patented uses of a branded drug,

including through its advertising. OSG.Br.12, 14.

The government disagrees merely with the Federal

Circuit’s bottom-line conclusion that the particular constellation of facts pleaded in Amarin’s operative complaint

passed the plausibility threshold at the pleading stage.

But that is just a request for fact-bound (purported) error

correction. Indeed, the invitation brief undermines multi-

2

ple arguments for certiorari advanced by the petition:

The government does not contest the brief in opposition’s

showing that this case implicates no true conflict, and that

the Federal Circuit identified the correct legal standard

for induced infringement. The government’s question

presented (Br.I)—“Whether respondents’ complaint

plausibly alleged that petitioners had actively induced

infringement”—confirms that this case comes to this

Court with no meaningful legal dispute, just an application of established law.

The government also fails to identify any error—let

alone a certworthy error—in the decision below. The government doesn’t contest the Federal Circuit’s finding that

petitioners did not dispute at the pleading stage their specific intent to infringe. So the motion to dismiss came

down to whether Amarin pleaded “௘‘active steps’௘” by petitioners to infringe, “includ[ing by] ‘advertising an infringing use.’௘” OSG.Br.14 (quoting Metro-Goldwyn-Mayer

Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 936-937 (2005)).

That is exactly what Amarin alleged in the complaint:

Amarin pleaded how petitioners’ promotional materials—

which included describing its generic product too broadly

so as to encompass patented uses—encouraged prescription of its product for infringing uses. The government

thinks it unlikely that petitioners’ website and press

releases influenced prescription decisions. But whether

petitioners succeeded in their (undisputed) specific intention to encourage infringement is a fact question currently

subject to fact and expert discovery. Amarin pleaded how

petitioners’ activities encouraged infringement, and those

claims will be determined at trial.

The government’s brief recycles—often verbatim—

the same policy concerns it offered unconvincingly three

Terms ago in Teva Pharmaceuticals USA, Inc. v. Glaxo-

3

SmithKline LLC, 143 S.Ct. 2483 (2023) (No. 22-37). Those

arguments have not aged well: Since this Court denied

review in Teva despite the government’s recommendation, the government does not show that its predictions of

an exodus from the section viii pathway have come to pass.

And the government shortchanges the enormous benefits

of recognizing patent protections for subsequent treatment indications for a drug, particularly given the immense investments often required to discover life-saving

treatments. Hatch-Waxman created a careful balance, but

the government skews it at the expense of the patients

who will benefit from future new and improved therapies.

Last, the government’s brief confirms that this petition is a bad vehicle. The government’s question presented resolves disputed issues of fact. The brief introduces new arguments that petitioners never raised below

and so the court of appeals never addressed. And even on

the government’s framing, granting review would have

virtually no practical application because Amarin would

be entitled on remand to amend its complaint with the

additional facts revealed in discovery that further support

petitioners’ actions, intent, and liability.

The petition should be denied.

A. The government identifies no legal question or error

warranting this Court’s review.

1. This Court does not grant certiorari “to review

evidence and discuss specific facts.” United States v.

Johnston, 268 U.S. 220, 227 (1925); see Sup. Ct. R. 10. Yet

that is all the government asks this Court to do: to determine “whether [this] complaint plausibly alleged that

petitioners had actively induced infringement.” OSG.Br.I.

That is classic fact-bound error correction.

4

The government does not endorse petitioners’ arguments claiming a conflict or that the court of appeals misunderstood applicable law. Instead, the invitation brief

shows that Amarin, the Federal Circuit, and the United

States all agree on the relevant standard: While the

patent laws do not “௘‘foreclose’௘” marketing a generic drug

limited to “௘‘unpatented’௘” methods, they do prohibit “encouraging infringing uses.” OSG.Br.12 (quoting Caraco

Pharm. Lab’ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399,

415 (2012)); accord Pet.App.13a-16a; Opp.8-9, 20-21. It’s

common ground that “culpable ‘active steps to encourage

infringement include advertising an infringing use or instructing how to engage in an infringing use.’௘” OSG.Br.14

(quoting Grokster, 545 U.S. at 936-937); accord Pet.App.

15a-21a; Opp.21-22. It’s also settled that alleging a “plausible chain of events through which statements made by

Hikma could lead a healthcare provider—presumably a

doctor or pharmacist—to prescribe or dispense Hikma’s

drug to reduce a patient’s cardiovascular risk” was all that

was required of Amarin at this threshold stage. OSG.Br.

14. That is what the Federal Circuit found to be plausible

here, based on the “totality” of Amarin’s case-specific

allegations. Pet.App.12a-13a. This is thus “an intensely

fact-specific case in which the court below unquestionably

applied the correct rule of law and did not unquestionably

err—precisely the type of case in which [this Court is]

most inclined to deny certiorari.” Kyles v. Whitley, 514

U.S. 419, 460 (1995) (Scalia, J., dissenting).

The government cautions (Br.12) that liability should

not attach to a generic manufacturer’s statements that

are “integral to the section viii pathway.” But as the government acknowledges (Br.11), the Federal Circuit did

not hold that a generic’s mere statement of biological

equivalence would meet the pleading burden. Pet.App.

21a. The complaint instead alleged multiple public state-

5

ments by petitioners that the government concedes

(Br.17) were “not necessary to the operation of the HatchWaxman scheme.”

The government doubts (Br.17-19) Amarin’s allegations that those statements influenced doctors and pharmacists. But whether petitioners’ identified statements

succeeded in their intended goal to increase the prevalence of infringing uses is a question of fact to be developed—and currently being developed—in fact and expert

discovery. At this stage, Amarin’s well-pleaded allegations about those influences must be “assume[d]” true,

and its legal theory need only be plausible. Ashcroft v.

Iqbal, 556 U.S. 662, 679 (2009). Besides, any question

about the “prevalence” of infringing uses, OSG.Br.12,

pertains only to damages, not liability: A “single instance”

of infringement suffices to state a claim for liability.

American Wood-Paper Co. v. Fibre Disintegrating, 90

U.S. 566, 600 (1874).

2. The government’s additional criticisms of Amarin’s pleading lack merit.

The government badly errs in arguing (Br.14) that the

complaint “contains only a conclusory statement” that

petitioners encouraged infringement. That overlooks Amarin’s detailed allegations. For example, petitioners chose

to use their website to go well beyond the scope of their

approval or the section viii pathway by advertising to buyers that their drug fell within the broad “hypertriglyceridemia” therapeutic category—a category that encompassed Amarin’s patents—rather than the “severe hypertriglyceridemia” patient category for which petitioners’

generic was approved. Opp.12-13; S.App.29a-38a. The

government recognizes (Br.18) that petitioners mounted

a “broad” marketing campaign that encompassed “both

infringing and non-infringing uses.” That is just what the

6

law forbids: A generic may “market a drug for only unpatented methods of use.” Caraco, 566 U.S. at 419 (emphasis added); see OSG.Br.12. Moreover, the government’s fact argument necessarily assumes without support that providers would view severe hypertriglyceridemia as a subset of hypertriglyceridemia rather than a

distinct therapeutic category.

The government also fails to construe petitioners’

alleged statements in the light most favorable to Amarin,

as Iqbal requires. The government minimizes (Br.17-19)

petitioners’ press releases as “orthogonal” and “anodyne”

because they were purportedly directed at “investors”

rather than healthcare providers. But the press releases

expressly reference “healthcare providers” and emphasize petitioners’ efforts to “quickly provide patients with

access” to their generic drug. C.A.App. 613, 709-710, 712713, 715-717. The government also misapprehends the

relevant timeline. It contends (Br.17) that petitioners

issued their press releases before marketing their drug,

when in fact the press releases were part of their marketing scheme: Petitioners issued one release on the cusp of

FDA approval, two more upon approval, and another

right after product launch. Pet. App.5a-7a.

The government likewise disregards (Br.16-19) the

content and context of petitioners’ statements. The May

22, 2020 press release, for instance, announced FDA

approval of a “generic equivalent to Vascepa.” S.App.4a;

see C.A.App.613. But the press release did not identify

any limitations on use, nor state that FDA’s approval was

limited to “AB-equivalence”—meaning equivalent only

when used for an approved use. Pet.App.18a. Petitioners’

September 3, 2020 press release (which announced victory in earlier litigation) similarly omitted any mention of

limitations on the use of their generic. S.App.31a-32a.

7

Instead, petitioners touted Vascepa’s “approximately $1.1

billion” in yearly U.S. sales, the bulk of which—as petitioners indisputably knew—related to the infringing CV

risk-reduction indication. Ibid. It is eminently plausible

that healthcare providers would have known that the most

common use of Vascepa was for the widely publicized

infringing CV risk-reduction indication that is close to

synonymous with Vascepa. Id. at 34a-37a.

As the government recognizes (Br.14-15), healthcare

providers’ “sophisticat[ion]” and “base of relevant knowledge” suggest that “even subtle efforts to encourage

infringing uses of a specific drug could prove efficacious.”

Factual discovery in other cases has shown that providers

“consider” and are “encourage[d]” by generics’ “press

releases.” E.g., GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc., 7 F.4th 1320, 1336-1337 (Fed. Cir. 2021), cert.

denied, 143 S.Ct. 2483 (2023). It is plausible that the same

is true here.

The government asserts (Br.15-16) that an FDAapproved carveout label itself will not encourage infringement “absent exceptional circumstances.” But that question is not implicated here. The Federal Circuit made

clear that its decision did not rest on petitioners’ label; it

turned instead on the “totality” of Amarin’s allegations,

including petitioners’ numerous and unnecessary public

statements marketing its generic drug for an infringing

use. Pet.App.12a-13a. Amarin has thus plausibly alleged

the “exceptional circumstances” that the government contemplates.

No case holds that FDA approval for a label establishes virtually per se immunity against patent-infringement liability. FDA disclaims patent expertise, performs

no patent analysis, and makes clear that it is the generic

applicant’s responsibility to ensure that a carveout is

8

adequate. See, e.g., 68 Fed. Reg. 36,676, 36,683 (2003);

S.App.26a. Petitioners’ particular label here, moreover,

provided detailed, medically oriented language that Amarin plausibly showed would communicate to sophisticated

healthcare providers that the generic drug should be used

for the infringing (and far more prevalent) use. What providers understood from that language—and whether it

“encourage[d]” them to infringe, OSG.Br.12—are fact

questions for a later stage, Opp.12-13, 17-18.

Last, the government suggests (Br.18, 22) that some

(not all) infringing conduct may be explained by States’

mandatory-substitution laws, rather than petitioners’

encouragement. But petitioners never raised that argument below, perhaps because it implicates other fact

questions of actual causation and damages that cannot be

determined on the pleadings. As the government concedes (Br.6), state law preserves healthcare providers’

discretion to specify a brand or generic. That confirms

that this argument pertains only to the ultimate measure

of Amarin’s damages to be determined at trial, not

whether Amarin has plausibly stated a claim for infringement—including whether Amarin is entitled to its

requested injunctive relief. S.App.59a.

B. The government’s retreaded policy arguments remain

unpersuasive.

Regarding purported certworthiness, the government

repeats the very same policy arguments from its invitation brief unsuccessfully urging review in Teva Pharmaceuticals. U.S. Br., 143 S.Ct. 2483 (No. 22-37). Those

contentions are even less persuasive here.

The government reiterates (Br.12-13, 19-20) that the

section viii pathway plays an important role in expediting

approval of certain generic drugs, and it claims once again

that this decision (like Teva) “subverts” Congress’s plan.

9

Cf. Teva U.S. Br.17, 20-21. But Congress permitted generics to market “only” “unpatented methods of use.”

Caraco, 566 U.S. at 419 (emphasis added); see id. at 415.

The government itself says that Congress “determin[ed]”

that “some measure of direct patent infringement” would

be acceptable only “so long as generic manufacturers do

not encourage infringing uses of their drugs.” OSG.Br.20

(emphasis added); see OSG.Br.12 (similar). Because the

court of appeals found that Amarin plausibly alleged that

petitioners intentionally encouraged a patented method of

use, the decision below is perfectly consistent with Congress’s balance.

The government speculates (Br.21-23) that the decision below will disincentivize the section viii pathway. But

the court of appeals was faithful to this Court’s decision in

Caraco, 566 U.S. 399, which has been on the books since

2012. The government ventured the exact same predictions in Teva, see U.S. Br.21, yet it identifies no evidence

from the last several years that FDA has seen meaningfully fewer applications. Nor does the government address Congress’s countervailing policy interests in preserving patent protections, including the imperative need

to incentivize companies to commit the millions—often

billions—of dollars required to discover and develop new

lifesaving treatments for an existing drug. Opp.26. As the

government acknowledges (Br.21), moreover, “[e]ven

without this Court’s intervention, [petitioners] might ultimately prevail at summary judgment or trial.”

The government also renews (Br.15-16) its earlier

argument that a generic lacks control over its carveout

label. Cf. Teva U.S. Br.14-15. That contention has even

less force here because the decision below, unlike in Teva,

does not turn solely on the content of petitioners’ label.

Pet.App.16a-21a.

10

C. The government’s brief confirms that the petition

presents a poor vehicle.

The government’s brief does nothing to fix the petition’s multiple vehicle defects. Opp.22-23. If anything, it

compounds them.

For one, the government’s articulation of the question

presented depends on resolving disputed facts: that petitioners accurately described their drug as a generic; that

they adequately carved out the patented use from their

label; and that they directed their communications solely

to investors. Even under the government’s fact-bound

framing, then, this case is an unsuitable vehicle to review

a motion-to-dismiss ruling.

The government also introduces two new arguments

that petitioners either forfeited or waived. Such latebreaking arguments by an amicus curiae offer no sound

basis for granting interlocutory review. First, the government asserts (Br.15) that courts should consider

whether prescribing pharmacists “know why a particular

drug is being prescribed” or are “compelled or constrained by state law” to select certain products. But

the court of appeals had no occasion to consider those

contentions because petitioners did not raise them. See

C.A.App.945-967. As a “court of review, not of first view,”

Cutter v. Wilkinson, 544 U.S. 709, 718 n.7 (2005), this

Court “does not ordinarily decide questions that were

not passed on below,” City & County of San Francisco v.

Sheehan, 575 U.S. 600, 609 (2015).

Second, the government fights the uncontested record

by questioning (Br.14, 22-23) whether Amarin adequately

alleged petitioners’ “specific, culpable intent.” That challenge is unpersuasive: The government cites (Br.23) the

pages of Hikma’s appellate brief that recited the legal

standard but challenged only the element of “active steps

11

to encourage” infringement. Petrs.C.A.Br.24-26. The

Federal Circuit thus found it “undisputed that Amarin’s

complaint sufficiently alleges … that Hikma had the

requisite intent and knowledge to induce th[e] infringement,” and the court proceeded on that basis. Pet.App.15a

(emphasis added). Tellingly, petitioners did not seek

review of that finding. Opp.22-23.

Similarly misplaced is the government’s expression

(Br.21-22) of “uncertainty as to the calculation of potential

damages” because, in its view, Teva’s discussion of lostprofits awards “could be read” to require petitioners to

“pay damages for all infringing uses of its drug, including

uses that [petitioners] played no causal role in inducing.”

The Federal Circuit has already foreclosed the result the

government fears. Brumfield v. IBG LLC, 97 F.4th 854,

876 (2024) (“An award of lost profits generally depends on

showing the existence and magnitude of profits lost to the

patentee on sales the patentee did not make, or made at

lower prices, as a result, under proper causation standards, of the infringement.” (emphasis added)).

The government nonetheless recommends review on

the theory (Br.22) that allegations like Amarin’s will

appear in “most” section viii cases. Not at all. Other

generics can and do avoid describing their drugs’ equivalence more broadly than their approvals; avoid citing sales

from patented uses; and avoid featuring their drugs on

websites in ways that encroach on patent claims. Nor will

a patented use always be the one that is overwhelmingly

familiar to healthcare providers and that drives nearly all

sales. Opp.28-31.

The government likewise errs in contending (Br.23)

that it would be “imprudent” to wait for a case with developed facts because “[m]any cases of this kind settle.” Most

civil cases of all kinds settle. But pharmaceutical patent

12

cases settle less often—and are tried more often—than

non-pharmaceutical patent cases. See, e.g., Lex Machina,

Patent Litigation Report 2023, at 17 (2023) (observing

that “only 33% of ANDA cases resolved with a likely settlement compared to 79% of non-ANDA cases”); John D.

Garretson, Litigating Patent Cases: Industry-Specific

Developments, Issues, and Strategies, Aspatore, 2013 WL

574399, at *5 (Jan. 2013) (“pharmaceutical patent cases

are much less likely to settle”). The parties here have litigated this case for months since the Federal Circuit reversed the district court’s order dismissing the complaint.

Finally, granting interlocutory review of the particular allegations in this operative complaint would have minimal impact—if any at all. As explained above (at 3-5), the

government raises case-specific issues that would not govern future cases. Indeed, a decision by this Court may not

“make any difference even to the[௘] litigants” in this case.

Ticor Title Ins. Co. v. Brown, 511 U.S. 117, 122 (1994); see

The Monrosa v. Carbon Black Export, Inc., 359 U.S. 180,

184 (1959). Even under the government’s fact-bound

framing, the appropriate disposition would be a remand

with leave for Amarin to amend the Complaint. Fed. R.

Civ. P. 15(a)(2). Amarin would then replead its claims by

adding the substantial evidence—derived from ongoing

documentary and deposition discovery—that has since

confirmed each element of petitioners’ intentional induced infringement and identified additional acts of

induced infringement.

13

CONCLUSION

The petition should be denied.

Respectfully submitted,

Nathan K. Kelley

Nicholas S. Crown

Jonathan I. Tietz

PERKINS COIE LLP

700 Thirteenth Street N.W.

Suite 800

Washington, DC 20005-3960

December 23, 2025

Michael R. Huston

Counsel of Record

PERKINS COIE LLP

2525 E. Camelback Road,

Suite 500

Phoenix, AZ 85016-4227

(202) 434-1630

mhuston@perkinscoie.com