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

Supreme Court briefFeb 25, 2026

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No. 24-889

IN THE

Supreme Court of the United States

————

HIKMA PHARMACEUTICALS USA INC. AND

HIKMA PHARMACEUTICALS PLC,

Petitioners,

AMARIN PHARMA, INC., ET AL.,

Respondents.

————

On Writ of Certiorari to the

United States Court of Appeals

for the Federal Circuit

————

BRIEF OF AMICUS CURIAE FORMER

CONGRESSMAN HENRY A. WAXMAN

IN SUPPORT OF PETITIONERS

————

WILLIAM B. SCHULTZ

Counsel of Record

MARGARET M. DOTZEL

ZUCKERMAN SPAEDER LLP

2100 L Street, NW, Suite 400

Washington, DC 20036

(202) 778-1800

wschultz@zuckerman.com

mdotzel@zuckerman.com

Counsel for Amicus Curiae,

Former Congressman

Henry A. Waxman

February 25, 2026

WILSON-EPES PRINTING CO., INC. – (202) 789-0096 – WASHINGTON, D.C. 20002

TABLE OF CONTENTS

TABLE OF AUTHORITIES ........................................ ii

STATEMENT OF INTEREST ......................................1

INTRODUCTION AND SUMMARY OF

ARGUMENT .................................................................2

ARGUMENT .................................................................4

A. Congress Considered and Accounted for the

Scenario in this Case. ........................................ 5

1. Background of the Hatch-Waxman

Compromise .................................................. 5

2. Congress Addressed the Issue Raised

in this Case ................................................... 6

B. The Federal Circuit’s Decision Is

Inconsistent with the Statute and Will

Have Major, Adverse Implications ................... 8

1. The Federal Circuit’s Reliance on

Language in the Label, Hikma’s Website

and Press Releases was Misplaced............ 10

2. The Fact that Hikma’s Generic Can

and May Be Prescribed or Dispensed

for an Off-label Use is Not a Sufficient

Basis to Allege Infringement ..................... 12

3. The Federal Circuit’s Decision has

Major Adverse Implications....................... 13

CONCLUSION ............................................................ 16

TABLE OF AUTHORITIES

CASES

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S,

566 U.S. 399 (2012) ........................................... 4, 7, 8

Eli Lilly and Co. v. Medtronic Inc.,

496 U.S. 661 (1990) ...................................................5

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

7 F.4th 1320 (Fed. Cir. 2021) ................ 5, 8, 9, 11, 14

King v. Burwell,

576 U.S. 473 (2015) ...................................................5

Mead Johnson Pharmaceutical Group v. Bowen,

838 F.2d 1332 (D.C. Cir. 1988)..................................2

Takeda Pharm. U.S.A., Inc. v. West-Ward Pharm.

Corp.,

785 F.3d 625 (Fed. Cir. 2015) ................................ 4, 8

Warner-Lambert Co. v. Apotex Corp.,

316 F.3d 1348 (Fed. Cir. 2003) ............ 2, 4, 6, 7, 8, 15

STATUTES

21 U.S.C. § 355(j)(2)(A)(v) ....................................... 7, 10

21 U.S.C. § 355(j)(2)(A)(viii) .................................... 3, 7

21 U.S.C. § 355(j)(4)(G) ............................................... 10

35 U.S.C. § 271(e)(1)......................................................6

iii

OTHER AUTHORITIES

Association for Accessible Medicines,

2025 U.S. Generic and Biosimilars Medicines

Savings Report, at 10 (Sept. 2025) [available at

https://accessiblemeds.org/wpcontent/uploads/2025/09/AAM-2025-GenericBiosimilar-Medicines-Savings-Report-WEB.pdf]

(last visited Feb. 23, 2026) .................................. 4, 16

Guidance for Industry,

180 Day Exclusivity: Questions and Answers at 2

(Jan. 2017) [available at

https://www.fda.gov/media/102650/download] (last

visited Feb. 23, 2026).................................................3

Harold Varmus,

“Winning Arguments on Capitol Hill,” Nature

(Oct. 8, 2009). .............................................................1

Mengde Liu & Lu Yao,

The effect of USA state generic substitution laws on

the generic utilization and market competition,

Pharmacoeconomics and Policy 1 (2025) 33–41

[available at

https://www.sciencedirect.com/science/article/pii/S2

950266725000023] (last visited Feb. 23, 2026) ...... 13

Overpatented, Overpriced: How Excessive

Pharmaceutical Patenting Is Extending

Monopolies and Driving up Drug Prices, I-MAK

(2018), [available at https://www.i-mak.org/wpcontent/uploads/2018/08/I-MAK-OverpatentedOverpriced-Report.pdf]

(last visited Feb. 23, 2026) ...................................... 15

William Haddad,

The Drug Price Competition and Patent Term

Restoration Act of 1984, Generic Drug Laws: A

Decade of Trial—A Prescription for Progress

(Theodore Goldberg et al. eds., U.S. Dep’t of

Health & Human Servs. 1986)................................ 13

RULES

Sup. Ct. R. 37.6..............................................................1

REGULATIONS

21 C.F.R. § 314.127(a)(7)...............................................7

21 C.F.R. § 314.53(b)(1).................................................9

21 C.F.R. § 314.94(a)(8)(iv) ..................................... 7, 10

FDA Amendment to NDA requirements,

68 Fed. Reg. 36676 (June 18, 2003) ..........................9

LEGISLATIVE MATERIALS

Drug Price Competition and Patent Term

Restoration Act of 1984, Pub. L. No. 98-417,

98 Stat. 1585 1984)

..................................... 1, 2, 3, 4, 5, 6, 8, 9, 12, 13, 16

H.R. Rep. No. 98-857, pt. I (June 21, 1984) .................6

H.R. Rep. No. 98-857, pt. II (Aug. 1, 1984) ..................2

STATEMENT OF INTEREST1

Congressman Henry Waxman served on the

U.S. House of Representatives’ Committee on Energy

and Commerce for 40 years, as Chair of its

Subcommittee on Health and the Environment from

1979 to 1994 and as Chair of the House Energy and

Commerce Committee from 2008 to 2010. He has been

described as “one of the most accomplished legislators

of our time” with “remarkable legislative records in

domains in which science is important, including

health care and regulatory policy. . . .”2

One of Congressman Waxman’s most significant

accomplishments was the Drug Price Competition and

Patent Term Restoration Act of 1984, Pub. L. No. 98417, 98 Stat. 1585 (1984) (Hatch-Waxman Act), a

landmark statute that created the modern generic drug

industry. Congressman Waxman is submitting this

brief in support of Hikma Pharmaceuticals, USA Inc.

and Hikma Pharmaceuticals Inc. (Hikma) because he

believes both that the Federal Circuit’s decision in this

case is flatly inconsistent with the language of the Act

and congressional intent, and that unless overturned it

will devastate the Hatch-Waxman Act’s generic drug

program, which has saved patients, the federal

government, and other payers trillions of dollars.

1 Amicus curiae certifies that no party’s counsel authored this brief

in whole or part, and no party or party’s counsel contributed

money intended to fund preparing or submitting the brief. Arnold

Ventures contributed money to fund the brief. Sup. Ct. R. 37.6.

2 Harold Varmus, Winning the Arguments on Capitol Hill, 461

Nature 730, 730–31 (Oct. 8, 2009).

INTRODUCTION AND

SUMMARY OF ARGUMENT

Following extensive negotiations that included

representatives of industry and consumers, in 1984

Congressman Waxman and Senator Orrin Hatch

developed a grand compromise “between two

competing sets of interests: those of innovative drug

manufacturers, who had seen their effective patent

terms shortened by the testing and regulatory

processes; and those of generic drug manufacturers,

whose entry into the market upon expiration of the

innovator’s patents had been delayed by . . . regulatory

requirements.” Warner-Lambert Co. v. Apotex Corp.,

316 F.3d 1348, 1358 (Fed. Cir. 2003).

One of the main purposes of the Hatch-Waxman

Amendments was to increase competition among

prescription drugs by facilitating the approval of

generic copies of brand name drugs. See H.R. Rep. No.

98-857, pt. II, at 8-9 (Aug. 1, 1984); see also Mead

Johnson Pharmaceutical Group v. Bowen, 838 F.2d

1332, 1333 (D.C. Cir. 1988). Congress did so by

eliminating

the

requirement

that

generic

manufacturers conduct expensive clinical trials

demonstrating a drug’s safety and efficacy. Congress

also created a mechanism for ensuring to the extent

possible that the brand’s patents do not block generic

drugs from getting on the market any longer than the

life of the patent.

Relevant here, Congress recognized that a drug

product could have more than one indication or use,

and that the generic may choose not to sell its drug for

all uses, and in particular may desire to exclude any

uses still covered by a patent. To advance its goal of

getting generic drugs on the market as soon as possible,

Hatch-Waxman explicitly allows an abbreviated new

drug application (ANDA) applicant to exclude a

particular use for a multiple-use product where the

excluded use is still protected by a patent or other

exclusivity. In this case, the generic applicant files

what is called a “section viii statement,” named after

the section in the statute that created it, 21 U.S.C. §

355(j)(2)(A)(viii), and “carves out” the protected use,

excluding it from the generic label. For this to be an

option, there must be at least one use for which a

patent or regulatory exclusivity is not preventing

approval of the generic and the exclusion of the

protected use must not make the ANDA product less

safe than the reference listed drug (RLD). See,

Guidance for Industry, 180 Day Exclusivity: Questions

and Answers at 2 (Jan. 2017) [available at

https://www.fda.gov/media/102650/download.] (last visited

Feb. 23, 2026).

This is a particularly important provision

because in some cases the brand can get a patent for a

new use (or multiple patents for multiple new uses)

years after its product has been approved, as occurred

in this case. Without the section viii procedure, brands

could effectively extend their patent protection and

block the marketing of a generic for many years by

getting approval of one or more patents for a new use

or multiple patents for multiple new uses, as patents

on the drug’s use or uses expire.

Congress anticipated this exact situation when

it enacted Hatch-Waxman. As this Court has

recognized, “[t]he Hatch-Waxman [Act] authorize[s]

the FDA to approve the marketing of a generic drug for

particular unpatented uses; and section viii provides

the mechanism for a generic company to identify those

uses, so that a product with a label matching them can

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

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

added). See also Takeda Pharm. U.S.A., Inc. v. WestWard Pharm. Corp., 785 F.3d 625, 630 (Fed. Cir. 2015);

Warner-Lambert, 316 F.3d at 1360 .

The Federal Circuit’s decision in this case would

completely undermine the section viii pathway and

seriously undercut the availability of generic drugs by

allowing brand companies to sue for induced patent

infringement regarding a patented use of a drug that

the generic company has carved out from its label

merely because the generic manufacturer has matched

the brand’s label except for the carved-out indication,

has identified its product a “generic version” and has

cited public information about the branded drug’s

sales.

ARGUMENT

For decades, the Hatch-Waxman Act has been

instrumental in maintaining the availability of less

expensive but equally safe and effective generic

medicines. In 2024 generic drugs comprised 90% of

prescriptions filled nationally, saving $447 billion,

including $142 billion in Medicare savings and $62.1

billion in Medicaid savings.3 The Federal Circuit’s

Association for Accessible Medicines, 2025 U.S. Generic and

Biosimilars Medicines Savings Report, at 10 (Sept. 2025)

[available

https://accessiblemeds.org/wp3

decision in an earlier case, GlaxoSmithKline LLC v.

Teva Pharm. USA, Inc., 7 F.4th 1320 (Fed. Cir. 2021),

had already threatened to destroy the hard-fought

compromise at the heart of the Act by effectively

eliminating the section viii pathway. This decision if

upheld would put a nail in the coffin for this important

generic pathway to market.

Congress Considered and Accounted

for the Scenario in this Case.

Courts “must respect the role of the Legislature,

and take care not to undo what it has done. A fair

reading of legislation demands a fair understanding of

the legislative plan.” King v. Burwell, 576 U.S. 473, 498

(2015). In the Hatch-Waxman Act, Congress attempted

to foresee and close loopholes and in so doing

anticipated the very scenario at issue in this case and

addressed it. The Federal Circuit’s decision ignores the

legislative text and undermines Congress’s careful and

considered “legislative plan.”

Background of the Hatch-Waxman

Compromise.

The Hatch-Waxman Act “was designed to

respond to two unintended distortions of the 17-year

patent term [that existed in 1984,] produced by the

requirement that certain products must receive

premarket regulatory approval.” Eli Lilly and Co. v.

Medtronic Inc., 496 U.S. 661, 669 (1990). Senator

Hatch, with the interests of brand pharmaceuticals

and innovative drug development in mind, sought to

content/uploads/2025/09/AAM-2025-Generic-BiosimilarMedicines-Savings-Report-WEB.pdf.] (last visited Feb. 23, 2026).

resolve the first of the two issues, which “arose from

the fact that an inventor ordinarily applies for patent

protection . . . well

before

securing

regulatory

approval. . . .” Warner-Lambert, 316 F.3d at 1357.

Congressman Waxman, with the interests of

consumers and lower drug prices in mind, sought to

resolve the second issue, which “inhered in the need for

a generic manufacturer . . . to provide its own safety

and efficacy data,” which was often prohibitively

expensive, resulting “in a de facto extension of the

patent term.” Id.

The

Hatch-Waxman

Act

gave

brand

manufacturers patent extensions of up to five years

and provided that “[g]eneric copies of any drugs may be

approved if the generic is the same as the original drug

or so similar that FDA has determined the differences

do not require safety and effectiveness testing.” H.R.

Rep. No. 98-857, pt. I at 14-15 (June 21, 1984). The Act

also established a regulatory scheme where there is no

gap between the expiration of applicable patents and

the marketing of the generic drug. See id. at 15; see also

35 U.S.C. § 271(e)(1).

Congress Addressed the Issue

Raised in this Case.

In this case, Amarin’s product Vascepa®

initially was approved and indicated to reduce

triglyceride levels in adult patients with severe

hypertriglyceridemia. Appellee’s Pet. Resp. App.13a–

14a, ¶ 56. This is the SH indication. Hikma filed its

ANDA and obtained approval of the SH indication.

Appellee’s Pet. Resp. App. 21a, ¶ 82. Amarin then

received approval for a new indication for cardiovascular

risk (the CV indication), which was protected by a

patent. Appellee’s Pet. Resp. App. 16a, ¶ 62.

Importantly, Congress had considered what would

happen if a generic drug entered the market after the

patent on the product’s basic compound had expired

but where one or more of the product’s specific uses

remained under patent—just as occurred here.

In this situation, the generic applicant may

provide a “section viii statement.” See 21 U.S.C.

§ 355(j)(2)(A)(viii). In developing such a procedure,

“Congress recognized that a single drug could have

more than one indication and yet that the [generic]

applicant could seek approval for less than all of those

indications.” Warner-Lambert, 316 F.3d at 1360.

With a section viii statement, the generic

company certifies that it will market the drug with

labeling “that ‘carves out’ from the brand’s approved

label the still-patented methods of use.” Caraco, 566

U.S. at 406 (citing 21 C.F.R. § 314.94(a)(8)(iv)). Such a

label is commonly referred to as a “skinny label.” From

there, “[t]he FDA may approve such a modified label []

as an exception to the usual rule that a generic drug

must bear the same label as the brand-name

product[.]” Id. (citing 21 C.F.R. § 314.127(a)(7); 21

U.S.C. §§ 355(j)(2)(A)(v), (j)(4)(G)). Critically, the

generic company relies on the brand company’s

“description of any method-of-use patent it holds” when

it “assure[s] the FDA that its proposed generic drug

will not infringe the brand’s patents.” See id. at 405–

06.

Congress thus anticipated this exact situation.

As the Supreme Court recognized, “[t]he Hatch-

Waxman [Act] authorize[s] the FDA to approve the

marketing of a generic drug for particular unpatented

uses; and section viii provides the mechanism for a

generic company to identify those uses, so that a

product with a label matching them can quickly come

to market.” Caraco, 566 U.S. at 415 (emphasis added);

see also Takeda, 785 F.3d at 630; Warner-Lambert, 316

F.3d at 1360.

Additionally, Congress was aware that the

approval of a generic drug as therapeutically

equivalent to the brand drug means that it may be

safely substituted for all uses, including those that are

carved out of the labeling. See Takeda, 785 F.3d at 631

(“[T]he statute was designed to enable the sale of drugs

for non-patented uses even though this would result in

some off-label infringing uses.”). Congress thus

intended that a generic would not be liable for

infringement simply because a physician prescribes

generic drugs or a pharmacy substitutes generic drugs

for patented off-label uses.

The Federal Circuit’s Decision Is

Inconsistent with the Statute and

Will Have Major, Adverse

Implications.

The Federal Circuit’s decision cannot be

reconciled with the plain statutory text and

congressional intent. It creates significant uncertainty

as to how generic companies can comply with the

Hatch-Waxman Act and avoid patent infringement

lawsuits such as this one, because the opinion permits

skinny labels to be proof of induced infringement. As

recognized by the dissent in GlaxoSmithKline LLC,

“it’s unclear what [Hikma] even did wrong—or, put

another way, what another generic in its shoes should

do differently.” 7 F.4th at 1360 (Prost, J., dissenting).

The Hatch-Waxman Act created a regulatory

scheme that provides a clear and considered roadmap

for generics to avoid infringement. “If a generic wanted

to avoid patented uses, it had the simple expedient of

omitting from its label the uses the brand identified.

And if a brand wanted to block a skinny label

containing a use it thought was patented, it had the

simple expedient of including that use in its FDA

patent declaration.” Id. at 1361 (Prost, J., dissenting);

see also 21 C.F.R. § 314.53(b)(1) (2003) (“For approved

applications, the applicant submitting the method-ofuse patent shall identify with specificity the section of

the approved labeling that corresponds to the method

of use claimed by the patent submitted.”) (emphasis

added);4 FDA Amendment to NDA requirements, 68

Fed. Reg. 36676, 36682 (June 18, 2003) (“In

determining whether [generic] can ‘carve out’ the

method of use, [the FDA] will rely on the description of

the approved use provided by the . . . patent owner”).

The Federal Circuit’s decision destroys the carefully

constructed roadmap.

The regulation currently states: “For approved [new drug

applications], the [entity] submitting information on the methodof-use patent must identify with specificity the section(s) and

subsection(s) of the approved labeling that describes the

method(s) of use claimed by the patent submitted.” 21 C.F.R.

§ 314.53(b)(1).

The Federal Circuit’s Reliance on

Language in the Label, Hikma’s

Website and Press Releases was

Misplaced.

The Federal Circuit relied, in part, on language

included, or not included, in Hikma’s label as evidence

of induced infringement. Pet. App. 16a-18a. What the

Federal Circuit failed to recognize, however, is that the

content of the label is determined by FDA pursuant to

statutory and regulatory requirements. 21 U.S.C. §

355(j)(2)(A)(v); 21 C.F.R. § 314.94(a)(8)(iv). The

manufacture has no real say. Yet the Federal Circuit

bought into Amarin’s allegations regarding the clinical

studies section of the label, which describes statintreated patients with the same cardiovascular event

history and lipid levels covered by the asserted patents.

Pet. App. 16a. But this is information that is and

always has been in the brand label (even before the

brand added the new patented CV indication). JA 88,

JA 98 and JA 109-110. Hikma is required to mirror the

brand label (minus the carved out patented indication,

which it did not include).

The Federal Circuit also pointed to the

elimination of the CV limitation of use and Hikma’s

inclusion of a warning of potential side effects for

patients with cardiovascular disease as communicating

to physicians that Hikma’s generic product could be

used for the off-label CV indication and thus serving as

evidence of induced infringement. Pet. App. 16a-18a

But again, Hikma was required to eliminate the CV

limitation of use language and include the warning of

potential side effects in order to mirror Amarin’s label,

as was required by law. Even though the Federal

Circuit expressed doubt that the label alone would be

sufficient to allege induced infringement, it believed

that the label together Hikma’s “public statements and

marketing materials” “plausibly state a claim for

induced infringement.” Pet. App. 17a-18a.

Specifically, the Federal Circuit referred to

Hikma’s website which promotes its product as ABrated

the

therapeutic