Amicus Curiae 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., ET AL.,

Petitioners,

v.

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 PUBLIC CITIZEN

IN SUPPORT OF PETITIONERS

SCOTT L. NELSON

Counsel of Record

ALLISON M. ZIEVE

PUBLIC CITIZEN

LITIGATION GROUP

1600 20th Street NW

Washington, DC 20009

(202) 588-1000

snelson@citizen.org

Attorneys for Amicus Curiae

February 2026

i

TABLE OF CONTENTS

Page

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

INTEREST OF AMICUS CURIAE ............................ 1

SUMMARY OF ARGUMENT .................................... 2

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

I.

The Hatch-Waxman Amendments do not

permit patent liability to be imposed on

generic manufacturers who play by the rules

when marketing drugs approved with skinny

labels..................................................................... 4

II. The Federal Circuit’s decisions upset the

balance drawn by the Hatch-Waxman

Amendments. ....................................................... 9

III. The Federal Circuit’s decisions threaten

serious harm to the consumer-protection and

public-health goals of the Hatch-Waxman

Amendments. ..................................................... 17

CONCLUSION.......................................................... 26

ii

TABLE OF AUTHORITIES

Cases

Pages

AT&T Mobility LLC v. Concepcion,

563 U.S. 333 (2011) ............................................... 8

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

566 U.S. 399 (2012) ..................... 5, 6, 7, 10, 22, 24

Epic Sys. Corp. v. Lewis,

584 U.S. 497 (2018) ............................................... 8

FDA v. Brown & Williamson Tobacco Corp.,

529 U.S. 120 (2000) ............................................... 8

FTC v. Actavis, Inc.,

570 U.S. 136 (2013) ............................................. 22

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

7 F.4th 1320 (2021)........................ 9, 11, 13, 14, 25

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

25 F.4th 949 (2022).................................. 12, 16, 18

H. Lundbeck A/S v. Lupin Ltd.,

87 F.4th 1361 (Fed. Cir. 2023) ............................ 13

Miles v. Apex Marine Corp.,

498 U.S. 19 (1990) ................................................. 9

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) ............................................. 10

Pugin v. Garland,

599 U.S. 600 (2023) ............................................... 8

United States v. Evers,

643 F.2d. 1043 (5th Cir. 1981) .............................. 9

iii

Statutes and Rules

Hatch-Waxman Amendments (Drug Price

Competition and Patent Term Restoration

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

98 Stat. 1585 ...................... 1–10, 12–15, 17, 19–25

21 U.S.C. § 353d(a)(3) ............................................... 14

21 U.S.C. § 355(j)(2)(A)(viii) ............................. 3, 7, 15

21 C.F.R. § 314.94(a)(8)(iv) ................................... 6, 12

Other

130 Cong. Rec. 24426 (Sept. 6, 1984) ......................... 5

Ass’n for Accessible Medicines, The U.S. Generic &

Biosimilar Medicines Savings Report (Sept. 2025),

https://accessiblemeds.org/wp-content/uploads/

2025/09/AAM-2025-Generic-BiosimilarMedicines-Savings-Report-WEB.pdf ............ 19, 20

M. Carrier, C. Duan & S. Tu, Prevent a legal catch-22

that could push thousands of generic drugs off the

market, L.A. Times (Sept. 21, 2022) ................... 18

CMS, NHE Fact Sheet (2026),

https://www.cms.gov/data-research/statistics-tren

ds-and-reports/national-health-expenditure-data/

nhe-fact-sheet ...................................................... 21

FDA, Estimating Cost Savings from New Generic

Drug Approvals in 2018, 2019, and 2020 (2022),

https://www.fda.gov/media/161540/download .... 20

FDA, Estimating Cost Savings from New Generic

Drug Approvals in 2021 (2023),

https://www.fda.gov/media/172608/download .... 20

iv

FDA, Estimating Cost Savings from New Generic

Drug Approvals in 2022 (2024),

https://www.fda.gov/media/182435/download#:~:

text=Estimates%20show%20that%20generic%20

drugs,approval%20cohorts%20are%20shown%20

below .................................................................... 20

FDA, Estimating Cost Savings from New Generic

Drug Approvals in 2023 (2025),

https://www.fda.gov/media/189635/download#

:~:text=In%202023%2C%20the%20FDA%20

granted,approval%20cohorts%20are%20shown

%20below ............................................................. 20

R. Feldman, May your drug price be evergreen,

2018 J.L. & Bioscis. 1, 7–8 (2018)

https://repository.uclawsf.edu/cgi/viewcontent.cgi?

article=2711&context=faculty_scholarship ........ 24

FTC, Generic Drug Entry Prior to Patent Expiration:

An FTC Study (2002),

https://www.ftc.gov/sites/default/files/documents/r

eports/generic-drug-entry-prior-patent-expirationftc-study/genericdrugstudy_0.pdf ................. 19, 22

HHS, Comprehensive Plan for Addressing High

Drug Prices: A Report in Response to the

Executive Order on Competition in the American

Economy (Sept. 9, 2021),

https://aspe.hhs.gov/sites/default/files/202109/Drug_Pricing_Plan_9-9-2021.pdf ................... 23

P. Minemyer, Express Scripts reveals drug classes

that are driving spending growth (Feb. 18. 2020),

https://www.fiercehealthcare.com/payer/

express-scripts-drug-classes-are-drivingspending-growth .................................................. 20

A. Scalia & B. Garner, Reading Law (2012) .............. 8

v

B. Walsh, et al., Frequency of First Generic

Drug Approvals With “Skinny Labels”

in the United States, JAMA Intern. Med.

Research Letter (Mar. 29, 2021),

https://jamanetwork.com/journals/jama

internalmedicine/fullarticle/2777965 ................. 25

Yan Song & D. Barthold, The effects of state-level

pharmacist regulations on generic substitution of

prescription drugs, 27 Health Econ. 1717 (2018),

https://pmc.ncbi.nlm.nih.gov/articles/PMC617215

1/#R24 .................................................................. 17

T. Ziaks, et al., Frequency of first generic drugs

approved through “skinny labeling,” 2021 to 2023,

31 J. Manag. Care Spec. Pharm. 343 (2025),

https://pubmed.ncbi.nlm.nih.gov/40152800/....... 25

INTEREST OF AMICUS CURIAE1

Public Citizen is a nonprofit consumer advocacy organization with members and supporters in every

state. Public Citizen advocates before Congress, administrative agencies, and courts on a wide range of

issues, including ensuring that patients’ and consumers’ interests are protected in the resolution of legal

and regulatory issues posed by prescription drugs and

medical devices. A central concern of Public Citizen,

embodied in Public Citizen’s Global Access to Medicines program, is protecting and expanding access to

affordable medicines both domestically and globally.

Among the key strategies that Public Citizen advocates for making medicines more affordable is the

adoption of policies that facilitate regulatory approval

and marketing of generic drugs that compete with expensive brand-name drugs. Competition from generic

drug manufacturers plays a critical role in checking

the excessive prescription-drug prices that drain consumers’ pocketbooks, impair the health of those who

cannot afford to pay those prices, and harm federal

and state governments by massively increasing the

costs of government health-care programs. Accordingly, Public Citizen has long supported the HatchWaxman Amendments—the landmark legislation

that created the legal framework for introduction and

regulation of generic medications in the United

States. Among other things, Public Citizen has sought

to ensure that the courts’ resolution of antitrust and

patent litigation involving generic and brand-name

manufacturers is consistent with the Hatch-Waxman

––––––––––––––––––––––––

1 This brief was not authored in whole or part by counsel for

a party. No one other than amicus curiae made a monetary contribution to preparation or submission of the brief.

2

Amendments’ provisions that promote the introduction of generic drugs while respecting valid patent

rights of name-brand drug manufacturers.2

Public Citizen submits this brief to explain that the

lower court’s opinion in the case disregards the language and structure of the Hatch-Waxman Amendments, is likely to cause significant harm to consumers, and runs counter to the strong federal policy of

promoting the availability of generic medications as a

means of lowering costs for patients.

SUMMARY OF ARGUMENT

The proper functioning of the statutory scheme

created by the Hatch-Waxman Amendments is critical

to the national goal of increasing public access to affordable prescription medications. Formally titled the

Drug Price Competition and Patent Term Restoration

Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585, the

Hatch-Waxman Amendments amended various provisions of the Food, Drug, and Cosmetic Act (FDCA) and

the patent laws to enhance patent protections in certain respects, while allowing streamlined marketing

approval of generic versions of prescription drugs that

do not violate valid patents.

Among the many innovations of the Hatch-Waxman Amendments were the provisions, at issue here,

that permit a generic drug manufacturer to obtain

––––––––––––––––––––––––

Public Citizen, through its Litigation Group, submitted

amicus curiae briefs in this Court on behalf of former Rep. Henry

Waxman, the architect of the generic drug provisions of the

Hatch-Waxman Act, in FTC v. Schering-Plough Corp., No. 05273, and FTC v. Actavis, Inc., No. 12-416, supporting the FTC’s

ultimately successful efforts to subject pay-for-delay agreements

between brand-name and generic manufacturers to antitrust

scrutiny.

2

3

approval to market a generic version of a drug even if

the drug still has methods of use that are protected by

valid patents, if the generic manufacturer does not

seek approval to market the drug for those uses and

carves them out from the labeling of the generic version. See 21 U.S.C. § 355(j)(2)(A)(viii). The resulting

regulatory approval of the generic drug permits the

generic manufacturer to market the drug for the unpatented uses specified in what is commonly called a

“skinny label.” As the statute’s terms make clear, Congress understood that drug manufacturers may have

patent protection limited to specific uses of their products, and it provided that, in that circumstance, the

Food and Drug Administration (FDA) may authorize

generic manufacturers to produce and market generic

versions for unpatented uses.

Staying within the bounds of that authorization

should protect a generic manufacturer from patent liability even when doctors predictably prescribe the generic version of the drug for uses that are not included

in the approved skinny label because they remain subject to the brand-name manufacturer’s patents. The

Federal Circuit, however, holds that the approved label, combined with innocuous statements by the manufacturer that say no more than the label does to alert

doctors to the possibility of additional uses, may suffice to constitute inducement of infringement, threatening generic drug manufacturers with immense liability if they use skinny labels to obtain marketing approval. The Federal Circuit’s holdings are impossible

to square with the Hatch-Waxman Amendments’ language, structure, and context.

The Federal Circuit’s decisions threaten serious

damage to the successful operation of the regulatory

regime created by the Hatch-Waxman Amendments.

4

The Amendments’ provisions facilitating and expediting the introduction of generic drugs have been singularly successful, saving consumers and governments

hundreds of billions of dollars and making it possible

to achieve more health benefits with less money. And

they have done so in an environment where nearly

every other category of health care expense—and especially the cost of brand-name drugs—has continued

to escalate, threatening the well-being of all Americans. The unwarranted imposition of patent liability

on generic manufacturers will discourage them from

seeking to market generic versions of any drug that

still has patent protection for any common use—a consequence that will have tremendous impact given the

propensity of brand-name drug manufacturers to seek

to extend patent monopolies by repeatedly patenting

additional uses of their products. Unless the decision

below is reversed, the aims of the Hatch-Waxman

Amendments will be thwarted, and the goal of reining

in excessive health care costs will be even further out

of reach.

ARGUMENT

I.

The Hatch-Waxman Amendments do not

permit patent liability to be imposed on

generic manufacturers who play by the

rules when marketing drugs approved

with skinny labels.

The Hatch-Waxman Amendments were designed

to balance two important objectives: first, providing

incentives for innovation in the development of new

drugs; and second, holding down drug prices by fostering competition with already-approved brand-name

drugs from generic equivalents. The Amendments advance the first objective by extending the term of

5

pharmaceutical patents to account for delays in the

FDA approval process that would otherwise eat into

the value of the patents; establishing procedures to

ensure that generic drugs approved by the FDA do not

infringe existing patents; and providing a period of

market exclusivity for innovative new drugs regardless of whether they are patented. The Amendments

pursue the second objective by allowing generic drugmakers to manufacture and use patented drugs for

purposes of preparing an application for FDA approval of a generic equivalent, and by establishing accelerated procedures for approval of generic drugs to

allow them to enter the market as soon as possible

without infringing brand-name manufacturers’ patents and statutory exclusivity rights. Together, the

Amendments’ provisions seek to achieve a “fundamental balance … that assures consumers of more low-cost

generic drugs when a valid patent expires and the

drug industry of sufficient incentive to develop innovative pharmaceutical therapies.” 130 Cong. Rec.

24426 (Rep. Waxman) (Sept. 6, 1984).

In a nutshell, the Hatch-Waxman Amendments

provide that “the FDA cannot authorize a generic drug

that would infringe a patent,” while “facilitat[ing] 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). The latter objective, moreover, is

not limited to allowing generic entry after all patent

protection for a brand-name drug has expired. Rather,

even when a brand-name drug is protected by unexpired patents, the Amendments provide two main

routes by which a generic manufacturer can expedite

access to the market. First, if the generic manufacturer believes the patents are invalid or unenforceable, it may so certify in its application for approval,

6

and the validity of the patents may then be litigated

immediately, with approval of generic entry following

if the generic manufacturer prevails.

The second avenue for generic entry in the face of

unexpired patents, at issue here, comes into play if a

brand-name manufacturer has valid patents that protect only some of the approved uses of its drug. The

Amendments allow for approval and marketing of generic equivalents in those circumstances, if the generic manufacturer certifies that it does not seek approval of the drug for a use claimed by any unexpired

method-of-use patent. When the FDA approves a generic drug subject to such a certification, it also approves labeling for the generic drug that excludes

those portions of the approved labeling of the brandname drug that the brand-name manufacturer has

identified as describing a use claimed by an unexpired

patent. See 21 C.F.R. § 314.94(a)(8)(iv). Otherwise,

however, the labeling must, like generic drug labeling

more generally, be identical to that of the brand-name

drug. See id. The statutes and regulations that provide for approval with labeling that excludes patented

uses—referred to colloquially as a “skinny label”—

simultaneously promote competition and protect patent rights by “allow[ing] the generic company to place

its drug on the market … but only for a subset of approved uses—i.e., those not covered by the brand’s patents.” Caraco Pharm., 566 U.S. at 406.

The clear import of this statutory scheme is that

marketing a generic drug using approved labeling

that carves out any remaining patented uses of the

drug does not in itself violate the brand-name manufacturer’s patent rights. This Court succinctly made

the point in Caraco Pharmaceutical:

7

[A]s Congress understood[,] a single drug may

have multiple methods of use, only one or some of

which a patent covers. … The Hatch-Waxman

Amendments authorize the FDA to approve the

marketing of a generic drug for particular unpatented uses; and section [355(j)(2)(A)(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. The

statutory scheme, in other words, contemplates

that one patented use will not foreclose marketing

a generic drug for other unpatented ones.

Caraco Pharm., 566 U.S. at 415 (emphasis added). In

short, establishing “that a method of use is unpatented … allows the FDA to authorize a generic drug.”

Id.

Any construction of the Hatch-Waxman Amendments must be consistent with the basic proposition

that a generic manufacturer may lawfully market an

approved generic version of a brand-name drug for unpatented uses notwithstanding that still-patented

uses of the drug are excluded from the skinny label.

This Court recognized as much in Caraco Pharmaceuticals, when it held that the Hatch-Waxman Amendments’ clear authorization of “approval of non-infringing generic drugs under section [355(j)(2)(A)(viii)],” id.

at 417, provides the “statutory context” for construction of other provisions of the law, id. at 414.

The same point applies to construction of the patent laws in the context of the marketing of generic

drugs with skinny labels. The Hatch-Waxman

Amendments, after all, amended not only the FDCA,

but also the patent laws, and the evident purpose of

such enactments is to create a “symmetrical and

8

coherent regulatory scheme.” FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133 (2000) (citation omitted). Faced with different federal statutory

provisions “touching on the same topic,” courts should

strive for “harmony” among them. Epic Sys. Corp. v.

Lewis, 584 U.S. 497, 511, 512 (2018); see Brown & Williamson, 529 U.S. at 133.3

Construing the patent laws to impose liability on a

generic drug manufacturer for doing what the provisions added to the FDCA by the Hatch-Waxman

Amendments expressly permit—that is, marketing

the generic version of a drug for unpatented uses described in a skinny label—would be anything but harmonious. Doing so would amount to “conclu[ding] that

Congress enacted a self-defeating statute,” Pugin v.

Garland, 599 U.S. 600, 607 (2023) (citation omitted),

and conflict with the maxim that an “act cannot be

held to destroy itself.” AT&T Mobility LLC v. Concepcion, 563 U.S. 333, 343 (2011).

To be sure, if a generic manufacturer expressly encourages the use of its drug for an indication that was

omitted from its skinny label to protect the brandname manufacturers’ patent rights, imposing liability

for inducing patent infringement does not conflict

with the Hatch-Waxman provisions that authorize the

FDA’s approval for marketing of the generic version:

The Hatch-Waxman Amendments do not authorize

marketing for the patented use and hence are not frustrated if patent liability is imposed for such unauthorized marketing.

––––––––––––––––––––––––

3 See also A. Scalia & B. Garner, Reading Law 252 (2012)

(“Hence laws dealing with the same subject—being in pari materia (translated as ‘in a like matter’)—should if possible be interpreted harmoniously.”).

9

Marketing a generic drug under a skinny label,

however, cannot in itself be considered active encouragement of patent infringement, even if physicians

are likely to prescribe the generic for patented indications excluded from the skinny label. After all, this

Court “assume[s] that Congress is aware of existing

law when it passes legislation.” Miles v. Apex Marine

Corp., 498 U.S. 19 (1990). Congress presumptively

knew when enacting the Hatch-Waxman Amendments of the longstanding consensus that the FDCA

permits doctors to prescribe drugs for off-label uses.

See United States v. Evers, 643 F.2d. 1043, 1049 (5th

Cir. 1981).4 Holding that marketing a generic pursuant to a skinny label “induces” infringement because

doing so implicitly informs doctors that they can prescribe the generic for patented uses would effectively

make marketing the generic as authorized by the

Hatch-Waxman Amendments unlawful, contradicting

the balance Congress struck in enacting the statute.

II. The Federal Circuit’s decisions upset the

balance drawn by the Hatch-Waxman

Amendments.

The Federal Circuit’s decision in this case and its

earlier opinion in GlaxoSmithKline LLC v. Teva

Pharms. USA, Inc., 7 F.4th 1320 (2021), do not hold

that marketing a generic drug using a skinny label by

itself constitutes inducement to infringe, but they

––––––––––––––––––––––––

4 Former Representative Waxman has confirmed that Con-

gress was aware of the obvious possibility that prescriptions for

patented uses may be filled by generics marketed with skinny

labels. See Brief of Amicus Curiae Former Congressman Henry

A. Waxman in Support of Petition for Rehearing En Banc, at 8–

9, GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., Nos. 181976 & 18-2023 (Fed. Cir. Dec. 30, 2020).

10

come dangerously close. The court’s decisions are

sharply at odds with the appropriate limits on liability

for induced infringement in two important respects.

First, they allow the required terms of the skinny labeling itself to be used as evidence of inducement. Second, they allow liability for inducement to infringe to

be based on the use of innocuous, truthful descriptions

of the generic drug—such as calling it the “generic version” or “generic equivalent” of the brand-name

drug—that add no information beyond what is inherent in the approval of a generic drug with a skinny

label. The court’s decisions thus create a threat of ruinous liability for marketing a generic drug in compliance with the terms of the Hatch-Waxman Amendments—a threat incompatible with the clear commands of the legislation.

A. Under any reasonable reading of the HatchWaxman Amendments, the terms of an approved

skinny label itself cannot constitute evidence of inducement to infringe. The patent-holder itself is required to identify all portions of its product labeling

that describe patented uses, see Caraco Pharm., 566

U.S. at 405–06, and the FDA must direct that the generic manufacturer exclude those portions while using

the remainder of the labeling. The generic manufacturer, in turn, is required to market the drug using the

brand-name drug’s labeling as modified in this manner, see PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011),

including all indications that the brand-name manufacturer has not designated as patented. Because the

generic manufacturer is stuck with the labeling, holding that the terms of the labeling itself induce infringing uses, or are evidence of inducement, would effectively preclude the generic manufacturer from marketing the drug. Treating the description of non-

11

infringing indications as inducements to infringe patented uses not addressed in the labeling would also

allow the brand-name manufacturer to sandbag the

generic manufacturer by claiming infringement based

on parts of the labeling that the manufacturer earlier

certified to the FDA did not describe patented uses of

the drug.

The Federal Circuit nonetheless takes the view

that a skinny label, despite its omission of all parts of

the brand-name drug’s labeling that the brand-name

manufacturer has designated as describing patented

uses, can, “in combination with [the generic manufacturer’s] public statements and marketing materials,”

be considered evidence of inducement to infringe. Pet.

App. 17a–18a; see GlaxoSmithKline, 7 F.4th at 1334.

Indeed, in this case, the court allowed Amarin to proceed with allegations of inducement based in part on

the skinny label while at the same time acknowledging that the label “does not provide an implied or express instruction to prescribe the drug for [a patented]

indication.” Pet. App. 16a.

The Federal Circuit’s approach places all generic

drugs marketed with skinny labels at risk. In every

case, a generic manufacturer will be required by the

terms of its FDA approval to use the skinny label. And

the skinny label, read together with the brand-name

drug’s label, can always be said in some sense to

“teach,” Pet. App. 16a, that the generic could be prescribed for the patented indications excluded from it.

Thus, under the Federal Circuit’s approach, whenever

a generic drug is marketed under a skinny label there

is evidence of inducement to infringe that, in combination with other factors, may support liability.

12

As the judges who dissented from denial of rehearing in GlaxoSmithKline observed, the use of the

skinny label as part of the evidence to support a finding of inducement to infringe is impossible to square

with the structure of the Hatch-Waxman Amendments. See GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc., 25 F.4th 949, 955 (2022) (“Congress enacted the skinny-label provisions as a way for generics

to avoid inducement liability—and thus litigation itself. … When a generic plays by the skinny-label rules,

the FDA-required label can’t be evidence of intent.”)

(Prost, J., dissenting from denial of rehearing); id. at

959 (“Canons of statutory construction demonstrate

that the more specific and later-enacted provisions of

the Hatch-Waxman Act override the general infringement provisions of the Patent Act.”) (Dyk, J., dissenting from denial of rehearing).

The features of the skinny label that Amarin has

pointed to in this case demonstrate just how problematic reliance on the label as “evidence” of inducement

to infringe can be. Amarin, and the panel below,

pointed to the absence from the skinny label of a “Limitation of Use” statement that appeared in the brandname labeling before the drug was approved for the

patented use of treatment to reduce cardiovascular

risk. But by the time the skinny label was approved,

Hikma could not have included that statement because it was not part of the then-current labeling for

the brand-name drug. The skinny label provisions authorize “omission” of language referring to patented

uses, 21 C.F.R. § 314.94(a)(8)(iv), not addition of language to prohibit patented uses. Moreover, the language that Amarin insists should have been part of

the label was not just a statement that a particular

use was not authorized; it was a factual statement

13

that the effect of the drug on cardiovascular mortality

and morbidity “has not been determined.” Pet. App.

3a. And that statement is no longer true: Amarin now

has authority to market Vascepa for treating cardiovascular risk because it has been determined to be

safe and effective for that use.

Amarin’s argument about the label, which formed

part of the basis for the Federal Circuit’s ruling that

it had “plausibly state[d] a claim for induced infringement,” Pet. App. 18a, amounted to the assertion that

a generic drug manufacturer’s failure to add to the

skinny label an unauthorized and false disclaimer of

effectiveness for a patented use is evidence of intent to

induce infringement. That assertion cannot be

squared with the text, structure, and context of the

Hatch-Waxman Amendments.

B. Although the Federal Circuit has indicated that

the prescribed terms of a skinny label “standing alone”

may be insufficient to state a claim for inducement of

infringement, Pet. App. 17a; see also H. Lundbeck A/S

v. Lupin Ltd., 87 F.4th 1361, 1370 (Fed. Cir. 2023), the

kinds of statements that the court has found sufficient

to state a claim “in combination” with the label, Pet.

App. 18a, are as troubling as its reliance on the label

itself. Both in the decision below and in GlaxoSmithKline, the court relied principally on isolated, innocuous phrases in public statements describing the generic drug—statements that do not mention patented

uses and do nothing more to encourage the prescription of the drug for such uses than does the FDA’s approval of the generic drug and its skinny label.

In particular, both below and in GlaxoSmithKline,

the court placed primary reliance on statements by

the generic manufacturer that its newly approved

14

drug is the “generic version” and the “generic equivalent” of the brand-name drug. Pet. App. 18a; GlaxoSmithKline, 7 F.4th 1324, 1336. But those statements

are truisms that describe every generic approval under

Hatch-Waxman, which requires that the generic drug

be the equivalent of a specific, previously approved

drug, see GlaxoSmithKline, 7 F.4th at 1353 (Prost, J.,

dissenting), of which the approved generic drug is by

definition a “generic version.” 21 U.S.C. § 353d(a)(3)

(“The term ‘generic version’ means a drug approved

under section 355(j) of this title whose reference listed

drug is a covered drug.”). Indeed, Amarin itself, in its

SEC 10-Q filings, characterizes Hikma’s drug as a “generic version of VASCEPA.”5 On Amarin’s reasoning,

its own 10-Q filing actively encouraged doctors to infringe its patents.

Of course, neither party’s use of the anodyne term

“generic version” or “generic equivalent” actively encouraged infringement. Such statements do not provide any more encouragement to doctors to infringe

the brand-name manufacturer’s patents than does the

FDA’s own approval of the generic drug and its skinny

label. The skinny label already lets doctors know that

the generic is bioequivalent to the brand-name drug,

and it effectively tells them that the reason certain indications for which the brand-name drug is approved

are not on the label is that they are patented. That

information provides ample reason for a doctor inclined to disregard (or ignorant of) the brand-name

manufacturer’s patent rights to prescribe the generic

for a patented use or, where allowed or required by

––––––––––––––––––––––––

https://www.sec.gov/Archives/edgar/data/897448/0001564

59021021572/amrn-10q_20210331.htm#ITEM_1_LEGAL_PROCEEDINGS 25 (Apr. 29, 2021).

5

15

state law, for a pharmacist to substitute the generic

when filling a prescription for the drug. Public statements about the drug that do no more than the label

itself to inform doctors of the possibility of prescribing

the generic version for patented indications do not

show that a generic manufacturer has actively encouraged infringement. If the skinny label itself cannot

constitute inducement to infringe, such statements

cannot do so either.

The FDA’s approval letter in this case, for example,

specifically stated that the approval was based on the

determination that Hikma’s drug is “bioequivalent

and therapeutically equivalent to the reference listed

drug (RLD), Vascepa Capsules.”6 Moreover, the FDA’s

letter (unlike the press releases on which the court below relied) specifically refers to the patented uses for

which the drug has not been approved solely because

they were excluded from Hikma’s application for approval pursuant to 21 U.S.C. § 355(j)(2)(A)(viii). That

information provides everything a doctor needs to

know if he or she wishes to prescribe the generic version for a use that is off-label because of patent protection. The generic manufacturer’s accurate descriptions of the drug as the “generic version” of or “generic

equivalent” to the brand-name drug (which are essential to inform doctors and pharmacists that the generic

drug can be substituted for the brand-name version

for the approved uses) provide no encouragement, beyond what is intrinsic in the system created by the

Hatch-Waxman Amendments, to prescribe the generic

version for patented uses not included in its labeling.

––––––––––––––––––––––––

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/

2020/209457Orig1s000ltr.pdf (May 21, 2020).

6

16

If intent to encourage infringement can be conjured up by combining statements using inoffensive

terms like “generic version” or “generic equivalent”

with the FDA-mandated labeling that carves out patented uses identified by the brand-name manufacturer, then, as Judge Prost stated in GlaxoSmithKline, “no skinny-label generic is safe.” 25 F.4th at 955

(dissenting from denial of rehearing). “[I]f left untouched, the [Federal Circuit’s decisions] may reasonably be read to mean that companies … may be held

liable for induced infringement despite demonstrated

compliance with the statutory and regulatory requirements to carve out everything from a skinny label that

the patent owner … itself designated as covered by its

patent.” Id. at 960 (Reyna, J., dissenting from denial

of rehearing).

Indeed, even if a generic manufacturer sought to

protect itself by warning against patented uses in

every public communication that referred to its generic version of a brand-name drug, it still would not

be safe: The brand-name manufacturer would undoubtedly point to those references to the patented

uses as indications that the generic manufacturer was

tacitly attempting to provide doctors with a roadmap

showing how to violate the patents through off-label

prescriptions. The Federal Circuit’s decision thus puts

generic manufacturers in a no-win position.

To be sure, some doctors aware of the existence of

the generic version of a drug will inevitably prescribe

the generic for patented uses (with or without

knowledge that those uses remain subject to patent).

And in light of state laws permitting or requiring

pharmacists to substitute generic drugs for brand-

17

name ones,7 prescriptions written based on patented

uses of the drug may often be filled by the generic version unless the doctor specifies that they may not be.

But that outcome is not the result of active encouragement by the generic manufacturer. It is an inherent

consequence of the Hatch-Waxman Amendments’ authorization of generic competition for drugs that have

both patented and unpatented uses. Imposing liability

on generic manufacturers for following the HatchWaxman Amendments’ path to approval cannot be

squared with Congress’s balancing of the interests at

stake.

III. The Federal Circuit’s decisions threaten

serious harm to the consumer-protection

and public-health goals of the HatchWaxman Amendments.

The consequences of imposing patent liability on

generic drug manufacturers for marketing drugs approved with skinny labels underscore the importance

of restoring the balance struck by the Hatch-Waxman

Amendments by reversing the Federal Circuit’s decision. When a generic manufacturer faces multimillion-dollar patent liability for marketing a product using its FDA-mandated skinny label, the result is not

likely to be limited to deterrence of infringing uses of

the drug. Rather, the consequence is likely to be that

generic competitors will be deterred from entering the

market at all when an indication remains patented,

even after one or more uses are no longer patented,

because it may be impossible to market a generic

––––––––––––––––––––––––

7 See Yan Song & D. Barthold, The effects of state-level phar-

macist regulations on generic substitution of prescription drugs,

27 Health Econ. 1717 (2018) (Table 1 and Figure 1),

https://pmc.ncbi.nlm.nih.gov/articles/PMC6172151/#R24.

18

version without incurring liability. Indeed, in cases

such as this one, it is hard to imagine what a generic

manufacturer could do to avoid infringement on the

theory accepted by the Federal Circuit, short of remaining out of the market altogether. And the threat

of patent liability will be an especially potent deterrent to marketing generic drugs that have patented

uses, because the damages for patent infringement

(measured by lost profits at the inflated prices typical

of brand-name drugs) are likely to dwarf the revenues

to be gained from selling a lower-priced generic version. In the GlaxoSmithKline case, for example, the

$234 million damages award based on the brandname manufacturer’s lost profits was more than three

times the total revenue generated by the generic manufacturer’s competing sales. See GlaxoSmithKline, 25

F.4th at 955 (Prost, J., dissenting from denial of rehearing).

The unavailability of generic drugs for unpatented

and patented uses alike that will result from driving

skinny-label generics off the market will be very costly

for consumers, as well as for government-funded

health programs. For example, after generic versions

of carvedilol, the drug at issue in the GlaxoSmithKline

case, appeared in 2007, 20 million patients benefited

from their use. The generic versions cost two cents a

dose; the brand-name version went for $4.81—about

24,000% higher. The cost to consumers if generic competitors had been unable to enter the market for carvedilol alone would have been enormous.8

––––––––––––––––––––––––

8 The figures in this paragraph are taken from M. Carrier, C.

Duan & S. Tu, Prevent a legal catch-22 that could push thousands

of generic drugs off the market, L.A. Times (Sept. 21, 2022).

19

The costs of the Federal Circuit’s legal error, of

course, are likely to be much higher. As this case illustrates, what one brand-name manufacturer can succeed in doing, others will surely attempt. And if those

attempts have the predictable results of deterring generic competition for the many brand-name drugs that

have unexpired method patents covering approved

uses, the great benefits that the Hatch-Waxman

Amendments have achieved over the past four decades will be substantially impaired.

The availability of generic drugs attributable to the

Hatch-Waxman Amendments has saved consumers

and government health programs literally trillions of

dollars since the legislation’s passage in 1984. Before

Hatch-Waxman, generic drugs accounted for only 19%

of prescriptions filled in the United States;9 today,

that figure is about 90%.10 The resulting savings are

truly staggering. The 90% of prescriptions filled by generic drugs account for only about 12% of prescription

drug costs because generic drugs are so much less expensive.11 Throughout the history of Hatch-Waxman,

the costs of brand-name medications, like other medical expenses, have continued to rise at rates much

higher than the overall rate of inflation, while overall

costs of generic drugs have decreased. For the five

––––––––––––––––––––––––

9 FTC, Generic Drug Entry Prior to Patent Expiration: An

FTC Study, at i (2002) (FTC Study), https://www.ftc.gov/sites/default/files/documents/reports/generic-drug-entry-prior-patent-ex

piration-ftc-study/genericdrugstudy_0.pdf.

10 Ass’n for Accessible Medicines, The U.S. Generic & Biosim-

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

https://accessiblemeds.org/wp-content/uploads/2025/09/

AAM-2025-Generic-Biosimilar-Medicines-Savings-Report-WEB.

pdf.

11 Id.

20

years between January 2014 and December 2019, for

example, brand-name drug prices increased by 70.5%,

more than seven times the overall inflation rate, while

generic drug prices fell by 40.9%.12 More recently, generic drug prices have continued to fall even as consumer prices overall have inflated and brand-name

drug prices have ballooned even more.13

As a result, generic drug approvals in the six years

from 2018 through 2023 were estimated to save $17.8

billion, $24.8 billion, $10.7 billion, $16.6 billion, $18.9

billion, and $18.6 billion, respectively, just in the first

year after approval.14 Total savings from generic

drugs for 2024 alone are estimated at over $467 billion, and savings for the entire decade from 2015 to

2024 add up to $3.4 trillion.15

Preserving the integrity of the Hatch-Waxman regime that has yielded these extraordinary benefits is

––––––––––––––––––––––––

12 P. Minemyer, Express Scripts reveals drug classes that are

driving spending growth (Feb. 18. 2020), https://www.fiercehealthcare.com/payer/express-scripts-drug-classes-are-drivingspending-growth.

13 See Savings Report, at 3.

14 FDA, Estimating Cost Savings from New Generic Drug Ap-

provals in 2018, 2019, and 2020, at 3 (2022), https://www.fda.gov

/media/161540/download; FDA, Estimating Cost Savings from

New Generic Drug Approvals in 2021, at 2 (2023), https://www.

fda.gov/media/172608/download; FDA, Estimating Cost Savings

from New Generic Drug Approvals in 2022, at 2 (2024),

https://www.fda.gov/media/182435/download#:~:text=Estimates

%20show%20that%20generic%20drugs,approval%20cohorts%20

are%20shown%20below; FDA, Estimating Cost Savings from

New Generic Drug Approvals in 2023, at 2 (2025), https://www.

fda.gov/media/189635/download#:~:text=In%202023%2C%20the

%20FDA%20granted,approval%20cohorts%20are%20shown%20

below.

15 Savings Report, at 10.

21

a matter of national importance. Americans pay too

much for medical care, including prescription drugs,

and medical costs continue to increase, threatening

the health and solvency of individuals and straining

the budgets of governments. In 2024, national health

expenditures grew 7.2%, to $5.3 trillion, accounting

for 18% of the nation’s gross domestic product (GDP).

Health expenditures are projected to continue increasing at a 5.8% average annual rate for the 10 years

from 2024–2033, exceeding the rate of GDP growth.

The federal government bears the largest share of

overall health expenditures, 31%, with private households coming in second at 28%, private businesses accounting for 18%, and state and local governments

16%. Prescription drug expenditures totaled $467 billion in 2024, and they, too, are increasing significantly

year-over-year: Prescription drug spending increased

by 7.9% in 2024 after growing by 10.8% in 2023.16

In light of the burdens created by these ever-increasing costs, holding down the rate of increase while

preserving and expanding access to and quality of care

is a paramount interest for both consumers and the

federal government. The Hatch-Waxman Amendments provide a rare example of a program that has

achieved huge successes on all these counts, dramatically reducing costs while expanding public access to

medications of the highest quality. Altering the

Hatch-Waxman balance in a way that reduces availability of generic drugs for non-patented uses threatens

to roll back those savings, place life-saving medications beyond the reach of low-income and elderly

––––––––––––––––––––––––

16 All figures in this paragraph are from CMS, NHE Fact

Sheet (2026), https://www.cms.gov/data-research/statistics-tren

ds-and-reports/national-health-expenditure-data/nhe-fact-sheet.

22

consumers, increase costs to Medicare, Medicaid, and

other critically important government programs—and

further exacerbate the serious national problem of excessive and increasing medical costs.

For these reasons, protection of the Hatch-Waxman balance against legal challenges from brandname manufacturers whose profits are threatened by

competition has long been a priority of the federal government. The FTC, for example, has long recognized

the important role of the Hatch-Waxman Amendments in fostering beneficial competition in the pharmaceutical industry and “taken an active role in ensuring that consumers benefit from [that] competition.”17 In particular, the FTC has directed antitrust

enforcement efforts against attempts by brand-name

manufacturers to preserve their monopolies by paying

generic manufacturers to delay entry. See FTC v. Actavis, Inc., 570 U.S. 136 (2013). The FTC also suggested amendments to Hatch-Waxman, which were

ultimately adopted in 2003, to ensure that generic

drug manufacturers could challenge false claims by

brand-name manufacturers that particular uses of approved drugs were covered by patents, allowing

Hatch-Waxman’s provisions permitting generics to

carve patented indications out of their labels to function effectively.18 In Caraco Pharmaceutical, 566 U.S.

399, this Court held that the 2003 amendments must

be read consistently with the Hatch-Waxman Amendments’ structure to facilitate approval of generic drugs

with labels carving out patented uses.

––––––––––––––––––––––––

17 FTC Study, at i.

18 See FTC Study, at v.

23

The Department of Health and Human Services

has similarly recognized the important role of the

Hatch-Waxman Amendments in the federal government’s efforts to address high drug prices. Indeed, in

its 2021 report on the subject, the Department noted

that the ability of generic manufacturers to carve out

patented uses from their labeling benefits patients

and the federal government:

Both the biosimilar and generic drug marketing

pathways created by Congress provide important

flexibility for biosimilars and generic drugs to

seek approval for fewer than all of the brand

product’s conditions of use, and, accordingly, to

exclude or “carve-out” certain uses from their labeling, including those that are protected by patents for the brand product. Biosimilar and generic drug manufacturers can thus seek timely

approval of and market their products for nonprotected uses, even when other uses of the brand

product remain patent protected. This practice,

sometimes described as “skinny labeling,” may

result in decreased costs to patients and to the

federal government, including reducing spending

on Medicare and Medicaid.19

The provisions allowing generic manufacturers to

carve out patented uses of a drug whose formulation

is no longer protected by a patent and that has approved, unpatented uses are critically important to

the balance struck by the Hatch-Waxman

––––––––––––––––––––––––

HHS, Comprehensive Plan for Addressing High Drug

Prices: A Report in Response to the Executive Order on Competition in the American Economy, at 21 (Sept. 9, 2021),

https://aspe.hhs.gov/sites/default/files/2021-09/Drug_Pricing_

Plan_9-9-2021.pdf.

19

24

Amendments and its goal of ensuring that generic

drugs marketed for unpatented uses “quickly come to

market.” Caraco Pharm. 566 U.S. at 415. Absent the

authority to approve a label that carved out patented

uses, the FDA would be unable to approve a generic

drug for unpatented uses as long as a single approved

use of the brand-name drug remained under patent.

That consequence would drastically undermine the

objectives of the Amendments, because patents claiming new uses for old drugs—and thus keeping patent

protection alive for the brand-name drug—are ubiquitous: A 2017 study found that 78% of drugs associated

with new pharmaceutical patents reported to the FDA

between 2005 to 2015 were existing drugs, not new

ones; that 70% of the roughly 100 best-selling drugs

had patent protection extended by new patents at

least once in that period, and 50% had their protection

extended more than once; that almost 40% of all drugs

available on the market received additional protection

from new patents; and that pharmaceutical companies that used this strategy tended to be repeat players, with 80% using it more than once.20

Not surprisingly, then, generic entrants frequently

must use skinny labels as a means to obtain marketing approval for drugs whose brand-name manufacturers have outstanding patents covering only some of

multiple approved uses for the drugs. A recent study

showed that 43% of the generic versions approved for

such drugs between 2015 and 2019 used skinny

––––––––––––––––––––––––

20 R. Feldman, May your drug price be evergreen, 2018 J.L. &

Bioscis. 1, 7–8 (2018). https://repository.uclawsf.edu/cgi/viewcontent.cgi?article=2711&context=faculty_scholarship

25

labels.21 That trend continued in the years immediately preceding the Federal Circuit’s decision in GlaxoSmithKline, but in 2023, soon after that decision,

skinny label approvals, and the associated savings,

fell off markedly.22

The improper threat of patent liability for generic

drug manufacturers that use skinny labels to obtain

marketing approval threatens the balance struck by

the Hatch-Waxman Amendments, and the resulting

benefits to consumers, patients, federal and state governments, and public health. This Court should put an

end to that threat.

––––––––––––––––––––––––

21 B. Walsh, et al., Frequency of First Generic Drug Approvals

With “Skinny Labels” in the United States, JAMA Intern. Med.

Research Letter (Mar. 29, 2021), https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2777965.

22 T. Ziaks, et al., Frequency of first generic drugs approved

through “skinny labeling,” 2021 to 2023, 31 J. Manag. Care Spec.

Pharm. 343 (2025), https://pubmed.ncbi.nlm.nih.gov/40152800/.

26

CONCLUSION

The Court should reverse the judgment of the court

of appeals and remand with instructions to affirm the

district court’s dismissal with prejudice of Amarin’s

complaint.

Respectfully submitted,

SCOTT L. NELSON

Counsel of Record

ALLISON M. ZIEVE

PUBLIC CITIZEN

LITIGATION GROUP

1600 20th Street NW

Washington, DC 20009

(202) 588-1000

snelson@citizen.org

Attorneys for Amicus Curiae

February 2026