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

Supreme Court briefFeb 25, 2026

Ask Donna

What actually matters in this document.

Text

No. 24-889

IN THE

Supreme Court of the United States

HIKMA PHARMACEUTICALS USA INC., ET AL.,

Petitioners,

AMARIN PHARMA, INC., ET AL.,

Respondents.

On Writ of Certiorari

to the United States Court of Appeals

for the Federal Circuit

BRIEF FOR

THE ASSOCIATION FOR ACCESSIBLE MEDICINES

AS AMICUS CURIAE SUPPORTING PETITIONERS

KARIN HESSLER

ASSOCIATION FOR

ACCESSIBLE MEDICINES

601 New Jersey Ave.,

NW, Suite 850

Washington, DC 20001

(202) 249-7100

WILLIAM M. JAY

Counsel of Record

JAIME A. SANTOS

ISABEL M. MARIN

GOODWIN PROCTER LLP

1900 N Street, NW

Washington, DC 20036

wjay@goodwinlaw.com

(202) 346-4000

February 25, 2026

Counsel for Amicus Curiae

TABLE OF CONTENTS

Page

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

INTRODUCTION AND SUMMARY OF

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

ARGUMENT ............................................................... 5

The Plausibility of Amarin’s Allegations

Must Take Into Account Several Legal

Principles Established by the HatchWaxman Act and State Laws. ............................ 6

A. Because Section viii applies only to

patents on methods of using an

unpatented drug, offering the drug for

sale does not induce infringement of a

carved-out method patent. ........................... 7

B. Section viii does not trigger pre-launch

infringement litigation because the

carve-out itself offers immediate

certainty: Skinny labels do not induce

infringement. .............................................. 10

C. For important regulatory reasons,

generic drugs are equivalent to brand

drugs. ........................................................... 13

D. Because of state automatic-substitution

laws that operate at the pharmacy,

generic companies do not market to

doctors and doctors do not prescribe a

specific manufacturer’s generic drug. ........ 15

II.

Active Inducement Requires an Affirmative

Encouragement of the Patented Use ................ 17

A. Referring to a drug as a generic is not

active inducement. ...................................... 18

B. A compliant skinny label cannot

support a claim of active inducement. ....... 20

C. Press releases directed to investors,

containing market sales figures, do not

show active inducement of doctors. ............ 22

III. The Federal Circuit’s Ruling Renders

Section viii Ineffective for Generic Market

Entry. ................................................................. 25

CONCLUSION ......................................................... 30

iii

TABLE OF AUTHORITIES

Page(s)

Cases:

Ashcroft v. Iqbal,

556 U.S. 662 (2009) ............................................. 7

AstraZeneca Pharms. LP v. Apotex Corp.,

669 F.3d 1370 (Fed. Cir. 2012).................... 11, 29

Bell Atl. Corp. v. Twombly,

550 U.S. 544 (2007) ....................................... 7, 25

Bonito Boats, Inc. v. Thunder Craft

Boats, Inc.,

489 U.S. 141 (1989) ............................................. 9

Caraco Pharm. Lab’ys, Ltd. v. Novo

Nordisk A/S,

566 U.S. 399 (2012) ................. 6, 8, 11, 12, 13, 25

Christopher v. SmithKline Beecham Corp.,

567 U.S. 142 (2012) ........................................... 16

In re Entresto (Sacubitril/Valsartan)

Patent Litig.,

2022 WL 4482717 (D. Del. Sept. 27, 2022) ....... 11

FTC v. Actavis, Inc.,

570 U.S. 136 (2013) ........................................... 11

GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc.,

25 F.4th 949 (Fed. Cir. 2022) ...................... 21, 26

GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc.,

7 F.4th 1320 (Fed. Cir. 2021) ............................ 10

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

563 U.S. 754 (2011) ............................................. 6

Inwood Lab’ys, Inc. v. Ives Lab’ys, Inc.,

456 U.S. 844 (1982) ..................................... 15, 16

Kordel v. United States,

335 U.S. 345 (1948) ........................................... 13

Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd.,

545 U.S. 913 (2005) ....................... 4, 6, 17, 19, 22

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) ..................................... 14, 15

Sears, Roebuck & Co. v. Stiffel Co.,

376 U.S. 225 (1964) ............................................. 9

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

Pharm. Corp.,

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

Warner-Lambert Co. v. Apotex Corp.,

316 F.3d 1348 (Fed. Cir. 2003).......................... 11

Statutes:

21 U.S.C.:

§ 321(m) ............................................................. 13

§ 353d(a)(3) ........................................................ 18

§ 355(j)(2)(A)(ii).............................................. 8, 13

§ 355(j)(2)(A)(iv) ............................................. 8, 13

§ 355(j)(2)(A)(v) .................................................. 13

§ 355(j)(2)(A)(vii)................................................ 11

§ 355(j)(2)(A)(vii)(III) ........................................... 8

§ 355(j)(2)(A)(vii)(IV) ........................................... 8

§ 355(j)(2)(A)(viii) ................................................ 2

§ 355(j)(2)(B) ...................................................... 11

§ 355(j)(5)(B)(ii).................................................... 8

§ 355(j)(5)(B)(iii) .................................................. 8

§ 355(j)(5)(F)(ii) .................................................... 9

§ 355(j)(8)(B) ...................................................... 14

35 U.S.C.:

§ 102 ................................................................... 10

§ 102(a)(1) ............................................................ 8

§ 103 ................................................................... 10

§ 154(a)................................................................. 8

§ 154(b)................................................................. 8

§ 156 ..................................................................... 8

§ 271(c) ........................................................... 9, 10

§ 271(e)(4)(A) ..................................................... 27

Regulations:

21 C.F.R. § 201.57(c)(2)(iv) ..................................... 20

21 C.F.R. § 314.53(b)(1) .......................................... 12

21 C.F.R. § 314.94(a)(7) .......................................... 14

Other Authorities:

Ass’n for Accessible Meds., 2020 Generic Drug &

Biosimilars Access & Savings in the U.S.

Report (2020), https://accessiblemeds.org/wpcontent/uploads/2024/12/AAM-2020-GenericsBiosimilars-Access-Savings-Report-USWeb.pdf .............................................................. 28

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

Biosimilar Medicines Savings Report (Sept.

2025), https://accessiblemeds.org/wpcontent/uploads/2025/09/AAM-2025-GenericBiosimilar-Medicines-Savings-ReportWEB.pdf ......................................................... 1, 27

Doni Bloomfield et al., Prescription Drug

Method-of-Use Patent Protection, 19912018, 41 J. Gen. Intern. Med. 261 (2025) ..... 3, 28

Georges El Hasbani et al., Colchicine: An

Ancient Drug with Multiple Benefits, 27

Current Pharmaceutical Design 2917 (2021)..... 2

vii

FDA, Approved Drug Products with

Therapeutic Equivalence Evaluations (46th

ed. 2026), https://www.fda.gov/media/

71474/download?attachment ............................ 14

FDA, Bioequivalence Studies With

Pharmacokinetic Endpoints for Drugs

Submitted Under an ANDA Guidance for

Industry, Draft Guidance (Aug. 2021),

https://www.fda.gov/media/87219/download .... 14

FDA, Frequently Asked Questions on Patents

and Exclusivity (Feb. 5, 2020),

https://www.fda.gov/drugs/developmentapproval-process-drugs/frequently-askedquestions-patents-and-exclusivity#What_

is_the_difference_between_patents_a ................ 9

FDA, Generic Competition and Drug Prices

(last updated Nov. 17, 2025),

https://www.fda.gov/about-fda/center-drugevaluation-and-research-cder/genericcompetition-and-drug-prices ............................. 27

FDA, Office of Generic Drugs 2021 Annual

Report (Feb. 2022), https://www.fda.gov/

media/156066/download?attachment ............... 27

H.R. Rep. No. 98-857 (1984) ..................................... 9

viii

HHS, White Paper: Policy Considerations to

Prevent Drug Shortages and Mitigation

Supply Chain Vulnerabilities in the

United States (Apr. 2, 2024), https://

aspe.hhs.gov/sites/default/files/documents/bd863be8f0aaf5380dc801390440b

c3d/HHS-White-Paper-Preventing-Shortages-Supply-Chain-Vulnerabilities.pdf ............ 26

Kevin J. Hickey, “Skinny Labels” for Generic

Drugs Under Hatch-Waxman, Cong. Rsch.

Serv. IF127000 (Jan. 28, 2026), https://

www.congress.gov/crs-product/IF12700 ............. 8

Kaiser Fam. Found., Prescription Drug

Trends: A Chartbook Update (Nov. 2001),

https://files.kff.org/attachment/reportprescription-drug-trends-a-chartbookupdate ................................................................ 27

Letter from Janet Woodcock, Dir., Ctr. for Drug

Evaluation & Rsch., FDA, to Joseph A. Cash,

Jr., AstraZeneca Pharms. (July 19, 2016),

https://downloads.regulations.gov/FDA-2016P-1485-0007/attachment_1.pdf ......................... 28

William H. Shrank, et al., The Consequences of

Requesting “Dispense as Written,” 124 Am.

J. Med. 309 (2011) ............................................. 16

Patrick J. Skerrett, Generic Drugs: Don’t Ask,

Just Tell, Harvard Health Publ’g (Jan. 7,

2013), https://www.health.harvard.edu/

blog/generic-drugs-dont-ask-just-tell201301075766 .............................................. 15, 16

Tracy Staton, Top 10 Drug Patent Losses of

2014, Fierce Pharma (Oct. 28, 2013),

https://www.fiercepharma.com/specialreport/top-10-drug-patent-losses-of-2014 ......... 28

U.S. Cong. Off. of Tech. Assessment, PatentTerm Extension and the Pharmaceutical

Industry (Aug. 1981), https://www.prince

ton.edu/~ota/disk3/1981/8119/8119.PDF ............ 6

Bryan S. Walsh et al., Frequency of First

Generic Drug Approvals with “Skinny

Labels” in the United States, 181 JAMA

Internal Med. 995 (2021) .............................. 3, 28

INTEREST OF AMICUS CURIAE 1

Amicus curiae the Association for Accessible

Medicines (AAM) is a nonprofit, voluntary association

representing manufacturers and distributors of

generic and biosimilar medicines and bulk active

pharmaceutical chemicals, as well as suppliers of

other goods and services to the generic pharmaceutical

industry. AAM’s members provide patients with

access to safe and effective generic and biosimilar

medicines at affordable prices. AAM’s core mission is

to improve the lives of patients by providing timely

access to safe, effective, and affordable prescription

medicines.

Generic manufacturers play an invaluable role in

the U.S. healthcare system. In 2024, for instance, the

availability of generic and biosimilar medicines kept

$467 billion in the pockets of patients and taxpayers,

and that figure exceeded $3.4 trillion over the last

decade. 2

AAM regularly participates as an amicus in

litigation of importance to the generic-pharmaceutical

industry and to the American public that benefits from

low-cost generic alternatives. AAM has filed amicus

briefs in cases concerning the skinny-label provisions

at issue here, which Congress created as part of the

Hatch-Waxman Act to allow manufacturers to provide

1 No counsel for any party authored this brief in whole or in part,

and no entity or person, aside from amicus curiae, its members,

or its counsel, made any monetary contributions intended to fund

the preparation or submission of this brief.

2 Ass’n for Accessible Meds., The U.S. Generic & Biosimilar Med-

icines Savings Report 10 (Sept. 2025) (AAM 2025 Savings Report),

https://accessiblemeds.org/wp-content/uploads/2025/09/AAM2025-Generic-Biosimilar-Medicines-Savings-Report-WEB.pdf.

affordable generic drugs to the American public. AAM

has a significant interest in this matter. The decision

below is the second decision in three years from the

Federal Circuit that has dramatically narrowed the

skinny-label pathway.

By putting generic drug

manufacturers at risk of extraordinary liability when

they follow Hatch-Waxman to the letter, the panel’s

decision makes the skinny-label pathway all but

unusable. The harms will be felt not just by AAM’s

members, but by the patients who rely on generic

manufacturers to produce affordable, life-saving

medications.

INTRODUCTION AND

SUMMARY OF ARGUMENT

What keeps drug prices high? Mainly the lack of

competition from generic alternatives. And as part of

their strategy to avoid generic competition, brandname drug companies can keep getting patents on

different ways of using a single drug: consider a patent

issued in 2011 for a new method of treatment involving

a drug that has been in use for 3500 years, back to

ancient Egypt. 3 If a single patent on a single way of

using a drug could keep generics off the market, there

would never be generics.

Enter Section viii, the statute at issue in this case—

formally 21 U.S.C. § 355(j)(2)(A)(viii). Congress wrote

Section viii as a specific, targeted exception to the

general rule that a generic drug cannot be approved

during the term of patents claiming the brand-name

drug or methods of using it, at least not without

3 See U.S. Patent No. 7,964,647; Georges El Hasbani et al., Col-

chicine: An Ancient Drug with Multiple Benefits, 27 Current

Pharmaceutical Design 2917 (2021).

litigation over whether the patent is valid or not

infringed. Under Section viii, the generic applicant

can skip all that if the drug itself is not patented and

the applicant is not “seeking approval” for the

patented use—i.e., if it will adopt a “skinny label” that

“carves out” the instructions that would infringe the

patent. The sole patented use of an unpatented drug

may be a very small tail on a very large dog. And

Congress determined that it would rather risk giving

up the tail than get no dog.

So with a skinny label, a generic can get on the

market immediately—no litigation, no delays, and

under a correct view of the law, no fear that the skinny

label will induce infringement. The results have been

spectacular—hundreds of generic drugs on the market

sooner, with billions of dollars in savings. 4

But if the Federal Circuit’s decision is not reversed,

Section viii will plummet in significance. The Federal

Circuit has opened the floodgates for litigation against

generic manufacturers, allowing cases to get past the

pleading stage merely by alleging conduct that is

utterly commonplace in skinny-label launches. A

reference to generic equivalence, some press releases

aimed at investors, and a skinny label that carves out

the patented use but makes some reference to

cardiovascular disease in a warning—that is enough

for the Federal Circuit.

But under a correct

understanding of the Section viii framework and the

generic market, none of those allegations states a

4 See Bryan S. Walsh et al., Frequency of First Generic Drug Ap-

provals with “Skinny Labels” in the United States, 181 JAMA Internal Med. 995, 995 (2021); Doni Bloomfield et al., Prescription

Drug Method-of-Use Patent Protection, 1991-2018, 41 J. Gen. Intern. Med. 261, 261 (2025).

plausible claim for actively inducing doctors to infringe

Amarin’s specific method-of-treatment patent. Active

inducement of infringement is not supposed to include

“ordinary acts incident to product distribution.”

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

545 U.S. 913, 937 (2005). The Federal Circuit failed to

follow that rule here. Allowing Amarin’s complaint to

proceed past the pleading stage risks closing off the

skinny-label pathway for all generic drugs.

The Federal Circuit fundamentally misunderstood

several key principles about Section viii and generic

drug approval that should govern inducement in this

context.

(1) Section viii applies only to method

patents. The sale (or offer for sale) of an unpatented

product cannot induce infringement of a patent that

claims only one way of using that product. (2) Skinny

labels do not induce infringement of the carved-out

patent. That is why the statute requires no notice to

the brand and no pre-launch adjudication when the

generic carves out the patent, whereas it does require

notice and provides for pre-launch adjudication (and

delayed FDA approval of the generic) when a generic

challenges a patent as invalid. (3) True statements

that a generic product is the “generic version” or

“generic equivalent” of a brand product merely echo

what the government itself says; they are

characterizations of the (unpatented) product, not the

labeled uses. (4) Generics generally do not market

their products, because of state automatic-substitution

laws, and because doctors do not specify which

company’s generic product will be used to fill a

prescription. Press releases directed to investors, not

doctors, have no bearing on doctors’ prescribing

decisions. Merely pointing to a statement in a press

release “to the marketplace” does not establish that

the statement actively induced doctors to infringe.

Adopting those principles would more than suffice to

reverse the Federal Circuit’s reliance on press releases

and websites, statements of generic equivalence, and

Hikma’s FDA-approved skinny label.

This Court should reverse the Federal Circuit

because the decision below makes the Section viii

pathway untenable, harming patients, taxpayers, and

generic manufacturers alike.

ARGUMENT

The skinny-label statute has one job within the

generic-drug regulatory framework: to make sure that

generics can avoid infringing a patent on one way of

using an unpatented drug.

Under the Federal

Circuit’s overbroad approach to inducement, no

manufacturer of a skinny-labeled generic can be sure

it can avoid infringement. This Court should reject

that approach and make Section viii usable again.

Congress understood what the Federal Circuit did

not: For Section viii to operate, a skinny label cannot

actively induce infringement of a patent on a carvedout use. Neither can the simple act of calling a generic

equivalent a generic equivalent. Allowing either of

those inducement theories past the pleading stage is

not just a legal error, but also an existential threat to

the operation of an important federal statute that

fosters competition and lowers prices.

I. The Plausibility of Amarin’s Allegations Must

Take Into Account Several Legal Principles

Established by the Hatch-Waxman Act and

State Laws.

Congress enacted Section viii as a targeted

response to a specific problem, after extensive study of

how generic drugs are developed and brought to

market. 5 Congress made a clear choice: “that one

patented use will not foreclose marketing a generic

drug for other unpatented ones.” Caraco Pharm.

Lab’ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 415

(2012). In other words, Section viii reflects Congress’s

judgment that patents on a specific use of an

unpatented drug must not delay approval of a generic

version of the drug itself, and its insight that removing

the patented use from the label suffices to prevent

inducement. Id. at 405.

Congress adopted the Section viii skinny-label

regime against the backdrop of inducement liability—

an aiding-and-abetting doctrine that requires an

inducer to take “affirmative steps” “to encourage direct

infringement” with the “affirmative intent that the

product be used to infringe.” Grokster, 545 U.S. at 936

(citation omitted); Global-Tech Appliances, Inc. v. SEB

S.A., 563 U.S. 754, 760, 764 (2011). Section 271(b) had

been on the books for thirty years by the time the

Hatch-Waxman Act added Section viii in 1984. And

because Congress limited Section viii to method

patents, to speed approval of unpatented uses for

unpatented products, Congress knew that inducement

5 U.S. Cong. Off. of Tech. Assessment, Patent-Term Extension and

the Pharmaceutical Industry (Aug. 1981), https://www.princeton.edu/~ota/disk3/1981/8119/8119.PDF.

was the only realistic source of liability for

manufacturers. It therefore structured Section viii—

especially the labeling carve-out—so as to avoid

creating inducement liability.

“Determining whether a complaint states a

plausible claim for relief will, as the Court of Appeals

observed, be a context-specific task.” Ashcroft v. Iqbal,

556 U.S. 662, 679 (2009); see Bell Atl. Corp. v.

Twombly, 550 U.S. 544, 562 (2007). Here both the

interpretation of Section viii and the context-specific

interpretation of an inducement complaint must take

account of several considerations about generic drug

approval, sale, and dispensing that Congress knew

well, but that the Federal Circuit has ignored. This

crucial legal background demonstrates that Amarin

has not stated a claim for inducement. All it has

pleaded is conduct that, at best, is “more likely

explained by” “lawful” behavior. Iqbal, 556 U.S. at

680. That is insufficient.

Because Section viii applies only to patents on methods of using an unpatented

drug, offering the drug for sale does not

induce infringement of a carved-out

method patent.

Section viii can only be used where “a method of use

patent” claims an FDA-approved way of using the

drug. The purpose of a skinny label is to permit

generic companies to launch without delay when the

drug itself is not patented, so a method-of-use patent

is the only obstacle. Understanding that framework

confirms that marketing the generic drug itself cannot

be sufficient to induce infringement of the carved-out

method of using the drug.

The generic manufacturer cannot use Section viii

to get around any patents on the active ingredient or

formulation itself; “[a] section viii statement is

typically used when the brand’s patent on the drug

compound has expired and the brand holds patents on

only some approved methods of using the drug.”

Caraco, 566 U.S. at 406. Section viii works to speed

generic approval only when any patents on the

compound or formulation itself have already expired

or been invalidated or (in limited circumstances)

That is because

successfully designed around. 6

Congress recognized that there can be only one patent

term on the active ingredient molecule 7—but

potentially many, many different patent terms on new

ways to use that molecule.

By the time there is an unpatented molecule with

at least one unpatented use, the brand manufacturer

already will likely have enjoyed years of patent

exclusivity on the compound and its original use. 35

U.S.C. §§ 154(a)-(b), 156 (patent term lasts for 20

years from filing, plus adjustments and extension for

regulatory delays); Kevin J. Hickey, “Skinny Labels”

for Generic Drugs Under Hatch-Waxman, Cong. Rsch.

Serv. IF127000 (Jan. 28, 2026). 8 There are also

several other forms of regulatory exclusivity that add

6 See 21 U.S.C. § 355(j)(2)(A)(vii)(III), (j)(5)(B)(ii) (approval per-

missible after patents expire); id. § 355(j)(2)(A)(vii)(IV),

(j)(5)(B)(iii) (approval permissible after patents declared invalid

or not infringed, or 30-month stay expires). The ability to design

around is limited by the requirement that the generic formulation

have the same active ingredient and be bioequivalent to the

brand’s. Id. § 355(j)(2)(A)(ii), (iv).

7 See, e.g., 35 U.S.C. § 102(a)(1) (no patent can issue on an invention that has previously been patented).

8 https://www.congress.gov/crs-product/IF12700.

to or overlap with the protection for new drugs. See

FDA, Frequently Asked Questions on Patents and

Exclusivity (Feb. 5, 2020). 9

Thus, the whole point of Section viii is to eliminate

obstacles to approval based on a method of using an

unpatented drug. It follows that merely selling or

offering the drug cannot amount to indirect

infringement of the carved-out method patent. The

expiration (or invalidation) of patents on the drug

means that the drug is in the public domain. See, e.g.,

Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489

U.S. 141, 153 (1989) (citing Sears, Roebuck & Co. v.

Stiffel Co., 376 U.S. 225, 231 (1964)). The patent

owner’s monopoly over the molecule is gone, and a

patent on one use (out of many) does not restore it.

That is precisely the purpose of the carve-out statute:

to ensure that the owner of a patent on a single use of

an unpatented drug cannot leverage that ownership to

bar access to the drug entirely. See, e.g., H.R. Rep. No.

98-857, at 21 (1984).

By definition, there is a “substantial noninfringing

use” of any public-domain molecule that is FDAapproved for at least one unpatented use; selling such

a drug therefore cannot be “contributory infringement”

under 35 U.S.C. § 271(c). And late in a product’s

lifecycle, after being studied or sold for years, a

patented use may be quite narrow (to avoid

invalidation by prior art, sales, public use, or

9 https://www.fda.gov/drugs/development-approval-process-

drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a. Most notably,

securing FDA approval of a new chemical entity entitles the

brand to five years of freedom from generic competition whether

it has any patents or not. See 21 U.S.C. § 355(j)(5)(F)(ii).

obviousness, see id. §§ 102, 103). For example, in one

of the Federal Circuit’s carve-out cases, the drug had

three FDA-approved indications, but the narrow

patented method of use claimed only part of one of

them—it required physicians to prescribe the drug

product (i) in order to decrease mortality (ii) caused by

congestive heart failure (iii) by administering a

therapeutically acceptable amount of carvedilol (iv) in

conjunction with one or more of three other drug

products (v) as a maintenance dose (vi) for more than

six months. GlaxoSmithKline LLC v. Teva Pharms.

USA, Inc., 7 F.4th 1320, 1324 (Fed. Cir. 2021). That is

both narrow and relatively hard to induce.

Because a carved-out patent by definition claims

only a method of using the product for some FDAapproved use, a manufacturer generally can infringe

such a patent only indirectly, by inducing a provider or

patient to practice the patented method. Carving the

patented indication out of the FDA-approved label

makes sure that the label itself does not induce any

such infringement.

Section viii does not trigger pre-launch

infringement litigation because the

carve-out itself offers immediate certainty: Skinny labels do not induce infringement.

The core innovation of Hatch-Waxman is the

ability to get patent issues resolved with certainty

before a generic launch. Congress recognized that

even a small possibility of patent-infringement

damages

could

well

disincentivize

generic

manufacturers from even trying to market a product

until after all patents expire. After all, generics

sometimes make just pennies per pill, but if found

liable for infringement, they can be responsible for the

brand’s lost profits—at its much larger profit margins.

So Congress created a process whereby generics and

brands could obtain certainty about whether the

brand’s patents are valid, and whether the generic

infringes them, before the generic launches—and

becomes exposed to damages for the brand’s lost

profits. Just filing an application to market a generic

before all patents expire (a so-called “Paragraph IV”

certification) is deemed an act of infringement,

triggering patent litigation. See FTC v. Actavis, Inc.,

570 U.S. 136, 143 (2013). In return, while that

litigation proceeds, the brand gets certainty that the

generic will not launch for at least 30 months (unless

it wins the litigation before then). Id.

None of that happens in the Section viii process,

which is not set up to “provok[e] litigation.” Caraco,

566 U.S. at 407. The applicant does not have to submit

a Paragraph IV certification, or provide notice to the

brand company, because it is not “seeking approval”

for the use that the brand’s method patent claims. 21

U.S.C. § 355(j)(2)(A)(vii); see id. § 355(j)(2)(B)

(Paragraph IV certification requires notice to the

brand company). There is no artificial act of patent

infringement. See AstraZeneca Pharms. LP v. Apotex

Corp., 669 F.3d 1370, 1377-78 (Fed. Cir. 2012) (citing

Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348,

1356-60 (Fed. Cir. 2003)). Indeed, when generics have

tried to obtain patent certainty from a court before

launching under a skinny-label, brand manufacturers

have successfully defeated those claims by arguing

that there is no statutory basis for them. In re Entresto

(Sacubitril/Valsartan) Patent Litig., 2022 WL

4482717, at *5 (D. Del. Sept. 27, 2022). Nor does the

generic have to wait for the method patent to expire.

Unlike with a Paragraph IV certification, there is not

even a 30-month stay on approval: If the only patent

is a carved-out method patent, the generic application

can be approved immediately.

Given its focus on providing generics with certainty

through pre-launch litigation, Congress plainly did not

create Section viii as a font of uncertainty. Rather, the

reason Section viii does not provoke pre-launch

litigation, or even require prompt notice from the

generic to the brand, is because it makes litigation

unnecessary: The carve-out from the label means that

the label will not induce infringement. There is

nothing to litigate.

Partly, this is because the skinny-label process

favors brand manufacturers. Brands get to identify

exactly what portions of their labeling they think are

claimed by their method-of-use patents. See 21 C.F.R.

§ 314.53(b)(1) (“[T]he [brand-name company with an

approved drug product] submitting information on the

method-of-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.”). In other words, they get to decide

what words they believe generics must carve out in

order to avoid even a “reasonabl[e]” claim of

infringement. Id. Their claim is summarized in a “use

code,” which FDA publishes “in a fat, brightly hued

volume called the Orange Book.” Caraco, 566 U.S. at

405-06. And FDA will not second-guess their claim: It

simply “will not approve” a generic application “if the

generic’s proposed carve-out label overlaps at all with

the brand’s use code.… [FDA] does not independently

assess the patent’s scope or otherwise look behind the

description authored by the brand.” Caraco, 566 U.S.

at 406. 10 This system therefore inherently favors

brands from the outset.

So a generic that gets FDA’s approval of a skinny

label has, by definition, carved out everything that the

brand itself has told FDA is necessary to avoid even a

claim of infringement. That is why Congress did not

set up a Section viii carve-out to trigger litigation—

again, there is nothing to litigate.

For important regulatory reasons, generic drugs are equivalent to brand

drugs.

Generic drugs save patients and the healthcare

system money precisely because they do not have to go

through the same round of clinical trials for approval.

Rather, FDA is able to find them safe and effective

based on their close equivalence to already-approved

drugs. A generic has the same active ingredient as the

brand, it works on the human body in equivalent ways

(“bioequivalence”), and it carries the same labeling 11—

except for any carve-out. Caraco, 566 U.S. at 406; see

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

Generally

speaking, however, the generic labeling can subtract

10 A generic’s only recourse to an overbroad characterization by a

brand company is a counterclaim in court to correct the Orange

Book. See Caraco, 566 U.S. at 408-09.

11 “[L]abeling” is defined as “all labels and other written, printed,

or graphic matter (1) upon any article or any of its containers or

wrappers, or (2) accompanying such article.” 21 U.S.C. § 321(m).

Labeling thus “embraces advertising or descriptive matter that

goes with the package in which the articles are transported,” in

addition to any label that may be placed directly on a pill bottle.

Kordel v. United States, 335 U.S. 345, 350 (1948).

aspects of the brand labeling, but cannot add to them.

PLIVA, Inc. v. Mensing, 564 U.S. 604, 614-16 (2011).

Thus, a generic label generally cannot include

warnings or disclaimers that the brand label does not

have; Section viii also does not allow a generic label to

drop portions of the brand label that are not claimed

in the carved-out patent(s).

Given this duty of sameness, FDA routinely

describes generics as the therapeutic equivalents of

brand products.

Indeed, FDA publishes such

determinations to the public in the Orange Book, and

explains at length that bioequivalent products are

“therapeutically equivalent” to each other. See, e.g.,

FDA, Approved Drug Products with Therapeutic

Equivalence Evaluations 2-1, 2-4 (46th ed. 2026),

https://www.fda.gov/media/71474/download?attachme

nt. That finding of equivalence is the basis of the

entire system allowing generic products to be

substituted for brand ones.

But that does not mean that representations about

the equivalence of the drug product are akin to

representations about how the drug product can or

should be used. Therapeutic equivalence is a function

of the product’s composition, not the uses for which it

is labeled. See, e.g., 21 U.S.C. § 355(j)(8)(B); 21 C.F.R.

§ 314.94(a)(7). Products are bioequivalent if they

result in the active ingredient being absorbed in the

body at comparable rates, id.; bioequivalence is often

tested in healthy subjects, 12 confirming that it has

12 See FDA, Bioequivalence Studies With Pharmacokinetic End-

points for Drugs Submitted Under an ANDA Guidance for Industry, Draft Guidance 3-4 (Aug. 2021), https://www.fda.gov/media/87219/download.

nothing to do with the prescribed indication.

Thus, every generic that FDA finds therapeutically

equivalent to the brand drug is the subject of a

government publication declaring that equivalence to

the world. That is because describing the drugs as

“equivalent” is both completely true and absolutely

indispensable to the operation of the entire system.

Generic drugs are determined to be safe and effective

as a result of their equivalence.

It follows that for a manufacturer to repeat FDA’s

finding of equivalence accurately cannot be

inducement of a method claim that encompasses only

one use of an unpatented product. Just as selling the

product cannot by itself be inducement, neither can

correctly repeating this crucial regulatory judgment.

Because of state automatic-substitution

laws that operate at the pharmacy, generic companies do not market to doctors and doctors do not prescribe a specific manufacturer’s generic drug.

Congress knew that most of the savings would be

achieved at the pharmacy. Because FDA certifies

brand and generic drugs as equivalent to one another,

laws in effect in all 50 States (then and now) authorize

pharmacies to substitute a generic product for a brand

one. U.S. Cert. Amicus Br. 5; see also PLIVA, 564 U.S.

at 628; Inwood Lab’ys, Inc. v. Ives Lab’ys, Inc., 456 U.S.

844, 847 n.4 (1982). And prescribing physicians

cannot prescribe a particular generic company’s drug

from among the available generic options (e.g.,

Hikma’s generic product over Apotex’s or Teva’s).

Instead, doctors prescribe drugs by either their brand

name or their non-proprietary name, Patrick J.

Skerrett, Generic Drugs: Don’t Ask, Just Tell, Harvard

Health Publ’g (Jan. 7, 2013), 13 and if there is more

than one option that FDA has certified as

therapeutically equivalent, the pharmacy can buy

from the wholesaler whichever products it wants, and

substitute whichever one it has in stock.

Indeed, the only specific manufacturer’s drug

product a physician can prescribe is the brand

manufacturer’s drug. Automatic substitution can be

avoided if doctors specifically write the brand name on

their prescription pad and then they (or sometimes

their patients) direct the pharmacy to “dispense as

written.” U.S. Cert. Amicus Br. 6; Inwood Lab’ys, 456

U.S. at 847 n.4. That happens in only a small fraction

of cases. William H. Shrank, et al., The Consequences

of Requesting “Dispense as Written,” 124 Am. J. Med.

309, 309-10 (2011).

The automatic substitution system, along with

generics’ thin profit-margins, disincentivizes generic

manufacturers from spending money to market

directly to doctors (or patients). Generics do not

maintain a sales force of tens of thousands of sales

representatives the way that brand companies do. See,

e.g., Christopher v. SmithKline Beecham Corp., 567

U.S. 142, 150 (2012). Generics sell their products to

wholesalers, not to doctors and (given the need for a

prescription) usually not to patients. Marketing might

well result in sales to a competitor: Doctors do not

decide which generic to fill a prescription with—

pharmacies do. And pharmacies do not infringe

method patents.

13 https://www.health.harvard.edu/blog/generic-drugs-dont-ask-

just-tell-201301075766.

* * * *

These contextual points shape the plausibility of

Amarin’s allegations—or lack thereof. Congress well

understood that generics would be equivalent

medicines, both chemically and in the human body—

and that it would be necessary for FDA, generics, and

even brands to say so. But generics do not market

their equivalence to doctors—they do not need to. The

only place in which they give instructions that doctors

might read is in the labeling. And that is precisely why

the carve-out statute operates the way it operates: so

that successfully carving out an indication from the

labeling will eliminate the risk of inducing a doctor to

practice that indication, and so that the carved-out

patent will not delay the generic from coming on the

market.

As the next section discusses, the Federal Circuit’s

treatment of both the label and other materials

Amarin cited took no account of any of these important

contextual points.

II. Active Inducement Requires an Affirmative

Encouragement of the Patented Use

Active inducement of patent infringement does not

include “ordinary acts incident to product

distribution.” Grokster, 545 U.S. at 937. Accordingly,

conduct basic to selling a skinny-labeled product

cannot

give

rise

inducement

liability.

Manufacturers have to be able to sell the unpatented

product, with the FDA-approved skinny label, and to

describe it as a “generic equivalent” to a brand

product, just as FDA does. Yet the Federal Circuit’s

decisions in this area treat that basic conduct as

actionable inducement. Under the ordinary principles

of inducement, as informed by the generic drug

regulatory framework and its history, those

allegations cannot state a plausible claim of

inducement.

Amarin’s complaint is insufficient

because it does not plausibly plead that Hikma

actively encouraged doctors to practice the specific

patented method of use—the method carved out of

Hikma’s product label.

Referring to a drug as a generic is not active inducement.

This Court should make clear that a truthful

statement that one drug is the generic version of

another cannot serve as the basis—in whole or in

part—for alleging active inducement of infringement.

The Federal Circuit recognized the point but failed to

follow it—holding that such a statement can be

actionable in combination with other matters. Pet.

App. 21a. The court never identified how the “generic

version” language could actively induce infringement,

and it cannot. As explained above, a statement of

generic equivalence accurately references the drug

product—which, for skinny-labeled drugs, is

unpatented. Such statements are necessary to sell the

product at all. And merely selling or offering the drug

product cannot infringe a carved-out patent. See pp.

7-10, 14-15, supra. Indeed, Congress itself has used

the precise terminology that the Federal Circuit found

probative of inducement. E.g., 21 U.S.C. § 353d(a)(3)

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

under section 355(j) … whose reference listed drug is

a covered drug.”). So has Amarin. Pet. Br. 36.

Given that active inducement requires a “clear

expression” or an “affirmative step[] taken to foster

infringement,” Grokster, 545 U.S. at 936-37, active

inducement to infringe a method patent requires, at

minimum, a clear expression encouraging the

recipient to practice every step of the specific patented

method of use. Demanding anything less violates this

Court’s precedents, which have consistently explained

that advertising a commercial product for uses that

are not “necessarily infringing,” even with “knowledge

that some would use [the product] to infringe,” is not

sufficient for indirect infringement. Id. at 931.

Here there is no such clear encouragement. Hikma

never stated that doctors or patients should use its

product just like Vascepa for the still-patented CV

indication. Hikma did not even point to Vascepa’s

patented uses in describing Hikma’s product as

Vascepa’s generic equivalent. Pet. App. 35a. And the

court did not even restrict itself to “generic equivalent”

communications directed to doctors or patients—the

class of people who could commit direct infringement

of the carved-out claims. See pp. 22-23, infra.

The most the court could point to is that Hikma

acknowledged obliquely that Vascepa had other

indications on its label, by stating that Vascepa was

approved “in part” for the unpatented SH indication.

Pet. App. 18a. That is substantively no different than

admitting that a label is a skinny label—every skinnylabeled product is the generic equivalent of a brandname product with at least one patented indication

that has been carved out of the generic label. The

Federal Circuit’s reasoning would make every skinny

label self-defeating—the label’s very skinniness would

necessarily be deemed inducement. That reasoning is

patently incorrect, because it comes nowhere close to

active inducement to practice any patented method.

A compliant skinny label cannot support

a claim of active inducement.

This Court should also make clear that a compliant

skinny label cannot support allegations of active

inducement to infringe—again, in whole or in part.

Here, too, the Federal Circuit’s reasoning was opaque:

It said that the label did not induce by itself, but

plausibly did so in combination with other materials.

Pet. App. 17a, 18a. The Hatch-Waxman framework

precludes basing inducement of a carved-out patent on

a label that has properly been through the carve-out

process. See pp. 10-13, supra.

Hikma carved out everything it was required to. If

it had not, FDA could not have approved the carve-out,

and if FDA somehow misapplied the information that

Amarin gave it, Amarin could have filed an APA action

against the agency (rather than a damages action

against Hikma). Indeed, the panel acknowledged that

there is absolutely nothing infringing in the

Indications & Usage section of the label—the first

section, where Amarin lists the patented indication

and Hikma’s label omits it. Pet. App. 16a.

That should have been the end of the matter.

Indeed, “[i]ndications or uses must not be implied or

suggested in other sections of the labeling if not

included in [the Indications and Usage] section.” 21

C.F.R. § 201.57(c)(2)(iv). In the carve-out context, just

alleging that doctors would read other sections as

teaching “that the product could be prescribed to treat

cardiovascular risk” is inadequate to state a plausible

claim. Pet. App. 16a. Clever pleading cannot just

disregard the countervailing evidence from the label:

the conspicuous silence on that point in the Indications

and Usage section, the absence of any instruction to

perform the steps of the method, and the absence of

any encouragement to perform the patented method at

all.

Because every skinny label is bound by the samelabel requirement except for the carved-out portion, p.

13-14, supra, the Federal Circuit’s decision is again a

recipe to negate the skinny-label regime. Labels may

often contain certain words or references that bear a

relationship with a carved-out indication.

E.g.,

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

Corp., 785 F.3d 625, 630 (Fed. Cir. 2015) (label

discussing unpatented use, preventing gout flareups,

mentioned but did not instruct patented use, treating

gout flareups). That is no accident: Because of the

duty of sameness, brands have substantial discretion

to bury land mines in obscure corners of their labeling

and force generics to copy them. As Judge Prost aptly

noted, “because most skinny labels contain language

that (with clever expert testimony) could be pieced

together to satisfy a patent claim, essentially all of

these cases will now go to trial.” GlaxoSmithKline

LLC v. Teva Pharms. USA, Inc., 25 F.4th 949, 955

(Fed. Cir. 2022) (“GSK”) (Prost, J., dissenting from

denial of rehearing en banc). This Court should not

encourage that type of game-playing. A brand that

owns a method patent must identify the language in

the label to be carved out—the portion actually

encouraging the performance of the patented method.

Once that is carved out, the label cannot establish

active inducement of the carved-out patent—that is

the point of the carve-out statute.

Relatedly, the Federal Circuit erred in relying on

Hikma’s statement on a website that its drug is a

generic

for

the

therapeutic