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 Petition for a Writ of Certiorari

to the United States Court of Appeals

for the Federal Circuit

_________

BRIEF FOR THE ASSOCIATION FOR

ACCESSIBLE MEDICINES AS AMICUS

CURIAE IN SUPPORT OF PETITIONERS

_________

KARIN HESSLER

ASSOCIATION FOR

ACCESSIBLE MEDICINES

601 New Jersey Avenue,

NW, Suite 850

Washington, DC 20001

(202) 249-7100

MATTHEW S. HELLMAN

Counsel of Record

JONATHAN J. MARSHALL

JENNER & BLOCK LLP

1099 New York Avenue,

NW, Suite 900

Washington, DC 20001

(202) 639-6000

mhellman@jenner.com

i

TABLE OF CONTENTS

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

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

INTRODUCTION AND SUMMARY OF THE

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

ARGUMENT........................................................................ 6

I.

II.

The Decision Below Eviscerates the

Protections Congress Provided Through the

Skinny-Label Process ................................................. 6

A.

The Decision Below Provides a

Roadmap for Branded Manufacturers

to State a Claim for Induced

Infringement in Every Skinny-Label

Case...................................................................... 7

B.

By Opening Up the Litigation

Floodgates, the Decision Below

Destroys the Economics of the SkinnyLabel Process and Vitiates Congress’s

Intent ................................................................. 10

C.

The Decision Below Will Also

Undermine the Paragraph IV Process ......... 11

The Decision Below Violates Black-Letter

Principles of Inducement Liability ......................... 13

III. The Decision Below Poses a Grave Threat to

Generic Pharmaceuticals, and Thus to

American Patients..................................................... 17

CONCLUSION .................................................................. 21

ii

TABLE OF AUTHORITIES

CASES

AstraZeneca Pharmaceuticals LP v. Apotex

Corp., 669 F.3d 1370 (Fed. Cir. 2012) ................... 13, 20

Bell Atlantic Corp. v. Twombly, 550 U.S. 544

(2007) ............................................................................... 10

Caraco Pharmaceutical Laboratories, Ltd. v.

Novo Nordisk A/S, 566 U.S. 399 (2012) .............. 6, 9, 12

Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661

(1990) ................................................................................. 6

GlaxoSmithKline LLC v. Teva Pharmaceuticals

USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020),

vacated on grant of reh’g, 7 F.4th 1320

(Fed. Cir. 2021) ................................................................ 6

GlaxoSmithKline LLC v. Teva

Pharmaceuticals USA, Inc., 7 F.4th 1320

(Fed. Cir. 2021) ..................................... 3-4, 6, 8-9, 11, 15

GlaxoSmithKline LLC v. Teva

Pharmaceuticals USA, Inc., 25 F.4th 949

(Fed. Cir. 2022) (mem.).......................... 3-4, 6, 10-11, 13

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

563 U.S. 754 (2011) ........................................................ 14

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

Ltd., 545 U.S. 913 (2005) ................................... 14, 16-17

Novartis Pharmaceuticals Corp. v. Alkem

Laboratories Ltd. (In re Entresto

(Sacubitril/Valsartan) Patent Litigation),

Nos. 20-cv-2930 etc., 2022 WL 4482717

(D. Del. Sept. 27, 2022) ................................................. 13

iii

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

Takeda Pharmaceuticals U.S.A., Inc. v. WestWard Pharmaceutical Corp., 785 F.3d 625

(Fed. Cir. 2015) ........................................................ 15-16

STATUTES

21 U.S.C. § 355(j)(2)(A)(v) ............................................... 17

21 U.S.C. § 355(j)(2)(A)(vii)(IV)...................................... 12

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

35 U.S.C. § 271(b) ....................................... 6, 10, 14-15, 17

35 U.S.C. § 271(e)(2)......................................................... 13

Drug Price Competition and Patent Term

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

98 Stat. 1585 ..................................................................... 2

§ 101 .................................................................................. 2

RULES

Fed. R. Civ. P. 12(b)(6) ................................................ 8, 10

Sup. Ct. R. 37.2 ................................................................... 1

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

OTHER AUTHORITIES

Ass’n for Accessible Medicines, 2020 Generic

Drug & Biosimilars Access & Savings in the

U.S. Report (2020), https://accessiblemeds.org

/wp-content/uploads/2024/12/AAM-2020Generics-Biosimilars-Access-Savings-ReportUS-Web.pdf ................................................................... 19

iv

Ass’n for Accessible Medicines,

The U.S. Generic & Biosimilar

Medicines Savings Report (Sept. 2024),

https://accessiblemeds.org/wpcontent/uploads/2025/01/AAM-2024-GenericBiosimilar-Medicines- Savings-Report.pdf........ 1, 3, 18

Brief for the United States as Amicus Curiae,

Teva Pharmaceuticals USA, Inc. v.

GlaxoSmithKline LLC, No. 22-37

(U.S. Mar. 29, 2023)............................................. 4, 15, 20

Briesacher, Becky A., et al., Medication

Adherence and the Use of Generic Drug

Therapies, 15 Am. J. Managed Care 450 (2009)........ 18

Choudhry, Niteesh K., et al., Improving

Adherence to Therapy and Clinical Outcomes

While Containing Costs: Opportunities from

the Greater Use of Generic Medications,

Annals Internal Med. (Nov. 24, 2015),

https://doi.org/10.7326/M14-2427 ................................ 18

Conrad, Ryan, et al., Center for Drug Evaluation

& Research, U.S. FDA, Estimating Cost

Savings from New Generic Drug Approvals in

2018, 2019, and 2020 (Aug. 2022),

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

Cubanski, Juliette, et al., What Does the Federal

Government Spend on Health Care?, KFF

(Feb. 24, 2025), https://www.kff.org/medicaid

/issue-brief/what-does-the-federal-governmentspend-on-health-care .................................................... 20

v

Day, Gregory & Steven Udick, Patent Law

and the Emigration of Innovation,

94 Wash. L. Rev. 119 (2019) ......................................... 11

Drug Spending, U.S. Dep’t of Health & Hum.

Servs. Off. of Inspector Gen. (updated Dec. 16,

2024), https://oig.hhs.gov/reports/featured/drugspending ......................................................................... 20

Generic Competition and Drug Prices, U.S. Food

& Drug Admin., https://www.fda.gov/aboutfda/center-drug-evaluation-and-re- searchcder/generic-competition-and-drug-prices (last

updated Oct. 17, 2024)................................................... 18

Kaiser Family Foundation, The, Prescription

Drug Trends: A Chartbook Update (Nov. 2001),

https://files.kff.org/attachment/reportprescription-drug-trends-a-chartbook-update .......... 18

Office of Generic Drugs 2021 Annual Report, U.S.

Food & Drug Admin., https://www.fda.gov

/drugs/generic-drugs/office-generic- drugs-2021annual-report (last updated Feb. 14, 2022) ................ 18

Rhoades, Katherine, Do Not Pass Go, Do Not

Stop for Summary Judgment: The U.S. District

Court for the District of Delaware’s Seemingly

Disjunctive Yet Efficient Procedures in HatchWaxman Litigation, 14 Nw. J. Tech. & Intell.

Prop. 81 (2016) ............................................................... 11

Staton, Tracy, Top 10 Drug Patent Losses of 2014,

Fierce Pharma (Oct. 28, 2013, 9:55 AM),

https://www.fiercepharma.com/specialreport/top-10-drug-patent-losses-of-2014 .................. 19

vi

Tu, S. Sean & Charles Duan, Pharmaceutical

Patent Two-Step: The Adverse Advent of

Amarin v. Hikma Type Litigation, 12 N.Y.U.

J. Intell. Prop. & Ent. L. 1 (2022) ............................... 12

Walsh, Bryan S., et al., Frequency of

First Generic Drug Approvals with

“Skinny Labels” in the United States,

181 JAMA Internal Med. 995 (2021) ....................... 3, 18

Woodcock, Janet, Director, Center for

Drug Evaluation & Research, FDA,

Letter to Joseph A. Cash, Jr., AztraZeneca

Pharmaceuticals (July 19, 2016),

https://downloads.regulations.gov

/FDA-2016-P-1485-0007/attachment_1.pdf................ 19

1

INTEREST OF AMICUS CURIAE1

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. Generic and biosimilar drugs

constitute 90% of all prescriptions dispensed in the United

States while accounting for just 13% of prescription-drug

spending.2 In 2023, for instance, the availability of generic

and biosimilar medicines kept $445 billion in the pockets

of patients and taxpayers, and that figure exceeded $3

trillion over the last decade.3

1 Pursuant to this Court’s Rule 37.6, amicus states that this brief was

not authored in whole or in part by counsel for any party, and that no

person or entity other than amicus and its counsel made a monetary

contribution intended to fund the preparation or submission of this

brief. Counsel of record for the parties received timely notice of the

intent to file this brief pursuant to this Court’s Rule 37.2.

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

cines Savings Report 2 (Sept. 2024), https://accessiblemeds.org/wpcontent/uploads/2025/01/AAM-2024-Generic-Biosimilar-MedicinesSavings-Report.pdf (AAM 2024 Savings Report).

3 Id. at 7.

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 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 THE ARGUMENT

The opinion below is the latest, and most extreme, in a

line of decisions by the Federal Circuit that have effectively nullified a key statutory protection allowing manufacturers to provide high-quality, affordable generic

drugs to the American public. This Court’s review is warranted.

Over forty years ago, Congress created the skinny-label process as part of the Hatch-Waxman Act. See Drug

Price Competition and Patent Term Restoration Act of

1984, Pub. L. No. 98-417, § 101, 98 Stat. 1585, 1586 (adding

21 U.S.C. § 355(j)(2)(A)(viii)). Congress’s goal was simple:

to ensure patient access to low-cost generic and biosimilar

3

medicines by protecting generic-drug manufacturers

from patent-infringement lawsuits. And Congress’s solution was elegant and effective. Generic manufacturers

could come to market with a “skinny label,” i.e., a label

that excludes uses that remain under patent. With skinny

labels, patients would no longer have to pay branded-drug

prices for uses that were not patented. That skinny-label

regime has indisputably worked. In nearly 50% of cases

where a drug is no longer patented and some (but not all)

of its uses are patented, a generic version of the drug is

brought to market with a skinny label.4 And since its enactment in 1984, the section viii skinny-label process has

saved the American public—both patients and taxpayers—trillions of dollars in unnecessary costs.5

But recent decisions by the Federal Circuit have eviscerated that skinny-label regime. What began as a shield,

“a way for generics to avoid inducement liability—and

thus litigation itself,” has been transformed into a sword

for branded manufacturers to wield against the very generics that Congress sought to protect. GlaxoSmithKline

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

Cir. 2022) (GSK III) (Prost, J., dissenting from the denial

of the petition for rehearing en banc) (emphasis omitted).

Three years ago in GlaxoSmithKline LLC v. Teva

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

(GSK II), the Federal Circuit held that a skinny label that

properly carved out all still-patented uses of the drug

4 Bryan S. Walsh et al., Frequency of First Generic Drug Approvals

with “Skinny Labels” in the United States, 181 JAMA Internal Med.

995, 997 (2021).

5 AAM 2024 Savings Report, supra note 2, at 7.

4

could still give rise to inducement liability based on label

language pertaining to unpatented uses. Id. at 1328-31.

That decision sounded alarm bells at multiple levels: several judges on the Federal Circuit issued dissents,6 and

the Solicitor General recommended that this Court grant

certiorari to correct the Federal Circuit’s distortion of the

Hatch-Waxman scheme and inducement principles.7

Fast-forward to this decision, which goes even further

in undermining the skinny-label regime. It is undisputed

in this case that the generic drug’s label “does not provide

an implied or express instruction to prescribe the drug”

for its patented use. Pet. App. 16a. Yet the Federal Circuit held that the branded manufacturer stated a claim for

inducement simply because it alleged that the generic

manufacturer (accurately) called its product a “generic”

version of the branded drug and had referred to the total

market size of the branded drug in marketing materials.

Id. at 18a.

If those threadbare allegations state a claim, then

every generic drug manufacturer who uses a skinny label

is at risk for an infringement suit. The panel insisted that

a generic manufacturer could ultimately prevail with “the

benefit of fact discovery and expert testimony.” Pet. App.

19a. But that is too late. Given the potential for ruinous

6 See GSK II, 7 F.4th at 1342-61 (Prost, J., dissenting); GSK III, 25

F.4th at 953-58 (Prost, J., dissenting from the denial of the petition

for rehearing en banc); id. at 958-59 (Dyk, J., dissenting from the denial of the petition for rehearing en banc); id. at 959-60 (Reyna, J.,

dissenting from denial of the petition for rehearing en banc).

7 See Brief for the United States as Amicus Curiae, Teva Pharms.

USA, Inc. v. GlaxoSmithKline LLC, No. 22-37 (U.S. Mar. 29, 2023)

(U.S. GSK Br.).

5

lost-profits damages, no generic manufacturer could risk

using a skinny label if it necessarily meant litigation before a factfinder. Congress intended the skinny-label regime to be a safe harbor; the Federal Circuit’s decisions

have made it a treacherous shoal.

The decision below is also flatly inconsistent with

black-letter principles of secondary liability for intellectual-property infringement. This Court (not to mention

Congress) has long made clear, in both the copyright and

patent contexts, that induced infringement requires an

active form of instruction, encouragement, or suggestion

that third parties infringe. The allegations here are not of

that sort. At most, the allegations are that the generic

manufacturer provided truthful information that enabled

third parties to infringe, and that has never been enough

for inducement liability.

Ultimately, the true losers in this decision are American patients—and the American taxpayers who fund

Medicare and Medicaid, which bear much of the country’s

drug expenditures. If generic manufacturers cannot

bring generic drugs to market without being forced to litigate infringement suits to summary judgment and beyond, it is likely the generics will never be developed at

all. Patients will thus be deprived of affordable generic

alternatives for uses that, by definition, are not patented.

This Court should grant the petition and reverse.

6

ARGUMENT

I.

THE DECISION BELOW EVISCERATES THE

PROTECTIONS

CONGRESS

PROVIDED

THROUGH THE SKINNY-LABEL PROCESS.

As this Court has repeatedly recognized, the HatchWaxman Act was “designed to speed the introduction of

low-cost generic drugs to market.” Caraco Pharm.

Lab’ys, Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 405

(2012); see Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661,

676 (1990). Part of Congress’s design was the section viii

process, whereby a generic manufacturer can carve out

infringing uses of an unpatented drug and thereby “avoid

inducement liability.” GSK III, 25 F.4th 949, 955 (Fed.

Cir. 2022) (Prost, J., dissenting from the denial of the petition for rehearing en banc) (emphasis omitted).

The Federal Circuit’s recent decisions in this area,

however, all but wipe out the section viii process. In both

GSK and this case, the Federal Circuit has endorsed

broad theories of liability against generic manufacturers

who “did everything right.” GlaxoSmithKline LLC v.

Teva Pharms. USA, Inc., 976 F.3d 1347, 1361 (Fed. Cir.

2020) (Prost, C.J., dissenting), vacated on grant of reh’g,

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

Going forward, it will be near-automatic that a generic

manufacturer who does “everything right” in bringing a

drug to market with a skinny label will be sued for induced

patent infringement under 35 U.S.C. § 271(b). But Section 271(b) should not be interpreted to negate Congress’s

efforts in the Hatch-Waxman Act, and respect for Congress’s intent requires far more scrutiny of respondents’

(Amarin’s) complaint than it received below.

7

A.

The Decision Below Provides a Roadmap for

Branded Manufacturers to State a Claim for

Induced Infringement in Every Skinny-Label Case.

If Amarin’s complaint can defeat petitioners’

(Hikma’s) motion to dismiss, there is no reason to think

that any generic manufacturer utilizing the skinny-label

process will be safe.

All Hikma is alleged to have done wrong in this case is

accurately describe its drug as a “generic equivalent” of

the branded version and accurately present market data

relating to the branded version’s sales in a press release.

Pet. App. 6a-7a. In fact, Hikma’s press releases also clarified, in conformity with the skinny label, that the generic

drug was approved only for a specific (unpatented) use

and that the “product is not approved for any other indication for the” branded version. Id. at 7a. Essentially

everything Amarin points to here—descriptions of a generic as “generic” and benign public statements about the

market—will be present in every skinny-label case.

By holding that Amarin has stated a claim, the ruling

below effectively eviscerates the section viii process and

leaves generic manufacturers in the lurch. For obvious

reasons, it is not realistic that a generic manufacturer

would make no public statements whatsoever about its generic products—or that it could somehow refrain from

even calling those products “generics.” For one thing,

federal securities laws mandate disclosure of material information—including information related to anticipated

or completed products—to shareholders and the public.

Yet, under the decision below, as soon as the manufacturer speaks about its generic product, the branded

8

manufacturer has enough to sue, and defeat a Federal

Rule of Civil Procedure 12(b)(6) motion, by alleging that

the generic manufacturer’s communications—however

innocuous sounding—were really a surreptitious effort to

induce physicians to prescribe the generic drug for off-label, patented uses. In short, if simply calling a generic

drug “generic” is enough to create a viable induced-infringement claim, no generic manufacturer utilizing the

skinny-label process will avoid litigation.

Consider the allegations here. One of Hikma’s alleged

sins in this case was referring to its generic drug as the

“generic equivalent” of the branded version. As Judge

Prost recognized in GSK, “[e]ssentially all” generics approved through the abbreviated Hatch-Waxman application process “are the ‘generic version’ or ‘generic

equivalent’ of a brand drug; the law requires them to be.”

GSK II, 7 F.4th at 1353 (Prost, J., dissenting). And as the

petition explains, referring to the type of drug at issue as

“generic” is a ubiquitous convention throughout the relevant statutes and regulations. See Pet. 27-29.

Nor is this case unusual due to the allegation that,

when describing the revenues associated with Amarin’s

branded drug, Hikma included the full revenue for both

patented and unpatented uses. Pet. App. 6a-7a, 18a. Naturally, in speaking to investors or the public about the potential marketability of a generic drug, the revenues

associated with both patented and unpatented uses are

relevant. That is because everyone knows that physicians

remain free to prescribe off-label as they see fit. It would

therefore not provide an accurate picture if generic manufacturers provided data relating only to prescriptions of

the unpatented use—indeed, in most cases, this data does

9

not even exist (or will not be available to the generic manufacturer). Forcing generic manufacturers to suppress

this information for fear of an induced-infringement suit

simply runs them headlong into other legal problems.

And even if the generic manufacturer avoids providing

this specific datum about total market for the branded

drug, there is no doubt the branded manufacturer will

latch on to whatever public statement is made about the

generic drug and allege that it induced physicians to infringe.

The Federal Circuit also faulted Hikma for calling its

drug the “generic version” without always noting its “AB

rating,” suggesting that physicians might read the lack of

an AB-rating notation as encouragement to prescribe the

drug for a carved-out indication. Pet. App. 19a-20a. Yet

the court of appeals said just the opposite in GSK, explaining that including “AB rated representations” was “affirmative evidence supporting” a finding of inducement.

GSK II, 7 F.4th at 1335. This, too, underscores how a generic manufacturer cannot win under the Federal Circuit’s precedent, no matter what it does or says (or omits).

The skinny-label process was meant to have the precisely opposite effect on the pharmaceutical industry: to

make it easier for generics to enter the marketplace, compete with branded drugs, and provide patients with

cheaper alternatives. See Caraco Pharm. Lab’ys, 566

U.S. at 405. It is directly contrary to Congress’s judgment

to subject a generic manufacturer to litigation based

solely on utilizing the section viii process Congress created and making the sorts of statements that necessarily

accompany the marketing of a new pharmaceutical product. If Amarin has stated a claim here, the branded

10

manufacturer in the next case will have no problem identifying a public statement that allegedly induced physicians to prescribe patented uses. Allowing Section 271(b)

to defeat the Hatch-Waxman Act in this way is not, and

cannot be, what Congress wanted.

B. By Opening Up the Litigation Floodgates, the

Decision Below Destroys the Economics of the

Skinny-Label Process and Vitiates Congress’s

Intent.

The Federal Circuit suggested that any concerns are

overblown because, with the benefit of discovery, the generic manufacturer may prevail. See Pet. App. 14a. This

is false comfort. These suits’ ability to withstand Rule

12(b)(6) motions will inflate the costs of bringing lowercost generic drugs to market. And because the branded

manufacturer will typically be able to find an expert to

agree with the allegations in the complaint, these cases

can generally be expected to survive summary judgment,

too. This will ultimately prevent those drugs from reaching the patients who need them—after all, “if playing by

the skinny-label rules doesn’t give generics some security

from label-based liability, generics simply won’t play.”

GSK III, 25 F.4th at 955 (Prost, J., dissenting from the

denial of the petition for rehearing en banc).

As this Court has recognized, even the potential to

come out victorious on summary judgment following a laborious discovery process is no true safeguard. See Bell

Atl. Corp. v. Twombly, 550 U.S. 544, 558-60 (2007). And

given the Federal Circuit’s low bar for what evidence can

support a jury’s finding of induced infringement, even a

summary-judgment victory for the generic manufacturer

in a meritless suit is far from guaranteed. And concerns

11

about litigation costs are already more serious in patentinfringement cases, in which discovery is particularly

complex and costly, and which are often brought in the

District of Delaware—where “judges rarely entertain”

summary-judgment motions to begin with.8

With the average cost of defending a patent-infringement lawsuit hovering around $3.5 million,9 even the expense of litigating through summary judgment will be a

costly albatross around generic manufacturers’ necks.

And these manufacturers already “sell their products for

considerably less than brands,” so these inflated litigation

costs may easily “dwarf whatever profits a generic could

make.” GSK III, 25 F.4th at 955 (Prost, J., dissenting

from the denial of the petition for rehearing en banc).

What is more, the Federal Circuit’s assurances about

summary-judgment resolution are difficult to swallow

given the court’s holding in GSK that a jury may properly

find induced infringement based on a section-viii-compliant skinny label mentioning only unpatented uses. See

GSK II, 7 F.4th at 1328-31. All this uncertainty and expense is exactly what section viii was meant to deter.

C. The Decision Below Will Also Undermine the

Paragraph IV Process.

The decision below will also have the effect of undermining another aspect of the Hatch-Waxman scheme that

8 Katherine Rhoades, Do Not Pass Go, Do Not Stop for Summary

Judgment: The U.S. District Court for the District of Delaware’s

Seemingly Disjunctive Yet Efficient Procedures in Hatch-Waxman

Litigation, 14 Nw. J. Tech. & Intell. Prop. 81, 95 (2016).

9 Gregory Day & Steven Udick, Patent Law and the Emigration of

Innovation, 94 Wash. L. Rev. 119, 125 (2019).

12

is supposed to ease the path of generic drugs to market.

Under that scheme, generic manufacturers can file “paragraph IV certification[s]” in which they seek approval for

patented methods of use and assert that these method-ofuse patents are invalid or not infringed. Caraco Pharm.

Lab’ys, 566 U.S. at 407-08; see 21 U.S.C.

§ 355(j)(2)(A)(vii)(IV).

It is common for a branded manufacturer to hold a

large number of patents on a drug. For instance, as of

July 2022, Amarin had 68 patents listed in FDA’s Orange

Book for the drug at issue in this case.10 Generic manufacturers commonly challenge some patents—such as formulation and compound patents—through a paragraph

IV certification, and utilize section viii statements for

method-of-use patents that can be carved out. Under the

decision below, however, the incentives for such paragraph IV challenges are distorted. If even one methodof-use patent remains as a basis for a damages claim after

launch, the risk of litigation will remain untenably high,

making it pointless to bring paragraph IV challenges in

the first place. These challenges will dwindle, and—precisely contrary to Congress’s intent—the scope of

branded manufacturers’ monopolies will expand.

The Federal Circuit’s decisions also distort the relationship between the section viii skinny-label process and

the paragraph IV certification process. When a generic

manufacturer files an abbreviated new drug application

(ANDA) using paragraph IV to claim invalidity or noninfringement of the branded manufacturer’s patents,

10 S. Sean Tu & Charles Duan, Pharmaceutical Patent Two-Step:

The Adverse Advent of Amarin v. Hikma Type Litigation, 12 N.Y.U.

J. Intell. Prop. & Ent. L. 1, 26 (2022).

13

Congress has deemed the application itself to be an act of

infringement that allows the patent dispute to be resolved

before launching the generic drug. See 35 U.S.C.

§ 271(e)(2); AstraZeneca Pharms. LP v. Apotex Corp.,

669 F.3d 1370, 1377 (Fed. Cir. 2012). But filing an ANDA

to bring a generic drug to market using a skinny label is

not an act of infringement; indeed, when generic manufacturers have tried to obtain patent certainty by seeking a

declaratory judgments prior to a skinny-label launch,

branded manufacturers have successfully defeated those

claims by arguing that there is no statutory basis for

them. See, e.g., Novartis Pharms. Corp. v. Alkem Lab’ys

Ltd. (In re Entresto (Sacubitril/Valsartan) Patent

Litig.), Nos. 20-cv-2930 etc., 2022 WL 4482717, at *5 (D.

Del. Sept. 27, 2022) (“An ANDA applicant that submits a

[s]ection viii statement does not create an ‘actual controversy’ because there is no cause of action.”).

Thus, the generic manufacturer has no reliable way to

obtain clarity prior to launch. Instead, it may have to

launch the generic drug while the branded manufacturer

lies in wait (running up the meter on potential damages all

the while) before the issue can be resolved. Again, this is

exactly contrary to Congress’s intent in the Hatch-Waxman Act: to make the skinny-label process “a way for generics to avoid inducement liability—and thus litigation

itself.” GSK III, 25 F.4th at 955 (Prost, J., dissenting

from the denial of the petition for rehearing en banc).

II.

THE DECISION BELOW VIOLATES BLACKLETTER PRINCIPLES OF INDUCEMENT LIABILITY.

The Federal Circuit’s decision also flies in the face of

this Court’s inducement precedents. This Court has long

14

held that liability for inducing infringement of intellectual

property attaches only when a defendant actively instructs or encourages others to infringe—not where, as

here, a defendant is alleged to have done no more than

provide information enabling infringement. Under these

principles, Amarin’s complaint should have been dismissed.

In setting out principles of inducement, this Court has

recognized that broad theories of liability “compromise legitimate commerce” and “discourage innovation having a

lawful promise.” Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd., 545 U.S. 913, 937 (2005). Accordingly, the

Court has made clear that inducement liability must be

premised on “purposeful, culpable expression and conduct.” Id. Inducement liability does not attach to “ordinary acts incident to product distribution, such as offering

customers technical support or product updates.” Id.

In the patent-infringement context, these principles

are directly implicated by the Patent Act’s requirement

that there is liability only for “actively induc[ing] infringement of a patent.” 35 U.S.C. § 271(b) (emphasis added).

As this Court has explained, the sorts of “active” steps

that create liability are “advertising an infringing use or

instructing how to engage in an infringing use.” Grokster,

545 U.S. at 936; see also Glob.-Tech Appliances, Inc. v.

SEB S.A., 563 U.S. 754, 768 n.8 (2011) (Section 271(b) imposes liability for “actively encourag[ing] others to violate

patent rights”).

The requirement that induced infringement must be

active should apply with even more force in the context of

generic drugs, given the Hatch-Waxman Act’s careful

scheme for enabling generics to reach the market.

15

Contrary to the Federal Circuit’s conclusion, this Court’s

inducement precedents require dismissal of Amarin’s

complaint here.

As the court of appeals observed, it is undisputed that

“Hikma’s label does not provide an implied or express instruction to prescribe the drug for the [patented] indication.” Pet. App. 16a. And the court further paid lip service

to the requirement that, to state a claim for a Section

271(b) violation, the complaint must allege that Hikma actively induced physicians to infringe by “encourag[ing],

recommend[ing], or promot[ing] infringement.” Id.

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

Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015)). But in

concluding that the label in conjunction with statements

in press releases sufficed to state a claim for inducement,

the court of appeals never even attempted to explained

how the “active” element of an inducement claim was satisfied. See id. at 16a-19a. Instead, the court concluded

that Amarin had stated a claim because its allegations

“depend on what Hikma’s label and public statements

would communicate to physicians and the marketplace.”

Id. at 18a.11

11 Even if the Federal Circuit were correct that Hikma’s label must

be “taken together” with Hikma’s public statements in analyzing

whether the complaint states a claim, Pet. App. 18a, it is difficult to

see how Hikma’s label supports liability. As the Solicitor General

noted when supporting certiorari in GSK, “carved-out labeling is

more naturally viewed as evidence of the generic manufacturer’s ‘inten[t] not to encourage infringement.’” U.S. GSK Br. 15 (alteration

in original) (quoting GSK II, 7 F.4th at 1350 (Prost, J., dissenting)).

Adding it to the mix of evidence should move the needle away from,

not toward, induced-infringement liability.

16

If this is right—if a defendant can be liable for inducing patent infringement based on how others interpret innocent behavior—there is nothing left of the requirement

that induced infringement be “active.” Whenever a third

party infringes a patent based on a defendant’s behavior,

the defendant will have taken some act. This Court (and,

until recently, the Federal Circuit) has always recognized

that culpable activity must go far beyond simply enabling

the infringement or providing information that makes infringement more likely.

The Federal Circuit suggested that Hikma could have

avoided liability by saying more—noting that a generic

manufacturer may avoid facing meritless suits through

“clarity and consistency in [its] communications regarding a drug marketed under a skinny label.” Pet. App. 22a.

This suggestion—that the onus was on Hikma to prevent

physicians from prescribing infringing uses—is another

major departure from inducement principles. Whether in

the patent or copyright context, inducement liability

never stems from the failure to take action to prevent infringement. See Grokster, 545 U.S. at 939 n.12 (no liability

“based on a failure to take affirmative steps to prevent infringement”); Takeda Pharms., 785 F.3d at 632 n.4 (plaintiff’s burden is to show defendant “took affirmative steps

to induce, not affirmative steps to make sure others avoid

infringement”); see also Pet. 20-21.

In fact, this distortion of inducement law is especially

problematic in the context of generic drug manufacturers,

as generic labels are statutorily required to bear the

“same . . . labeling approved” for the branded drug.

PLIVA, Inc. v. Mensing, 564 U.S. 604, 612-13 (2011)

17

(quoting 21 U.S.C. § 355(j)(2)(A)(v)).

“disclaimer” insert is legally possible.

Accordingly, no

Respondents’ allegations cannot possibly state a claim

for induced infringement under this Court’s precedents.

Put simply, Hikma cannot have “actively” induced infringement because it is not alleged to have even mentioned the existence of infringing uses. The entirety of the

allegations against Hikma are that its skinny label did not

disclaim patented uses (which would be prohibited); that

it accurately stated that its generic drug was a therapeutic

equivalent to Amarin’s branded version (which Hikma

was required to establish to gain FDA approval); and that

Hikma accurately noted sales data of Amarin’s drug without specifically differentiating between various uses

(which is the sort of “ordinary act[] incident to product

distribution,” Grokster, 545 U.S. at 937, always considered

permissible). Nowhere in that list is anything even approaching the sort of active encouragement, recommendation, or instruction that is supposed to be the

prerequisite for liability under 35 U.S.C. § 271(b).

III. THE DECISION BELOW POSES A GRAVE

THREAT TO GENERIC PHARMACEUTICALS,

AND THUS TO AMERICAN PATIENTS.

By exploding the litigation risks and costs associated

with bringing generic drugs to market, the Federal Circuit’s recent decisions are not just crushing for generic

manufacturers. They will also be devastating to the patients who rely on affordable, high-quality generic medications.

The Hatch-Waxman scheme has been incredibly successful in increasing the availability of generics and bringing down drug prices for American patients. By 1996,

18

generics already accounted for roughly 42.5% of all prescriptions dispensed—a huge victory for patients, as generics were roughly three times less expensive than their

branded counterparts.12

Today, generics make up

roughly 90% of all prescriptions dispensed,13 while the

median price of generics is a fraction of the price of

branded drugs.14 And across the United States, the robust market for generics has led to enormous financial

and health benefits.15

Skinny labels have proven particularly important for

generic competitors of blockbuster drugs, for which patent owners frequently seek to extend their monopolies by

obtaining seriatim method-of-use patents. Generic versions of no-longer-patented drugs with patented uses

launch with a skinny label nearly 50% of the time,16 saving

12 The Kaiser Fam. Found., Prescription Drug Trends: A Chartbook

Update 27, 36 (Nov. 2001), https://files.kff.org/attachment/reportprescription-drug-trends-a-chartbook-update.

13 Office of Generic Drugs 2021 Annual Report, U.S. Food & Drug

Admin.,

https://www.fda.gov/drugs/generic-drugs/office-genericdrugs-2021-annual-report (last updated Feb. 14, 2022).

14 See Generic Competition and Drug Prices, U.S. Food & Drug

Admin., https://www.fda.gov/about-fda/center-drug-evaluation-andresearch-cder/generic-competition-and-drug-prices (last updated

Oct. 17, 2024).

15 See AAM 2024 Savings Report, supra note 2, at 7 (estimating $445

billion in savings in 2023 alone); Becky A. Briesacher et al., Medication Adherence and the Use of Generic Drug Therapies, 15 Am. J.

Managed Care 450 (2009); Niteesh K. Choudhry et al., Improving Adherence to Therapy and Clinical Outcomes While Containing Costs:

Opportunities from the Greater Use of Generic Medications, Annals

Internal Med. (Nov. 24, 2015), https://doi.org/10.7326/M14-2427.

16 Walsh, supra note 4, at 997.

19

patients (and the federal government) billions. For example, Crestor, a branded drug used to treat high cholesterol, cost patients and payors $6.2 billion annually before

the entry of generics.17 AstraZeneca’s patent on the compound expired in 2016, but AstraZeneca had other

method-of-use patents that would not expire until 2022.18

Because the generics were able to omit those patented

uses and obtain FDA approval of a skinny label, they were

able to enter the market in 2016 rather than waiting until

2022.19 Patients benefitted immediately from the introduction of generics—the savings were in excess of $8.4 billion in 2019 alone for just that one drug.20

In this and other cases, the use of skinny labels saved

patients money and improved their access to life-saving

medications. FDA has estimated that “[g]eneric drugs

approved between 2018 and 2020 . . . have saved consumers more than $50 billion in the first 12 months of generic

sales,” and the approval of the first generic version of a

brand-name drug, often with a carved-out condition of

17 Tracy Staton, Top 10 Drug Patent Losses of 2014, Fierce Pharma

(Oct. 28, 2013, 9:55 AM), https://www.fiercepharma.com/special-report/top-10-drug-patent-losses-of-2014.

18 Letter from Janet Woodcock, Dir., Ctr. for Drug Evaluation &

Rsch., FDA, to Joseph A. Cash, Jr., AztraZeneca Pharms. 19 & n.59

(July 19, 2016), https://downloads.regulations.gov/FDA-2016-P-14850007/attachment_1.pdf.

19 Id. at 1.

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

Access & Savings in the U.S. Report 21 (2020),

https://accessiblemeds.org/wp-content/uploads/2024/12/AAM-2020Generics-Biosimilars-Access-Savings-Report-US-Web.pdf.

20

use, has reduced prices by more than 75%.21 But without

a clear skinny-label pathway, generic manufacturers will

be disinclined to use section viii, allowing brands to “maintain de facto indefinite exclusivity over a pharmaceutical

compound by obtaining serial patents for approved methods of us[e].” AstraZeneca, 669 F.3d at 1380. Not only

will patients be forced to pay higher brand prices for even

longer, they may be deprived of access to life-saving alternatives altogether if a generic is never developed.

And it is not only patients that lose. The federal government’s health-care expenditures are massive. In fiscal

year 2024, the government spent nearly $2 trillion on

health care—the largest category of federal spending and

over a quarter of the federal budget.22 Over $150 billion

of this sum is spent on prescription drugs.23 The unavailability of generic drugs will further inflate these figures,

ultimately passing on a significant amount of the damage

to the American taxpayers.

21 U.S. GSK Br. 20 (citing Ryan Conrad et al., Ctr. for Drug Evalua-

tion & Rsch., U.S. FDA, Estimating Cost Savings from New Generic

Drug Approvals in 2018, 2019, and 2020, at 3-4 (Aug. 2022),

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

22 Juliette Cubanski et al., What Does the Federal Government

Spend

on

Health

Care?,

KFF

(Feb.

24,

2025),

https://www.kff.org/medicaid/issue-brief/what-does-the-federal-government-spend-on-health-care.

23 See Drug Spending, U.S. Dep’t of Health & Hum. Servs. Off. of

Inspector Gen. (updated Dec. 16, 2024), https://oig.hhs.gov/reports/featured/drug-spending.

21

CONCLUSION

For the foregoing reasons and those stated in the petition for a writ of certiorari, the petition should be granted.

Respectfully submitted.

KARIN HESSLER

ASSOCIATION FOR

ACCESSIBLE MEDICINES

601 New Jersey Avenue,

NW, Suite 850

Washington, DC 20001

(202) 249-7100

MARCH 2025

MATTHEW S. HELLMAN

Counsel of Record

JONATHAN J. MARSHALL

JENNER & BLOCK LLP

1099 New York Avenue,

NW, Suite 900

Washington, DC 20001

(202) 639-6000

mhellman@jenner.com