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 A ppeals for the Federal Circuit

BRIEF OF THE ACADEMIC MEDICAL

CENTERS AS AMICI CURIAE

IN SUPPORT OF RESPONDENTS

Steven P. Caltrider

Kyle Wasden Grimshaw

Dana-Farber Cancer

Institute, Inc.

450 Brookline Avenue, D1618

Boston, MA 02215

William R. Boudreaux

Barnes & Thornburg LLP

24 Frank Lloyd Wright Dr.,

Suite A-3300

Ann Arbor, MI 48105

Ronald E. Cahill

Counsel of Record

Barnes & Thornburg LLP

One Marina Park Drive

Boston, MA 02210

(617) 516-5312

rcahill@btlaw.com

Hilary J. Libka

Memorial Sloan-Kettering

Cancer Center, Memorial

Hospital for Cancer and

Allied Diseases, and SloanKettering Institute for

Cancer Research

1275 York Avenue

New York, NY 10065

Attorneys for Amici Curiae

391721

A

(800) 274-3321 • (800) 359-6859

i

TABLE OF CONTENTS

TABLE OF CONTENTS .............................................. i

TABLE OF CITED AUTHORITIES ......................... iii

IDENTIFICATION AND INTEREST OF THE

ACADEMIC MEDICAL CENTERS ........................... 1

SUMMARY OF THE ARGUMENT ........................... 3

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

I. The Hatch-Waxman Amendments Struck a

Delicate Balance of Supporting Critical Research to

Discover and Develop Drugs, Including New Uses of

Old Drugs, While Providing Generic Companies a

Path to Compete for Unpatented Uses. ..................... 4

II. The Drug Market is a Complex Payer, Rather

Than Consumer or Physician, Driven Market, Which

Impacts the Type of Evidence That Shows Induced

Infringement ............................................................... 9

A. How Prescriptions Are Filled When Generic

Drugs Are Available .............................................. 10

B. In the Generic Drug Market Subtle Acts Can

Induce Infringement, and More Overt Acts, if Any,

Are Embedded in Private Contracts Between the

Generic Drug Company and PBM/Insurance

Companies ............................................................. 12

III.

Active Inducement is Context Dependent, and

in the Complex, Payer Driven Pharmaceutical

ii

Market, Minimal Acts are Sufficient to Induce

Infringement ............................................................. 14

A. Intent is a Critical Aspect of the Legal

Requirements for Active Inducement ................... 14

B. The Evidence of Intent for Proving Active

Inducement is Context Dependent and Relies Upon

the Relevant Market ............................................. 15

C. In Grokster, this Court Highlighted the

Importance of Understanding the Relevant Market

and Defendant’s Profit Motives to the Active

Inducement Analysis............................................. 17

D. Law and Policy in the Case Counsel Affirming

and Remanding to Allow the Development of a

Fulsome Factual Record, Tied Specifically to the

Market, to Determine Whether Active Inducement

Occurred as Alleged .............................................. 19

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

iii

TABLE OF CITED AUTHORITIES

Page(s)

Cases

Amarin Pharma, Inc. v. Hikma Pharms.

USA Inc.,

104 F.4th 1370 (Fed. Cir. 2024) .................... 12, 13

AstraZeneca LP v. Apotex, Inc.,

633 F.3d 1042 (Fed. Cir. 2010) ............................ 16

Barry v. Medtronic, Inc.,

914 F.3d 1310 (Fed. Cir. 2019) ............................ 15

Caraco Pharma. Labs., Ltd. V. Novo

Nordisk A/S,

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

Eli Lilly & Co. v. Medtronic, Inc.,

496 U.S. 661 (1990) ............................................... 4

Eli Lilly & Co. v. Teva Parenteral

Medicines, Inc.,

845 F.3d 1357 (Fed. Cir. 2017) ............................ 14

F.T.C. v. Actavis, Inc.,

570 U.S. 136 (2013) ............................................... 4

GlaxoSmithKline LLC v. Teva

Pharmaceuticals USA, Inc.,

7 F.4th 1320 (2021).............................................. 16

Global-Tech Appliances, Inc. v. SEB

S.A.,

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

iv

Metro-Goldwyn-Mayer Studios Inc. v.

Grokster, Ltd.,

545 U.S. 913 (2005) ................................. 17, 18, 19

Vanda Pharm. Inc. v. W.-Ward Pharm.

Int'l Ltd.,

887 F.3d 1117 (Fed. Cir. 2018) ............................ 15

Warsaw Orthopedic, Inc. v. NuVasive,

Inc.,

824 F.3d 1344 (Fed. Cir. 2016) ............................ 15

Statutes

21 U.S.C. 355(j)(2)(A)(viii) ........................ 3, 7, 8, 9, 12

35 U.S.C. § 271(b) ..................................................... 14

21 C.F.R. pt. 314 ....................................................... 16

Other Authorities

Applications for FDA Approval to

Market a New Drug, 68 Fed. Reg.

36,676 (2003) ....................................................... 16

Garth Boehm et al., Development of the

generic drug industry in the US after

the Hatch-Waxman Act of 1984, 3

Acta Pharmaceutica Sinica B 297

(2013) ................................................................... 11

K. Budde et al., FTY720 (Fingolimod) in

Renal Transplantation, 20 Clin.

Transplantation 15 (2006) .................................... 7

v

Eric Budish et al., Missing Markets for

Innovation: Evidence from New Uses

of Existing Drugs (Nat’l Bureau of

Econ. Rsch., Working Paper No.

34222, 2025) ........................................................... 9

Wojciech Danysz et al., Parkinson’s

Disease Therapy: What Lies Ahead?,

128 J. Neural Transmission 127

(2021) ................................................................... 11

The Role of Pharmacy Benefits

Managers in Prescription Drug

Markets Part III: Transparency and

Accountability: Hearing Before the

H. Comm. on Oversight &

Accountability, 118th Cong., Serial

No. 118-123 (2024) ............................................... 10

Sreeji Pushpakom et al., Drug

Repurposing: Progress, Challenges

and Recommendations, 18 Nat. Rev.

Drug Discov. 41 (2019) .......................................... 5

Benjamin N. Roin, Solving the Problem

of New Uses (Oct. 1, 2013)

(unpublished manuscript),

https://ssrn.com/abstract=2337821 ....................... 6

Yan Song & Douglas Barthold, The

Effects of State-Level Pharmacist

Regulations on Generic Substitution

of Prescription Drugs, 27 Health

Econ. 1717 (2018) .......................................... 10, 11

1

IDENTIFICATION AND

INTEREST OF THE

ACADEMIC MEDICAL

CENTERS1

Pursuant to Supreme Court Rule 37, the

Academic Medical Centers respectfully submit this

brief amici curiae in support of Respondent. The

Academic Medical Centers include The Dana-Farber

Cancer Institute, Memorial Sloan-Kettering Cancer

Center, Memorial Hospital for Cancer and Allied

Diseases, Sloan-Kettering Institute for Cancer

Research, and The Johns Hopkins University on

behalf of the Johns Hopkins University School of

Medicine.

The Dana–Farber Cancer Institute blends

leading science and exceptional care into

transformative medicine. Founded in Boston in 1947,

Dana-Farber is a teaching affiliate of Harvard

Medical School and federally designated a

Comprehensive Cancer Center that develops and

disseminates innovative patient therapies and

scientific discoveries throughout the world.

Memorial Sloan-Kettering Cancer Center,

Memorial Hospital for Cancer and Allied Diseases,

and Sloan-Kettering Institute for Cancer Research

(collectively, “MSK”) are not-for-profit corporations

united by a singular mission: ending cancer for life.

Founded in New York City in 1884, MSK is committed

1 This brief conforms to the Court’s Rule 37, in that no counsel

for a party authored this brief in whole or in part, and no person

or entity other than Amici Curiae funded its preparation or

submission.

2

to delivering exceptional patient care, conducting

leading-edge research, and providing superb

educational programs. A National Cancer Institutedesignated Comprehensive Cancer Center, MSK has

been recognized as one of the top two cancer hospitals

in the country by U.S. News & World Report for more

than 30 years.

The Johns Hopkins University School of

Medicine, established in 1893 in Baltimore, is a

globally renowned institution and premier biomedical

research center, recognized for pioneering modern

medical education, consistently ranking among the

top medical schools in the United States, and

operating in close affiliation with the top-ranked

Johns Hopkins Hospital founded in 1889. Considered

to be the founding institution of modern American

medicine, The Johns Hopkins University School of

Medicine was the birthplace of numerous famed

medical traditions, including rounds, residents, and

house staff.

These Academic Medical Centers represent

world-leading research institutions in the fight

against cancer and other life-threatening diseases. We

represent both the clinical interests of our patients as

well as the basic research that leads to tomorrow's

cures. As such, we are sensitive to the need for

unpatented generic drugs to be readily available and

affordable to patients. We also have unique and

profound insight into discoveries of new uses of old

drugs made in our laboratories and clinics that fail to

reach patients broadly due to the failure to protect the

exclusivity of the patented uses. We understand that

robust protection of the patented uses is necessary to

3

enable the investment necessary for these uses to

secure FDA approval and reach patients and see a

current system that too often fails patients waiting for

cures.

Amici submit this brief in hope that the Court

rectifies the delicate balance that Congress intended

to protect – and therefore to provide a viable path to

clinical and commercial development – patented new

uses of old drugs while enabling unfettered access to

unpatented indications. Doing so in the unique

marketplace of prescription generic products will

enable the promising discoveries in our laboratories to

save the lives of patients.

SUMMARY OF THE ARGUMENT

The Hatch-Waxman Amendments to the

Federal Food, Drug, and Cosmetic Act sought to strike

a delicate balance of supporting critical research and

innovation to discover and develop drugs, including

new uses of drugs, while providing generic companies

a clear path to compete for unpatented treatments.

Due to judicial interpretation, measures by federal

regulators and states, and the influence of pharmacy

benefit managers, this balance has been lost over

time, so much so that there is no longer a viable path

for investment in new uses of old drugs. That is a

travesty to patients waiting for tomorrow’s cures.

Reversing the Federal Circuit and dismissing

the complaint at this early stage of the proceedings

would undermine any remaining semblance of

balance in the statutory scheme. It would recast 21

U.S.C. 355(j)(2)(A)(viii) (the statutory section that

allows a generic manufacturer to “carve out” patented

4

indications), not as an integral component of the

compromise between innovator and generic interests,

but as a free pass from even an allegation of

infringement. In allowing “skinny labels,” Congress

did not intend to hand broad power to the FDA to

decide questions of patent infringement, nor did

Congress intend to insulate a generic manufacturer

from infringing acts relating to the patented

indication.

The delicate balance of the Hatch Waxman Act

should be restored. There need to be clear paths to

support the investment necessary to develop

innovative, patented new treatment options for

patients and for generic companies to enter the

market for unpatented indications. The first step to

restore this balance is for this Court to affirm the

Federal Circuit that sufficient facts have been pled for

the case to continue.

ARGUMENT

I.

The Hatch-Waxman Amendments Struck a

Delicate Balance of Supporting Critical

Research to Discover and Develop Drugs,

Including New Uses of Old Drugs, While

Providing Generic Companies a Path to

Compete for Unpatented Uses.

As this Court has recognized in its precedents

such as Actavis, Caraco and Eli Lilly,2 the HatchWaxman Act struck a delicate balance between

2 F.T.C. v. Actavis, Inc., 570 U.S. 136 (2013); Caraco Pharma.

Labs., Ltd. V. Novo Nordisk A/S, 566 U.S. 399 (2012); Eli Lilly

& Co. v. Medtronic, Inc., 496 U.S. 661 (1990).

5

providing financial incentives sufficient to allow

companies to expend the time and money needed to

research and develop new drugs and treatments,

while at the same time, providing a pathway for

generic companies to provide nonpatented medicines

at a low cost. “Old drugs”, i.e. drugs for which there is

no remaining patent protection, constitute an

important class under the Hatch-Waxman legal

framework. Such old drugs may be used to treat a new

disease or a new sub-population of patients, or they

may be used in a different way for an existing

indication. Congress clearly intended that such old

drugs be researched for new methods and indications,

specifically allowing for patents and data package

exclusivity to be granted for new methods of using

these old drugs to treat patients.

Congress sought to foster these new methods of

using old drugs for good reason—they are a potential

goldmine of new treatment options for patients.3

3 Sreeji Pushpakom et al., Drug Repurposing: Progress,

Challenges and Recommendations, 18 Nat. Rev. Drug Discov.

41 (2019) (“First, and perhaps most importantly, the risk of

failure is lower; because the repurposed drug has already been

found to be sufficiently safe in preclinical models and humans if

early-stage trials have been completed, it is less likely to fail at

least from a safety point of view in subsequent efficacy trials.

Second, the time frame for drug development can be reduced,

because most of the preclinical testing, safety assessment and,

in some cases, formulation development will already have been

completed. Third, less investment is s needed, although this

will vary greatly depending on the stage and process of

development of the repurposing candidate. The regulatory and

phase III costs may remain more or less the same for a

repurposed drug as for a new drug in the same indication, but

there could still be substantial savings in preclinical and phase

I and II costs. Together, these advantages have the potential to

6

Researchers now suspect that our current arsenal of

drugs could provide effective medical treatments for

most of the major diseases, including cancer and

Alzheimer’s disease, and effective treatments for most

or all 8000 rare diseases, which together afflict 15 to

20 percent of the global population.4

A classic example of this is the molecule

amantadine, which was developed in the 1960s for

anti-influenza, but in the 1970s became a significant

treatment for Parkinson’s disease.5 The amantadine

story highlights exactly why amici submit this brief.

This medicine was repurposed from its initial use and

later became an important treatment for Parkinson’s

disease. However, the potential to develop known

compounds for new uses today is severely limited

because drug companies will not invest in the clinical

trials needed to bring this new, second use to the

result in a less risky and more rapid return on investment in

the development of repurposed drugs, with lower average

associated costs once failures have been accounted for (indeed,

the costs of bringing a repurposed drug to market have been

estimated to be US$300 million on average, compared with an

estimated ~$2–3 billion for a new chemical entity ). Finally,

repurposed drugs may reveal new targets and pathways that

can be further exploited.”) (footnotes removed).

4 E.g., Benjamin N. Roin, Solving the Problem of New Uses at 46

(Oct. 1, 2013) (unpublished manuscript),

https://ssrn.com/abstract=2337821 (“Many researchers now

suspect that our current arsenal of drugs could provide effective

medical treatments for most of the major remaining diseases,

including cancer and Alzheimer’s disease. There is also hope

that repurposing old drugs for new indications will allow

researchers to identify effective treatments for most or all of the

8000 rare diseases, which together afflict 15 to 20 percent of the

global population.”).

5 Wojciech Danysz et al., Parkinson’s Disease Therapy: What

Lies Ahead?, 128 J. Neural Transmission 127 (2021).

7

marketplace because they worry that section viii

carve-outs—if taken too far—will prevent them from

recouping their investment. Thus, there needs to be a

proper balance to section viii that will allow

companies who invest in research of new uses of old

compounds to protect their interests and be rewarded

financially for their research and development.

Otherwise, these promising treatments simply fail to

reach patients.6

Often, these old compounds are available to

researchers and thus can be studied at reasonable

costs, especially at academic research centers like the

present amici. Congress and patients—like the

multiple sclerosis and Parkinson’s patients who take

these old drugs—want and need these old molecules

to be studied, researched and developed for new

indications.

At the same time, Congress also wants generic

versions of old drugs on the market—which is why it

allowed for the section viii carve-out. Thus, if a drug

is off-patent for one indication, but there is a new

method of use for a second, later treatment (as is the

case here), the congressional intent in passing section

viii was to allow the generic to sell the drug for the

unpatented method and “not foreclose marketing a

6 See, also, K. Budde et al., FTY720 (Fingolimod) in Renal

Transplantation, 20 Clin. Transplantation 15 (2006).

(providing the further example of the therapeutic fingolimod,

which was initially researched and failed clinical trials for

patients receiving a kidney transplant, but later was studied,

approved and became a game-changing treatment for multiple

sclerosis).

8

generic drug for other unpatented ones.” Caraco, 566

U.S. at 415.

Yet, the section viii carve-out can be taken too

far. Permission to sell the generic drug for the

unpatented use is not carte blanche for the generic

drug marketer to sell for all uses where one or more of

those further uses is patented. The reason for that is

obvious—if the generic company essentially receives a

free pass to produce and sell the drug without

consequence for all uses, that would effectively

obviate the later patent. That would destroy all

incentives to research new uses of an old drug. There

would be no way for a party to recoup their investment

and drug companies would simply stop researching

new uses of old drugs as the end of patent exclusivity

approaches. Under these circumstances, the discovery

of new uses by academic researchers will fail to spur

the

investment

necessary

for

commercial

development. The position advocated by Hikma and

the supporting amici would be the nail in the coffin for

new uses.

Amici submit this fear is not ethereal. Rather,

it is one that amici deal with every day. Amici, which

often conduct research of new uses of old drugs due to

their known properties and availability of the drug,

cannot get industry to license and partner with them

to develop these new uses because industry cannot get

a return on their investment. For example, the

therapeutic metformin, which was approved for

treatment of diabetes in 1995 and for which generics

entered the market in 2002, has been viewed for many

years as a promising compound for cancer treatment,

but (as of 2025) no one is willing to fund a clinical trial

9

because the market participants understand that the

section viii carve-out provisions will prevent them

from being able to recoup their investment. Eric

Budish et al., Missing Markets for Innovation:

Evidence from New Uses of Existing Drugs (Nat’l

Bureau of Econ. Rsch., Working Paper No. 34222,

2025) at 2-3; See, also, Roin, supra n. 4, at 42 (noting

that a known cancer-treating molecule bexarotene has

been shown to be “remarkably effective against

Alzheimer’s in several important preclinical models”,

yet because the patent life on this molecule is limited,

“finding industry sponsors for these trials will be

difficult, if not impossible.”); Budish at 4 (finding that

market dynamics for new uses, i.e. first 10 years see

7% of drugs re-approved for a new indication, then

declines dramatically after that and is roughly zero at

loss of patent exclusivity).

This result does not help patients and needs to

be rectified. One step to doing this is to ensure that

section viii carve-outs do not “swallow the whole” and

destroy the incentives to fund research on old, known

drugs.

II.

The Drug Market is a Complex Payer,

Rather Than Consumer or Physician,

Driven Market, Which Impacts the Type

of Evidence That Shows Induced

Infringement

The substitution of generic drugs in place of

brand name drugs is a unique market driven strongly

by the structure of the healthcare industry. The

unique market structure and incentives also impact

the types of activities that might constitute active

inducement of infringement.

10

A.

How Prescriptions Are Filled When

Generic Drugs Are Available

A healthcare provider examines a patient,

selects the drug best suited for treatment, and writes

a prescription for a drug. The prescription identifies

the drug, either by brand name or non-proprietary

name and dosage. The prescription is provided to the

pharmacy, nowadays often electronically. Unless the

prescriber indicates “dispense as written,” state

generic-substitution rules generally permit the

pharmacy to dispense FDA therapeutically equivalent

generic drug in place of the brand name drug.7 How

the prescription is filled, however, is most often

dictated by the pharmacy benefit managers (PBM).8

The three largest PBMs control more than 80% of

prescriptions in the United States.9 The PBM

effectively determines whether the prescription is

filled with the generic drug, and which generic drug if

generic drugs from multiple manufactures are

available. Notably, PBM and pharmacies profit more

from dispensing generic drugs versus brand-name

7 In some states, generic substitution rules are mandated. See,

Yan Song & Douglas Barthold, The Effects of State-Level

Pharmacist Regulations on Generic Substitution of Prescription

Drugs, 27 Health Econ. 1717 (2018).

8 The Role of Pharmacy Benefits Managers in Prescription Drug

Markets Part III: Transparency and Accountability: Hearing

Before the H. Comm. on Oversight & Accountability, 118th

Cong., Serial No. 118-123 (2024) (“House Report”).

9 Id. at 53. (“The PBM market has become highly consolidated

with the three largest PBMs controlling roughly 80 percent of

prescriptions. The top six PBMs account for 97 percent and in

Medicare Part D, four PBMs managed benefits for a combined

90 percent of beneficiaries.”)

11

drugs.10 Therefore, the choice about which generic

drug is available through the PBM or pharmacy is not

made by the patient or the doctor and it is not

influenced by consumer marketing. The choice of

which generic drug is dispensed is determined by the

economics negotiated between the generic drug

manufacturer and PBM and/or pharmacy.11

The consequence of this economic system is

that generic drug manufacturers are pushing through

an open door to have the prescription filled by a

generic drug. The FDA enables generic drug

substitution by assigning a therapeutic equivalence

rating. State law encourages or mandates filling the

prescription with the generic drug for on-label

indications, and the PBM and pharmacies are more

profitable dispensing the generic drug. The generic

drug company needs to do nothing to effectuate the

sale—other than privately contract with PBM and/or

pharmacy to be included on the drug formulary.12

The complaint alleges that Hikma deleted from

its final labeling that the generic drug was not

approved for the use that remains under patent

10 Song, supra n.7 (“Indeed, gross profit dollars are

approximately 50 percent higher for generic drugs than for

brand name drugs … pharmacists have a strong incentive to

substitute generic for brand name drugs … .”)

11 The three largest PBMs are vertically integrated. That is, the

pharmacy is owned or managed by the PBM. House Report,

supra n. 8, at 31.

12 Garth Boehm et al., Development of the generic drug industry

in the US after the Hatch-Waxman Act of 1984, 3 Acta

Pharmaceutica Sinica B 297, 308 (2013) (“Generic

profitability to the pharmacy ensures that new generic products

are ‘pulled’ into the distribution chain and that generic

substitution rate is rapid.”).

12

protection.13 Therefore, while the change in labeling

may appear facially immaterial to the issue of active

inducement of the patented indication, this change is

consequential to generic substitution as there is no

express limitation on the label that indicates that it is

unapproved for the patented indication that could

limit the substitution of the generic drug for the

patented use.

B.

In the Generic Drug Market Subtle

Acts Can Induce Infringement, and

More Overt Acts, if Any, Are

Embedded in Private Contracts

Between the Generic Drug

Company and PBM/Insurance

Companies

The real-world dynamics of the generic drug

market are clear—there is no consumer advertising or

promotion of the drug to physicians or patients. There

is no role of the consumer or physician in the selection

of which generic drug will be dispensed by the

pharmacy for administration to the patient.14 The

typical acts of inducement for a consumer product,

such as advertising or instructions to consumers, are

not relevant in this market. All that is needed is an

agreement with the PBM and/or pharmacy with

13 Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th

1370, 1373 (Fed. Cir. 2024) (“Although Hikma's original

proposed label included the CV Limitation of Use, Hikma later

amended the label to remove that limitation around the same

time it submitted its section viii statement carving out the uses

covered by the asserted patents.”)

14 Absent a “dispense as written” for the brand designation.

13

financial terms that place the generic drug in a

preferred placement on the formulary.

The negotiation of the generic-PBM/pharmacy

agreement(s) would only be available through

discovery. Whether or not representations were made

relating to patented use in this case are not part of the

record. But, what has been alleged—label changes to

delete reference to the drug not being approved for the

patented indication, various unqualified statements of

being generic version, reference to whole market

(patented and unpatented sales data), the “small

lettering” on the website vaguely describing that the

generic version was not approved for all approved

uses—in the context of this market should be enough

to plausibly state a claim.15

Finding otherwise and accepting Hikma’s

position that the complaint be dismissed before

discovery based on the labeling effectively gives a free

pass to the generic drug industry to exploit the

patented indication. This eliminates any remaining

semblance of the balance Congress sought between

supporting innovative new treatments by the brand

manufacturers and ensuring the accessibility of

generic drugs on unpatented treatments when the

Hatch Waxman Amendments were promulgated.

15 Amarin, 104 F.4th at 1373-75. Amici take no position

whether on a more fulsome record the evidence is sufficient to

establish Hikma actively induced infringement.

14

III.

Active Inducement is Context Dependent,

and in the Complex, Payer Driven

Pharmaceutical Market, Minimal Acts

are Sufficient to Induce Infringement

This Court’s and the Federal Circuit’s decisions

make clear that evidence of all of the accused inducer’s

actions, as well as its intent, are important to the

inducement analysis. While the courts below were

correct to consider evidence beyond the label in

determining whether inducement had been

sufficiently pleaded, none considered the unique

circumstances of the market into which the products

were being delivered. Set in the proper economic

context, it is even more important that the Federal

Circuit decision not be reversed.

A.

Intent is a Critical Aspect of the

Legal Requirements for Active

Inducement

“Whoever actively induces infringement of a

patent shall be liable as an infringer.” 35 U.S.C. §

271(b). “The addition of the adverb “actively” suggests

that the inducement must involve the taking of

affirmative steps to bring about the desired result.”

Global-Tech Appliances, Inc. v. SEB S.A., 563 U.S.

754, 760 (2011)

“The patentee must also show that the alleged

infringer possessed the requisite intent to induce

infringement, which we have held requires that the

alleged infringer knew or should have known his

actions would induce actual infringements.” Eli Lilly

& Co. v. Teva Parenteral Medicines, Inc., 845 F.3d

1357, 1364 (Fed. Cir. 2017) (internal quotation marks

15

omitted). “Circumstantial evidence can support a

finding of specific intent to induce infringement.”

Vanda Pharm. Inc. v. W.-Ward Pharm. Int'l Ltd., 887

F.3d 1117, 1129 (Fed. Cir. 2018); Warsaw Orthopedic,

Inc. v. NuVasive, Inc., 824 F.3d 1344, 1347 (Fed. Cir.

2016).

B.

The Evidence of Intent for Proving

Active Inducement is Context

Dependent and Relies Upon the

Relevant Market

The case law shows that the circumstantial

evidence used to support a finding of specific intent in

support of active inducement varies with the context

of the alleged infringement.

In Barry v. Medronic, the patent claims recited

a method that involved rotating vertebrae to

ameliorate an aberrant spinal column deviation

during surgery. Barry v. Medtronic, Inc., 914 F.3d

1310, 1317-18 (Fed. Cir. 2019). There, evidence

supporting a finding of liability for induced

infringement included a survey of spine surgeons,

training materials for surgeons, instructions for using

surgical tools, and the education of surgeons by

salespeople. Id. at 1336. This evidence was tied to the

context—the market for medical devices and their

sales and marketing in the U.S.

In the consumer product market, this Court

found evidence showing the copying of a cool-touch

fryer along with the arranging of U.S. product

distribution and a willful avoidance of an

understanding of the patents covering the copied

product to be appropriate to the active inducement

16

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

563 U.S. 754, 758-59 (2011).

Like this case, GlaxoSmithKline v. Teva

involved a “skinny label.” GlaxoSmithKline LLC v.

Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 132728 (2021). Because, as in the present case, the accused

product was on the market, the evidence for active

inducement went beyond the label and included

marketing efforts, catalogs, press releases, and

testimony from the defendant’s witnesses. Id. at 133537, 1338-40. In addition, the plaintiff presented

evidence that the label did not successfully carve out

the patented use. Id. at 1338.

Importantly, the Federal Circuit recognized

with respect to the labeling that, “the FDA is not the

arbiter of patent infringement issues.” AstraZeneca

LP v. Apotex, Inc., 633 F.3d 1042, 1061 (Fed. Cir.

2010). In fact, the FDA has made clear that use codes

in the Orange Book “are not meant to substitute for

the [ANDA] applicant's review of the patent and the

approved labeling.” Applications for FDA Approval to

Market a New Drug, 68 Fed. Reg. 36,676, 36,683

(June 18, 2003) (codified at 21 C.F.R. pt. 314). The

FDA further concluded that it has no expertise in

patent law and that a court is the appropriate forum

for determining the scope of patent rights. Id. That is,

simply because the FDA allows the use of skinny

labels, that does not mean that the FDA weighs in on

whether use according to skinny labels infringes a use

patent.

In each case, the evidence depends upon

context—in particular, the manner in which sales are

made and to whom the product is being sold.

17

C.

In Grokster, this Court Highlighted

the Importance of Understanding

the Relevant Market and

Defendant’s Profit Motives to the

Active Inducement Analysis

In analyzing the inducement of copyright

infringement, this Court looked to the inducement of

patent infringement as a model. Metro-GoldwynMayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913,

936-37 (2005). Looking to patent law, the Court

summarized the relevant evidence for inducing patent

infringement this way:

Evidence of “active steps ... taken to encourage

direct infringement,” Oak Industries, Inc. v.

Zenith Electronics Corp., 697 F.Supp. 988, 992

(N.D.Ill. 1988), such as advertising an

infringing use or instructing how to engage in

an infringing use, show an affirmative intent

that the product be used to infringe, and a

showing that infringement was encouraged

overcomes the law's reluctance to find liability

when a defendant merely sells a commercial

product suitable for some lawful use.

Id. at 936. The Court went on to compare evidence of

intent for inducing patent infringement to evidence of

intent applied to tort liability. Id. (citing, W. Keeton,

D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton

on Law of Torts 37 (5th ed. 1984), “There is a definite

tendency to impose greater responsibility upon a

defendant whose conduct was intended to do harm, or

was morally wrong.”).

18

In Grokster, the Court found “particularly

notable” three aspects of the evidence of defendants’

intent, all of which are relevant here. Id. at 939-40.

First, the defendants were “aiming to satisfy a known

source of demand for copyright infringement, the

market comprising former Napster users.” Id.

Similarly in this case, defendant is distributing its

generic drug to PBMs that are already supplying the

brand name drug to physicians for the patented use.

Second, the “evidence of unlawful objective is given

added significance by [plaintiff’s] showing that

neither [defendant] attempted to develop filtering

tools or other mechanism to diminish the infringing

activity … .” Id. In the present case, defendant

removed from its label the instruction not to apply its

generic drug to the patented use. Third, the Court

looked to the market and the manner in which

defendants generated revenue—by selling advertising

revenue, which increased with increasing infringing

use of defendants’ product. Id. In this case,

defendant’s revenue increases with increasing

replacement of plaintiff’s brand name drug with

defendant’s generic version, including when that

replacement is for patented uses.

This Court distinguished the Sony case, in

which liability for induced infringement was not

found, from the Grokster case, in which liability for

induced infringement was found, in this way:

Sony dealt with a claim of liability based solely

on distributing a product with alternative

lawful and unlawful uses, with knowledge that

some users would follow the unlawful course.

*

*

*

19

Here, evidence of the distributors' words and

deeds going beyond distribution as such shows

a purpose to cause and profit from third-party

acts of copyright infringement.

Id. at 941. The Court then explained the critical

import of the evidence of intent:

If liability for inducing infringement is

ultimately found, it will not be on the basis of

presuming or imputing fault, but from inferring

a patently illegal objective from statements and

actions showing what that objective was.

Id.

In this case, evidence of the defendant’s

statements and actions with respect to the PBMs and

whether they planned to profit from infringing use of

their generic drug will be informed through discovery.

D.

Law and Policy in the Case Counsel

Affirming and Remanding to Allow

the Development of a Fulsome

Factual Record, Tied Specifically to

the Market, to Determine Whether

Active Inducement Occurred as

Alleged

Without discovery, a patentee cannot know

whether the negotiations between the accused inducer

and the PBM(s) evidence an intent to induce

infringement of a patented use by making a generic

substitution for that use. Without discovery, a

patentee cannot know whether the accused inducer

expected revenue from infringing uses. In Grokster,

20

applying patent law inducement principles, the Court

found a “purpose to cause and profit from third party

acts of copyright infringement.” Such a finding can

only be based on discovery. At the pleading stage, we

know that the defendant issued press releases touting

their pharmaceutical as a generic replacement for all

purposes. We also know that the defendant removed

from the label a contraindication for the patented use

and that the defendant provided in press releases

reference to full U.S. sales (i.e., patented and

unpatented indications) of Vascepa®. One could draw

the conclusion that defendant planned to profit from

all uses of the generic equivalent, including the

patented one. Of course, these circumstances could

also be completely innocent, but only discovery could

provide the evidence needed for one side or the other.

The parties correctly frame the issues as

including whether any steps taken by the defendant

amount to “active” inducement. But again, the

framing is short on details about the relevant market

and what kind of guidance should be considered

“active” in the context of generic substitution by

PBMs.

Amici submit that patent protection for new

uses of existing pharmaceuticals and the critical

incentives that such patent protection provides for

treating patients counsel affirmance and remand to

allow discovery to further develop the facts supporting

or denying active inducement. Patients are counting

on us to get this balance right.

21

CONCLUSION

For the foregoing reasons, the Court should

affirm and remand.

DATED: March 27, 2026

Respectfully submitted,

RONALD E. CAHILL*

BARNES & THORNBURG LLP

One Marina Park Drive

Boston, MA 02210

(617) 516-5312

rcahill@btlaw.com

STEVEN P. CALTRIDER

KYLE WASDEN GRIMSHAW

DANA-FARBER CANCER

INSTITUTE, INC.

450 Brookline Avenue,

D1618

Boston, MA 02215

HILARY J. LIBKA

MEMORIAL SLOAN-KETTERING

CANCER CENTER, MEMORIAL

HOSPITAL FOR CANCER AND

ALLIED DISEASES, AND SLOANKETTERING INSTITUTE FOR

CANCER RESEARCH

1275 York Avenue

New York, NY 10065

22

WILLIAM R. BOUDREAUX

BARNES & THORNBURG LLP

24 Frank Lloyd Write Dr.,

Ste. A-3300

Ann Arbor, MI 48105

Attorneys for Amici Curiae

*Counsel of Record