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

NO. 20-1119

In the

Supreme Court of the United States

________________

AMARIN PHARMA, INC. and

AMARIN PHARMACEUTICALS IRELAND LIMITED,

Petitioners,

v.

HIKMA PHARMACEUTICALS USA INC.,

HIKMA PHARMACEUTICALS INTERNATIONAL LIMITED,

DR. REDDY’S LABORATORIES, INC. and

DR. REDDY’S LABORATORIES, LTD.,

Respondents.

________________

On Petition for Writ of Certiorari to the

United States Court of Appeals for the

Federal Circuit

________________

BRIEF FOR AMICUS CURIAE AIMED

ALLIANCE IN SUPPORT OF PETITIONERS

________________

ASHLEY C. PARRISH

Counsel of Record

JESSE D.H. SNYDER

KING & SPALDING LLP

1700 Pennsylvania Avenue NW

Washington, DC 20006

(202) 737-0500

aparrish@kslaw.com

March 4, 2021

Counsel for Amicus

Curiae Aimed Alliance

TABLE OF CONTENTS

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

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

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

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

I.

The Federal Circuit’s Entrenched Approach

to Evaluating Obviousness Calls for Review ..... 4

A. The Federal Circuit’s Burden-Shifting

Test Violates This Court’s Precedents......... 4

B. This Case Presents an Ideal Vehicle for

Addressing the Question Presented ............ 6

II. The Question Presented Is Very Important ....... 9

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

ii

TABLE OF AUTHORITIES

Cases

Caraco Pharm. Labs., Ltd. v.

Novo Nordisk A/S,

566 U.S. 399 (2012) ................................................ 10

Graham v. John Deere Co. of Kan. City,

383 U.S. 1 (1966) ...................................................... 5

Hotchkiss v. Greenwood,

52 U.S. 248 (1850) .................................................... 4

KSR Int’l Co. v. Teleflex Inc.,

550 U.S. 398 (2007) .................................................. 5

Microsoft Corp. v. i4i Ltd. P’ship,

564 U.S. 91 (2011) .................................................... 5

Pfizer Inc. v. Dr. Reddy’s Labs., Ltd.,

359 F.3d 1361 (Fed. Cir. 2004) .............................. 10

Radio Corp. of Am. v. Radio Eng’g Labs.,

293 U.S. 1 (1934),

as modified on denial of r’hrg (Oct. 8, 1934)........... 5

Statutes

35 U.S.C. § 103 ........................................................... 5

35 U.S.C. § 271 ......................................................... 10

35 U.S.C. § 282 ........................................................... 5

Other Authorities

Am. Heart Ass’n,

AHA Names Top Heart Disease

and Stroke Research Advances of 2018,

Heart.org (Dec. 31, 2018) ......................................... 9

iii

Bhatt, Deepak L. et al.,

Cardiovascular Risk Reduction with

Icosapent Ethyl for Hypertriglyceridemia,

380 N. Eng. J. Med. 11 (2019) ............................... 12

Campbell, Todd

Is It Time to Ditch Your Fish

Oil Pills for this “Miracle” Medicine?,

Motley Fool (Sept. 24, 2018) .............................. 8, 14

Centers for Disease Control & Prevention,

COVID-19, People with

Certain Medical Conditions,

CDC.gov (Dec. 29, 2020) ........................................ 14

Centers for Disease Control & Prevention,

Data Brief No. 254: Changes in the Leading

Cause of Death: Recent Patterns in Heart

Disease and Cancer Mortality (Aug. 2016) ........... 13

Centers for Disease Control & Prevention,

Heart Disease Facts,

CDC.gov (Sept. 8, 2020) ......................................... 13

Curtin, Sally C.

Trends in Cancer and Heart Disease

Death Rates Among Adults Aged 45-65:

United States 1999-2017,

68 Nat’l Vital Stat. Rep. 1 (May 22, 2019) ............ 13

DiMasi, Joseph A. & Henry G. Grabowski,

The Cost of Biopharmaceutical R&D:

Is Biotech Different?,

28 Managerial & Decision Econ. 469 (2007) ......... 11

iv

DiMasi, Joseph A. et al.,

Innovation in the Pharmaceutical Industry:

New Estimates of R&D Costs,

47 J. Health Econ. 20 (2016) ................................. 11

Federal Trade Commission,

To Promote Innovation: The Proper

Balance of Competition and Patent Law

and Policy, ch. 3 (2003) .......................................... 11

Feuerstein, Adam

Amarin Prescription

Fish-Oil Pill Approved,

The Street (July 26, 2012) ....................................... 7

Furberg, Curt D.,

Bengt D. Furberg, & Larry D. Sasich,

Knowing Your Medications: A Guide

to Becoming an Informed Patient (2009) .............. 13

Hackett, Catherine

“Phenomenal” REDUCE-IT

Establishes Triglyceride Theory,

MDedge.com (Nov. 20, 2018) ................................... 7

Hartung, Thomas

Food for Thought Look Back in Anger –

What Clinical Studies Tell Us About

Preclinical Work,

30 ALTEX 275 (2013) ............................................ 11

Kastelein, John J.P. & Erick S.G. Stroes,

FISHing for the Miracle of

Eicosapentaenoic Acid,

380 N. Engl. J. Med. 89 (2019) ................................ 9

v

Krumholz, Harlan M.

NEJM Journal Watch Cardiology

2018 Top Stories

(Dec. 26, 2018).......................................................... 9

Press Release, Amarin Corp.,

Amarin Highlights VASCEPA® (Icosapent

Ethyl)-Related Data Presented at American

College of Cardiology’s Annual Scientific

Session Together with World Congress of

Cardiology (ACC.20/WCC) (Mar. 31, 2020) .......... 14

Press Release, Amarin Corp.,

Amarin Receives FDA Approval of

Vascepa® (Icosapent Ethyl) to Reduce

Cardiovascular Risk (Dec. 13, 2019) ..................... 12

Press Release, FDA,

FDA Approves Use of Drug to Reduce Risk

of Cardiovascular Events in Certain Adult

Patient Groups (Dec. 13, 2019) ............................... 8

Press Release, HLS Therapeutics Inc.,

HLS Therapeutics Announces Vascepa®

(icosapent ethyl) Showed 30% Reduction in

Total Cardiovascular Events Including

Recurrent Events in REDUCE-IT™

(Mar. 19, 2019) ......................................................... 7

Ries, Julia

How the New FDA-Approved

Fish Oil Drug Can Help Your Heart,

Healthline.com (Dec. 16, 2019) ............................... 8

vi

Roy, Trisha & Saumya Joseph,

FDA Panel Unanimously Backs Expanding

Use of Amarin’s Heart Drug Vascepa®,

Reuters (Nov. 14, 2019) ......................................... 14

Sainato, Michael

The Americans Dying Because They Can’t

Afford Medical Care,

Guardian (Jan. 7, 2020) ......................................... 10

Wehrwein, Peter

Statin Use Is Up, Cholesterol Levels Are

Down: Are Americans’ Hearts Benefiting?,

Harv. Health Pub. (Apr. 15, 2011) ........................ 13

STATEMENT OF INTEREST 1

Aimed Alliance is a not-for-profit health-policy

organization that works to protect and enhance the

rights of health-care consumers and providers. Aimed

Alliance advances its mission by engaging in activities

that help patients gain access to medical treatments

and care, including by educating patients on their

legal rights and their available treatment options.

Among its policy priorities, Aimed Alliance focuses on

the importance of value and innovation in helping

patients gain access to the medications they need.

Aimed Alliance assists patients with complex, chronic,

and debilitating conditions, including patients who

suffer from cardiovascular diseases and severe

hypertriglyceridemia.

As part of its efforts to achieve meaningful

improvements to the country’s health-care system,

Aimed Alliance collaborates with a diverse range of

health-care stakeholders, including patient advocacy

organizations, industry groups, state and federal

governments, and charitable foundations. Amarin

Corporation plc, the parent to petitioners Amarin

Pharma, Inc. and Amarin Pharmaceuticals Ireland

Limited, is one of those stakeholders.

1 As directed by Supreme Court Rule 37.6, amicus curiae states

that no counsel for any party authored this brief in whole or in

part and that no entity or person, aside from amicus curiae, its

members, and its counsel, made any monetary contribution

toward the preparation or submission of this brief. In compliance

with Supreme Court Rule 37.2(a), counsel of record for all parties

have consented to this filing via email correspondence.

2

Aimed Alliance is familiar with Amarin’s

Vascepa® product and the significant benefits it

provides to patients with severe hypertriglyceridemia,

as well as to patients with elevated triglycerides levels

who are on statin therapy. Because Vascepa® meets

important, unmet needs for treating such patients,

Aimed Alliance submitted comments to the U.S. Food

& Drug Administration (“FDA”) in November 2019,

urging the agency to approve Amarin’s supplemental

new drug application. It also testified before FDA’s

Endocrinologic and Metabolic Drugs Advisory

Committee. In addition, in August 2019, Aimed

Alliance submitted a comment to the Institute of

Clinical and Economic Review (“ICER”) in response to

its “Additive Therapies for Cardiovascular Disease:

Effectiveness and Value Draft Evidence Report,”

because ICER sought feedback on its value-based

assessment of Vascepa®.

Drawing on its substantial experience and

knowledge in this area, Aimed Alliance offers an

important, patient-focused perspective on the issues

presented by Amarin’s petition. Aimed Alliance

submits this amicus brief in hopes that it will aid the

Court in understanding the distressing ramifications

of the Federal Circuit’s approach to evaluating when

a patented invention is obvious. In urging the Court

to grant certiorari, Aimed Alliance also offers its views

on why this case raises an issue of extraordinary, farreaching importance.

3

SUMMARY OF ARGUMENT

Ensuring that manufacturers have proper

incentives to develop and market new, safe and

effective medicines is one of the cornerstones of drug

patent law. In this case, however, the Federal Circuit

let stand a district court decision that undermines

that important objective by invalidating the patents

on a groundbreaking, one-of-a-kind invention for

treating patients who suffer from a life-threatening

lipid disorder. In finding the patented invention

obvious in light of prior art, the lower courts departed

from this Court’s settled precedents. Instead of

requiring the patent challenger to prove obviousness

with clear and convincing evidence, the district court

applied a growing body of Federal Circuit precedent

that, upon a mere prima facie showing, shifts the

burden of production—and in effect persuasion—onto

the patent holder. Because the lower courts applied

this improper prima facie test, they fell victim to

hindsight bias and failed to consider the totality of the

evidence, including objective evidence that Amarin’s

invention was a significant advancement over the

prior art.

Without this Court’s intervention, the Federal

Circuit’s approach will undermine the incentives that

Congress created for individuals and companies to

invest in developing innovative medications. The

decision below is also expected to reduce the number

of patients who are adequately informed about

Amarin’s innovative therapy, placing those patients at

a higher risk for heart attack, stroke, and

cardiovascular death. Because this case presents an

ideal vehicle for clarifying the standard for evaluating

4

the obviousness of a patented invention, and because

the Federal Circuit’s decision reflects that court’s

entrenched position on what legal test applies, there

is no reason to await further developments in the law.

The Court should instead grant the petition for

certiorari.

ARGUMENT

I.

The Federal Circuit’s Entrenched Approach

to Evaluating Obviousness Calls for Review.

The Federal Circuit’s test for obviousness

comports with neither the statutory text nor this

Court’s precedents. In permitting a patent challenger

to make a prima facie showing of obviousness as a

hair-trigger to shifting the burden of proving validity

to the patent holder, the Federal Circuit’s test erodes

the statutory presumption of patent validity. This

case offers an ideal vehicle for addressing the Federal

Circuit’s test and clarifying this important area of

federal law.

A. The Federal Circuit’s Burden-Shifting

Test Violates This Court’s Precedents.

The point of the obviousness inquiry is to identify

advancements that are so slight or trivial that they

would have occurred without the need for patent

protection. See Hotchkiss v. Greenwood, 52 U.S. 248,

267 (1850) (concluding that a clay doorknob was not

entitled to patent protection because the improvement

was merely the “work of the skillful mechanic, not that

of the inventor”). Section 103 of Title 35 directs that a

claim is obvious “if the differences between the subject

matter sought to be patented and the prior art are

such that the subject matter as a whole would have

5

been obvious at the time the invention was made to a

person having ordinary skill in the art to which said

subject matter pertains.” 35 U.S.C. § 103. The burden

of proving obviousness is supposed to remain at all

times with the patent challenger. “[B]y its express

terms, [35 U.S.C.] § 282 establishes a presumption of

patent validity, and it provides that a challenger must

overcome that presumption to prevail on an invalidity

defense.” Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S.

91, 100 (2011).

As interpreted by this Court, federal law requires

a court asked to invalidate a patent to take account of

all relevant factors, including objective indicia of nonobviousness. See Graham v. John Deere Co. of Kan.

City, 383 U.S. 1, 17–18 (1966). The factors bearing on

obviousness are to be considered in their totality,

weighed together with the burden of persuasion

squarely on the patent challenger. See KSR Int’l Co.

v. Teleflex Inc., 550 U.S. 398, 406 (2007); Graham, 383

U.S. at 17–18. In rejecting the position that a patent

challenger is capable of “shifting both the burden of

production and the burden of persuasion” to the

patentee upon a certain showing, Microsoft, 564 U.S.

at 103 (internal quotation marks omitted), this Court

has affirmed that “a defendant raising an invalidity

defense b[ears] ‘a heavy burden of persuasion,’

requiring proof of the defense by clear and convincing

evidence,” id. at 102 (quoting Radio Corp. of Am. v.

Radio Eng’g Labs., 293 U.S. 1, 8 (1934), as modified

on denial of r’hrg (Oct. 8, 1934)).

Instead of anchoring its analysis to the

presumption of validity and a patent challenger’s

burden to show obviousness clearly and convincingly,

6

the Federal Circuit’s approach relies on an improper

burden-shifting framework. Under that approach, as

long as the patent challenger makes a prima facie

showing of obviousness, the burden of production—

and in effect persuasion—shifts to the patent holder to

prove that secondary considerations refute that prima

facie showing. See App. 81a; see also Pet. 26, 29. By

shifting the burden and discounting objective indicia

of non-obviousness, the Federal Circuit’s test raises a

particular risk of impermissible hindsight bias. Under

the Federal Circuit’s approach, patents on even the

most novel inventions risk being invalidated when

challenged.

B. This Case Presents an Ideal Vehicle for

Addressing the Question Presented.

This case presents an ideal vehicle for the Court

to clarify the proper standards for determining when

a patented invention is obvious. The case brings into

sharp focus the serious consequences of the Federal

Circuit’s burden-shifting approach, which relaxes the

standards for demonstrating obviousness. There also

can be no doubt that the time is ripe for this Court’s

intervention. Despite the extraordinary importance of

this case, the Federal Circuit views its burden-shifting

approach to be so entrenched that it summarily

affirmed without even issuing an opinion.

If Amarin’s drug is not entitled to patent

protection, no drug manufacturer can be confident

that its patented inventions will withstand an

obviousness defense. Amarin’s drug indisputably

addresses a previously unmet medical need and took

hundreds of millions of dollars to develop. It has been

heralded as a “game changer” for patients, Catherine

7

Hackett, “Phenomenal” REDUCE-IT Establishes

Triglyceride Theory, MDedge.com (Nov. 20, 2018), and

described as a “groundbreaking” drug within the field,

see Press Release, HLS Therapeutics Inc., HLS

Therapeutics Announces Vascepa® (icosapent ethyl)

Showed 30% Reduction in Total Cardiovascular

Events Including Recurrent Events in REDUCE-IT™

(Mar. 19, 2019). Amarin’s drug has received that

recognition because, unlike other medications, it has

been shown (1) to treat severe hypertriglyceridemia

without increasing bad cholesterol and (2) to reduce

the risk of major cardiovascular events in statintreated patients with persistent elevated levels of

triglycerides.

Before Amarin’s drug, other available treatments

for severe hypertriglyceridemia increased bad

cholesterol, a major cause of cardiovascular disease.

See App. 8a (explaining that treatment other than

Vascepa® “dramatically increase[d] LDL-C levels”).

Amarin’s novel solution was to mitigate this harmful

tradeoff. See Adam Feuerstein, Amarin Prescription

Fish-Oil Pill Approved, The Street (July 26, 2012).

Where others had tried and failed, Amarin’s invention

demonstrated success. In doing so, it met a “long-felt

need for a drug ... that could reduce [triglyceride]

levels without raising [bad cholesterol] levels.”

App. 89a.

Moreover, because the patent system is designed

to protect inventions, like Vascepa®, Amarin

continued to invest to provide patients with additional

innovative benefits. After conducting a clinical trial

following more than 8,000 patients for approximately

five years, researchers discovered that Amarin’s drug

8

provides significant benefits to patients with

persistent elevated triglycerides. Before Vascepa®,

heart disease was typically treated with only a single

class of drugs, called statins, that acted to reduce bad

cholesterol. Vascepa® can be taken in tandem with

statins. Compared with a placebo, Vascepa® was

shown to reduce the risk of major cardiovascular

events in patients by 25%. See Todd Campbell, Is It

Time to Ditch Your Fish Oil Pills for this “Miracle”

Medicine?, Motley Fool (Sept. 24, 2018). Studies show

that this decrease was on top of the 25%-plus

reduction historically observed in patients taking

statins. See id.

Vascepa®’s benefits have also been recognized by

government regulators. It is the only drug that FDA

has approved to reduce cardiovascular risk among

patients with elevated triglyceride levels, as an addon to statin therapy. See Press Release, FDA, FDA

Approves Use of Drug to Reduce Risk of

Cardiovascular Events in Certain Adult Patient

Groups (Dec. 13, 2019). It is also the only FDAapproved treatment for severe hypertriglyceridemia

shown to provide the cardiovascular benefit of

lowering bad cholesterol. See App. 89a; see also Julia

Ries, How the New FDA-Approved Fish Oil Drug Can

Help Your Heart, Healthline.com (Dec. 16, 2019)

(“Vascepa

significantly

lower[s]

people’s

cardiovascular risk and triglyceride levels”).

Respected journals and organizations have

reported on the significance of Vascepa®’s remarkable

testing results. For example, The New England

Journal of Medicine “welcome[d]” Vascepa®’s testing

results “with surprise, speculation, and hope” because

9

the drug provides such a “substantial benefit with

respect to major adverse cardiovascular events.” John

J.P. Kastelein & Erick S.G. Stroes, FISHing for the

Miracle of Eicosapentaenoic Acid, 380 N. Engl. J. Med.

89, 89, 90 (2019). In fact, The New England Journal

of Medicine deemed the study’s results to be so

significant that its editorial board selected a story on

Vascepa®’s clinical results as its top story concerning

“the most important research in the field from the past

year.” Harlan M. Krumholz, NEJM Journal Watch

Cardiology 2018 Top Stories (Dec. 26, 2018).

Similarly, the American Heart Association included

Vascepa®’s clinical results in its “annual list of major

[research] advances in heart disease and stroke.” Am.

Heart Ass’n, AHA Names Top Heart Disease and

Stroke Research Advances of 2018, Heart.org (Dec. 31,

2018).

Both the Federal Circuit and the district court

brushed aside these important objective indicia that

Amarin’s invention was not obvious. Their failure to

consider the totality of evidence was driven not only

by improper 20/20 hindsight, but also more

fundamentally by their failure to apply the correct

legal standard. The Federal Circuit’s burden-shifting

approach was dispositive of the outcome of this case.

II. The Question Presented Is Very Important.

The patent system that Congress created seeks to

achieve a careful balance between incentivizing

pathbreaking inventions and enabling robust

competition. In the drug context, this balance is vital

to encouraging manufacturers to develop innovative

treatments that respond to unmet needs, and to

ensuring that innovative treatments are affordable

10

and accessible to patients. The Hatch-Waxman Act

balances these considerations by creating a simplified

procedure “to speed the introduction of low-cost

generic drugs to market,” Caraco Pharm. Labs., Ltd.

v. Novo Nordisk A/S, 566 U.S. 399, 405 (2012), while

simultaneously extending patent protection to

incentivize companies “to develop and market

products.” Pfizer Inc. v. Dr. Reddy’s Labs., Ltd., 359

F.3d 1361, 1364 (Fed. Cir. 2004). Both components—

patent protection and simplified generic approval—

are important to the patient community and for

improving public health.

Many Americans cannot afford medical services

or treatments due to high out-of-pocket costs, causing

them to choose between forgoing vital care and taking

on significant debt or even bankruptcy. See Michael

Sainato, The Americans Dying Because They Can’t

Afford Medical Care, Guardian (Jan. 7, 2020). For

that reason and others, FDA has taken significant

steps to accelerate the approval of generic drugs. The

benefits of generic competition, however, cannot be

realized unless a novel drug is developed in the first

instance and the public knows about it. That is why

competitors must wait until patent exclusivity expires

before they can sell a generic version of an FDAapproved drug. See 35 U.S.C. § 271(e)(3), (4)(A)–(B).

Patent protection is important because it

incentivizes pioneering companies to undertake costly

research and development to discover new treatments

and bring them to market. Bringing a new drug to

market requires a massive investment. Indeed, recent

estimates suggest that the average research-anddevelopment costs of bringing a new drug to market

11

are nearly $2.6 billion. See Joseph A. DiMasi, Henry

G. Grabowski, & Ronald W. Hansen, Innovation in the

Pharmaceutical Industry: New Estimates of R&D

Costs, 47 J. Health Econ. 20, 31 (2016).

Bringing a new drug to market also entails

significant risk, not least because relatively few new

drugs are successful. Government studies suggest

that only 20 in 5,000 compounds (approximately 0.4%)

of screened compounds ever enter preclinical testing

in laboratories and on animals. See FTC, To Promote

Innovation: The Proper Balance of Competition and

Patent Law and Policy, ch. 3, at 6 (2003). Moreover,

“95% of drugs that enter clinical trials do not make it

to the market.” Thomas Hartung, Food for Thought

Look Back in Anger – What Clinical Studies Tell Us

About Preclinical Work, 30 ALTEX 275, 275 (2013). In

addition, when a compound is found to be adequately

safe to test on humans, there are three phases of

clinical testing, each of which is required to determine

the compound’s safety and efficacy. See FTC, To

Promote Innovation, supra, ch. 3, at 6. As a result,

developing and commercializing a drug often takes

more than a decade. See Joseph A. DiMasi & Henry

G. Grabowski, The Cost of Biopharmaceutical R&D: Is

Biotech Different?, 28 Managerial & Decision Econ.

469, 475 (2007).

Without patent protection, most companies would

not undertake the investments necessary to develop

an innovative drug for patients, only to face immediate

competition from generic versions. Here, for example,

Amarin spent “$465 million in research and

development” to discover Vascepa®’s second

indication to reduce the risk of cardiovascular events

12

for patients. App. 55a. That second indication

represented the culmination of years of clinical

development that succeeded where others had failed.

See Deepak L. Bhatt et al., Cardiovascular Risk

Reduction

with

Icosapent

Ethyl

for

Hypertriglyceridemia, 380 N. Eng. J. Med. 11, 12

(2019); Press Release, Amarin Corp., Amarin Receives

FDA Approval of Vascepa® (Icosapent Ethyl) to

Reduce Cardiovascular Risk (Dec. 13, 2019). Even

with patent protection, it is reported that Amarin

investors do not expect to recoup their investment in

Vascepa® until 2024. See App. 55a.

Beyond fostering innovation, patent protection

also encourages patent holders to educate patients,

caregivers, and health-care providers about new

treatments. The district court noted that “marketing

spending tends to be higher at the beginning of a

pharmaceutical product’s lifecycle, given the need to

educate physicians about the clinical profile of the new

drug in question.” App. 55a. While that is true, it is

also true that when a company conducts additional

groundbreaking research, or when a medication

receives expanded approval for new indications,

renewed efforts are needed to educate patients,

caregivers, and health-care providers.

The hard reality is that without patent rights,

many patients will remain in the dark. Significantly,

although Amarin received initial approval for

Vascepa® in 2012, it did not receive its second

indication until December 2019 (just months before

the district court’s judgment). See App. 3a, 25a. As a

result, health-care providers, caregivers, and patients

are only beginning to understand and appreciate the

13

significance of the new indication. But because

Vascepa® is Amarin’s only product, the company is

unlikely to maintain its nascent educational campaign

if its efforts are undercut by generic competition. And

generic competitors are unlikely to make up the

difference because that is not part of their business

model. See Curt D. Furberg, Bengt D. Furberg, &

Larry D. Sasich, Knowing Your Medications: A Guide

to Becoming an Informed Patient 56 (2009) (noting

that “generic manufacturers spend much less on

marketing and accept much lower profit margins”

than brand-name manufacturers”).

There is thus an important public need to

maintain the incentives for Amarin to educate

healthcare providers on the benefits of its

pathbreaking drug. Cardiovascular disease has long

been the leading cause of mortality in the United

States. See CDC, Heart Disease Facts, CDC.gov (Sept.

8, 2020). Although the number of deaths due to heart

disease declined substantially between 2000 and 2010,

the trend has since reversed. See Sally C. Curtin,

Trends in Cancer and Heart Disease Death Rates

Among Adults Aged 45-65: United States 1999-2017,

68 Nat’l Vital Stat. Rep. 1, 2, Fig. 1 (May 22, 2019); see

also CDC, Data Brief No. 254: Changes in the Leading

Cause of Death: Recent Patterns in Heart Disease and

Cancer Mortality 1, 1 (Aug. 2016). Nearly 650,000

Americans die from heart disease each year—“that’s 1

in every 4 deaths.” CDC, Heart Disease Facts, supra.

About 805,000 Americans suffer a heart attack each

year. Id. More than 30 million Americans take

statins. See Peter Wehrwein, Statin Use Is Up,

Cholesterol Levels Are Down: Are Americans’ Hearts

Benefiting?, Harv. Health Pub. (Apr. 15, 2011).

14

Between 50 to 70 million adults in the United States

have high levels of triglycerides. Campbell, Is It Time

to Ditch Your Fish Oil Pills, supra. These statistics

coincide with the CDC last year listing “heart

conditions” as presenting an “increased risk of severe

illness from the virus that causes COVID-19.” CDC,

COVID-19, People with Certain Medical Conditions,

CDC.gov (Dec. 29, 2020).

Information presented by Amarin’s scientists to

the American College of Cardiology suggests that

Vascepa® may help prevent more than 70,000

cardiovascular events each year in adults in the

United States with known cardiovascular disease or

diabetes. See Press Release, Amarin Corp., Amarin

Highlights VASCEPA® (Icosapent Ethyl)-Related

Data Presented at American College of Cardiology’s

Annual Scientific Session Together with World

Congress of Cardiology (ACC.20/WCC) (Mar. 31,

2020). Moreover, because Vascepa® is “highly costeffective,” it could be the “rare[]” therapy that results

in “net healthcare cost-savings to patients, payers and

society.” Id.

There is thus “no doubt that” Amarin’s Vascepa®

“is a medication that could benefit a substantial

portion of the U.S. and meets an unmet need.” Trisha

Roy & Saumya Joseph, FDA Panel Unanimously

Backs Expanding Use of Amarin’s Heart Drug

Vascepa®, Reuters (Nov. 14, 2019) (quoting Dr. Jack

Yanovski of the National Institutes of Health). It

represents a significant step forward—an innovative

advance in the treatment of cardiovascular disease

and severe hypertriglyceridemia—that is now

available to meet a previously unmet need for

15

patients, provided that Amarin continues to invest in

publicizing its life-saving drug so that patients,

caregivers, and health-care practitioners are

adequately aware of the medication’s benefits. In

short, Vascepa® is precisely the type of invention that

patent law is designed to encourage and protect. The

Federal Circuit’s decision to the contrary is worthy of

this Court’s review.

*

*

*

The Federal Circuit has made up a test for which

there is no support and on which actual public-health

outcomes turn. If the Federal Circuit’s precedential

departures are not corrected, they will undermine the

patent system by discouraging pioneering companies

from pursuing the development of innovative

treatments for serious diseases. As a result, new

medications that treat otherwise unmet medical needs

may not be available to the patients who need them.

More immediately, without patent protections,

Amarin will be unable to continue making the

investments needed to educate patients, caregivers,

and health-care providers about Vascepa®’s clinical

trial results and its newly discovered benefits. In

addition, many health-care practitioners may never

become aware of, and therefore may not prescribe, a

treatment to patients for whom Vascepa® may be

medically necessary.

16

CONCLUSION

This Court should grant the petition for certiorari.

Respectfully submitted,

ASHLEY C. PARRISH

Counsel of Record

JESSE D.H. SNYDER

KING & SPALDING LLP

1700 Pennsylvania Avenue NW

Washington, DC 20006

(202) 737-0500

aparrish@kslaw.com

March 4, 2021

Counsel for Amicus

Curiae Aimed Alliance