Petition for Writ of Certiorari — Edwards Lifesciences Corporation, et al., Petitioners v. Meril Life Sciences Pvt. Ltd., et al.

No.

In the Supreme Court of the United States

EDWARDS LIFESCIENCES CORPORATION, ET AL.,

PETITIONERS

v.

MERIL LIFE SCIENCES PVT. LTD., ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

GAIL A. KATZ

TRACEY DAVIES

AVRAHAM SCHWARTZ

JESSICA A. HUDAK

EDWARDS LIFESCIENCES

CORPORATION

One Edwards Way

Irvine, CA 92614

DANIEL L. GEYSER

Counsel of Record

HAYNES AND BOONE, LLP

2801 N. Harwood Street, Ste. 2300

Dallas, TX 75201

(303) 382-6219

daniel.geyser@haynesboone.com

ANGELA M. OLIVER

HAYNES AND BOONE, LLP

800 17th Street, N.W., Ste. 500

Washington, DC 20006

QUESTION PRESENTED

This case presents an exceptionally important question regarding the proper scope of the Hatch-Waxman

Act’s regulatory safe harbor.

Under the Act, Congress declared that “[i]t shall not

be an act of infringement to make, use, offer to sell, or sell

within the United States or import into the United States

a patented invention * * * solely for uses reasonably related” to the federal regulatory process. 35 U.S.C.

271(e)(1) (emphasis added).

In a split decision, the Federal Circuit held that Section 271(e)(1)’s safe harbor applies by identifying any regulatory “use,” even if there are “additional” non-regulatory uses (including blatant commercial conduct) by the

infringing party. The dissent disagreed: an infringing act

with “alternative uses” is not “solely for [regulatory]

uses” (35 U.S.C. 271(e)(1))—and the circuit’s contrary position “ignore[s]” the “word ‘solely’ in the statute,” invites

“future mischief,” and cements an “unsupported expansion of the safe harbor.”

This issue is significant. It frequently arises in disputes with massive stakes. It is the repeat subject of industry and expert analysis. It has split Federal Circuit

panels, divided district courts, and prompted criticism

from judges and academics. This Court has twice granted

review to consider the scope of the same safe-harbor provision—underscoring its obvious importance. And it sets

the proper boundary between innovation and competition

in a trillion-dollar industry.

The question presented is:

Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely for uses reasonably related” to the

federal regulatory process, when the infringing act is performed for both regulatory and non-regulatory uses.

(I)

II

PARTIES TO THE PROCEEDING BELOW AND

RULE 29.6 STATEMENT

Petitioners are Edwards Lifesciences Corporation

and Edwards Lifesciences LLC, the appellants below and

plaintiffs in the district court. Each has no parent corporation, and no publicly held company owns 10% or more of

their stock.

Respondents are Meril Life Sciences Pvt. Ltd. and

Meril, Inc., the appellees below and defendants in the district court.

RELATED PROCEEDINGS

United States District Court (N.D. Cal.):

Edwards Lifesciences Corporation, et al. v. Meril Life

Sciences Pvt. Ltd., et al., No. 4:19-cv-6593-HSG

(Oct. 16, 2020) (summary judgment)

Edwards Lifesciences Corporation, et al. v. Meril Life

Sciences Pvt. Ltd., et al., No. 4:19-cv-6593-HSG

(May 18, 2022) (final judgment)

United States Court of Appeals (Fed. Cir.):

Edwards Lifesciences Corporation, et al. v. Meril Life

Sciences Pvt. Ltd., et al., No. 22-1877 (Mar. 25,

2024) (judgment)

Edwards Lifesciences Corporation, et al. v. Meril Life

Sciences Pvt. Ltd., et al., No. 22-1877 (Aug. 21, 2024)

(order denying rehearing)

III

TABLE OF CONTENTS

Page

Opinions below ................................................................................ 1

Jurisdiction ...................................................................................... 1

Statutory provision involved ......................................................... 2

Introduction ..................................................................................... 2

Statement ......................................................................................... 5

A. Statutory background ....................................................... 5

B. Facts and procedural history ........................................... 9

Reasons for granting the petition............................................... 18

A. The decision below vastly expands Section

271(e)(1)’s safe harbor, contravening its

plain text, history, and purpose ..................................... 18

B. The question presented is exceptionally

important and warrants review in this case ................ 25

Conclusion ......................................................................................30

Appendix A — Court of appeals opinion (Mar. 25, 2024) ........ 1a

Appendix B — District court opinion (Oct. 16, 2020)............. 31a

Appendix C — Court of appeals order (Aug. 21, 2024) ......... 59a

TABLE OF AUTHORITIES

Cases:

AbTox, Inc. v. Exitron Corp., 122 F.3d 1019

(Fed. Cir. 1997) ........................................................... 13, 14

Abtox, Inc. v. Exitron Corp., 888 F. Supp. 6

(D. Mass. 1995) .................................................................. 26

Amgen, Inc. v. Hoechst Marion Roussel, Inc.,

3 F. Supp. 2d 104 (D. Mass. 1998)................................... 26

Badgerow v. Walters, 596 U.S. 1 (2022) .............................. 22

Classen Immunotherapies, Inc. v. Elan Pharms., Inc.,

786 F.3d 892 (Fed. Cir. 2015) ............................................ 5

IV

Page

Cases—continued:

Elan Transdermal Ltd. v. Cygnus Therapeutic Sys.,

No. 91-1314, 1992 WL 368678

(N.D. Cal. June 23, 1992) ................................................. 26

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

496 U.S. 661 (1990) ............................... 3, 6-9, 21-23, 25, 26

Jennings v. Rodriguez, 583 U.S. 281 (2018) ....................... 21

Life Techs. Corp. v. Promega Corp.,

580 U.S. 140 (2017) ............................................................ 24

Limelight Networks, Inc. v. Akamai Techs., Inc.,

572 U.S. 915 (2014) ............................................................ 24

Merck KGaA v. Integra Lifesciences I, Ltd.,

545 U.S. 193 (2005) .................................................. 3, 26, 27

Momenta Pharm., Inc. v. Amphastar Pharm., Inc.,

686 F.3d 1348 (Fed. Cir. 2012) .................................. 26, 27

Proveris Sci. Corp. v. Innovasystems, Inc.,

536 F.3d 1256 (Fed. Cir. 2008) ...................................... 8, 9

Roche Products, Inc. v. Bolar Pharmaceutical Co.,

733 F.2d 858 (Fed. Cir. 1984) ...................................6-8, 22

TRW Inc. v. Andrews, 534 U.S. 19 (2001)........................... 20

Statutes:

28 U.S.C. 1254(1) ...................................................................... 1

Drug Price Competition and Patent Term Restoration Act

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

Tit. II, § 202, 98 Stat. 1603 ........... I, 2, 3, 5, 6, 8, 18, 27, 28

35 U.S.C. 156(a) ........................................................................ 9

35 U.S.C. 271 ............................................................................. 2

35 U.S.C. 271(a) ........................................................................ 2

35 U.S.C. 271(e)(1) ......... I, III, 2, 3, 5-9, 13-22, 24, 25, 27-29

V

Page

Miscellaneous:

Courtenay C. Brinckerhoff, et al., Federal Circuit Applies

Safe Harbor to Imported Medical Device Samples,

The National Law Review (Mar. 27, 2024)

<https://natlawreview.com/article/federal-circuitapplies-safe-harbor-imported-medical

-device-samples> ........................................................25, 26

Dr. Fangli Chen, et al., The Broad Impact of Edwards v.

Meril on the Safe Harbor Provision, Minding Your

Business (Aug. 27, 2024) <https://tinyurl.com/broadimpact-edwards-meril> .........................................4, 19, 25

Dennis Crouch, Federal Circuit Debates Scope of

271(e)(1) Safe Harbor and the Meaning of “Solely,”

PatentlyO (Mar. 27, 2024) <https://patentlyo.com/

patent/2024/03/federal-circuit-debates.html> ..............28

Ryan Davis, Patent Cases To Watch In The Second Half

Of 2024, Law360 (July 11, 2024) <https://tinyurl.com/

law360-2024-patent-cases> ...............................................4

Darby T.R. Findley, There’s A Storm A Brewin’: Can the

Hatch-Waxman “Safe Harbor” Provision Shield

Commercial Stockpiling from A Potential Downpour

of Patent Infringement Allegations?,

26 Fed. Circuit B.J. 307 (2017) ........................................27

H.R. Rep. No. 857, 98th Cong., 2d Sess.

Pt. 1 (1984).................................................................. 6-9, 22

H.R. Rep. No. 857, 98th Cong., 2d Sess.

Pt. 2 (1984)....................................................... 7-9, 21-23, 25

Mark Payne, Life Sciences Cases To Watch 2024: A

Midyear Report, Law360 (July 30, 2024)

<https://tinyurl.com/law360-2024-life-sciences> .....4, 25

Amy Stark, The Exemption from Patent Infringement

and Declaratory Judgments: Misinterpretation of

Legislative Intent?, 31 San Diego L. Rev. 1057

(1994) ...................................................................................27

In the Supreme Court of the United States

No.

EDWARDS LIFESCIENCES CORPORATION, ET AL.,

PETITIONERS

v.

MERIL LIFE SCIENCES PVT. LTD., ET AL.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

Edwards Lifesciences Corporation and Edwards

Lifesciences LLC respectfully petition for a writ of certiorari to review the judgment of the United States Court

of Appeals for the Federal Circuit in this case.

OPINIONS BELOW

The opinion of the court of appeals (App., infra, 1a30a) is reported at 96 F.4th 1347. The order and opinion

of the district court (App., infra, 31a-58a) is unreported

but available at 2020 WL 6118533.

JURISDICTION

The judgment of the court of appeals was entered on

March 25, 2024. A petition for rehearing was denied on

August 21, 2024 (App., infra, 59a-60a). The jurisdiction of

this Court is invoked under 28 U.S.C. 1254(1).

(1)

2

STATUTORY PROVISION INVOLVED

Section 271 of Title 35 of the United States Code provides in relevant part:

Infringement of patent

(a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or

sells any patented invention, within the United States

or imports into the United States any patented invention during the term of the patent therefor, infringes

the patent.

* * * * *

(e)(1) It shall not be an act of infringement to make,

use, offer to sell, or sell within the United States or

import into the United States a patented invention * * * solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale

of drugs or veterinary biological products.

* * * * *

INTRODUCTION

This case presents an important and recurring statutory question under the Hatch-Waxman Act. Under the

Act, Congress created a limited safe harbor for infringing

activity “solely for uses reasonably related” to the federal

regulatory process. 35 U.S.C. 271(e)(1) (emphasis added).

Notwithstanding that plain text (“solely for [regulatory]

uses”), the Federal Circuit held that identifying any regulatory use also immunizes all other non-regulatory uses,

even if an infringer also engages in purely commercial

conduct. That holding split the panel below: in a forceful

3

dissent, Judge Lourie faulted the Federal Circuit for “ignor[ing]” the text, distorting Congress’s design, and

“vast[ly] expan[ding]” the safe harbor.

As it now stands, a safe harbor designed “solely” for

regulatory approval now also shields “alternative” commercial activities—those seeking economic benefits and

market advantages. The Federal Circuit’s profound misreading of Section 271(e)(1) cries out for review—and the

certworthiness calculus is compelling.

As a baseline matter, the Federal Circuit’s position is

at odds with Hatch-Waxman’s plain text, history, and purpose. When a party imports a device for any non-regulatory use, it is not acting “solely for [regulatory] uses.” The

2-1 decision rewrites the careful balance Congress struck

in the Act, and extends statutory immunity to conduct

that Congress had no reason to protect. It offers a recipe

for letting infringers off the hook so long as they strategically engage in some protected conduct—manipulating

the safe harbor, exploiting good-faith competitors, and

undermining Congress’s scheme.

The issue’s significance is also obvious. It involves an

important legal question affecting countless industry

stakeholders and cutting-edge technologies. This Court

has twice granted review to consider the scope of this

same safe-harbor provision. See Merck KGaA v. Integra

Lifesciences I, Ltd., 545 U.S. 193 (2005); Eli Lilly & Co. v.

Medtronic, Inc., 496 U.S. 661 (1990). It is the repeat subject of industry and expert analysis, and judges and commentators have long criticized the Federal Circuit’s position as wrong and atextual. The decision below distorts

the market for patented products and undermines the patent bargain—while granting a competitive advantage to

those parties most willing to exploit the safe harbor to

smuggle in impermissible uses. The opportunity for “future mischief” is palpable, and “the law could usefully be

4

clarified” by further review, “expressly returning the

word ‘solely’ to its Congressionally-enacted place in the

statute.” App., infra, 30a. 1

At bottom: It is essential for a trillion-dollar industry

to operate under a system of clear rules and fair competition. This issue dictates the industry baseline for that

competition. Yet the decision below judicially redlines

that crucial baseline and forces all stakeholders into a race

to the bottom. There is a reason experts have deemed this

a “pivotal moment in the interpretation of the safe harbor

provision.” Dr. Chen, The Broad Impact of Edwards, supra.

Finally, this is an ideal vehicle for resolving this important question. The petition raises a pure question of

law: the proper construction of the statute. That issue was

resolved at summary judgment, and each court below declared exhaustive evidence of Meril’s commercial use “irrelevant” under the Federal Circuit’s (incorrect) test.

See, e.g., Dr. Fangli Chen, et al., The Broad Impact of Edwards

v. Meril on the Safe Harbor Provision, Minding Your Business (Aug.

27, 2024) <https://tinyurl.com/broad-impact-edwards-meril> (the

decision below “underscores the breadth of the safe harbor” and “has

garnered significant attention”; the Federal Circuit’s refusal to reconsider the case has “significant implications, as it solidifies the

broader interpretation of the safe harbor,” “potentially allowing more

tangentially related activities to be shielded”); Mark Payne, Life Sciences Cases To Watch 2024: A Midyear Report, Law360 (July 30,

2024) <https://tinyurl.com/law360-2024-life-sciences> (flagging this

question as “crucial to the life sciences industry”; “[i]f the ruling [below] stands,” “‘the safe harbor provision [would] cover[] allegedly infringing activities that were not previously contemplated as being

covered’”); Ryan Davis, Patent Cases To Watch In The Second Half

Of 2024, Law360 (July 11, 2024) <https://tinyurl.com/law360-2024-patent-cases> (“[a] strong dissent by Judge Alan Lourie decried

* * * an overly expansive reading of the statute that wrongly protects

activities done for commercial reasons”; recognizing “‘very significant

financial interests on both sides’”).

1

5

There are no complicating factors or obstacles to resolving the statutory issue. And Judge Lourie’s dissent confirms the Act’s proper construction is outcome-determinative: Edwards lost under the Federal Circuit’s (atextual) reading, but would have prevailed under Judge

Lourie’s plain-text interpretation.

The question presented raises legal and practical issues of substantial importance, and its correct disposition

is essential to the Act’s proper operation. Further percolation is pointless. There is no possibility of any split (in

light of the Federal Circuit’s exclusive jurisdiction), and

the Federal Circuit’s position is entrenched—as the full

court’s rehearing denial confirms. The entire industry will

remain bound by the Federal Circuit’s misinterpretation

of the Act until this Court intervenes. Because this case

presents an ideal vehicle for resolving this significant

question, the petition should be granted.

STATEMENT

A. Statutory Background

1. Under the Hatch-Waxman Act, Congress created a

“safe harbor” for “certain uses” of patented inventions in

“the federal regulatory process” (Classen Immunotherapies, Inc. v. Elan Pharms., Inc., 786 F.3d 892, 896 (Fed.

Cir. 2015))—immunizing infringing activities “solely for

uses reasonably related to the development and submission of information under a Federal law which regulates

the manufacture, use, or sale of drugs” (35 U.S.C.

271(e)(1)). See Drug Price Competition and Patent Term

Restoration Act of 1984 (Hatch-Waxman Act), Pub. L.

No. 98-417, Tit. II, § 202, 98 Stat. 1585, 1603.

The Act’s “new” protection was important but purposely narrow: it “allow[ed] competitors” to take infringing steps “necessary to obtain [federal] regulatory ap-

6

proval,” but it “imposed” this exemption “only for the purpose of obtaining premarketing approval.” Eli Lilly & Co.

v. Medtronic, Inc., 496 U.S. 661, 671, 678 (1990) (emphasis

added). 2 The safe harbor did not extend to “commercial

activity” (which had to wait until the “patent expires”),

and “[t]he information * * * developed” under the safe

harbor was merely “the type * * * required to obtain approval of the drug.” H.R. Rep. No. 857, 98th Cong., 2d

Sess. Pt. 1, at 45-46 (1984). As Congress explained, this

limited scope would advance regulatory aims without impairing patent rights: such “experimental activity [would]

not have any adverse economic impact on the patent

owner’s exclusivity during the life of a patent.” Id. at 46.

In short, the Act declared it “not an act of patent infringement * * * to import or to test a patented drug [1] in

preparation for seeking FDA approval [2] if marketing of

the drug would occur after expiration of the patent.” H.R.

Rep. No. 857, Pt. 1, supra, at 15 (brackets and emphasis

added). Congress carefully inserted these conditions in

Section 271(e)(1)’s operative clause, limiting the safe harbor “solely for [regulatory] uses.” 35 U.S.C. 271(e)(1).

2. This legislation was a direct response to the Federal

Circuit’s earlier decision in Roche Products, Inc. v. Bolar

Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984), which

refused to excuse infringing activities “even though

the[ir] only purpose” was “to seek FDA approval.” H.R.

Rep. No. 857, Pt. 1, supra, at 45-46 (describing Roche); Eli

Lilly, 496 U.S. at 670 (recounting Roche barred infringing

In general terms, premarket approval is a process of scientific and

regulatory review (by federal agencies like the FDA) to determine if

a medical product or device is safe and effective. For the devices at

issue here, premarket approval is necessary before the device can be

marketed or sold in the United States. See, e.g., App., infra, 3a, 33a

(so explaining).

2

7

activities “even” for the “sole purpose” of seeking “regulatory approval”); see also Roche, 733 F.2d at 861 (“the issue in this case is narrow: does the limited use of a patented drug for testing and investigation strictly related

to FDA drug approval” constitute “actionable” infringement; “[t]he district court held it does not”; “[t]his was an

error of law”) (emphasis added).

Congress found that Roche was “wrongly decided”

and created a problem of artificially extending the patent

term. H.R. Rep. No. 857, 98th Cong., 2d Sess. Pt. 2, at 28

n.18 (1984); see also H.R. Rep. No. 857, Pt. 1, supra, at 46

(“prevent[ing] such activity would extend the patent

owner’s commercial exclusivity beyond the patent expiration date”). If regulatory “activity could not be commenced * * * until [the patent’s] expiration,” “the patentee’s de facto monopoly would continue for an often

substantial period until [a competitor’s] regulatory approval was obtained.” Eli Lilly, 496 U.S. at 670. This created an improper “advantage” not from “patent law” per

se but “from the operation of law respecting FDA approval of drugs before they can be marketed.” H.R. Rep.

No. 857, Pt. 2, supra, at 28 n.18. 3

Congress thus sought to “overturn” Roche (H.R. Rep.

No. 857, Pt. 2, supra, at 27 n.18), and it targeted the specific problem the Federal Circuit created: Because Roche

barred activities “strictly related” to regulatory approval

(Roche, 733 F.2d at 861), Congress shielded activities

“strictly related” to regulatory approval—those “solely

See also H.R. Rep. No. 857, Pt. 2, supra, at 28 n.18 (“‘If one must

wait until expiration of the patent to use the patented item to develop

the necessary test[] results for submission to FDA for its approval,

the lapse of time between testing through submission to approval to

marketing is likely to be a period of years, all of which time the original patent holder enjoys the benefit of his patent past its expiration

date.’”).

3

8

for [regulatory] uses.” 35 U.S.C. 271(e)(1); see also Eli

Lilly, 496 U.S. at 678 (the “new” Section 271(e)(1) excused

infringing “use[s] * * * only for the purpose of obtaining

premarketing approval”). Under the new safe harbor, “all

that the generic can do is test the drug for purposes of

submitting data to the FDA.” H.R. Rep. No. 857, Pt. 2,

supra, at 30. This revived the category of activity that

Roche prohibited, without otherwise “touch[ing]” the

“value” of “the patents.” Id. at 29 n.18.

Congress’s reversal was thus coterminous with the

root problem in Roche: Section 271(e)(1) had “the net effect of reversing [its] holding.’” H.R. Rep. No. 857, Pt. 2,

supra, at 27; accord H.R. Rep. No. 857, Pt. 1, supra, at 4546.

3. In creating this safe harbor, Congress also struck a

delicate balance within the industry—one that addressed

two “unintended distortions” from delays in the regulatory process. Eli Lilly, 496 U.S. at 661; see also Proveris

Sci. Corp. v. Innovasystems, Inc., 536 F.3d 1256, 1260

(Fed. Cir. 2008). The “first distortion” was “the reduction

of effective patent life” for patentees, based on “the early

years of the patent term [being] spent obtaining premarket approval.” Proveris, 536 F.3d at 1260-1261. If an

invention requires “regulatory approval, the ‘clock’ on

[the] patent term will be running even though [the inventor] is not yet able to derive any profit from the invention.”

Eli Lilly, 496 U.S. at 669-670. The “second distortion” (as

described above) was a “de facto extension * * * at the end

of the patent” while “competitors spent time following patent expiration obtaining FDA premarket approval necessary for market entry.” Id. at 1261 (detailing preHatch-Waxman law under Roche, supra).

Congress thus sought to “eliminate this distortion

from both ends of the patent period” (Eli Lilly, 496 U.S.

at 670): it simultaneously extended the patent term to

9

compensate for regulatory delays in commercializing patents (35 U.S.C. 156(a)), while also “allow[ing] competitors

to begin the regulatory approval process while [a] patent

[is] still in force” (Proveris, 536 F.3d at 1261 (describing

Section 271(e)(1))); see also Eli Lilly, 496 U.S. at 670-671.

Given the sole focus on permitting competitors to initiate the regulatory process, Section 271(e)(1)’s “interference” with exclusive patent rights was deemed “de

minim[i]s”—as competitors were “not permitted to market the patented drug during the life of the patent.” H.R.

Rep. No. 857, Pt. 2, supra, at 30. Indeed, “the generic”

was limited to “test[ing] the drug for purposes of submitting data to the FDA for approval,” and the patent owner

“retain[ed] the right to exclude others from the major

commercial marketplace.” Id. at 8, 30. 4

B. Facts And Procedural History

1. Edwards is a leading innovator and supplier of medical devices for treating heart disease, including its renowned, patented line of “SAPIEN®” transcatheter

prosthetic heart valves. App., infra, 32a. Meril is an Indiabased competitor that also makes transcatheter heart

valves. Id. at 2a. Its Myval valve is nearly identical to Edwards’ SAPIEN® valve; it received regulatory approval

to sell the device in India in October 2018, and received

Some stakeholders objected that permitting regulatory-based activities during the patent term would interfere with patent rights and

constitute a “taking.” See, e.g., H.R. Rep. No. 857, Pt. 2, supra, at 27

& n.18, 29-30. Congress responded by noting the limited nature of the

safe harbor, that it addressed only regulatory uses, that it did not permit any commercialization or market activity during the patent term,

and accordingly that the effect on patent rights, again, was “de

minim[i]s.” Id. at 27-30 & n.18; H.R. Rep. No. 857, Pt. 1, supra, at 46.

Each aspect of this response holds under a plain-text reading of Section 271(e)(1)—the safe harbor is “solely for [regulatory] uses”; it

does not necessarily follow under the Federal Circuit’s conflicting

view of the safe harbor.

4

10

so-called CE-mark approval (authorizing European sales)

in April 2019. Id. at 2a-3a, 33a.

A few months after receiving CE-mark approval,

Meril imported two of its Myval devices into the United

States for use at a major industry event in San Francisco—the 2019 Transcatheter Cardiovascular Therapeutics Conference. App., infra, 4a-5a. This trade conference

is an annual symposium attended by thousands of industry participants. Id. at 4a, 35a, 37a; C.A. J.A. 730. 5 The infringing Myval devices were transported into the country

by a Meril employee, along with a declaration stating the

devices were for demonstration purposes only. App., infra, 5a.

Before arriving, Meril circulated a digital flyer advertising Meril’s trade booth at the conference. App., infra,

35a; C.A. J.A. 884-886. The promotion invited thousands

of registrants to “[e]xperience Meril’s latest technologies,” featuring a “[h]ands-on simulation” of the Myval device (available for all attendees, including those focused on

commercial or marketing transactions); it said nothing

about regulatory uses, recruiting investigators for clinical

trials, or limiting the simulator’s use to potential investigator candidates. C.A. J.A. 885-886; see also id. at 640

(“anybody who wants to come can do the hands-on session”).

Meril separately sent an email blast to thousands of

registrants, advertising Myval as “CE APPROVED,”

highlighting a “Myval CE [i.e., European sales] Announcement,” and inviting recipients (including hundreds

The conference host advertised the event as attracting “more

than 11,000 attendees from over 100 countries,” presenting “unparalleled marketing opportunities” to “[b]uild your brand,” “increase visibility of products and services,” “generate new leads,” and “connect

with key clients.” C.A. J.A. 730.

5

11

in Europe where the Myval system is commercially available) to Meril’s trade booth for “hands-on and VR sessions” with the imported device. C.A. J.A. 570, 670, 745748, 889-893; see also id. at 746-748 (“We invite you to our

Booth #943 to learn more about our innovations.”). Again,

the email said nothing about regulatory uses or clinical recruiting. Id. at 890-893. Meril also updated its Myval brochure specifically for the conference, again touting its CEmark approval and even providing “Myval – THV Ordering Information.” Id. at 825-826, 852.

Before the conference, Meril consulted with attorneys

to draft “Instructions for TCT 2019 for Myval THV System.” App., infra, 4a. It conveyed those instructions orally

to the twenty Meril employees attending the event:

Do not make any sales or offers for sale at the conference, or while in the United States for the US market.

You can make offer [sic] for other countries.

Ibid. (emphasis added). The instructions permitted Meril

employees to carry the imported Myval “demo units,” and

again did not restrict the devices’ use or display to potential clinical investigators (or require any other nexus to

regulatory submissions). C.A. J.A. 909.

At the conference, Meril “provided information” on

the Myval system, including “visual displays,” “presentations to attending physicians,” “case studies” describing

implantation of the Myval System, and results from a

“clinical trial.” App., infra, 36a. In addition to its marketing activities, Meril “also discussed” the Myval device

with “several U.S. doctors to identify potential clinicians”

for future clinical trials. Ibid. Meril itself later posted on

LinkedIn that “2,000 people visited” its conference trade

booth. App., infra, 37a.

Despite its advanced planning and advertising, Meril

ultimately did not display the imported Myval devices at

12

the conference. App., infra, 37a, 42a. Although Meril intended to use those devices in its publicized “hands-on”

simulation—Meril’s undisputed reason for importing the

devices—Meril’s simulator malfunctioned. Id. at 42a. It

was those “technical difficulties” alone that prompted

Meril to keep the devices in a “hotel closet” and a conference “storage room.” Id. at 2a, 37a, 42a. Meril otherwise

would have used those devices in the simulator for anyone

at the conference—including for potential clinical investigators (a regulatory use) and for all other attendees (a

non-regulatory use). Id. at 42a; C.A. J.A. 640, 747, 885886. 6

In December 2019, months after the conference, Meril

sought FDA guidance through a voluntary presubmission, proposing a clinical trial with clinical sites both inside

and outside the United States. App., infra, 6a. 7 In response, the FDA noted that Meril’s proposed trial lacked

sufficient human test subjects at domestic sites. Ibid.

Meril accordingly revised its proposal to meet FDA requirements (ibid.), but years later it still has not pursued

a single U.S. clinical trial.

2. In October 2019, Edwards sued Meril for importing

the infringing Myval devices for non-regulatory uses.

6

See also App., infra, 42a (Meril admitting that “technical difficulties with the simulation system” “result[ed]” in “the Myval Samples

remain[ing] stored away during the time they were in San Francisco”).

7

The FDA’s presubmission program “allows device manufacturers

to request formal regulatory feedback on the device before officially

engaging in the premarket approval process.” App., infra, 34a.

13

App., infra, 6a. Meril responded that its infringing activity was protected under Section 271(e)(1)’s safe harbor.

Id. at 6a, 38a. 8

3. The district court granted summary judgment for

Meril. App., infra, 31a-58a.

The court acknowledged the safe harbor was enacted

for the limited purpose of “address[ing] issues created by

the legal requirements for pre-market FDA approval.”

App., infra, 38a (describing Section 271(e)(1)’s history).

But the court also found the Federal Circuit had assigned

the provision a “br[oad]” scope. Id. at 40a.

According to the court (following Federal Circuit

“guidance”), if an “allegedly infringing act[]” is “reasonably related to FDA approval,” any “‘alternative [non-regulatory] uses are irrelevant.’” App., infra, 52a & n.7 (quoting AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 1030

(Fed. Cir. 1997)). Section 271(e)(1) applied even if infringing activities are “conducted in part for ‘commercial reasons’” (id. at 51a), and even if the “actual purpose” is “promot[ional] rather than regulatory” (id. at 40a (internal

quotation marks omitted)). In short, the court concluded,

if an infringing act has at least some regulatory use, it is

protected by “the section 271(e)(1) shield”—“alternative

[commercial] uses are not relevant to the application of

the safe harbor.” Id. at 52a & n.7 (so concluding without

any mention of the term “solely”).

In its rehearing opposition, Meril suggested Edwards filed suit to

“saddle Meril with legal fees to delay Meril’s efforts to get FDA approval for a competing product.” C.A. Reh’g Opp. 3. This is both bizarre (how would legal fees delay Meril’s efforts?) and baseless. As

the court below recognized, “[c]linical trials are expensive” (App., infra, 16a)—and the cost of developing a Class III medical device and

obtaining regulatory approval easily overwhelms whatever marginal

legal expense Meril has in mind.

8

14

Based on this analysis, the court found Meril’s infringing activity “fall[s] squarely within the safe harbor.” App.,

infra, 52a. Meril imported “the Myval Samples to the

[conference]” to “‘select[] qualified investigators’” for clinical trials. Ibid. Because that use was “reasonably related

to FDA approval,” it was “‘irrelevant’” whether Meril’s

“alternative uses” were commercial. Id. at 52a & n.7 (emphasis added; quoting AbTox, 122 F.3d at 1030). As the

court reasoned, once Meril established it imported the devices for at least one regulatory use, the safe harbor applied and it “need not reach” other issues. Ibid. The court

thus brushed aside Edwards’ extensive evidence that

Meril imported the Myval devices for commercial uses,

and declared “there is no infringement” under Section

271(e)(1). Id. at 52a & n.7.

4. In a split decision, the Federal Circuit affirmed.

App., infra, 1a-30a.

a. The majority noted the Federal Circuit had “interpreted § 271(e)(1) on numerous occasions,” and it found

circuit precedent “clear.” App., infra, 8a. According to the

majority, “the relevant inquiry” is “whether the act of importation was for a use reasonably related to submitting

information to the FDA.” Id. at 11a (emphasis added).

Once any such regulatory use is identified, Section

271(e)(1) was deemed satisfied—“regardless of whether

there are additional [commercial] uses by [a] defendant.”

Id. at 18a (emphasis omitted). Indeed, in the majority’s

view, “‘alternative uses’” are “‘irrelevant’” to the safe-harbor inquiry. Id. at 9a, 11a (quoting AbTox, 122 F.3d at

1030).

The majority acknowledged the term “solely” in the

statute, but it disagreed that “the use must only be reasonably related * * * to the FDA [process].” Id. at 11a

(emphasis in original); contra 35 U.S.C. 271(e)(1) (protect-

15

ing activities “solely for [regulatory] uses”). On the contrary, the majority declared, the safe harbor applied unless an infringing activity was “‘entirely unrelated’” to

regulatory approval. Id. at 15a (emphasis altered); contra,

again, 35 U.S.C. 271(e)(1) (setting out the opposite standard). Rather than ask whether the infringing act was

“solely for [regulatory] uses,” the majority instead asked

whether the defendant’s “‘sole purpose’” was “‘supporting

* * * commercial sales,’” and whether “‘the importation

was wholly unrelated * * * to any FDA submission.’” Id.

at 16a (second emphasis added). So long as “a[ny] use”

concerned the FDA process—even if “‘alternative uses’”

did not—the majority held “the safe harbor is available.”

Id. at 9a, 11a.

Applying that standard, the majority found that

Meril’s importation “firmly resides in the § 271(e)(1) safe

harbor.” App., infra, 13a. According to the majority, Meril

identified at least one qualifying regulatory use: it imported the infringing devices “to recruit[] investigators

for a clinical trial to support FDA approval.” Id. at 7a.

Having identified one such qualifying use, any evidence of

Meril’s (non-regulatory) “‘alternative uses’” became irrelevant. Id. at 9a, 18a (safe harbor applied “regardless of

whether there are additional uses by defendant”). The

majority thus discarded Edwards’ “numerous evidentiary

bases” showing Meril imported the devices “‘to support

commercial sales.’” Id. at 13a-14a. Under the majority’s

reasoning, the safe harbor applied unless Meril’s importation was “‘entirely unrelated’ to any clinical recruiting.”

Id. at 15a. In fact, “[a]t bottom,” Edwards lost because

Meril identified at least some regulatory use—in the majority’s view, Edwards failed to establish “‘that Meril’s

sole purpose for importing Myval Devices was to support

its commercial sales efforts,’” and that Meril’s “‘importa-

16

tion was wholly unrelated to recruiting clinical investigators and wholly unrelated to any FDA submission.’” Id. at

16a.

The majority accordingly held that “summary judgment of noninfringement [wa]s appropriate as a matter of

law.” App., infra, 12a; see also id. at 19a (affirming the

“summary judgment of noninfringement under

§ 271(e)(1)’s safe harbor”).

b. Judge Lourie dissented. App., infra, 19a-30a. As he

established, the majority’s holding “perpetuates the failure of [the Federal Circuit] and others to recognize the

meaning of the word ‘solely’ in interpreting § 271(e)(1).”

Id. at 19a. He flagged “[t]he tension between the plain language of the statute and [the Federal Circuit’s] precedent,” and warned the Federal Circuit’s “misconstruction

of § 271(e)(1) should not be left to create future mischief.”

Id. at 29a-30a. Concluding that “[Federal Circuit] case law

has incorrectly given short shrift to the word ‘solely’ in the

statute,” he declared “[i]t is time to fix those errors.” Id.

at 20a.

As Judge Lourie explained, the term “solely” is a “key

limitation on the meaning of the statute.” App., infra, 27a.

He recounted how “[t]he word ‘solely’ was included

* * * to ensure that infringing activity” “performed for

[non-regulatory] purposes * * * would not be exempt” (id.

at 21a), and how the word “creates a safe harbor only for

uses, sales, and importations that solely are for, as the

statute says, development of information for the FDA.”

Id. at 19a-20a.

Judge Lourie then traced the history of Federal Circuit decisions to show how “solely” was judicially dropped

from the text over time, producing an “unsupported expansion of the safe harbor” contrary to the “plain language of the statute itself.” App., infra, 25a. He faulted

those earlier cases for “disregard[ing]” “alternative uses

17

* * * once a fact-finder identifies any use reasonably related to obtaining FDA approval.” Id. at 29a. And he explained how “alternative uses are crucial to determining

compliance with the statute” (id. at 25a): “How is a factfinder able to properly determine whether an infringing

act is ‘solely for uses reasonably related to the development and submission of information’ under federal law,

when our precedent instructs him or her to turn a blind

eye to the party’s intent or alternative uses?” Ibid. (citing

35 U.S.C. 271(e)(1)).

In short, Judge Lourie concluded, “the law could usefully be clarified by an en banc holding of this court, expressly returning the word ‘solely’ to its Congressionallyenacted place in the statute.” App., infra, 30a.

Judge Lourie finally analyzed how the district court

mirrored the Federal Circuit’s errors in examining Section 271(e)(1). As Judge Lourie explained, “the district

court here wholly ignored the presence of the word ‘solely’

in the statute”—“[n]owhere in [its] holding and analysis

does the word ‘solely’ appear.” App., infra, 23a. This left

“[a] key part of the statute * * * ignored.” Ibid. And Judge

Lourie found “the absence of ‘solely’ in the district court’s

stated holding was not merely a harmless omission”

(ibid.): “the court ignored ‘solely’ in both its stated holding

and its substantive analysis, effectively disregarding any

evidence concerning Meril’s commercial uses corresponding to the importation at issue” (id. at 24a).

Under Judge Lourie’s view, this error was outcomedeterminative: “under a correct interpretation of the law,

particularly including adequate consideration of the word

‘solely,’ summary judgment for Meril should be reversed”—“the importations occurred, at least partially,

for commercial reasons and thus were not entitled to the

safe harbor.” App., infra, 30a.

18

5. Edwards filed a petition for rehearing en banc, directly challenging the Federal Circuit’s misreading of

Section 271(e)’s safe harbor. The court called for a response to the petition, but it ultimately denied rehearing,

refusing to reconsider its interpretation of the statute.

App., infra, 60a.

REASONS FOR GRANTING THE PETITION

A. The Decision Below Vastly Expands Section

271(e)(1)’s Safe Harbor, Contravening Its Plain

Text, History, And Purpose

Under the Hatch-Waxman Act, Congress created a

limited safe harbor for otherwise-infringing acts “solely

for uses reasonably related” to obtaining regulatory approval. 35 U.S.C. 271(e)(1) (emphasis added). This language is not difficult to understand. When a party imports

a device for any non-regulatory use, it is not acting “solely

for [regulatory] uses.” 35 U.S.C. 271(e)(1) (emphasis

added). Congress identified a single category of protected

uses (those concerning regulatory approval), refused to

expand that category to include anything else, and textually cabined its boundaries with an unambiguous term—

“solely.”

Yet according to the 2-1 split panel below, any protected use automatically insulates all non-protected uses.

If “a use” is covered, the safe harbor applies, sweeping in

“‘alternative uses’” irrelevant to regulatory approval

(App., infra, 9a, 11a (emphasis added))—including obvious attempts to commercialize competing products. In

fact, under the panel’s view, the only way to stop infringing activity is to prove the challenged uses were solely

commercial in nature (id. at 16a)—the inverse of Section

271(e)(1)’s actual terms.

The Federal Circuit’s position is at odds with the statutory text, history, and purpose. It judicially rewrites the

19

careful balance Congress struck in Section 271(e)(1), and

extends statutory immunity to conduct that Congress did

not protect and had no reason to protect. It offers a recipe

for letting infringers off the hook so long as they strategically engage in some protected conduct, exploiting the

safe harbor and undermining Congress’s design.

There is a reason this issue has split Federal Circuit

panels, divided district courts, prompted criticism from

experts and stakeholders, and generated undue controversy and confusion—all of which could be avoided by

simply reading Section 271(e)(1) to mean what it plainly

says. Yet rather than course-correct, the panel below decided to double-down. For the first time, the Federal Circuit has confirmed that any regulatory use now sweeps in

all other uses—even blatant commercial conduct. Rather

than asking whether any uses are commercial, the court

now asks whether all uses are commercial. The Federal

Circuit has flipped the plain text on its head, and Congress’s key limitation (“solely for [regulatory] uses”) is

now entirely gratuitous.

The panel below did not merely “perpetuate[] the

[Federal Circuit’s] misconstruction of the law.” App., infra, 20a (Lourie, J., dissenting). Its novel misreading

broadly expands Section 271(e)(1) to protect a new universe of infringing conduct, which is why experts view this

as a “pivotal” moment for the safe harbor. Dr. Fangli

Chen, et al., The Broad Impact of Edwards v. Meril on the

Safe Harbor Provision, Minding Your Business

(Aug. 27, 2024) <https://tinyurl.com/broad-impact-edwards-meril>.

The Federal Circuit has left Section 271(e)(1) at its

breaking point. This is a critical provision affecting the

proper administration of a trillion-dollar industry with

20

mission-critical stakes. “It is time to fix [the court’s] errors” (App., infra, 20a (Lourie, J., dissenting)), and this

Court’s review is urgently warranted.

1. a. First and foremost, the decision below flouts the

plain text and reads “solely” straight out of the statute.

Section 271(e)(1) has the same meaning under Federal

Circuit law with or without the term—it is entirely superfluous. Contra TRW Inc. v. Andrews, 534 U.S. 19, 31

(2001) (barring such readings). If Congress wanted the

safe harbor to apply whenever any qualifying use was

present, it would have said exactly that—protecting acts

where any “use[]” is “reasonably related” to regulatory

approval. Yet the “solely” qualifier has a crucial role: it

excludes protection when both protected and unprotected

uses are present. That forces parties to focus strictly on

regulatory compliance, without exploiting “alternative

uses” to insulate commercial conduct.

In short, there is no textual way to square the Federal

Circuit’s decision with the statute. “Solely” must do some

work, and the work it does is obvious: the safe harbor applies if the infringing conduct is “solely” for a qualifying

reason. That means any “alternative” use is disqualifying.

App., infra, 25a (Lourie, J., dissenting). Yet the Federal

Circuit wrongly instructs courts to ignore “‘alternative

uses’” (App., infra, 9a, 18a)—which it can only do by

“giv[ing] short shrift to the word ‘solely’ in the statute.”

Id. at 20a (Lourie, J., dissenting). “The tension between

the plain language” and controlling Federal Circuit “precedent” is palpable. Id. at 29a.

b. Rather than focus on the key term in the actual text

(“solely”), the Federal Circuit instead expanded Section

271(e)(1) to sweep in concepts that indisputably are not

there: the notion that Congress must also have intended

(silently) to authorize commercial “uses”—“fund raising

and other business purposes”—to ensure a party could

21

immediately compete on day one once the patent term expires. App., infra, 9a (citing earlier circuit decisions).

Yet that is not what Section 271(e)(1) is designed to do.

The specific harm identified by Congress was addressed

by the specific language Congress chose for the provision.

Congress recognized that the regulatory-approval process could take years—and the inability to pursue that

process in advance would effectively extend a patent’s

term. Eli Lilly, 496 U.S. at 669-670 (discussing “premarket regulatory approval”). That has nothing to do with

any separate concerns about commercializing competing

technology, setting up supply chains, conducting marketing and publicity efforts, etc. There is no hint, anywhere,

that those separate tasks justify infringement—particularly in a provision limited “solely for [regulatory] uses.”

35 U.S.C. 271(e)(1).

If the Federal Circuit is indeed correct that Congress

was surely aware of those separate tasks, then there is especially no reason to presume Congress omitted them by

accident. On the contrary, there is every reason to presume their omission was intentional—and Congress enumerated a single basis for the safe harbor because it intended to exclude all others. See, e.g., Jennings v. Rodriguez, 583 U.S. 281, 300 (2018) (expressio unius). And, in

fact, that principle has special force in this setting: not

only did Congress list one item and refuse to include others—it further restricted the safe harbor, textually, by underscoring that “solely” the specified “uses” would escape

the usual rule that parties cannot exploit a patent during

its term. H.R. Rep. No. 857, Pt. 2, supra, at 30 (declaring

any “interference” with patent rights “de minim[i]s”).

While the Federal Circuit insists that Congress would

have understood the need to take advanced steps toward

marketing and commercializing a product, those separate

“uses” are found nowhere in the operative text. Contrary

22

to the Federal Circuit’s view, courts have no license to judicially “redline” the statute to improve upon the provision. Badgerow v. Walters, 596 U.S. 1, 11 (2022).

2. Section 271(e)(1)’s history and purpose confirm

what the text already makes clear: the safe harbor applies

“solely” for protected uses. 35 U.S.C. 271(e)(1).

Initially, Section 271(e)(1) was designed to override

the Federal Circuit’s earlier decision in Roche, which rejected any protection for activities “strictly related” to

seeking regulatory approval (733 F.2d at 861). On its face,

the limited safe harbor corresponds to the same question

Roche addressed and Congress overturned. H.R. Rep.

No. 857, Pt. 2, supra, at 27 & n.18. There is no hint Congress intended to expand the safe harbor to protect nonregulatory uses (which were not at issue), and Section

271(e)(1) accordingly should be limited to the same footprint. Eli Lilly, 496 U.S. at 670.

Put simply: “the legislative history expressly states

that the provisions of § 271(e) ‘have the net effect of reversing [Roche’s] holding.’” App., infra, 21a (Lourie, J.,

dissenting); see also H.R. Rep. No. 857, Pt. 2, supra, at 27;

accord H.R. Rep. No. 857, Pt. 1, supra, at 45-46. Congress

retained that “net effect” by enforcing a reciprocal correction; the Federal Circuit’s contrary rule eliminates that

calibration by sweeping in activity broader than the “narrow” category addressed by Roche.

The remainder of the legislative record is likewise unambiguous: the safe harbor was limited strictly to seeking

regulatory approval, not other non-regulatory uses. Eli

Lilly, 496 U.S. at 671; App., infra, 21a-22a (Lourie, J., dissenting). That was the essential compromise. Nowhere

did Congress hint that parties could engage in commercial

activity so long as they could also hook their infringing

acts to some regulatory “use.” See, e.g., H.R. Rep. No.

23

857, Pt. 2, supra, at 30 (“all that the generic can do is test

the drug for purposes of submitting data to the FDA”).

As this Court itself recounted, Congress expanded patent rights on the front end (solely to account for regulatory delay), so it restricted patent enforcement on the

back end (again, solely to account for regulatory delay).

Eli Lilly, 496 U.S. at 669-670. The entire provision targets

the regulatory process. It recognizes the delay from that

process, and it sought to avoid “de facto” patent extensions while parties sought regulatory approval. Ibid. But

there is no hint that Congress also sought to give competitors a head-start on commercial activities. Those activities have the potential to distort the market and unduly

interfere with exclusive patent rights before the patent

term expires. If Congress wished to permit those kinds of

acts, it would have said so directly—rather than unambiguously specifying the “sole[]” uses (read: not commercial)

that fall within the statutory safe harbor. See, e.g., H.R.

Rep. No. 857, Pt. 2, supra, at 8, 30 (competitors were “not

permitted to market the patented drug during the life of

the patent”; the patent owner “retain[ed] the right to exclude others from the major commercial marketplace”).

Neither the Federal Circuit nor Meril could identify a

single snippet of legislative material endorsing the Federal Circuit’s sweeping position—ignoring an infringer’s

“alternative uses” and permitting commercial activity so

long as some regulatory use is also present. It is rare to

find such a perfect fit between the plain text and every

primary component of the legislative record; it is rarer

24

still to find a court willing to discard that uniform legislative directive in favor of its own atextual judge-made rule. 9

*

*

*

As this Court has readily confirmed, like all other statutes, the patent laws should be construed according to

“the text of the statute” (Life Techs. Corp. v. Promega

Corp., 580 U.S. 140, 146 (2017)), yet the Federal Circuit

has once again adopted a rule “untethered to the statutory

text” (Limelight Networks, Inc. v. Akamai Techs., Inc.,

572 U.S. 915, 926 (2014)). The Federal Circuit has struck

the critical term in the key clause of a crucial provision,

and in doing so expanded a safe harbor designed “solely”

for one “use” into immunity for any associated infringing

activity—even for separate “uses” extending far beyond

the regulatory process. App., infra, 9a, 11a, 18a.

It is exceptionally important to reestablish that Section 271(e)(1)’s text means what it says: it excuses infringing acts “solely” for “uses” concerning regulatory approval, not any corresponding marketing, advertising,

commercialization, etc., so long as a party identifies some

qualifying use along the way. The Federal Circuit has refused to reconsider its position, and this Court alone can

now fix its mistake. Immediate review is warranted.

Contrary to Meril’s position below (C.A. Reh’g Opp. 11-12), the

plain-text analysis has nothing to do with motivation or subjective intent. It is not a question of what one hopes or aspires to accomplish

with a given use. The question is both factual and objective: Meril imported the device for a specific use(s), and the statute asks whether

that particular use(s) “solely” concerns regulatory approval. In this

case, it is undisputed that Meril imported the devices to use in a simulator at the conference (e.g., C.A. Reh’g Opp. 6 (so conceding))—displayed for both potential clinical investigators (a regulatory use) and

other attendees (a non-regulatory use). That has nothing to do with

mens rea—and courts can readily examine the operative question

based on an ordinary factual record.

9

25

B. The Question Presented Is Exceptionally Important And Warrants Review In This Case

1. The question presented is of obvious legal and practical importance. The need for further review is self-evident. The real-world stakes are consequential: this provision defines the proper boundary between innovation and

competition, and sets the marketplace rules for billiondollar technologies in a trillion-dollar industry. Congress

legislated specifically to address this problem, calibrating

a solution that accounts for regulatory delay while respecting the rights of patent holders. Yet the Federal Circuit has distorted Congress’s framework in a significant

way—permitting extensive commercial activity that is anything but “de minim[i]s.” H.R. Rep. No. 857, Pt. 2, supra,

at 30.

It is thus no surprise that experts recognized the import of the court’s ruling—flagging this as a “pivotal moment in the [safe harbor’s] interpretation” with “farreaching implications” (Dr. Chen, The Broad Impact of

Edwards, supra); highlighting a sudden allowance of commercial acts that previously were barred (Payne, Life Sciences Cases To Watch, supra); and underscoring Section

271(e)(1)’s novel expansion (Courtenay C. Brinckerhoff,

et al., Federal Circuit Applies Safe Harbor to Imported

Medical Device Samples, The National Law Review

(Mar. 27, 2024) <https://natlawreview.com/article/federal-circuit-applies-safe-harbor-imported-medical-device-samples> (the decision below “suggests the [safe]

harbor could be wider than many believed”)).

Aside from its sheer magnitude, the issue also arises

with great frequency. The Federal Circuit has had “numerous” encounters with the subject. App., infra, 8a. This

Court has twice granted review on related questions, underscoring the safe harbor’s “importan[ce].” Eli Lilly, 496

26

U.S. at 661; see Merck, 545 U.S. at 193; see also, e.g., Abtox, Inc. v. Exitron Corp., 888 F. Supp. 6, 7 (D. Mass.

1995) (acknowledging the issue’s “significance”). The

question has split Federal Circuit panels, 10 divided district

courts, 11 and garnered close attention from experts and industry stakeholders—who are carefully tracking this very

case. See, e.g., Brinckerhoff, Federal Circuit Applies Safe

Harbor, supra; see also p. 4 n.1, supra. And yet all stakeholders are now bound by the Federal Circuit’s mistaken

ruling until this Court intervenes.

In the meantime, under the decision below, patent

holders have no reliable way to enforce their rights. Goodfaith market entrants face disadvantages when aggressive counterparts are willing to push the limit—exploiting

the Federal Circuit’s “misconstruction” to pursue commercial uses while others properly await a patent’s expiration before engaging in non-regulatory conduct. The opportunities for “mischief” are tangible (App., infra, 30a

(Lourie, J., dissenting)): parties are free to import patented devices to set up commercial relationships, promote and market those devices, and (incidentally) obtain

FDA approval. App., infra, 9a, 11a, 18a. Under Federal

Circuit law, any commercial activity is arguably fair game

See, e.g., App., infra, 19a (Lourie, J., dissenting); Momenta

Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348, 1361, 13731374 (Fed. Cir. 2012) (Rader, J., dissenting).

10

See, e.g., Amgen, Inc. v. Hoechst Marion Roussel, Inc., 3 F.

Supp. 2d 104, 107-108 (D. Mass. 1998) (flagging earlier district-court

conflicts); Elan Transdermal Ltd. v. Cygnus Therapeutic Sys., No.

91-1314, 1992 WL 368678, at *7 (N.D. Cal. June 23, 1992) (same).

While the lower-court conflicts were generally supplanted by the

Federal Circuit, the fact that objective jurists initially read the safe

harbor to mean what it says is a telling indication of the Federal Circuit’s interpretive errors. See Amgen, 3. F. Supp. 2d at 107 (recounting judicial “h[olding] that the defendant must use the invention for

meeting FDA requirements, and for no other purposes”).

11

27

so long as the party also establishes some nexus to the

regulatory process (id. at 18a)—despite Congress restricting the safe harbor to the regulatory process alone

(35 U.S.C. 271(e)(1)). As others have long recognized,

“eliminating the word ‘solely’” from the safe harbor ignores the text and upsets the “narrow compromise between pioneer and generic drug companies” that Congress crafted in Hatch-Waxman. Amy Stark, The Exemption from Patent Infringement and Declaratory Judgments: Misinterpretation of Legislative Intent?, 31 San

Diego L. Rev. 1057, 1074-1075 (1994).

The Federal Circuit’s atextual position will continue to

create confusion, foster litigation, and generate uncertainty—all in a regulatory environment where clear rules

and fair competition are essential for industry stakeholders to plan and execute million- and billion-dollar research

investments. Yet the “current trend towards expansiveness” has left “many practitioners wonder[ing] if there

are any uses or commercial activities that will be outside

the scope of the safe harbor provision.” Darby T.R. Findley, There’s A Storm A Brewin’: Can the Hatch-Waxman

“Safe Harbor” Provision Shield Commercial Stockpiling

from A Potential Downpour of Patent Infringement Allegations?, 26 Fed. Circuit B.J. 307, 309 (2017). 12

The Federal Circuit’s decision assumes even greater significance

in light of this Court’s decision in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005)—which assigned the safe harbor a

broad scope for actual regulatory uses. 545 U.S. at 202, 207; see Momenta, 686 F.3d at 1356 (describing the Court’s “expansive view”).

Because the safe harbor covers a wide swath of qualifying uses, it becomes easier to identify (or fabricate) any use that might qualify—

and thus, under Federal Circuit precedent, easier to excuse infringing acts with both protected and non-protected aims. A proper reading of “solely” is now essential to ensure that non-qualifying uses are

not excused, and parties can safely pursue FDA approval without others abusing the system.

12

28

In the words of one expert: “Judge Lourie may be

right that the ‘law could usefully be clarified,” “expressly

returning the word ‘solely’ to its Congressionally-enacted

place in the statute.’” Dennis Crouch, Federal Circuit Debates Scope of 271(e)(1) Safe Harbor and the Meaning of

“Solely,” PatentlyO (Mar. 27, 2024) <https://patentlyo.com/patent/2024/03/federal-circuit-debates.html>.

This Court’s immediate review is warranted.

2. This case is an ideal opportunity to resolve this significant question. The dispute turns on a pure question of

law: the proper construction of the statute. It arises in a

clean vehicle: it was resolved at summary judgment, and

each court below declared Meril’s “alternative” uses “irrelevant” under (incorrect) circuit precedent. There are

no complicating factors or obstacles to reaching the statutory issue. And Judge Lourie’s dissent confirms the

Act’s proper construction is outcome-determinative: Edwards lost because the majority applied its (atextual)

reading, but would have prevailed under Judge Lourie’s

plain-text construction. As Judge Lourie confirmed, the

legal errors were dispositive. 13

The majority (playfully) minimized Meril’s infringing activity,

suggesting the imported devices simply “sat in a bag.” App., infra, 2a.

This is twice inapposite. First, as established above, the only reason

the devices were not displayed was Meril’s simulator malfunctioned.

See, e.g., App., infra, 37a. Had Meril not experienced technical difficulties, the devices would have been prominently used at the conference. Second, the relevant focus is on Meril’s importation—and there

is no dispute that Meril imported the devices to use in a simulator at

the conference (for both regulatory and non-regulatory uses). That

tees up the statutory question perfectly: Meril’s infringing act was for

both “regulatory” uses and “alternative” uses. The split panel held

the Act’s safe harbor applied if Meril identified any regulatory use—

even if Meril also engaged in “alternative” non-regulatory uses. Id.

at 9a, 18a. If the panel’s reading is correct, Meril wins; if the dissent’s

13

29

Nor is there any reason to postpone review. There is

no possibility of a circuit conflict (given the Federal Circuit’s exclusive jurisdiction), and the full circuit denied rehearing. The Federal Circuit’s position is now entrenched.

It will remain the last word on this critical issue until this

Court intervenes.

At bottom, the statutory question is binary: one view

of “solely” is correct and the other is wrong, and “alternative” commercial uses are either permitted or not. The answer has serious economic and practical stakes. The Federal Circuit has advanced an atextual construction that

undermines Congress’s design and interferes with Section 271(e)(1)’s scope. This Court alone can now correct

the Federal Circuit’s mistake—and finally align the governing standard with the safe harbor’s plain text. There is

an urgent and compelling need to restore the proper statutory meaning.

reading is correct (and “solely” means what it says), Meril loses. The

vehicle is as clean as it gets.

30

CONCLUSION

The petition for a writ of certiorari should be granted.

Respectfully submitted.

GAIL A. KATZ

TRACEY DAVIES

AVRAHAM SCHWARTZ

JESSICA A. HUDAK

EDWARDS LIFESCIENCES

CORPORATION

One Edwards Way

Irvine, CA 92614

OCTOBER 2024

DANIEL L. GEYSER

Counsel of Record

HAYNES AND BOONE, LLP

2801 N. Harwood Street, Ste. 2300

Dallas, TX 75201

(303) 382-6219

daniel.geyser@haynesboone.com

ANGELA M. OLIVER

HAYNES AND BOONE, LLP

800 17th Street, N.W., Ste. 500

Washington, DC 20006