United States Court of Appeals 

for the Federal Circuit ______________________ 

EDWARDS LIFESCIENCES CORPORATION, 

EDWARDS LIFESCIENCES LLC,

Plaintiffs-Appellants

v.

MERIL LIFE SCIENCES PVT. LTD., MERIL, INC.,

Defendants-Appellees

______________________ 

2022-1877

______________________ 

Appeal from the United States District Court for the 

Northern District of California in No. 4:19-cv-06593-HSG, 

Judge Haywood S. Gilliam, Jr.

______________________ 

Decided: March 25, 2024

______________________ 

STEVEN MARK HANLE, Stradling Yocca Carlson & 

Rauth, PC, Newport Beach, CA, argued for plaintiffs-appellants. Also represented by CHRISTY G. LEA, Knobbe, 

Martens, Olson & Bear, LLP, Irvine, CA; GAZAL POURMOEZZI, I, CARLO FRANK VAN DEN BOSCH, Sheppard Mullin 

Richter & Hampton LLP, Costa Mesa, CA. 

 J. DAVID HADDEN, Fenwick & West LLP, Mountain 

View, CA, argued for defendants-appellees. Also represented by MELANIE LYNE MAYER, JONATHAN THOMAS 

MCMICHAEL, Seattle, WA. 

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 ______________________ 

Before LOURIE, STOLL, and CUNNINGHAM, Circuit Judges. 

Opinion for the court filed by Circuit Judge STOLL. 

Dissenting opinion filed by Circuit Judge LOURIE. 

STOLL, Circuit Judge. 

Travel isn’t always pretty. This case concerns the

seven-day trip of two transcatheter heart valve systems in 

and out of San Francisco to attend a medical conference. 

Once in San Francisco, however, the two heart valve systems did not attend the medical conference. Instead, they 

sat in a bag: first, in a hotel closet; then in a storage 

room—never displayed or offered for sale—before leaving

the country to attend the next medical conference in Europe. 

Edwards Lifesciences Corporation and Edwards 

Lifesciences LLC (collectively, “Edwards”) appeal the 

Northern District of California’s summary judgment in favor of Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collectively, “Meril”) that Meril’s act of importation of the two 

transcatheter heart valve systems fell within the safe harbor provision of 35 U.S.C. § 271(e)(1). Because we conclude 

the undisputed evidence shows Meril’s importation of the 

two transcatheter heart valve systems was reasonably related to submitting information to the United States Food 

and Drug Administration, we affirm the district court’s 

summary judgment of noninfringement. 

BACKGROUND

Meril is an India-based medical device company that 

created its Myval-branded transcatheter heart valves, as 

part of its Myval System, to treat heart disease. Edwards, 

a competitor medical device company, likewise supplies 

medical devices aimed at the treatment of heart disease, 

namely artificial heart valve systems. 

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I 

Meril started clinical trials for its Myval System in India in June 2017 and received regulatory approval to market the Myval System in India in October 2018. In 

April 2019, the Myval System received CE certification, 

meaning it conformed to health and safety standards for 

products sold within the European Economic Area. As a 

result, Meril was allowed to market the Myval System in 

the European Economic Area.

Here in the United States, the Myval System is considered a “Class III” medical device and is thus subject to certain regulatory standards. See 21 U.S.C. 

§ 360c(a)(1)(C)(ii)(1) (classifying a Class III device as “for a 

use in supporting or sustaining human life or for a use 

which is of substantial importance in preventing impairment of human health”). As such, Meril cannot market or 

sell the Myval System in the United States without first 

receiving mandatory premarket approval from the United 

States Food and Drug Administration (FDA). See

21 U.S.C. § 360c; 21 C.F.R. § 812.20; 21 C.F.R. § 812.42.

To receive premarket approval from the FDA, Meril 

must first apply for and obtain an investigational device 

exemption, identify clinical investigators to implant the device in human subjects, collect data from those subjects, 

and then submit the data to the FDA. Because the premarket approval process can be lengthy and difficult to 

navigate, Meril first started work on a premarket submission to the FDA. A premarket submission allows device 

manufacturers, like Meril, to request formal regulatory 

feedback on the device before officially engaging in the premarket approval process. Separately, Meril began planning a “Landmark Trial”—a three-arm trial comparing the 

Myval System with the market leading devices in Europe, 

including Edwards’s SAPIEN valves—that could be included as part of future submissions to the FDA. 

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In August 2019, Meril contacted the FDA to inquire 

about the applicability of its Landmark Trial and the preliminary requirements for filing a premarket submission. 

The FDA responded in early September 2019. Shortly 

thereafter, Meril also contacted CardioMed LLC, a medical 

device consulting company that provides regulatory and 

clinical trial consulting services, including for premarket 

approval submissions. Meril sought its help in preparing 

a premarket approval submission for the Myval System to 

file with the FDA. Over the next two months, Meril worked 

with CardioMed on the premarket approval submission’s 

content and form. 

II

In parallel, Meril sought out potential clinical researchers for FDA clinical trials at the 2019 Transcatheter 

Cardiovascular Therapeutics Conference in San Francisco 

(“TCTC”). TCTC is an annual scientific symposium hosted 

by the Cardiovascular Research Foundation featuring the 

latest developments in interventional cardiovascular medicine. TCTC lasted from September 25 through September 29, 2019, and Meril had a booth at TCTC from 

September 26 through September 28, 2019.

In advance of TCTC, Meril consulted with its attorneys 

and drafted “Instructions for TCT 2019 for Myval THV System.” Appellants’ Br. 12. It then orally conveyed these instructions to the twenty Meril employees who attended 

TCTC. These instructions include: 

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.

Id. On September 24, 2019, Nilay Lad, a Meril employee, 

traveled to San Francisco to attend TCTC. He carried two 

sample Myval Systems with him on his flight to San 

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Francisco International Airport. The two samples were in 

a bag, accompanied by a written declaration stating:

This is to inform you that the demo samples carried 

by Mr. Nilay Lad is for the demonstration purpose 

only. It is consist [sic] of Demo samples of Medical 

devices. They have no commercial value & hence it 

is not used for any sales purpose. 

The demo samples are NON-STERILE. NOT FOR 

HUMAN USE. NOT FOR SALE. NOT 

APPROVED FOR SALE IN UNITED STATES. 

FOR DEMO PURPOSE ONLY AT TCT 2019, SAN 

FRANCISCO.

Appellees’ Br. 11. Mr. Lad initially placed the bag containing the two samples in his hotel room closet. On September 27, 2019, Mr. Lad carried the bag containing the two 

sample Myval Systems to TCTC, where the bag was kept 

in a storage room overnight. It is undisputed that the sample Myval Systems were never taken out of the bag or 

shown to anyone after they was imported into the United 

States. 

At TCTC, Meril provided information on, inter alia, its 

Myval System with displays and presentations. None of 

these displays and presentations, however, included pricing or commercially promoted the Myval System. Meril 

stated to conference attendees that the Myval System was 

not yet approved by the FDA and that it was not available 

for sale in the United States. Moreover, it is undisputed 

that TCTC is attended by researchers and clinicians. Meril 

discussed the details of the Myval System with several U.S. 

doctors to identify potential clinicians for its premarket approval application. And it is undisputed that Meril did not 

offer for sale or sell the Myval System to anyone at TCTC. 

On September 28, Mr. Lad handed the Myval Samples to 

another Meril employee to take to Europe on September 30.

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Later, in December 2019, Meril submitted a premarket 

approval submission to the FDA proposing that Meril conduct clinical trials both in the United States and outside 

the United States, with about 30% of patients enrolled at 

U.S. clinical sites. Appellees’ Br. 14. In February 2020, the 

FDA responded, advising that to obtain FDA approval

Meril would need to enroll at least 50% of human test subjects at U.S. clinical sites. Id. Then, in May 2020, Meril 

provided a supplemental submission revising the study to 

enroll at least 50% of human test subjects at U.S. clinical 

sites. Id.

In October 2019, following TCTC, Edwards filed suit 

against Meril for infringement based on the importation of 

the two heart valve systems, seeking a litany of remedies. 

And one year later, the district court granted Meril’s motion for summary judgment, determining that Meril’s importation of the Myval System was exempt from patent

infringement under the safe harbor of 35 U.S.C. 

§ 271(e)(1). See Edwards Lifesciences Corp. v. Meril Life 

Scis. Pvt. Ltd., No. 19-CV-06593, 2020 WL 6118533 (N.D. 

Cal. Oct. 16, 2020). 

Edwards appeals. We have jurisdiction under 

28 U.S.C. § 1295(a)(1).

DISCUSSION

This court reviews summary judgment decisions under 

the law of the regional circuit, here the Ninth Circuit. 

MAG Aerospace Indus., Inc. v. B/E Aerospace, Inc., 

816 F.3d 1374, 1376 (Fed. Cir. 2016); Spigen Korea Co., 

Ltd. v. Ultraproof, Inc., 955 F.3d 1379, 1382–83 (Fed. Cir. 

2020). The Ninth Circuit reviews a grant of summary judgment de novo. MAG Aerospace, 816 F.3d at 1376 (citing 

Greater Yellowstone Coal. v. Lewis, 628 F.3d 1143, 1148 

(9th Cir. 2010)). “Summary judgment is appropriate if, after viewing the evidence in the light most favorable to the 

nonmoving party [and drawing all reasonable inferences in 

its favor], no genuine issue of material fact exists.” Pauma 

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Band of Luiseno Mission Indians of the Pauma & Yuima 

Rsrv. v. California, 973 F.3d 953, 961 (9th Cir. 2020). Important here, a fact issue is genuine “if the evidence is such 

that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 

242, 248 (1986).

This case presents the question of whether 35 U.S.C. 

§ 271(e)(1)’s safe harbor applies when undisputed evidence 

shows Meril’s importation of two demonstration samples of 

its transcatheter heart valves to a medical conference was 

reasonably related to recruiting investigators for a clinical 

trial to support FDA approval. We hold that it does.

I 

Section 271(e)(1) is a safe harbor for defendants for 

what would otherwise constitute infringing activity. And

it applies to medical devices like Meril’s transcatheter 

heart valves. See Eli Lilly & Co. v. Medtronic, Inc., 

496 U.S. 661, 670–71, 674 (1990). Section 271(e)(1) sets 

forth: 

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 . . . . 

35 U.S.C. § 271(e)(1) (emphases added). The safe harbor 

“provides a wide berth for the use of patented [inventions] 

in activities related to the federal regulatory process.” 

Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 

202 (2005). As the Supreme Court in Merck explained, “it 

[is] apparent from the statutory text that § 271(e)(1)’s exemption from infringement extends to all uses of patented 

inventions that are reasonably related to the development 

and submission of any information under the [Federal 

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Food, Drug, and Cosmetic Act].” Id. at 202. Moreover, the 

§ 271(e)(1) exemption is not limited temporally. Mooring

in the safe harbor is available to defendants irrespective of 

the stage of research and even if the information is never 

ultimately submitted to the FDA. See id. (“There is simply 

no room in the statute for excluding certain information 

from the exemption on the basis of the phase of research in 

which it is developed or the particular submission in which 

it could be included.”). 

This court has interpreted § 271(e)(1) on numerous occasions, and “[t]hough the contours of this provision are not 

exact in every respect,” Merck KGaA, 545 U.S. at 202, our 

precedent is clear that “[t]he exemption applies ‘as long as 

there is a reasonable basis for believing’ that the use of the 

patented invention will produce the types of information 

that are relevant to an FDA submission,” Amgen Inc. 

v. Hospira, Inc., 944 F.3d 1327, 1338 (Fed. Cir. 2019) (quoting Merck KGaA, 545 U.S. at 207–08). “The breadth of the 

exemption extends even to activities the ‘actual purpose’ of 

which may be ‘promot[ional]’ rather than regulatory, at 

least where those activities are ‘consistent with the collection of data necessary for filing an application with the 

[FDA] . . . .’” Momenta Pharm., Inc. v. Teva Pharm. USA 

Inc., 809 F.3d 610, 619 (Fed. Cir. 2015) (alterations in original) (quoting AbTox, Inc. v. Exitron Corp., 122 F.3d 1019, 

1027 (Fed. Cir. 1997)). A review of our decisions in AbTox, 

Momenta, and Amgen is instructive to the issue before us. 

Starting with AbTox, we held the statute “does not look 

to the underlying purposes or attendant consequences of 

the activity . . . as long as the use is reasonably related to 

FDA approval.” AbTox, 122 F.3d at 1030. We so held because “[§] 271(e)(1) requires only that the otherwise infringing act be performed ‘solely for uses reasonably related 

to’ FDA approval.” Id. In AbTox, defendants conducted 

limited tests consistent with the collection of data necessary for filing an application with the FDA for approval of 

its medical device—activity squarely within the safe 

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harbor. See id. at 1027. However, plaintiff alleged that the 

actual purpose of these tests was not to secure FDA approval; rather, it was to promote the medical device to potential customers and induce a third-party to purchase 

rights to the medical device, which the third-party ultimately did. Id. Still, we determined “intent or alternative 

uses” were “irrelevant” to the invocation of § 271(e)(1) because “the statutory language allows [defendant] to use its 

data from the tests for more than FDA approval.” Id. 

at 1030 (citing Telectronics Pacing Sys., Inc. v. Ventritex, 

Inc., 982 F.2d 1520, 1524–25 (Fed. Cir. 1992) (“If Congress 

intended to make [immediate competition at the end of the 

patent term] more difficult, if not impossible, by preventing 

competitors from using, in an admittedly non-infringing 

manner, the derived test data for fund raising and other 

business purposes, it would have made that intent clear.”)); 

see also Eli Lilly, 496 U.S. at 665–69 (holding § 271(e)(1) 

exempts from infringement the use of patented inventions 

reasonably related to the development and submission of 

information needed to obtain marketing approval of medical devices). 

Our decision in Momenta followed AbTox and clarified 

its holding. Momenta addressed whether “routine record 

retention requirements associated with testing and other 

aspects of the commercial production” as part of the postapproval, commercial production process were protected by 

the § 271(e)(1) safe harbor. And we held they were not. 

The defendant cited AbTox in support of its argument that 

such activity was “for a use reasonably related to the development and submission of information to the FDA.” Momenta, 809 F.3d at 620. Addressing this argument, we 

clarified that the test announced in AbTox applies to preFDA approval: “AbTox stated ‘[a]s long as [an] activity is 

reasonably related to obtaining FDA approval.’” Id. 

at 620–21. At the same time, we re-emphasized that

“§ 271(e)(1) ‘does not look to the underlying purposes or 

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attendant consequences of the activity.’” Id. at 621 (citing 

AbTox, 122 F.3d at 1030). 

Later, consistent with our holdings in AbTox and Momenta, this court in Amgen held that a set of challenged 

jury instructions “struck the appropriate balance by telling 

the jury that [defendant]’s additional underlying purposes 

[for alleged safe harbor activity] do not matter as long as 

[defendant] proved that the manufacture of any given 

batch of drug substance was reasonably related to developing information for FDA submission.” Amgen, 944 F.3d 

at 1339. “The relevant inquiry . . . is not how [defendant] 

used each batch it manufactured, but whether each act of 

manufacture was for uses reasonably related to submitting 

information to the FDA.” Id. at 1339. In Amgen, defendant 

had manufactured twenty-one batches of a drug substance—an otherwise infringing act—and a jury found 

seven of the twenty-one batches entitled to the § 271(e)(1)

safe harbor. Id. at 1338–39. Because the defendant manufactured some batches for “pre-approval inspection” and 

others “for various types of [commercial] testing,” substantial evidence supported the jury’s findings that some 

batches, i.e., the former category, fell into the safe harbor, 

while others, i.e., the latter category, did not. Id. at 1339–

41. This some-in, some-out result for the same type of infringing act makes sense given the language of the statute.

The safe harbor exception in § 271(e)(1) applies “solely

for uses reasonably related to the development and submission of information” to the FDA. Read in context, “solely” 

modifies “for uses.” Meaning, for each act of infringement

the safe harbor is available only for acts or uses that bear 

a reasonable relation to the development and submission 

of information to the FDA. Merck KGaA, 545 U.S. at 205–

07. It is not that the use must only be reasonably related 

to the development and submission of information to the 

FDA. See, e.g., Amgen, 944 F.3d at 1339. 

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Here, therefore, in view of the discussion above, it is 

clear the relevant inquiry is not why Meril imported the 

two transcatheter heart valve systems, or how Meril used 

the imported transcatheter heart valve systems, but 

whether the act of importation was for a use reasonably 

related to submitting information to the FDA. With this 

rule in mind, we determine whether the district court erred 

in granting summary judgment to Meril.

The district court’s safe harbor inquiry was consistent 

with our precedent and the court did not err in granting 

summary judgment under the undisputed facts. See Edwards Lifesciences, 2020 WL 6118533, at *4–6, *9–10. The 

parties do not dispute the following material facts: Ahead 

of TCTC, Meril had taken steps towards obtaining FDA approval for its transcatheter heart valves, including: “(1) preparing a formal clinical trial synopsis for its 

Landmark Trial; (2) preparing a draft presubmission to 

seek FDA input on its clinical trial; (3) communicating with 

the FDA regarding Meril’s proposed clinical study and its 

presubmission; and (4) hiring an FDA consultant to help 

with the FDA presubmission.” Id. at *6 (citations omitted). 

Additionally, “Meril transported the medical device to 

[TCTC], which was attended by a large number of potential 

clinical trial investigators.” Id. And no sales or offers for 

sale were made at TCTC. Id. Moreover, after TCTC, Meril 

submitted its premarket approval submission to the FDA 

and continued to communicate with the FDA about the 

submission and Meril’s proposed clinical study.

Based on these undisputed facts, we agree with the district court that summary judgment of noninfringement is 

appropriate as a matter of law. Prior to TCTC, Meril had 

taken significant steps towards obtaining FDA approval. 

Meril’s importation of the transcatheter heart valves constituted another step in the right direction “on the road to 

regulatory approval.” Merck, 545 U.S. at 207. We have 

recognized that under U.S. law, “device sponsors,” like 

Meril, “are responsible for selecting qualified investigators 

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and providing them with the necessary information to conduct clinical testing.” Telectronics Pacing Sys., 982 F.2d 

at 1523 (citing 21 C.F.R. § 812.40). We have also held that 

such activity falls within the safe harbor of § 271(e)(1). Id. 

It follows that the importation and transportation of the 

transcatheter heart valves to TCTC is “reasonably related

to FDA approval.” Id. And here, it is undisputed that 

TCTC was attended by many potential clinical investigators. Thus, Meril’s importation of the two transcatheter 

heart valves to TCTC firmly resides in the § 271(e)(1) safe 

harbor. 

II

Edwards presents three primary challenges to the district court’s grant of summary judgment of noninfringement. First, Edwards attempts to create a genuine issue 

of material fact, arguing the district court disregarded contemporaneous evidence and failed to view such evidence in 

the light most favorable to Edwards (the nonmovant). Second, Edwards argues the district court did not apply the 

safe harbor with an objective standard because, in Edwards’s view, the district court solely relied on Meril’s alleged subjective intent for the importation. Third, 

Edwards argues the district court improperly relied on declarations from Meril employees who, according to Edwards,

lack personal knowledge of the material facts. None of 

these arguments convinces us that the district court erred 

in granting summary judgment of noninfringement under 

the undisputed facts of this case. 

A 

To generate a genuine dispute of material fact, Edwards argues that the district court “erroneously disregarded” the “strong contemporaneous evidence from the 

time of the importation from which a jury could reasonably 

conclude that [the transcatheter heart valves] were imported exclusively for use as commercial sales tools.” Appellants’ Br. 34–35 (emphasis in original). In support, 

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Edwards identifies numerous evidentiary bases in the record from which it contends “a jury could reasonably conclude that Meril imported the [transcatheter heart valves]

solely to support commercial sales, rather than to recruit

clinical investigators.” Appellants’ Br. 37; see also Appellants’ Br. 25–27, 42–44. We have reviewed the cited evidence, however, and the inferences that Edwards asks this 

court to draw are not reasonably drawn from the evidence, 

and thus no “genuine” dispute exists. Anderson, 477 U.S. 

at 248–50. Therefore, we conclude no genuine dispute of 

material fact exists as to whether Meril’s importation of the 

two transcatheter heart valves to TCTC is exempt under 

the § 271(e)(1) safe harbor. To further illuminate our 

views, we address three such arguments by Edwards below. 

First, Edwards contends that instructions to Meril 

sales personnel attending TCTC “are the most probative 

evidence of Meril’s planned use for the imported 

[transcatheter heart valves].” Appellants’ Br. 25–26. 

These instructions, inter alia, state: “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 for 

other countries.” Appellants’ Br. 35. In Edwards’s view, 

“[t]he district court’s finding that ‘no sales or offers for sale’ 

occurred at TCT is clearly rebutted by Meril’s Instructions 

to its TCT marketing team to ‘make offer for other countries.’” Appellants’ Br. 36. This view, however, is untethered from the factual record as a whole in this case. The 

instructions clearly instruct Meril employees not to sell or 

make offers to sell while at the conference or in the United 

States for the U.S. market. Moreover, it remains undisputed that no sales or offers for sale—either in the United 

States or outside the United States—occurred at TCTC, despite Meril’s instruction regarding sales outside the United 

States. Based on that undisputed fact alone, no reasonably 

minded juror could conclude that Meril’s importation and 

transportation of the transcatheter heart valves was 

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“solely to support commercial sales, rather than to recruit 

clinical investigators.” Appellants’ Br. 37.

Second, Edwards contends it is reasonable to infer that 

“Meril’s importation was to support its sales efforts entirely unrelated to any clinical recruiting or FDA-related 

activities” because Meril had not planned to bring the imported transcatheter heart valves to a dinner for potential 

clinical investigators. Appellants’ Br. 42–43 (emphasis in 

original). Here, it is undisputed that TCTC was attended 

by potential clinical investigators. And Meril interacted 

with potential clinical investigators at TCTC. The dinner 

was only one of several opportunities for Meril to recruit 

and interact with potential clinical investigators. Just because Meril did not bring the transcatheter heart valves to 

dinner, it does not follow that Meril’s importation was to 

support its sales efforts and was “entirely unrelated” to any 

clinical recruiting. 

Third, Edwards contends that “the fact that Meril routinely ignored its own FDA consultant and FDA guidance 

regarding the voluntary presubmission and study design, 

signal[s] it had no genuine plans to convert the Landmark 

Trial to one that could be used for FDA approval.” Appellants’ Br. 44 (citing J.A. 1036, 1047, 1049–50). Again, here, 

it is undisputed that Meril hired a regulatory consultant to 

assist with preparing a voluntary premarket submission to 

the FDA. And it is undisputed that Meril contacted the 

FDA regarding the voluntary premarket submission ahead 

of TCTC. After a back and forth with its FDA consultant, 

Meril submitted a premarket approval submission to the 

FDA proposing about 30% of patients enrolled at U.S. clinical sites contrary to its consultant’s recommendation. 

From this, it is not reasonable to infer that Meril had “no 

genuine plans” to conduct trials in the United States. In 

fact, Meril provided a supplemental submission to the FDA 

revising the study to enroll at least 50% of human test subjects at U.S. clinical sites. Clinical trials are expensive. 

And we fail to see how one could reasonably infer Meril 

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lacked an overall commitment to conducting a U.S.-based 

study from its business decision to push the envelope in 

hopes that the FDA might allow for a lower percentage of 

U.S.-based study subjects. 

At bottom, none of the evidence Edwards points to creates a genuine issue of material fact precluding summary 

judgment because no reasonably minded juror could draw 

an inference “that Meril’s sole purpose for importing Myval 

Devices was to support its commercial sales efforts, and the 

importation was wholly unrelated to recruiting clinical investigators and wholly unrelated to any FDA submission.” 

Appellants’ Br. 52 (emphasis in original). 

B 

Separately, Edwards contends that because Meril 

never actually used the devices after their importation, its 

safe harbor defense fails as a matter of law since § 271(e)(1) 

requires a use distinct from the otherwise infringing acts 

(make, use, offer to sell, sell, import) delineated in the statute. From this premise, Meril further argues that “because 

there was no actual post-importation use, evidence of 

Meril’s intent appears to be the only probative evidence on 

applicability of the safe harbor.” Appellants’ Br. 49 (emphasis in original). Continuing, Edwards asserts that because the district court cited to Meril’s “self-serving” 

declarations—“the only evidence connecting the importation to obtaining FDA approval[, which] is evidence of 

Meril’s subjective intent”—the district court erred in 

“deeming Meril’s intent irrelevant in the absence of evidence of a protected use.” Appellants’ Br. 49–50. 

Edwards’s argument fails for at least two reasons. To 

start, nothing in the text of § 271(e)(1) requires an actual 

use separate and distinct from the delineated infringing 

acts. Edwards presented this argument to the district 

court, and we agree with the district court’s analysis:

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[A]s noted, the safe harbor provides 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 development and 

submission of information” to the FDA. 35 U.S.C. 

§ 271(e)(1). The statute lists each of the possibly 

infringing acts (making, using, offering to sell, selling, and importing) separately, making clear that 

importation by itself (without actual use) can fall 

within the safe harbor. The clause “solely for uses 

reasonably related to the development and submission of information” to the FDA also does not require an “actual use.” As the Federal Circuit has 

explained, the safe harbor applies “[a]s long as the 

[allegedly infringing] activity [e.g., making, using, 

selling, offering for sale, and importing] is reasonably related to obtaining FDA approval.” AbTox, 

122 F. 3d at 1030.

Edwards Lifesciences, 2020 WL 6118533 at *5. Second, 

Edwards’s argument is contrary to our law. As discussed 

above, our interpretation of § 271(e)(1) applies the safe harbor regardless of the defendant’s intent or purpose behind 

the otherwise infringing act. See, e.g., Amgen, 944 F.3d 

at 1338–39; AbTox, 122 F.3d at 1030. Nothing in our jurisprudence suggests that the availability of the safe harbor 

turns on the party’s subjective intent behind an act. And 

that remains true regardless of whether there are additional uses by defendant. Thus, Edwards’s argument that

the district court erred because it did not consider Meril’s 

intent is contrary to our jurisprudence and lacks merit.

C 

Finally, Edwards argues “the district court erred by 

crediting Meril’s uncorroborated declaration testimony as 

the sole basis for finding that Meril’s importation ‘was reasonably related to the submission of information to the 

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FDA.’” Appellants’ Br. 41–42 (quoting J.A. 10). Specifically, Edwards takes issue with the declaration of Nilay 

Lad, the Meril employee who carried the Myval Samples 

with him on the flight to San Francisco. According to Edwards, Mr. Lad “lacked personal knowledge of the facts declared.” Appellants’ Br. 41. 

First, while the district court cites to the Lad declaration quite frequently, it did not only rely on this declaration 

in reaching its conclusion. For example, the district court 

cites to other expert and witness testimony and declarations when concluding that Meril’s importation was reasonably related to the submission of information to the 

FDA. Edwards Lifesciences, 2020 WL 6118533 at *6 & n.4

(citing to the Mayer Declaration, Nair Deposition, Stephens Declaration, and Bhatt Deposition). Second, it is

simply not true that Mr. Lad lacked personal knowledge of 

the facts in his declaration because “Mr. Lad personally 

transported the Myval Samples to the TCT Conference, 

and he testified that he consulted with counsel and 

Mr. Bhatt about bringing the Myval System to the TCT 

Conference.” Id. at *6 n.4. Edwards objected to portions of 

the Lad Declaration before the district court and the district properly overruled the objections. Nothing in the record before us suggests that the district court abused its 

discretion in so ruling based on its finding that Mr. Lad 

had personal knowledge concerning the facts in his declaration.

CONCLUSION

We have considered the parties’ remaining arguments 

and find them unpersuasive. For the reasons above, we 

affirm the district court’s decision granting summary judgment of noninfringement under § 271(e)(1)’s safe harbor.

AFFIRMED

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United States Court of Appeals 

for the Federal Circuit ______________________ 

EDWARDS LIFESCIENCES CORPORATION, 

EDWARDS LIFESCIENCES LLC,

Plaintiffs-Appellants

v.

MERIL LIFE SCIENCES PVT. LTD., MERIL, INC.,

Defendants-Appellees

______________________ 

2022-1877

______________________ 

Appeal from the United States District Court for the 

Northern District of California in No. 4:19-cv-06593-HSG, 

Judge Haywood S. Gilliam, Jr.

______________________ 

LOURIE, Circuit Judge, dissenting.

I respectfully dissent. I do so because the majority perpetuates the failure of this court and others to recognize 

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

The majority also errs in following the error of AbTox, Inc. 

v. Exitron Corp., 122 F.3d 1019 (Fed. Cir.), opinion 

amended on reh’g, 131 F.3d 1009 (Fed. Cir. 1997), and its 

progeny that the purposes of the infringing act do not matter in evaluating the safe harbor. 

I believe that “solely” creates a safe harbor only for 

uses, sales, and importations that solely are for, as the statute says, development of information for the FDA. The 

purpose of the infringing act is meaningful and important 

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to determining the safe harbor. And attempts to tie the 

word “solely” to be modifying one or another subsequent 

term does not change that meaning. 

Arguably, the district court in this case reasonably followed the decisions of this court in finding no genuine dispute of fact as to whether Meril’s importation of two 

allegedly infringing Myval devices fell within the safe harbor of § 271(e)(1). However, I believe that the court erred 

by incorrectly applying the law, perhaps because of a series 

of pronouncements by this court, in its holdings and explanatory language, and on specific facts, that failed to focus on the full language of the statute. For one reason or 

another, our case law has incorrectly given short shrift to 

the word “solely” in the statute. The majority, in its opinion, perpetuates the courts’ misconstruction of the law. It 

is time to fix those errors. 

Under the plain language of the law, if the district 

court had been writing on a clean slate, Meril’s importation 

of the accused Myval devices and its subsequent actions 

during TCTC (i.e., a conference on advances in cardiovascular medicine) should have raised a genuine dispute as to 

whether the importation was “solely for uses reasonably related to the development and submission of information” 

under federal law, thereby precluding a grant of summary 

judgment. 35 U.S.C. § 271(e)(1) (emphasis added). 

There is no question that § 271(e)(1) was enacted as 

part of the Hatch-Waxman Act to permit generic drug manufacturers to perform otherwise-infringing activity (e.g., 

making or using a patented compound) during the life of a 

patent in order to be able to go on the market when the 

patent expires or is invalidated. See H.R. Rep. No. 98-857, 

pt. 1, at 45–46 (1984), as reprinted in 1984 U.S.C.C.A.N. 

2647, 2678–79 (“The purpose of sections 271(e)(1) and (2) is 

to establish that experimentation with a patented drug 

product, when the purpose is to prepare for commercial activity which will begin after a valid patent expires, is not a 

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patent infringement.”). Such activity, before the enactment of this statute, was an infringement. See Roche 

Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858, 861 (Fed. 

Cir. 1984) (“[T]he issue in this case is narrow: does the limited use of a patented drug for testing and investigation 

strictly related to FDA drug approval requirements during 

the last 6 months of the term of the patent constitute a use 

which, unless licensed, the patent statute makes actionable? The district court held that it does not. This was an 

error of law.” (emphasis added)). Indeed, the legislative 

history expressly states that the provisions of § 271(e) 

“have the net effect of reversing the holding of the court in 

[Roche].” H.R. Rep. No. 98-857, pt. 2, at 27–30 (1984), as 

reprinted in 1984 U.S.C.C.A.N. 2686 at 2711–14; see also 

H.R. Rep. No. 98-857, pt. 1, at 45–46. 

The word “solely” was included in the statute to ensure 

that infringing activity that was performed for purposes 

other than the development and submission of information 

under a federal law regulating drugs would not be exempt. 

See H.R. Rep. No. 98-857, pt. 2, at 27–30 (explaining that 

the exemption created by § 271(e)(1) does not rise to the 

level of an unconstitutional taking without just compensation) (“In this case the generic manufacturer is not permitted to market the patented drug during the life of the 

patent; all that the generic can do is test the drug for purposes of submitting data to the FDA for approval. Thus, 

the nature of the interference [of § 271(e) with patent 

rights] is de minimis.”). 

“Solely” is a simple, but clear word, meaning “[a]s a single person (or thing); without any other as an associate, 

partner, sharer, etc.; alone; occasionally, without aid or assistance” or “[a]part from or unaccompanied by others; solitary.” 15 Oxford English Dictionary 261 (2d ed. 1989) 

(emphases added). It does not mean “partially,” “slightly,” 

“jointly,” or have any other ambiguous meaning. And the 

relevant inquiry under the statute is whether the accused 

activity is “solely for uses reasonably related to the 

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development and submission of information” under federal 

law, not whether the accused activity is solely, or even 

partly, for commercial uses. 35 U.S.C. § 271(e)(1). 

The legislative history makes clear that the exemption 

“does not permit the commercial sale of a patented drug by 

the party using the drug to develop [federal regulatory] information,” H.R. Rep. No. 98-857, pt. 1, at 45, and the same 

was understood by commentators at the time. See Ellen J. 

Flannery & Peter B. Hutt, Balancing Competition and Patent Protection in the Drug Industry: The Drug Price Competition and Patent Term Restoration Act of 1984, 40 Food 

Drug Cosm. L.J. 269, 308 (1985) (“[T]he provision allows 

for testing and experimental activity only for the purpose 

of developing information which is required to obtain approval of a drug. It does not allow the commercial sale of a 

patented drug by the person using the patented drug to develop such information.”). Like commercial sales, importing falls into the same category—an infringement, unless 

excused by the safe harbor provision. 

The Supreme Court, in Eli Lilly & Co. v. Medtronic, 

Inc., 496 U.S. 661 (1990), held that this safe harbor applies 

to medical devices as well as drugs. Accordingly, if a factfinder had concluded that the importation of Myval devices 

in this case was solely for uses reasonably related to the 

development and submission of information under Federal 

law, as it did, then the importation would properly be exempt from infringement.

However, the district court here wholly ignored the 

presence of the word “solely” in the statute. It stated:

The Court finds that the undisputed evidence gives 

rises to no genuine dispute of fact as to whether 

Meril’s transportation of non-commercial Myval 

Samples to the TCT Conference is exempt under 

the safe harbor. It is undisputed that Meril transported the medical device to the TCT Conference, 

which was attended by a large number of potential 

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clinical trial investigators. It is also undisputed 

that Meril did not sell or offer to sell its medical 

device at the medical conference. Therefore, 

Meril’s transportation of the Myval Samples to the 

TCT Conference, where Meril did not sell or offer 

to sell the device, was reasonably related to the 

submission of information to the FDA, including 

educating the investigators at the TCT about the 

Myval System. 

Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd., No. 

19-cv-06593, 2020 WL 6118533, at *6 (N.D. Cal. Oct. 16, 

2020), J.A. 10 (citations omitted). Nowhere in that holding 

and analysis does the word “solely” appear. A key part of 

the statute was thus ignored. 

Moreover, the absence of “solely” in the district court’s 

stated holding was not merely a harmless omission, as the 

court seemed to ignore that term’s meaning throughout its 

analysis. The court, in footnote 7 in its opinion, stated that 

“[b]ecause intent and alternative uses are not relevant to 

the application of the safe harbor once it is determined that 

the allegedly infringing acts were reasonably related to 

FDA approval, the Court need not reach the issue of Meril’s 

alleged commercial intent.” Id. at *10 n.7, J.A. 16 (citing 

AbTox, 122 F.3d at 1030 and Amgen Inc. v. Hospira, Inc., 

944 F.3d 1327, 1339 (Fed. Cir. 2019)). As such, 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. 

The district court’s deviation from the full language of 

the statute is not totally surprising in view of various statements from our court that have similarly done so. At first, 

such deviation was inapparent, as illustrated by this 

court’s opinion in Telectronics Pacing Systems, Inc. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992). There, the issue 

was whether an accused infringer who demonstrated a 

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potentially infringing medical device at several medical 

conferences to both physicians and non-physicians, the latter not being able to generate data for presentation to the 

FDA, was exempt from infringement under the safe harbor. 

There was no dispute as to the purpose for the accused infringer’s allegedly infringing demonstrations—recruiting 

clinical investigators for clinical trials. Id. at 1523. Accordingly, because the party alleging infringement “admitted that the demonstrations were not a sale or an offer to 

sell,” we held those demonstrations exempt. Id. (“Absent 

some showing that Ventritex’s purpose is disputed . . . such 

demonstrations constitute an exempt use reasonably related to FDA approval, because device sponsors are responsible for selecting qualified investigators and providing 

them with the necessary information to conduct clinical 

testing.”). The effect of the word “solely” did not enter the 

case. 

Less than five years later, this court issued its opinion 

in AbTox, which involved an accused infringer who conducted tests on its potentially infringing medical device 

consistent with the collection of data necessary for an FDA 

application. 122 F.3d at 1027. Unlike Telectronics, the 

parties disputed whether those tests were actually conducted for the purpose of regulatory approval, or whether 

they were instead conducted for promotional purposes. Id.

at 1027–28. Relying on Telectronics, our court wrote that 

§ 271(e)(1) “does not look to the underlying purposes or attendant consequences of the activity . . . , as long as the use 

is reasonably related to FDA approval.” Id. at 1030 (citing 

982 F.2d at 1524–25). Not only was the effect of the word 

“solely” once again ignored, but now the accused infringer’s 

purpose for the infringement—which was not disputed in 

Telectronics—was rendered irrelevant. AbTox’s unsupported expansion of the safe harbor reads in contradiction 

to the plain language of the statute itself. How is a factfinder able to properly determine whether an infringing act 

is “solely for uses reasonably related to the development 

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and submission of information” under federal law, when 

our precedent instructs him or her to turn a blind eye to a 

party’s intent or alternative uses? 35 U.S.C. § 271(e)(1) 

(emphasis added). Contrary to AbTox, intent and alternative uses are crucial to determining compliance with the 

statute. 

To be sure, the Supreme Court, in Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), endorsed a 

broad reading of § 271(e)(1)’s safe harbor. But it stopped 

short of sanctioning the expansive precedent of AbTox. 

545 U.S. at 202 (“Though the contours of this provision are 

not exact in every respect, the statutory text makes clear 

that it provides a wide berth for the use of patented drugs 

in activities related to the federal regulatory process.”). 

The Court explained:

Congress did not limit § 271(e)(1)’s safe harbor to 

the development of information for inclusion in a 

submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval of a generic drug. 

Rather, it exempted from infringement all uses of 

patented compounds “reasonably related” to the 

process of developing information for submission 

under any federal law regulating the manufacture, 

use, or distribution of drugs. We decline to read the 

“reasonable relation” requirement so narrowly as 

to render § 271(e)(1)’s stated protection of activities 

leading to FDA approval for all drugs illusory. 

Properly construed, § 271(e)(1) leaves adequate 

space for experimentation and failure on the road 

to regulatory approval: At least where a drugmaker 

has a reasonable basis for believing that a patented 

compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if 

successful, would be appropriate to include in a 

submission to the FDA, that use is “reasonably 

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related” to the “development and submission of information under . . . Federal law.” § 271(e)(1).

Id. at 206–07 (citation omitted). Although the Court in 

Merck emphasized the portion of this passage exempting 

“all uses of patented compounds ‘reasonably related’ to the 

process of developing information for submission under any

federal law regulating the manufacture, use, or distribution of drugs,” id. at 206, the surrounding context evidences 

that the Court’s statement referred to the situation in 

which the results of a regulatory-intended experiment are 

not actually submitted to the FDA. Such an interpretation 

is directly supported by Congressional intent, as the legislative history states that a “party which develops such information, but decides not to submit an application for 

approval, is protected as long as the development was done 

to determine whether or not an application for approval 

would be sought.” H.R. Rep. No. 98-857, pt. 1, at 45. As 

such, that statement should not be read to endorse the indiscriminate disregard of intent and alternative uses once 

a reasonable relation to FDA regulatory approval is established. Indeed, the Court seemed to recognize this, all 

while implicitly rejecting a categorical approach to this issue, such as the one taken in AbTox, stating that “[b]asic 

scientific research on a particular compound, performed 

without the intent to develop a particular drug or a reasonable belief that the compound will cause the [desired physiological effect], is surely not ‘reasonably related to the 

development and submission of information’ to the FDA.” 

Id. at 205–06 (emphases added). Accordingly, although the 

Supreme Court’s decision in Merck certainly warned 

against narrow application of the § 271(e)(1) safe harbor, 

at least with respect to what it means for a use to be “reasonably related” to FDA approval, it should not be read as 

going so far as to endorse the vast expansion of the exemption in AbTox, which rendered intent irrelevant. In fact, 

other than quoting the statute’s language, the Court’s opinion in Merck failed to even mention the word “solely,” and 

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therefore cannot be read to have considered the effect of 

that key limitation on the meaning of the statute. 

Our departure from the plain statutory language continued in Momenta Pharmaceuticals, Inc. v. Amphastar 

Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) (“Momenta I”), albeit within a discussion regarding whether 

post-FDA approval activities could fall within § 271(e)(1)’s 

safe harbor. The majority held that the application of the 

safe harbor should not depend on a pre-approval/post-approval distinction. Id. at 1359–60 (concluding that 

“‘[s]olely’ modifies ‘uses reasonably related to the development and submission of information,’ but does not place 

any other restriction on when the patented invention may 

be used without infringing” (emphasis added)). Accordingly, the majority vacated the district court’s ruling that 

the testing for post-approval uses at issue in that case did 

not fall under the safe harbor. The majority defended its 

opinion against dissenting contentions in a footnote; however, its defense relied only on the Supreme Court’s inconclusive statements in Merck and our own court’s 

unsupported expansion of the safe harbor in AbTox. Id. at 

1360 n.2. See supra. 

The same dispute came before our court again in Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA 

Inc., 809 F.3d 610 (Fed. Cir. 2015) (“Momenta II”), after the 

district court had found the accused testing exempt under 

the safe harbor at summary judgment. At that juncture, 

we reversed course on our earlier determination in Momenta I as to the application of § 271(e)(1)’s exemption, 

finding that the law of the case doctrine did not apply. Momenta II, 809 F.3d at 619–20. Concluding that our decision 

in Momenta I “would result in manifest injustice,” id. at 

621, we vacated the district court’s ruling that the safe harbor applied, id. at 622. In doing so, we seemingly recognized the problematic reach of the precedent of AbTox and 

attempted to cabin its influence. Id. at 620–21 (clarifying 

that AbTox’s categorical language is limited to activities 

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reasonably related to obtaining FDA approval, not merely 

complying with any FDA regulation, including those which 

apply post-approval). But that additional limitation provided by Momenta II still did not fully realign our precedent with the plain language of § 271(e)(1), as AbTox still 

allows for (and, in fact, instructs) the disregard of intent 

and alternative uses in the pre-approval context once a 

fact-finder identifies any use reasonably related to obtaining FDA approval.

The tension between the plain language of the statute 

and our court’s precedent was again apparent in our decision in Amgen. There, an accused infringer manufactured 

twenty-one batches of a potentially infringing drug, and a 

jury found that only seven of the twenty-one batches were 

entitled to the safe harbor defense. 944 F.3d at 1333. Of 

particular interest, the final sentence of the jury instructions stated that if the accused infringer “proved that the 

manufacture of a particular batch was reasonably related 

to developing and submitting information to the FDA in order to obtain FDA approval, [the accused infringer’s] additional underlying purposes for the manufacture and use of 

that batch do not remove that batch from the Safe Harbor 

defense.” Id. at 1338. Applying de novo review, we ruled 

that this jury instruction was not legally erroneous, again 

relying on the Supreme Court’s discussion in Merck. Id. at 

1338–39. Nevertheless, that jury instruction cannot be 

squared with the plain language of § 271(e)(1) in determining whether an accused infringing act is “solely for uses 

reasonably related to the development and submission of 

information” under federal pharmaceutical regulations 

necessarily requires the examination of any potential additional purposes and uses. 35 U.S.C. § 271(e)(1) (emphasis 

added). It did not address it. 

Given those statements and conclusions, on admittedly 

varying fact situations, the law could usefully be clarified 

by an en banc holding of this court, expressly returning the 

word “solely” to its Congressionally-enacted place in the 

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statute. Although this case only relates to the importation 

of two accused devices that were admittedly never used or 

sold, our court’s misconstruction of § 271(e)(1) should not 

be left to create future mischief. The district court erred in 

determining that there were no genuine disputes of fact as 

to whether Meril’s importation was “solely for uses reasonably related to the development and submission of information” under federal pharmaceutical regulations under 

the correct interpretation of the law. 35 U.S.C. § 271(e)(1)

(emphasis added). 

As the majority has well explained, the facts in this 

case were sufficient for a reasonable fact-finder to decide in 

favor of Meril under what could appear to have been existing precedent. However, in my view, under a correct interpretation of the law, particularly including adequate 

consideration of the word “solely,” summary judgment for 

Meril should be reversed because the facts here support the 

reasonable view that the importations occurred, at least 

partially, for commercial reasons and thus were not entitled to safe harbor. 

I therefore respectfully dissent. 

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