Case: 22-1877 Document: 57 Page: 1 Filed: 03/25/2024
`
`
`
`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-ap-
`pellants. Also represented by CHRISTY G. LEA, Knobbe,
`Martens, Olson & Bear, LLP, Irvine, CA; GAZAL POUR-
`MOEZZI, 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 repre-
`sented by MELANIE LYNE MAYER, JONATHAN THOMAS
`MCMICHAEL, Seattle, WA.
`
`

`

`Case: 22-1877 Document: 57 Page: 2 Filed: 03/25/2024
`
`2
`
`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
` ______________________
`
`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 sys-
`tems 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 Eu-
`rope.
`Edwards Lifesciences Corporation and Edwards
`Lifesciences LLC (collectively, “Edwards”) appeal the
`Northern District of California’s summary judgment in fa-
`vor of Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collec-
`tively, “Meril”) that Meril’s act of importation of the two
`transcatheter heart valve systems fell within the safe har-
`bor 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 re-
`lated 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.
`
`

`

`Case: 22-1877 Document: 57 Page: 3 Filed: 03/25/2024
`
`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`3
`
`I
`Meril started clinical trials for its Myval System in In-
`dia in June 2017 and received regulatory approval to mar-
`ket 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 consid-
`ered a “Class III” medical device and is thus subject to cer-
`tain
`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 impair-
`ment 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 de-
`vice in human subjects, collect data from those subjects,
`and then submit the data to the FDA. Because the pre-
`market approval process can be lengthy and difficult to
`navigate, Meril first started work on a premarket submis-
`sion to the FDA. A premarket submission allows device
`manufacturers, like Meril, to request formal regulatory
`feedback on the device before officially engaging in the pre-
`market approval process. Separately, Meril began plan-
`ning 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 in-
`cluded as part of future submissions to the FDA.
`
`

`

`Case: 22-1877 Document: 57 Page: 4 Filed: 03/25/2024
`
`4
`
`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
`In August 2019, Meril contacted the FDA to inquire
`about the applicability of its Landmark Trial and the pre-
`liminary 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 re-
`searchers 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 med-
`icine. TCTC lasted from September 25 through Septem-
`ber 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 Sys-
`tem.” Appellants’ Br. 12. It then orally conveyed these in-
`structions to the twenty Meril employees who attended
`TCTC. These instructions include:
`Do not make any sales or offers for sale at the con-
`ference, or while in the United States for the US
`market. You can make offer [sic] for other coun-
`tries.
`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
`
`

`

`Case: 22-1877 Document: 57 Page: 5 Filed: 03/25/2024
`
`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`5
`
`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 contain-
`ing the two samples in his hotel room closet. On Septem-
`ber 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 sam-
`ple 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 pric-
`ing 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 ap-
`proval 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 Septem-
`ber 30.
`
`

`

`Case: 22-1877 Document: 57 Page: 6 Filed: 03/25/2024
`
`6
`
`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
`Later, in December 2019, Meril submitted a premarket
`approval submission to the FDA proposing that Meril con-
`duct 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 sub-
`jects 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 mo-
`tion for summary judgment, determining that Meril’s im-
`portation 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.
`28 U.S.C. § 1295(a)(1).
`
`jurisdiction under
`
` We have
`
`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 judg-
`ment 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, af-
`ter 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
`
`

`

`Case: 22-1877 Document: 57 Page: 7 Filed: 03/25/2024
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`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`7
`
`Band of Luiseno Mission Indians of the Pauma & Yuima
`Rsrv. v. California, 973 F.3d 953, 961 (9th Cir. 2020). Im-
`portant here, a fact issue is genuine “if the evidence is such
`that a reasonable jury could return a verdict for the non-
`moving 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 im-
`port into the United States a patented inven-
`tion . . . 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 ex-
`emption 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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`Case: 22-1877 Document: 57 Page: 8 Filed: 03/25/2024
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`8
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`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
`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 oc-
`casions, 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) (quot-
`ing 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 collec-
`tion 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 orig-
`inal) (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 be-
`cause “[§] 271(e)(1) requires only that the otherwise in-
`fringing act be performed ‘solely for uses reasonably related
`to’ FDA approval.” Id. In AbTox, defendants conducted
`limited tests consistent with the collection of data neces-
`sary for filing an application with the FDA for approval of
`its medical device—activity squarely within the safe
`
`

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`Case: 22-1877 Document: 57 Page: 9 Filed: 03/25/2024
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`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`9
`
`harbor. See id. at 1027. However, plaintiff alleged that the
`actual purpose of these tests was not to secure FDA ap-
`proval; rather, it was to promote the medical device to po-
`tential customers and induce a third-party to purchase
`rights to the medical device, which the third-party ulti-
`mately did. Id. Still, we determined “intent or alternative
`uses” were “irrelevant” to the invocation of § 271(e)(1) be-
`cause “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 medi-
`cal 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 post-
`approval, 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 devel-
`opment and submission of information to the FDA.” Mo-
`menta, 809 F.3d at 620. Addressing this argument, we
`clarified that the test announced in AbTox applies to pre-
`FDA 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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`Case: 22-1877 Document: 57 Page: 10 Filed: 03/25/2024
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`10
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`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
`attendant consequences of the activity.’” Id. at 621 (citing
`AbTox, 122 F.3d at 1030).
`Later, consistent with our holdings in AbTox and Mo-
`menta, 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 develop-
`ing 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 sub-
`stance—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 man-
`ufactured some batches for “pre-approval inspection” and
`others “for various types of [commercial] testing,” substan-
`tial 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 in-
`fringing 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 submis-
`sion 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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`Case: 22-1877 Document: 57 Page: 11 Filed: 03/25/2024
`
`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`11
`
`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 Ed-
`wards 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 ap-
`proval
`for
`its
`transcatheter heart valves,
`includ-
`ing: “(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 dis-
`trict 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 con-
`stituted 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
`
`

`

`Case: 22-1877 Document: 57 Page: 12 Filed: 03/25/2024
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`12
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`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
`and providing them with the necessary information to con-
`duct 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 investiga-
`tors. 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 dis-
`trict court’s grant of summary judgment of noninfringe-
`ment. First, Edwards attempts to create a genuine issue
`of material fact, arguing the district court disregarded con-
`temporaneous evidence and failed to view such evidence in
`the light most favorable to Edwards (the nonmovant). Sec-
`ond, Edwards argues the district court did not apply the
`safe harbor with an objective standard because, in Ed-
`wards’s view, the district court solely relied on Meril’s al-
`leged subjective intent for the importation. Third,
`Edwards argues the district court improperly relied on dec-
`larations 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, Ed-
`wards argues that the district court “erroneously disre-
`garded” the “strong contemporaneous evidence from the
`time of the importation from which a jury could reasonably
`conclude that [the transcatheter heart valves] were im-
`ported exclusively for use as commercial sales tools.” Ap-
`pellants’ Br. 34–35 (emphasis in original). In support,
`
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`Case: 22-1877 Document: 57 Page: 13 Filed: 03/25/2024
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`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`13
`
`Edwards identifies numerous evidentiary bases in the rec-
`ord from which it contends “a jury could reasonably con-
`clude that Meril imported the [transcatheter heart valves]
`solely to support commercial sales, rather than to recruit
`clinical investigators.” Appellants’ Br. 37; see also Appel-
`lants’ Br. 25–27, 42–44. We have reviewed the cited evi-
`dence, 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 be-
`low.
`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 coun-
`tries.’” Appellants’ Br. 36. This view, however, is unteth-
`ered 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 undis-
`puted that no sales or offers for sale—either in the United
`States or outside the United States—occurred at TCTC, de-
`spite 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
`
`

`

`Case: 22-1877 Document: 57 Page: 14 Filed: 03/25/2024
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`14
`
`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
`“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 en-
`tirely unrelated to any clinical recruiting or FDA-related
`activities” because Meril had not planned to bring the im-
`ported 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 be-
`cause 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 rou-
`tinely 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.” Appel-
`lants’ 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. clin-
`ical 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 sub-
`jects at U.S. clinical sites. Clinical trials are expensive.
`And we fail to see how one could reasonably infer Meril
`
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`Case: 22-1877 Document: 57 Page: 15 Filed: 03/25/2024
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`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`15
`
`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 cre-
`ates 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 in-
`vestigators 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 stat-
`ute. 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 (em-
`phasis in original). Continuing, Edwards asserts that be-
`cause the district court cited to Meril’s “self-serving”
`declarations—“the only evidence connecting the importa-
`tion 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 evi-
`dence 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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`Case: 22-1877 Document: 57 Page: 16 Filed: 03/25/2024
`
`16
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`EDWARDS LIFESCIENCES CORPORATION v.
` MERIL LIFE SCIENCES PVT. LTD.
`
`[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, sell-
`ing, 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 submis-
`sion of information” to the FDA also does not re-
`quire 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 reason-
`ably 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 har-
`bor 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 juris-
`prudence 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 addi-
`tional 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 rea-
`sonably related to the submission of information to the
`
`

`

`Case: 22-1877 Document: 57 Page: 17 Filed: 03/25/2024
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`EDWARDS LIFESCIENCES CORPORATION v.
`MERIL LIFE SCIENCES PVT. LTD.
`
`17
`
`FDA.’” Appellants’ Br. 41–42 (quoting J.A. 10). Specifi-
`cally, Edwards takes issue w