Court Opinion

ID: 9953982
Source: CourtListenerOpinion
Date Created: 2024-03-25 14:01:06.12952+00
Date Added: 2024-06-11T08:12:57.749702
License: Public Domain

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.                           3
 MERIL LIFE SCIENCES PVT. LTD.

                                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
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 MERIL LIFE SCIENCES PVT. LTD.

 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.
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 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.          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 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
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 EDWARDS LIFESCIENCES CORPORATION v.                          7
 MERIL LIFE SCIENCES PVT. LTD.

 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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 8                     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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 EDWARDS LIFESCIENCES CORPORATION v.                        9
 MERIL LIFE SCIENCES PVT. LTD.

 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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 10                    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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 EDWARDS LIFESCIENCES CORPORATION v.                       11
 MERIL LIFE SCIENCES PVT. LTD.

     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
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 12                    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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 EDWARDS LIFESCIENCES CORPORATION v.                            13
 MERIL LIFE SCIENCES PVT. LTD.

 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
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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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 MERIL LIFE SCIENCES PVT. LTD.

 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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      [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
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 FDA.’” Appellants’ Br. 41–42 (quoting J.A. 10). Specifi-
 cally, 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 Ed-
 wards, Mr. Lad “lacked personal knowledge of the facts de-
 clared.” Appellants’ Br. 41.
      First, while the district court cites to the Lad declara-
 tion 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 declara-
 tions when concluding that Meril’s importation was rea-
 sonably 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, Ste-
 phens 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 dis-
 trict properly overruled the objections. Nothing in the rec-
 ord 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 decla-
 ration.
                         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 judg-
 ment 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 per-
 petuates 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 mat-
 ter 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 stat-
 ute says, development of information for the FDA. The
 purpose of the infringing act is meaningful and important
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                               MERIL LIFE SCIENCES PVT. LTD.

 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 fol-
 lowed the decisions of this court in finding no genuine dis-
 pute of fact as to whether Meril’s importation of two
 allegedly infringing Myval devices fell within the safe har-
 bor 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 ex-
 planatory language, and on specific facts, that failed to fo-
 cus 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 opin-
 ion, 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 cardiovas-
 cular medicine) should have raised a genuine dispute as to
 whether the importation was “solely for uses reasonably re-
 lated 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 man-
 ufacturers 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 ac-
 tivity which will begin after a valid patent expires, is not a
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 patent infringement.”). Such activity, before the enact-
 ment 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 lim-
 ited 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 actiona-
 ble? 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 compensa-
 tion) (“In this case the generic manufacturer is not permit-
 ted to market the patented drug during the life of the
 patent; all that the generic can do is test the drug for pur-
 poses 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 sin-
 gle person (or thing); without any other as an associate,
 partner, sharer, etc.; alone; occasionally, without aid or as-
 sistance” or “[a]part from or unaccompanied by others; sol-
 itary.” 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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 4                     EDWARDS LIFESCIENCES CORPORATION v.
                               MERIL LIFE SCIENCES PVT. LTD.

 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] in-
 formation,” 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 Pa-
 tent Protection in the Drug Industry: The Drug Price Com-
 petition 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 ap-
 proval of a drug. It does not allow the commercial sale of a
 patented drug by the person using the patented drug to de-
 velop such information.”). Like commercial sales, import-
 ing 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 fact-
 finder 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 ex-
 empt 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 trans-
     ported 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 substan-
 tive analysis, effectively disregarding any evidence con-
 cerning 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 state-
 ments 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. Ven-
 tritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992). There, the issue
 was whether an accused infringer who demonstrated a
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 6                      EDWARDS LIFESCIENCES CORPORATION v.
                                MERIL LIFE SCIENCES PVT. LTD.

 potentially infringing medical device at several medical
 conferences to both physicians and non-physicians, the lat-
 ter 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 in-
 fringer’s allegedly infringing demonstrations—recruiting
 clinical investigators for clinical trials. Id. at 1523. Ac-
 cordingly, because the party alleging infringement “admit-
 ted 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 re-
 lated to FDA approval, because device sponsors are respon-
 sible 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 con-
 ducted 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 con-
 ducted 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 at-
 tendant 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 unsup-
 ported expansion of the safe harbor reads in contradiction
 to the plain language of the statute itself. How is a fact-
 finder 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 alterna-
 tive uses are crucial to determining compliance with the
 statute.
     To be sure, the Supreme Court, in Merck KGaA v. Inte-
 gra 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 exemp-
     tion applicable only to the research relevant to fil-
     ing 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 biologi-
     cal process, to produce a particular physiological ef-
     fect, 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 in-
     formation 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 distribu-
 tion 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 legis-
 lative history states that a “party which develops such in-
 formation, 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 in-
 discriminate disregard of intent and alternative uses once
 a reasonable relation to FDA regulatory approval is estab-
 lished. Indeed, the Court seemed to recognize this, all
 while implicitly rejecting a categorical approach to this is-
 sue, 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 reason-
 able belief that the compound will cause the [desired phys-
 iological 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 “rea-
 sonably related” to FDA approval, it should not be read as
 going so far as to endorse the vast expansion of the exemp-
 tion in AbTox, which rendered intent irrelevant. In fact,
 other than quoting the statute’s language, the Court’s opin-
 ion 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 con-
 tinued in Momenta Pharmaceuticals, Inc. v. Amphastar
 Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) (“Mo-
 menta 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-ap-
 proval distinction.      Id. at 1359–60 (concluding that
 “‘[s]olely’ modifies ‘uses reasonably related to the develop-
 ment and submission of information,’ but does not place
 any other restriction on when the patented invention may
 be used without infringing” (emphasis added)). Accord-
 ingly, 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; how-
 ever, its defense relied only on the Supreme Court’s incon-
 clusive 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 Mo-
 menta 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 Mo-
 menta I as to the application of § 271(e)(1)’s exemption,
 finding that the law of the case doctrine did not apply. Mo-
 menta 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 har-
 bor applied, id. at 622. In doing so, we seemingly recog-
 nized 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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                              MERIL LIFE SCIENCES PVT. LTD.

 reasonably related to obtaining FDA approval, not merely
 complying with any FDA regulation, including those which
 apply post-approval). But that additional limitation pro-
 vided by Momenta II still did not fully realign our prece-
 dent 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 obtain-
 ing FDA approval.
     The tension between the plain language of the statute
 and our court’s precedent was again apparent in our deci-
 sion 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 instruc-
 tions 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 or-
 der to obtain FDA approval, [the accused infringer’s] addi-
 tional 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 determin-
 ing 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 addi-
 tional 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 reason-
 ably related to the development and submission of infor-
 mation” 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 exist-
 ing precedent. However, in my view, under a correct inter-
 pretation 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 enti-
 tled to safe harbor.
     I therefore respectfully dissent.