Federal Circuit to Consider the Relevance of an Alleged Infringer’s “Intent” in a Hatch-Waxman Safe Harbor Analysis

The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.¹ The District Court granted summary judgment that Meril’s importations of its heart valve for a presentation at an industry conference and pre-clinical testing were exempt from infringement under the safe harbor.

Statutory Background

The safe harbor provision, 35 U.S.C. § 271(e)(1), was enacted as part of the Hatch-Waxman Act. It provides:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

(emphasis added).

Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.

Edwards Lifesciences moved for summary judgment, alleging that Meril’s importations of its Myval-branded transcatheter heart valve into the United States for a presentation at a conference and for pre-submission testing infringed Edwards’ patents.² In particular, Meril imported heart valves into the United States on two separate occasions – first in January 2017 to allow the University of Washington to conduct pre-clinical investigations using the accused device; and second, in September 2019 to display the device at the 2019 Transcatheter Cardiovascular Conference in San Francisco.³ Meril argued that the importations were covered by the safe harbor because it never displayed the heart valve at the conference, and both importations were reasonably related to its eventual Food and Drug Administration submissions.⁴

Judge Haywood Gilliam, Jr., of the District Court for the Northern District of California, began his analysis by reviewing the contours of the safe harbor. He recognized that “Section 271(e)(1) allows competitors, before the expiration of a patent, to engage in otherwise infringing activities if the use is ‘reasonably related to’ obtaining regulatory approval.”⁵ Quoting Merck KGaA v. Integra Lifesciences I, Ltd.,⁶ the court stated that the safe harbor “‘extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA [Federal Food, Drug, and Cosmetic Act]’ which ‘necessarily includes preclinical studies.’”⁷ Indeed, the safe harbor protects conduct “regardless of the phase of research, and even if the information is never ultimately submitted to the FDA as part of an approval application.”⁸ Whether alleged infringing acts fall under the safe harbor “focuses on acts or uses, and not on purposes, intent, or motive.”⁹

The court proceeded to separately analyze each importation. Reviewing Meril’s importation for the 2019 conference, the court noted that the Federal Circuit had found that demonstrations at medical conferences are covered by the safe harbor.¹⁰ Given that transporting a device to a conference is necessary for displaying it, “transportation of an accused device into a country for display at a medical conference is also exempt under the safe harbor.”¹¹ Moreover, at the time of the conference, Meril had taken significant steps towards obtaining FDA approval, including preparing a formal synopsis for a clinical trial, preparing a draft presubmission to obtain FDA’s input on the proposed clinical trial, communicating with FDA regarding the presubmission and clinical trial, and hiring an FDA consultant to help with its presubmission.¹² The court noted that Edwards did not dispute these facts, yet argued that because Meril never actually displayed the device at the conference, Meril’s safe harbor defense failed.¹³ The court disagreed and recognized that Meril did not sell or offer to sell its medical device at the conference.¹⁴ 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.”¹⁵

The court then considered whether Meril’s importation of the Myval device for the use by the University of Washington for preclinical investigations was protected by the safe harbor.¹⁶ The study “investigated whether the Myval System could be safely implanted in human subjects in future clinical studies.”¹⁷ The investigators placed the heart valve into cadavers, and Meril used the resulting data to understand the “mechanics of positioning the Myval transcatheter valve in a human body.”¹⁸ The court found that there was no genuine dispute that the preclinical study generated information relevant to the FDA approval process and, therefore, was “reasonably related” to FDA approval.¹⁹ Edwards, however, stressed that Meril never submitted the results to the FDA.²⁰ But the court referenced the Supreme Court’s holding that “the safe harbor applies to preclinical studies even if the data is not ultimately submitted to the FDA.”²¹

Edwards also argued that Meril’s importations of the Myval devices to the conference and the University of Washington were not protected by the safe harbor because Meril had a commercial purpose for bringing the devices to both locations.²² But the court held that Meril’s intent was irrelevant in determining whether the importations were protected by the safe harbor.²³ “If Defendants’ otherwise infringing act is reasonably related to FDA approval, the safe harbor applies regardless of the purported purpose behind the use.”²⁴

Relying on the Federal Circuit precedent in Abtox Inc. v. Exitron Corp.²⁵, the court found that application of the safe harbor is determined without ascertaining the defendant’s intent or purpose.²⁶ In Abtox, the plaintiff, like Edwards, argued that the infringing activity was driven by commercial purposes.²⁷ Regardless, the Federal Circuit affirmed the grant of summary judgment of non-infringement, stating: “The [safe harbor] statute, therefore, does not look to the underlying purposes or attendant consequences of the activity . . . , as long as the use is reasonably related to FDA approval.”²⁸ There, because the device’s testing was “reasonably related” to obtaining FDA approval, “the safe harbor applied, regardless of defendant’s intent or purpose.”²⁹

The court then considered Edwards’ reliance on Amgen Inc. v. Hospira³⁰ that commercial intent is relevant to whether an act is “reasonably related” to regulatory approval.³¹ In Amgen, Hospira objected to a jury instruction that stated: “‘If Hospira has 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, Hospira’s additional underlying purposes for the manufacture and use of that batch do not remove that batch from the Safe Harbor defense.’”³² The Federal Circuit affirmed the jury instruction, holding that the “‘underlying purposes do not matter as long as Hospira proved that the manufacture of any given batch of drug substance [the accused activity] was reasonably related to developing information for FDA submission.’”³³ The district court in Edwards, therefore, found the safe harbor inquiry properly focused on Meril’s infringing acts, not its intent,³⁴ and granted Meril’s motion for summary judgment of non-infringement.³⁵

Edwards’ Appeal

Edwards appealed the District Court’s grant of summary judgment.³⁶ Briefing was completed in January 2023, but a date for oral argument has not yet been set.

Edwards only appealed the District Court’s decision regarding the importation of the accused devices in connection with the conference.^37,38 Edwards raised an interesting issue about the use of Meril’s intent in determining if the safe harbor applies.³⁹ The District Court had held that intent is irrelevant in determining whether the safe harbor applies. “‘[C]onsistent with the language of the statute, the safe harbor inquiry focuses on acts or uses, and not on purposes, intent or motive.’”⁴⁰

Edwards recognized the Federal Circuit precedent had held “[a]s long as the activity is reasonably related to obtaining FDA approval, [the accused infringer’s] intent or alternative uses are irrelevant to its qualification to invoke the section 271(e)(1) shield.”⁴¹ To avoid these holdings, Edwards argues that before Meril’s intent could have been deemed irrelevant, the District Court should have determined “that the activity [was] reasonably related to obtaining FDA approval.”⁴² Since Meril never used the Myval devices at the conference, Edwards argues that the “only evidence connecting the importation to obtaining FDA approval is evidence of Meril’s subjective intent.”⁴³ Accordingly, Edwards argues that the District Court improperly found Meril’s intent irrelevant.⁴⁴

Edwards also argues that the District Court erred in holding that demonstrations at medical conferences were automatically covered by the safe harbor regardless of their actual or intended use.⁴⁵ Unlike the precedent the District Court cited, Edwards argues that there was no actual demonstration of the Myval devices to clinical investigators.⁴⁶ Moreover, Meril was not close to obtaining the necessary regulatory approval required for clinical trials, and furthermore, the contemporaneous evidence disputed that Meril was attempting to recruit clinical investigators for FDA approval.⁴⁷ Edwards therefore argues that “the evidence supports 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.”⁴⁸

Conclusion

Given the nature of summary judgment, the Federal Circuit’s decision in Edwards v. Meril Lifesciences will be fact-intensive. However, this appeal presents an interesting issue of what role, if any, intent plays in a safe harbor analysis regarding presentations at industry conferences.

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¹ Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 22-1877 (Fed. Cir. 2022).
² Edwards Lifesciences Corp. v. Meril Life Scis. Pvt., 2020 U.S. Dist. LEXIS 192337, at *1, *9 (N.D. Cal. Oct. 16, 2020).
³ Id. at *2-*3, *6-*7.
⁴ Id. at *9-*10.
⁵ Id. at *10-*11.
⁶ 545 U.S. 193, 202 (2005).
⁷ Edwards Lifesciences Corp., 2020 U.S. Dist. LEXIS 192337, at *11 (emphasis in original).
⁸ Id. at *11.
⁹ Id. at *12.
¹⁰ Id. at *14-*15 (citing Intermedics, Inc. v. Ventritex Co., 1993 U.S. App. LEXIS 3620, at *3 (Fed. Cir. Feb. 22, 1993) and Chartex Intern. PLC v. M.D. Personal Products Corp., 1993 WL 306169, at *4 (Fed. Cir. 1993)).
¹¹ Id. at *15.
¹² Id. at *15-*16.
¹³ Id. at *16.
¹⁴ Id.
¹⁵ Id. at *16-*17.
¹⁶ Id. at *17.
¹⁷ Id.
¹⁸ Id. at *18-*19.
¹⁹ Id. at *19.
²⁰ Id.
²¹ Id. at *20 (citing Merck, 545 U.S. at 207).
²² Id. at *22-*23.
²³ Id. at *23.
²⁴ Id. at *23 (citing Momenta Pharm., Inc. v. Teva Pharm. USA, Inc., 809 F.3d 610, 619 (Fed. Cir. 2015)).
²⁵ 122 F.3d 1019, 1030 (Fed. Cir. 1997).
²⁶ Edwards Lifesciences Corp., 2020 U.S. Dist. LEXIS 192337, at *23-*24 (citing Abtox, 122 F.3d at 1030).
²⁷ Id. at *23-*24 (citing Abtox, 122 F.3d at 1027).
²⁸ Id. at *24 (citing Abtox, 122 F.3d at 1030).
²⁹ Id.
³⁰ 944 F.3d 1327 (Fed. Cir. 2019).
³¹ Edwards Lifesciences Corp., 2020 U.S. Dist. LEXIS 192337, at *25.
³² Id. at *25 (citing Amgen, 944 F.3d at 1338).
³³ Id. at *25-*26 (citing Amgen, 944 F.3d at 1339) (emphasis omitted).
³⁴ Id. at *26.
³⁵ Id.
³⁶ See Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 22-1877 (Fed. Cir. 2022).
³⁷ No. 22-1877, Dkt. 27 at 2.
³⁸ Edwards’ appeal regarding the other alleged errors by the district court are not addressed in this blog post.
³⁹ No. 22-1877, Dkt. 27 at 47.
⁴⁰ Id. at 47 (quoting Edwards Lifesciences Corp. v. Meril Life Scis. Pvt., 2020 U.S. Dist. LEXIS 192337, at *12).
⁴¹ Id. at 49 (citations and emphasis omitted).
⁴² Id.
⁴³ Id.
⁴⁴ Id. at 50.
⁴⁵ Id. at 51.
⁴⁶ Id. at 52.
⁴⁷ Id.
⁴⁸ Id. (emphasis in original).