Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor

Written by:Ari Feinstein and Joseph Mallon, Ph.D.

On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S. Supreme Court.[2]   The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely for uses reasonably related” to the federal regulatory process, when the infringing act is performed for both regulatory and non-regulatory uses.”  The alleged distinction between regulatory and non-regulatory uses is illustrated by the following summary of the facts as set forth in Edwards’s petition.

Edwards supplies medical devices for treating heart disease, including its patented line of SAPIEN® transcatheter prosthetic valves.  Meril[3] is an India-based competitor that makes transcatheter heart valves as well, including the “Myval valve” that Edwards maintains is “nearly identical” to its SAPIEN® valve.  Meril received regulatory approval to sell the Myval valve in India in October 2018 and authorization to sell it in Europe in April 2019.  A few months later, Meril imported two of its Myval devices into the United States to use at an industry trade conference in San Francisco.  Before the conference, Meril promoted its attendance by, among other things, touting its regulatory approval in Europe and inviting registrants to experience Meril’s latest technology.  But none of Meril’s promotional emails and flyers said anything, Edwards asserts, “about regulatory uses, recruiting investigators for clinical trials, or limiting the [device’s] use to potential investigator candidates.”

At the conference, Meril did not actually display its imported devices because they malfunctioned.  But Meril provided information about the Myval system and discussed its device with several U.S. doctors to identify potential clinicians for future clinical trials.    In December 2019, Meril sought FDA guidance and proposed a clinical trial with clinical sites inside and outside the United States.  The FDA deemed the proposed trial inadequate and, though Meril revised its proposal to address the FDA’s concern, never pursued a clinical trial in the United States.

Edwards sued Meril for importing the Myval devices for nonregulatory uses, and Meril responded that it was protected by the Section 271(e)(1) safe harbor.  The district court granted Meril’s summary judgment motion after finding that the safe harbor applied.[4]  A Federal Circuit panel affirmed 2-1, with Judge Lourie dissenting, and the Federal Circuit denied Edwards’ petition for a rehearing en banc.[5]

Though Edwards’ petition focuses on just two devices Meril imported, an amicus brief filed by the Advanced Medical Technology Association (“AdvaMed”) highlights that the stakes are potentially much greater.[6]  AdvaMed, which bills itself as “the largest medical technology association,” warns in its brief that the Federal Circuit’s “decision … gives non-innovator drug and medical technology competitors carte blanche to intentionally infringe a patent, so long as they make some de minimis effort to pursue regulatory approval.”[7]  AdvaMed added that the “uncertainty” resulting from the Federal Circuit’s decision “harms not only innovator companies, but also good-faith generic competitors” that “need to know what is allowed under the safe harbor and what isn’t.”[8]

Whether the Supreme Court decides to hear this case remains to be seen, but those following this case may be able to glean more from Meril’s responsive brief, which is currently due December 20, 2025.

Editor: Brenden S. Gingrich, Ph.D.

[1] “Edwards” collectively refers to Edwards Lifesciences Corporation and Edwards Lifesciences LLC.

[2] See Petition for a Writ of Certiorari, Edwards Lifesciences Corp., et al. v. Meril Life Sciences Pvt. Ltd., et al., No. 24-428 (Oct. 16, 2024), available at https://www.supremecourt.gov/DocketPDF/24/24-428/328035/20241011115944585_edwards%20v.%20meril%20--%20cert.%20petition%20--%20FILED.pdf.

[3] “Meril” collectively refers to Meril Life Sciences Pvt. Ltd. and Meril, Inc.

[4] Id. at 13.

[5] Id. at 14, 16-18.

[6] See Brief of Advanced Medical Technology Association as Amicus Curiae in Support of Petitioners, Edwards Lifesciences Corp., et al. v. Meril Life Sciences Pvt. Ltd., et al., No. 24-428 (Nov. 15, 2024), available at https://www.supremecourt.gov/DocketPDF/24/24-428/331955/20241115135902522_Edwards%20v.%20Meril_AdvaMed%20Amicus%20Brief.pdf.

[7] Id. at 12-13.

[8] Id. at 15-16.