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 dev