On August 21, 2024, the U.S. Court of Appeals for the Federal Circuit declined Edwards Lifesciences’ request for en banc review of the Court’s precedential decision affirming summary judgment of non-infringement in favor of Fenwick client, Meril Life Sciences. This decision marks a significant win for Meril Life Sciences in a case involving the application of the safe harbor provision of 35 U.S.C. § 271(e)(1), which applies to acts that are “solely for uses reasonably related to the development and submission of information” to the Food and Drug Administration (FDA).
Edwards initially filed the lawsuit in 2019, alleging that Meril’s Myval transcatheter heart valve system infringed patents related to Edwards’ Sapien system. However, the Federal Circuit upheld a California federal court's ruling that Meril’s importation of the Myval system to recruit clinical trial investigators at a medical conference was protected under the safe harbor provision.
The Federal Circuit’s refusal to rehear the case further solidifies the precedent that the safe harbor applies to preparatory activities related to FDA submissions, such as recruiting clinical trial investigators, and that application of the safe harbor does not turn on a party’s subjective intent.
Fenwick’s litigation team was led by partners David Hadden and Melanie Mayer, along with associate Jonathan McMichael.
The case is Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., case number 22-1877, in the U.S. Court of Appeals for the Federal Circuit.