Insights

On March 25, 2024, the Federal Circuit issued a precedential opinion in Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd., a case with significant implications for the application of the safe harbor provision of 35 U.S.C. § 271(e)(1). This case involved the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd., an India-based medical device company, to San Francisco for a medical conference. According to Meril, these heart valve systems, part of Meril’s Myval System designed to treat heart disease, were never displayed or offered for sale at the conference but were instead stored in a bag in a hotel closet and later in a storage room. The Court’s decision to affirm the district court’s grant of summary judgment of noninfringement in favor of Meril brings to light the nuances of applying the safe harbor provision in patent infringement cases.