Dennis Crouch

Following my recent post examining the Edwards v. Meril safe harbor challenge, the Supreme Court has requested a response from Meril after initially receiving only a waiver. The Court’s November 20, 2024 request suggests that at least one Justice sees potential merit in Edwards’ challenge to the Federal Circuit’s broad interpretation of Section 271(e)(1)’s safe harbor provision.  It’s important to note that a request for response does not guarantee that the Court will grant the petition. In fact, the case still has a <50% odds of being granted certiorari.

The case has garnered my attention for its potential to reshape how courts interpret the “solely for uses reasonably related” language in Section 271(e)(1). The dispute arose from what might seem like a minor incident – two transcatheter heart valve systems that were brought to San Francisco from abroad for a medical conference but, as the Federal Circuit noted, ended up spending their week-long U.S. visit sitting unused in a hotel closet and storage room before heading to Europe.  Still importation is a form of infringement.