2024 Federal Circuit IP Appeals – Cementing a Holistic Approach to the FDA Safe-Harbor: Edwards Lifesciences Corp. v. Meril Life Scis. Pvt. Ltd., 96 F.4th 1347 (Fed. Cir. 2024) (Lourie, Stoll, Cunningham)

Edwards Lifesciences brought suit against Meril, alleging infringement of Edwards’s heart-valve patents. Meril invoked the safe-harbor defense, arguing that its activities were protected because they were aimed at obtaining regulatory approval, including submissions to foreign regulatory bodies.

The safe harbor provision under 35 U.S.C. § 271(e)(1) was introduced as part of the Hatch-Waxman Act to facilitate the development of generic drugs and medical devices. It exempts activities from patent infringement that are “solely for uses reasonably related” to obtaining U.S. Food and Drug Administration (FDA) approval to market the accused product. The provision allows companies to conduct necessary testing without the risk of infringement litigation.

The Federal Circuit’s decision turned on the scope of the term “solely” within the context of the safe-harbor provision. In one of the accused activities, Meril imported its preapproval heart-valve device to the United States for a conference. It did not sell or otherwise disclose the system and kept it in a hotel closet and storage room. Meril’s activities also included conducting clinical trials and gathering data for submission to foreign regulatory bodies.

The Federal Circuit found that Meril’s activities, as a whole, fell within the safe harbor provision, as they were reasonably related to obtaining regulatory approval of its heart-valve technology. This decision continues the court’s trend of refusing to parse alternative uses or consequences of premarket activities. Even if a defendant’s activities are conducted with multiple objectives, as long as one of those objectives is to secure FDA approval, the safe harbor generally applies.

Edwards petitioned for an en banc rehearing, challenging the panel’s interpretation of the term “solely.” The full court denied the petition. Edwards has since petitioned the Supreme Court for certiorari. That petition is pending as of the publication of this review.

This article appeared in the 2024 Federal Circuit IP Appeals: Summaries of Key 2024 Decisions report.