For many consumers, understanding the composition of food products is key to making informed decisions about healthy eating. As ultra-processed foods (“UPFs) occupy a growing share of grocery stores and American diets, UPFs have drawn increasing scrutiny by litigators, regulators, and lawmakers.
U.S. Food and Drug Administration (FDA)
The Broad Impact of Edwards v. Meril on the Safe Harbor Provision
By Fangli Chen, Erik Milch & Nicholas C. Prairie on
The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. § 271(e)(1). The Federal Circuit’s ruling, and the subsequent denial of Edwards’s petition for rehearing en banc, underscores the breadth of the safe harbor, putting to bed the question of whether “solely” means “only” in the context of the safe harbor.