Federal Circuit Says Biosimilar Applicants Can Decline Patent Dance

Director Paul A. Calvo, Ph.D. discusses the aftermath of Amgen Inc. v. Sandoz Inc. with Managing Intellectual Property, addressing potential consequences the opinion holds for biosimilar applicants and reference product sponsors.

Calvo told Managing IP, “This opens the door for Sandoz to start marketing, and it also lays out at least the initial framework for what requirements people who have already filed are going to need to put forth and which ones they are not going to have to as long as this decision holds.”