Federal Circuit Rules That BPCIA Preempts State Law

Introduction

Last week, the Federal Circuit issued its opinion on remand in Amgen Inc. v. Sandoz Inc., holding that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) preempts state law remedies for a biosimilar applicant's refusal to comply with information disclosure requirements. Accordingly, to the extent a biosimilar applicant opts, as Sandoz did in this case, not to provide a reference product sponsor (RPS) with its biosimilar application per the timelines set forth in the BPCIA, the sponsor's only recourse is to bring a declaratory judgment action against the biosimilar applicant. Per the Federal Circuit's holding yesterday, an RPS may not pursue state law claims such as unfair competition, conversion, or injunctive relief based on such state law claims, to penalize a biosimilar applicant for declining to comply with federal requirements.