August 2015

Amgen v. Sandoz: Riddles, Mysteries, and Enigmas

By: Sandra King  |   August 5, 2015

On July 21, 2015, the Court of Appeals for the Federal Circuit provided its interpretation of two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), more specifically, the information-disclosure and notice-of-commercial-marketing provisions codified as 42 U.S.C. § 262(l)(2)(A) and (l)(8)(A), respectively. The Court held that the information-disclosure provision, i.e., the “patent dance,” was not mandatory and that the 180-day notice-of-commercial-marketing period was not effective until the biosimilar product was licensed by the FDA.