Tag Archives: Biologics Price Competition and Innovation Act

The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen

By Laura Gordon on June 28, 2017 Posted in Biosimilars

On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers (applicants).[1] In particular, the Court held that (1) a federal injunction is not available to compel biosimilar applicants to disclose application and manufacturing … Continue Reading

Federal Circuit Confirms That the BPCIA Always Requires Post-Licensure Notice

By Gary Levin and Rik Parker on July 6, 2016 Posted in Biosimilars

The Federal Circuit answered one of the questions left open by its July 27, 2015, decision in Amgen Inc. v. Sandoz Inc. (Appeal No. 2015-1499): whether the 180-day commercial marketing notice under the Biologics Price Competition and Innovation Act (BPCIA) is mandatory even for a biosimilar applicant that has participated in the so-called patent dance. … Continue Reading