Tag Archives: Biosimilars

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

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

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

Sandoz Requests Supreme Court Review of the Federal Circuit’s Interpretation of Biosimilar Law

On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The petition presents the following questions to the Court: Whether notice of commercial marketing given before FDA approval … Continue Reading