Federal Circuit Rules in 180 Day Notice Under the BPCIA in Amgen Inc. v. Apotex Inc.

Yesterday, the Federal Circuit provided further interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen Inc. v. Apotex Inc., the Court ruled that the BPCIA requires a biosimilar applicant to give 180 days’ notice before commercially marketing its product. Apotex had argued that the notice was not mandatory if, like Apotex, the biosimilar applicant participated in the “patent dance,” a statutory information exchange that the Court found to be voluntary in last year’s decision of Amgen Inc. v. Sandoz Inc.