Amgen Inc. v. Apotex Inc., No. 16-1308 (Fed. Cir. July 5, 2016)

From the Opinion

The passage below is extracted verbatim from the opening of the document. It has not been editorially summarized — consult the full opinion for the court's complete reasoning.

This appeal involves an action brought by Amgen Inc. and Amgen Manufacturing Limited (collectively Amgen) AMGEN INC. v. APOTEX INC. 3 against Apotex Inc. and Apotex Corp. (collectively Apotex) under the Biologics Price Competition and Inn ovation Act of 2009 (Biologics Act or BPCIA ). Apotex has an applic a- tion pend ing with the Food and Drug Admi nistration, filed under the Biologics Act, that seeks permission to begin marketing a product allegedly “biosimilar” to Amgen’s FDA -approved Neulasta®.