Amgen Inc. v. Hospira, Inc., No. 19-1067 (Fed. Cir. Dec. 16, 2019)

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.

Hospira, Inc. ( Hospira) appeals the District of Dela- ware’s denial of its motion for judgment as a matter of law (JMOL), or alternative motion for new trial, upholding the jury’s verdict that: (1) Amgen, Inc. and Amgen Manufac- turing, Ltd.’s (Amgen) U.S. Patent No. 5,856,298 (the ’298 patent) was infringed and not invalid; (2) fourteen batches of drug substance for Hospira’s erythropoietin biosimilar drug product were not covered by the Safe Harbor provi- sion of 35 U.S.C.