Amgen Inc. v. Apotex Inc., No. 17-1010 (Fed. Cir. Nov. 13, 2017)

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.

Amgen Inc. and Amgen Manufacturing Limited (co l- lectively, Amgen) own U.S. Patent No. 8,952,138, which describes and claims methods of refolding recombinant proteins expressed in non-mammalian cells, such as bacteria and yeast. ’138 Patent, col. 1, lines 10–20; col. 2, lines 52–61. Amgen also holds Biologics License Applica- tion Nos. 125031 and 103353, approved by the Food and Drug Administration (FDA), for therapeutic products made from the recombi nant proteins pegfilgrastim (Neulasta®) and filgrastim (Neupogen®). Apotex Inc. and Apotex Corp.