Amgen Sues Coherus Under BPCIA After Completing Patent Dance

On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act ("BPCIA"), Coherus infringed Amgen's U.S. Patent No. 8,273,707 (the "'707 patent") by filing an abbreviated Biologic License Application ("aBLA") for a biosimilar version of Amgen's Neulasta (pegfilgrastim) product. Amgen asserted that the biosimilar manufacturing process disclosed in the Coherus aBLA will infringe the '707 patent's claimed protein purification process.

In contrast with some other pending BPCIA infringement suits, the parties here apparently followed all steps of the BPCIA "patent dance" information exchange procedure codified at 42 U.S.C. § 262(l). Specifically, Coherus allegedly submitted its aBLA in August 2016 and, around October 6, 2016, received notification from FDA that the aBLA was accepted. In accordance with § 262(l)(2), the parties began the patent dance on