New BPCIA Litigation: Amgen v. Coherus (D. Del.)

Amgen has filed a BPCIA suit in the District of Delaware against Coherus Biosciences, Inc., alleging infringement of U.S. Patent No. 8,273,707—a patent “directed to a process for purifying proteins.”  The complaint alleges that following FDA’s acceptance of Coherus’s abbreviated biologics application for a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) product, the parties engaged in the BPCIA patent dance and agreed that the ’707 patent would be the subject of an immediate patent infringement action under § 262(l)(6)(A).

The complaint does not allege any violations of the BPCIA patent dance provisions.  Amgen’s complaint includes a request for declaratory judgment of infringement upon information and belief that “Coherus believes that FDA may act upon the Coherus aBLA as soon as June 9, 2017.”  Amgen also notes in the complaint that “Coherus has publicly stated that it anticipates ‘commercial launch mid-second half of 2017 depending on Supreme Court decision on 180-day notice of commercialization and other litigation matters.’”

This past March, Amgen also filed a complaint relating to Coherus’s pegfilgrastim application in California state Superior Court, alleging “a massive conspiracy by disloyal former Amgen employees” at Coherus “to steal Amgen’s trade secrets” to “obtain[] an unfair head start in their effort to bring…a biosimilar candidate to Neulasta® to market.” See further coverage of the California state suit here:

Stay tuned for updates on the Big Molecule Watch.