Coherus BioSciences, Inc., announced that the United States Court of Appeals for the Federal Circuit has affirmed the decision of the United States District Court for the District of Delaware that Coherus’ UDENYCA (pegfilgrastim-cbqv), a pegfilgrastim biosimilar, does not infringe Amgen’s asserted patent. Coherus launched UDENYCA in the United States in January 2019.

THE 707 PATENT

As previously reported, on May 10, 2017, Amgen filed a patent infringement complaint under the Biologics Price Competition and Innovation Act (“BPCIA”) against Coherus asserting U.S. Patent 8,273,707 (“the ’707 patent”). In June 2017, Coherus filed a motion to dismiss the lawsuit on the grounds that Coherus’ UDENYCA could not be found to infringe Amgen’s patent. The District Court granted Coherus’ motion to dismiss the case in March 2018. Amgen subsequently appealed, and the parties participated in an oral argument before the Federal Circuit on May 8, 2019.

The Federal Circuit’s precedential opinion affirmed the District Court’s judgment in Coherus’ favor. The Federal Circuit held that the doctrine of prosecution history estoppel barred Amgen from succeeding on its infringement claim and affirmed the District Court’s dismissal.

“We are pleased by the Federal Circuit’s precedential decision and have always been confident that the District Court’s decision would be affirmed on appeal,” said Thomas Fitzpatrick, Coherus’ Chief Legal Officer. “We are particularly pleased to continue our mission to successfully lower healthcare costs and expand patients’ access to life-saving drugs.”