BREAKING NEWS: Federal Circuit Affirms Coherus Victory Over Amgen in Pegfilgrastim Patent Dispute

As we previously reported, last year Amgen appealed a Delaware district court’s decision dismissing Amgen’s patent infringement complaint under the BPCIA against Coherus on the ground that Coherus’s biosimilar of NEULASTA (pegfilgrastim) could not be found to infringe Amgen’s patent under the doctrine of equivalents (Amgen’s only asserted basis for alleging infringement) in view of Amgen’s clear and unmistakable disclaimer of claim scope during prosecution. The parties participated in an oral argument before a Federal Circuit panel on May 8, 2019.

This morning, the Federal Circuit panel issued a precedential opinion affirming the district court’s judgment. The Federal Circuit found that the doctrine of prosecution history estoppel barred Amgen from succeeding on its infringement claim under the doctrine of equivalents, and therefore the district court did not err in dismissing Amgen’s complaint.

The FDA approved Coherus’s biosimilar, UDENYCA (pegfilgrastim-cbqv), this past November. Coherus launched the product in the U.S. in January 2019.