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Jenner & Block achieved a victory on behalf of Coherus BioSciences when the Federal Circuit affirmed the decision of the district court that the manufacturing process for Coherus’ UDENYCA® product does not infringe Amgen’s U.S. Patent No. 8,273,707, which is directed to a process for purifying proteins using a particular pair of salts. In June 2017, Coherus filed a motion to dismiss on the ground that the manufacturing process for UDENYCA® could not be found to infringe the ‘707 patent under the doctrine of equivalents (Amgen’s only asserted basis for infringement) in view of Amgen’s clear and unmistakable disclaimer of claim scope during patent prosecution. The United States District Court for the District of Delaware granted Coherus’ motion to dismiss the case in March 2018.
On July 29, 2019, the Federal Circuit affirmed the district court’s judgment in Coherus’ favor. The Court held that argument-based prosecution history estoppel barred Amgen from expanding the scope of the claims beyond the recited salt pairs, and thus Coherus’ manufacturing process was determined not to infringe the asserted patent.
“We agree with the district court that, during prosecution of the ‘707 patent, Amgen clearly and unmistakably surrendered salt combinations other than the particular combinations recited in the claims,” the Federal Circuit wrote.
UDENYCA®, a biosimilar to Neulasta®, is a biologic drug that stimulates bone marrow to prevent infection in patients undergoing chemotherapy.
News of the Federal Circuit decision was reported in Law360.