Redwood City, CA (GLOBE NEWSWIRE) - Coherus BioSciences, Inc. (“Coherus” or “the Company”, Nasdaq: CHRS), today 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.
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.”
About Coherus BioSciences, Inc.
Coherus BioSciences is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing and clinical-regulatory development, Coherus BioSciences is positioned as a leader in the global biosimilar marketplace. Coherus BioSciences commercializes UDENYCA® (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA® in the European Union. Coherus BioSciences is advancing two late-stage clinical products towards commercialization, CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), and developing a robust pipeline of future products in ophthalmology (including CHS-3351, a ranibizumab biosimilar, and CHS-2020, an aflibercept biosimilar), as well as CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis. For additional information, please visit www.coherus.com.
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