Yesterday, in an opinion authored by Judge Moore, the Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s decision that: 1) U.S. Patent No. 5,856,298 (the ‘298 patent) belonging to Amgen was infringed by Hospira and not invalid; 2) 14 batches of drug substance for Hospira’s erythropoietin biosimilar drug product were not covered by the Safe Harbor provision of 35 USC § 271(e)(1); and 3) Amgen had proven that it was entitled to a jury verdict of $70 million in damages. Additionally, the CAFC affirmed the jury’s verdict of noninfringement of U.S. Patent No. 5,756,349 (the ‘349 patent).
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