As we previously reported, on January 24, 2019, Coherus filed a complaint against Amgen in the District of Delaware alleging that Amgen’s adalimumab product for sale in Europe, Amgevita, infringes three Coherus formulation patents related to adalimumab because Amgen allegedly manufactures its European product in the United States. As we also reported, Coherus amended its complaint to add allegations of infringement of a fourth patent.
On April 18, 2019, Amgen answered Coherus’s amended complaint. In its Answer, Amgen denied that it infringes the four asserted patents, alleged that all four of the asserted patents are invalid, and alleged that all four patents are unenforceable for inequitable conduct. Specifically, Amgen alleged that the four asserted patents are either anticipated or rendered obvious by two AbbVie patents, which Amgen alleges Coherus deliberately withheld from the U.S. Patent and Trademark Office during prosecution of the applications for the patents-in-suit. Additionally, although Amgen denies infringement of the four patents-in-suit, Amgen alternatively alleges that even if it is found to infringe any asserted claim, it is entitled to a complete defense under 35 U.S.C. § 273 based on its alleged prior commercial use.