Federal Circuit Affirms Lack of Enablement of Select Claims of Amgen Patents

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As we previously reported in August 2019, the District Court for the District of Delaware issued an opinion granting Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were invalid for failing to comply with the enablement requirement.  On February 11, the Federal Circuit affirmed the district court’s determination of lack of enablement of claims 19 and 29 of the ’165 patent and claim 7 of the ’741 patent.  The claims cover antibodies that bind to one or more of fifteen residues of the protein PCSK9 and block PCSK9 from binding to LDL receptors.

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