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Monday, February 22, 2021 Summary The Federal Circuit issued an opinion on February 11, 2021, invalidating antibody claims covering Amgen’s Repatha® (evolocumab) product. The court found, in a unanimous decision, that a genus of antibodies claimed only by epitope-binding activity is invalid for lack of enablement if it does not satisfy a new higher bar imposed by the court.   Background Repatha® is Amgen’s blockbuster biologic, cholesterol-lowering drug with more than $20 billion in annual sales and is indicated for reducing the risk of heart attack and stroke. Amgen owns U.S. Patents 8,829,165 (the ’165 patent) and 8,859,741 (the ’741 patent), which claim evolocumab antibodies that bind to proprotein convertase subtilisin/kexin type 9 (PCSK9). According to the ’165 and ’741 patents, the claimed antibodies block PCSK9 from binding to low-density lipoprotein (LDL) receptors in order to prevent mediation of LDL-receptor degradation and to allow LDL receptor

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