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1 1 (June 1, 2023)

handle is hein.crs/govelvc0001 and id is 1 raw text is: Congressional_______ R a esearch Service Amgen v. Sanofi: Supreme Court Holds Patents Claiming Antibody Genus Invalid as Not Enabled June 1, 2023 In Amgen v. Sanofi, the Supreme Court held that Amgen's patent on a class of antibodies used to treat high cholesterol was invalid under patent law's enablement requirement. Justice Neil Gorsuch's unanimous opinion held that while Amgen could (and did) patent the specific antibodies it discovered, it could not patent an entire antibody class (known as a genus) unless the patent disclosure contained enough technical information to enable a scientist skilled in the field to make and use every antibody in the genus with reasonable experimentation. On the facts, the Court held that Amgen's patents were not enabled because the techniques it offered to generate each of the potentially millions of antibodies in the claimed genus would not reliably yield a desired antibody without painstaking experimentation. Amgen has significant implications for patents on biological products (biologics) and for innovation and competition in the pharmaceutical industry. While Amgen strove to leave the blackletter law of patent enablement unaltered by relying heavily on its enablement precedents, its application of those cases to modern medical treatments will likely make it harder in practice to patent functionally described genus claims, particularly for biologics. Legal and Factual Background The dispute in Amgen concerns antibody treatments for high low-density lipoprotein (LDL) cholesterol, commonly called bad cholesterol because of its association with heart disease. Because a naturally occurring protein called PCSK9 binds to and degrades the body's LDL receptors-which extract LDL from the bloodstream-an antibody that inhibits (i.e., blocks) PCSK9 can be used to lower levels of LDL cholesterol. In the early 2000s, scientists at Amgen developed a PCSK9 inhibitor known as Repatha (evolocumab), while Sanofi developed a different PCSK9-inhibiting antibody now marketed as Praluent (alirocumab). In 2011, Amgen obtained a patent claiming Repatha as described by its specific amino acid sequence, and Sanofi did the same for Praluent. Amgen also obtained patents claiming the broader genus of antibodies to Congressional Research Service https://crsreports.congress.gov LSB10971 CRS Legal Sidebar Prepared for Members and Committees of Congress

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