Amgen v. Sanofi: A Supreme Court decision steers drug developers into uncharted waters

[Image courtesy of Philip/Adobe Stock]

The Supreme Court’s recent decision in the case of Amgen v. Sanofi (No. 21-757) could chart a new course for both the pharmaceutical industry and patent law. In its decision, the Supreme Court clarified the enablement requirement in the Patent Act, raising the bar for the level of detail needed in patents. In particular, the Court emphasized the need for ‘genus’ type patents, which encompass an entire class of substances or processes, to provide adequate detail to reproduce and use the entire class of items covered.

At the heart of the case were Amgen’s patents covering their pioneering monoclonal antibody Repatha (evolocumab), an LDL cholesterol-lowering agent, and two related patents. Amgen’s patents detailed 26 specific antibodies alongside a broader genus patent covering a potential universe of antibodies. Despite an extensive 400-page docu…

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