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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For biotech, much is riding on the Supreme Court’s Amgen v. Sanofi decision

[Image courtesy of Joe Ravi via Wikimedia Commons]

The U.S. Supreme Court’s decision in Amgen v. Sanofi could have far-reaching consequences for the biotech industry.

The court will consider how much a patent must disclose to comply with enablement requirements.

In February 2021, the Federal Circuit ruled that two Amgen patents (8,829,165 and 8,859,741) for the cholesterol drug Repatha (evolocumab) do not meet enablement requirements because the patent claims require “undue experimentation.”

Now, the Supreme Court will consider whether to uphold the ruling, overrule it or send it back down to the lower court.

Suppose the Supreme Court’s justices choose to uphold the Federal Circuit’s ruling in Amgen v. Sanofi. The consequences could be devastating to the molecular biology and biotechnology industry, said Patrice Jean, chair of Hughes Hubbard & Reed’s l…

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