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Partner Andrew Wasson contributed a chapter to the Food & Drug Law Institute’s annual publication identifying the top food and drug cases of the year. Andrew’s chapter relates to the Supreme Court case, Amgen v. Sanofi, 598 U.S. 594, 143 S. Ct. 1243 (2023).This publication is shared with the permission of FDLI.
Amgen v. Sanofi is undeniably and thoroughly a patent case, but its adjacency to the regulation of biologics, especially to the patent-specific provisions of the Biologics Price Competition and Innovation Act (BPCIA), makes it worth a close look by FDA regulatory attorneys.
In Amgen v. Sanofi, the Supreme Court examined the statutory “enablement” requirement for patents with claims that essentially recite an antibody by its function. Broadly, the “enablement” requirement necessitates that a patent specification describe a claimed invention in terms that “enable” persons ordinarily skilled in the art “to make and use” the invention. Here, the Court upheld the determinations of the lower courts that Amgen’s patent description failed to enable a skilled artisan to make and use the claimed invention over the full scope of the claims. The Supreme Court’s holding in Amgen is a clear caution signal regarding functionally drafted claims relating to antibodies.
To read more, see related PDFs.