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Treatment of Antibody Claims In the U.S. After 'Amgen v. Sanofi'
The future of antibody claiming in the United States is uncertain following the U.S. Supreme Court's May 2023 ruling in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), a highly anticipated decision concerning enablement and whether the traditional way to claim antibodies — claiming antibodies by their function — will survive as a valid claiming strategy.
Since the Amgen decision and as of November 2023, the case has been cited in seven Patent Trial and Appeal Board (PTAB) decisions, seven district court cases and three federal circuit cases. Of those, three focused on antibodies.
To recap, the U.S. Supreme Court held in Amgen that claims 19 and 29 of Amgen's '165 patent (U.S. Patent No. 8,829,165) and claim 7 of their '741 patent (U.S. Patent No. 8,859,741) were invalid for lack of enablement.
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