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ARTICLE · 22 JANUARY 2024

USPTO Issues Enablement Guidelines Following Amgen v. Sanofi

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On January 10, 2024, the United States Patent and Trademark Office (USPTO) released Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court...

United StatesIntellectual Property
Patrick M. Torre
Patrick M. Torre
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On January 10, 2024, the United States Patent and Trademark Office (USPTO) released Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.12 The Guidelines are intended to inform U.S. patent examiners and the public about the process to be followed when assessing whether a claim satisfies the enablement requirement under 35 U.S.C. 112(a), after the U.S. Supreme Court's holding in Amgen v. Sanofi.3

35 U.S.C. §112(a)

The enablement requirement under 35 U.S.C. 112(a) is met as to a particular claim of a patent or application when that claim is "supported" by the patent or application disclosure. If it can be demonstrated that the patent disclosure as filed contained sufficient information about the subject matter of the claim so as to enable one skilled in the pertinent art to make and use the claimed invention without "undue experimentation," the claim is enabled. The

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