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ARTICLE · 13 SEPTEMBER 2023

Enablement Bar For Drug Patents

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On May 18, 2023, the Supreme Court affirmed the Federal Circuit's (CAFC) decision on enablement in Amgen Inc. v. Sanofi, 987 F.3d 1080 (CA Fed. 2021). The Court thus left in place a significant CAFC...

United StatesIntellectual Property
Aaron Barlow
Aaron Barlow
Louis Fogel
Louis Fogel
Shaun Van Horn
Shaun Van Horn

On May 18, 2023, the Supreme Court affirmed the Federal Circuit's (CAFC) decision on enablement in Amgen Inc. v. Sanofi, 987 F.3d 1080 (CA Fed. 2021). The Court thus left in place a significant CAFC decision making it more difficult for drug companies to block competitive products in the United States that are functionally equivalent, but structurally different.

Background of the Patent and Lower Court Proceedings

The case involved Amgen's patents on monoclonal antibodies that block a protein that leads to high?cholesterol levels. It was undisputed in the case that there are a "vast" number of possible antibodies that?would fall within the scope of Amgen's claims. However, Amgen's patent only disclosed 26 examples of antibodies that met its claims. A jury found Amgen's claims enabled, but the trial judge and the CAFC held the claims were invalid as a matter of law for lack of enablement.

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