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ARTICLE · 10 APRIL 2023

SCOTUS Hears Argument On Patent Enablement Standard

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On Monday, March 27, 2023, the Supreme Court held oral argument regarding the proper legal standard for patent enablement in Amgen v. Sanofi.

United StatesIntellectual Property
Mark H. Remus
Mark H. Remus
Alexis White
Alexis White

Key Takeaway

  • The Supreme Court is likely to confirm that patent invalidity for lack of enablement requires a showing of "undue experimentation" and that whether the amount of experimentation is "undue" depends on the factors set forth in the long-standing Wands decision.

On Monday, March 27, 2023, the Supreme Court held oral argument regarding the proper legal standard for patent enablement in Amgen v. Sanofi. This closely-watched case is of great interest because it is the first time the Court has addressed section 112 of the Patent Act since it addressed indefiniteness in 2014. The case has divided the pharmaceutical industry where some pharmaceutical companies have filed amicus briefs in support of Amgen (AbbVie, Biogen, Bristol Myers Squibb, GSK and Merck Sharp & Dohme), while others have filed amicus briefs in support of Sanofi (AstraZeneca, Bayer, Eli Lilly, Fresenius Kabi, Genentech, Gilead, Johnson & Johnson and Viatris).

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