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Implications of 'Amgen v. Sanofi' On the State of Enablement Law
On Feb. 11, 2021, the Federal Circuit affirmed the district court's judgment as a matter of law (JMOL) that Amgen's asserted claims to genera of antibodies were invalid for lack of enablement. Amgen Inc. v. Sanofi, No. 2020-1074, 2021 WL 501114 (Fed. Cir. Feb. 11, 2021). The panel consisting of Chief Judge Prost and Judges Lourie and Hughes unanimously affirmed the District of Delaware's holding that undue experimentation would be required to practice the full scope of the claims-at-issue. Id.
Although this decision was highly fact-dependent, turning on the scope of particular antibody claims and the level of detail in the attendant specifications, its implications potentially stretch beyond the biotech space to the state of enablement law more generally. In particular and as further explained below, the decision appears to take steps to harmonize the prior cases that appropriately were guided by the Wands factors with the cases discussing the "full scope" of enablement that have engendered some confusion in the law.
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