Supreme Court of the United States
Amgen Inc. v. Sanofi
May 18, 2023598 U.S. 594
Summary
Justice Gorsuch delivered the unanimous opinion holding that Amgen’s broad antibody claims failed the Patent Act’s enablement requirement. A specification must enable the full scope of the claimed invention, although reasonable experimentation is permissible and every embodiment need not be individually described. Amgen’s disclosure of 26 antibodies and two trial-and-error methods did not enable the much larger class of functionally defined antibodies it claimed. The Court rejected Amgen’s arguments that the Federal Circuit had improperly measured cumulative effort or imposed a heightened enablement standard for genus claims, and affirmed its judgment. There were no separate opinions.
Holding
- Whether Amgen enabled the full scope of its functionally defined antibody claims.. Amgen’s claims were invalid for lack of enablement because the disclosed examples and methods did not enable a person skilled in the art to make and use the entire claimed class.
- Whether cumulative time and effort to produce every claimed embodiment measures enablement.. Enablement is not measured against the cumulative time and effort required to make every embodiment within a claim.
- Whether functionally defined genus claims receive a heightened enablement standard.. There is one statutory enablement standard, and requiring broader claims to be supported by correspondingly broader enablement applies that standard rather than heightening it.
Cited authorities
- 35 U.S.C. § 112
- 35 U.S.C. § 112
- 1 Stat. 110
- 35 U.S.C. § 112
- 132 Yale L.J. 994
- U.S. Patent No. 8,829,165
- U.S. Patent No. 8,859,741
- 35 U.S.C. §§ 111