Supreme Court Grants Certiorari in Amgen v. Sanofi to Decide Enablement Question

By: Trent Hoffman and David Barker

On November 4, 2022, the Supreme Court granted certiorari in Amgen v. Sanofi, No. 21-757, to review “[w]hether enablement is governed by the statutory requirement that the specification teach those skilled in the art to make and use the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art to reach the full scope of claimed embodiments without undue experimentation.”

Amgen sued Sanofi in 2014, alleging that Sanofi had infringed its cholesterol-lowering drug patents. Sanofi argued that the patents were invalid because, among other things, they failed to meet the enablement requirement, reasoning that the specifications did not enable those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. Amgen and Sanofi twice tried issues of validity to a jury, which both times found that Sanofi failed to prove invalidity for lack of enablement. But the District Court granted Sanofi’s motion for judgment as a matter of law for lack of enablement.  Amgen appealed, and the Federal Circuit affirmed. Amgen’s appeal to the Supreme Court followed.

This is a significant case for the patent industry, as the enablement requirement under 35 U.S.C. § 112 must be met for an invention to be patented. The requirement facilitates public access to technical information needed to understand and use the invention and encourages innovation by rewarding inventors for their contributions to the field. However, whether an invention is “enabled” under the statute is a debated issue. The Supreme Court’s decision in Amgen v. Sanofi could have a significant impact on the scope of patent protection available for inventors. Hopefully it also will provide important guidance regarding the level of detail required to meet the enablement requirement under 35 U.S.C. § 112.