U.S. Supreme Court Clarifies Enablement for Functional Claims in Amgen v. Sanofi

In a unanimous decision published on May 18, 2023, the U.S. Supreme Court invalidated two of Amgen’s patents for its cholesterol drug, Repatha, making it more difficult for patentees to obtain broadly worded patents.

The case – Amgen Inc. v. Sanofi – involves a dispute between the two pharmaceutical companies over the “enablement” requirement of 35 U.S.C. Section 112, specifically how much a patent must disclose in order to “enable” a skilled person to make and use the claimed invention without undue trial and error.  The Supreme Court held that Amgen failed to provide enough detail to recreate the full scope of its claimed invention, and that if a patent claims an entire class of processes, machines, manufactures or compositions of matter then the patent must include sufficient information that enables a person skilled in the art to make and use the entire class.

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