Amgen Inc. v. Sanofi

Summary

The Supreme Court held that Amgen’s antibody patent claims were invalid under the Patent Act’s enablement requirement because the specification did not enable skilled artisans to make and use the full claimed genus of antibodies. The Court affirmed the Federal Circuit, explaining that functional claims covering an entire class must be supported by disclosure sufficient to enable the entire class, subject to a reasonable amount of experimentation. The decision was unanimous.

Holdings

1. Amgen's patent specifications failed to satisfy the enablement requirement because they enabled 26 disclosed antibody embodiments but did not enable the full scope of the much broader genus of antibodies covered by the claims.
2. The Federal Circuit did not apply an impermissibly heightened standard; there is one statutory enablement standard, and the principle that broader claims require broader enabling disclosure is consistent with § 112(a) and Supreme Court precedent.
3. Enablement is not measured by the cumulative time and effort required to make every embodiment within a claim, although the need for extensive trial-and-error experimentation may demonstrate that the specification fails to enable the claimed invention.

Questions Presented

1. Whether Amgen's patent specifications enabled a person skilled in the art to make and use the full scope of the claimed genus of PCSK9-inhibiting antibodies under 35 U.S.C. § 112(a).
2. Whether the Federal Circuit improperly applied a heightened enablement standard to genus claims defined by function.
3. Whether enablement is measured by the cumulative time and effort required to make every embodiment within a broad claim.

Disposition

affirmed