Is the genus claim dead, or has its demise been greatly exaggerated? We may soon have the Supreme Court’s answer. On April 18, following eight years of patent infringement litigation between Amgen and Sanofi, including two trials and two Federal Circuit appeals, the Supreme Court called for the views of the Solicitor General (“SG”) on Amgen’s petition for a writ of certiorari after the Federal Circuit invalidated its asserted patent claims for failing to satisfy the enablement requirement. See Amgen Inc. v. Sanofi, 987 F. 3d 1080 (Fed. Cir. 2021). The subject patents are directed to a genus of antibodies defined not by their structure (e.g., amino acid sequence) but by their function—specifically, the ability of the antibodies to bind certain parts of the PCSK9 antigen. Although these antibodies are not per se immunotherapeutic—PCSK9 is a target for treating high cholesterol and does not implicate immune system modulation—the Supreme Court’s resolution of the enablement questions presented will certainly have consequences for patenting protein immunotherapies, particularly antibodies, where claims are frequently drawn to genus-type claims with limitations to binding of immunoregulatory antigen targets.

The issue for the Supreme Court’s review if certiorari is granted is the standard for assessing enablement for broadly drafted claims to a functionally defined genus covering potentially many thousands (if not millions) of compositions when only a relatively few working embodiments are disclosed in the specification. Amgen’s petition argues that
Continue Reading Amgen Inc. v. Sanofi: Does the Supreme Court’s Call for the Solicitor General’s Views Signal an Intention to Resolve Important Enablement Questions for Genus Claims?