By: Cindy Rothschild, PhD, Andrew T. Serafini, PhD, and Christopher Thomas
Last week, the Supreme Court granted Amgen’s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. Sanofi improperly created a new and heightened test for enablement of genus claims with functional limitations. The Supreme Court declined to review Amgen’s first question in the petition regarding whether enablement is a question of fact to be determined by the jury or a question of law determined by the court. Notably, the Supreme Court granted Amgen’s petition for certiorari against the recommendation of the Solicitor General.
As we reported late last year, Amgen’s petition for certiorari stems from the Federal Circuit’s decision that patents covering Amgen’s cholesterol medication Repatha® were not enabled because reaching their full scope would require undue experimentation. In its petition, Amgen argues that the Federal Circuit decision creates a new standard for enablement of genus claims that evaluates how much “time and effort” is required to make and test every embodiment so as “to reach the full scope of claimed embodiments” thereby requiring the Applicant to identify every embodiment meeting the claimed function. The full scope enablement of genus claims would require an Applicant to identify and make every embodiment that falls within the scope of the claims, which places a heavy burden on the Applicant to disclose and enable the entire genus that is claimed.
The Supreme Court’s decision to determine the standard for enabling genus claims and whether the “full scope of the claim” standard is an improper heightened standard for enablement will be closely watched by biotechnology companies. At the heart of the issue is the balance between the scope of genus claims and their potentially preemptive effect and the disclosure requirements of a patent owner to properly enable one of ordinary skill in the art to make and use their invention. As the law currently stands, functional genus claims will be heavily scrutinized for enablement under the “full scope of the claim” standard. Therefore, patentees drafting such claims should consider subgenus claims and species claims with sufficient evidence of enablement.
Cynthia Rothschild, PhD is a partner in the Winston-Salem, NC office, Andrew T. Serafini, PhD is a partner in the Seattle, WA office, and Christopher Thomas is a senior associate in the Washington, DC office of Kilpatrick Townsend & Stockton LLP.
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