Background
Teva asserted patent claims covering methods of reducing or treating headache by administering an effective amount of a humanized monoclonal antibody that acts as an anti-CGRP antagonist. The representative claim contained both an antibody-function limitation and a treatment limitation.
After the Federal Circuit issued its panel opinion in the appeal, Eli Lilly petitioned for panel rehearing and rehearing en banc. Teva responded, and several pharmaceutical companies and individuals received permission to file amicus briefs. The petition was referred first to the original panel and then to the active circuit judges, who conducted a poll.
The Court’s Holding
In a per curiam order, the Federal Circuit denied both panel rehearing and rehearing en banc after the en banc poll failed. The order therefore left the panel’s merits decision in place, including its treatment of enablement for the asserted method claims.
Judge Dyk dissented from the denial. He argued that a method claim depending on a functionally defined genus of antibodies cannot satisfy enablement across its full scope when identifying and producing the antibodies themselves would require undue experimentation. In his view, distinguishing a method-of-treatment claim from a claim to the antibody genus created an improper path around the Supreme Court’s enablement analysis in Amgen Inc. v. Sanofi.
Key Takeaways
- The court denied both panel rehearing and rehearing en banc; it did not issue a new merits ruling.
- The denial leaves intact the panel’s conclusion that the asserted headache-treatment method claims satisfied enablement despite assumed difficulty in making and humanizing all antibodies within the recited anti-CGRP antagonist genus.
- Judge Dyk warned that the panel’s approach could allow patentees to avoid genus-claim enablement requirements by drafting claims as methods of using the genus.
Why It Matters
The denial preserves a potentially important distinction between claims to a broad genus of compounds and claims to methods using that genus for a specified therapeutic purpose. That distinction may affect how life-sciences patents are drafted, challenged, and evaluated under the enablement requirement.
The dissent also highlights continuing uncertainty after Amgen about whether every functionally defined component of a method claim must independently be enabled across its full scope. Pharmaceutical companies participating as amici warned that the panel’s approach could affect research investment and permit method claims to restrict later-developed treatments.