On November 4, the U.S. Supreme Court granted Amgen’s petition for certiorari against the advice of the U.S. government – taking up Amgen’s challenge to the Federal Circuit’s enablement review of its PCSK9 antibody patents covering evolocumab (Repatha®). In its petition, Amgen asserts that the Federal Circuit has gone too far in invalidating its PCSK9 antibody patents by imposing a disclosure burden beyond the requirements of 35 U.S.C. § 112. Notably, the Supreme Court, albeit with a different composition, recently declined to hear several other similar cases raising issues with the Federal Circuit’s enablement precedent.
Enablement
- Amgen Reply Brief Addresses Mischaracterizations by Sanofi, U.S. Government on Proper Enablement Inquiry for Genus Claims
- Will the Supreme Court Save Biopharma from CAFC Enablement Insanity?
- Amici for Sanofi Add Their Two Cents as Amgen’s Day in High Court Approaches
- SCOTUS Takes on Scope of Enablement Inquiry in Amgen v. Sanofi: Implications for Pharma/ Biotech and Beyond
- Amgen Says Solicitor General’s ‘Disagreement With Everyone’ Further Supports SCOTUS Review of Legal Standard for Enablement
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