With its recent opinion in AAM, Inc. v. Neapco Holdings, LLC, No. 18-1763 (Fed. Cir. July 31, 2020), and a 6-6 stalemate by the court’s active judges on whether to take the case en banc, the Federal Circuit has now adopted—under the rubric of 35 U.S.C. §101—a formalized set of enablement-like requirements for patent claims. For a simple “threshold” eligibility test, section 101 has grown remarkably complex. Indeed, since the Supreme Court’s 2012 Mayo and 2014 Alice decisions re-cast patent eligibility into a “two-step framework,” the Section 101 test adjudges not just subject-matter eligibility and the three “limited” exceptions thereto, but also patentability or “inventive-concept” challenges predicated on comparisons to the prior art, see 35 U.S.C. §§ 102-103. And now the enablement-type requirements imposed by AAM v. Neapco.
Enablement
- 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
- Review Not Warranted: SG Tells SCOTUS to Scrap Amgen’s Case on Enablement Test for Biotech Patents
- CAFC Denies Amgen Petition to Reconsider Enablement Test for Biotech Patents
- Federal Circuit Says Amgen’s Repatha® Patent Claims Require ‘Undue Experimentation’ to Practice
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