Federal Circuit Clarifies §101 Eligibility for Recombinant Cells in Regenxbio V. Sarepta

In a significant § 101 decision for biotech and gene therapy, the Federal Circuit reversed the District of Delaware’s summary‑judgment ruling that the claims of U.S. Patent No. 10,526,617 (“the ’617 patent”) were ineligible under § 101. The decision clarifies that recombinant, human‑engineered host‑cell compositions—viewed as a whole—remain patent‑eligible, even when their constituent sequences have natural origins. REGENXBIO Inc. v. Sarepta Therapeutics, Inc., No. 2024‑1408 (Fed. Cir. Feb. 20,... By: Dinsmore & Shohl LLP