On February 20, 2026, the Federal Circuit revived a gene therapy patent owned by Regenxbio and the University of Pennsylvania, holding that the claimed technology is patent-eligible under Section 101 because it is “markedly different from anything occurring in nature.”
The case centers on U.S. Patent No. 10,526,617, which covers a human-made host cell containing a recombinant nucleic acid molecule created by splicing together genetic material from two different species. A Delaware district court had ruled the patent ineligible, finding it merely combined naturally occurring materials without meaningful modification.
The Federal Circuit disagreed. In a precedential opinion (link below), the panel held that the claimed recombinant molecule “does not and cannot exist in nature” and must be created through human intervention. That structural and functional difference, the Court said, makes the invention patent-eligible.
The Court compared the claims to those upheld in Diamond v. Chakrabarty, involving a genetically engineered bacterium, and to the cDNA claims found eligible in Association for Molecular Pathology v. Myriad Genetics. It distinguished the case from Funk Brothers, where naturally occurring bacteria were simply combined, and from ChromaDex, where isolated vitamin compounds were found insufficiently different from natural sources.
The panel concluded that engineering genetic sequences from separate species into a single molecule and incorporating it into a host cell is materially different from merely grouping natural substances together.
Judges Timothy Dyk, Todd Hughes, and Kara Stoll issued the decision in Regenxbio Inc. v. Sarepta Therapeutics Inc., No. 24-1408 (Fed. Cir. 2026).
Link: www.cafc.uscourts.gov/opinions-orders/24-1408.OPINION.2-20-2026_2650255.pdf
