Sarepta pushes DNA‑patent review
Sarepta Therapeutics filed for full Federal Circuit (en banc) review in a patent dispute over when altered DNA qualifies for patent protection. The petition has refocused attention on DNA patent eligibility and could affect licensing and platform rights in gene‑therapy supply chains. (news.bloomberglaw.com)
A patent fight over gene therapy has turned into a fresh test of when engineered DNA is different enough from nature to be patented. (bloomberglaw.com) Sarepta Therapeutics asked the full U.S. Court of Appeals for the Federal Circuit to rehear REGENXBIO Inc. v. Sarepta Therapeutics, Inc. on March 23, 2026, after a three-judge panel revived REGENXBIO’s suit on February 20, 2026. (antheros.legal) The panel said claims in U.S. Patent No. 10,526,617 cover a human-made host cell carrying recombinant nucleic acid molecules and are patent-eligible under Section 101 of the Patent Act. It reversed a Delaware ruling that had thrown the claims out as a natural phenomenon. (cafc.uscourts.gov) DNA is the cell’s instruction code, and patent law generally bars ownership of code found in nature. The dispute is over whether inserting altered genetic material into a lab-made cell creates a new composition of matter, or just repackages something natural. (law.cornell.edu) That line has mattered since the Supreme Court’s 2013 Myriad Genetics ruling, which said naturally occurring DNA segments are not patentable merely because they are isolated, while complementary DNA, or cDNA, can be patented because it is not naturally occurring. (supreme.justia.com) REGENXBIO and the University of Pennsylvania sued Sarepta in Delaware in September 2020, alleging Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys infringed the ’617 patent. Judge Richard Andrews ruled for Sarepta on January 5, 2024, weeks before a scheduled January 29, 2024 trial. (goodwinlaw.com) The Federal Circuit panel rejected that approach, writing that the claimed cells are “markedly different” from anything found in nature because they combine recombinant DNA and other non-AAV genetic material in a cultured host cell. The court sent the case back for further proceedings. (cafc.uscourts.gov) Sarepta’s rehearing petition argues the panel created a broader rule that could let routine manipulation of natural DNA qualify for patents. Lawyers quoted by Bloomberg Law said the petition has reopened debate over how far Section 101 reaches for gene-therapy tools used across licensing and manufacturing chains. (bloomberglaw.com) Industry-side commentary has read the panel opinion the other way, saying it gives biotech companies firmer ground for patents on engineered cells used to make adeno-associated virus vectors, the delivery shells common in gene therapy. Those vectors sit at the center of platform deals, royalties and supply agreements. (cooley.com) Rehearing en banc is “not favored” under Federal Rule of Appellate Procedure 40, and the Federal Circuit posts non-ministerial rehearing orders on its opinions-and-orders page. The next signal in this case is whether the court lets the February ruling stand or takes the patent-eligibility question to the full bench. (law.cornell.edu)
