Home / Business and Economy / Appeals Court Revives Gene Therapy Patent Lawsuit
Appeals Court Revives Gene Therapy Patent Lawsuit
21 Feb
Summary
- Appeals court revived a patent lawsuit over a Duchenne muscular dystrophy treatment.
- The ruling allows Regenxbio's gene-therapy patent case against Sarepta to proceed.
- The disputed patent concerns gene-therapy technology used in Sarepta's Elevidys drug.
A U.S. appeals court has reinstated a patent lawsuit involving biotech companies Regenxbio and Sarepta Therapeutics over a gene therapy for Duchenne muscular dystrophy (DMD). The U.S. Court of Appeals for the Federal Circuit reversed a lower court's decision that had invalidated a key patent held by Regenxbio, which it licenses from the University of Pennsylvania.
The patent in question pertains to gene-therapy technology that Regenxbio claims was infringed by Sarepta's Elevidys, the first approved gene therapy for DMD. The federal judge had initially dismissed the case, deeming the patent invalid because it covered naturally occurring DNA sequences. However, the appeals panel found the patent covered genetically engineered cells that were "markedly different from anything occurring in nature."
Regenxbio, based in Rockville, Maryland, is developing its own DMD treatment and filed the lawsuit in 2020. The company and Penn are seeking over $900 million in damages. Elevidys, approved by the FDA in 2023, generated $898.7 million in revenue for Cambridge, Massachusetts-based Sarepta in 2025. This ruling allows the patent infringement claims to move forward.
