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Sarepta Triumphs Over Regenxbio and UPenn in Patent Lawsuit for Duchenne Muscular Dystrophy Treatment

Delaware federal court ruled in favor of Sarepta Therapeutics, bringing an end to a patent lawsuit filed by Regenxbio and the University of Pennsylvania concerning Sarepta’s treatment for Duchenne muscular dystrophy (DMD). U.S. District Judge Richard Andrews declared the patent in question, linked to Regenxbio’s competing gene-therapy technology, as invalid.

Regenxbio, a biotech company based in Rockville, Maryland, had sought over $900 million in patent damages, contending that Sarepta’s gene therapy, Elevidys, infringed upon a gene-therapy patent licensed from Penn. In response to the court’s decision, Regenxbio’s chief legal officer, Patrick Christmas, expressed disappointment and confirmed plans to appeal. The University of Pennsylvania, a co-plaintiff, declined to comment on the ruling.

A spokesperson for Sarepta conveyed the company’s satisfaction with the court’s decision, characterizing it as a “win for innovation.” Elevidys, the first gene therapy for DMD, received approval from the U.S. Food and Drug Administration (FDA) in the previous year. However, a late-stage trial in October revealed that Elevidys had failed to meet its primary goal.

The legal dispute centered around allegations of patent infringement related to gene-therapy technology for treating DMD. Sarepta’s victory was based on the argument that the patent, which it was accused of infringing, is invalid as it pertains to naturally occurring DNA sequences.

Despite this resolution, a separate, related patent lawsuit filed by Regenxbio and UPenn against Sarepta last year remains ongoing. The case, titled “Regenxbio Inc v. Sarepta Therapeutics Inc,” is registered in the U.S. District Court for the District of Delaware under No. 1:20-cv-01226.

Legal representation in the case includes Susan Morrison, Casey Kraning, Jeremy Saks, Kurt Glitzenstein, Peter Fasse, John Lane, and Brian Coggio from Fish & Richardson for Regenxbio; Julie Goldemberg, Janice Logan, and Amy Dudash from Morgan Lewis & Bockius for UPenn; and Andrew Berdon, Robert Wilson, James Baker, Laura Fairneny, Anastasia Fernands, and Steven Madison from Quinn Emanuel Urquhart & Sullivan, along with William Raich, Mike Flibbert, and Charles Lipsey from Finnegan Henderson Farabow Garrett & Dunner for Sarepta.


Joan David-Leonhard

Joan David Leonhard is a recent Pharm.D graduate with a strong passion for the pharmaceutical industry and a particular interest in pharmaceutical media and communication. Her brief internship experience includes roles in pharmacy where she built strong patient-pharmacist relationships and a pharmaceutical media internship where she actively contributed to drug information articles, blog posts, social media engagement, and various media projects.
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