Regenxbio and UPenn Lose Legal Battle Over Muscular Dystrophy Treatment Patent to Sarepta
Published on January 6, 2024
In a major legal showdown over patents and innovation, Sarepta Therapeutics (SRPT.O) has emerged victorious against Maryland biotech company Regenxbio (RGNX.O) and the University of Pennsylvania in a Delaware federal court. The dispute centered around Sarepta’s groundbreaking treatment for Duchenne muscular dystrophy (DMD), a severe genetic disorder primarily affecting young boys.
U.S. District Judge Richard Andrews made a pivotal decision, declaring that the patent in question, related to Regenxbio’s competing gene-therapy technology, was invalid. This decision marked a significant triumph for Sarepta, which has been pioneering gene therapy solutions for DMD.
The legal battle stemmed from Regenxbio’s 2020 lawsuit, where they alleged that Sarepta’s Elevidys, the first gene therapy for DMD approved by the U.S. Food and Drug Administration (FDA) in the previous year, infringed on a gene-therapy patent licensed by Regenxbio from the University of Pennsylvania.
Regenxbio’s Chief Legal Officer, Patrick Christmas, expressed disappointment at the court’s decision and revealed the company’s intentions to appeal. On the other hand, the University of Pennsylvania declined to comment on the ruling. A spokesperson for Sarepta welcomed the outcome, characterizing it as a “win for innovation.”
Duchenne muscular dystrophy is a debilitating genetic condition that progressively weakens muscles, often leading to severe disability and a shortened lifespan. Sarepta’s Elevidys represented a ray of hope for many affected individuals and their families. However, in a setback for the therapy, Sarepta reported in October that Elevidys had failed to meet the primary goal in a late-stage trial.
Meanwhile, Regenxbio, headquartered in Rockville, Maryland, has been actively developing its own treatment for DMD. Their lawsuit against Sarepta, seeking more than $900 million in monetary damages, was rooted in claims that Elevidys infringed upon their licensed gene-therapy patent.
Judge Andrews’ ruling was based on the argument that the patent in question covered naturally occurring DNA sequences, rendering it invalid. This decision has important implications not only for the ongoing dispute but also for the broader landscape of gene therapy innovation and patent protection.
While Sarepta celebrates this legal victory, it’s worth noting that a separate, related patent lawsuit filed by Regenxbio and the University of Pennsylvania against Sarepta last year remains ongoing. The outcome of this case will likely continue to shape the future of DMD treatments and the legal framework surrounding gene therapy patents.
In an industry where groundbreaking discoveries and legal disputes often go hand in hand, the battle between Sarepta and Regenxbio serves as a testament to the critical role played by patent law in fostering innovation while ensuring fair competition.
The case is Regenxbio Inc v. Sarepta Therapeutics Inc, U.S. District Court for the District of Delaware, No. 1:20-cv-01226.
- About the Author
- Latest Posts
BioBuzz is a community led, experience focused, biotech and life sciences media and events company. BioBuzz highlights regional breaking news, industry professionals, jobs, events, and resources for business and career growth. Their weekly newsletter is subscribed to by thousands in the BioHealth Capital Region and Greater Philadelphia as the go-to for industry updates.
