Sanofi’s subsidiary, Genzyme, has filed a significant lawsuit against Sarepta Therapeutics, claiming that Sarepta’s innovative Duchenne muscular dystrophy (DMD) gene therapy, Elevidys, infringes on two of its manufacturing patents. The complaint, lodged in the U.S. District Court in Delaware, asserts that Elevidys encroaches on Genzyme’s patents related to the production of viral vectors, specifically those involving formulations and methods that ensure viral vector particles remain soluble and prevent clumping during the manufacturing process. These patents are critical to the integrity and efficiency of gene therapy production and are set to expire on June 1, 2025.
This legal challenge arrived six months after Sarepta successfully defended against a different patent infringement claim concerning its $3.2 million gene therapy. Genzyme’s current complaint, which also names Sarepta’s contract manufacturer Catalent but not as a defendant, seeks a jury trial and damages. The lawsuit was reported by Reuters, which published the filed documents on Tuesday.
In the detailed complaint, Genzyme emphasizes the uniqueness and importance of its patented technologies, which they claim are integral to the manufacturing process of Elevidys. By allegedly using these protected methods, Sarepta is said to be infringing upon Genzyme’s intellectual property, thereby undermining Genzyme’s competitive edge and potentially its market share in the lucrative gene therapy sector.
Sarepta Faces Continued Legal Battles Amid Expanding Success of Duchenne Muscular Dystrophy Gene Therapy, Elevidys
Earlier this year, in January, U.S. District Judge Richard Andrews in Delaware dismissed claims by Regenxbio and the University of Pennsylvania against Sarepta, ruling that the patent they alleged was infringed upon was invalid. Despite this victory, Sarepta faces ongoing legal challenges, as Regenxbio and Penn have another lawsuit pending against both Sarepta and Catalent.
Since its approval by the Food and Drug Administration (FDA) in June of last year, Elevidys has experienced a highly successful launch, generating impressive sales of $334 million through the first quarter of this year alone. The therapy’s reach was further expanded last month when the FDA broadened the eligibility to include all DMD patients aged 4 and older, encompassing both ambulatory and non-ambulatory patients. Initially, the approval was limited to ambulatory boys aged 4 to 5.
This expansion of the patient base is expected to significantly increase Elevidys’ market potential. William Blair analyst Tim Lugo projects that Elevidys’ sales will peak at $5 billion in 2027 before gradually declining as the eligible patient population decreases. This optimistic sales forecast underscores the therapy’s potential impact on the DMD treatment landscape.
Global Stakes High as Roche and Sarepta Navigate Duchenne Muscular Dystrophy Gene Therapy Amid Genzyme Lawsuit
In the international arena, Roche handles the regulatory efforts and commercialization of Elevidys outside of the United States. This arrangement is part of a substantial $1 billion partnership between Roche and Sarepta, reflecting the global strategic importance of Elevidys in treating Duchenne muscular dystrophy. Genzyme’s lawsuit against Sarepta marks another chapter in the fiercely competitive field of gene therapy, where companies are increasingly protective of their technological advancements and market positions. The outcome of this legal battle could have profound implications for the future of gene therapy treatments, particularly for Duchenne muscular dystrophy.
By challenging the FDA-approved manufacturing processes of Elevidys, Genzyme is not only defending its patents but also sending a strong message about the value of its innovations in gene therapy. If successful, Genzyme could secure significant financial compensation and potentially influence the regulatory landscape for gene therapy manufacturing standards. Sarepta, on the other hand, remains steadfast in its commitment to defending its therapies and manufacturing methods. The company argues that its production processes for Elevidys do not infringe on Genzyme’s patents and maintains that the FDA’s approval process was thorough and lawful.
This ongoing legal dispute highlights the broader tensions within the pharmaceutical industry, where patent rights, regulatory approvals, and market exclusivity are crucial to maintaining competitive advantage and driving innovation. As the case unfolds, industry stakeholders will closely watch the proceedings, given the potential ripple effects on gene therapy development and commercialization strategies worldwide.
Resource: Fierce Pharma, July 30, 2024
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