Sanofi sues Sarepta over Duchenne gene therapy patents

Genzyme, a subsidiary of Sanofi, has initiated legal action against Sarepta Therapeutics, alleging patent infringement related to Sarepta's Duchenne muscular dystrophy (DMD) treatment, Elevidys. The lawsuit, filed in Delaware federal court, claims that Sarepta's Elevidys utilizes Genzyme's adeno-associated virus (AAV) vector technology, which is employed in delivering genes into the body for gene therapy treatments. The suit further details that the production of Elevidys is managed by Catalent at two facilities in Maryland. Sanofi contends that Sarepta's production of Elevidys infringes on two of its patents, both of which remain valid until June 2025.

Elevidys received accelerated approval from the FDA in June of the previous year, initially limited to ambulatory pediatric patients aged 4-5 years with a confirmed mutation in the DMD gene. In the following year, the FDA expanded the approval to include all individuals with DMD who have a confirmed mutation in the DMD gene and are at least 4 years old, irrespective of their ambulatory status.

Elevidys is considered one of the most costly treatments globally, priced at $3.2 million. The therapy generated over $200 million in revenue for Sarepta last year.

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