On June 26, 2025, Sarepta Therapeutics filed IPR2025-01194, challenging as obvious claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent), and IPR2025-01195 challenging claims 1-4, 6-7 and 11 of U.S. Patent No. 7,704,721 (“the ’721 patent”) as obvious.  The ’542 patent claims a composition for the storage of purified, recombinant adeno-associated virus (rAAV) vector particles, and the ’721 patent claims manufacturing methods of preventing aggregation of rAAV virions.  In July 2024, Genzyme accused Sarepta’s Elevidys^® (delandistrogene moxeparvovec-rokl) of infringing these patents in Case No. 1:24-cv-00882 (D. Del.), which is ongoing (previously reported Genzyme Files Complaint Against Sarepta Concerning Gene Therapy Elevidys^®).  In June 2023, Genzyme statutorily disclaimed claims 1-2 of the ’542 patent when it was challenged in IPR2023-00608 and IPR2023-00609 by Novartis Gene Therapies.

Elevidys^® is a onetime adeno-associated virus vector-based gene therapy used to treat patients with Duchenne muscular dystrophy (“DMD”) caused by a mutation in the DMD gene.

Sarepta reported $820.8 million in net revenue from Elevidys^® in 2024.

For more information on these and other gene therapy and biosimilar patent disputes, please visit BiologicsHQ.com.

 

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The author would like to thank April Breyer Menon for her contributions to this article.