On November 6, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Sarepta Therapeutics’ IPR2025-01194 against claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent) and IPR2025-01195 against claims 1-4, 6-7 and 11 of U.S. Patent No. 7,704,721 (“the ’721 patent”). The denials were issued as Director summary notices with no reasoning provided. 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.

The ’542 patent and the ’721 patent have been asserted in Case No. 1:24-cv-00882 (D. Del.), which is ongoing (previously reported Genzyme Files Complaint Against Sarepta Concerning Gene Therapy Elevidys^®).

Elevidys^® (delandistrogene moxeparvovec-rokl) 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 about these and other biosimilar patent disputes, please visit BiologicsHQ.

 

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