On December 2, 2025, Sarepta Therapeutics filed three petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to the characterization of recombinant adeno-associated virus (rAAV) vector preparations.

Sarepta filed IPR2026-00166, seeking review of claims 1–27 of U.S. Patent No. 12,298,313 (“the ’313 patent”), IPR2026-00167, challenging claims 1–20 U.S. Patent No. 11,698,377 (“the ’377 patent”), and IPR2026-00168, seeking review of claims 1–21 of 12,123,880 (“the ’880 patent”). The ’313, ’377, and ’880 patents are directed to methods for the analysis of preparations of AAV particles. Sarepta argues that the ’313, ’377, and ’880 patents are obvious over the Satkunanathan, Shytuhina, Ansong, and Byeon references.

All three patents are 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 one-time 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 this and other biologic patent disputes, please visit BiologicsHQ.com.

 

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