On November 25, 2025, Sarepta Therapeutics filed two petitions for inter partes review (“IPR”) challenging Genzyme’s patents relating to the characterization of recombinant adeno-associated virus (rAAV) vector preparations.

Sarepta filed IPR2026-00149, seeking review of claims 1–5, 7–9, 12–23, and 25–30 of U.S. Patent No. 12,013,326 (“the ’326 patent”), and IPR2026-00150, challenging claims 1–7 and 10–30 of U.S. Patent No. 12,031,894 (“the ’894 patent”). The ’326 and ’894 patents are directed to methods to characterize preparations of recombinant viral particles using analytical ultracentrifugation. Sarepta argues that the ’326 and ’894 patents are obvious over the Le Bec, de la Maza, Sommer, and Cole references.

Both 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.