On May 6, 2026, the Director of the U.S. Patent and Trademark Office issued bulk order institution decisions in two inter partes review (“IPR”) proceedings filed by Sarepta Therapeutics, Inc. against Genzyme relating to patents associated with gene therapy products, including Elevidys^® (delandistrogene moxeparvovec-rokl).

In IPR2026-00149, Sarepta challenged claims of U.S. Patent No. 12,013,326, which is directed to methods for characterizing recombinant adeno-associated virus (rAAV) particles using analytical ultracentrifugation. The Director denied institution on the merits, finding that the petitioner had not demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim.

In IPR2026-00150, Sarepta challenged claims of U.S. Patent No. 12,031,894, which relates to similar analytical ultracentrifugation methods for characterizing rAAV particles. The Director granted institution on the merits, determining that the petition demonstrated a reasonable likelihood that at least one challenged claim is unpatentable.

Both patents are assigned to Genzyme. The IPRs are related to ongoing litigation between the parties, including Case No. 24-cv-00882 (D. Del.).

Sarepta reported $898.7 million in net revenue from Elevidys^® in 2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

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