On July 21, 2026, the Director of the U.S. Patent and Trademark Office issued a bulk Order denying institution on the merits of IPR2026-00270, filed by Sarepta Therapeutics, Inc. against Genzyme. The Director found that Sarepta had not demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim. As with previous bulk Orders by Director Squires, the denial did not provide substantive reasoning.
In IPR2026-00270, Sarepta challenged claims 1–27 of U.S. Patent No. 12,298,313, titled “Methods for Detecting AAV.” The ’313 patent is directed to methods of detecting post-translational modifications and heterogeneity in preparations of adeno-associated virus (“AAV”) particles using liquid chromatography-mass spectrometry (“LC-MS”) on intact proteins, as well as methods of preparing pharmaceutical compositions of such particles.
The denial follows the Director’s prior denials of institution in IPR2026-00167 and IPR2026-00168, which challenged related Genzyme patents directed to LC-MS methods for analyzing and characterizing AAV particles and viral proteins (previously reported PTAB Denies Institution of Two Elevidys® Gene Therapy IPRs).
The ’313 patent is assigned to Genzyme. The IPR is 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® (delandistrogene moxeparvovec-rokl) in 2025.
For more information about these and other biologic drug patent disputes, please visit BiologicsHQ.
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The authors would like to thank April Breyer Menon for her contributions to this article.
