On October 7, 2026, the Court granted REGENXBIO and Sarepta’s joint stipulations of dismissal of Case Nos. 1:20-cv-01226 (D. Del.) and 1:23-cv-00667 (D. Del.) alleging infringement of The Trustees of the University of Pennsylvania and REGENXBIO’s U.S. Patent Nos. 10,526,617 (“the ’617 patent”) and 11,680,274 (“the ’274 patent”) by Sarepta’s gene therapy product Elevidys® (delandistrogene moxeparvovec-rokl) (previously reported Federal Circuit Reverses § 101 Unpatentability Finding for Gene Therapy Patent Asserted Against Elevidys®).
On October 8, 2026, the CAFC granted REGENXBIO and Sarepta’s joint stipulation of dismissal of CAFC Appeal No. 26-1071, appealing the Final Written Decision in IPR2024-00580 finding claim 8 of the ’274 patent not unpatentable.
The dismissals come as a result of a September 2026 settlement agreement under which Sarepta agreed to pay $39 million to REGENXBIO to settle all ongoing patent disputes related to the ’617 and ’274 patents as well as a covenant not to assert U.S. Patent No. 9,198,984 or related patents and applications. REGENXBIO additionally agreed not to pursue patent claims against Sarepta, its affiliates, licensees, or commercial partners over patents covering the existing form of Elevidys® or its AAVrh74-based capsid sequence.
Sarepta reported $898.7 million in net revenue from Elevidys® in 2025.
For more information about these and other biologic drug patent disputes, please visit BiologicsHQ.
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The author would like to thank April Breyer Menon for her contributions to this article.
