Stipulated Dismissal of Gene Therapy Elevidys® Manufacturing Litigation

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On February 19, 2025, Wilson Wolf Manufacturing and Sarepta’s stipulated dismissal with prejudice of Case No. 1:19-cv-02316 (D. Del.) related to the manufacturing of Elevidys® (delandistrogene moxeparvovec-rokl) was granted.  In its Complaint, Wilson Wolf alleged that Elevidys® was made using its patented Corning HYPERstack cell culture device.  The case had been stayed since 2021.

Sarepta is involved in two other ongoing infringement litigations related to Elevidys®, Case No. 1:24-cv-00882 (D. Del.) brought by Genzyme (previously reported Genzyme Files Complaint Against Sarepta Concerning Gene Therapy Elevidys®) and Case No. 1:23-cv-00667 (D. Del.) brought by REGENXBIO, both related to Adeno-Associated Virus (“AAV”) vector technology.  The REGENXBIO case has been stayed pending the outcome of Sarepta’s instituted IPR2024-00580 against U.S. Patent No. 11,680,274, which was asserted in the litigation.

Sarepta reported $820.8 million in net revenue from Elevidys® in 2024.

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

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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