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Stipulated Dismissal of Gene Therapy Elevidys® Manufacturing Litigation

by Robert S. Schwartz, Ph.D.
February 24, 2025

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.

For more information on these and other gene therapy and biosimilar litigations, visit BiologicsHQ.com.

 

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

    Methodology

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