On July 26, 2024, Genzyme filed a complaint (“Complaint”) against Sarepta Therapeutics (“Sarepta”) in the District of Delaware. Genzyme Corp. v. Sarepta Therapeutics, Inc., No. 1:24-cv-00882 (D. Del.).  In its complaint, Genzyme alleges that Sarepta infringed Genzyme’s U.S. Patent Nos. 7,704,721 and 9,051,542 (collectively, “the Patents-In-Suit”) by making, using, offering for sale, and/or selling Elevidys^® (delandistrogene moxeparvovec-rokl) in the U.S.

Elevidys^® is a onetime adeno-associated virus vector-based gene therapy used to treat patients with Duchenne muscular dystrophy (“DMD”) caused by a mutation in the DMD gene.  The Patents-In-Suit recite claims directed to methods for the preparation of compositions for the storage of recombinant adeno-associated virus (rAAV) vector particles in which the particles do not significantly aggregate.

On June 22, 2023, Sarepta obtained FDA approval to market Elevidys^® for the treatment of ambulatory pediatric patients aged 4 through 5 years with DMD with a confirmed mutation in the DMD gene. Sarepta then obtained FDA approval on June 20, 2024 for an expanded indication for Elevidys^® which includes non-ambulatory DMD patients aged 4 years and older and similarly have a confirmed mutation in the DMD gene. Genzyme alleges that Sarepta has been marketing Elevidys^® in the U.S. since obtaining FDA approval in 2023.

Genzyme is seeking, inter alia, a judgment of infringement and willful infringement of the Patents-In-Suit, damages, and reasonable attorneys’ fees, costs, and expenses.

There are currently pending an IPR and several litigations involving Elevidys^®.  See, e.g., Sarepta Therapeutics, Inc. v. Trustees of The University of Pennsylvania, IPR2024-00580 (awaiting Institution Decision); Regenxbio Inc. v. Sarepta Therapeutics, Inc., No. 1:23-cv-00667 (D. Del.) (stayed pending IPR2024-00580); Regenxbio Inc. v. Sarepta Therapeutics, Inc., No. 1:20-cv-01226 (D. Del.) (summary judgment of invalidity, pending Federal Circuit appeal); Wilson Wolf Mfg. Corp. v. Sarepta Therapeutics, Inc., No. 1:19-cv-02316 (D. Del.) (stayed).

In 2023 Elevidys^® had U.S. sales of about $200.4 million.

We continue to monitor this case.  For more information on this and other gene therapy and biosimilar litigations, visit BiologicsHQ.com.

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