As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product, ELEVIDYS (delandistrogene moxeparvovec-rokl). Sarepta and Catalent each subsequently filed answers denying infringement and asserting that they are “immune or otherwise protected from suit under the Safe Harbor provision of 35 U.S.C. § 271(e)(1).”
On September 19, 2023, the Court issued a scheduling order. Per the order, the Court will hold a Claim Construction Hearing on August 22, 2024, and fact discovery will be completed by December 6, 2024. The parties will file dispositive motions on June 4, 2025, with responsive and reply briefing complete by July 2, 2025, and July 25, 2025, respectively. The Court further scheduled a five-day jury trial to begin on November 17, 2025.
Stay tuned to Big Molecule Watch for more updates on this litigation.