REGENXBIO and Sarepta Agree to Stay Litigation Pending Outcome of Sarepta’s IPR Petition

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).  On September 19, 2023, the Court issued a scheduling order setting trial for November 17, 2025.  On February 21, 2024, Sarepta filed a petition at the Patent Trial and Appeal Board (“PTAB”) seeking inter partes review of claims 1, 3-6, and 8 of the ‘274 patent.  In view of Sarepta’s IPR petition, the parties filed on March 19, 2024 a Joint Stipulation and [Proposed] Order to Stay the District Court litigation.  In the Joint Stipulation, the parties indicate that “the PTAB will render an institution decision on the IPR no later than August 28, 2024, and, if instituted, is expected to issue a final written decision and terminate the IPR no later than August 28, 2025.”  Because the litigation is in the early stages and “may be substantially impacted if any or all of the Asserted Claims are invalidated in the IPR Proceeding,” the parties “have agreed to stay the Litigation pending final resolution of the IPR Proceeding.”  On March 20, the Court issued the proposed order and administratively closed the case.