Last week REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging that the defendants’ adeno-associated virus (“AAV”) technology gene therapy product has infringed or will infringe U.S. Patent No. 11,680,274 (“the ‘274 Patent”).  According to the complaint, “gene therapy can involve the use of a ‘vector’ that packages and delivers a transgene into the body’s cells. REGENXBIO has exclusive license rights to vectors invented at [the] University [of Pennsylvania], known as NAV® Vectors, composed of ‘capsid proteins’ that package the transgene used to treat genetic defects or supply therapeutic factors such as antibodies to treat other serious conditions. Upon administration to a patient, the recombinant vectors deliver the transgenes to the nucleus of affected cells. Once there, transgenes serve as a genetic blueprint for new proteins that supply the function needed to treat or cure disease.”  REGENXBIO alleges that the ‘274 Patent claims “an adeno associated virus comprising an AAV capsid and a minigene,” that “can be used in the process of delivering a transgene into cells in animal laboratory studies, or to deliver the transgene into cells in human subjects.”

As for allegedly infringing acts, REGENXBIO alleges, among other things, that defendants are making and/or using the AAV technology gene therapy product in the United States, or inducing others to do so; that the defendants or their partners “have manufactured and are continuing to build a commercial stock of SRP-9001 in the United States”; that such pre-launch uses are not reasonably related to the development and submission of information to a regulatory agency in the United States; and that the defendants will imminently commercialize the product upon FDA approval.

Two days after REGENXBIO filed suit, Sarepta announced FDA approval for its product, SRP-9001, which is indicated “for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.”  The Biologics License Application (BLA) for SRP-9001 was accepted for priority review by the FDA in November 2022.

Stay tuned for more coverage of this and other big molecule litigations!

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