As we previously reported, REGENXBIO’s litigation against Sarepta, alleging infringement of U.S. Patent No. 11,680,274 (the “’274 patent”) by Sarepta’s gene therapy product, was stayed pending resolution of Sarepta’s IPR against the ’274 patent. The PTAB now has granted institution of Sarepta’s IPR, which challenges claims 1, 3-6, and 8…
On July 26, 2024, Genzyme Corp. (a wholly owned subsidiary of Sanofi) filed suit in the District Court for the District of Delaware against Sarepta Therapeutics, Inc., and Sarepta Therapeutics Three, LLC (collectively, “Sarepta”). Genzyme alleges that Sarepta’s manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl)—a gene therapy treatment for Duchenne…
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,…
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and developments in the biosimilars and biologics space in 2023 that we covered…
On January 5, 2024, in litigation between REGENXBIO and Sarepta Therapeutics, Judge Richard Andrews of the U.S. District Court for the District of Delaware District Court granted summary judgment for Sarepta and ruled that University of Pennsylvania’s (“Penn”) U.S. Patent No. 10,526,617 (the ’617 Patent; licensed to REGENXBIO) is invalid…
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…
As we previously reported, 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 infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product. Sarepta’s gene therapy product, SRP-9001, was approved this June…
Many pre-commercialization gene or cell therapy companies are aware of the patents that could threaten their product after launch, but assume that they are protected from patent infringement suits before they obtain FDA approval and sell their products under the so-called “safe harbor.” In this webinar on August 2, 2023,…
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”)….