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 of the ’274 patent as obvious over four prior art references: US 2003/0138772 A1 (“’772 Publication”), Qing Xie et al., The atomic structure of adeno-associated virus (AAV-2), a vector for human gene therapy, 99 Proc. Nat’l Acad. Sci., 10405–10410 (2002) (“Xie”), Stephen Snowdy, Nuclear targeting by adeno-associated virus capsid proteins and virions (2003) (Ph.D. dissertation, University of North Carolina, Chapel Hill)  (“Snowdy”), and/or Stewart A. Fabb et al., Adeno-associated virus vector gene transfer and sarcolemmal expression of a 144 kDa micro-dystrophin effectively restores the dystrophin-associated protein complex and inhibits myofiber degeneration in nude/mdx mice, 11 Human Molecular Genetics 733–741 (2002) (“Fabb”).

Patent Owner’s response is due November 14, 2024, with Petitioner’s reply due February 6, 2025, and Patent Owner’s sur-reply due March 20, 2025.

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