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 being directed to ineligible subject matter. As background, REGENXBIO sued Sarepta on September 15, 2020, alleging that Sarepta's ELEVIDYS (delandistrogene moxeparvovec-rokl; SRP-9001) infringed the '617 Patent. A trial was scheduled to begin on January 29, 2024. A separate, related patent lawsuit filed by REGENXBIO and Penn against Sarepta and Catalent, Inc. last year is ongoing.
The claims at issue in the '617 Patent are directed to host cells comprising adeno-associated virus ("AAV") sequences encompassing AAV-rh10 and AAV-rh74. ELEVIDYS is an AAV-rh74-based gene therapy FDA-approved for the treatment of Duchenne muscular dystrophy. Sarepta moved for summary judgement of invalidity under 35 U.S.C. § 101. Sarepta argued that the claims of the '617 Patent are directed to naturally occurring AAV sequences and the inventors' contribution was only the identification of the naturally occurring sequences. REGENXBIO countered Sarepta's argument by asserting that the patented claims are directed to "cultured host cells which must contain a recombinant nucleic acid molecule that encodes the sequence of AAVrh.10 (or a sequence at least 95% identical) and a heterologous, non-AAV sequence" is not found in nature.
The Court held the claims of the '617 Patent are invalid under § 101 because the isolated AAVrh.10 sequences are not different from those found in nature and isolation alone is not sufficient to create patentable subject matter. The Court also wrote that the non-AAV sequences or other elements of the claimed invention have not been altered from the naturally occurring counterparts. Thus, the Court held that the '617 Patent's "inventors combined natural products and put them in a host cell does not make the invention patentable under § 101."
Originally, Sarepta asserted that the allegations in the complaint related to activities that fell under the protections of 35 U.S.C. § 271(e)(1) (the "safe harbor"). REGENXBIO countered that safe harbor was inapplicable because the claims at issue were not directed to the therapeutic itself. With regards to the safe harbor issue, the Court held in January 2022 that a patent product that is not subject to FDA premarket approval is not a "patented invention" under the statute. Since the patented cultured host cells are not subject to FDA regulatory approval, they were not protected by safe harbor.
REGENXBIO's chief legal officer Patrick Christmas said that the company was disappointed by the decision and plans to appeal. Stay tuned.
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