Recent Decision Raises Patent Eligibility Concerns Regarding Certain Gene Therapy-Related Inventions

This past Friday, a federal district court held that the mere fact of combining certain natural products – such as isolated, naturally occurring AAV sequences and a heterologous non-AAV sequence – and putting them into a cultured host cell, without some change, does not give rise to a patent eligible invention under 35 U.S.C. § 101.

Specifically, 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 granted summary judgment for Sarepta and ruled that U.S. Patent No. 10,526,617 was not directed to patent eligible subject matter.

The claims of the '617 patent were directed towards a "cultured host containing a recombinant nucleic acid molecule" that encoded one or more viral proteins (i.e., capsid proteins of an adenovirus-associated virus, or AAV) or a protein with "a sequence at least 95% identical to the" viral protein. For example, claim 1 of the '617