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 patent recited:

A cultured host cell containing a recombinant nucleic acid molecule encoding an AAV vp1 capsid protein having a sequence comprising amino acids 1 to 738 of SEQ ID NO: 81 (AAVrh.10) or a sequence at least 95% identical to the full length of amino acids 1 to 738 of SEQ ID NO: 81, wherein the recombinant nucleic acid molecule further comprises a heterologous non-AAV sequence.

Judge Andrews concluded that “the claims at issue are similar to the ineligible claims in Funk Brothers,” because taking “two sequences from two different organisms and putting them together” is no different from the facts of Funk Brothers, which found patent ineligible the notion of taking two strains of bacteria and mixing them together.  The Court found that the claimed invention was not “markedly different” from natural products because the inventors of the ’617 patent had not changed any of the claimed invention’s naturally occurring components and, without some change, “the mere fact that the ’617 patent’s inventors combined natural products and put them in a host cell does not make the invention patentable under § 101.”

Judge Andrews also considered the plaintiffs’ argument that the claimed host cells have a utility in gene therapy.  The Court found, however, that plaintiffs had not pointed to anything in the claims or the specification that required utility for gene therapy.  Given the specification mentioned gene therapy only in certain parts and merely indicated that the claimed sequences were “useful in the production of rAAV,” it was found inappropriate to read a limitation or requirement from the specification into the claims. Even if some embodiments of the claimed invention had utility for gene therapy, that only means the claims cover both eligible and ineligible subject matters.  Such claims, according to the Court, are not patent eligible.

The plaintiffs did not address whether, even if the claims were directed to a natural product, they nonetheless include an inventive concept under step two of the Alice/Mayo framework that could transform the claimed invention into patent eligible subject matter.  The Court, however, did expressly find that the claimed invention was made using well-understood, routine, and conventional steps and therefore lacked an inventive concept.