Judge Sweet held that products isolated from nature must possess “markedly different characteristics” from the product in nature to constitute patentable subject matter.

On March 29, 2010, Judge Sweet of the U.S. District Court for the Southern District of New York granted the plaintiffs’ motion for summary judgment in the closely watched case Association for Molecular Pathology, et al v. USPTO and Myriad, et al., Case No. 09 Civ 4515. The case sought to challenge on statutory and constitutional grounds whether Myriad’s patent claims directed to the BRCA1 and BRCA2 genes were invalid as unpatentable subject matter. Judge Sweet ruled that Myriad’s patent claims directed to isolated DNA sequences, methods of detecting BRCA mutations and methods of using cells transformed with BRCA to screen for potential drugs are unpatentable subject matter under 35 U.S.C. § 101. The court did not reach the plaintiffs’ constitutional claims and dismissed them without prejudice.

Myriad’s gene patents claimed isolated DNA encoding the BRCA1 or 2 proteins (or fragments thereof). Judge Sweet held these claims were unpatentable subject matter because they claimed a product of nature. In doing so, Judge Sweet held that products isolated from nature must possess “markedly different characteristics” from the product in nature to constitute patentable subject matter. Notably, the court rejected the application of the isolated DNA in gene therapy, or for use in recombinant protein expression, as evidence of a marked difference. In rejecting this evidence, the court focused on the similar properties of the claimed isolated DNA and DNA in nature (i.e., the genetic information encoded in its sequence).

Myriad’s method patents claimed methods of detecting BRCA mutations in a patient. Judge Sweet held these claims invalid under the U.S. Court of Appeals for the Federal Circuit’s machine or transformation test because (1) the claimed methods constituted unpatentable abstract mental processes of comparing or analyzing two gene sequences, and (2) the claimed steps of analyzing and comparing failed to recite specific transformation steps. The court further noted that even if the analyzing or comparing steps were interpreted to include the steps of isolating DNA from a patient and sequencing that DNA, these transformation steps would be nothing more than data gathering, which is insufficient to meet the transformation requirement.

Myriad’s cell screening patent claimed methods of identifying compounds useful in treating BRCA-associated cancer by screening compounds against cells transformed with BRCA. Again, Judge Sweet held that these method claims failed the transformation test because the transformative steps were mere data gathering. In a footnote, Judge Sweet rejected the argument that drugs that affect the BRCA-cell impart a patentable transformation for the claim because compounds that fail in the screen would have no such transformative effect.

This decision will likely be appealed to the Federal Circuit in the near future.