District Court Invalidates Claims to Isolated DNA Molecules and Methods of Their Use; Finds Subject Matter Ineligible For Patent Protection

On March 29, 2010, in a ruling that may have a tremendous impact on the biotechnology community, the U.S. District Court for the Southern District of New York held that patent claims related to the BRAC1 and BRAC2 genes, as well as claims to methods of using nucleotide sequences within those genes to assess susceptibility to cancer, were invalid, in Association for Molecular Pathology v. USPTO, Myriad Genetics, et al. (Myriad). The patent claims were challenged by the ACLU and the Public Patent Foundation, whose motion for summary judgment was granted on the basis that the isolated DNA was a product of nature and the methods constituted nothing more than a mental process, neither of which are eligible for patent protection.

To analyze whether the claims covering DNA were valid—a representative claim was directed to "isolated DNA coding for a BRCA1 polypeptide"—the Myriad court applied a "markedly different" test. Relying on language from Diamond v. Chakrabarty,1 as well as the holdings in American Fruit Growers,2 and Funk Brothers,3 the Myriad court asked whether the claimed, isolated DNA possessed markedly different characteristics than the same DNA in vivo. The court noted that DNA possesses characteristics that are distinct from other chemical compounds because DNA encodes protein and is therefore "a physical embodiment of information." Despite the fact that DNA may have to be isolated in order to be used, the court found that "the purification of native DNA does not alter its essential characteristic—its nucleotide sequence—that is defined by nature and central to both its biological function within the cell and its utility as a research tool in the lab." Accordingly, the court concluded that the isolated DNA claimed was not markedly different from native DNA as it exists in nature and, therefore, constituted unpatentable subject matter under 35 U.S.C. § 101.

Myriad asserted that the motion for summary judgment should be dismissed in deference to the U.S. Patent and Trademark Office (USPTO), which has awarded numerous patents directed to isolated or purified DNA sequences under the guidelines it adopted in 2001 to resolve controversies over the patentability of gene sequences discovered in the Human Genome project.4 Myriad also relied on Parke-Davis, as establishing that purification of a natural product necessarily renders it patentable.5 The Myriad court, however, determined it owed no deference to the USPTO and that reliance on...

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