US Court invalidates Myriad Genetics patent claims covering isolated breast cancer genes. May 2, 2010. This case concerned in part the patentability of genes useful in the identification of individuals susceptible to breast cancer. The defective genes of interest (BRCA 1 and BRACA 2) are claimed in an “isolated” form in Myriad’s patent. Patent attorneys have routinely claimed genes in their isolated form to confer novelty over the naturally occurring form of the gene present in the cocktail of chemicals inside a cell. In this case, however, the Southern New York District Court held that even though the claimed genes were isolated, they are nonetheless a “product of nature”, and therefore contrary to section 101 of the US patent code.
Judge Sweet considered how different an isolated gene would need to be from a naturally occurring gene in order to clear the “product of nature” bar. The judge concluded that “purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess ‘markedly different characteristics’ in order to satisfy the requirements [of patentability]”. It was reasoned that because the function DNA is to encode information, and that function is not altered in the process of isolating the DNA from a natural source, then the isolated form is not markedly different. This outcome relies on the unprecedented assertion that a DNA molecule can be so narrowly characterised as a vehicle for the storage of information.
Myriad’s attorneys probably expected that they could rely on other claims directed to methods for assaying for the presence of the defective BRCA 1 and BRCA 2 genes. Not so. These claims were also held invalid because they did not satisfy the “machine or transformation” test proposed in the recent Bilski case. That’s bad luck, to say the least.
Is this the end of gene patenting in the United States? Possibly not. Myriad will likely appeal to the US Federal Circuit, whose decision will be of significantly greater importance since it will be binding on all Federal Courts (with the exception of the Supreme Court). In the meantime, the US Patent Office does not appear to be considering amendment to its own guidelines for assessing the patentability of genes. In this writer’s opinion, this fight is far from over and it would be a brave company that would ignore any possibility of litigation based on this decision of this lower Court. Back