In a decision that’s sure to find its way to the Supreme Court, the US Court of Appeals for the Federal Circuit has ruled that isolated genetic sequences are patentable. The decision is an important win for Myriad Genetics and the biotech industry.
The Court of Appeals decision follows an appeal by Myriad and the University of Utah against the ruling of Judge Sweet in the US District Court, in 2010, that patents for the detection of inheritable breast cancer were invalid, on the basis that the inventions were directed towards a law of nature.
The Court of Appeals held that claims to isolated DNA sequences were patentable. While genes are products of nature and not eligible for patent protection, DNA sequences that are isolated from their natural environment will be entitled to protection. Judge Lourie’s decision focused on the chemical features of DNA and specifically, the differences between naturally-occurring DNA and isolated DNA. Because Myriad were claiming distinct chemical molecules that “as claimed do not exist in nature” they were entitled to protection.
The Court of Appeals also held that claims to methods of analysing or comparing genes, per se, were not patentable since they were for abstract, mental steps that did not encompass any transformative process. However, particular claims directed toward methods of screening for cancer compounds via changes in cell growth rates were patentable given that there would be a transformation of the cell culture.
In Australia, where concurrent litigation in the Federal Court is still in the early evidentiary stages, the Court of Appeals decision will come as a blow to Cancer Voices Australia and Ms D’Arcy. No doubt a central argument put by Myriad and the other respondents will focus on the specific chemical differences between naturally occurring and isolated DNA to argue that the latter is patentable, and not just a mere discovery or naturally occurring substance. It will also be interesting to see whether the Senate Community Affairs Committee Inquiry into Gene Patents comments on this decision when it reports on its findings in September.
The Court of Appeals decision can be found here.