February 12, 2013

Supreme Court Oral Argument Set for AMP v. Myriad Genetics

Association for Molecular Pathology v. Myriad Genetics: the oral argument at the Supreme Court is set for April 15, 2013. The litigation is a challenge to the eligibility of genes as patentable subject matter; specifically, to Myriad Genetics’ patents on the BRCA1 and BRCA2 genes. The question presented at the Court is the following: Are human genes patentable? See here and here for more background.

I have filed an amicus brief in support of the Petitioners (original plaintiffs). The brief makes three central points. First, DNA (and a gene) is a molecule which requires a specific patent eligibility analysis that accounts for its complexity, where it is both a chemical and a template. The genetic code is embodied in DNA, and is a law of nature; patenting of genes preempts the genetic code because it violates the prohibition on patenting laws of nature. Second, the gene is ineligible for patenting as a product of nature; that analysis requires that the structure and the function of a proposed invention be considered. The isolated gene retains its natural structure and implements its natural function, and there is not an inventive distinction between the cellular gene and the isolated gene, violating the prohibition on patenting products of nature. Third, the symmetry formulation for patent eligibility from the Court’s Mayo v. Prometheus decision last year requires that a patent be scored for its inventive contribution, measured against its potential to limit innovation. When that comparison is applied to gene patenting, I conclude that because gene discovery does not qualify as an inventive contribution (based on the previous two arguments above) and because the patenting of genes has exacted demonstrable costs on innovation in the genetic testing field, the resulting asymmetry violates Mayo’s requirement that the costs of a patent not exceed its benefits. The brief concludes, based on all of these arguments, that the Court should invalidate the patent claims to the BRCA1 and BRCA2 genes.

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