March 26, 2012
Supreme Court Sends Gene Patent Case Back to Federal Circuit
Today, and not surprisingly, the Supreme Court decided that it would not grant review of the pending patent law case on gene patents - Association for Molecular Pathology v. U.S. Patent and Trademark Office (AMP v. USPTO) - which had been sought by the plaintiffs’ coalition of patients, doctors and researchers. The Federal Circuit upheld the Myriad Genetics breast cancer gene patents in their July 2011 decision, generally rejecting arguments that genes are products of nature and cannot be patented. The Court announced that it would now send the case back to the Federal Circuit to reconsider in light of its Mayo v. Prometheus decision from last week. In the Mayo case, the Supreme Court ruled that the drug treatment method at issue could not be patented because the patent claim was essentially to a law of nature and effectively put a basic scientific fact under private control. Now, the Federal Circuit is to get another chance to look at gene patenting in view of the Supreme Court’s renewed emphasis in the Mayo case on the importance of avoiding patents on laws of nature or natural principles. I have argued in an amicus brief filed at the Federal Circuit that genes and genetic mutations cannot be patented as such patenting preempts the underlying natural laws of genetic science (the genetic code and genotype-phenotype correlations). The 2011 Federal Circuit decision (2-1) upheld the Myriad patents, partially relying on deference to the USPTO (which had been granting such patents) and further highlighting certain chemical alterations of an isolated gene to support patentability. The 9-0 Mayo decision from the Supreme Court addressed the eligibility of method claims in view of patent law's prohibition on patenting laws of nature, and its logic must now be applied to the composition patent claims on DNA. Conceptually, I think this can be done (here’s my central argument developed in detail) and the task necessarily focuses attention on the unique, template-oriented features of DNA, as distinct from other molecules. Can we imagine a DNA-centric decision that does not affect the patenting of other biomolecules? I think that’s possible. The unresolved gene patenting issue is the other prong of the patentable subject matter debate in biotechnology. It's not possible to avoid the fact that DNA/gene patenting (and its implications for the use of DNA in all kinds of genetic testing and applications) has specifically troubled many in the medical and genetic testing fields, because the paradigm of DNA patentability ramifies through the whole field of genetic medicine (and has caused real limitations for patients in some fields of genetic testing). Many of the same professional organizations (e.g., American Medical Association) that successfully opposed the drug treatment method in Mayo have also opposed the patents on the breast cancer genes, mutations, and genetic testing methods in AMP v. USPTO. It remains to be seen whether the Federal Circuit will now take a dimmer view of gene patenting in view of the Mayo decision; if it reaffirms its earlier endorsement of gene patenting, that conclusion could then be appealed back up to the Supreme Court. So we may have at least another year ahead before these current debates in biotechnology patenting are resolved. However, over 30 years have passed since Diamond v. Chakrabarty in 1980 (Supreme Court upheld a patent on a genetically engineered bacterium), with relatively little case law on these subjects in the interim.