January 31, 2013

Briefing Developments in Supreme Court Gene Patent Litigation

In November, the Supreme Court agreed to hear the challenge to gene patents in the case of Association for Molecular Pathology v. Myriad Genetics (see here). The grant of review followed several years of the patentable subject matter litigation initiated by a coalition of plaintiffs that made its way through the lower courts, ending this summer with the Federal Circuit upholding the gene patents (again, following the Supreme Court remand to reconsider in view of Mayo v. Prometheus). The plaintiffs include researchers, genetic counselors, patients, cancer survivors, breast cancer and women's health groups, and scientific associations. Now, as the case gets ready for oral argument later this spring, the briefs from parties and amici are being filed. The ACLU filed the Petitioner's Brief last week at the Court. The brief outlines the arguments of the plaintiffs as to why genes are not patentable subject matter and the patent claims on the BRCA1 and BRCA1 genes should be invalidated. The Court must consider how to define an an isolated gene (isolated DNA) – as either a product/law of nature (not patentable) or a nonnaturally occurring processed product (patentable). The ACLU brief presents several arguments that invoke the Court's exclusions and apply them to the genes at issue. They further argue that although the USPTO has issued gene patents for several decades, the Court need not be guided by any deference to the USPTO. Lastly, they argue that a First Amendment issue is presented because gene patent claims can control the use of knowledge, a violation of that constitutional clause. The oral argument will likely occur around April; no exact date yet.

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