By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) The US Supreme Court is sending the most high-profile gene patenting case to date, focusing on Myriad Genetics' breast and ovarian cancer tests, back to a lower court for reconsideration in light of its decision last week to invalidate patents held by Prometheus Laboratories.

The decision to remand the case back to the US Court of Appeals for the Federal Circuit, which last year decided that patents Myriad has licensed and used related to the isolated gene sequences in the BRCA 1 and BRCA2 genes are valid, means that the Prometheus decision could influence or impact the case, though the effect of that case is unclear, as it centerd on different types of claims than the Myriad litigation.

The case against Myriad was brought by the Public Patent Foundation, American Civil Liberties Union, the Association for Molecular Pathology, and others who filed the suit in 2009 claiming that patents cannot cover natural phenomena and that Myriad's patents, and others like them, will hinder genetics research and keep some people from receiving the personalized medicine tests and second opinions.

Myriad has held that its patents have not hindered science, that is has not impeded research, that the pricing of its BRACAnalysis tests are not prohibitive, and that most insurers cover them. Additionally, the company also says that there are other options for people seeking second opinions.

Those assertions may not mean much if the Supreme Court at some point decides that isolated DNA is not patentable, but the CAFC in its ruling in August 2011 decided that Myriad's patents covering isolated DNA are eligible under Section 101 of the US Patent Act.

That decision in part overturned an earlier ruling from the Federal District Court for the Southern District of New York, which decided that isolated DNA was not much different from gene sequences found in nature and therefore is not patentable.

"While, this case should not have any direct impact to Myriad and its operations because of our extensive patent estate, it has great importance to the medical, pharmaceutical, biotechnology and other commercial industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection," Myriad Genetics President and CEO Peter Meldrum said today in a statement.

"Thus, we are prepared to vigorously defend the patent claims granted to Myriad by the U.S. Patent and Trademark Office and believe that we will be successful," he said.

The plaintiffs, led by ACLU and PUBPAT, have suggested that the Prometheus decision could impact the CAFC's second look at the Myriad case, and are holding to their core argument about the special status of genes in the natural world.

The rest is here:
Supreme Court Bounces Myriad BRCA Gene Patent Case Back to Appeals Court for Review