Supreme Court Asks for Reconsideration on BRCA1 and BRCA2 Patents

The US Supreme Court has asked an appellate court to reconsider its decision regarding patents held on two genes.

On Monday, the Supreme Court remanded the case of The Association for Molecular Pathology, et al., v. Myriad Genetics, Inc., et al (Docket No. 11-725) to the Federal Circuit Court of Appeals. That case concerned patents held on the BRCA1 and BRCA2 genes, which are both closely associated with the risk of developing breast and ovarian cancer. The genes were isolated by Myriad Genetics and the University of Utah, and Myriad manufactures the only test currently available to identify the two genes.

In July 2011, the appellate court ruled 2-to-1 in favor of Myriad, stating that the genes could be patented because they did not occur in isolation in nature. This reversed a decision made by a US District Court in New York in March 2010 that stated that Myriad could not patent the genes.

However, last week, the Supreme Court made a decision regarding patents on molecular testing that prompted the nation’s highest judicial authority to ask the appellate court to reconsider its previous decision with regard to Myriad: The case of Mayo Collaborative Services, Mayo Medical Laboratories, et al., v. Prometheus Laboratories, Inc. (Docket No. 10-1150) concerned a blood test used to identify thiopurine metabolites formed when the body breaks down thiopurine drugs taken by patients with gastrointestinal and nongastrointestinal autoimmune diseases to determine whether a prescribing physician should raise or lower the drug dosage.

The Supreme Court ruled that a blood test developed by Prometheus was not eligible for a patent “because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable,” according to the published decision.

The history of the Myriad case dates back to 2009, when the Association for Molecular Pathology (AMP), the American Civil Liberties Union (ACLU), and the Public Patent Foundation filed the lawsuit against the US Patent and Trademark Office and Myriad. They argued that Myriad was creating a monopoly with their patent, since the company has the only test available for the BRCA1 and BRCA2 genes. Additionally, they argued that the company also restricts access of other researchers to the genes.

In a statement released on Monday, Peter Meldrum, president and CEO of Myriad, said he does not believe the decision in the Prometheus case will cause a reversal of the appellate court’s original decision. However, Meldrum indicated that there could be larger consequences of the decision.

“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,” Meldrum said. “Thus, we are prepared to vigorously defend the patent claims granted to Myriad by the US Patent and Trademark Office and believe that we will be successful.”