By Turna Ray
NEW YORK (GenomeWeb News) – The American Civil Liberties Union and the Public Patent Foundation have decided to ask the US Supreme Court to take up their case challenging Myriad Genetics' patents on the BRCA 1 and BRCA 2 genes.
Even since American Molecular Pathology et al. v. US Patent and Trademark Office et al. first came before a New York federal district court in late 2009, legal experts have predicted that the case, which could have a broad impact on the patentability of genes, would eventually go the Supreme Court.
This week, ACLU and PUBPAT proved those predictions right by announcing that they will petition the high court following the Federal Circuit Court of Appeals' decision not to rehear the case. The Supreme Court may decide to hear the case, or it may instruct the Court of Appeals to reconsider its decision, which it issued in August.
Myriad spokesperson Rebecca Chambers told GenomeWeb Daily News sister publication PGx Reporter that the company is still considering its options in terms of next steps. "We have not made a public statement regarding our intent to petition the Supreme Court," Chambers said. "We are actively assessing the situation and have until Dec. 15 to decide." She declined to provide any further comment.
The Court of Appeals in had ruled that isolated gene sequences claimed in patents held by the University of Utah and licensed to Myriad are not products of nature and are therefore patentable — a decision that overturned an earlier ruling by the federal district court. The appeals court determined, however, that several of Myriad's method claims that describe "comparing" and "analyzing" gene sequences were invalid.
Earlier this year the US Supreme Court decided that it would hear Prometheus v Mayo, another case that could potentially impact Myriad's method claims should the company seek to challenge the federal appeals court's decision.
Depending on how the Supreme Court rules on the patentability of Prometheus' claims, it could set a precedent for the patentability of other methods based on biological discoveries, such as genetic testing methods. This in turn could affect the advancement of personalized medicine products that rely on the help of a diagnostic to identify patients that have certain gene mutations and would therefore respond to a drug.
See this week's issue of Pharmacogenomics Reporter for a more in-depth look at the issues involved should the US Supreme Court take the case.