NEW YORK (GenomeWeb News) – The US Supreme Court decided on Friday to once again hear the American Civil Liberty Union's case against Myriad Genetics challenging the firm's patent rights related to BRCA1 and BRCA2 genes.
The decision by the court to hear the case — originally filed by ACLU, the Public Patent Foundation, the Association for Molecular Pathology and others in 2009 — comes a little more than three months after a federal appeals court issued a mixed ruling in which it found that isolated genes are patentable, but that certain methods patents that compare or analyze gene sequences may not be.
The US Court of Appeals for the Federal Circuit issued its decision in August after the Supreme Court asked it in March to reconsider a decision rendered by the appeals court in 2011 in light of the Supreme Court's decision in another case, Mayo Collaborative Services v. Prometheus Laboratories. In that case, the Supreme Court invalidated patents held by Prometheus, saying the patents merely described laws of nature but did not apply those laws of nature in a markedly different manner as to warrant a patent.
The appeals court originally ruled in July 2011 that Myriad's patents covering isolated DNA are patentable under Section 101 of the US Patent Act, reversing a decision by the Federal District Court for the Southern District of New York that isolated DNA is not much different from gene sequences found in nature and therefore is not patentable.
This past September, ACLU and the Public Patent Foundation asked the Supreme Court to once again take up the issue of whether Myriad's claims on genes that predict the risk of ovarian and breast cancer can be patented. ACLU and the foundation contend that Myriad's BRCA1 and BRCA2 gene patents should be invalidated because the genes are products of nature and allowing Myriad patent protection stifles scientific research and patient access to medical care.
"Myriad did not invent human genes, and has no right to claim ownership of them just because they removed them from the body," Daniel Ravicher, executive director of PUBPAT, said in a statement on Friday. "The government does not have the right to give a corporation the exclusive power to control what we know about our own genetic makeup."
Myriad President and CEO Peter Meldrum said in a statement, however, that patent protection is necessary to drive technological innovation.
"Two previous decisions by the Federal Circuit Court of Appeals confirmed the patentability of our groundbreaking diagnostic test that has helped close to 1 million people learn about their hereditary cancer risk," he said. "Myriad devoted more than 17 years and $500 million to develop its BRACAnalysis test. The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our US patent system is the engine that drives this innovation.
"This case has great importance for the hundreds of millions of patients whose lives are saved and enhanced by the life science industry's products," he said.