Myriad Genetics, a molecular diagnostic company, reports that the US Supreme Court  has granted certiorari agreeing to hear the case of The Association for Molecular Pathology, et al., v. Myriad Genetics, Inc., et al. (Docket No. 12-398). The Supreme Court will review an earlier decision by a federal appeals court, which declared that Myriad's composition of matter claims covering isolated DNA of the BRCA1 and BRCA2 genes are patent-eligible under Section 101 of the United States Patent Act.

The US Supreme Court’s decision to hear the case is the latest legal battle regarding the patentability of human genes and has important implications for pharmaceutical/biopharmaceutical companies. In August 2012, a US federal appeals court ruled that the company's composition of matter claims covering isolated DNA of the BRCA1 and BRCA2 genes were patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences. The federal appeals court upheld Myriad’s right to patent the isolated genes, BRCA1 and BRCA2, which are linked to hereditary breast and ovarian cancers. These genes serve as the basis for the intellectual property for the company’s BRACAnalysis test, a predictive test for assessing a woman’s risk for developing hereditary breast and ovarian cancer.

"Two previous decisions by the Federal Circuit Court of Appeals confirmed the patentability of our groundbreaking diagnostic test that has helped close to one million people learn about their hereditary cancer risk," said Peter Meldrum, president and CEO of Myriad Genetics, in a Nov. 30th, company press release. "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."

See related story:

Myriad Genetics Receives Favorable Ruling on Gene Patentability (Aug. 2012, ePT)