The fight over BRCA genes is now over Credit: Tom Williams/CQ Roll Call/Newscom

A unanimous US Supreme Court ruled on June 13 that a naturally occurring DNA segment is a product of nature and not eligible for patenting merely because it has been isolated. But cDNA, because it is not naturally occurring, may be the subject of patent claims. The mixed outcome ends the long-running patent case brought against Myriad Genetics of Salt Lake City, Utah. The Supreme Court accepted the case after a contrary ruling by the US Court of Appeals for the Federal Circuit, which had found both isolated DNA and cDNA claims patent eligible (Nat. Biotechnol. 29, 771, 2011). Myriad is the developer of a test for BRCA1 and BRCA2 gene mutations, which it uses to assess the risk of breast and ovarian cancer. “Myriad's claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together,” the court wrote, or by the argument that the US Patent and Trademark Office's past practice of awarding gene patents is entitled to deference.Further, the court noted, the case did not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been artificially altered. Myriad president and CEO, Peter Meldrum, wrote in a press release, “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward.” The mixed ruling may have only a minimal effect on Myriad's business, given its announced plans to fold BRCA testing into a new product, myRisk Hereditary Cancer, a 25-gene panel that identifies genetic predisposition risk to six different cancers, including breast and ovarian, this fall.