The U.S. Justice Department dropped a bombshell on the biotech industry late Friday, saying that unmodified DNA should not be patentable. Federal attorneys outlined the policy shift in a friend-of-the-court brief filed in a closely watched lawsuit featuring a challenge to Myriad Genetics' patents on the BRCA1 and BRCA2 genes. Myriad has developed a diagnostic test used to identify women susceptible to breast and ovarian cancer.
"The United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter," says Justice, reversing longstanding IP policy that is considered essential for biotechs developing genetically tailored drugs and the diagnostics needed to identify patients who can benefit from them. The news was broken on Friday by the New York Times.
"We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA," the brief said. "The district court's judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature."
"It's major when the United States, in a filing, reverses decades of policies on an issue that everyone has been focused on for so long," biotech attorney Edward Reines tells the Times.