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What a difference a week makes. Two Fridays ago, Chris Hansen of the American Civil Liberties Union read the brief filed by Myriad Genetics and the Utah Research Foundation at the U.S. Court of Appeals for the Federal Circuit. The ACLU lawyer, who last winter won a controversial ruling in which Manhattan federal district court judge Robert Sweet invalidated seven Myriad-licensed patents on two gene mutations, found no surprises in the Myriad brief calling for the Federal Circuit to overturn Judge Sweet. Then, a week later, Hansen got word that the Justice Department had filed an amicus brief in the Myriad appeal. When he read this one, “I jumped up and down,” he told us Monday. “This is the U.S. government speaking. This is going to be very influential.” In a 46-page brief that has the biotech world buzzing (see, for example, here and here), the Justice Department’s civil division argues that human genes, in and of themselves, are not patentable. “[Judge Sweet] correctly held…that genomic DNA that has merely been isolated from the human body, without further alteration or manipulation, is not patent-eligible,” the brief says. “The unique chain of chemical base pairs that induces a human cell to express a [cancer] protein is not a ‘human-made invention.’ Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer.” (The New York Times broke the news of the Justice Department’s filing Saturday.) The brief does say manmade inventions based on DNA, such as vaccines and genetically modified crops, are eligible for patent protection. Judge Sweet erred, it argues, in invalidating certain claims in Myriad patents that fit the manmade criterion. But the big surprise in the DOJ brief, Hansen said, is that the U.S. Patent and Trademark Office previously had a policy of granting patents on human genes, as codified in the PTO’s eligibility guidelines in the Federal Register. So Justice’s new filing, Hansen said, marks “a fairly momentous” reversal of the government’s position on gene patenting. (The brief says that the PTO previously deemed isolated DNA molecules patentable because they do not occur in isolated form in nature.) “This is very big news,” Hansen told us. “The Department of Justice, on behalf of the entire government, is saying the Patent & Trademark Office got it wrong.” Moreover, Hansen said, some of Myriad’s arguments, both at trial and on appeal, were based on the PTO’s policy of granting patents for isolated genes. The new government brief puts the kibosh on that line of reasoning. “The Justice Department explicitly rejects arguments that Myriad makes in its brief,” Hansen said. Hansen told us that both sides in the gene patent case lobbied the Justice Department, but that DOJ was mum about its position until it filed the amicus brief. He also said it’s evident that scientists and researchers from outside of the Patent Office advised the Justice Department. We left word with Myriad appellate counsel Gregory Castanias of Jones Day but didn’t hear back with comment from the company.

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