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Cancer Discovery quotes Konstantin Linnik in “Myriad Genetics Notches Another Legal Victory”

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Konstantin Linnik, a member of the firm’s Intellectual Property and Life Sciences practice groups, was quoted in “Myriad Genetics Notches Another Legal Victory” in Cancer Discovery on September 6. The article discusses the August 16 ruling by the U. S. Court of Appeals for the Federal Circuit in Association for Molecular Pathology et al v. U.S. Patent and Trademark Office et al, which upheld its earlier decision allowing Myriad to keep its patents on BRCA1 and BRCA2. The ruling dealt only with whether the genes are eligible for patenting. Konstantin notes that “to be patentable, inventions also have to be novel and nonobvious, but the plaintiffs never challenged Myriad’s claims with respect to those additional criteria.”

For years, Myriad has fought off legal challenges that genes can't be patented because they're products of nature. Myriad argues that BRCA genes are isolated and manipulated using processes that require human ingenuity and in this case the Federal Circuit agreed. This is a crucial distinction because in March the U.S. Supreme Court ruled that correlations between drug dosage and metabolite levels in the body comprise a “law of nature” that can't be claimed as intellectual property (Mayo Collaborative v. Prometheus Laboratories). In light of the Prometheus decision, the Supreme Court remanded the Myriad case, which it had been scheduled to hear, back to the Federal Circuit.

By upholding its previous ruling, the Federal Circuit affirms that Prometheus does not apply to “composition” claims such as those having to do with DNA that's been isolated and then chemically manipulated, Linnik explains. “But it's possible the U.S. Supreme Court could overturn this decision,” he adds. “The Court already took the case once before so they likely will take it again if it's appealed.” Assuming the Supreme Court agrees with the Federal Circuit, future gene cases will be determined on the basis of novelty and nonobviousness, or inventiveness. “The eligibility criteria will have already been settled,” Linnik says.

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