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Aug 16, 2012

Gene Patentability Reaffirmed, But Not Myriad Method Claims

Gene Patentability Reaffirmed, But Not Myriad Method Claims

The U.S. Court of Appeals for the Federal Circuit ruled that BRCA 1 and 2 genes represent “a nonnaturally occurring composition of matter,” and thus are patentable. [© ungureanusergiu - Fotolia.com]

  • A divided U.S. Court of Appeals for the Federal Circuit today delivered a mixed verdict to Myriad Genetics in its three-year legal wrangle to uphold seven patents for breast cancer susceptibility genes BRCA 1 and 2 and its method for analyzing those genes for mutations associated with the disease.

    Writing for the court in a 2–1 decision, Circuit Judge Alan Lourie upheld a lower court’s denial of patent eligibility for Myriad’s method claims directed to comparing or analyzing DNA sequences using the genes: “Such claims include no transformative steps and cover only patent-ineligible abstract, mental steps,” the judges wrote in their decision. (Read the decision here: http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf)

    That portion of the decision sided with part of a 2010 decision by the U.S. District Court for the Southern District of New York. But two other parts of that decision were overturned by the appellate majority. It found that the BRCA 1 and 2 genes represented “a nonnaturally occurring composition of matter,” and thus were patentable under § 101 of Title 35, U.S. Code.

    Using that reasoning, the appellate majority also upheld Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells, rejecting the district court’s finding that it was directed to a patent-ineligible scientific principle.

    Today's decision echoed a 2011 ruling by the same court, which largely but not entirely overturned the district court. In March, the U.S. Supreme Court remanded the case to the Federal Circuit’s appeals court in light of the high court’s Prometheus v. Mayo decision overturning Prometheus’ patents on a drug-dosage calibration method, saying it was too close to a natural phenomenon.

    Circuit Judge Kimberly A. Moore concurred in part with Lourie, while Circuit Judge William Bryson dissented from the part of the decision holding BRCA 1 and 2 as patent-eligible: “The court’s decision, if sustained, will likely have broad consequences, such as preempting methods for whole-genome sequencing.”

    Bryson sided with plaintiffs in the original case Association for Molecular Pathology v. U.S. Patent and Trademark Office. The American Civil Liberties Union (ACLU) is counsel-of-record to AMP and co-plaintiffs, which advocate a ban on gene patenting. They argue that gene patenting stifles basic scientific inquiry, and is therefore a violation of the spirit and letter of the intellectual property clause of Article I, § 8, of the U.S. Constitution.

    Myriad rejects that argument and contends patenting is vital to recouping development costs. The company has said it spent $500 million over 17 years on its BRCAnalysis test before breaking even.

    Last year, a three-judge panel of the Federal Circuit overturned the district court, finding that Myriad’s gene composition-of-matter claims and its methods of screening for cancer compounds patent-eligible but found Myriad’s claims for the mutation analysis were not patentable, dismissing them as “abstract mental processes.”


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