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Ruling upholds Gene Patent, What is Next?

The Court of Appeals for the Federal Circuit, which specializes in patent cases, said that Myriad Genetics was entitled to patents on 2 human genes used to predict if women have an increased risk of getting breast and ovarian cancer.
  • The court ruled that DNA isolated from the body was eligible for patents because it was “markedly different” in its chemical structure from DNA that exists inside the chromosomes in the body. As a result, the isolated DNA is not simply a product of nature, which would not be eligible for a patent;
  • The 2 to1 decision on the gene patenting issue was also a rejection of arguments made by the Obama administration, which had filed a friend of the court brief arguing that isolated DNA should not be patented;
  • The brief went against the long-standing policy of the US PTO to grant such patents. (A Pollack, NY Times)

The Bottom Line: A federal appeals court ruled on Friday, 7/29/11 that gene(s) can be patented, overturning a lower court decision that had shocked the biotechnology industry. Thousands of human genes have been patented, and some patents are essential for encouraging innovation. The court had  said that Myriad’s patent claims on the process of analyzing whether a patient’s genes had mutations that raised the risk of cancer was not patentable because it involved only “patent-ineligible abstract mental steps. “The claims cover molecules that are markedly different – have a distinctive chemical identity and nature – from molecules that exist in nature,” Judge Alan D. Lourie wrote for the court. The prevailing opinion rejected that analogy, saying that isolating DNA created a new chemical entity. It was not simply a matter of separating or purifying the DNA, he said, and not like snapping off a leaf or extracting a mineral from the earth. The next legal iteration will be whether Induced Pluripotent Stem Cell (iPSC) patents will be subject to similar constraints.