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ARTICLE · 31 OCTOBER 2011

Is An Isolated DNA Patentable?

Is DNA patentable? Are isolated genes representative of what the Supreme Court characterizes as patent-ineligible "products of nature"? In a much anticipated decision, the Federal Circuit recently reversed a District Court’s decision that Myriad Genetics’ composition claims to "isolated DNA" are unpatentable under 35 USC § 101.

United StatesIntellectual Property

Is DNA patentable? Are isolated genes representative of what the Supreme Court characterizes as patent-ineligible "products of nature"? In a much anticipated decision, the Federal Circuit recently reversed a District Court's decision that Myriad Genetics' composition claims to "isolated DNA" are unpatentable under 35 USC § 101.

The disputed patent claims were directed to DNA compositions associated with breast cancer and methods for using these isolated DNAs for diagnosing breast cancer and screening for potential cancer therapeutics targeting breast cancer. More than 20 plaintiffs, including researchers, professional societies, and women affected by cancer brought the lawsuit against Myriad Genetics and the United States Patent & Trademark Office. Myriad Genetics, which owns the patents, carries out commercial testing for mutations in the breast cancer susceptibility genes, BRCA1 and BRCA2. Much of the controversy and debate centered on whether gene patents incite

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