United States Weighs in on Myriad Genetics Case

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On Friday, October 29, 2010, the United States submitted an amicus curiae brief in the Myriad Genetics, Inc. case. (The Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., Federal Circuit Case No. 2010-1406.) Myriad Genetics holds several patents covering genomic materials relating to the human Breast Cancer Susceptibility Genes 1 and 2. A group of several health organizations and researchers brought suit seeking to have the patent claims declared invalid. The District Court held that 15 challenged claims from seven patents were invalid under 35 U.S.C. §101 because the challenged composition claims were allegedly directed to unpatentable products of nature and the challenged method claims were allegedly directed to unpatentable abstract ideas. That decision is on appeal.

In its amicus brief the United States clarifies its position as to whether (1) human engineered DNA molecules, such as cDNAs, are patent-eligible subject matter under 35 U.S.C. §101; and (2) isolated but otherwise unmodified genomic DNA is patent-eligible subject matter under 35 U.S.C. §101. The United States has taken the position that human engineered DNA molecules are eligible for patent protection (assuming the other requirements of Title 35 are met), but that isolated but unmodified genomic DNA is not eligible for patent protection because it is an article of nature.

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