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On April 15, 2013, the Supreme Court heard oral argument in Ass'n for Molecular Pathology v. U.S. Patent and Trademark Office (hereinafter “Myriad“). The sole question before the Supreme Court, following its grant of certiorari on Nov. 30, 2012, is whether human genes are patent-eligible subject matter under 35 U.S.C. ' 101.
Background
On May 12, 2009, a coalition of scientific and medical groups along with patients previously diagnosed with breast cancer (collectively “Plaintiffs”) brought a declaratory judgment action against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation (collectively “Myriad”) in the Southern District of New York seeking to invalidate 15 claims contained in seven Myriad patents directed to isolated DNA from Breast Cancer Susceptibility Genes, referred to as BRCA1 and BRCA2. The BRCA1 and BRCA2 genes are significant in that mutations in these genes have been linked to a woman's increased risk of developing breast and ovarian cancer. Myriad's disputed claims were categorized as: 1) composition claims directed to isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence; and 2) method claims directed to “comparing” or “analyzing” the sequences of these two genes.
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