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U.S. Supreme Court to decide if human genes patentable

Last Updated: 2012-11-30 17:00:15 -0400 (Reuters Health)

By Jonathan Stempel

(Reuters) - The U.S. Supreme Court on Friday agreed to decide whether human genes can be patented, a hotly contested issue with broad consequences for the future of gene-based medicine.

The nation's highest court agreed to review a case over whether Myriad Genetics Inc may patent two genes linked to hereditary breast and ovarian cancer.

In a 2-1 ruling on Aug. 16, a panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., upheld the biotechnology company's right to patent "isolated" genes that account for most inherited forms of the two cancers.

But that ruling also denied Myriad's effort to patent methods of "comparing" or "analyzing" DNA sequences.

The Federal Circuit had ruled in Myriad's favor in July 2011, but that ruling was set aside by the Supreme Court, which asked it to revisit the case in light of later developments.

The genes in question, BRCA1 and BRCA2, can be used to detect risk of breast and ovarian cancer and aid in treatment options. Women who test positive using Myriad's gene test, BRACAnalysis, have an 82 percent higher risk of breast cancer and 44 percent higher risk of ovarian cancer in their lifetimes.

The appeal against Myriad and the University of Utah Research Foundation was being pursued by a variety of medical associations led by the Association for Molecular Pathology.

They contended that Myriad's patents are illegal, prohibit standard clinical testing of the BRCA1 and BRCA2 genes, and restrict scientific research and patients' access to medical care, including their own genetic information.

A decision by the Supreme Court is expected by the end of June.

The case is Association for Molecular Pathology et al v. Myriad Genetics Inc et al, U.S. Supreme Court, No. 12-398.

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