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U.S. Supreme Court Invalidates Patents on Breast and Ovarian Cancer Genes
Date:6/13/2013

Chicago, IL (PRWEB) June 13, 2013

The U.S. Supreme Court today invalidated patents on two genes associated with hereditary breast and ovarian cancer in response to a lawsuit filed by the American Civil Liberties Union (ACLU), which includes the American Society for Clinical Pathology (ASCP) and several other medical professional associations, on behalf of researchers, genetic counselors, patients, and breast cancer and women’s health groups that has far-reaching implications for pathology, laboratory medicine, and patients.

“Isolated DNA is a product and law of nature, not an invention, so it is not open to patent protection,” said Steve Kroft, MD, FASCP, president-elect of ASCP. “Gene patents hinder advances in patient care and make the process slower and more expensive for women to find out if they have certain gene mutations that could adversely affect their health.”

The patents allowed a Utah company, Myriad Genetics, to control access to the genes, known as BRCA1 and BRCA2, which gave them the right to limit others from doing research or diagnostic testing of the genes, which can be crucial for individuals making important medical decisions. By enforcing its patent for the testing of patients for BRCA1 and BRCA2 gene alterations for many years, Myriad Genetics has prevented other laboratories from developing tests for these mutations and limited research on these gene alterations that could lead to advances in diagnosis and treatment for patients.

“I know the costs of these tests will be considerably lower without patent protection, allowing more women at risk to be tested,” said Ossama Tawfik, MD, PhD, FASCP, a member of the ASCP Fellow Council and an expert in breast cancer pathology at the University of Kansas Medical Center.

The Court’s unanimous decision found that naturally occurring DNA is a product of nature and not patent eligible merely because it has been isolated. “Laws of nature
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