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CAP Joins Landmark Lawsuit Challenging Legality of Myriad Genetics Gene Patents

The College of American Pathologists today joined a lawsuit against the U.S. Patent and Trademark Office and Myriad Genetics, challenging the legality of Myriad's patents for the genes known as BRCA1 and BRCA2, which are indicators for hereditary predisposition to breast and ovarian cancer.

Washington, D.C. (Vocus) May 13, 2009 -- The College of American Pathologists today joined a lawsuit (United States District Court for the Southern District of New York 1:09-CV-4515) against the U.S. Patent and Trademark Office and Myriad Genetics, challenging the legality of Myriad's patents for the genes known as BRCA1 and BRCA2, which are indicators for hereditary predisposition to breast and ovarian cancer.

According to CAP, as a result of these patents, patients have been adversely affected because Myriad restricts most laboratories from providing full gene testing, requiring patients and their physicians to rely solely on Myriad to provide the test.

"As medical specialists in the diagnosis of disease, pathologists have a keen interest in ensuring that gene patents do not restrict the ability of physicians to provide quality diagnostic services to the patients they serve," said CAP spokesperson, Dr. Jeffrey A. Kant MD PhD, immediate past Chair of CAP/ACMG Biochemical and Molecular Genetics Resource Committee and Professor of Pathology and Human Genetics at the University of Pittsburgh Medical Center.

"When patents are granted, a single-lab only is authorized to do the test unless the test is licensed to other labs. In these cases, high licensing fees can be so prohibitive they prevent physicians and other laboratories from providing diagnostic services or developing improved tests," Kant said.

The complaint cites specific cases where patients were directly impacted because the diagnostic test services were not readily and affordably accessible.

The College has long opposed the issuance of human health-related gene patents because the doing so in violates the principle restricting patents on laws of nature. Patenting human health-related gene patents limits access to medical care, jeopardizes the ability to practice medicine in the best interest of patients and raises the cost of care.

The lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation in the United States District Court for the Southern District of New York on Tuesday, May 12, 2009.

The College is joined by nineteen other plaintiffs in the lawsuit including patient advocates, cancer patients, individual clinicians, and other medical societies.

The College of American Pathologists is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world's largest association composed exclusively of board certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective medical care.

Contact: Jodi Greenblatt at 1-800-392-9994, ext. 7102


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