"Women whose doctors recommend genetic testing should be able to find out whether they have the gene mutations linked to breast and ovarian cancer so that they are able to make choices that could save their lives, and these patents interfere with their ability to do so," said Lenora Lapidus, Director of the ACLU Women's Rights Project.

"The patents on the BRCA genes block women's access to medical information necessary for making vital health care decisions, impeding their control over their own bodies," said Sandra Park, staff attorney with the ACLU Women's Rights Project.

Because the ACLU's lawsuit challenges the whole notion of gene patenting, it could have far reaching effects beyond the patents on the BRCA genes. Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other illnesses.

"Scientific research and testing have been delayed, limited or even shut down as a result of gene patents, stifling the development of new diagnostics and treatments," said Tania Simoncelli, ACLU science advisor. "The government should be encouraging scientific innovation, not hindering it."

"Patenting human genes is counter to common sense, patent law and the Constitution," said Daniel B. Ravicher, Executive Director of PUBPAT and co-counsel in the lawsuit. "Genes are identified, not invented, and patenting genetic sequences is like patenting blood, air or e=mc2."

If Myriad's BRCA genes patents were invalidated, the clinicians, pathologists and researchers represented by the ACLU would be able to engage freely in research, testing and clinical practice involving the BRCA1 and BRCA2 genes, and the patients would be able to obtain second opinions on test results and have access to genetic testing services from multiple, and perhaps more affordable, sources.

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