In a lawsuit filed yesterday in U.S. District Court for the Southern District of New York, the American Civil Liberties Union and the Public Patent Foundation charge that patents on BRCA1 and BRCA2, genes associated with hereditary breast and ovarian cancer, stifle valuable medical research. The lawsuit argues that the patents on these genes are unconstitutional and should be invalidated because genes are "products of nature." The suit is the first to apply the First Amendment to a gene patent challenge.

The lawsuit's long list of plaintiffs includes women's health groups, individual women, and scientific associations such as the Association for Molecular Pathology, the American College of Medical Genetics, the American Society for Clinical Pathology, and the College of American Pathologists. The defendants are the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation, which hold the patents on the BRCA genes.

Myriad's gene patents give the Salt Lake City-based company exclusive rights to perform diagnostic tests on the BRCA1 and BRCA2 genes. It does so through its flagship BRCAnalysis test, which assesses a woman's risk of developing breast or ovarian cancer based on detection of BRCA1 and BRCA2 gene mutations. The highly profitable test is performed in Myriad's CLIA-certified laboratory and costs approximately $3,200, with operating margins of nearly 50%. The test is reimbursed by most insurance providers.

For more on this story, see the June issue of Diagnostic Testing and Technology Report