The College of American Pathologists (CAP) and the American Society for Clinical Pathology (ASCP) has joined the American Civil Liberties Union (ACLU; New York City) and the Public Patent Foundation (New York City) in a lawsuit against U.S. Patent and Trademark Office, Myriad Genetics (Salt Lake City), and directors of the University of Utah Research Foundation, charging that patents on BRCA1 and BRCA2, genes associated with hereditary breast and ovarian cancer, stifle valuable medical research. The suit is the first to apply the First Amendment to a gene patent challenge.
The lawsuit was filed on May 12 in the United States District Court in the Southern District of New York on May 12. The lawsuit’s long list of plaintiffs includes women’s health groups, individual women, and scientific associations, such as the Association for Molecular Pathology and the American College of Medical Genetics. The lawsuit argues that the patents on these genes are unconstitutional and should be invalidated because genes are “products of nature.” Approximately 20 percent of all human genes are patented, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, and asthma.
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 percent. The test is reimbursed by most insurance providers. According to the ACLU lawsuit, Myriad’s control over BRCA1 and BRCA2 hampers clinical diagnosis and serves as a disincentive for research because Myriad not only has the right to enforce its patents against other entities but also has the rights to future mutations discovered on the BRCA2 gene.
June 2009 - Table of Contents
Archives