Breast Cancer Gene Patents
On May 12, 2009, PUBPAT and the American Civil Liberties Union (ACLU) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers. Support for this project comes from the Nathan Cummings Foundation.
The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.
Since the PTO granted patents on the BRCA genes to Myriad Genetics, Myriad’s lab is the only place in the country where diagnostic testing can be performed. Because only Myriad can test for the BRCA gene mutations, others are prevented from testing these genes or developing alternative tests. Myriad’s monopoly on the BRCA genes makes it impossible for women to use other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford.
The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed on May 12, 2009, in the United States District Court for the Southern District of New York in Manhattan against the PTO, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. On March 29, 2010, Judge Robert Sweet issued his opinion holding all of the challenged patents invalid.
Support for this project comes from the Nathan Cummings Foundation.
Watch our video on why we're fighting to Liberate the Breast Cancer Genes
Related Documents
- Opinion by Judge Robert Sweet Holding Patents on Human Genes Invalid (March 29, 2010) (PDF; 859KB)
- Court Decision Denying Motions to Dismiss and Allowing Case to Proceed (November 2, 2009) (PDF; 1.4MB)
- Summary Judgment Motion Filed by PUBPAT and ACLU Against Breast Cancer Gene Patents (August 26, 2009)
- Complaint Filed by PUBPAT and ACLU Against Breast Cancer Gene Patents (May 12, 2009)
Related News
- April 2, 2010: PBS' NewsHour Interviews PUBPAT Executive Director, Dan Ravicher, Regarding Gene Patents and the Myriad Case
- March 29, 2010: PATENTS ON BREAST CANCER GENES RULED INVALID IN PUBPAT/ACLU CASE
- February 2, 2010: PUBPAT AND ACLU ARGUE TODAY THAT PATENTS ON BREAST CANCER GENES ARE UNCONSTITUTIONAL AND INVALID: First Hearing In Federal Court About The Patentability Of Human Genes
- December 11, 2009: NPR Hosts Discussion of Breast Cancer Genes Patent Case with PUBPAT Executive Director, Dan Ravicher
- November 2, 2009: COURT UPHOLDS RIGHT OF SCIENTISTS AND PATIENTS TO CHALLENGE GENE PATENTS: PUBPAT/ACLU Lawsuit Challenging Patents On Breast Cancer Genes Can Go Forward
- August 27, 2009: AMA, MARCH OF DIMES AND OTHERS SUPPORT PUBPAT/ACLU CHALLENGE TO PATENTS ON BREAST CANCER GENES: Briefs Filed In Support Of PUBPAT/ACLU Motion To Declare Patents Unconstitutional
- May 12, 2009: ACLU AND PUBPAT CHALLENGE PATENTS ON BREAST CANCER GENES: Gene Patents Stifle Patient Access To Medical Care And Critical Research