BRCA 1 and BRCA 2 genes are found to be associated with the increased risk of breast cancer as well as ovarian cancer. In 1990, a team of scientists from University of California, Berkeley declared the association of BRCA 1 gene (present in long arm of chromosome 17) with the risk of breast cancer.[ii] In 1994, researchers of Myriad genetics along with colleagues at the University of Utah, the National Institutes of Health (NIH), and McGill University isolated and published the sequence of BRCA 1.[iii] In the same year, the first BRCA 1 U.S. patent was filed by the University of Utah, National Institute of Environmental Health Sciences (NIEHS), and Myriad. In 1995 isolation and sequencing of the BRCA2 gene was done by Myriad, in collaboration with University of Utah and the first BRCA2 patent was filed in the U.S. In 1996, Myriad launched their BRCA Analysis product, which detects certain mutations in the BRCA1 and BRCA2 genes that put women at high risk for breast cancer and ovarian cancer. USPTO issued several gene patents to Myriad Genetics and the University of Utah Research Foundation, allowing extensive control over BRCA1 and BRCA2 breast cancer genes. The patents also contained some broad claims to diagnostic methods. Myriad is the only laboratory in the United States where commercial diagnostic testing for BRCA1 and BRCA2 can be performed. Moreover, the tests are expensive and Myriad has charged a relatively high rate (over $3,000) for the tests, which places them out of the reach of many.
The AMP (Association for Molecular Pathology) with the University of Pennsylvania, researchers at Columbia, NYU, Emory, and Yale; and with several patient advocacy groups and several individual patients filed the case against Myriad, the Trustees of the University of Utah, and the U.S. Patent and Trademark Office (USPTO). The USPTO was severed from the case by the district court. The complaint made against specific claims on isolated genes, diagnostic methods, and methods to identify drug candidates, in seven of Myriad’s 23 patents on BRCA1 and BRCA2.[iv] The plaintiffs claimed that these patents were invalid on the grounds that they are not patentable subject matter under §101 of Title 35 of the United States Code as the isolated genes are unpatentable products of nature, and that the diagnostic method claims are mere thought processes that do not yield any real transformations, and that the drug screening claims were just describing the basic processes of science.