The ACLU and the nonprofit Public Patent Foundation last week jointly filed a lawsuit against the PTO, Myriad Genetics, and the University of Utah Research Foundation, claiming the latter parties’ patents on the genes BRCA1 and BRCA2, which are associated with breast and ovarian cancer, are unconstitutional and invalid. More than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, women’s health groups, genetic counselors, and individual women have signed on in support of the lawsuit.
With their government-protected monopoly , Myriad has claimed the exclusive right to perform a diagnostic test for mutations in these genes. No one else is permitted to develop an alternative test, and women can not even take their test results elsewhere for a second opinion. What’s more, Myriad’s price tag for the test, over $3,000, is prohibitively expensive for many women.
This will be an important test case that will be watched closely in the biotech community, where personalized genomic medicine seems poised on the cusp of breaking big. While the PTO has granted thousands of patents on human genes, many question the validity of patents that protect a naturally occurring gene rather than a legitimate “invention,” arguing that they have a chilling effect on research. And growing support in the biotech community for open-source models certainly seems to leave Myriad swimming against the tide.
Stay tuned. The case, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York in Manhattan.
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