After Myriad obtained its patents, it sent letters ordering other labs to
stop testing. A survey of U.S. laboratory directors showed:
- 25% stopped performing a genetic test that they had been offering as a result of gene patent or license-holders exercising their intellectual property rights.
- More than 50% had decided not to develop or perform a genetic test for clinical or research purposes because of a patent.
- More than 90% thought patents had negative effects on the development of genetic tests and increased the cost of testing.
January 18, 2012
On May 12, 2009, the ACLU and the Public Patent Foundation (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The suit charges that the patents stifle diagnostic testing and research that could lead to cures and that they limit women's options regarding their medical care.
The lawsuit, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., was filed on behalf of researchers, genetic counselors, women patients, cancer survivors, breast cancer and women's health groups, and scientific associations representing 150,000 geneticists, pathologists, and laboratory professionals. The lawsuit was filed against the U.S. Patent and Trademark Office, as well as Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the genes, BRCA1 and BRCA2. The lawsuit charges that patents on human genes violate the First Amendment and patent law because genes are "products of nature" and therefore can't be patented.
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.
On March 29, 2010 a New York federal court ruled that the patents on the BRCA1 and BRCA2 genes are invalid. The U.S. Court of Appeals for the Federal Circuit heard Myriad's appeal of that ruling in April 2011.
In July 2011, the appeals court ruled that companies can obtain patents on the genes but cannot patent methods to compare those gene sequences.