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BRCA Gene Patent Ruled Invalid
April 2, 2010 On Monday, a federal court judge ruled that it was illegal for the BRCA1 and BRCA2 genes to be patented. This is very important news—and I will tell you why.
This ruling followed a lawsuit brought by a group of patients and scientist who were represented by the American Civil Liberties Union (ACLU) and Public Patent Foundation. Significantly, it marks the first time a court had found patents on genes unlawful. The ruling also calls into question whether the patents now held on about 2,000 other human gene are also valid.
The lawsuit against Myriad Genetics and the University of Utah Research Foundation, which hold the patent on the BRCA genes, argued that allowing scientists to patent genes would restrict scientific research and access to medical care. It also charged that it should be illegal to patent genes because they are products of nature that have been discovered, and not something that has been created or invented.
By patenting the BRCA1 and BRCA2 genes, and not the test it had developed, Myriad Genetics ensured it was the only company that could perform BRCA1/2 genetic testing. This meant that Myriad could charge whatever it wanted for the test, because they were the only ones who could do it. There also was no way for a woman to get a second test done from another company to ensure the first test's accuracy.
The patent also prevented any researcher from studying the genes without first getting the company's permission.
All of us have BRCA1/2 genes. A small percentage of women have mutations in these genes that increase their risk of breast and ovarian cancer. Men who have these mutations are at increased risk for breast and prostate cancer. Genetic testing can provide individuals with a family history of breast and/or ovarian cancer important information that can be used to determine prevention and treatment options. Also, recent studies suggest that certain forms of chemotherapy may be more effective in women who have a BRCA mutation. Yet, because of the patent, there was no way for any women who might have wanted a second test performed by another lab using another test to get one. This is strikingly different from other tests—like those that assess whether a tumor is hormone sensitive or HER2-positive or to assess whether a tumor has spread—that that used to make treatment decisions.
Last year, the American Civil Liberties Union asked me to submit a declaration in support of the plaintiff's case. I was pleased to do so because I firmly believed that the patents on the BRCA1 and BRCA2 gene—and any other gene for that matter—were obstacles to the clinical care of breast cancer patients and did not further the progress of medicine. I'm very happy the judge agreed! But it's not over. Myriad Genetics says it intends to appeal the decision to the Court of Appeals for the Federal Circuit.
