A lawsuit organized by The American Civil Liberties Union and filed in the U.S. District Court for the Southern District of New York is challenging the practice of gene patenting in a case that could have wide-reaching consequences for medical research and genetic diagnostics, the New York Times reports.
At issue was a decision made 10 years ago by the U.S. Patent and Trademark Office to grant Myriad Genetics, based in Salt Lake City, exclusive rights to two genes -- BRCA1 and BRCA2 -- closely associated with increased risk for breast and ovarian cancer and on testing methods to measure that risk. The lawsuit, filed on behalf of several cancer patients, professional organizations and genetic researchers, argues that gene patents restrict the practice of medicine and new research and block alternatives to the patented tests or interpreting or comparing gene sequences that involve these genes, according to the Times.
The specific case involved a Texas woman who had received a diagnosis of breast cancer in 2006 then took a genetic test to see if her genes also put her increased risk for ovarian cancer. When her test came back positive, she wanted a second opinion, but discovered that under the patent granted, there could be no second opinion, the Times reported.
Companies like Myriad argue that the patent system promotes innovation by giving firms a temporary monopoly that rewards their investment in research and development. Two panels of government experts have not found significant impediments to research or medical care caused by gene patents, and a report from the National Research Council found that patented biomedical research rarely imposes a significant burden for biomedical researchers, the Times said. But, the report added, the patent landscape could become considerably more complex and burdensome over time.
About 20 percent of the human genome, involving thousands of individual genes, are already included in patent claims, a draft report from the National Institutes of Health says, according to the Times. The report warned that it may be difficult for any one developer to obtain all the needed licenses to develop the next generations of tests.