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SALT LAKE CITY -- A lawsuit has been filed against Myriad Genetics and the U.S. Patent and Trademark Office challenging the decision to grant a patent on a gene to Myriad and companies like it.
The Patent and Trademark Office granted Myriad the sole rights to study two genes closely associated with increased risk of breast and ovarian cancer over a decade ago.
Through the patent, Myriad is the only company that can offer a test to predict a woman's chance of getting one cancer if she's already had the other. That test can cost more than $3,000 and is not covered by all types of insurance.
The cost is a big issue with women like Lisbeth Ceriani, a breast cancer survivor. She's a single mom who worries about her health and what she could pass on to her child.
"I ended up with this type of breast cancer at such an early age that it could mean that I have a significantly higher risk of getting ovarian cancer, and the only way to determine that is through this genetic test," Ceriani said.
Now, the ACLU is suing the Patent and Trademark Office and Myriad. "Myriad has the authority under patent law to say: ‘It's my gene. It's not your gene. I get to decide whether you look at it. I get to decide whether you think about its consequences. I get to decide whether you do research on it.' And in our view, that's unacceptable," explained Chris Hansen, senior staff attorney for the ACLU.
Myriad, on the other hand, says the government has already issued tens of thousands of genetic and genetic-related patents for pharmaceutical and diagnostic products. In a statement, the company said it "strongly believes that its patents are valid and enforceable and will be upheld by the courts."
University of Utah law professor and patent attorney Ken Chahine says the case raises key medical, legal and health care coverage issues.
"Do we as a society make a decision that we're going to cover that cost, like we do for many other treatments? I think that really is the fundamental question here, rather than whether patents should be allowed on genes or not," Chahine said.
The Patent and Trademark Office had no comment on the lawsuit.
Meanwhile, it could take years for this case to be resolved. Myriad's attorney says the company believes the entire issue should be decided not in court, but in Congress.