The US Supreme Court on Monday takes up a case with widespread implications for scientific innovation and health care in the US. The question: Are human genes patentable?
DNA may be the building blocks of life, but can something taken from it be the building blocks of a multimillion-dollar medical monopoly? The Supreme Court will grapple with that question Monday as it delves into an issue that could reshape medical research in the United States.
Alex Brandon/AP
EnlargeThe US Supreme Court is scheduled on Monday to take up a case with widespread implications for scientific innovation and health care in the US. The question: Are human genes patentable?
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The issue arises in a challenge to patents held by Myriad Genetics, a Utah-based diagnostic testing and research firm that developed a way to detect genetic mutations (called BRCA1 and BRCA2) that scientists associate with a higher risk of breast and ovarian cancer.
The process is described by the company?s lawyers as akin to locating a particular grain of sand in a space the size of the Empire State Building. The tests have helped over a million patients identify risks and develop treatment strategies.
But the American Civil Liberties Union and the Public Patent Foundation charge that Myriad Genetics is actually hindering scientific innovation and undercutting access to medical care for patients who need it.
They charge that the company is using its patents to prevent other researchers from developing new tests and that the company has prevented thousands of women from obtaining more accurate screening tests.
Kathleen Maxian is a patient undergoing treatment for Stage-4 ovarian cancer. Her doctors told her after surgery that she had a 20 percent chance of living for five years.
She said two years earlier her sister was diagnosed with breast cancer. At the time, the sister went to Myriad to determine whether the disease might be genetically-based. The results suggested it was not.
What Maxian and her sister did not understand was that Myriad only performed one test. There is a second test that can be performed, but Myriad only performs it on women with a family history of breast or ovarian cancer. Since no one in Maxian?s family had that history, her sister did not receive that test.
Later, after Maxian?s own diagnosis, the sister qualified for the second test and was identified as positive for the genetic mutations.
Maxian told her story to reporters during a recent ACLU teleconference. She said if her sister had been tested more thoroughly by Myriad, her own cancer might have been prevented.
Other laboratories are willing and able to provide the extra testing, but Myriad threatened them with patent-infringement lawsuits, she said.
?I can?t stand up to take my genes back,? she said. ?I stand up to help you take your genes back. And until my last breath I will tell this story for all the other women and families like me who want to be able? to make lifesaving decisions based on the best scientific information available.?
ACLU lawyers said it was improper for the government to issue patents that allow Myriad exclusive control over the mutated genes.
Since Myriad Genetics did not invent the genes, the company should not enjoy monopoly power over them by virtue of a patent, they argue.
?Myriad has a monopoly on clinical testing of its genes in the US, dictating the type and terms of BRCA genetic testing,? wrote ACLU lawyer Christopher Hansen in his brief to the court.
Mr. Hansen says the patents allow Myriad to block avenues of scientific research and stop the development of new types of clinical testing of BRCA genes that seek to utilize newer innovations. ?
?Myriad can even prevent scientists from looking at their own genes,? Hansen said.
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