SC: “A naturally occurring DNA segment is a product of nature and is not patent eligible merely because it has been isolated” Woo Hoo!!!
— Francis S. Collins (@NIHDirector) June 13, 2013
That tweet came from the director of the National Institutes of Health, Francis S. Collins.
Why is Collins so giddy?
Because the Supreme Court ruled June 13 that nobody can patent your genes. (Read full decision .pdf)
Collins and others at NIH, like Eric Green, M.D., the head of NIH’s Human Genome Research Institute, believe the unanimous decision in the Myriad Genetics case removes a significant obstacle to research. Before the decision, companies like Myriad, could stake out any piece of the genome and charge fees to researchers and patients who want to use the critical information in a gene. If DNA’s double helix were a highway, the decision was like “removing tollbooths,” Green says.
Researchers, patients and society will all benefit. As we said in an earlier post, one specific result of this decision might be significantly lower costs for the kind of test that alerted Angelina Jolie to her risk of breast and ovarian cancer. Those tests now can cost more than $3,000.
The case decided pitted Myriad Genetics of Salt Lake City against other companies — with an array of groups, including AARP, filing “friend of the court” briefs. The court weighed the validity of Myriad’s patents on two genes that can cause breast cancer (BRCA1 and BRCA2).
Myriad argued that by isolating the genes, it had created something new and should be given the exclusive right to use those genes in tests for dangerous mutations. The opposing side countered that nobody had the right to patent pieces of nature they hadn’t created. (You should know that Myriad says it never sought to actually patent genes, but most commentators, and the court, approached the issue as if it had.)
AARP released a statement June 13, which focuses both on costs, and on the public’s right to information: “Limitations on the study and public access to genetic tests are important because genetic diagnostic tests can determine how a patient will respond to a specific drug or a patient’s risk of developing Alzheimer’s, heart disease, hearing loss, other cancers, and a variety of other illnesses.”
When asked about particular relevance for those over 50, Green also cited cancer. What is “absolutely some of the lower hanging fruit in all of genomics,” he says, “is the application of genomic technologies to the study of cancer and to the diagnostics associated with cancer care.” Today’s decision, he says, opens the floodgates to that work.
Listen to our interview with Green, which took place at the National Museum of Natural History, where an exhibition on the human genome opens June 14:
Although denying part of Myriad’s claim, the court’s decision, written by Clarence Thomas, did give it and other companies the right to patent material derived from DNA, including something called complementary or cDNA, though not genes themselves.
That’s the reason Myriad, too, declared victory, saying “Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis ® test.” It also voiced strong optimism about other aspects of its business.
The stock market seemed to agree with the company’s analysis, sending its stock up nearly 10 percent soon after the decision.
Photo: Pasieka/Science Photo Library/Corbis
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