Justice Clarence Thomas, who wrote the court’s decision, said that Myriad’s assertion—that the DNA it isolated from the body for its proprietary breast and ovarian cancer tests were patentable—had to be dismissed because it violates patent rules. The court has said that laws of nature, natural phenomena and abstract ideas are not patentable.“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Thomas said.
This is a big deal. Patent protection for gene isolation would have made it very difficult for other companies to do genetic research or design tests of their own, and could have put a serious damper on one of the most promising areas of medical research. While the case was still making its way through the court system, Eric Hoffman wrote a piece in the American Interest profiling the damage that could be wrought by gene patents:
Myriad Genetics, for example, charges up to $4,000 for its breast cancer diagnostic test, a price too steep for many patients and health insurance providers. If allowed, labs could run the same genetic test for only a few hundred dollars.3 Myriad also sent cease-and-desist letters to researchers who were looking at the BRCA1/2 genes in their labs, providing diagnostic tests to patients and even providing patients second-opinion tests to confirm the test provided by Myriad.Gene patents have a detrimental impact on health care and research.4 Gene patents can prevent more accurate, affordable and complex diagnostic tests from being developed.5 A survey of genetics labs found that 53 percent stopped doing research due to concerns about patented genes,6 and there has been a significant decline in published material on patented genetic information.7 The future of personalized medicine may be crushed by the weight of gene patent thickets if a company must ask permission from hundreds of patent holders to scan a single patient’s genome.Gene patents also drive research towards gene-to-disease correlations and away from factors that actually cause disease, such as exposure to toxic chemicals. Most genetic tests offer only an estimate of the chances for developing a particular disease and fail to account for the influence of other genes and environmental factors that cause disease.8 The predictive power of the test for BRCA breast cancer mutations is high for persons from families with a history of particular kinds of breast or ovarian cancer, but very low for women without a family history of breast cancer; many women who test positive for a BRCA1 mutation do not get the disease.9 Gene patents lock-in our knowledge on these DNA sequences to only their potential correlation to a disease while preventing others from looking at how that gene may interact with other genes or the outside environment.
Although the court decision does still allow for the patenting of fully synthesized genes, it should undo most of the problems described above. When this ruling goes into effect, it should lead to improved medical research, more available procedures based on cutting-edge genetics, and lower costs. It’s a good day when the Supreme Court gets it right.[Supreme Court image courtesy of Shutterstock]