Sandra S. Park is an attorney at the American Civil Liberties Union.
In the next month, the Supreme Court will resolve a profound question: Can a company patent our genes – the blueprint for our cells, organs and bodies, inherited from our parents? The court's answer will have serious ramifications for the future of genetics and medicine. The two genes at the heart of the case before the court are BRCA1 and BRCA2. We all have these genes, but people with certain mutations are at much higher risk for breast and ovarian cancer.
Myriad Genetics, the company that controls the patents on the BRCA genes, asserts that the genes become its "invention" once they are "isolated," or removed from the cell and body. The implications of the argument are astonishing – what would prevent patents on a kidney separated from the body, or a leaf snapped from a tree? In response to tough questioning by several justices, Myriad's attorney conceded that under the view presented by that side, scientists in an earlier era could have patented an entire chromosome and possibly even parts of organs. He previously told a lower court that elements of the periodic table, such as lithium, could also be patented once isolated.
Yet, these patents are in direct conflict with more than a century of Supreme Court case law that prohibits the patenting of products and laws of nature. When scientists identify something in nature, like an element or a gene, they deserve wide recognition. But what they find should belong to the public storehouse of knowledge, not be locked up by one company for its exclusive use. This is particularly true when millions of dollars in federal funding financed Myriad's search for the BRCA genes.
Gene patents interfere with scientific advancement and patient health. Myriad has a monopoly on BRCA genetic testing in the U.S. and therefore controls the type and price of testing. While scientists have developed new genetic testing technologies that can sequence all 23,000 human genes for $1,000, Myriad still charges over $4,000 for testing two genes. Other laboratories cannot provide second opinions to most patients, and they cannot include the BRCA genes when offering testing of the more than a dozen genes that are now associated with breast and ovarian cancer risk. Gene patents also have a chilling effect on research. Researchers must either obtain permission from the patent holder or run the risk of being sued. And by virtue of its patents, Myriad controls most of the data about the BRCA genes and has refused to share that information with the scientific community.
Supporters of gene patents often cite the need to incentivize research through patent protection. But patents on genes, unlike patents on drugs or tests, create an insurmountable hurdle to research. They force us to rely on one company to develop every possible scientific and commercial application of a gene, rather than giving all scientists access to a fundamental element of human biology. Moreover, a federal genetics task force advising the Department of Health and Human Services concluded in 2010 that human gene patents were not necessary as an incentive to either identifying genes or developing genetic tests.
BRCA1 and BRCA2 are only two of the thousands of patented human genes connected with a wide range of diseases including colon cancer, muscular dystrophy, and Alzheimer's disease. If the Supreme Court invalidates gene patents, it will lift a major barrier to progress in further understanding how we can better treat and prevent life-threatening conditions.