Will the U.S. Supreme Court Allow a Patent for a Human Gene?
On April 15, 2013, the United States Supreme Court heard oral argument over the question of whether human genes may be patented in the case of Association for Molecular Pathology v. Myriad Genetics. The case is the result of a group of researchers, medical groups and patients suing Myriad Genetics, a Utah biotechnology company, in 2009. Myriad Genetics discovered and isolated two genes (BRCA 1 and BRCA 2) that are recognized as being closely related to hereditary breast and ovarian cancer. The company obtained a patent for this discovery, which effectively gave it a twenty-year exclusive to the use and research of these genes. The challenging parties claim that this patent is invalid.
Natural occurrences cannot be patented, and therein lies the question of whether a human gene may be patented. Mark Capone, president of Myriad Genetics Laboratories, was quoted by NPR as stating that the 20,000 genes in the human body are part of a six-foot-long molecule that’s “coiled and compacted and stuffed into each cell.” Additionally, “What Myriad was able to do is sort through all those 20,000 genes and find the two that were highly linked to hereditary breast and ovarian cancer.”
In a release the day before oral arguments, Peter Meldrum, President and CEO of Myriad Genetics, wrote in USA Today. “We think it is right for a company to be able to own its findings, just as pharmaceutical and other companies do all the time. The Supreme Court case could have broad implications for biotech, agriculture and animal health industries and the development of cutting-edge services of enormous benefit to society.”
During oral argument, the attorney for Myriad Genetics, Gregory Castanias stated that, “What Myriad inventors created in this circumstance was a new molecule that had never before been known to the world.”
The opposing parties are adamant that this process is not patentable since this human gene is something that occurs naturally. NPR quoted Christopher Hansen of the American Civil Liberties Union, the attorney for the challengers, as stating, “All Myriad does is take a part of the body out of the body. . . It is no different than taking a kidney out of the body. Just because you are the [first] person who takes the kidney out of the body doesn’t entitle you to a patent on kidneys.”
If the Supreme Court eventually rules in favor of Myriad Genetics, it will be granting the company the exclusive right to use and research the genes for diagnoses and treatments. This, in effect, will not allow diagnostic and therapeutic companies to compete over the quality and price of their tests. Despite these concerns, it appears that after oral arguments that the Supreme Court may not rule in favor of Myriad Genetics. According to a NBC report, “It would be one thing, several of the justices said during Monday’s oral arguments, for a company to seek a patent on a test for breast cancer that was developed by analyzing a human gene, but it would be going too far to be awarded a patent on the gene itself.”