In a unanimous decision, the U.S. Supreme Court has ruled that companies cannot patent human genes. While this may seem like common sense, over the last 30 years the U.S. Patent Office has issued patents on thousands of human genes, including genes associated with colon cancer, Alzheimer's disease, muscular dystrophy, and many other devastating diseases. The status quo meant that companies controlling gene patents had the right to stop all other scientists from examining, studying, testing, and researching our genes.
The case before the court was brought by the ACLU and the Public Patent Foundation. It involved patents on two genes, called “BRCA1” and “BRCA2,” controlled by a Utah-based company, Myriad Genetics. We all have these genes, but people with certain mutations are at much higher risk of breast and ovarian cancer. It’s therefore important for some people to have their genes tested in order to make informed medical decisions (as Angelina Jolie described in a recent op-ed in The New York Times).
But the patents on the genes allowed Myriad to exercise a monopoly, dictating what types of testing were offered, at what cost, and the availability of second opinions.
Myriad argued that the genes become its "invention" once they are "isolated," or removed from the cell and body.
The court rejected that view in the unanimous decision written by Justice Clarence Thomas. Thomas noted simply: "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
The ruling should also impact the many other patents that have been granted on "isolated" genes.
By invalidating these patents, the court lifted a major barrier to progress in further understanding about effective treatment, and even prevention, of certain diseases.
The decision will also help, not hinder, the biotechnology industry. Most of the industry is focused on using genes as a starting point to create new tools, tests, and therapeutics. While all of these applications could be patented, the genes themselves should remain in the public storehouse of knowledge, for scientists at universities and corporations to freely study and use.
A federal task force advising the Department of Health and Human Services concluded in 2010 that gene patents were not necessary as an incentive to finding genes or providing genetic testing.
The ACLU also argued to the court that a form of DNA, called complementary DNA ("cDNA"), should not be patentable when it is a mirror copy of naturally-occurring human mRNA. The court concluded otherwise in its decision.
While we disagree with that finding, the decision as a whole represents a huge shift in patent law. The Supreme Court's ruling shields parts of the human body from the assertion of private property rights. And because cDNA is not required for genetic testing, laboratories will now be able to offer testing of the BRCA genes to their patients.
The ACLU and the Public Patent Foundation filed the case four years ago on behalf of 20 plaintiffs, including organizations representing over 150,000 medical professionals, geneticists, breast cancer and women's health advocacy groups, and patients.
-- Sandra Park, ACLU Women's Rights Project