Most court cases involving patent law are corporate battles, with one company suing another for infringing on its intellectual property rights and, therefore, profits. Big companies fighting over big money can seem painfully irrelevant, especially when so many of us are simply struggling to get by.
But the case coming before the U.S. Supreme Court on Monday challenging two patents is a different animal, with enormous implications for both our health and shared humanity. The patents in question are on two human genes, BRCA1 and BRCA2, commonly referred to as the "breast cancer genes."
We all have these genes in the cells of our bodies, but certain variants in some people significantly increase the risk of breast and ovarian cancer. Learning whether you have these risk-elevating mutations can be important because it gives you the opportunity to consider increased surveillance (such as cancer screenings and mammography) and even surgery to remove healthy organs.
The patents give one biotechnology company, Myriad Genetics Inc., sweeping control of the two genes. Myriad's monopoly harms women's health, impedes cancer research and raises important ethical questions about control over the human genome.
Myriad's patents cover both the normal versions of the genes and all mutations and rearrangements within them. This monopoly has prevented other scientists and doctors from using the BRCA1 and BRCA2 genes in research, medicine, diagnosis and treatment.
With revenue from the patents approaching half a billion dollars a year, Myriad frequently restricts access to these genes. It sends cease-and-desist notices to prevent other researchers from working with them.
Myriad's strict patent enforcement means its test is the only available one to determine whether a woman has a genetic variant that increases her risk of cancer. Women cannot get a second opinion about the results, even when faced with a decision about removing healthy organs to reduce their cancer risk. And too many women cannot even have the test because it is too expensive.
Furthermore, since Myriad's test focuses on the variants that have already been identified, some women, especially women of color, are more likely to get ambiguous results. They are told they have a genetic variant but that Myriad doesn't know whether it increases their risk of cancer.
The lawsuit before the Supreme Court next week has united women's health organizations, research groups, genetic counselors and breast cancer patients. The American Civil Liberties Union and the Public Patent Foundation, the lead plaintiffs, make a straightforward argument (full disclosure: Breast Cancer Action is also a plaintiff; Center for Genetics and Society has signed several briefs): U.S. case law and patent statute plainly say that patents can be awarded only for human inventions.
Genes are not inventions but products of nature. You can't patent the sun; you can't patent a new species of insect you find in a forest; you can't patent the speed of light. And you cannot patent human genes.
Beyond U.S. patent law lie broader questions: Should we treat human genes as private property to be exploited for profit rather than shared resources managed in the public interest? Should we allow corporate ownership to penetrate deeply into areas previously considered outside the commercial realm?
Several international organizations have taken up these questions, declaring the human genome part of the "commons" — akin to the moon and the air we breathe. The Universal Declaration on the Human Genome and Human Rights, ratified by the U.N. General Assembly in 1998, states that the human genome "is the heritage of humanity" and "in its natural state shall not give rise to financial gains." In 1999, the Parliamentary Assembly of the Council of Europe declared that "neither plant-, animal- nor human-derived genes, cells, tissue or organs can be considered as inventions, nor be subject to monopolies granted by patents." The World Medical Assn., an umbrella for 84 national medical associations, states that "human genes must be seen as mankind's common heritage."
Despite these strong declarations and the robust legal precedent for limiting patent protection to inventions, much of the human genome has been patented in a rush to profit from the incredible amount of information our genetic makeup holds, often to the detriment of our health. We believe there has been a misapplication of patent law, as acknowledged by the U.S. solicitor general's amicus brief on our behalf.
It was not always this way, and it need not stay this way. In 1955, Jonas Salk, who had invented the polio vaccine, was asked who owned the patent on the vaccine. "The people," he replied. "There is no patent. Could you patent the sun?"
A ruling in favor of the plaintiffs in this landmark case could effectively outlaw human gene patents. It would be a victory for all who put the public's health and interests above efforts to privatize what all of us should share. And it would restore our genomic heritage, the very DNA in our bodies, to the rightful owners — the people.
Marcy Darnovsky is executive director of the Center for Genetics and Society. Karuna Jaggar is executive director of Breast Cancer Action.