A Myriad Genetics lab. (AP Photo/Douglas C. Pizac)
Do you own the rights to your own genes? Only 59 percent of the time, according to one recent study; the other 41 percent of the genes in the human genome have already been patented. This means that once your blood is drawn, nearly half of your genetic material cannot legally be isolated, studied or tested by anyone but the patent holder.
Not all institutions and corporations enforce their patents. But some do: one genetic testing company who has been very aggressive in policing its patent rights—Myriad Genetics—is in the midst of a Supreme Court battle over their right to control the use of two genes—called BRCA1 and BRCA2—which, when damaged, lead to a very high risk of breast and ovarian cancer. It’s estimated that as many as one in every 400 American women carries one of these mutations.
On April 15, the Supreme Court heard arguments in Association of Molecular Pathologists v. Myriad Genetics, addressing Myriad’s right to hold the BRCA gene patents. The suit was first initiated in 2009 in New York Federal Court by an unusually diverse coalition of plaintiffs, including the ACLU; several professional associations of research scientists, including the Association for Molecular Pathology and the American College of Medical Genetics; individual researchers; women’s health and breast cancer advocacy groups Breast Cancer Action and Our Bodies Ourselves; and individual women who have breast and ovarian cancer. (Notably absent from this list: the Susan G. Komen Foundation. Interestingly enough, Myriad is a Komen donor.) In 2010, a New York federal court ruled against Myriad, invalidating all of Myriad’s gene patents. But an appeals court overturned the ruling a year later. Now the Supreme Court is weighing the case.
Christopher Hansen, a lawyer from the ACLU, delivered the oral argument before the Supreme Court, emphasizing that genes are “products of nature” and thus are ineligible for patent protection, asking, “What exactly did Myriad invent? The answer is nothing.” Myriad’s lawyer countered this claim by insisting that in snipping the individual gene from the DNA sequence, Myriad is in fact creating a new product. He argued that “know[ing] where to snip” constitutes a new invention.
At the center of the Myriad case is a question that extends well beyond the parameters of breast and ovarian cancer: Is it even legal for the US Patent and Trade Office (USPTO) to issue patents for genetic material? Over the past two decades, the USPTO has issued thousands of gene patents. As Supreme Court Justice Elena Kagan commented during the Myriad arguments, “The Patent Office seems very patent-happy.” And some of these patents, like Myriad’s BRCA patents, are stunningly expansive: one corporation can legally control and charge licensing fees for all uses of a particular gene. So the study of any disease that may have a genetic component is potentially at issue in this case. Will scientists and doctors be able to choose what genes they study and what treatments they develop, or will the corporations who own these genes be able to dictate the terms under which science and medicine may proceed?