Can genes be patented? This spring, the Supreme Court will hear a case that may well decide the question, and the consequences for American biomedicine could be huge.1 Over three years ago, in May 2009, the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PPF) filed a lawsuit in the Federal District Court for the Southern District of New York seeking to overturn the patents on DNA isolated from two human genes.2 Called BRCA1 and BRCA2, the genes significantly increase a woman's risk of breast and ovarian cancer. The main defendant was the Myriad Genetics Corporation, a biotechnology firm in Utah that controls the patents—and is legally entitled for the life of the patent (now twenty years) to exclude all others from using these genes in breast cancer research, diagnostics, and treatment. Other defendants were the University of Utah Research Foundation, which had come to own the patents, and the United States Patent and Trademark Office (PTO), which had granted them.
The plaintiffs were not the usual parties in patent suits: competitors concerned with their balance sheets. They included medical geneticists, pathologists, and advocates for women's health, as well as biomedical researchers, genetic counselors, and several women with breast cancer or at risk for it. They were distressed that Myriad's patents allowed it to exercise such monopolistic control over a biological substance as essential to research, medicine, and patients as DNA implicated in cancer. They contended that BRCA DNA—and by implication all human DNA—should not be eligible for patents as a matter of law and that Myriad's enforcement of its patents interfered with the progress of science and the delivery of medical services.
The plaintiffs had the support, expressed in friend-of-the-court briefs, of many parties representing the medical profession, biomedical researchers, and patients, all opponents of allowing anyone monopoly rights on human DNA. The Myriad Genetics Corporation, however, had many allies from the biotechnology industry, patent lawyers, and various genomic companies—all of whom said the grant of such rights was needed for their business. In American law, opponents of a public policy cannot ordinarily pursue their objections in the federal courts, including in patent suits, unless the policy causes an injury that gives them standing to sue.3The plaintiffs contended that they had suffered harms, offering in evidence how Myriad enforced its BRCA patents—in the clinic and the laboratory—to stop others from using the genes to do research on cancer. On November 2, 2009, over the objections of Myriad and the PTO, Judge Robert W. Sweet, the presiding judge, granted all the plaintiffs standing to sue Myriad, holding that, given the gravity of the issue for health and science, they had every right to call Myriad, the PTO, and gene patents to account.
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