All these actions, from taking out the patents to keeping data private, are currently legal in the United States. To understand why, back up to 1980. Under American law, it has long been impossible to patent a “product of nature”—a duck, a lemon, a finger. Patents can be issued only on inventions. Then, in 1980, the Supreme Court held that patents could be granted on “anything under the sun that is made by man.” The U.S. Patent and Trademark Office interpreted that decision to mean that once a gene, or any other part of a living organism, was removed from the body and isolated or altered, it could be patented by, and considered the property of, the company that had done the work. The patent office itself determines, on a case-by-case basis as it reviews applications, what exactly constitutes altering a product of nature. Today, of the estimated 25,000 genes in the human body, 20 percent have been patented, including genes associated with Alzhei-mer’s, colon cancer and asthma.
Of the genes now patented, the one for breast cancer is among the most lucrative. For the fiscal year that ended in June 2011, Myriad’s BRCA test accounted for $345 million, or 86.4 percent, of the company’s total revenue. But these profits did not come without a significant initial investment—which is the strongest argument in favor of the practice of patenting. It boils down to economics: Scientists need money to do their work, and without the commercial rewards from gene patenting, say patent holders, research and development will grind to a halt. “Myriad spent over $500 million between 1995 and 2005,” says Myriad chief counsel Richard Marsh. “It took us 10 years to recoup our investment. Nobody will make that investment without the promise of patents.” In addition, he points out, the company’s patents will start to expire in 2014, 20 years after they were first granted. “Patents are only for a limited time,” he says, “and people need to remember that.”
When asked about Myriad’s decision to stop contributing to the NIH database, Marsh said, “Part of our concern was that people were starting to rely on the data in the database to make clinical decisions, and we were concerned about the rigor and quality of information going into the database. We still want anybody who wants to do research with the BRCA gene to do whatever they want. We encourage people to research and publish, and we have never resisted that.” A spokesperson for the company says that Myriad does not charge a fee to use the gene for research and that it has never denied or impeded any research on the genes.
But in Andrews’s view, Myriad’s profits have come at women’s expense. For the past decade, she has argued that the restrictions imposed by patent holders cause financial hardship and health risks for millions of women. Big biotech concerns are “putting patents before people,” she says, contending that besides forcing sick people in need of tests to pay fees to patent holders, patents restrict researchers from devising better tests and treatments. She argues that under current law, merely “thinking” about patented genes in terms of further research is illegal because the patent holder controls all uses of his or her invention. “This ability to control all uses makes sense for a machine,” Andrews says, “but not for the information code of the human body.” She unpacks example after example in the even, measured tone of someone expert at provoking disagreement without raising blood pressure. The company that has the patents on the hepatitis C genome, she says, has prevented other companies from offering inexpensive tests for the deadly disease, and gene patents have also resulted in people’s deaths, when patent holders have withheld use of their genes for diagnostic testing in anything other than the patented use. She insists that a gene is a product of nature even in its isolated form and shouldn’t be subject to patent. “If isolating a bodily product were enough to make it patentable,” she says, “the first doctor to remove a kidney would have been able to get a patent covering all kidneys and get a royalty each time any other doctor removed one.”