Can We Patent Life?

On April 12, 1955, Jonas Salk, who had recently invented the polio vaccine, appeared on the television news show “See It Now” to discuss its impact on American society. Before the vaccine became available, dread of polio was almost as widespread as the disease itself. Hundreds of thousands fell ill, most of them children, many of whom died or were permanently disabled.

The vaccine changed all that, and Edward R. Murrow, the show’s host, asked Salk what seemed to be a reasonable question about such a valuable commodity: “Who owns the patent on this vaccine?” Salk was taken aback. “Well, the people,” he said. “There is no patent. Could you patent the sun?”

The very idea, to Salk, seemed absurd. But that was more than fifty years ago, before the race to mine the human genome turned into the biological Klondike rush of the twenty-first century. Between 1944, when scientists determined that DNA served as the carrier of genetic information, and 1953, when Watson and Crick described it as a double helix, the rate of discovery was rapid. Since then, and particularly after 2003, when work on the genome revealed that we are each built out of roughly twenty-five thousand genes, the promise of genomics has grown exponentially.

The intellectual and commercial bounty from that research has already been enormous, and it increases nearly every day, as we learn ways in which specific genes are associated with diseases—or with mechanisms that can prevent them. It took thousands of scientists and technicians more than a decade to complete the Human Genome Project, and cost well over a billion dollars. The same work can now be carried out in a day or two, in a single laboratory, for a thousand dollars—and the costs continue to plummet. As they do, we edge closer to one of modern science’s central goals: an era of personalized medicine, in which an individual’s treatment for scores of illnesses could be tailored to his specific genetic composition. That, of course, assumes that we own our own genes.

And yet, nearly twenty per cent of the genome—more than four thousand genes—are already covered by at least one U.S. patent. These include genes for Alzheimer’s disease, colon cancer, asthma, and two in particular—BRCA1 and BRCA2—that are highly associated with breast cancer. Myriad Genetics, a company that specializes in molecular diagnostics, holds the rights to those two genes. Anyone conducting an experiment on them without a license can be sued for infringement of patent rights. This means that Myriad can decide what research is carried out on those genes, who can do that research, and how much any resulting therapy or diagnostic test will cost. The same holds true for other genes and for any pharmaceutical company, scientist, or university that holds patents similar to those held by Myriad.

In 2009, the American Civil Liberties Union and the Public Patent Foundation brought a lawsuit, on behalf of more than twenty plaintiffs, against Myriad and the U.S. Patent and Trademark Office, challenging claims on Myriad’s patents and on the right of any company to patent gene sequences. (The company’s responding brief is here, and a collection of documents pertaining to the suit, assembled by the Genomics Law Report, can be found here.) On April 15th, after several years of appeals and reversals, the Supreme Court will hear arguments on the essential issue: Should human genes be patented?

Traditionally, patents have applied solely to inventions, granted as a reward for ingenuity and to encourage innovation. Naturally occurring substances, like DNA, were exempt from such laws. Then, in 1980, Ananda Mohan Chakrabarty, a scientist working for General Electric, filed an application for a patent on a bacterium that he had modified genetically so that it could consume oil. The Patent and Trademark Office rejected Chakrabarty’s application on the ground that the bacterium was a product of nature. Chakrabarty sued, arguing that, by altering the organism, it was his ingenuity that made the bacterium valuable. The case ended up before the Supreme Court, which, by a vote of five to four, ruled in favor of the engineer. “The fact that micro-organisms are alive is without legal significance for the purpose of patent law,” the Court wrote. Chakrabarty’s creation became the first life-form to receive a patent.

Since then, genes considered to have been “isolated from their natural state and purified” have been eligible for patent protection. The first such patents were issued for DNA that had been altered to produce specific proteins, such as the insulin used daily by millions of diabetics. Those patents were rarely controversial. Over the years, however, patents have also been granted to people who have identified genes with mutations that are likely to increase the risk of a disease. Any scientist who wants to conduct research on such a gene—even on a small sequence of its DNA—has to pay license fees. The practical effect has been chilling. According to public-health officials and academic leaders, it has stymied research into many types of disease.

“A patent on a product of Nature would authorize the patent holder to exclude everyone from observing, characterizing or analyzing, by any means whatsoever, the product of Nature,” Eric S. Lander wrote in an amicus brief. Lander is the president and founding director of the Broad Institute of Harvard and M.I.T. He is among the country’s most eminent scientists, and helped run the Human Genome Project. “This barrier is inherently insurmountable: one cannot study a product of Nature if one cannot legally possess it.”

Moreover, when a company patents a gene, it also patents the rights to what that gene (or any fragment of its DNA) might tell us about our health, including our chances of living or dying. A woman who inherits a harmful version of either of the genes that Myriad has under patent, for example, is five times more likely to develop breast cancer than a woman who does not. She is also at significantly greater risk of developing ovarian cancer. Women who want to know whether they possess those harmful mutations have just one way of finding out: by taking a three-thousand-dollar blood test offered by Myriad Genetics. To seek a second opinion on such a critical issue, their only option is to pay to take the test again. This is because Myriad, as is its right under patent law, has prevented laboratories from performing the test or developing alternative versions. It is important to remember what is at stake: breast cancer kills more women in the Western world than any other kind of cancer. Even the best tests are sometimes wrong; second opinions save lives.

“If these patents are enforced, our genomic liberty is lost,” Christopher E. Mason, of Weill Cornell Medical College, said. He and Jeffrey Rosenfeld, an assistant professor of medicine at the University of Medicine & Dentistry of New Jersey, published a study last week in the journal Genome Medicine demonstrating that, when one looks not just at entire genes but at DNA sequences contained within them, nearly the entire human genome is covered by patents. “Just as we enter the era of personalized medicine, we are ironically living in the most restrictive age of genomics. You have to ask, how is it possible that my doctor cannot look at my DNA without being concerned about patent infringement?” The biotechnology industry contends that if the patents aren’t upheld, entrepreneurs and many businesses, particularly pharmaceutical and agricultural companies that rely heavily on genetically-modified products, will have less incentive to innovate.

In arguments before the appeals court, lawyers for Myriad compared the use of the genes that the company has patented with efforts to extract minerals from the ground. Without the man-made process of extraction, the minerals are useless. When Judge William Bryson of the United States Court of Appeals for the Federal Circuit asked Myriad’s attorney Greg Castanias if that meant that simply getting an element out of the ground ought to be considered an invention—he used lithium as an example, but he could have chosen anything from the periodic table of elements—Myriad’s lawyer said yes.

Jonas Salk would not be amused, but if the Supreme Court buys Myriad’s argument, the sun, along with the carbon, hydrogen, and oxygen contained within it, will indeed be up for grabs. And so will every gene in our bodies, as well as all the DNA that scientists have mined, with increasing success, in their efforts to overcome the diseases that plague us all.

Original Article
Source: newyorker.com
Author: Michael Specter