Patent Medicine

By Karen Wright|Wednesday, January 01, 1997
Since the late 1970s the U.S. Patent and Trademark Office has issued more than 1,500 patents on genetic material, including the DNA sequences of many human genes. But that practice came under fire last spring, when gene patenting entered the highly politicized arena of women’s health. In May, biotechnology gadfly Jeremy Rifkin announced that a coalition had been formed to oppose the patenting of a gene implicated in early-onset breast cancer. The coalition’s challenge sparked a public debate some observers say was long overdue.

Rifkin’s move was prompted by the marketing of the first commercial tests for genetic mutations that cause breast cancer. These mutations occur in a tumor-suppressor gene called brca1, which is known to play a role in a hereditary cancer that usually develops before age 50. Whereas most American women have a 10 percent risk of breast cancer, women who carry mutations in the brca1 gene have an 82 percent risk. Mutations in brca1 can also increase a woman’s risk of ovarian cancer from 1 percent to 44 percent.

A team of researchers assembled by Myriad Genetics of Salt Lake City discovered the brca1 gene in 1994 and applied for a patent. In the fall of 1996, Myriad began marketing a test that can identify mutations in brca1 from blood samples. Rifkin’s genetics rights coalition warned in its May press conference that such tests could pose a threat to women’s privacy and jeopardize their ability to get health insurance. The group, which includes the prominent feminists Bella Abzug, Gloria Steinem, and Betty Friedan, as well as members of various women’s health advocacy groups, also questioned whether genetic tests would actually save lives. And the coalition objected to gene patenting in principle, claiming that it stifles research competition, drives up the price of medical products and services, and allows private industry to profit from publicly sponsored research.

We feel that any type of natural product, such as a gene, should be a common resource available to everyone--particularly since the government is funding a lot of this research, says Ted Waugh, a staff attorney for Rifkin’s Foundation for Economic Trends in Washington, D.C.

Other critics object to what they see as a commercial encroachment on the sanctity of life. That encroachment began, they say, when the first microorganism (an oil-degrading bacterium) was patented in 1980 and progressed when the first mammal (a genetically engineered mouse) was patented in 1988. We have been socialized into accepting the patenting of genes as inevitable, when it’s not, says Sheldon Krimsky, an environmental policy professor at Tufts University and a member of the Council for Responsible Genetics.

But proponents of gene patenting--including a number of prominent women’s health groups that did not join Rifkin’s coalition--say that it creates an essential incentive for pharmaceutical research, just as it was designed to do, and just as patents on drugs have always done. The private sector may be getting a break in government funding, but it’s also going to bring products to sick individuals much more quickly than a government operation would, says Harold Edgar, professor of law at Columbia University School of Law in New York City. There are people who invest DNA with this kind of quasi-religious significance. But no one has been able to explain to me why, when the protein that a gene codes for is patentable, the structure of the gene itself should not be. It’s not as if the person who owns the brca1 patent owns a piece of every woman’s breast.

John Doll, director of the examination group for biotechnology at the patent office, points out that genes fall well within the boundaries of patentable subject matter established by Congress and the courts. People like Jeremy Rifkin want to blame the patent office for what we’re doing, but we’re just administering the laws, he says. We don’t have the authority to change them.

Some of the coalition’s concerns may be answered without a revision of patent law. The law already requires the patent application for brca1 to include an allowance enabling university researchers to continue using the breast cancer gene free of charge. And last summer President Clinton signed a bill that prohibits insurance companies from treating a genetic susceptibility as a pre-existing condition for which coverage can be denied. Such legislation acknowledges that genetics-rights issues will soon affect broader medical constituencies. Myriad Genetics, for example, has already received a patent on a gene involved in high blood pressure, and it is working on DNA tests for prostate and colon cancers as well as asthma, obesity, and osteoporosis.
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