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It may sound bizarre, but it's true: A company can actually "own" human genes. That's the brave new world of gene patents, where big biotech firms are claiming rights to our genetic blueprints and guarding them with teams of lawyers. And the result, say scientists like Grody, is stalling vital medical research, perhaps even delaying lifesaving cures.
"I don't think most people realize what's occurring," says Lori Andrews, a law professor at the Illinois Institute of Technology who specializes in the subject. "People find that the genes within their bodies have been patented without their knowledge and consent."
About one-fifth of the recently decoded human genome, which contains about 24,000 genes, has already been patented. Those patents include ownership of genes related to breast cancer, diabetes, Alzheimer's disease and epilepsy. Under U.S. law, the holders of these patents -- often biotechnology companies -- enjoy total control over those genes for 20 years. That means they can stop other people from doing any research whatsoever involving the genes. Or they can charge hefty fees to anyone who wants to work with the genes -- costs that already are stifling science.
Why, exactly, are companies even allowed to hold these patents? After all, human genes are part of nature, like sunlight or zebra stripes. "It's as if you patented a star that you discovered, then charged people to look at it," says Andrews. Here's the loophole: In order to work on individual genes, scientists process DNA to isolate them. The U.S. Patent and Trademark Office says this means the isolated gene is no longer in its natural state, and thus can be patented.
But Dr. Debra Leonard, vice chair of laboratory medicine at Cornell's Weill Medical College, contends that's "really a technicality." We're still talking about the basic genetic information. And given the effect patents could have on scientific progress, says Dr. Leonard, "it's just not in the best interests of public health to have this system continue."
There's no denying that patents are a vital part of our free-enterprise system, and biotech companies say the financial rewards of gene patents are driving important research. These companies "don't have products yet -- they have incredibly novel technologies that they've patented," says Lila Feisee of the Biotechnology Industry Organization. "If you want to get rid of patents on genes, you have to think about what that would mean for companies that are innovative and risk-taking, and have no other way [to raise money]."
But there's a larger obligation here. It's one thing to patent drugs you've manufactured; other drugmakers can still market slightly different versions of them. Human genes, however, are gateways that everyone must pass through to conduct certain medical research. Block these entrances, and you may prevent exciting breakthroughs.
A 2002 Nature magazine article looked at the effects of patents on laboratories capable of testing for specific gene mutations that can cause hemochromatosis, a potentially fatal iron-overload disorder. According to the article, after the patent-holder began asking for up-front fees of as much as $250,000 -- plus royalties up to $20 per test -- nearly one-third of the laboratories reported that they avoided tests on the gene.
Then there's the case of BRCA1, a gene linked to breast cancer. Among white women in the United States, 5-10 percent of the breast cancer cases stem from flaws in this gene, and another related to it. A Salt Lake City-based company called Myriad Genetics holds patent number 5,693,473, giving it control over a test that detects flaws in BRCA1. That enables Myriad to charge up to $3,000 to screen for the genetic flaws most associated with breast cancer -- a test that, according to an article in The Journal of the American Medical Association, is faulty up to 12 percent of the time among patients with a significant amount of cancer in their family histories.
Myriad says that relatively few patients fall into this category, and that its patent has brought "tremendous benefit" to those tested. Critics argue that the patent stifles competition, which might lead to a better and less expensive test.
It's no wonder some people want to cancel all gene patents. But that could cause economic chaos. A wiser reform might be to allow patents on the gene tests that companies devise, but not on "God's handwriting": the underlying genetic information. This would still enable companies to profit from their research and inventiveness.
There's also precedent for government to step in to protect the public welfare. In 1996, Congress decided that doctors would not have to pay licensing fees to new patent holders for performing surgical procedures. You can help get Congress to tackle gene patents, too, by contacting your representatives in Washington.
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