This growth in subsidies provided the legal justification for researchers to exploit human genes. And when I use the word “exploit,” I’m not using it in an ideological way — I'm simply using the terminology of a patent lawyer. During an interview with a New York Times reporter, Todd Dickinson, the former U.S. Patent and Trademark Office’s commissioner, took exception to the idea that patents allow a “government sponsored monopoly,” a phrase he found imprecise. Instead, Commissioner Dickinson corrected the reporter, saying candidly and without irony, “We like to say ‘right to exploit.’ ”Today, private pharmaceutical companies (many of which are partnered with universities) are engaged in a manic — maniacal, even — race to patent every imaginable human gene, protein, and cell line that might be profitable.
The BRCA-1 and BRCA-2 genes are linked to breast cancer and are owned by Myriad Genetics, whose literature reports, “Women with a BRCA mutation have a 33 to 50 percent risk of developing cancer by age 50 and a 56 to 87 percent risk by age 70.”Myriad has a monopoly right over the use of the gene in diagnostic tests or therapies, which means that every time a woman is tested to find out if she carries those mutated genes, a hefty royalty has to be paid to Myriad. Also, if a researcher discovers a therapy that prevents cancerous mutations in these genes, he or she is obligated under the law to secure a license from Myriad, and the company has used its patent to block research on the gene. This is one of the ways that these kinds of gene patents contribute to the skyrocketing costs of drugs and medical care in the United States and throughout the world.
Helena Chaye, like many I’ve spoken with in the business of drugs and science, feels uncomfortable about these kinds of situations. As the director of Business Development at the biotech corporation MediGene, she secures and sells gene patent licenses for the company. Chaye finds herself in an uneasy position. She has both a Ph.D. in molecular genetics and a degree in law, and is intimately familiar with both areas. “From a private company’s perspective,” she tells me, “you want everything to be protected. You want the ability to block other people, and you want the ability to monopolize a certain sector or a certain product and block others from entering, even though you may not be the one [who’s] actually developing it.” For many commercial entities, it simply makes no business sense to put anything in the public domain.
“I personally don’t believe in that,” Chaye says. “From what I do for a living, it’s a struggle, philosophically, that I’m having to patent everything.” She continues: “If genetic sequencing was publicly available for diagnostics, for example, you wouldn’t have to go through Myriad and pay four thousand dollars for a breast cancer test. If that was available to other parties, then you could have somebody else develop it at a much cheaper rate and be available for everyone.” She pauses. “I mean, the flip side of that is they say, ‘Well, we’re not going to be able to develop something so expensive unless there’s some sort of monopoly that protects us in the future.’ But I think there’s a reasonable level at which certain things should be protected, and certain things should be left to the public domain.”
My favorite patent request was submitted by a British waitress and poet who protested the gobbling up of the genetic commons by filing patent application GB0000180.0. She wanted to patent herself.
“It has taken 30 years of hard labor for me to discover and invent myself,” Donna MacLean drily wrote in the application, “and now I wish to protect my invention from unauthorized exploitation, genetic or otherwise. I am new. I have led a private existence and I have not made the invention of myself public.” MacLean added, “I am not obvious.” The provocateur poet didn’t receive her patent, but she made her point.
While many are still happily riding the moneymaking bandwagon, there are a growing number of scientists, medical researchers, and even companies that believe certain gene patents can inhibit research. The chief scientific officer at Bristol-Myers Squibb, Peter Ringrose — hardly a radical anti-capitalist Luddite — said that there were “more than fifty proteins possibly involved in cancer that the company was not working on because the patent holders either would not allow it or were demanding unreasonable royalties.” Dr. Gareth Evans, a consultant in medical genetics, also believes that the economic value of genetic patents make research more secretive and restrictive, and therefore lessens the chances of scientists finding cures.
The hoarding of these kinds of patents threatens to create a “tragedy of the anti-commons,” as Rebecca Eisenberg, a National Institutes of Hea l th-affiliated law professor at the University of Michigan, calls it. The phrase “tragedy of the commons” was coined by Garrett Hardin in his classic essay of the same name, and its primary argument goes like this: If anyone can use common property — a pasture where farm animals can freely graze, for instance — then it can be overused and trashed. While this can happen to physical resources, a patented gene won’t suffer the same fate, but as Eisenberg points out by inverting the phrase, tragedies do occur from fencing off the genetic commons. Yes, it’s true that patent protection provides the financial incentive for companies to invest in research and development, which, in turn, generates many useful drugs and inventions. Patents aren’t inherently bad, but Eisenberg argues that certain patents can be problematic when the protected materials resemble a discovery, rather than an invention.
This kind of patent ownership creates bureaucratic stumbling blocks and economic disincentives that can dissuade laboratories from dealing with certain genes. This was the case with hemochromatosis, a hereditary condition that can cause liver or heart failure (the gene that carries the disorder is found in one in ten people). In 1999 two companies were fighting over the ownership rights of the patented gene connected to hemochromatosis. This created confusion over who owned the patent and to whom medical laboratories should pay licensing fees, helping to shut down research on DNA tests that screened for the condition. Five labs halted testing for hemochromatosis, and twenty-one others decided not to offer the test at all.[1]
Professor Eisenberg argues that the existence of a genetic commons speeds efficiency in medical research because it eliminates the need to track down and negotiate with numerous patent owners.
This point was highlighted in 1999 when ten of the world’s largest drug companies created an alliance with five of the leading gene laboratories. The alliance invested in a two-year plan to uncover and publish three hundred thousand common genetic variations to prevent upstart biotechnology companies from patenting and locking up important genetic information. The companies (including Bayer AG and Bristol-Myers Squibb) wanted the data released into the public domain to ensure that genetic information could be freely accessed and used for research. Its mission undermined the assertion that a genetic commons inevitably leads to commercial suicide and the end of research incentives.[2]
What’s most troubling about thousands of DNA sequences being owned by a handful of companies is the fact that genes are deeply interrelated. For instance, there is no single gene that causes Alzheimer’s disease, which instead results from a variety of environ-mental factors and interactions with other genes. Scientists have mapped much of the human genome, figuring out that there are roughly one hundred thousand pieces of a genetic jigsaw puzzle. But in order to effectively fight diseases with genetic technologies, researchers have to learn how each privately owned gene connects and reacts with the ones around it. Imagine trying to put together a puzzle if you had to buy a random assortment of jigsaw pieces from dozens of companies. You might get frustrated, even give up. When you have to secure multiple licenses from several companies just to begin research, it is all the more difficult for scientists to efficiently and affordably do their job.
1
Washington Post, To own the human genome, 1998; P. Cohen, New Scientist; T.Wilkie, Independent (London), 1995.