With the announcement last month that a biotechnology company has sequenced more than 90% of the human genome, the race to license and patent human genes continues to heat upas does the controversy. The most important and lucrative hoard of intellectual property ever is up for grabs. But geneticists, physicians, and medical ethicists are joining the chorus of protest against those doing the grabbing and the way they are doing it.
Religious organizations, along with biotechnology critics such as Jeremy Rifkin of Washington, D.C.s Foundation on Economic Trends, formed the vanguard of opposition to gene patenting. In 1995, a coalition of more than 80 religious groups held a press conference denouncing all patents involving human genes, including patents on transgenic animals.
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Some bioethicists address these objections by arguing that buying and selling of intellectual property should not be equated with ownership of an individuals genes, and that the buying and selling of blood, and even sperm and eggs with their genetic material, are accepted. More importantly, they argue, patenting may be expected to have positive social consequences in the form of medical advances that are likely to outweigh the negatives.
"A human gene patent would be analogous to a patent for making or manipulating other kinds of human body parts, such as hair, bones, or hearts," according to David Resnik, Ph.D., a bioethicist at East Carolina University in Greenville, N.C. Resnik wrote in the Kennedy Institute Ethics Journal in 1997, "If the patenting of technologies for transplanting, growing, analyzing, or modifying bone marrow is morally acceptable, then [so is] the patenting of human genetic technologies." But legal boundaries should be established to fence off the slippery slope, he added, such as bans on selling materials capable of creating a person, whether human embryos or whole genomes.
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Many scientists who accept gene patenting in principle nevertheless object to the way it is practiced. The Human Genome Organization publicized its concerns in 1995, stating "HUGO is worried that the patenting of partial and uncharacterized cDNA sequences will reward those who make routine discoveries but penalize those who determine biological function or application. Such an outcome would impede the development of diagnostics and therapeutics, which is clearly not in the public interest." And at a White House symposium on genomics last October, Eric Lander, Ph.D., director of the Whitehead Institute Center for Genome Research at the Massachusetts Institute of Technology in Cambridge, said the U.S. Patent and Trademark Office was "creating a thicket of patents" through its lax standards for gene patenting.
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Resnik said in an interview that "what the patent office and all of us are struggling to figure out is what kind of patenting is going to promote science and what kind of patenting is not." Patents that impede research progress clearly should not be allowed, he said. The PTO recently took the step of tightening its requirements for patenting DNA markers called expressed sequence tags, or ESTs, that often have no known utility (see News, Jan. 19, 2000).
Companies holding gene patents are able to "tie up the ability to do continued exploratory research and development," even extending as far as control over any future drug development, said Jon Merz, Ph.D., J.D., a bioethicist at the University of Pennsylvania. For example, Myriad Genetics of Salt Lake City holds numerous patents on the BRCA1 and BRCA2 breast and ovarian cancer genes, and a deal between Myriad and Eli Lilly and Co. of Indianapolis gives Lilly exclusive rights to market treatments based on the BRCA1 sequence. Instead of granting all-encompassing rights to the first group to clone the gene, "it would make more sense to impose patent protection as we get closer to end products," Merz said.
In the past year, a groundswell of opposition to gene patenting has emerged from within the medical community. Critics generally concede that patents covering drugs developed from genetic information are necessary to protect companies investments. Their complaints are focused mainly on the use of genes in diagnostic testing; specifically, they charge that patents stifle research and compromise patient care by granting control of gene tests to single entities that can charge whatever the market will bear.
Paying Royalties
In August, the American College of Medical Genetics issued a position statement that genes and gene mutations should not be patented, but if patents on genes with clinical implications are issued, they must be very broadly licensed at nominal cost.
"The decision of the Patent and Trademark Office to permit the patenting of naturally occurring genes and disease-causing mutations has produced numerous difficulties" in medical practice and research, ACMG stated.
It was the patenting of the gene for Canavan syndrome, a rare and fatal neurological disease occurring among Ashkenazi Jews, that spurred the hottest opposition to gene patenting in the clinical genetics community. Prospective parents of Jewish heritage are routinely and inexpensively tested for various mutations, such as those causing Tay-Sachs and Niemann-Pick diseases, that are frequently found in that population. But Miami Childrens Hospital, which holds the Canavan gene patent, requires labs to pay a $12.50 royalty for each test they do. Although that may not sound like much, critics point out that costs mount quickly as the number of available tests increases, and insurers impose limits on reimbursement.
"Nobody should have sole possession of these" genetic tests, said Kurt Hirschhorn, M.D., a geneticist at Mount Sinai School of Medicine in New York, who until recently chaired ACMGs ethics committee. "The moment theyve got a monopoly on it, the royalties jump. . . . Its become scientifically and ethically counterproductive." Ideally, the tests should be freely available, like blood cell counts or cholesterol screens, he said, but if not, patent holders should at least charge less exorbitant royalties.
Myriad Genetics charges $2,400 to $3,500 to sequence a womans DNA in search of BRCA mutations, which number in the hundreds, and most insurers cover BRCA testing for women at high risk for breast cancer. Myriad did not attempt to enforce its patents against researchers until recently, said James Hanson, M.D., acting chief of the National Cancer Institutes Clinical and Genetic Epidemiology Research Branch. But now that the company is cracking down, costs can be prohibitive for researchers who need to test hundreds of people. Myriads patents also raised thorny questions in the research community about intellectual property, patient privacy, and related issues. Last year, Merz noted, Barbara Weber, M.D., who heads the NCI-sponsored Cancer Genetics Network center at the University of Pennsylvania, resigned from Myriads scientific advisory board after the company prohibited one of her colleagues from performing BRCA tests in her research. To address these and other needs of the research community, NCI recently signed an agreement with Myriad that gives National Institutes of Health-funded investigators access to the tests at less than half the commercial cost and spells out conditions about ownership of data, Hanson said.
"Some people will feel that this is still not satisfactory public policy," Weber acknowledged, "but it was the best we could do at this time," given Myriads intellectual property rights to the gene. Researchers at the National Institute of Environmental Health Sciences shared in the discovery of BRCA1, and NIH funded the University of Utah researchers involved, but NIH long ago exclusively licensed its share of the rights to the university, which in turn assigned its rights to Myriad.
Michael S. Watson, Ph.D., director of the cytogenetics laboratory at Washington University in St. Louis, chairs the ACMGs patent subcommittee. He said U.S. law prohibits the enforcement of patents against health care providers performing medical procedures such as surgery, but the biotech industry successfully lobbied for an exemption of its products. Watson believes this exemption is misguided and harmful, because tests using standard technology like DNA sequencing are common procedures performed by medical geneticists, comparable to the surgeons use of the knife or laser.
New inventions like microarrays that permit automated testing for many mutations at once, by contrast, are truly useful innovations that may be deserving of patent protection, he said. But the prospects for developing these tests are clouded by the potential difficulties imposed when a number of companies hold patents for different mutations in the same gene.
For some, opposition to gene test patents is further grounded in the principle that medical scientists are patenting and profiting from tests that were made possible only with the cooperation of patients and their families.
"As physicians and as researchers, they have an obligation to these human subjects," Merz said. Families of Canavan patients are outraged, he said, because "when they enrolled their very sick and dying children in these studies, they had no idea the hospital was going to go off and patent its discovery. They thought it would be something like a Tay-Sachs test that would be freely available to everybody at risk for the disease."
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