From: [EMAIL PROTECTED] Date sent: Sat, 20 May 2000 20:09:20 EDT Subject: WHO OWNS HUMAN GENOME? GENESIS? To: [EMAIL PROTECTED] http://www.discoveryhealth.com/DH/ihtIH/EMDSC000/20729/24239/27825 1.ht ml?d=dmt Content WHO OWNS HUMAN GENOME? GENESIS? A new gold rush is on. But this time financiers are pouring fabulous sums into prospecting for something far more valuable than gold. It is the hunt for the genes that make humans function. Although scientists predict the discoveries will fuel rapid advances in medical care, many are concerned that the predicted miracle therapies may be delayed and prove too pricey for many patients to afford. Their fears focus on the U.S. Patent and Trademark Office, which has amassed a backlog of more than 10,000 applications for patents on genetic discoveries, with more flooding in every day. Many leading genetic scientists fear that if the office approves most of these applications, the resulting swamp of overlapping patents could bog down genetic testing and stagnate the development of new drugs. In part, the concern stems from powerful new technologies that are making many of the discoveries possible. Until recently, identification and location of a human gene was a laborious search that started with a protein and worked backward to the gene that produces it. Usually, scientists understood an important function of the gene before they found it. But today, the sequence has been reversed. Robotic laboratories are shredding and sequencing DNA on an industrial scale and spitting out the code for almost countless pieces of genes. With powerful computers combing through public databases, scientists can find similar snippets of genome to which scientists have traced a function. These so-called homology searches may be enough to satisfy the patent examiners that a newly "discovered" piece-of-a-gene is useful enough to get a patent, according to John Doll, who heads the office's biotechnology section. That could produce "a cross-licensing nightmare," complains Michael Watson, former co-chairman of the genetic testing group advising the National Institutes of Health and Department of Energy, in which many parties wind up with rights to parts of the same gene. Dr. Francis Collins, director of the National Institutes of Health's National Human Genome Research Institute, shares that fear. When researchers want to study a broad cross-section of genes, Collins theorizes, "they're going to have a very hard time doing it without infringing on several people's patents." "You'll have the whole genome sort of Balkanized with all these pieces that have fences around them," Collins says. The result, he fears, is that much important research will not be performed. What's more, Collins argues that proposed new gene patenting rules will allow people to get a patent based on educated guesses that a section of DNA does what similar pieces do — guesses that in many cases will prove wrong or insignificant compared to the gene's other functions. And others worry that patents will drive up the cost of genetic testing while chilling the improvement of test methods — or that they already have. Myriad Genetics Inc. of Salt Lake City, for instance, warned the University of Pennsylvania's genetics laboratory to stop conducting broad tests for two genes that have been linked to elevated breast cancer risk. Penn said it was performing the tests for half the price that Myriad Genetics charges for its test for the genes. Dr. Debra G. B. Leonard, director of Penn's Molecular Pathology Laboratory and president of the Association for Molecular Biology, compares Myriad's move to a company monopolizing appendectomies and charging $10,000 for them. Some people won't be able to afford the procedure, she says, and the monopoly prevents others from improving the test. Myriad argues that it was the first to find the breast cancer genes and patent the test for them. "We don't want people to use that to go into business and compete with us," says the firm's spokesman, Bill Hockett. Hockett contends Myriad's test is more accurate than Penn's, that it can be obtained by doctors across the United States, and that the company has a program to lower the cost to patients who cannot afford the full price. But Leonard's view is widely shared in the medical community. "We feel strongly that the whole fruits of the genome project will be unavailable" if most of the backlogged applications lead to patents, says (Dr.) Rod Howell, president of the American College of Medical Genetics. "It's absolutely essential that we have testing that is accessible and affordable." An ethical swamp, too Some people voice moral objections to patenting human genes. Dr. Robert Nussbaum, a molecular geneticist at NIH, calls patenting human DNA "abhorrent." And doing it by searching public databases for similar pieces of DNA is "intellectually dishonest," Nussbaum says. Since most public data have been amassed by government-funded research, Nussbaum complains that the "discoverers" of many new genes stand on the backs of taxpayer-financed scientists. With such talk rising, Dr. Myron Genel, professor of pediatrics and associate dean of Yale University School of Medicine, predicts that Congress may pass a law to restrict gene patents. "There is going to be extreme legislative pressure to do something," Genel says, "and it could do more harm than good." In March 2000, President Clinton and British Prime Minister Tony Blair called on private gene-research companies to make their raw data "freely available to scientists everywhere." "Unencumbered access to this information will promote discoveries that will reduce the burden of disease, improve health around the world, and enhance the quality of life for all humankind," they declared. Their words sent tremors through biotech stocks but appeared to have little impact on the companies. Though Celera promised to release its sequences to researchers, it and other private companies delayed such releases while they sought patents on potentially valuable discoveries. And even Clinton and Blair affirmed the companies' right to pursue patents. The biotechnology industry says it needs patents to attract the capital to develop new tests, drugs and therapies. To date, money has not been a problem. Investment capital has been flooding into genetic research. Over two months in early 2000, two relatively young genetic research companies, Incyte Pharmaceuticals, Inc. and Celera Genomics, raised $1.4 billion between them. Randall Scott, president and chief scientific officer of Incyte, argues that self-interest will drive most patent holders to broadly license their discoveries to researchers who might find new, commercially valuable uses. "How many times do you see somebody say you can't do research on this molecule?" he asks. "I think it will be a small number of cases." But Collins is concerned: "Nobody really knows just how complicated things could get." * Take the Genome Quiz * The Human Genome Project Main Page * Genome Explained * The Genome Race * Medical Marvels * Who Owns Human Genes? * The Discriminating Gene * NIH - The Human Genome Project * Year of the Genome * Gene Hunters * Double Helix Explained - Audio * Animated Genomics Education With Audio ________________________________ Go to The Discriminating Gene >> ------- End of forwarded message ------- <A HREF="http://www.ctrl.org/">www.ctrl.org</A> DECLARATION & DISCLAIMER ========== CTRL is a discussion & informational exchange list. 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