Every cell in the human body contains between 50,000 and 150,000 genes—tiny biological units that determine the development and characteristics of individuals. So complex is every human gene that geneticists often spend years identifying a single gene and determining its function. Many geneticists say that doctors eventually will be able to treat diseases by designing drugs based on knowledge of how genes work, or by injecting altered genes into patients. As a result, the owners of gene patents could reap rich financial benefits. Partly because of that prospect, scientists are involved in a worldwide race to identify and understand the thousands of genes in every human cell. Now, in a controversial development, a U.S. government agency, the Bethesda, Md.-based National Institutes of Health (NIH), has attempted to gain legal and commercial control over the exploitation of many specific genes by seeking patents on them even
before scientists have fully mapped them or determined their functions. And critics say that the competition to exercise ownership over genes could spread, with at least one commercial laboratory moving to patent gene fragments in the near future.
The U.S. Patents and Trademarks Office in Washington began granting patents for genes in 1980, and since then scientists from the United States and other countries have won 5,500 patents related to human and animal genes. The holder of such a patent becomes the owner of genetic information about the chemical composition of the gene and can demand a royalty or negotiate a licensing agreement from anyone who uses the information for commercial purposes. The European Community, Japan and several other countries also issue patents for genetic discoveries, and individual scientists can apply in those countries for patent protection. The flurry of patenting activity arises in part from the Human Genome
Project, a 15-year, $3-biUion research program launched in the United States in 1988. About half a dozen countries, including Canada, have since joined in the project, in which geneticists are attempting to identify and determine the function of all human genes and map their exact location. All of the genes in the human body are known collectively as the human genome.
The NlH’s attempt to patent fragments of genes before their functions are known is a radical departure from customary scientific practice. Until recently, scientists have usually attempted to patent only genes which they have completely identified and whose functions they fully understand. But NIH ignited a dispute among geneticists, lawyers and other experts in the field when it first applied in June, 1991, for patents based on results of a process that identifies only parts of individual genes. The patents office still has not ruled on any of those applications and is not expected to issue a ruling for at least a year.
Defending the NIH’S patents applications, the institute’s director, Bernardine Healy, says that resolving ownership rights to genetic discoveries will stimulate further research. She insists that scientists will be encouraged to share information if they know they have secured the rights to their discoveries by obtaining patents. Said Healy: “We are concerned that the public benefit from these discoveries through rapid development of health care products.”
Despite the controversy that has engulfed
the Human Genome Project in the United States, Canadian scientists have convinced Ottawa to make funds available to participate in the program. In June, Science Minister William Winegard and representatives of two federal agencies announced that Ottawa would provide $22 million during a five-year period for genome research. In June, Ronald Worton, who is geneticist-in-chief at Toronto’s Hospital for Sick Children, was appointed to head a committee that will decide how the money will be used. “If we’re not one of the players today, we won’t be there in 15 years to take advantage of the new discoveries,” Worton said. “Genetically designed drugs will be the thing of the 21st century. We’re trying to protect Canada’s interest well into the future.”
Many experts on genetic research say that the controversy over the NIH patent applications has left a cloud of uncertainty over the biotechnology industry. The controversy began about two years ago when an NIH scientist,
Craig Venter, developed a fast and highly automated method of identifying genes by studying the long and complicated sequences of basic chemicals that make up genes. The chemical sequences are usually expressed in computer printouts consisting of rows of letters or symbols. Venter and his associates claimed to identify new genes by analyzing only between onetenth and one-third of the chemical sequences of genes. They were soon identifying as many as 2,000 gene fragments a month. But the dozens of other scientists around the world working on the Human Genome Project have been relying on slower but more thorough methods of analysing the entire chemical sequences. As a result, in the entire four years of the project, they have only identified about 3,000 genes, because they have been analysing the entire chemical sequences that make up each gene.
Initially, Venter’s work attracted little attention within the scientific community. But the debate commenced in June, 1991, when the NIH filed an application to patent 347 gene sequences that Venter and his associates had identified. Last February, the NIH applied for patents on another 2,375 sequences. Then, in another controversial move, Venter resigned from the NIH, along with 30 associates, on July 13. They went to work as a group for a new, privately-funded venture called the Institute for Genomic Research in Germantown, Md., which, according to some scientists, now plans to apply for patents on the genes it identifies using Venter’s methods.
That institute has received financing from a 10-year, $70-million grant from New Jerseybased HealthCare Investment Corp., a private venture capital company that funds medical research. HealthCare chairman Wallace Steinberg contends that unless American scientists patent their genetic discoveries, they risk being shut out of the fast-growing international biotechnology industry by Japanese and European competitors. Said Steinberg: “I suddenly
said to myself that if this thing doesn’t get done in a substantive way in the United States, that is the end of biotechnology in the United States.” But the emerging race to patent alarms some experts. Said Boston University lawyer and medical ethicist George Annas: “This is not science. This is like the gold rush. That’s why there are no scientists saying this is a wonderful thing.”
Some critics also say that Venter has not demonstrated the commercial usefulness of any of the gene sequences that he has identified—one key test of whether something can be patented. Worton said that trying to identify genes on the basis of partial sequences of unknown origin would be like sifting through automobile blueprints that had been tom into
pieces and trying to patent the results.
The critics also contend that issuing patents for gene fragments could lead to costly and contentious disputes in the future. Declared Richard Godown, president of the Washingtonbased Industrial Biotechnology Association: “Patents are the very lifeblood of the biotechnology industry. They are our most precious commodity.” But, Godown said, scientists working independently could identify different fragments of the same gene and end up with two patents for a single gene. That could eventually lead to conflict between patent holders over who is entitled to royalties. He also noted that if a patent is issued for a fragment of a gene, other scientists will be reluctant to
undertake the difficult task of identifying and describing the entire gene because they might not be entitled to any financial rewards. Added Godown: “If somebody spends a lot of time and money to discover the whole gene and its function, and then discovers they’ve got to deal with somebody who owns a patent to part of it, suddenly the commercial possibilities become clouded.”
As many scientists have discovered, obtaining a patent is a long, slow process. In the summer of 1989, a team of scientists under geneticist Lap-Chee Tsui of Toronto’s Hospital for Sick Children announced that they had discovered the gene that causes cystic fibrosis, a debilitating genetic disease that affects one in 2,000 children. Even before the scientists published their findings, the hospital and a group of scientists from the University of Michigan, who collaborated on the project, filed applications to patent the discovery in Canada, the United States and several European countries. But according to Barbara Lavers, the hospital’s manager of technology licensing, the applications are still under review, and it could be another two years before any decisions are reached. Said Lavers: “The problem is that biotechnology has expanded so rapidly that a backlog has developed. Patent applications can sit for up to two years before they even get looked at.” The delays inevitably mean that the development of treatments will be postponed. Nevertheless, the discovery has allowed doctors to test prospective parents to determine whether they carry the cystic fibrosis gene. And an expectant mother can have her fetus tested to find out whether they have passed on the gene.
Still, most geneticists and biotechnology companies sup| port the underlying idea of pat| enting discoveries involving y complete genes whose functions are known. Norton Zinder, a professor of molecular genetics at Rockefeller University in New York City, said that scientists in hospitals, research institutes and universities can spend several years, and consume enormous amounts of research funding, to identify and describe a single gene. Patents can ensure that individual scientists, or the institutions they represent, are rewarded for their work. Said Zinder: “I’m not against patenting at all. In fact, I’m all for it.” But almost everyone agrees that the NIH patent applications have thrown the whole issue into disarray—and it could be years before it is resolved.
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