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What the U.S. could learn about patenting life forms--and about civic engagement--by looking to Canada.
Most of the industrialized world is already busily patenting and manufacturing genetically altered organisms. Canadians, much to their credit, want to think things over. A case before Canada's Supreme Court concerning the patenting of lab-produced mice strains has focused national attention on the legal and social implications of genetic technologies. The Canadians are conducting this debate with the kind of verve and attention that Americans generally reserve for hot-button issues like the pledge of allegiance or gay marriage.
The stakes are high. Canada has the world's second-largest biotechnology industry after the United States'; roughly 400 Canadian biotech companies will do a projected $5 billion (Canadian) worth of business this year, according to BioteCanada, a Canadian biotech industry group. Considering that the U.S. Patent Office has wholeheartedly allowed the patenting of animal species and that Europe is slowly moving in the same direction, the pressure for Canada to follow suit is immense. If Canada adopts restrictive gene technology policies or delays a decision too long, multinational companies might well flee. Yet despite that threat, Canada is taking its time to deliberate on the policy ramifications of transgenic technology.Canada's caution is wise because tough policy issues, tightly linked to today's patent case, lie ahead. Human cloning is at the doorstep. A host of new breakthroughs, like those in human stem cell research, promise treatments that raise profound ethical questions. Should we allow human beings to be cloned under any circumstances? Should we allow human germline treatments-manipulating genes in sperm and egg cells-to try to remove genetic diseases? These questions are closely tied to intellectual-property policy because patents help drive research. For instance, should companies that genetically alter the germline of an animal species be allowed to patent that species? That, in fact, was the question that sparked Canada's current debate.
Call it the oncomouse that roared. It all started back in 1982 when geneticists Phil Leder and Timothy Stewart at Harvard University inserted cancer-causing genes, or oncogenes, into a mouse. The resulting "oncomouse" and its offspring were useful because they offered a living model in which researchers could study the onset of cancer and test the efficacy of treatments. In the United States, Leder, Stewart and Harvard handily won a patent on transgenic mammals as a research tool in 1988 (more on that in a moment). In Canada, however, the legal fate of transgenic mice has been considerably more twisted.
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