Of Oncomice and Men

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.

First, in 1985, Canada’s patent office refused to grant a patent for the oncomouse, saying it had no specific authority to grant ownership rights over a species of mammal. In 1998, a Canadian federal court sided with the patent office, but two years later, Harvard scored a victory in Canada’s appellate court. The new decision offered the opposite argument: that the oncomouse patent must be granted because nothing in Canada’s 1869 Patent Act specifically prohibits it. The Canadian patent office appealed to the Supreme Court of Canada. Insiders say a verdict could come as early as this fall.

In the meantime, the public has been engaged. The nation’s environmental and biotech-industry groups were invited to submit their opinions and eagerly did so. Lawmakers proposed a sweeping package of legislation on everything from patenting higher species to human cloning and surrogate motherhood. (For more, see the Web site of Canada’s ministry of health-www.hc-sc.gc.ca-and search for “reproductive and genetic technology.”) When TR went to press no legislation had yet passed. But ultimately, the whirl of public interest surrounding the case will surely result in new policies that reflect citizens’ concerns. Which is, I believe, as it should be.

Compare that story to the situation in the United States. In 1988, when the oncomouse received its first U.S. patent, the U.S. Supreme Court had long since flung open the door to such a claim. In a 1980 case called Diamond v. Chakrabarty, the high court validated (in a five-four decision) a patent on genetically engineered bacteria designed to fight oil slicks by breaking down crude oil. A 1987 case known as Ex Parte Allen extended the principle to include nonhuman multicellular organisms. It was just a matter of time before the Court would sanction the idea that a species of mouse with a slight genetic alteration could be considered a patentable invention.

That U.S. policy on something with such far-reaching implications is best explained by a recitation of obscure legal precedents makes a larger point: Americans are too content to leave vital policy matters to the courts. In the case of patenting, this is not just a mistake that will return to haunt us but an abdication of our civic duty as citizens in a democracy. Justice William Brennan of the U.S. Supreme Court had it right in his 1980 dissent on the original bacteria case when he wrote that lawmakers, not judges, are the ones who should broaden or narrow the reach of patent laws, especially when the subject of a patent “uniquely implicates matters of public concern.” Before disputes over transgenic human patenting reach the U.S. courts, maybe we’ll learn something from the engaged debate of our northern neighbors.