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Biotechnology researchers denounce Supreme Court decision

The Supreme Court decision that a genetically modified mouse cannot be patented in Canada may have severe consequences for biotechnology researchers in this country, say U of T experts. In a 5-4 ruling Dec. 5, the court determined that the so-called Harvard Mouse could not be patented as an invention according to current Canadian law. The mouse, developed at Harvard University during the 1980s to have a genetic predisposition to cancer, is already patented in several other countries. The majority decision, written by Justice Michel Bastarache, said that the current Patent Act provides no guidance for the patenting of “higher life forms.”From the University of Toronto:Biotechnology researchers denounce Supreme Court decision
Industry may not be interested in university’s basic research, says biomedical engineer
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Dec. 6, 2002 — The Supreme Court decision that a genetically modified mouse cannot be patented in Canada may have severe consequences for biotechnology researchers in this country, say U of T experts.

In a 5-4 ruling Dec. 5, the court determined that the so-called Harvard Mouse could not be patented as an invention according to current Canadian law. The mouse, developed at Harvard University during the 1980s to have a genetic predisposition to cancer, is already patented in several other countries. The majority decision, written by Justice Michel Bastarache, said that the current Patent Act provides no guidance for the patenting of “higher life forms.”

Proponents of the biotechnology industry immediately denounced the decision, arguing that it would drive companies out of Canada to countries where such research would qualify as intellectual property. That impact will echo in the halls of academia, said Professor William Stanford of U of T’s Institute of Biomaterials and Biomedical Engineering.

Researchers, themselves, hold a patent but biotech companies that fund the research hold the licence to the patent, Stanford explains. If a mouse or other higher life form is not under patent, then biotech companies cannot charge other researchers licensing fees for its use. “Companies want to be able to license a patent from us and if we can’t patent it, then they have no protection. I’m certainly worried that a company may not want to sponsor some of our more basic research.”

Although Toronto is becoming known for using mice as models for human disease, he said it may become more difficult to develop biotech spin-off companies here. “One of the strengths of the University of Toronto and the Toronto community is mouse genetics and the development of animal models. I think it’s a real blow against those who are trying to turn Toronto and southern Ontario into a biotech hub.”

George Adams, president of the Innovations Foundation at U of T, said the decision is bad news for biotech researchers and companies in Canada. If investigators can’t patent such an invention in Canada, said Adams, industry partners can’t expect any return on their investment. Instead, they may choose to support research where they can expect to generate revenue.

He added that foreign laboratories may refuse to provide animals to Canadian researchers, since their patent protection does not extend to Canada. “We’re out of step with the rest of the research community in other countries. The Canadian research community is going to have trouble getting their hands on higher life forms,” Adams said.

But other U of T researchers support the Supreme Court ruling. Professor Corrine Lobe of the Department of Medical Biophysics said that while researchers may be frustrated or hindered by this decision, it avoids other problems.

“I don’t think the mice should be patented,” said Lobe. The restrictions imposed by DuPont, the company that holds the Harvard Mouse patent in the U.S., have interfered with academic research, she noted. “I think that it was an insightful decision.”

Adams said that the effect of the Supreme Court ruling will take time to assess. “We’ll have to see how it rolls out in terms of how much impact it will have on the brain drain and how much impact it will have on business creation.”



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