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GiveLife.ca

    

PRINT EDITION
Harvard mice on thin ice
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Our Supreme Court set us apart from other biotech nations
by refusing to allow a patent on the Harvard mouse.
This may not be a bad thing -- if we understand
the implications, says MAUREEN McTEER


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By MAUREEN MCTEER 
  
  
Email this article Print this article
Monday, December 9, 2002 – Page A13

Just after scientists published a genetic map of the common mouse, Canada's Supreme Court narrowly refused to allow a patent on its genetically engineered, Harvard-bred cousin. Why all the fuss about this little fellow?

The Harvard mouse, or oncomouse, is no ordinary rodent. Its genetic makeup has been changed by the insertion of a cancer-causing gene into its embryo so it can be made-to-measure for cancer research. That spells big bucks for Harvard University, the patent holder, which can charge a royalty fee.

Some consider patents on higher life forms immoral. Or they fear the presence of a patent will hinder research. Some fear that the costs of acquiring patents could increase the cost of future drugs and therapies.

Others see patents as the key to private investment in costly but promising research. Most of the other countries with patent regimes like Canada's have approved a patent for this mouse. Now Canada is on its own.

How did this happen? While the majority of Supreme Court judges would allow a patent on the process that created the oncomouse, they refused a patent on the mouse itself. They argued that Canada's Patent Act does not allow for patents on higher life forms. Effectively, they drew a line between bacteria, fungus and moulds and higher life forms such as animals. A minority of judges found no such limitation in the language of the act, and held that both the mouse, and the process to create it, were patentable. Unlike the European Patent Convention (EPC) of 1973, which denies a patent to inventions whose "publication or exploitation would be contrary to ordre public or morality," Canada's patent law contains no such limitation.

Critics of the Canadian decision fear that it will have a negative impact on investment in biotechnology. A world leader in biotechnology, Canada earns millions of dollars from the industry, which provides top jobs for our brightest minds. Biotechnology needs private investment, and investors demand consistency with those countries (especially those in the World Trade Organization) with which we compete.

One reason why this case is so important is because it denies the innovative step that transformed the ordinary mouse into an oncomouse. Will other microbiological discoveries be unpatentable in Canada? Much is at stake -- and investment issues are just one part of the public-policy equation. The case also raises issues of human and animal rights; private investment and profit; scientific freedom; and the public good. All must be addressed.

The majority of the judges were concerned about the future patentability of human life. In our common law, people cannot own other people; but what about human genes, cell lines or genetically altered human embryos? We have diminished the status of IVF-created human embryos to nothing more than human tissue, which lets us more easily appropriate and use them for research. Without amending the Patent Act, human embryos would not be protected if higher life forms could be patented. Patents are already awarded in Canada on human genes and cell lines.

The court has tossed this political hot potato to the federal government, urging it to draft clear and unequivocal legislation. Let's hope it starts by asking if patents are the appropriate legal tool to handle the special investment and other needs of biotechnology. When a similar problem arose with plants, the federal government tailored a special response with the Plant Breeders Act in 1990; perhaps it should consider some similar law for all living organisms.

Some argue that patents can actually hinder the discovery of new drugs and therapies. In a public lecture in the United Kingdom last week, Dr. Michael Morgan -- former executive director of research, partnerships and ventures with Britain's charitable Wellcome Trust -- observed that research and competition were enhanced when the results of the Human Genome Project were immediately made public over the Internet: It meant that companies and researchers could just download the data, and apply it to their research into the causes and cures of disease.

By contrast, patent applications are notoriously costly and time-consuming. This is an important consideration for Canada, because so many of our indigenous biotech companies are small, and need access to information to prosper. For them, patents can be as much a burden as a blessing.

Because we need openness in scientific research, we should question claims for far-reaching patents on human genes. The threat of a lawsuit by Myriad Inc., which claims a far-reaching patent in breast and ovarian cancer genes BRCA1 and BRCA2, seriously challenges Canada's public health-insurance schemes, and affects the testing of Canadian women at risk of cancer.

Future discoveries by Canadian scientists working with these genes would belong to the company holding their patent claim. How do such patents help Canadians or develop cures? The Harvard mouse case has raised a big question: How can we reward genuine scientific discovery and still protect the public's broader rights, the "commons"?

The Supreme Court decision has put Canada, a world leader in biotechnology, out of step with our major competitors. We must look at all the options and develop solutions to these complex challenges. Mr. Prime Minister, when can we expect action?
Maureen McTeer is a visiting research fellow in the department of law at the University of Sheffield, England, and is at the Sheffield Institute of Biotechnological Law and Ethics.


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