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At a conference in Ottawa tomorrow, a group of business people and investors will listen to a lawyer describe how to apply for a patent on a gene, if their companies discover one. It's not a get-rich-quick scheme, since it can take several years before a genetic discovery results in marketable gene-based tests or therapies. But it could be a highly profitable enterprise for those who play their cards well.

A company in Salt Lake City, Utah, is paving the way. The company, Myriad Genetics, holds patents on the breast-cancer genes BRCA1 and BRCA2. According to Myriad, any woman who needs to be tested for those genes -- because multiple members of her family have been diagnosed with breast or ovarian cancer, for example -- must have her test sample sent to the company's worldwide testing facility in Salt Lake.

Last year, Myriad told Ontario's Ministry of Health to stop testing for breast-cancer genes at the provincial Regional Genetics Centres. The province says it won't abide by Myriad's request because the costs are prohibitive. Myriad wants $3,850 for the tests. Right now, provincial centres are charging $800. Experts in patent law predict that eventually Myriad could sue Ontario to try and enforce its patent.

Now, another U.S.-based company, Bio-Rad Laboratories, is following Myriad's lead. Bio-Rad owns patents on the genes for hereditary haemochromatosis, a disorder in which the liver and heart become overloaded with iron. According to an article in Nature earlier this month, any laboratory that wants to test for the disorder has to pay Bio-Rad an amount that may run to hundreds of thousands of dollars (U.S.). As a result, numerous labs in the U.S. have stopped offering the genetic test for haemochromatosis. And once again, genetic-testing facilities across Canada have to decide whether to discontinue the test, or risk being sued.

Most genetic disorders are rare. Yet as more and more diseases are found to have a genetic basis, the patent problem may affect an increasing segment of the population. Here's how it works. Let's say someone in a family is diagnosed with hereditary haemochromatosis. It's the most common inherited disease in adults, and the symptoms usually don't show up until a person is between 40 and 60 years old. The earlier a person is treated for it, the better, in terms of preventing its long-term effects, which can include liver disease, heart disease and diabetes.

So doctors may suggest a genetic consultation for all close relatives of the person who's been diagnosed. The genetic counsellor will try to advise the person's relatives about the possibility that they may be at risk for haemochromatosis. And the counsellor may recommend that family members be tested for the haemochromatosis gene, also called the HFE gene.

Medical geneticists (doctors in a genetic laboratory) or genetic counsellors will then explain the test and why it's being recommended. They'll describe how the results of the test might affect an individual's medical treatment. Then the next step will be a personal decision by each family member about whether or not to have the test. Those who choose to have it will . . .

And that's where the problems begin. If the provinces where these family members live don't want to ante up the cash that Bio-Rad demands, and Bio-Rad fights in court over patent infringement, then each individual family member may not be able to take the test so simply. They may have to first come up with a significant payment. In addition, they may have to travel to another province or the U.S. to have the test done at a specialized genetic-testing laboratory that's agreed to pay the royalties the company wants.

Those who wind up in that situation should spend a lot of time talking to a medical geneticist to determine how crucial the specific genetic test is for their health. But it's not right that patients and families could be in that situation.

Canadian authorities, including Ron Carter, a McMaster University geneticist who is president of the Canadian College on Medical Genetics, have argued that companies shouldn't be able to enforce gene patents in the way they're trying to. Jon Merz, a bioethicist at the University of Pennsylvania, agrees. He says it would be worth it for a province or a country to take on Myriad or Bio-Rad, even if it involves a lengthy court battle. Merz thinks there's a good chance the companies would lose.

Stay tuned. In France, the Curie Institute and the Gustave Roussy Institute are offering the test for breast-cancer genes to French women. And no, the institutes aren't sending their test samples to Utah. It looks as if there's going to be a court battle very soon. Miriam Shuchman, MD, teaches medical ethics at the State University of New York at Buffalo and the University of Toronto. She is also board certified in psychiatry.