Ownership of genes at stake in potential lawsuit

The genetic test that Teacher Nancy Kumer had two years ago may have saved her life.

Ms. Kumer says the test likely prevented her from developing breast cancer, which would have been "a horror." But an international battle is brewing over who owns the genes used in that test. It's a fight that will determine the expense and availability of such tests, which in turn could affect thousands of lives.

The province of Ontario is effectively daring the Utah-based Myriad Genetics to take it to court over the firm's claim to the exclusive use of the genes. In Europe, several dozen hospitals, researchers, and others are already legally contesting Myriad's patent claim. Such cases could determine who - if anyone - owns the right to what have been called the building blocks of human life.

"This is really a landmark case," said Abdallah Daar, an ethicist at the University of Toronto, who anticipates a Canadian court challenge. "And I would hope that it will not be resolved on a technicality, but that it will go to a higher court that will probe the principles behind it and the societal implications of owning broad patents."

Based in Salt Lake City, Myriad Genetics has patented mutated parts, or sequences, of the BRCA1 and BRCA2 genes, and a test to detect those genes, which indicate an elevated risk of developing breast and ovarian cancer. In a news release, Myriad's president, Gregory Critchfield, called the test "a powerful tool in the fight against cancer."

While presence of the mutations does not inevitably lead to cancer, studies in last year's New England Journal of Medicine showed that women past childbearing who tested positive and then had their ovaries removed cut their risk of ovarian cancer "completely," and reduced their chances of breast cancer by 53 percent.

Myriad moved to protect its patents by warning Canadian provinces that they should cease and desist from using any other test that employs the same genetic material, and they should pay royalties for unauthorized tests or face legal action, according to Ontario's health minister Tony Clement.

However, Mr. Clement called gene patenting "abhorrent" and served notice that Ontario would fight Myriad. "We do not accept their claim and we are disregarding that claim," he said.

In April, Ontario will offer its own test, which uses the same gene in a different process. The province says its test provides results quicker than Myriad's and costs two-thirds less than the approximately $2,300 that Myriad charges for its test. Alberta is also offering its own test.

Myriad did not answer requests for interviews.

Dr. Daar likens Myriad to an inventor of a mousetrap, claiming he owns any device that traps mice. "Nobody can own our genes," he says. "They are the property of us human beings."

Groups that oppose gene patenting, like the Canadian Cancer Society, say that as more genetic therapies come into use, gene-patent owners may stop others from making new, possibly better tests. "It really puts a chilling effect on research," says Society president Julie White.

With millions of dollars to be made, biotech companies are hoping to stake out promising genes. It is yet unclear how many genes have been patented. Published reports say 20,000, though both Canadian and US patent offices say that is exaggerated.

In a ruling in 2000, the US patent office required that for genes to be patented, the applications must demonstrate "substantial, real-world utility." Canada's patent manager, the Canadian Intellectual Property Office, also requires that all patent applications - including genes - demonstrate "well-founded" utility, according to Dr. Michael Gillen of Canada's Patent Appeals Board.

Dr. Gillen argues that gene patents are a new take on old practices. Patents have been awarded for years for proteins, plant alkaloids, even for certain drugs - although all occur in nature or in peoples' bodies.

"Patents are granted because once they're isolated from nature and purified in some way, they have a practical utility," Gillen says. "For example, the BRCA1 cancer gene - as an isolated gene - you can put that into a kit and use it in a test to test for cancer. The gene as it occurs in nature doesn't have that same utility. That's where the value-added comes, and that's the intellectual part of the equation and that's why patents are granted."

BioteCanada, which says it represents 85 percent of Canadian genetic researchers, defends gene patents. Communications director Cate McCready says that patents balance the risk and high costs of genetic research with the hope of financial returns.