
By CAROLYN ABRAHAM
MEDICAL REPORTER
Tuesday, January 7, 2003
Page A5
The Ontario government has set itself up for a showdown with the U.S. company that holds patents on the genes involved in breast and ovarian cancer. Myriad Genetics of Salt Lake City, Utah, has claimed intellectual property rights over the BRCA1 and BRCA2 genes, which contain information that can reveal a woman's risk of developing hereditary forms of breast and ovarian cancer.
But in announcing funding for a new method to test for defects in these genes, Ontario Health Minister Tony Clement said yesterday that he is willing to challenge Myriad's patents all the way to the Supreme Court of Canada.
Myriad's ownership claims would essentially deny women speedier and cheaper access to the genetic tests that can predict their chances of developing these diseases, the minister said.
"[Myriad's] point of view is not only do we have to use their tests, but if we use any other test that relates to that particular gene sequence for breast or ovarian cancer, we have got to get their permission, and we have got to pay, basically, a royalty to them," Mr. Clement said.
"I have disregarded their claim . . . We will go to the highest court in the land on this."
The case is shaping up to be a landmark battle that could have considerable impact on the biotechnology industry in Canada. To date, hundreds of patents have been issued on human genes and biotech advocates warn that undermining the patent system will be bad for business and science, because companies will not undertake research they cannot commercially protect.
But many other public groups and researchers criticize Myriad for acting as though they hold a complete monopoly on the genes.
"There should not be the ability to appropriate a piece of someone's body," said Jane Pepino, who chairs the Women's Health Council that advises the Ontario health ministry. "It is for the courts to decide."
Ms. Pepino said that Ontario's new test is 95 per cent accurate, and can scan the sequence within the genes more quickly and thoroughly than previous tests. Furthermore, it is at least 10 per cent more accurate than the test Myriad offers -- and is far less expensive, she said.
Ontario, which yesterday promised $1.2-million to fund the new test at seven hospitals in the province, says the tests will cost $1,100 each, roughly a third of Myriad's price.
More than a year ago, Myriad threatened both British Columbia and Ontario with legal action if they continued to provide breast and ovarian cancer genetic testing without honouring the company's terms.
B.C. stopped providing the test in response and is now sending its tests to be done in Ontario, which has continued to offer the screening despite Myriad's warnings.
Yesterday, Myriad spokesman William Hockett said he was "disappointed" to hear the Health Minister's comments that suggest the province can selectively decide which patents it will honour and which ones it won't.
"It was the government of Canada who issued these patents to Myriad," he said. "We have made repeated efforts to bring Ontario to the table and those efforts have not been fruitful."
Mr. Hockett said the Health Minister has met with company officials only once and that Myriad was prepared to discuss a number of scenarios -- including discounted royalty fees.
But Myriad's position has brought criticism not just from Canada, but also from Europe. This is because the company has refused to allow other labs to provide the genetic tests, even those willing to pay royalty fees.
"Generally, we just don't license other labs to do these tests because we don't feel the other methods are [the most accurate]," Mr. Hockett said.
He added Myriad would continue to try to reach an agreement with Ontario, preferably out of court, calling Mr. Clement's comments "bravado." But he added: "We have a duty to protect our intellectual property and we will do what is necessary to protect it."
|