U.S. gene-patent ruling could mean better cancer genetic tests for Canadians
Published Friday, June 14, 2013 9:02AM EDT
Last Updated Friday, June 14, 2013 9:10AM EDT
While Canada is not directly affected by a U.S. Supreme Court decision this week that says human genes cannot be patented, it will likely result in better and faster genetic tests for Canadians down the road, says an expert on intellectual property law.
Richard Gold, the director of the Centre for Intellectual Property at McGill University, says while the decision affects only researchers and biotechnology companies in the U.S., it puts Canadian patent laws into question.
What’s more, he says, it opens the door to allowing U.S. researchers to develop better, faster and cheaper gene tests.
“In the United States, it will drastically open the market,” Gold told CTV’s Canada AM Friday, speaking from Montreal.
“There will be increased competition. So we expect new types of testing, and better-performing testing to be given.”
The U.S. court decided unanimously Thursday that while certain types of genetic tests can be protected by patents, genes themselves cannot be patented.
The decision directly affects Myriad Genetics Inc., which has had patents on the BRCA1 and 2 genes, as well as a patent for a specific test called BRACAnalysis, which has been for many years the only test available to look for abnormalities in these genes.
The test is widely used among women with strong family histories of breast and/or ovarian cancer. Research has shown that certain mutations in either of the BRCA genes exposes women to a much higher risk of developing breast or ovarian cancer.
Angelina Jolie recently made headlines when she announced she had undergone a double mastectomy and would also be having her ovaries removed as well because testing had revealed she had one of those mutations.
Many groups have come out in opposition to Myriad holding a patent on the genes, including the Canadian Cancer Society, which accused Myriad of using its patents on the genes to keep others from offering such tests.
It noted that the patents meant Canadian labs had to send all tests samples to Myriad’s headquarters in the United States for analysis. That has limited Canadians’ access to the testing and raised the costs unnecessarily, the group has said.
On Thursday, the U.S. Supreme Court struck down those patents saying that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."
Gold says the decision means scientists will now to able to engage in free research on these genes without fear of being sued.
“U.S. women will have much greater access to this diagnostic, but also, there will be increased competition,” he said. “And the more players that are in it, frankly, the more advances we’re going to get: more accurate tests, faster tests, cheaper tests.”
As early as Thursday, there were already announcements from a number of genetic-testing companies that they were going to immediately start to offer their own BRCA testing.
But Gold notes that the U.S. court decision doesn’t mean that laws in Canada are changing.
“The Canadian patents read almost identically to those in the U.S., but this Supreme Court decision doesn’t touch us. So here, we’re sitting in a situation where these patents exist on paper and nobody knows now if Canadian courts will follow the U.S. lead,” he said.
The decision also affects Canadian biotechnology companies working on their own breast cancer gene-testing. But the decision was somewhat moot, because most companies have already moved on from trying to patent specific, isolated genes to patenting synthetically-created DNA, known as cDNA.
The U.S. Supreme Court ruling decided that synthetic DNA can be patented "because it is not naturally occurring.”
As well, biotech companies are now focusing on how to test for multiple gene mutations at once.
“We’ve already moved into next-generation sequencing so we can analyse multiple genes at a time. All these patents are based on the old technology when we did only one gene at a time,” Gold said.
“So we expect to have a lot of innovation in this field.”