Patenting of gene sequences
The Canadian Cancer Society is concerned that patenting of genes may hinder accessible, affordable and reliable genetic testing. These tests are important for Canadians who have been advised by their doctors that such testing would be beneficial to them because of a strong family history of hereditary cancer. We also believe that these patents will have a negative impact on research as patents can hinder collaboration among researchers and can add to the cost of research.
We have spoken out about the patents on the BRCA1 and 2 genes which affect the risk of breast and ovarian cancers. Myriad Genetics Inc. holds the patents to the BRCA1 and 2 genes, as well as a patent for a specific test, called BRACAnalysis, which is used to detect abnormalities in these genes. As a result, all samples must be sent to the company’s headquarters in the United States for analysis. The high costs associated with this process limits Canadians’ access to genetic testing. As a result, the Canadian Cancer Society has called on the federal and provincial governments to ensure Canadians have access to high quality appropriate genetic testing.
The Canadian Cancer Society opposes patents on genes and gene sequences. We support patents for specific diagnostic, therapeutic or other innovations that derive from the knowledge of genes or gene sequences.
Patenting of the BRCA1 and 2 genes
Every year there are approximately 23,000 new diagnoses of breast cancer. The inherited genetic abnormalities carried in BRCA1 and 2 genes have been shown to be a factor in 5% to 10% of breast cancers. Women who carry one of these two genes are much more likely than other women to develop breast cancer and they are more likely to develop the breast cancer at a younger age. These mutations also carry an increased probability of developing ovarian cancer.
Myriad holds patents on the BRCA1 and 2 genes
The patents awarded Myriad a monopoly for 20 years from the filing date of the patent application. Although it has been suggested that Myriad’s patents also provide exclusive right to any information derived from these genes, as well as any methods developed to diagnose and treat hereditary breast and ovarian cancer, experts do not believe the courts will uphold this.
The American College of Medical Genetics has stated its concern that gene patents can limit the accessibility of genetic testing, and restrict quality assurance. Other organizations have expressed similar concerns.
Impact of Myriad’s patents on Canadians
The implications of genetic testing are complex. Finding out that you carry a harmful mutation may lead to difficult decisions about prevention options (for example, prophylactic mastectomy), and to social and ethical complications (for example, family members who would prefer not to know that they are at risk, learning that they are at risk and the risk of discrimination from insurers and employers). It is generally recommended that expert counselling services should be provided along with the genetic test. This ensures that patients and their families understand all the implications of their test result, both for themselves and for their relatives. Expert counselling is a feature of provincial genetic testing programs, but is not offered as part of Myriad’s services.
BRCA1 and 2 testing for patients that meet certain criteria is currently paid for by provincial health care programs. Genetic testing programs in Canada use a variety of tests other than Myriad’s that are also known to be accurate.
In July 2001 Myriad issued a cease and desist notice in Canada instructing provincial governments to stop using any other tests to detect the BRCA1 and 2 genes other than BRACAnalysis. The response of provinces to Myriad’s order has varied. If Myriad is able to force all provinces to use their testing services, provinces may decide to stop paying for this test, which is more expensive when conducted through Myriad.
Current legal issues regarding Myriad’s patents
In 2009 the American Civil Liberties Union, along with several scientific associations, patient groups and individuals, filed a lawsuit against the US Patent and Trademark Office and Myriad Genetics claiming that the patents on BRCA1 and BRCA2 “stifle research that could lead to cures and limit women’s options regarding their medical care ” The Canadian Cancer Society will continue to monitor this case to assess any impact it might have in Canada.