Thousands of human genes, many associated with human disease processes and diagnosis, have been patented in Canada. The scope of these patents has restricted public access to genetic testing and raised the question of whether human genetic material should be subject to differential treatment by our patent law regime. The Canadian Intellectual Property Office (CIPO) has failed to offer guidelines on the application of patent laws to genetic material, symptomatic of the broader problem of a lack of strong federal leadership in this area. In this paper I will engage the debate over patenting of human genes specifically as it relates to disease gene patents and will critically discuss various proposals for reform. For the purpose of my discussion I have assumed that access to genetic testing (specifically for breast cancer susceptibility) is desirable, that restricting access to testing is not ethically justifiable and that commodification of human genes can be harmful. Re-establishing an appropriate balance between private and public interests in biotechnology requires patent reform. In arguing for patent reform, I will focus on Myriad Genetics, a company that holds patent rights to breast cancer susceptibility genes [discussed infra] and is attempting to establish a worldwide monopoly on breast cancer susceptibility testing. Myriad's claims have begun to stir a debate in the public over the application of patent law to the human genome and the potential harms of permitting commercial monopolies over genetic testing services.
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S Jodi Gallagher, "Towards a Canadian Policy for Patenting Disease Genes" (2002) 11 Dal J Leg Stud 88.