Access Denied: A Review and Critique of the Patented Medicines (Notice of Compliance) Regulations

In Canada, proceedings brought under the Patented Medicines (Notice of Compliance) Regulations are among the most contentious. At stake is a pharmaceutical company's ability to enter a drug onto the market.Applications under the PMNOC regime involve an innovator, or brand, company pitted against a generic drug-making company, wherein the brand company seeks to prohibit the generic from releasing a generic drug until the expiry of listed patents.In practice, the Regulations create many obstacles for the release of generic drugs. This paper reviews the provisions and critically evaluates the process of obtaining approval to release a generic drug. It is submitted, the PMNOC Regulations do not provide ideal conditions for efficient patent litigation. The provisions create undesirable litigation practices and ultimately result in a loss for the Canadian people.