Data Protection: Defining Innovative Drug In Canada

Canada amended its Data Protection Regulations in 2006 to provide protection for innovative drugs in a second attempt to implement Canada's 1994 NAFTA (North American Free Trade Agreement) and TRIPS (Trade-Related Aspects of Intellectual Property rights treaty obligations. These treaties require the protection of data that is originated from considerable effort and required to be submitted for government approval. The current term of protection is eight years counting from the innovative drug's date of approval (issuance of the notice of compliance (NOC)). For the first six years, no one else may file a submission that makes a direct or indirect comparison based on the innovator's data. In the final two years, such a submission may be filed but an NOC cannot issue until expiry of the eight year term. In addition, subject to certain conditions, a pediatric six month extension is available. If CETA (Comprehensive Economic and Trade Agreement), is concluded, among other things, the term could be extended to ten years.

The Register of innovative drugs is maintained by the...