I Want A New Drug: Developments In Data Protection For Innovative Drugs

In the highly competitive market for pharmaceuticals, the market exclusivity provided to the manufacturers of innovative drugs by the data protection regime of the Food and Drug Regulations (the Regulations) is important, and has the potential to be extremely lucrative. Two recent federal court decisions highlight some of the ambiguities in the Regulations and provide guidance on how courts interpret the Regulations.

Overview of Data Protection Regime in Canada

In order for a new drug to be sold in Canada, it must be approved by the Minister of Health (the Minister) in the form of a Notice of Compliance (NOC). The approval process is different for brand name drugs, many of which are also "innovative drugs", as compared to their generic counterparts. An "innovative drug" is defined in the Regulations as "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal