I\u27m Still Your Baby: Canada\u27s Continuing Support of U.S. Linkage Regulations for Pharmaceuticals

Canada\u27s linkage regime for pharmaceuticals, modeled after the originating U.S. Hatch-Waxman regime, was brought in under intense political pressure to balance effective patent enforcement over new and innovative drugs with the timely market entry of lower-priced generic competitors. It has been almost two decades since the regulations were enacted, and to date, there has been little objective assessment as to whether the regulations have, in fact, stimulated innovation and timely generic entry. We recently completed three empirical studies on the linkage between drug approval and drug patenting under the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). Of particular interest was the nexus between the innovative character of new and follow-on drugs approved by Canadian regulators and the scope of intellectual property protection afforded to these drugs via operation of linkage regulations. The first study focused on the type of brand-name and generic drug approvals over an eight-year term following the coming into force of the linkage regime and leading up to the debate on progressive licensing of drug products. The second was an analysis of patenting characteristics for therapeutic products before and after the coming into force of the NOC Regulations. That study also involved a detailed analysis of patent and therapeutic classes in which multinational drug companies are focusing their attention and how these can be used to support various types of new and follow-on drug development. The third was a more nuanced analysis of the innovative nature of new and follow-on drugs approved by regulators over this time frame coupled with an investigation into how patent monopoly periods for pharmaceuticals were extended via the linkage regulations. The implications of the data for the vires of pharmaceutical linkage are discussed in light of the stated goals of government to stimulate new and innovative drug development and facilitate timely entry of generic products and, thus, to balance the goals and objectives of food and drug law with those of enabling patent legislation. The Article finishes with a brief description of the global evolution of pharmaceutical linkage and raises issues for further research into local and global systems of pharmaceutical law and policy