CSP Versus SPC: Time for Canada to Make Formulation Patents Eligible for Certificates of Supplementary Protection

Abstract:

Certificates of supplementary protection (CSPs) are intended to compensate pharmaceutical patentees for patent term lost while medicines undergo research and regulatory approval. Canada introduced the CSP Regulations under the Patent Act to meet its commitment to provide patent term restoration for pharmaceuticals under the Canada–European Union Comprehensive Economic and Trade Agreement (CETA). CETA’s patent term restoration provisions generally mirror the European Union’s preexisting Supplementary Protection Certificate (SPC) Regulation. This article argues that the Federal Court of Appeal’s first CSP decision, in Canada (Health) v Glaxosmithkline Biologicals SA, represents a departure from EU SPC law concerning formulation patent eligibility. The European Union’s broader approach to formulation claim eligibility is more consistent with the policy objectives of patent term restoration, while Canada’s failure to recognize formulation claim eligibility arbitrarily denies CSP protection for otherwise patented innovative drugs. The article concludes by recommending that Canada should amend section 3(2) of the CSP Regulations to allow patents with formulation claims to support CSPs for first medicinal ingredient approvals.