In Canada, pharmaceutical patent cases have dominated patent litigation for the past two decades. This is partly due to the significant role played by the generic pharmaceutical industry in the country’s healthcare system. More importantly, Canada’s unique legal framework governing pharmaceutical patents has propelled the proliferation. This article highlights a few unique procedural and substantive issues regarding Canada’s pharmaceutical patent litigation, which may be of interest to Chinese pharmaceutical companies considering entering the Canadian market.
Canada does not have Hatch-Waxman Act litigation, as per the American system. In Canada, the Patented Medicines (Notice of Compliance) Regulations link the ability of a generic pharmaceutical manufacturer to obtain regulatory approval to market its product, to an innovator’s patents. The Minister of Heath cannot grant regulatory approval, called a notice of compliance (NOC), to a generic seeking approval for its product based on a comparison with an innovator’s product, until the generic has addressed all patents listed by the innovator on the patent register for the brand name product. In this regard, the Canadian system is similar to the American system. Beyond this, the Canadian system is quite different procedurally.
Douglas Deeth is a partner and Chen Junyi is an associate at Deeth Williams Wall