Should Scientific Research in the Lead-up to Invention Vitiate Obviousness under the Patented Medicines (Notice of Compliance) Regulations: To Test or Not to Test?

Abstract

In Canada, the availability of generic drugs owes its his article is an analysis of case law pertaining to pedigree to compulsory licensing. 1 As part of its perT whether scientific research in the lead-up to invenceived obligations under the North American Free Trade tion should vitiate a finding of obviousness in pharmaAgreement (NAFTA) and the World Trade Organizaceutical litigation under the Patented Medicines (Notice tion’s Agreement on Trade Related aspects of Intellectual of Compliance) Regulations (the ‘‘NOC Regulations’’). Property (TRIPS), Canada repealed its compulsory The NOC Regulations belong to a class of legal instrulicensing regime for pharmaceuticals in favour of ments referred to as ‘‘linkage regulations’’ that tie patent ‘‘ linkage regulations ’’ referred to as the Patented protection for marketed pharmaceuticals to the CanaMedicines (Notice of Compliance) NOC Regulations dian drug approval process. Therefore, the NOC Regula(the ‘‘NOC Regulations’’). 2 The substance and procedure tions control entry of generic drugs into the market and of the NOC Regulations were modelled on analogous access by the public to affordable medication. The issue legislation in the United States. 3 So-called linkage regulaof testing arises out of the complex and inverse relationtions tie patent protection for marketed pharmaceuticals ship between inventiveness and obviousness in patent to the drug approval process, and thus control both entry law such that the lower the threshold for inventive ingeof generic drugs into the Canadian market and access by nuity in the patentability analysis, the higher the Canadians to affordable medication. Under the Canathreshold for parties attacking patents on grounds of dian linkage regulation regime, the typical route for a obviousness. The present analysis demonstrates there is generic pharmaceutical company to obtain market substantial uncertainty in Canadian jurisprudence over access for its product is to attack the relevant brandwhat constitutes the accepted test for obviousness. Some name pharmaceutical company’s patents for being either cases stand for the proposition that no testing whatsoinvalid (on the grounds of, for example, obviousness, ever is allowed, others for the opposite proposition that anticipation, double patenting, and claims broader than some testing is allowed, while still others purport to disclosure) or to claim that its product will not infringe follow the former while actually applying the latter. Hislisted patents. Given that a substantial percentage of the torical cases supporting the ‘‘no testing’’ line of cases cases litigated under linkage regulations in Canada and were analysed and found to offer no strong legal precethe United States involve allegations of invalidity based dent for this approach. It is suggested that courts adopt a on obviousness, 4 the test for obviousness determines, in ‘‘purposive test’’ for obviousness based on Canadian law part, the availability of generic medications in North requiring patents to be construed purposively rather America. than literally, federal policy underlying the NOC Regula-