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?

Authors

Ron A. Bouchard

Keywords

Patented Medicines (Notice of Compliance) Regulations, pharmaceutical litigation

Abstract

This article is an analysis of case law pertaining to whether scientific research in the lead-up to invention should vitiate a finding of obviousness in pharmaceutical litigation under the Patented Medicines (Notice of Compliance) Regulations (the ‘‘NOC Regulations’’). The NOC Regulations belong to a class of legal instruments referred to as ‘‘linkage regulations’’ that tie patent protection for marketed pharmaceuticals to the Canadian drug approval process. Therefore, the NOC Regulations control entry of generic drugs into the market and access by the public to affordable medication. The issue of testing arises out of the complex and inverse relationship between inventiveness and obviousness in patent law such that the lower the threshold for inventive ingenuity in the patentability analysis, the higher the threshold for parties attacking patents on grounds of obviousness. The present analysis demonstrates there is substantial uncertainty in Canadian jurisprudence over what constitutes the accepted test for obviousness. Some cases stand for the proposition that no testing whatsoever is allowed, others for the opposite proposition that some testing is allowed, while still others purport to follow the former while actually applying the latter. Historical cases supporting the ‘‘no testing’’ line of cases were analysed and found to offer no strong legal precedent for this approach. It is suggested that courts adopt a ‘‘purposive test’’ for obviousness based on Canadian law requiring patents to be construed purposively rather than literally, federal policy underlying the NOC Regulations requiring application of regulations in a manner that is fair and balanced to all parties, and Supreme Court of Canada jurisprudence requiring fair, unequivocal, and predictable application of laws. The proposed test would be consistent with appellate court jurisprudence in other jurisdictions with analogous patent legislation and policy.

Recommended Citation

Ron A. Bouchard, "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?" (2007) 6:1 CJLT.