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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?, Ron A. Bouchard
Canadian Journal of Law and Technology
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 …