Master of Laws
Samuel E Trosow
Generic drug approval cases involving Canada’s Patented Medicines (Notice of Compliance) Regulations are adjudicated at the Federal Court through the judicial review process. The European Union alleges that this abbreviated process is unfair to litigants who hold patents on medicines, since it does not encompass all of the features of a trial, nor is it an actual suit for patent infringement. In addition, the process has unequal appeal rights for the patent holder and the patent challenger, where the generic challenger can appeal a decision at Federal Court, but the patent holder cannot.
When examining the pattern of decision making in Patented Medicines (Notice of Compliance) Regulations cases at the Supreme Court of Canada, there is little evidence to suggest that the Supreme Court Justices are making wrong or unfair decisions because the lower court cases were decided through the judicial review process. The decision making pattern is very similar to the pattern in the Supreme Court patent cases, and to Supreme Court jurisprudence overall, so there is little reason to think that wrong decisions on these cases are being made because of the abbreviated process. In addition, the pattern of decision making in the Patented Medicines (Notice of Compliance) cases is much different than the Supreme Court jurisprudence on copyright, an area of law that has been through a period of significant change due to issues surrounding digital music. The copyright cases are quite comparable to the Patented Medicines (Notice of Compliance) cases, in that the original adjudication of both case types was through the process of judicial review. However, the decision making pattern in the copyright cases contrasts the pattern in the Patented Medicines (Notice of Compliance) cases, in that there are few concurring opinions in the Patented Medicines (Notice of Compliance) cases and a high proportion of concurring opinions in the copyright cases, which indicates that the interpretation of the Patented Medicines (Notice of Compliance) Regulations is not creating divided opinions amongst the Justices, nor is the abbreviated process of judicial review from the lower court contributing to significant judicial disagreement. This study therefore provides evidence that a full trial for patent infringement in these cases would not necessarily change the outcomes in these cases.
Newman, Jason D., "The Patented Medicines (Notice of Compliance) Regulations: An Examination of the Decision Making Patterns in these Cases at the Supreme Court of Canada" (2016). Electronic Thesis and Dissertation Repository. 3807.