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The Patented Medicines (Notice Of Compliance) Regulations: An Examination Of The Decision Making Patterns In These Cases At The Supreme Court Of Canada, Jason D. Newman
The Patented Medicines (Notice Of Compliance) Regulations: An Examination Of The Decision Making Patterns In These Cases At The Supreme Court Of Canada, Jason D. Newman
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Abstract
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 …