Case: Apotex Inc. v. Minister of Health et al.; Canadian Generic Pharmaceutical Association v. Attorney General of Canada et al. (SCC docket nos. 34084 and 34085)
Nature of case: Judicial Review challenging the validity and constitutionality of the Data Protection provisions of the Food and Drug Regulations (section C.08.004.1)
Successful party: The Minister of Health et al.; The Attorney General of Canada et al.
Date of decision: July 14, 2011
Decision of the Supreme Court of Canada
On July 14, 2011, the Supreme Court of Canada dismissed two related applications for leave to appeal submitted by Apotex Inc. (Apotex) and the Canadian Generic Pharmaceutical Association (CGPA).
Apotex and the CGPA sought leave to appeal from the December 9, 2010 Federal Court of Appeal order affirming the validity and constitutionality of the Data Protection provisions of the Food and Drug Regulations (the “Data Protection Regulations”). The Federal Court of Appeal decision and trial decision were reported in previous Pharma In Briefs.
The Data Protection Regulations were adopted on October 5, 2006 and provide eligible “innovative drugs” with eight years of market exclusivity beginning on the date of issuance of the notice of compliance. An additional six-months of market exclusivity is available if eligible pediatric data is submitted within the first five years of the eight-year term. Generic drug manufacturers are prohibited from filing abbreviated new drug submissions using an innovative drug as the comparator drug during the first six years of the eight-year term.
As a result of the dismissal of the leave applications, the decision of the Federal Court of Appeal upholding the validity of the Data Protection Regulations has been confirmed. The Supreme Court of Canada’s decision brings clarity to the existence of data protection in Canada, as Apotex and the CGPA have been challenging the validity of the Data Protection Regulations since they were first adopted in 2006.
Link to decision:
Judgments in Appeal and Leave Applications (July 14, 2011)
Download Pharma in brief - Validity of Data Protection Regulations Confirmed (pdf 90kb)