Challenges to Food and Drug (Data Protection) Regulation Will Proceed

In two recent decisions, the Federal Court of Appeal (FCA) has allowed applications for judicial review by Apotex Inc (Apotex) and the Canadian Generic Pharmaceutical Association (CGPA), respectively, to proceed. The proceedings were brought for review of the Regulations Amending the Food and Drug Regulations (New Data Protection Regulations) (New Regulations) which would prohibit a generic manufacturer from seeking a Notice of Compliance (NOC) based on comparison with an innovative drug until six years after the issuance of an NOC for the innovative drug, and to prevent the Minister of Health from issuing an NOC to the generic manufacturer for two more years. In the first of the two cases, Justice Shore of the Federal Court of Canada had refused Apotex's application for standing in a judicial review application in which the validity of the New Regulations was questioned (see E-TIPS®, "Motion Dismissed for Judicial Review of the Food and Drug (Data Protection) Regulations" Vol 5, No 18, March 14th, 2007). On appeal the FCA reversed Justice Shore's ruling, noting that if the New Regulations were valid, in accordance with their terms Apotex would be prohibited from asserting any standing at all. As a result, the only opportunity for Apotex to take a position regarding the alleged invalidity of the New Regulations was in the present, before the New Regulations took effect in the context of a particular case affecting Apotex. In the words of Justice Sexton in the FCA decision,

"Vires challenges often necessarily occur in a factual vacuum. In this case, the challenge is concerned with the enactment of regulations pursuant to an enabling provision. The factual scenario envisioned by [Justice Shore] would in no way assist in the adjudication of such questions as the power to enact regulations, or any federalism arguments with respect to the enabling provision."

In the second of the two cases, the Attorney General of Canada was unsuccessful in appealing a motion allowing the CGPA to proceed with another challenge to the New Regulations, based on public interest standing (see E-TIPS®, "Judicial Review of the Regulations Amending the Food and Drug Regulations (Data Protection) to Proceed – Rx&D Granted Intervener Status".) The applications of Apotex and the CGPA, respectively, will proceed in the Federal Court and it appears likely they will be heard together, at which time the arguments for standing will be decided finally. Eli Lilly Canada Inc has recently been granted intervener status in the Apotex proceeding and Canada's Research-Based Pharmaceutical Companies (Rx&D) were granted intervener status in the CGPA matter in early 2007. For the FCA decisions, see: http://decisions.fca-caf.gc.ca/en/2007/2007fca374/2007fca374.html (2007 FCA 374); and http://decisions.fca-caf.gc.ca/en/2007/2007fca375/2007fca375.html (2007 FCA 375 Summary by: Tom Feather