Motion Dismissed for Judicial Review of the Food and Drug (Data Protection) Regulations

The Federal Court of Canada has dismissed the motion of Apotex Inc (Apotex) for judicial review of the Regulations Amending the Food and Drug Regulations (Data Protection) (Data Protection Regulations) (Apotex Inc v Canada (Governor in Council), 2007 FC 232, Court File No T-2047-06). For more information regarding the application, see E-TIPS®, "Canadian Generic Pharmaceutical Association Challenges the Regulations Amending the Food and Drug Regulations (Data Protection)" Vol 5, No 12, December 6, 2006. Justice Shore of the Federal Court found that Apotex lacked standing to bring an application for judicial review because it was not directly affected by the matter in which relief was sought: "There is no evidence that the Data Protection Regulations have been applied to impose any actual limitation on Apotex – or on any other drug manufacturer seeking a notice of compliance … [T]he possibility that Apotex

may at some time in the future be affected by the Regulations does not give it standing now

[emphasis of the Court]." As reported in the previous issue of E-Tips® (see "Judicial Review of the Regulations Amending the Food and Drug Regulations (Data Protection) to Proceed – Rx&D Granted Intervener Status" Vol 5, Number 17, February 28, 2007), the Data Protection Regulations were also challenged by the Canadian Generic Pharmaceutical Association (CGPA) and the Attorney General of Canada brought a motion to strike the judicial review application. In the CGPA decision, Justice Harrington of the Federal Court dismissed the Attorney General of Canada's motion to strike for lack of standing (Canadian Generic Pharmaceutical Association v Governor in Council et al, 2007 FC 154), a decision made less than a month before the decision of Justice Shore in the Apotex matter. In the CGPA case, Justice Harrington focused on whether it would be appropriate to decide the issue of standing on the motion to strike or whether that decision should be made at the time of hearing of the case on its merits. Justice Harrington noted that the Court discourages interlocutory motions in applications for judicial review, since applications for judicial review are to be determined in a summary way. Ultimately, Justice Harrington found that it was not plain and obvious that the CGPA lacked standing in its own right, or as informally representing a class of litigants, or that public interest mitigates against giving it standing. The Attorney General has appealed the decision of the Federal Court in the CGPA case. Depending on the outcome of the Attorney General's appeal and whether Apotex also appeals form the decision of Justice Shore, the conflict on the issue of standing between these two decisions should be resolved in the Federal Court of Appeal. For the full text of the Apotex decision, see: http://decisions.fct-cf.gc.ca/en/2007/2007fc232/2007fc232.html Summary by: Andrei Edwards and Katharine McGinnis