CASE: Canadian Generic Pharmaceutical Association v. The Minister of Health et al. (A-360-09/T-1976-06)

Apotex Inc. v. The Minister of Health et al. (A-352-09/T-2047-06)

NATURE OF CASE: Judicial Review of the 2006 enactment of section C.08.004.1 of the Food and Drug Regulations

SUCCESSFUL PARTY: The Minister of Health et al.

DATE OF DECISION: July 17, 2009

APPEALS FILED: September 11, 2009 (Apotex Inc.); September 14, 2009 (CGPA)

SUMMARY:

On September 11, 2009 Apotex Inc. ("Apotex") filed a Notice of Appeal with the Federal Court of Appeal to set aside the decision of Mr. Justice Mandamin dated July 17, 2009, which upheld the validity of section C.08.004.1 of the data protection provisions in the Food and Drug Regulations, as enacted in 2006 (the "Data Protection Regulations"). A Notice of Appeal was also filed by the Canadian Generic Pharmaceutical Association ("CGPA") on September 14, 2009.

The Apotex and CGPA challenges to the Data Protection Regulations were heard together before Justice Mandamin in December of 2008. Justice Mandamin's July 17th decision dismissing the judicial review applications was discussed in a July 22, 2009 Pharma in Brief.

A decision on these appeals from the Federal Court of Appeal would not be expected until about Q1 or Q2 of 2010.

LINK TO DECISION:

Decision of Justice Mandamin dated July 17, 2009

http://decisions.fct-cf.gc.ca/en/2009/2009fc725/2009fc725.html

LINK TO THE GENERIC NOTICES OF APPEAL:

Apotex Inc. v. The Minister of Health et al. (A-352-09/T-2047-06)

Canadian Generic Pharmaceutical Association v. The Minister of Health et al. (A-360-09/T-1976-06)