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

Apotex Inc. v. The Minister of Health et al. (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


On July 17, 2009, Mandamin J. of the Federal Court of Canada (the "Court") dismissed the judicial review applications of the Canadian Generic Pharmaceutical Association and Apotex Inc. and upheld the constitutional validity of section C.08.004.1 of the Food and Drug Regulations, as enacted in 2006 (the "Data Protection Regulations"). The Court declared that the Data Protection Regulations were within the jurisdiction of the federal Parliament.

Data Protection Regulations - On October 5, 2006, the Data Protection Regulations were enacted pursuant to subsection 30(3) of the Food and Drugs Act (the "Act") for the purpose of implementing specified data protection provisions of the North American Free Trade Agreement ("NAFTA") and the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS"). The Data Protection Regulations introduced an eight-year period of market exclusivity for drugs that qualified as an "innovative drug", as well as a six-year no file period prohibiting a generic manufacturer from relying upon the data submitted to Health Canada by the innovative drug manufacturer. An additional six-month period of market exclusivity may be available based on qualifying data regarding the use of the innovative drug in the pediatric population. The Data Protection Regulations are applicable to "innovative drugs" that received a Notice of Compliance after June 17, 2006. Prior to the 2006 enactment of the Data Protection Regulations, Canada did not have a sufficient data protection regimen.

The primary issue for the Court was whether subsection 30(3) of the Act and the Data Protection Regulations were a valid exercise of federal power under the Constitution Act. Mandamin J. applied the test from General Motors of Canada v. City National Leasing1 and held that in "pith and substance", the Regulations balance the protection of an innovative drug manufacturer’s investments in preparing its new drug submission with the eventual approval of a generic ANDS for a lower cost version of the drug. Mandamin J. held that this is not within the federal power over criminal law. However, the Regulations are "adjunct" to the federal regulatory scheme for marketing drugs in Canada and bring the approval of generic drugs into conformity with Canada’s obligations in NAFTA and TRIPS. Mandamin J. thus held that the Regulations are a valid exercise of the federal government’s legislative power under s. 91(2) of the Constitution Act as a matter pertaining to the regulation of "trade and commerce" in Canada.

Justice Mandamin held that the data submitted by an innovative drug manufacturer to Health Canada in a New Drug Submission satisfies the meaning of trade secrets and confidential information as contemplated by NAFTA and TRIPS, respectively. Accordingly, the Court held that the Data Protection Regulations are rationally connected to the grant of authority under subsection 30(3) of the Act.

Finally, as Parliament gave the Governor in Council limited authority to enact regulations in a narrow area specific to the NAFTA and TRIPS data protection provisions, the Court held that subsection 30(3) of the Act was a permissible subdelegation of power by Parliament to the Governor in Council. Such delegated power is confined by the limitations contained in the NAFTA and TRIPS agreements.


The decision has not yet been posted. The citation will be 2009 FC 725.