| Citation: |
Canadian Generic Pharmaceutical Assn. v. Canada (Minister of Health), 2009 FC 725, [2009] 4 F.C.R. D-5 |
T-1976-06, T-2047-06 |
Patents
Judicial review of Governor in Council’s 2006 enactment of section C.08.004.01 (data protection regulation) of Food and Drug Regulations, C.R.C., c. 870—Vires of Food and Drugs Act, R.S.C., 1985, c. F-27, s. 30(3), data protection regulation at issue herein—Act, s. 30(3) giving Governor in Council authority to enact regulations for purpose of implanting specified data protection provisions of North American Free Trade Agreement (NAFTA), Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)—Data protection regulation, introducing period of market exclusivity by imposing eight year moratorium on approval for marketing of generic copy of previously approved new drug, intra vires as constitutionally valid exercise of federal legislative power under Constitution Act, 1867, s. 91(2) regulation of trade, commerce—Not beyond regulatory power of Governor in Council as properly concerned with data protection for innovator drug companies required to provide confidential data to secure notice of compliance—Permissible sub-delegation by Parliament to Governor in Council since delegated power constrained by limitations in NAFTA, TRIPS—Applications dismissed.
Canadian Generic Pharmaceutical Assn. v. Canada (Minister of Health) (T-1976-06, T-2047-06, 2009 FC 725, Mandamin J., judgment dated July 17, 2009, 63 pp.)