Canadian Generic Pharmaceutical Association v. Canada (Minister of Health) et al.

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Court of Appeal (Canada)
• Judge: Nadon, Sharlow and Layden-Stevenson, JJ.A.
• Citation: (2010), 413 N.R. 89 (FCA),2010 FCA 334
• Date: 07 June 2010
• Subject Matter: CONSTITUTIONAL LAW,FOOD AND DRUG CONTROL

Cdn. Generic Pharmaceutical v. Can. (2010), 413 N.R. 89 (FCA)

MLB headnote and full text

Temp. Cite: [2010] N.R. TBEd. DE.031

Apotex Inc. (appellant) v. The Minister of Health and the Attorney General of Canada (respondents) and Eli Lilly Canada (respondent)

(A-352-09)

Canadian Generic Pharmaceutical Association (appellant) v. Attorney General of Canada and The Minister of Health (respondents) and Canada's Research-based Pharmaceutical Companies (respondent)

(A-360-09; 2010 FCA 334)

Indexed As: Canadian Generic Pharmaceutical Association v. Canada (Minister of Health) et al.

Federal Court of Appeal

Nadon, Sharlow and Layden-Stevenson, JJ.A.

December 9, 2010.

Summary:

Section 30(3) of the Food and Drugs Act gave the Governor in Council the authority to enact regulations for the purpose of implementing specified data protection provisions of the North American Free Trade Agreement (NAFTA) and the World Trade Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS). In 2006, pursuant to s. 30(3), the Governor in Council enacted s. C.08.004.1 of the Food and Drug Regulations (known as the "Data Protection Regulation" (DPR)). The DPR introduced a period of market exclusivity by imposing an eight year moratorium on approval for the marketing of a generic copy of a previously approved new drug. Prior to the enactment of the DPR the only restriction on a generic drug manufacturer's ability to gain approval to market a generic drug was any unexpired patent protection. After the enactment of the DPR the drug company pursuing approval for a generic copy had to wait until expiry of the market exclusivity period of the new drug before its generic copy could receive approval, even if there was no existing patent protection. The Canadian Generic Pharmaceutical Association (CGPA), an association of generic drug manufacturers and their suppliers, and Apotex Inc., the largest generic drug manufacturer in Canada applied for judicial review. Both applications raised the issue of whether Parliament had the constitutional power to enact s. 30(3) of the Act and the DPR and whether the Governor in Council could enact the DPR in the present form. There was also an issue respecting whether the CGPA had standing.

The Federal Court, in a decision reported 348 F.T.R. 29, dismissed the applications. The court held that s. 30(3) of the Act and the DPR were intra vires as a valid exercise of the federal constitutional power under the regulation of trade and commerce, s. 91(2) of the Constitution Act, 1867. Further, the DPR was rationally connected with s. 30(3) of the Act and came within the regulatory authority Parliament had given to the Governor in Council. On the procedural question, the court found that the CGPA had standing on the basis of public interest. Apotex and CGPA appealed.

The Federal Court of Appeal dismissed the appeal. The court held that the applications judge erred in concluding that the DPR was a valid exercise of the trade and commerce power. However, the DPR was valid federal legislation under the s. 91(27) (i.e., the criminal law power).

Constitutional Law - Topic 604.1

Powers of Parliament and the legislatures - Delegation of power - Delegation of legislative power - Validity of - Section 30(3) of the Food and Drugs Act gave the Governor in Council the authority to enact regulations for the purpose of implementing specified data protection provisions of the North American Free Trade Agreement (NAFTA) and the World Trade Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) - In 2006, pursuant to s. 30(3), the Governor in Council enacted s. C.08.004.1 of the Food and Drug Regulations (known as the "Data Protection Regulation" (DPR)) - The DPR introduced a period of market exclusivity by imposing an eight year moratorium on approval for the marketing of a generic copy of a previously approved new drug - At issue was whether the DPR was properly delegated by Parliament to the Governor in Council, pursuant to the permissible sub-delegation of treaty implementation responsibilities, and if so whether the DPR was intra vires the authority of the Governor in Council, pursuant to s. 30(3) of the Food And Drugs Act - The Federal Court of Appeal held that the DPR was properly delegated by Parliament to the Governor in Council and that it was intra vires the authority of the Governor in Council - See paragraphs 57 to 94.

Constitutional Law - Topic 6505

Federal jurisdiction (s. 91) - Criminal law - Respecting particular matters - Health - [See Constitutional Law - Topic 6509 ].

Constitutional Law - Topic 6509

Federal jurisdiction (s. 91) - Criminal law - Respecting particular matters - Drug legislation - The Governor in Council, pursuant to s. 30(3) of the Food and Drugs Act (Can.), enacted the Food and Drug Regulations (known as the "Data Protection Regulation" (DPR)) - The DPR introduced a period of market exclusivity by imposing an eight year moratorium on approval for the marketing of a generic copy of a previously approved new drug - Interested parties challenged the vires of the DPR - The Federal Court of Appeal held that the pith and substance of the DPR was to implement article 1711 of the North American Free Trade Agreement and paragraph 3 of article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights so as to encourage the development of new drugs, a valid public health and safety purpose - The court stated further that the DPR constituted a valid exercise of the federal criminal law power under s. 91(27) of the Constitution Act - See paragraphs 95 to 133.

Constitutional Law - Topic 8241

Implementation of treaties - Conditions precedent to valid federal legislation - General - [See Constitutional Law - Topic 604.1 ].

Food and Drug Control - Topic 1102

Drugs - New drugs - Legislation re (incl. international treaty obligations) - The Federal Court of Appeal reviewed the regulatory scheme enacted by Parliament with respect to the marketing of drugs in Canada and the relevant provisions of the North American Free Trade Agreement and the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights - See paragraphs 8 to 28.

Food and Drug Control - Topic 1102

Drugs - New drugs - Legislation re (incl. international treaty obligations) - [See Constitutional Law - Topic 604.1 and Constitutional Law - Topic 6509 ].

Food and Drug Control - Topic 1112

Drugs - New drugs - Approval of generic drugs - [See Constitutional Law - Topic 604.1 and Constitutional Law - Topic 6509 ].

Cases Noticed:

Bayer Inc. v. Canada (Attorney General) et al. (1998), 155 F.T.R. 184; 84 C.P.R.(3d) 129 (T.D.), affd. (1999), 243 N.R. 170; 87 C.P.R.(3d) 293 (F.C.A.), leave to appeal refused (2000), 259 N.R. 200 (S.C.C.), refd to. [para. 24].

Canadian National Transportation Ltd. et al. v. Canada (Attorney General), [1983] 2 S.C.R. 206; 49 N.R. 241; 49 A.R. 39, refd to. [para. 40].

City National Leasing Ltd. v. General Motors of Canada Ltd., [1989] 1 S.C.R. 641; 93 N.R. 326; 32 O.A.C. 332, refd to. [para. 41].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 2005 SCC 26, refd to. [para. 52].

Gray, Re (1918), 57 S.C.R 150, folld. [para. 58].

Law Society of Upper Canada v. Canada (Minister of Citizenship and Immigration) et al. (2006), 307 F.T.R. 141; 2006 FC 1489, refd to. [para. 63].

Canada (Attorney General) v. Giacomelli, 2010 ONSC 985, refd to. [para. 63].

R. v. J.P. (2003), 177 O.A.C. 313; 67 O.R.(3d) 321 (C.A.), refd to. [para. 63].

Canadian Western Bank et al. v. Alberta, [2007] 2 S.C.R. 3; 362 N.R. 111; 409 A.R. 207; 402 W.A.C. 207; 2007 SCC 22, refd to. [para. 96].

Reference Re Firearms Act (Can.), [2000] 1 S.C.R. 783; 254 N.R. 201; 161 A.R. 201; 225 W.A.C. 201, refd to. [para. 116].

RJR-MacDonald Inc. et Imperial Tobacco Ltd. v. Canada (Procureur général), [1995] 3 S.C.R. 199; 187 N.R. 1, refd to. [para. 119].

Standard Sausage Co. v. Lee (1934), 1 W.W.R. 81 (B.C.C.A.), refd to. [para. 122].

R. v. Wetmore et al., [1983] 2 S.C.R. 284; 49 N.R. 286, refd to. [para. 122].

Jamieson (C.E.) & Co. (Dominion) Ltd. et al. v. Canada (Attorney General) (1988), 12 F.T.R. 167; 46 D.L.R.(4th) 582 (T.D.), refd to. [para. 127].

Statutes Noticed:

Data Protection Regulation - see Food and Drugs Act Regulations (Can.), Food and Drug Regulations.

Food and Drugs Act, R.S.C. 1985, c. F-27, sect. 30(3) [para. 4].

Food and Drugs Act Regulations (Can.), Food and Drug Regulations, C.R.C. 1978, c. 870, sect. C-08.004.1 [para. 1].

Food and Drug Regulations - see Food and Drugs Act Regulations (Can.).

NAFTA - see North American Free Trade Agreement.

North American Free Trade Agreement, art. 1711 [para. 18].

World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (1994), art. 39 [para. 29].

Authors and Works Noticed:

Hogg, Peter W., Constitutional Law of Canada (5th Ed.) (2007 Looseleaf Supp.) (2009 Update, Release 1), vol. 1, p. 15-13 [para. 95].

Counsel:

Edward Hore and Georgg Langen, for the appellant, in action no. A-360-09;

H.B. Radomski, for the appellant, in action no. A-352-09;

F.B. Woyiwada, for the Crown respondents, in both action nos.;

Martin Mason and Graham Ragan, for the respondent, Canada's Research-based Pharmaceutical Companies, in action no. A-360-09;

Richard Dearden and Wendy Wagner, for the respondent, Eli Lilly Canada Inc.

Solicitors of Record:

Hazzard & Hore, Toronto, Ontario, for the appellant, in action no. A-360-09;

Goodmans LLP, Toronto, Ontario, for the appellant, in action no. A-352-09;

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, in both action nos.;

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the respondents, Canada's Research-based Pharmaceutical Companies, in action no. A-360-09 and Eli Lilly Canada Inc., in action no. A-352-09.

This appeal was heard at Toronto, Ontario, on June 7, 2010, before Nadon, Sharlow, and Layden-Stevenson, JJ.A., of the Federal Court of Appeal. The following judgment was delivered for the court at Ottawa, Ontario, by Nadon, J.A., on December 9, 2010.