Apotex Inc. v. Canada (Minister of Health) et al., (2012) 443 N.R. 291 (FCA)

• Judge: Sharlow, Dawson and Trudel, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: October 24, 2012
• Jurisdiction: Canada (Federal)
• Citations: (2012), 443 N.R. 291 (FCA);2012 FCA 322

Apotex Inc. v. Can. (2012), 443 N.R. 291 (FCA)

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Temp. Cite: [2013] N.R. TBEd. JA.022

Apotex Inc. (appellant) v. Minister of Health and Attorney General of Canada (respondents)

(A-452-11; 2012 FCA 322; 2012 CAF 322)

Indexed As: Apotex Inc. v. Canada (Minister of Health) et al.

Federal Court of Appeal

Sharlow, Dawson and Trudel, JJ.A.

December 7, 2012.

Summary:

Apotex Inc. brought an application challenging three decisions made by the Minister of Health in connection with the rejection of Apotex's submission for a Notice of Compliance (NOC) for Omeprazole Magnesium tablets. The Minister contended that the application failed to meet the 30-day filing requirement of s. 18.1(2) of the Federal Courts Act. Apotex argued that it did not file the application out of time because the actions of which it complained represented a course of ongoing unfair conduct by the Minister that were open to being judicially reviewed at any time. In the alternative, Apotex brought a motion to extend the time for bringing the application.

The Federal Court, in a decision reported at 400 F.T.R. 28, found that the application was brought outside the time period specified in s. 18.1(2) of the Federal Courts Act and it dismissed Apotex' motion to extend the time in which the application could be commenced. The court also rejected Apotex' argument that it had a vested right to a NOC. In the result, the application for judicial review was dismissed. Apotex appealed.

The Federal Court of Appeal dismissed the appeal.

Administrative Law - Topic 2267

Natural justice - The duty of fairness - Reasonable expectation or legitimate expectation - [See Food and Drug Control - Topic 1106 ].

Courts - Topic 4071.3

Federal Court of Canada - Jurisdiction - Trial Division - Practice - Judicial review applications - Time for - Apotex Inc. commenced an application for judicial review of the Minister of Health's treatment of its submission for a Notice of Compliance for Omeprazole Magnesium tablets - The Federal Court dismissed the application on the ground that, in substance, Apotex' application was brought in respect of three discrete decisions made by the Minister during the drug review process - The application for judicial review was commenced 13 months after the last of the three decisions - Therefore, the judge found that the application was brought outside the time period specified in s. 18.1(2) of the Federal Courts Act - Apotex appealed - Apotex argued that its application was not filed out of time because the actions it complained of formed a continuing course of unfair and seemingly biased conduct, to which the 30-day time limit did not apply - The Federal Court of Appeal dismissed the appeal - Apotex' amended notice of application supported the judge's conclusion that it sought prerogative relief in connection with three separate decisions and so was subject to s. 18.1(2) of the Federal Courts Act - See paragraphs 7 to 11.

Courts - Topic 4072

Federal Court of Canada - Jurisdiction - Federal Court - Practice - Limitation periods - Extension of - Apotex Inc. commenced an application for judicial review of the Minister of Health's treatment of its submission for a Notice of Compliance for Omeprazole Magnesium tablets - The Federal Court dismissed the application on the ground that, in substance, Apotex' application was brought in respect of three discrete decisions made by the Minister during the drug review process - The application for judicial review was commenced 13 months after the last of the three decisions - Therefore, the judge found that the application was brought outside the time period specified in s. 18.1(2) of the Federal Courts Act - The judge also dismissed Apotex' motion to extend the time in which the application could be commenced - Apotex appealed - Apotex argued that the judge erred in law by only considering the first and last elements of the test to be applied on motions to extend time - Moreover, Apotex argued that "where the underlying judicial review application has strong merits, or where justice so requires, the court should give less or even no weight to the other factors of the test" - The Federal Court of Appeal dismissed the application - The judge did not err in principle by failing to consider expressly the merits of the application and the issue of prejudice - The court also rejected Apotex' contention that the judge did not have regard to the merits of the application - See paragraphs 12 to 20.

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compliance - Issuance of - Apotex Inc. commenced an application for judicial review of the Minister of Health's treatment of its submission for a Notice of Compliance (NOC) for Omeprazole Magnesium tablets (Tablets) - The Federal Court dismissed the application on the ground that, in substance, Apotex' application was brought in respect of three discrete decisions made by the Minister during the drug review process - The application for judicial review was commenced 13 months after the last of the three decisions - Therefore, the Judge found that the application was brought outside the time period specified in s. 18.1(2) of the Federal Courts Act - The judge also dismissed Apotex' motion to extend the time in which the application could be commenced - Finally, the judge dismissed Apotex' argument that it had a vested right to a NOC because the Minister had previously concluded her examination of Apotex' submission and decided that a NOC would issue when the requirements of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) were met - Those requirements would be met on the expiration of a patent owned by AstraZeneca Canada Inc. - Until the expiration of that patent, Apotex' submission was on "patent hold" - Apotex appealed - The Federal Court of Appeal rejected Apotex' argument that it had a vested right to a NOC - While the Food and Drug Regulations did not expressly contemplate the effect of a patent hold under the PMNOC Regulations, the broader purpose of the Regulations, and the discretion given to the Minister to give it effect, contemplated that the Minister had the discretion to revisit an application which was on patent hold when she deemed it necessary to reconsider the safety and efficacy of the drug - Apotex' position was essentially that, based upon the Minister's initial approval, it had a legitimate expectation that the NOC would issue at the end of the patent hold - However, the doctrine of legitimate expectations did not confer substantive rights of the nature sought by Apotex - See paragraphs 21 to 48.

Food and Drug Control - Topic 1108

Drugs - New drugs - Notice of compliance - Judicial review - [See Courts - Topic 4071.3 and Courts - Topic 4072 ].

Cases Noticed:

Krause et al. v. Canada et al., [1999] 2 F.C. 476; 236 N.R. 317; 86 A.C.W.S.(3d) 4 (F.C.A.), refd to. [para. 7].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 9].

Sellathurai v. Canada (Minister of Public Safety and Emergency Preparedness) (2011), 420 N.R. 235; 2011 FCA 223, refd to. [para. 14].

Grewal v. Minister of Employment and Immigration, [1985] 2 F.C. 263; 63 N.R. 106 (F.C.A.), refd to. [para. 16].

Exeter v. Canada (Attorney General) (2011), 423 N.R. 262; 2011 FCA 253, refd to. [para. 19].

Mount Sinai Hospital Center et al. v. Quebec (Minister of Health and Social Services), [2001] 2 S.C.R. 281; 271 N.R. 104; 2001 SCC 41, dist. [para. 22].

Apotex Inc. v. Merck & Co. and Merck Frosst Canada Inc., [1994] 1 F.C. 742; 162 N.R. 177 (F.C.A.), affd. [1994] 3 S.C.R. 1100; 176 N.R. 1 (S.C.C.), refd to. [para. 22].

Apotex Inc. v. Canada (Attorney General) - see Apotex Inc. v. Merck & Co. and Merck Frosst Canada Inc.

Minister of National Revenue v. Canada Trustco Mortgage Co., [2005] 2 S.C.R. 601; 340 N.R. 1; 2005 SCC 54, refd to. [para. 26].

Celgene Corp. v. Canada (Attorney General), [2011] 1 S.C.R. 3; 410 N.R. 127; 2011 SCC 1, refd to. [para. 27].

Information Commissioner (Can.) v. Canada (Minister of National Defence), [2011] 2 S.C.R. 306; 416 N.R. 105; 2011 SCC 25, refd to. [para. 27].

Montreal (City) v. 2952-1366 Québec Inc., [2005] 3 S.C.R. 141; 340 N.R. 305; 2005 SCC 62, refd to. [para. 28].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [para. 29].

Conseil de la magistrature (N.-B.) v. Moreau-Bérubé, [2002] 1 S.C.R. 249; 281 N.R. 201; 245 N.B.R.(2d) 201; 636 A.P.R. 201; 2002 SCC 11, refd to. [para. 48].

Moreau-Bérubé v. New Brunswick (Judicial Council) - see Conseil de la magistrature (N.-B.) v. Moreau-Bérubé.

Authors and Works Noticed:

Brown, Donald, J.M., and Evans, John M., Judicial Review of Administrative Action, vol. 2, p. 7-24 [para. 48].

Counsel:

H.B. Radomski and Daniel Cohen, for the appellant;

J. Sanderson Graham and Agnieszka Zagorska, for the respondents.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the appellant;

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondents.

This appeal was heard on October 24, 2012, at Toronto, Ontario, before Sharlow, Dawson and Trudel, JJ.A., of the Federal Court of Appeal. The following judgment of the Court of Appeal was delivered by Dawson, J.A., on December 7, 2012.