Pfizer Canada Inc. v. Canada (Minister of Health) et al., (2014) 470 F.T.R. 204 (FC)

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Federal Court (Canada)
• Judge: Gleason, J.
• Citation: (2014), 470 F.T.R. 204 (FC),2014 FC 1243
• Date: 12 June 2014

Pfizer Can. Inc. v. Can. (2014), 470 F.T.R. 204 (FC)

MLB headnote and full text

Temp. Cite: [2015] F.T.R. TBEd. JA.013

Pfizer Canada Inc. (applicant) v. The Minister of Health, The Attorney General of Canada and Teva Canada Limited (respondents)

(T-1703-13; 2014 FC 1243)

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

Federal Court

Gleason, J.

December 19, 2014.

Summary:

Pfizer Canada Inc. applied for judicial review of the decision of the Minister of Health awarding an early Notice of Compliance to Teva Canada Ltd. for a drug that was the pharmaceutical and bioequivalent of a drug that Pfizer produced and held patent rights for under a patent listed on the Patent Register established under ss. 3 and 4 of the Patented Medicines (Notice of Compliance) Regulations.

The Federal Court allowed the application.

Administrative Law - Topic 3202

Judicial review - General - Scope or standard of review - [See Food and Drug Control - Topic 1115 ].

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compliance - Issuance of - Pfizer Canada Inc. applied for judicial review of the decision of the Minister of Health awarding an early Notice of Compliance (NOC) to Teva Canada Ltd. for a drug that was the pharmaceutical and bioequivalent of a drug that Pfizer produced and held patent rights for under a patent listed on the Patent Register - The Minister issued the NOC in question to Teva pursuant to amendments to its Guidance Document, Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) - These amendments purported to allow the Minister to issue early NOCs to companies who marketed a generic version of a drug listed on the Patent Register, without being required to serve a Notice of Allegation on the patent-holder under s. 5 of the PMNOC Regulations, if the company had been licensed to sell the drug by another company that had previously complied with s. 5 of the PMNOC Regulations - The Federal Court allowed the application - The Minister was prevented from issuing the impugned NOC to Teva pursuant to ss. 5(1) and 7(1) of the PMNOC Regulations - Teva made a submission for an NOC that directly or indirectly compared its product to Pfizer's product within the meaning of s. 5(1) of the PMNOC Regulations - Under s. 7 of the PMNOC Regulations, the Minister could not issue Teva an NOC when it made such a submission until Teva addressed the patent - Thus, the Minister's decision to issue Teva the NOC was made in contravention of s. 7 of the PMNOC Regulations and had be set aside - See paragraphs 121 to 145.

Food and Drug Control - Topic 1108

Drugs - New drugs - Notice of compliance - Judicial review - [See Food and Drug Control - Topic 1106 and Food and Drug Control - Topic 1115 ].

Food and Drug Control - Topic 1115

Drugs - New drugs - Judicial review - Scope of - Pfizer Canada Inc. applied for judicial review of the decision of the Minister of Health awarding an early Notice of Compliance (NOC) to Teva Canada Ltd. for a drug that was the pharmaceutical and bioequivalent of a drug that Pfizer produced and held patent rights for under a patent listed on the Patent Register - The Federal Court discussed the applicable standard of review - First, one had to consider whether the previous case law had satisfactorily settled the standard of review to be applied - Where the case law was post-Dunsmuir (SCC 2009) and applied the standard of review analysis mandated by the Supreme Court of Canada, it would have satisfactorily settled the issue and could be applied - Likewise, where the case law pre-dated Dunsmuir and mandated reasonableness or patent unreasonableness as the standard of review, then it would have satisfactorily established that the standard of review was reasonableness, given the preference for deference set out in Dunsmuir and subsequent cases - The case law would also settle the standard of review where the issue being reviewed involved "a constitutional question, a question of general importance to the legal system as a whole that is outside the administrative decision-maker's specialized expertise, determination of the respective jurisdiction of two or more administrative decision-makers or a true question of vires." - Conversely, where the issue being determined involved a factual determination, a determination of mixed fact and law from which a pure legal question could not be extricated, the exercise of a statutorily-conferred discretion or the making of a policy decision that the decision-maker was mandated to make, then the reasonableness standard was applicable as the case law post-Dunsmuir indicated that such decisions were to be afforded deference - Finally, where what was being reviewed was a legal issue that involved the interpretation of the decision-maker's constituent statute or a statute or regulation closely related to its function, there was a presumption that reasonableness applied - That presumption, however, could be rebutted by a contextual analysis if it demonstrated that the issue in question was not one that the legislature intended to leave to the decision-maker to determine because it fell more appropriately within the expertise of a reviewing court - In conducting the contextual analysis, the reviewing court could have regard to such factors as "the presence or absence of a privative clause, the purpose of the tribunal, the nature of the question at issue, and the expertise of the tribunal." - Here, the presumption of reasonableness applied, but was rebutted - Accordingly, the applicable standard of review was correctness - See paragraphs 57 to 120.

Patents of Invention - Topic 8142

Practice - Judicial review - Scope or standard of - [See Food and Drug Control - Topic 1115 ].

Cases Noticed:

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. 14].

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. 14].

Harris v. GlaxoSmithKline Inc. et al. (2010), 272 O.A.C. 214; 78 C.C.L.T.(3d) 52; 2010 ONCA 872, refd to. [para. 14].

Teva Canada Ltd. v. Canada (Minister of Health) et al. (2011), 390 F.T.R. 1; 95 C.P.R.(4th) 423; 2011 FC 507, refd to. [para. 14].

Nu-Pharm Inc. v. Canada (Attorney General) et al. [1998] F.T.R. Uned. 238; 73 C.P.R.(3d) 510 (T.D.), affd. (1998), 224 N.R. 386; 80 C.P.R.(3d) 74 (F.C.A.), refd to. [para. 17].

Apotex Inc. v. Merck & Co. et al. (2009), 391 N.R. 336; 76 C.P.R.(4th) 1; 2009 FCA 187, refd to. [para. 17].

Apotex Inc. v. Canada (Minister of Health) et al. (2009), 369 F.T.R. 18; 79 C.P.R.(4th) 1; 2009 FC 721, refd to. [para. 17].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (2007), 364 N.R. 325; 59 C.P.R.(4th) 416; 2007 FCA 163, refd to. [para. 32].

Eli Lilly Canada Inc. v. Canada (Minister of Health) (2003), 300 N.R. 76; 23 C.P.R.(4th) 289; 2003 FCA 24, refd to. [para. 59].

Takeda Canada Inc. v. Canada (Minister of Health) et al. (2013), 440 N.R. 346; 225 A.C.W.S.(3d) 524; 2013 FCA 13, refd to. [para. 59].

Agraira v. Canada (Minister of Public Safety and Emergency Preparedness) et al. (2013), 446 N.R. 65; 2013 SCC 36, refd to. [para. 59].

Canadian National Railway Co. v. Canada (Attorney General) et al., [2014] 2 S.C.R. 135; 458 N.R. 150; 240 A.C.W.S.(3d) 262; 2014 SCC 40, consd. [para. 59].

Merck & Co. et al. v. Canada (Attorney General) et al. (1999), 176 F.T.R. 21 (T.D.), affd. (2000), 254 N.R. 68; 5 C.P.R.(4th) 138 (F.C.A.), refd to. [para. 61].

New Brunswick (Board of Management) v. Dunsmuir, [2008] 1 S.C.R. 190; 372 N.R. 1; 329 N.B.R.(2d) 1; 844 A.P.R. 1; 2008 SCC 9, refd to. [para. 63].

Alberta Teachers' Association v. Information and Privacy Commissioner (Alta.) et al., [2011] 3 S.C.R. 654; 424 N.R. 70; 519 A.R. 1; 539 W.A.C. 1; 2011 SCC 61, refd to. [para. 65].

McLean v. British Columbia Securities Commission (2013), 452 N.R. 340; 347 B.C.A.C. 1; 593 W.A.C. 1; 2013 SCC 67, refd to. [para. 65].

Nolan v. Kerry (Canada) Inc. - see Nolan et al. v. Superintendent of Financial Services (Ont.) et al.

Nolan et al. v. Superintendent of Financial Services (Ont.) et al., [2009] 2 S.C.R. 678; 391 N.R. 234; 253 O.A.C. 256; 2009 SCC 39, refd to. [para. 68].

Celgene Corp. v. Canada (Attorney General), [2011] 1 S.C.R. 3; 410 N.R. 127; 2011 SCC 1, refd to. [para. 68].

Alliance Pipeline Ltd. v. Smith, [2011] 1 S.C.R. 160; 412 N.R. 66; 2011 SCC 7, refd to. [para. 68].

Canada (Attorney General) v. Mowat, [2011] 3 S.C.R. 471; 422 N.R. 248; 2011 SCC 53, refd to. [para. 68].

Georgia Strait Alliance et al. v. Canada (Minister of Fisheries and Oceans) et al. (2012), 427 N.R. 110; 2012 FCA 40, refd to. [para. 74].

Toledo v. Canada (Minister of Citizenship and Immigration) et al. (2013), 454 N.R. 139; 2013 FCA 226, refd to. [para. 75].

Prescient Foundation v. Minister of National Revenue (2013), 444 N.R. 234; 358 D.L.R.(4th) 541; 2013 FCA 120, refd to. [para. 75].

Bartlett v. Canada (Attorney General) (2012), 434 N.R. 241; 2012 FCA 230, refd to. [para. 75].

Sheldon Inwentash and Lynn Factor Charitable Foundation v. Minister of National Revenue (2012), 432 N.R. 338; 2012 FCA 136, refd to. [para. 75].

Kandola v. Canada (Minister of Citizenship and Immigration) (2014), 456 N.R. 115; 372 D.L.R.(4th) 342; 2014 FCA 85, refd to. [para. 78].

Manitoba Association of Health Care Professionals v. Nor-Man Regional Health Authority Inc., [2011] 3 S.C.R. 616; 423 N.R. 95; 2011 SCC 59, refd to. [para. 94].

Khosa v. Canada (Minister of Citizenship and Immigration), [2009] 1 S.C.R. 339; 385 N.R. 206; 2009 SCC 12, refd to. [para. 103].

Rogers Communications Inc. et al. v. Society of Composers, Authors and Music Publishers of Canada et al., [2012] 2 S.C.R. 283; 432 N.R. 1; 2012 SCC 35, refd to. [para. 117].

Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) et al. (2001), 199 F.T.R. 142; 10 C.P.R.(4th) 318 (T.D.), affd. (2002), 288 N.R. 24; 16 C.P.R.(4th) 425 (F.C.A.), refd to. [para. 127].

Ferring Inc. v. Canada (Attorney General) et al. (2003), 310 N.R. 186; 26 C.P.R.(4th) 155; 2003 FCA 274, leave to appeal refused (2004), 329 N.R. 197;  29 C.P.R.(4th) vii (S.C.C.), refd to. [para. 127].

Toba Pharma Inc. v. Canada (Attorney General) et al. (2002), 227 F.T.R. 261; 21 C.P.R.(4th) 232; 2002 FCT 927, refd to. [para. 127].

AstraZeneca Canada Inc. v. Canada (Minister of Health) (2004), 253 F.T.R. 195; 36 C.P.R.(4th) 58; 2004 FC 736, affd. (2005), 335 N.R. 6; 39 C.P.R.(4th) 366; 2005 FCA 175, refd to. [para. 127].

Hoffmann-La Roche Ltd. v. Canada (Minister of Health) et al. (2005), 336 N.R. 383; 40 C.P.R.(4th) 108; 2005 FCA 140, refd to. [para. 127].

GlaxoSmithKline Inc. v. Canada (Attorney General) et al. (2004), 264 F.T.R. 162; 38 C.P.R.(4th) 27; 2004 FC 1302, refd to. [para. 129].

Rizzo & Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1, refd to. [para. 131].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 5(1) [para. 19]; sect. 7(1) [para. 22].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Counsel:

Paul Michell and Paul Fruitman, for the applicant;

Karen Lovell, for the respondent, Attorney General of Canada;

Jonathan Stainsby, for the respondent, Teva Canada Inc.

Solicitors of Record:

Lax O'Sullivan Lisus LLP, Toronto, Ontario, for the applicant;

William F. Pentney, Deputy Attorney General of Canada, Toronto, Ontario, for the respondent, Attorney General of Canada;

Aitken Klee LLP, Ottawa, Ontario, for the respondent, Teva Canada Inc.

This application was heard at Ottawa, Ontario, on June 12, 2014, by Gleason, J., of the Federal Court, who delivered the following judgment on December 19, 2014.