2014 FC 1243, 2014 FC 1243

T-1703-13 2014 FC 1243 Pfizer Canada Inc. ( Applicant ) v. The Minister of Health , the Attorney General of Canada and Teva Canada Limited ( Respondents ) Indexed as: Pfizer Canada Inc. v. Canada (Attorney General) Federal Court, Gleason J.—Ottawa, June 12 and December 19, 2014.

Patents — Judicial review seeking to set aside decision of respondent Minister of Health (Minister) awarding early notice of compliance (NOC) to respondent Teva Canada Limited (Teva) for pharmaceutical, bioequivalent of drug applicant holding patent rights for pursuant to Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), ss. 3 , 4 — Amendments to Guidance Document, Patented Medicines (Notice of Compliance) Regulations allowing Minister to issue early NOC if company licensed to sell drug by another company that has previously complied with PMNOC Regulations, s. 5 — Applicant selling exemestane under brand name AROMASIN, Patent No. 2409059 ('059 patent) — Teva filing administrative abbreviated new drug submission (ANDS) based on licensing agreement with generic company — NOC issued to Teva showing AROMASIN as Canadian reference product — Applicant submitting, inter alia, that Minister prohibited from issuing NOC to Teva under PMNOC Regulations, arguing that clear wording of regulations, authorities supporting its position as Teva made comparison to AROMASIN in submission, falling within scope of PMNOC Regulations, s. 5(1) — Whether Minister correctly interpreting PMNOC Regulations — Governor in Council not intending that Health Canada officials be the ones to determine question at issue herein — Minister having no discretion under PMNOC Regulations to issue NOC until criteria in PMNOC Regulations, s. 7 met — Ultimate determination of whether NOC should be issued under PMNOC Regulations left to Court — Minister incorrect in issuing NOC to Teva — Clear that Teva’s NOC based on direct comparison of its drug to AROMASIN or on indirect comparison of its drug to AROMASIN by piggy-backing on generic company’s comparison — Such comparisons engaging PMNOC Regulations, s. 5(1) — Minister could not issue NOC until Teva addressed '059 patent pursuant to PMNOC Regulations, s. 7 — Application allowed.

Administrative Law — Judicial Review — Standard of Review — Judicial review seeking to set aside decision of respondent Minister of Health (Minister) awarding early notice of compliance (NOC) to respondent Teva Canada Limited (Teva) for pharmaceutical, bioequivalent of drug that applicant producing, holding patent rights for pursuant to Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), ss. 3 , 4 — Amendments to Guidance Document, Patented Medicines (Notice of Compliance) Regulations allowing Minister to issue early NOC if company licensed to sell drug by another company that has previously complied with PMNOC Regulations, s. 5 — Applicant selling exemestane under brand name AROMASIN — Teva filing administrative abbreviated new drug submission (ANDS) based on licensing agreement with generic company — NOC issued to Teva showing AROMASIN as Canadian reference product — Whether correctness or reasonableness standard applying to Minister’s decision awarding NOC to Teva — Correctness standard applicable to Minister’s decision,

interpretation of PMNOC Regulations despite recent Supreme Court of Canada (S.C.C.) case law mandating greater degree of deference by reviewing courts — Minister or Health Canada officials not to be afforded deference in interpreting PMNOC Regulations — S.C.C. decision in Canadian National Railway Co. v.

Canada (Attorney General) (CN) not to be read so broadly as establishing fixed rule limiting ways to rebut presumption of reasonableness — S.C.C. confirming need for contextual analysis in appropriate cases — CN not deciding no longer any place for contextual analysis in standard of review case — Governor in Council not intending that Health Canada officials be the ones to determine question at issue herein — Presumption of applicability of reasonableness standard of review therefore rebutted, correctness standard applicable to review of Health Canada’s decision to issue NOC.

This was an application for judicial review seeking to set aside the decision of the respondent Minister of Health (Minister) awarding an early notice of compliance (NOC) to the respondent Teva Canada Limited (Teva) for a drug that is the pharmaceutical and bioequivalent of a drug that the applicant produces and holds patent rights for under a patent listed on the patent register established under sections 3 and 4 of the Patented Medicines (Notice of Compliance) Regulations (the PMNOC Regulations).

The Minister issued the NOC pursuant to amendments to its Guidance Document , Patented Medicines (Notice of Compliance) Regulations (Guidance Document). These amendments purport to allow the Minister to issue early NOCs to companies who market a generic version of a drug listed on the patent register, without being required to serve a notice of allegation (NOA) on the patent holder under

section 5 of the PMNOC Regulations, if the company has been licensed to sell the drug by another company that has previously complied with

section 5 of the PMNOC Regulations. The applicant sells exemestane, a breast cancer drug, under the brand name AROMASIN, listed as Patent No. 2409059 ('059 patent). The applicant received an NOA from Generic Medical Partners Inc. (GMP), a generic company, with respect to the '059 patent. The applicant did not commence a prohibition application against GMP. Teva filed an administrative abbreviated new drug submission (ANDS) with Health Canada, based on a licensing agreement with GMP, and Health Canada determined the Canadian reference product for Teva’s NOC was AROMASIN.

The NOC issued to Teva also showed AROMASIN as the Canadian reference product. The applicant submitted, inter alia , that the Minister was prohibited from issuing the NOC to Teva under the PMNOC Regulations , arguing that both the clear wording of the regulations and the decided authorities supported its position as Teva made a comparison to AROMASIN in its submission, thereby falling within the scope of subsection 5(1) of the PMNOC Regulations; and that in reviewing the Minister’s decision to issue the NOCs, the Court should apply the correctness standard of review.

The main issues were whether the correctness or reasonableness standard applied to the review of the Minister’s decision to award an NOC to Teva, and whether the Minister, through officials at the Office of Patented Medicines and Liaison (OPML) at Health Canada, correctly interpreted the PMNOC Regulations .

Held, the application should be allowed. The correctness standard was applicable to the Minister’s decision and

interpretation of the PMNOC Regulations, set out in theamendments to the Guidance Document, despite the recent case law of the Supreme Court of Canada (S.C.C.) which mandates a greaterdegree of deference by reviewing courts. The relevant regulatory and statutory context indicates that the

interpretation of the PMNOCRegulations is not a matter in respect of which the Minister or officials in the OPML are to be afforded deference. The S.C.C.’s decision in Canadian National Railway Co. v.

Canada (Attorney General) (CN) should not be read so broadly asestablishing a fixed rule that the only way one can rebut the presumption of reasonableness would be if the decision maker’s decisionfalls into one of the four categories of a constitutional question, a true jurisdictional issue, the determination of the bounds of jurisdictionbetween two administrative tribunals or a question of law of general importance to the legal system as a whole that is outside theadministrative decision maker’s expertise. So doing would contradict both the approach set out in Dunsmuir v.

New Brunswick anddetailed in several subsequent S.C.C. cases. In multiple statements the S.C.C. confirmed the need for a contextual analysis in appropriatecases. One cannot read the decision in CN as changing the law and deciding that there is no longer any place for a contextual analysis ina standard of review case. It would take a much more deliberate treatment of the issue by the S.C.C. than that which is contained in CNto effect this result.

The question at issue in this case concerned whether an applicant who files an administrative ANDS based on a licence from anothergeneric company has made a “submission for an NOC” that “directly or indirectly compares” its product to that of the innovatorcompany whose drug is listed on the patent list established under the PMNOC Regulations such that the company is caught by

section 5of the PMNOC Regulations. There is nothing in the PMNOC Regulations that indicates that the Governor in Council intended that thisissue be left to officials at Health Canada to determine. Indeed, the regulatory and statutory contexts indicate the converse. The PMNOCRegulations do not afford the Minister discretion to make a decision as to when to issue an NOC but rather are cast in mandatory termsand prevent the Minister from issuing an NOC until the criteria in

section 7 of the PMNOC Regulations are met. The Governor inCouncil left the ultimate determination of whether an NOC should be issued under the PMNOC Regulations to the Court. The roleassigned to the Court under the PMNOC Regulations is inconsistent with application of the reasonableness standard to

interpretations bythe Minister or officials at Health Canada of the Regulations. The presumption of the applicability of the reasonableness standard ofreview was therefore rebutted here and the correctness standard was applicable to the review of Health Canada’s decision to issue anNOC to Teva and to the implicit

interpretation of the PMNOC Regulations enshrined in that decision. The Minister was incorrect in issuing the NOC to Teva. It was clear that Teva sought an NOC to market a drug in Canada based on thedirect comparison of its product to AROMASIN or on an indirect comparison of its drug to AROMASIN by piggy-backing on GMP’scomparison. Such comparisons engage subsection 5(1) of the PMNOC Regulations under a purposive

interpretation because theRegulations strike the required balance between competing interests by requiring generic companies who make such comparisons toaddress the patents on the patent register. Under

section 7 of the PMNOC Regulations, the Minister could not issue Teva an NOC whenit made such a submission until Teva addressed the '059 patent. STATUTES AND REGULATIONS CITED Canada Transportation Act, S.C. 1996, c. 10, s. 120.1(1). Federal Courts Rules, SOR/98-106, Tariff B, Column III. Food and Drug Regulations, C.R.C., c. 870, ss. A.01.010 “manufacturer”, C.08.001, C.08.001.1(a) “Canadian reference product”,C.08.002(2), C.08.002.1, C.08.003, C.08.004, C.08.004.01. Food and Drugs Act, R.S.C., 1985, c. F-27. Immigration and Refugee Protection Act, S.C. 2001, c. 27, s. 34(2).

National Energy Board Act, R.S.C., 1985, c. N-7. Patent Act, R.S.C., 1985, c. P-4, s. 55.2. Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 “notice of compliance”, 3, 4, 5, 6, 7. CASES CITED NOT FOLLOWED: Takeda Canada Inc. v. Canada (Health), 2013 FCA 13, [2014] 3 F.C.R. 70; David Suzuki Foundation v. Canada (Fisheries andOceans), 2012 FCA 40, [2013] 4 F.C.R. 155; Tobar Toledo v. Canada (Citizenship and Immigration), 2013 FCA 226, [2015] 1 F.C.R.215; Prescient Foundation v. Canada (National Revenue), 2013 FCA 120, 358 D.L.R. (4th) 541; Bartlett v.

Canada (Attorney General),2012 FCA 230, 365 D.L.R. (4th) 743; Sheldon Inwentash and Lynn Factor Charitable Foundation v. Canada, 2012 FCA 136, 2012D.T.C. 5090. applied: Bristol-Myers Squibb Co. v. Canada (Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533; Nu-Pharm Inc. v. Canada (AttorneyGeneral), , 73 C.P.R. (3d) 510 (F.C.T.D.), affd , 80 C.P.R. (3d) 74 (F.C.A.); Agraira v. Canada(Public Safety and Emergency Preparedness), 2013 SCC 36, [2013] 2 S.C.R. 559; Merck & Co., Inc. v. Canada (Attorney General),, 176 F.T.R. 21 (F.C.T.D.), affd , 5 C.P.R. (4th) 138 (F.C.A.); Dunsmuir v.

New Brunswick, 2008SCC 9, [2008] 1 S.C.R. 190; McLean v. British Columbia (Securities Commission), 2013 SCC 67, [2013] 3 S.C.R. 895; Nor-ManRegional Health Authority Inc. v. Manitoba Association of Health Care Professionals, 2011 SCC 59, [2011] 3 S.C.R. 616.

DISTINGUISHED: Glaxosmithkline Inc. v. Canada (Attorney General), 2004 FC 1302, 38 C.P.R. (4th) 27. considered: Canadian National Railway Co. v. Canada (Attorney General), 2014 SCC 40, [2014] 2 S.C.R. 135; Smith v. Alliance Pipeline Ltd., 2011SCC 7, [2011] 1 S.C.R. 160; Canada (Canadian Human Rights Commission) v. Canada (Attorney General), 2011 SCC 53, [2011] 3S.C.R. 471; Kandola v.

Canada (Citizenship and Immigration), 2014 FCA 85, [2015] 1 F.C.R. 549; Rogers Communications Inc. v.Society of Composers, Authors and Music Publishers of Canada, 2012 SCC 35, [2012] 2 S.C.R. 283; Rizzo & Rizzo Shoes Ltd. (Re), (SCC), [1998] 1 S.C.R. 27, (1998), 36 O.R. (3d) 418. referred to: AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] 2 S.C.R. 560; Harris v. Glaxosmithkline Inc., 2010ONCA 872 , 106 O.R. (3d) 661; Teva Canada Limited v. Canada (Health), 2011 FC 507, 95 C.P.R. (4th) 423; Apotex Inc. v.Merck & Co., 2009 FCA 187, [2010] 2 F.C.R. 389; Apotex Inc. v.

Canada (Health), 2009 FC 721, 79 C.P.R. (4th) 23; Sanofi-AventisCanada Inc. v. Novopharm Ltd., 2007 FCA 163, [2008] 1 F.C.R. 174; Eli Lilly Canada Inc. v. Canada (Minister of Health), 2003 FCA24, [2003] 3 F.C. 140; Alberta (Information and Privacy Commissioner) v. Alberta Teachers’ Association, 2011 SCC 61, [2011] 3S.C.R. 654; Nolan v. Kerry (Canada) Inc., 2009 SCC 39, [2009] 2 S.C.R. 678; Celgene Corp. v. Canada (Attorney General), 2011 SCC1, [2011] 1 S.C.R. 3; Canada (Citizenship and Immigration) v. Khosa, 2009 SCC 12, [2009] 1 S.C.R. 339; Bristol-Myers Squibb CanadaInc. v.

Canada (Attorney General), , 10 C.P.R. (4th) 318 (F.C.T.D.), affd 2002 FCA 32, 16 C.P.R. (4th) 425; FerringInc. v. Canada (Attorney General), 2003 FCA 274, 26 C.P.R. (4th) 155; Toba Pharma Inc. v. Canada (Attorney General), 2002 FCT927, 21 C.P.R. (4th) 232; AstraZeneca Canada Inc. v. Canada (Minister of Health), 2004 FC 736, 36 C.P.R. (4th) 58, affd 2005 FCA175, 39 C.P.R. (4th) 366; Hoffman-La Roche Ltd. v. Canada (Minister of Health), 2005 FCA 140, [2006] 1 F.C.R. 141. AUTHORS CITED Health Canada.

Changes in Manufacturer’s Name and/or Product Name, online: <http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/pol/chang_name_nom_pol-eng.pdf.> Health Canada. Guidance Document, Patented Medicines (Notice of Compliance) Regulations. Minister of Public Works andGovernment Services Canada, 2012, online: <http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.pdf.> Health Canada.

Guidance for Industry: Management of Drug Submission, Minister of Public Works and Government Services Canada,2013, online: <http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/mgmt-gest/mands_gespd-eng.pdf.> Regulatory Impact Analysis Statement, SOR/2006-228, C.

Gaz. 2006.II.1408. application for judicial review seeking to set aside the decision of the respondent Minister of Health awarding an early notice ofcompliance to the respondent Teva Canada Limited for a drug that is the pharmaceutical and bioequivalent of a drug that the applicantproduces and holds patent rights for under a patent listed on the patent register established under sections 3 and 4 of the PatentedMedicines (Notice of Compliance) Regulations. Application allowed. APPEARANCES M. Paul Michell and Paul Fruitman for applicant.

Karen Lovell for respondents Minister of Health and Attorney General of Canada. Jonathan Stainsby for respondent Teva Canada Inc. SOLICITORS OF RECORD Lax O'Sullivan Scott Lisus LLP, Toronto, for applicant. Deputy Attorney General of Canada for respondents Minister of Health and Attorney General of Canada. Aitken Klee LLP, Ottawa, for respondent Teva Canada Inc.

The following are the reasons for judgment and judgment rendered in English by [1] Gleason J.: In this application for judicial review the applicant, Pfizer Canada Inc. (Pfizer), seeks an order setting aside thedecision of the Minister of Health, awarding an early notice of compliance (NOC) to the respondent, Teva Canada Limited (Teva), for adrug that is the pharmaceutical and bioequivalent of a drug that Pfizer produces and holds patent rights for under a patent listed on thepatent register established under sections 3 and 4 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (thePMNOC Regulations). [2] The Minister of Health issued the NOC in question to Teva pursuant to amendments to its Guidance Document, PatentedMedicines (Notice of Compliance) Regulations (the Guidance Document).

These amendments purport to allow the Minister of Health toissue early NOCs to companies who market a generic version of a drug listed on the patent register, without being required to serve anotice of allegation (NOA) on the patent holder under

section 5 of the PMNOC Regulations, if the company has been licensed to sell thedrug by another company that has previously complied with

section 5 of the PMNOC Regulations.

[ 3 ] To put this matter into context, it is necessary to review the relevant regulatory provisions as well as the background to this application. I. The Regulations [ 4 ] In approving drugs for sale in Canada, the Minister of Health, through the officials at Health Canada, applies two sets of regulations, the Food and Drug Regulations , C.R.C., c. 870 (the FDA Regulations), promulgated under the Food and Drugs Act , R.S.C., 1985, c. F-27, and the PMNOC Regulations , promulgated under

section 55.2 of the Patent Act , R.S.C., 1985, c. P-4. A. The FDA Regulations [ 5 ] Under the FDA Regulations, no one can sell a new drug in Canada unless the Minister of Health issues the person or company who proposes to sell the drug an NOC, authorizing the sale.

Section C.08.001 of the FDA Regulations defines a new drug in relevant part as follows: C.08.001. … (

a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug; [ 6 ] It is common ground between the parties that the drug for which Teva was issued an NOC in this case falls within the FDA Regulation’s definition of a “new drug”.

Therefore, Teva required an NOC to legally offer it for sale in Canada. [ 7 ] Under the FDA Regulations, there are three main methods by which a drug company can obtain an NOC. [ 8 ] First, it may file an application called a “new drug submission” (NDS). This is typically the route chosen by innovator companies when they develop new drugs. The production of an NDS is usually a complex and expensive undertaking as the innovator company is required to conduct and produce evidence of clinical trials.

It must also file a long list of other information set out in subsection C.08.002(2) of the FDA Regulations to “enable the Minister to assess the safety and effectiveness of the new drug”. [ 9 ] The FDA Regulations secondly allow for a shorter process, called an abbreviated new drug submission (ANDS), under which a drug company may be authorized to sell a drug if it establishes that it is the same or very similar to another drug that has been authorized for sale in Canada. Subsection C.08.002.1(1) of the FDA Regulations provides in this regard: C.08.002.1.

(1) A manufacturer of a new drug may file an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for the new drug where, in comparison with a Canadian reference product, (

a) the new drug is the pharmaceutical equivalent of the Canadian reference product; (

b) the new drug is bioequivalent with the Canadian reference product, based on the pharmaceutical and, where the Minister considers it necessary, bioavailability characteristics; (

c) the route of administration of the new drug is the same as that of the Canadian reference product; and (

d) the conditions of use for the new drug fall within the conditions of use for the Canadian reference product. [ 10 ] A “Canadian reference product” is defined in paragraph C.08.001.1(

a) of the FDA Regulations as meaning “a drug in respect of which a notice of compliance is issued under

section C.08.004 or C.08.004.01 and which is marketed in Canada by the innovator of the drug”. [ 11 ] Thus, under the ANDS process, to obtain an NOC, a drug company needs to satisfy the Minister of Health of the matters referred to in subsection C.08.002.1(1) of the FDA Regulations by comparing its product to a Canadian reference product. [ 12 ] The process to produce an ANDS is much more streamlined and less expensive than that required for an NDS as the applicant under the ANDS process need only show comparability to another drug already approved by Health Canada.

Generic drug manufacturers typically seek their NOCs through the ANDS process and generally compare their drugs to those of an innovator company that obtained approval through the NDS process. [ 13 ] Finally, the FDA Regulations provide for the filing of supplemental submissions where a drug company makes certain changes to its process, labels, drug name, representations regarding the drug or other similar matters.

Section C.08.003 of the FDA Regulations provides in this regard in relevant part as follows: C.08.003. (1) … no person shall sell a new drug in respect of which a notice of compliance has been issued to the manufacturer of that new drug … if any of the matters specified in subsection (2) are significantly different from the information or material contained in the new drug submission, extraordinary use new drug submission, abbreviated new drug submission or abbreviated extraordinary use new drug submission, unless (

a) the manufacturer of the new drug has filed with the Minister a supplement to that submission; (

b) the Minister has issued a notice of compliance to the manufacturer of the new drug in respect of the supplement; … (

d) the manufacturer of the new drug has submitted to the Minister specimens of the final version of any label, including any package

insert, product brochure and file card, intended for use in connection with the new drug, where a change with respect to any of thematters specified in subsection (2) is made that would require a change to the label.

(2) The matters specified for the purposes of subsection (1), in relation to the new drug, are the following: … (

b) the brand name of the new drug or the identifying name or code proposed for the new drug; … (

g) the labels used in connection with the new drug; …

(3) A supplement to a submission referred to in subsection (1), with respect to the matters that are significantly different from thosecontained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectivenessof the new drug in relation to those matters. [14] As is apparent from the foregoing provisions (and from the FDA Regulations in their entirety), the role of the Minister of Healthin issuing an NOC under these regulations is to assess the safety and efficacy of drugs to be sold in Canada.

Indeed, that this is thepurpose of these provisions in the FDA Regulations has been confirmed by the case law (see, e.g. Bristol-Myers Squibb Co. v. Canada(Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533 (Biolyse), at paragraph 13; AstraZeneca Canada Inc. v. Canada (Minister ofHealth), 2006 SCC 49, [2006] 2 S.C.R. 560 (AstraZeneca), at paragraph 12; Harris v. Glaxosmithkline Inc., 2010 ONCA 872 ,106 O.R. (3d) 661, at paragraph 8; Teva Canada Limited v. Canada (Health), 2011 FC 507, 95 C.P.R. (4th) 423, at paragraph 23). B.

The PMNOC Regulations [15] The PMNOC Regulations were passed when Parliament abolished the previous system for compulsory licensing of generic drugmanufacturers and enacted

section 55.2 of the Patent Act. This

section allows generic companies to “early work” a product, withoutinfringing an innovator company’s patents for the drug, in order to develop a generic version of the drug and make it available as soon aspossible following expiry of the relevant patents. As counsel for the Attorney General premised much of her arguments on

section 55.2of the Patent Act, the relevant portions of the

section are reproduced; they provide as follows: Exception 55.2

(1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely foruses reasonably related to the development and submission of information required under any law of Canada, a province ora country other than Canada that regulates the manufacture, construction, use or sale of any product. (2) and (3) [Repealed, 2001, c. 10, s. 2] Regulations(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing theinfringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance withsubsection (1), including, without limiting the generality of the foregoing, regulations (

a) respecting the conditions that must be fulfilled before a notice, certificate, permit or other document concerning anyproduct to which a patent may relate may be issued to a patentee or other person under any Act of Parliament that regulatesthe manufacture, construction, use or sale of that product, in addition to any conditions provided for by or under that Act; (

b) respecting the earliest date on which a notice, certificate, permit or other document referred to in paragraph (

a) that isissued or to be issued to a person other than the patentee may take effect and respecting the manner in which that date is tobe determined; (

c) governing the resolution of disputes between a patentee or former patentee and any person who applies for a notice,certificate, permit or other document referred to in paragraph (

a) as to the date on which that notice, certificate, permit orother document may be issued or take effect; (

d) conferring rights of action in any court of competent jurisdiction with respect to any disputes referred to in paragraph (c)and respecting the remedies that may be sought in the court, the procedure of the court in the matter and the decisions andorders it may make; and (

e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (

a) incircumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in theinfringement of a patent. [16] The PMNOC Regulations, unlike the FDA Regulations, are not aimed at protecting the public from unsafe or inefficacious drugsbut, rather, are aimed at protecting the patent rights of innovator companies and balancing those rights with the timely entry of lowerpriced generic competitors into the market place. The Regulatory Impact Analysis Statement (RIAS) published in the Canada GazettePart II on October 18, 2006 [SOR/2006-228, C.

Gaz. 2006.II.1408], when a number of amendments were made to the PMNOCRegulations, notes [at page 1510] in this regard that the PMNOC Regulations are designed to “balance effective patent enforcement overnew and innovative drugs with the timely market entry of their lower priced generic competitors.”. It elaborates as follows [at page1511]: … while early-working is intended to promote the timely market entry of generic drugs by allowing them to undergo the regulatoryapproval process in advance of patent expiry, the PM(NOC) Regulations are intended to provide effective patent enforcement by

ensuring the former does not result in the actual issuance of a generic NOC until patent expiry or such earlier time as the court orinnovator considers justified having regard to the generic company’s allegation.

Despite their seemingly competing policy objectives, itis important that neither instrument be considered in isolation as the intended policy can only be achieved when the two operate in abalanced fashion. [17] The case law confirms the PMNOC Regulations are aimed at protecting the rights of patentees while ensuring that genericversions of patented medicines are available to the public as early as possible (see e.g. Biolyse, at paragraphs 45–47; Nu-Pharm Inc. v.Canada (Attorney General), , 73 C.P.R. (3d) 510 (F.C.T.D.), at paragraph 22, affd , 80 C.P.R. (3d)74 (F.C.A.) (Nu-Pharm 1); Apotex Inc. v.

Merck & Co., 2009 FCA 187, [2010] 2 F.C.R. 389, at paragraph 60; Apotex Inc. v. Canada(Health), 2009 FC 721, 79 C.P.R. (4th) 23, at paragraph 55). [18] Under the PMNOC Regulations, innovator companies may have their drug-related patents listed on the patent register,established under the regulations, provided they meet the criteria for registration.

Registration allows a patentee to forestall the entry of ageneric version of the patented drug onto the Canadian market until the patents expire, the innovator company consents to the genericcompany’s producing the drug or this Court determines that the generic company’s allegation of non-infringement or invalidity isjustified. This is accomplished through the combined effect of sections 5 to 7 of the PMNOC Regulations. [19] By virtue of

section 5 of the PMNOC Regulations, a “second person” (typically, a generic company), who files a submission foran NOC that directly or indirectly compares or references its product to that of a “first person” (typically the innovator company) whosepatent(

s) is listed on the patent register, must either (1) wait for patent expiry before receiving an NOC, or (2) serve an NOA upon thefirst person alleging invalidity and/or non-infringement of the listed patents. Subsection 5(1) of the PMNOC Regulations, which is thekey provision in this application for judicial review, provides in this regard as follows: 5.

(1) If a second person files a submission for a notice of compliance in respect of a drug and the submission directly or indirectlycompares the drug with, or makes reference to, another drug marketed in Canada under a notice of compliance issued to a first person andin respect of which a patent list has been submitted, the second person shall, in the submission, with respect to each patent on the registerin respect of the other drug, (

a) state that the second person accepts that the notice of compliance will not issue until the patent expires; or (

b) allege that (

i) the statement made by the first person under paragraph 4(4)(

d) is false, (ii) the patent has expired, (iii) the patent is not valid, or (iv) no claim for the medicinal ingredient, no claim for the formulation, no claim for the dosage form and no claim for the use of themedicinal ingredient would be infringed by the second person making, constructing, using or selling the drug for which the submissionis filed. [20] Under

section 6 of the PMNOC Regulations, the first person (i.e. the innovator company) who receives an NOA may seek anorder of prohibition from this Court to prevent the Minister of Health from issuing an NOC to the second person (i.e. the genericcompany). Where this occurs, the Court is called upon to determine if the NOA is substantiated. If the Court determines that the NOA isnot substantiated, a prohibition order will issue, preventing the Minister from issuing an NOC to the generic company until the expiry ofthe patent(

s) at issue. [21]

Section 7 of the PMNOC Regulations prevents the Minister of Health from issuing an NOC to a second person until the latest ofthe following events: (1) the second person complies with

section 5 of the PMNOC Regulations; (2) the patents at issue expire; (3) 45days elapse after the service of the NOA and the first person has not filed a prohibition application with the Court; (4) the Courtdismisses a prohibition application; (5) the first person consents to the making, constructing, using or selling of the drug in Canada bythe second person; or (6) 24 months elapse following the date the first person commenced a prohibition application in this Court. [22] Subsection 7(1) of the PMNOC Regulations is cast in mandatory terms, stating that the Minister of Health “shall not” issue asecond company an NOC until the latest of the events described in the foregoing paragraph has occurred.

It provides in relevant part: 7.

(1) The Minister shall not issue a notice of compliance to a second person before the latest of … (

b) the day on which the second person complies with

section 5, (c) … the expiration of any patent on the register that is not the subject of an allegation, (d) … the expiration of 45 days after the receipt of proof of service of a notice of allegation under paragraph 5(3)(

a) in respect of anypatent on the register, (e) … the expiration of 24 months after the receipt of proof of the making of any application under subsection 6(1), and (

f) the expiration of any patent that is the subject of an order pursuant to subsection 6(1). [23] By virtue of the foregoing provisions, innovator drug companies possess the ability to enjoin generic companies from enteringthe Canadian market with a competing version of a patented drug for 24 months or a shorter period if the prohibition application isdismissed, withdrawn or discontinued before the 24 months have elapsed. The filing of an application for prohibition therefore functions

like an injunction, preventing the second company from entering the market for up to 24 months. [ 24 ] The PMNOC Regulations tie into the FDA Regulations through the definition of an “NOC”, which is defined in

section 2 of the PMNOC Regulations as “a notice issued under

section C.08.004 or C.08.004.01 of the Food and Drug Regulations ”. [ 25 ] A final point bears mention as concerns the two regulations, namely, that neither provides for “administrative” drug submissions, which, as is discussed below, constitute another type of submission that Health Canada recognizes. II. The Guidelines and Health Canada’s Practices [ 26 ] For some time, Health Canada has required filings it terms “administrative” drug submissions when drug companies make changes that Health Canada views as being purely administrative in nature.

Such administrative matters include changes in a vendor company’s name (which may have been the result of a corporate merger, buy-out or a licensing agreement) or changes in the product name. Vendor companies are termed “manufacturers” under the FDA Regulations by virtue of

section A.01.010 of those regulations which defines a “manufacturer” as a person that sells a drug under its own name in Canada.

Thus, when a vendor company is different or changes its name, it must file an administrative drug submission with Health Canada to obtain a new NOC to allow it to sell the same drug for which an NOC had previously been issued. [ 27 ] Health Canada defines what it considers an administrative drug submission in its policy document entitled Guidance for Industry: Management of Drug Submissions [at page 3] as “a submission that does not require scientific review (for example [e.g.] change in manufacturer or product name).” [ 28 ] Another Health Canada policy, the Changes in Manufacturer’s Name and/or Product Name policy [Name Change policy], details the requirements for an administrative drug submission and the circumstances in which such a submission can be utilized.

This policy provides [at page 2] that administrative submissions may be filed where there has been “a change in the manufacturer’s name and/or product name subsequent to a merger, buy-out or other corporate restructuring or the establishment of a licensing agreement.” It further defines a licensing agreement as “an agreement between two firms whereby one firm supplies a drug product to another firm for sale under the second firm’s name.” [ 29 ] In terms of the content of an administrative submission, this policy provides that all that is required is the submission of a simplified, one-page form.

In that form the applicant is required to set out the reason for the submission, identify the previous submission and manufacturer approved by Health Canada through the issuance of an NOC and certify that “all aspects of the [administrative] submission pertaining to [the drug] are identical to [the previously approved submission] except for a change in the manufacture/sponsor’s name and/or product name and that the product will be manufactured at the same location with identical specifications and procedures.” [ 30 ] Such minimal information is required because, from a safety and efficacy point of view, nothing changes when the manufacturer and/or the product name are the only variations from a drug previously approved under an NDS or ANDS. [ 31 ] Until the changes to the Guidance Document giving rise to this litigation, which became effective in April 2012, Health Canada required licensees who submitted administrative drug submissions as a result of a licensing agreement to comply with

section 5 of the PMNOC Regulations and therefore required them to address any patents on the patent register to which they directly or indirectly compared their products. Thus, prior to the disputed amendments to the Guidance Document, a second generic company that obtained a licence from a first generic company to sell an identical drug, under the label and name of the second generic company, was required to comply with

section 5 of the PMNOC Regulations. In some circumstances, this, in turn, afforded the innovator company that held the listed patents for the drug in question the ability to benefit from sections 6 and 7 of the PMNOC Regulations. [ 32 ] More specifically, such rights previously accrued to an innovator company whose patents were listed on the patent register in any circumstance involving licensing from one generic company to another except where the innovator company had already lost a prohibition application on similar grounds before this Court in respect of the drug produced by the first generic company.

If that had occurred, the doctrine of abuse of process, as provided for in paragraph 6(5) (

b) of the PMNOC Regulations , would have prevented the innovator company from re-litigating the same allegations against the second generic company (see in this regard Sanofi-Aventis Canada Inc. v. Novopharm Ltd. , 2007 FCA 163 , [2008] 1 F.C.R. 174). [ 33 ] Under the disputed change to the Guidance Document , Health Canada no longer requires compliance with

section 5 of the PMNOC Regulations by licensees who obtain a licence from another generic company to market a drug that is identical to the drug produced by a licensor who has been issued an NOC. Health Canada described this change in the following terms in the current version of the Guidance Document [at pages 17–18]: When a manufacturer of a currently marketed drug licenses another manufacturer to sell the identical drug in Canada under a different name, the licensee is required to file an administrative drug submission and such a submission must be cross-referenced to the licensor’s drug submission.

Under the previous requirements, drug manufacturers who submitted administrative drug submissions pursuant to a licensing agreement triggered the application of

section 5 of the PM(NOC) Regulations . While compliance with

section 5 is appropriate for most new drug submissions approved on the basis of a direct or indirect comparison or reference to an innovative drug, such compliance becomes redundant, for example, in the case where an administrative drug submission is approved on the basis of a cross-reference to a previously submitted new drug submission (NDS) or ANDS, which in turn was approved on the basis of a direct or indirect comparison or reference to an innovative drug. Requiring a licensee, who seeks approval to sell the identical drug in Canada as that of the licensor under a different name, to re-address patents already addressed by the licensor in its submission is not specifically required under

section 5 of the PM(NOC) Regulations . Under the current requirements, only the originating NDS or originating ANDS (i.e. the licensor’s drug submission) which directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under an NOC issued to a first person, triggers the application of

section 5 of the PM(NOC) Regulations and, as such, the licensor must address any patents listed on the Patent

Register in respect of the innovative product. [ 34 ] Health Canada provided advance notice to affected parties of its intent to change the Guidance Document in this fashion and invited comments from interested parties. Pfizer made no complaints about the proposed changes, and there is no suggestion that it was not aware of them. III.

The Background to this Application [ 35 ] Having reviewed the relevant regulatory provisions and policy documents, I turn now to discuss the background to the present judicial review application. [ 36 ] In this regard, Pfizer sells exemestane, a breast cancer drug, in Canada under the brand name AROMASIN. Since May 18, 2006, the patent register has listed Patent No. 2409059 (the '059 patent) against AROMASIN. The '059 patent expires on April 25, 2021. A.

The first NOC to Teva [ 37 ] On May 22, 2012, a generic company called Generic Medical Partners Inc. (GMP) filed an ANDS with the Minister seeking approval to market 25 mg exemestane tablets under the trade-name MED-EXEMESTANE. [ 38 ] On June 27, 2012, GMP sent Pfizer an NOA with respect to the drug CRESTOR (rosuvastatin calcium), which is not marketed by Pfizer but, rather, by another innovator company, AstraZeneca Canada Inc.

It seems that GMP meant to serve Pfizer with an NOA for AROMASIN but accidentally sent the wrong one. [ 39 ] Health Canada issued an NOC for exemestane to GMP on June 10, 2013. [ 40 ] On June 18, 2013, Teva filed an administrative drug submission with Health Canada seeking approval to market exemestane tablets under the trade-name TEVA-EXEMESTANE. Health Canada granted an NOC to Teva on July 4, 2013. [ 41 ] On July 10, 2013, Pfizer discovered that NOCs had been issued to GMP and Teva for exemestane.

On August 10, 2013, Pfizer commenced an application for judicial review in this Court seeking to quash the NOC issued to Teva (in Court File T-1321-13). [ 42 ] On August 13, 2013, GMP sent a letter to the Office of Patented Medicines and Liaison (OPML) at Health Canada indicating that it had sent the wrong NOA to Pfizer. On August 14, 2013, Health Canada informed GMP and Teva that the NOCs issued to them in respect of exemestane should not have been issued and would be rescinded.

Consequently, Pfizer discontinued its judicial review application in Court File T-1321-13. [ 43 ] As a result of these proceedings, Pfizer was put on notice of the likelihood that GMP would license Teva to produce exemestane under Teva’s label if GMP were issued an NOC for its version of the drug. Teva is engaged in the Canadian market as a marketer of generic drugs but GMP is not. B. The second NOC to GMP and Teva [ 44 ] On August 16, 2013, Pfizer received an NOA from GMP with respect to the '059 patent.

Pfizer chose not to commence a prohibition application against GMP, and claims that it made this choice because GMP does not sell products in Canada. [ 45 ] On October 1, 2013, Health Canada issued a new NOC to GMP for exemestane. An excerpt from Health Canada’s database shows that Health Canada determined the Canadian reference product for GMP’s second NOC was AROMASIN. [ 46 ] On October 1, 2013, Health Canada also issued an NOC to Teva with respect to exemestane.

The printout from Health Canada’s Drug Submission Tracking System that Health Canada filed as part of the tribunal record in this matter shows that Teva filed an administrative ANDS with Health Canada, based on a licensing agreement with GMP, and that Health Canada determined the Canadian reference product for Teva’s NOC was AROMASIN. The NOC issued to Teva also shows AROMASIN as the Canadian reference product. IV.

The Parties’ Positions [ 47 ] Pfizer submits that the Minister of Health was prohibited from issuing the NOC to Teva under the PMNOC Regulations , arguing that both the clear wording of the regulations and the decided authorities support its position as Teva made a comparison to AROMASIN in its submission, thereby falling within the scope of subsection 5(1) of the PMNOC Regulations.

Although the administrative submission Teva made was not filed, the NOC issued by the Minister of Health names AROMASIN as the Canadian reference Product, which Pfizer says shows that Teva either directly or indirectly compared its product to AROMASIN. It submits that under the clear wording of subsection 5(1) of the PMNOC Regulations, Teva was required to serve it with an NOA because its submission made such a comparison.

As it failed to do so, Pfizer says that the Minister of Health was prohibited from issuing the NOC by virtue of the combined effect of subsections 7(1) and 5(1) of the PMNOC Regulations. [ 48 ] Pfizer submits that in reviewing the Minister’s decision to issue the NOCs, the Court should apply the correctness standard of review. It points to several cases in support of this assertion, where this Court and the Federal Court of Appeal have applied the correctness standard to similar decisions.

It concedes, though, that these authorities predate several of the recent pronouncements by the Supreme Court of Canada on standard of review issues which mandate a greater degree of deference to administrative decision makers’ decisions. [ 49 ] Pfizer argues in the alternative that even if the reasonableness standard of review is applied by reason of the recent Supreme Court jurisprudence, Pfizer nonetheless should be afforded the remedies it seeks because the Minister’s

interpretation of the PMNOC Regulations is unreasonable in light of their clear wording.

[ 50 ] Counsel for the Minister of Health submitted as a preliminary matter that the Attorney General should be added as a respondent. None of the other parties takes issue with this and the style of cause will accordingly be amended to add the Attorney General as a respondent.

For simplicity’s sake I term the governmental respondents in these reasons the “Attorney General”. [ 51 ] On the merits of the application, counsel for the Attorney General, who carried the argument in response, submits that the recent standard of review jurisprudence requires that the reasonableness standard be applied to the review of the Minister’s decision to issue an NOC to Teva because the decision was premised on the

interpretation of the PMNOC Regulations , which she argues are the Minister of Health’s “home territory”. More specifically, counsel argued that under the recent jurisprudence from the Supreme Court of Canada and some of the case law from the Federal Court of Appeal, decisions like the present—that involve

interpretation of an administrative decision maker’s home statute or regulation—must be afforded deference. Counsel for the Attorney General in addition submits that officials at the OPML possess significant expertise in the

interpretation of the PMNOC Regulations, which this Court lacks, providing another reason why the applicable standard of review should be reasonableness. She also says that the change in

interpretation of the PMNOC Regulations, reflected in the impugned amendments to the Guidance Document, represents policy choices made by the Minister of Health, which should be afforded deference. [ 52 ] The Attorney General also argues that the PMNOC Regulations allow for two reasonable

interpretations as to whether a licensee like Teva needs to comply with subsection 5(1) of the PMNOC Regulations, particularly when one applies a purposive approach to

interpretation. In this regard, the Attorney General says that the PMNOC Regulations exist to balance the rights of patentees, generic companies and the public so as to afford patentees the opportunity to protect their patents while ensuring the entry onto the market of cheaper generic versions of a drug as soon as possible.

When read in this light, the PMNOC Regulations do not require Teva to address the '059 patent, according to the Attorney General, because Pfizer had the opportunity to protect its rights to the '059 patent and could have commenced a prohibition application when GMP served it with an NOA, particularly as it should have realized that GMP was likely to issue a licence to Teva.

Thus, according to counsel for the Attorney General, it was not necessary that Pfizer receive an NOA from Teva as Pfizer was given but declined to take up the opportunity to protect its rights to the '059 patent when it received the NOA from GMP for its exemestane product. In addition, the Attorney General says that the equities of the situation should weigh heavily in favour of the respondents as the current

interpretation afforded to the PMNOC Regulations by the Minister of Health fully protects innovator companies’ patent rights and avoids unnecessary administrative burdens. [ 53 ] In the alternative, the Attorney General argues that the current

interpretation afforded to the PMNOC Regulations by the Minister of Health is correct and that this application should therefore be dismissed. V. The Issues and

Summary of the Conclusions Reached [ 54 ] As is apparent from the foregoing, the first issue that must be determined is whether the correctness or reasonableness standard is to be applied to the review of the Minister of Health’s decision to award an NOC to Teva. Implicit in this decision is the adoption by the Minister of the new

interpretation of the PMNOC Regulations , set out in the amendments to the Guidance Document. Thus, determination of the appropriate standard of review requires assessment of the standard applicable to the Minister’s

interpretation of the PMNOC Regulations. [ 55 ] For the reasons more fully set out below, I have concluded that the correctness standard is applicable to this decision and

interpretation, despite the recent case law of the Supreme Court of Canada which mandates a greater degree of deference by reviewing courts. I have so concluded because the relevant regulatory and statutory context indicates that the

interpretation of the PMNOC Regulations is not a matter in respect of which the Minister of Health (or more accurately officials in the OPML at Health Canada) are to be afforded deference. [ 56 ] Selection of the appropriate standard of review in this case determines the outcome as I agree with the Attorney General that there is more than one reasonable

interpretation of the PMNOC Regulations . However, there is only one correct

interpretation and, as is more fully discussed below, under that

interpretation the Minister was prevented from issuing the impugned NOC to Teva as subsections 5(1) and 7(1) of the PMNOC Regulations prevent this. VI.

The Appropriate Standard of Review [ 57 ] Turning, first, to more fully discuss the standard of review, the parties raise several issues with respect to the principles applicable to the selection of the appropriate standard of review in this case. [ 58 ] First, they differ as to whether the jurisprudence of this Court and of the Federal Court of Appeal, previously applying a correctness standard to decisions of the Minister of Health under the PMNOC Regulations , settles the question because that jurisprudence predates much of the recent case law from the Supreme Court of Canada and several recent decisions from the Federal Court of Appeal, mandating increased deference to administrative decision makers’ decisions.

Pfizer argues that despite this, the previous decisions under the PMNOC Regulations are binding and that I am therefore required to apply a correctness standard to the review of the Minister’s decision in this case. The Attorney General argues the converse. [ 59 ] Second, the parties differ as to the impact of the fact that the decision maker in this case is the Minister of Health (through officials at the OPML) as opposed to an administrative tribunal. Pfizer argues that in light of the decisions of the Federal Court of Appeal in Eli Lilly Canada Inc. v.

Canada (Minister of Health) , 2003 FCA 24 , [2003] 3 F.C. 140 ( Tazidime ), at paragraph 5 and Takeda Canada Inc. v. Canada (Health) , 2013 FCA 13 , [2014] 3 F.C.R. 70 ( Takeda ), at paragraphs 26–30 , ministers and ministerial delegates are not to be afforded deference in respect of their

interpretations of the statutory provisions they are applying. The respondents disagree and note that this line of authority from the Federal Court of Appeal is not unanimous and say that in any event it has been foreclosed by the decisions of the Supreme Court of Canada in Agraira v. Canada (Public Safety and Emergency Preparedness) , 2013 SCC 36 , [2013] 2 S.C.R. 559 ( Agraira ) and Canadian National Railway Co. v. Canada (Attorney General) , 2014 SCC 40 , [2014] 2 S.C.R. 135 ( CN ).

They therefore argue that the identity of the decision maker in this case does not necessarily mandate the selection of the correctness standard of review. [ 60 ] Finally, the parties differ as to the impact of the decision of the Supreme Court of Canada in CN , a recent authority on standard of

review issues.

The Attorney General submits that in CN the Supreme Court held that the reasonableness standard is always applicablewhenever an administrative decision maker interprets its constituent statute or regulation or a statute or regulation that is closelyconnected with its function, unless the decision falls into one of four exceptions, being decisions involving a true question of jurisdiction,a question of law of general importance to the legal system as a whole and outside the expertise of the decision maker, determination ofthe respective jurisdiction of two or more administrative tribunals or a constitutional issue.

The Attorney General therefore argues that itis no longer appropriate to have regard to the contextual factors mentioned in previous decisions as being relevant to the selection of thestandard of review, namely, the presence or absence of a privative clause, the nature of the decision maker and the assessment of itsexpertise in respect of the question at issue as compared to the Court’s expertise on the issue. Pfizer disagrees and asserts that thesefactors continue to be relevant and in this case point to the selection of the correctness standard of review. A.

The Impact of the Previous Case Law applying a Correctness Standard to the Review of Decisions of the Minister of Healthunder the PMNOC Regulations [61] Insofar as concerns the first of these arguments, as Pfizer correctly notes, this Court and the Federal Court of Appeal havepreviously overturned decisions of the Minister of Health under the PMNOC Regulations and in so doing have afforded no deference tothe Minister’s decisions.

For example, in Nu-Pharm 1, both this Court and the Federal Court of Appeal overturned a decision of theMinister issuing an NOC to a generic company that had compared its product to that of another generic company without serving anNOA on the patentee. In overturning the decision to issue the NOC in that case, the Courts held that the Minister had incorrectlyinterpreted the requirements of sections 5 and 7 of the PMNOC Regulations and therefore set the decision aside. A similar determinationwas made in Merck & Co., Inc. v.

Canada (Attorney General), , 176 F.T.R. 21 (F.C.T.D.), affd , 5C.P.R. (4th) 138 (F.C.A.) (Nu-Pharm 2).

Both Nu-Pharm cases involved situations similar to the present. [62] The correctness standard has likewise previously been applied in the review of other types of decisions made by the Minister ofHealth under the PMNOC Regulations (see in this regard Tazidime, at paragraph 5; AstraZeneca, at paragraph 25; Takeda, at paragraphs26–30). [63] Pfizer argues that the foregoing authorities mandate that the correctness standard of review be applied in this case as thedecisions of the [Federal] Court of Appeal are binding on me and have settled the issue. Pfizer notes that in the seminal decision ofDunsmuir v.

New Brunswick, 2008 SCC 9, [2008] 1 S.C.R. 190 (Dunsmuir), where the Supreme Court of Canada laid out the currentapproach to standard of review issues, the Court held that a full standard of review analysis is not required in circumstances where theprevious jurisprudence has satisfactorily settled the applicable standard to be applied. Pfizer points to paragraphs 57 and 62 in Dunsmuir,where Justices LeBel and Bastarache, who wrote for the Court, stated as follows: An exhaustive review is not required in every case to determine the proper standard of review.

Here again, existing jurisprudence may behelpful in identifying some of the questions that generally fall to be determined according to the correctness standard (CartawayResources Corp. (Re), [2004] 1 S.C.R. 672, 2004 SCC 26). This simply means that the analysis required is already deemed to have beenperformed and need not be repeated. … … the process of judicial review involves two steps. First, courts ascertain whether the jurisprudence has already determined in asatisfactory manner the degree of defence to be accorded with regard to a particular category of question.

Second, where the first inquiryproves unfruitful, courts must proceed to an analysis of the factors making it possible to identify the proper standard of review. [64] Pfizer says that in application of the foregoing, the correctness standard must be applied to the decision of the Minister in thiscase as the jurisprudence has settled that this is the standard of review applicable to ministerial decisions to issue NOCs under thePMNOC Regulations. [65] The Attorney General disagrees and argues that the forgoing passages in Dunsmuir must be read in light of the subsequentjurisprudence from the Supreme Court of Canada.

The Attorney General asserts that this subsequent case law makes it clear that there isat least a presumption that the reasonableness standard should be applied whenever an administrative decision-maker interprets itsconstituent statute or regulation or a statute or regulation closely connected with its function, unless the decision involves a constitutionalissue, a question of general importance for the legal system as a whole that is outside the decision maker’s expertise, the division ofjurisdiction between two or more administrative tribunals or a true question of jurisdiction.

In support of this argument, the AttorneyGeneral relies on Dunsmuir, at paragraphs 55 and 60, Alberta (Information and Privacy Commissioner) v. Alberta Teachers’Association, 2011 SCC 61, [2011] 3 S.C.R. 654 (Alberta Teachers), at paragraph 39 and McLean v.

British Columbia (SecuritiesCommission), 2013 SCC 67, [2013] 3 S.C.R. 895 (McLean), at paragraph 33. [66] In light of these pronouncements from the Supreme Court of Canada subsequent to Dunsmuir, the Attorney General says thatpre-Dunsmuir case law mandating the correctness standard of review cannot be said to satisfactorily settle that the correctness standardis applicable where what is at issue is an administrative decision maker’s

interpretation of its constituent statute or regulations it is calledupon to apply. [67] I agree with the position advanced by the Attorney General on this point as the case law of the Supreme Court of Canadasubsequent to Dunsmuir makes it clear that the reasonableness standard is presumptively applicable whenever an administrative decisionmaker interprets its constituent statute or a statute or regulation that is closely connected with its function, unless the decision involves aconstitutional issue, a question of general importance for the legal system as a whole that is outside the decision maker’s expertise, thedivision of jurisdiction between two or more administrative tribunals or a true question of jurisdiction. [68] For example, the deferential standard was applied to the review of: (

i) a decision by the Financial Services Tribunal declining toaward costs to the appellants out of its pension trust fund on the basis that it lacked the authority to do so (Nolan v. Kerry (Canada) Inc.,2009 SCC 39, [2009] 2 S.C.R. 678, at paragraph 34); (ii) a decision by the Patented Medicine Prices Review Board interpreting itsenabling legislation (Celgene Corp. v. Canada (Attorney General), 2011 SCC 1, [2011] 1 S.C.R. 3, at paragraph 34); (iii) the ArbitrationCommittee’s

interpretation of a provision in its enabling statute regarding the awarding of costs (Smith v. Alliance Pipeline Ltd., 2011

SCC 7 , [2011] 1 S.C.R. 160 ( Smith ), at paragraph 28 ); (iv) the Canadian Human Rights Commission’s decision that it had the authority under its enabling legislation to award costs in Canada (Canadian Human Rights Commission) v. Canada (Attorney General) , 2011 SCC 53 , [2011] 3 S.C.R. 471 ( Mowat ), at paragraphs 15–27 ; (

v) a decision by implication by the Information and Privacy Commissioner of Alberta that it was entitled under its enabling statute to extend the statutory time limit to complete an inquiry ( Alberta Teachers , at paragraph 30); (vi) an implicit decision by the British Columbia Securities Commission interpreting a limitation provision in its home statute ( McLean , at paragraphs 21–22 ); and (vii) a decision of the Governor in Council under the Canada Transportation Act , S.C. 1996, c. 10 ( CN , at paragraph 55). [ 69 ] In each of these cases the Supreme Court wrote broadly, indicating that there is a presumption that the reasonableness standard applies whenever an administrative decision maker interprets its constituent statute or a statute closely related to its function (unless one of the foregoing four exceptions applies).

In so doing, the Court did not carve out an additional exception for situations where the pre- Dunsmuir case law had applied the correctness standard to review of an administrative decision maker’s

interpretation of its constituent statute or a statute closely related to its function. [ 70 ] In light of these decisions, in my view, one cannot regard case law that predates them and which mandates the selection of correctness standard as necessarily settling the standard of review in a satisfactory way. [ 71 ] Indeed, the Supreme Court of Canada expressly endorsed this conclusion in Agraira , where Justice LeBel, writing for the Court, stated as follows (at paragraph 48): As this Court held in Dunsmuir , a court deciding an application for judicial review must engage in a two-step process to identify the proper standard of review.

First, it must consider whether the level of deference to be accorded with regard to the type of question raised on the application has been established satisfactorily in the jurisprudence. The second inquiry becomes relevant if the first is unfruitful or if the relevant precedents appear to be inconsistent with recent developments in the common law principles of judicial review.

At this second stage, the court performs a full analysis in order to determine what the applicable standard is. [ 72 ] Thus, the decisions in Nu-Pharm 1 and Nu-Pharm 2 do not obviate the need for a standard of review analysis in this case because they do not undertake the standard of review analysis mandated in Dunsmuir and subsequent Supreme Court of Canada decisions. B.

The Impact of the Identity of the Decision Maker [ 73 ] On the second argument involving the impact of the decision in this case having been made by the Minister of Health (through officials at the OPML branch at Health Canada), I once again agree with the position of the Attorney General and concur that the identity of the decision maker does not of itself result in the conclusion that the appropriate standard of review is correctness. [ 74 ] There is a line of authority from the Federal Court of Appeal that holds that the presumptive application of the reasonableness standard is inapplicable when a court is asked to review a decision made by a minister or ministerial delegate under a statutory grant of authority, where the Minister or ministerial delegate has interpreted the statutory provisions being applied.

Justice Mainville, writing for the majority in David Suzuki Foundation v. Canada (Fisheries and Oceans) , 2012 FCA 40 , [2013] 4 F.C.R. 155 ( Suzuki or Georgia Strait ) first enunciated this notion in the following terms (at paragraphs 96–99): [The Dunsmuir ] analytical framework and this presumption must be understood in the context in which they were developed: they concern adjudicative tribunals. The presumption is derived from the past jurisprudence which had extensively considered the standard of review applicable to the decisions of such tribunals.

By empowering an administrative tribunal to adjudicate a matter between parties, Parliament is presumed to have restricted judicial review of that tribunal’s

interpretation of its enabling statute and of statutes closely connected to its adjudicative functions. That presumption may however be rebutted if it can be found that Parliament’s intent is inconsistent with the presumption. The Minister is inviting this Court to expand the above-described Dunsmuir analytical framework and presumption to all administrative decision makers who are responsible for the administration of a federal statute. I do not believe that Dunsmuir and the decisions of the Supreme Court of Canada which followed Dunsmuir stand for this proposition. What the Minister is basically arguing is that the

interpretation of the SARA and of the Fisheries Act favoured by his Department and by the government’s central agencies, such as the Department of Justice, should prevail. The Minister thus seeks to establish a new constitutional paradigm under which the Executive’s

interpretation of Parliament’s laws would prevail insofar as such

interpretation is not unreasonable. This harks back to the time before the Bill of Rights of 1688 where the Crown reserved the right to interpret and apply Parliament’s laws to suit its own policy objectives. It would take a very explicit grant of authority from Parliament in order for this Court to reach such a far-reaching conclusion. The issues in this appeal concern the

interpretation of a statute by a minister who is not acting as an adjudicator and who thus has no implicit power to decide questions of law. Of course, the Minister must take a view on what the statute means in order to act. But this is not the same as having a power delegated by Parliament to decide questions of law. The presumption of deference resulting from Dunsmuir , which was reiterated in Alberta Teachers’ Association , at paragraphs 34 and 41, does not extend to these circumstances.

The standard of review analysis set out at paragraphs 63 and 64 of Dunsmuir must thus be carried out in the circumstances of this case in order to ascertain Parliament’s intent. [ 75 ] This approach has been followed by other panels of the Federal Court of Appeal (see e.g. Tobar Toledo v. Canada (Citizenship and Immigration) , 2013 FCA 226 , [2015] 1 F.C.R. 215 ( Toledo ), at paragraph 43 (reasons by Pelletier J.A, concurred by Gauthier and Trudel JJ.A.); Prescient Foundation v.

Canada (National Revenue) , 2013 FCA 120 , 358 D.L.R. (4th) 541 ( Prescient ), at paragraph 13 (reasons by Mainville J.A., concurred by Gauthier and Pelletier JJ.A.); Bartlett v. Canada (Attorney General) , 2012 FCA 230 , 365 D.L.R. (4th) 743 ( Bartlett ), at paragraph 46 (reasons by Mainville J.A, concurred by Sharlow and Pelletier JJ.A.) and Sheldon Inwentash and Lynn Factor Charitable Foundation v. Canada , 2012 FCA 136 , 2012 D.T.C. 5090 ( Sheldon ), at paragraphs 18–23 (reasons by Dawson J.A., concurred by Trudel and Stratas JJ.A.)).

[ 76 ] In Takeda , Justice Dawson writing for the majority stated as follows (at paragraphs 113–116): Application of the presumption of deference to the Minister’s

interpretation of the Data Protection Regulations is inconsistent with the prior decision of this Court in Georgia Strait . In my view, any departure from such a recent decision creates unacceptable uncertainty. This is particularly so where, in the present case, the issue was not raised. The parties were in agreement that the applicable standard of review is correctness, no one argued that the presumption of reasonableness applied and no one argued that Georgia Strait was improperly decided. Furthermore, the Supreme Court has in the past applied the correctness standard to such decisions.

For example, in AstraZeneca Canada Inc. v. Canada (Minister of Health) , 2006 SCC 49 , [2006] 2 S.C.R. 560, the Court wrote at paragraph 25: The outcome of this appeal turns on conflicting

interpretations of the NOC Regulations . On a question of legal

interpretation, the Minister’s opinion is not entitled to deference. The Federal Court of Appeal properly found that the standard of review on the point in issue is correctness. As well, the Supreme Court has, albeit without discussion of the standard of review, applied a correctness review to the Minister of Citizenship and Immigration’s

interpretation of a provision of the Immigration and Refugee Protection Act , S.C. 2001, c. 27, ( Medovarski v. Canada (Minister of Citizenship and Immigration) ; Esteban v. Canada (Minister of Citizenship and Immigration) , 2005 SCC 51 , [2005] 2 S.C.R. 539). In Hilewitz v. Canada (Minister of Citizenship and Immigration); De Jong v. Canada (Minister of Citizenship and Immigration) , 2005 SCC 57 , [2005] 2 S.C.R. 706, at paragraph 71 , the Supreme Court accepted the joint submission of the parties that correctness should be applied to a visa officer’s

interpretation of the Immigration Act , R.S.C., 1985, c. I-2. Under the Immigration Act , a “visa officer” was an “immigration officer stationed outside Canada and authorized by order of the Minister [of Citizenship and Immigration] to issue visas” (subsection 2(1) of the Immigration Act ). A visa officer was, therefore, a delegate of the Minister. [ 77 ] However, as the Attorney General notes, the Federal Court of Appeal has not unanimously adopted the approach enunciated by Justice Mainville in Suzuki .

For example, Justice Stratas in his dissenting reasons in Takeda concluded that the presumption of deference referred to in Alberta Teachers should apply not only to decisions made by adjudicative tribunals but also in the context of ministerial decisions. He wrote as follows (at paragraph 33): I am reluctant to carve out administrative decisions from the Alberta Teachers’ Association approach merely because the administrative decision maker is a minister, as is the case here.

For one thing, the Alberta Teachers’ Association approach aptly handles the breadth of ministerial decision making, which comes in all shapes and sizes, and arises in different contexts for different purposes. In addition, ministerial decision-making power is commonly delegated, as happened here. It would be arbitrary to apply the Alberta Teachers’ Association approach to decisions of administrative board members appointed by a minister (or, practically speaking, a group of ministers in the form of the Governor in Council), but apply the Georgia Strait approach to decisions of delegates chosen by a minister.

Finally, although this Court’s decision in Georgia Strait postdates that of the Supreme Court in Alberta Teachers’ Association , I consider myself bound by the latter absent further direction from the Supreme Court: see Canada v. Craig , 2012 SCC 43 , [2012] 2 S.C.R. 489, at paragraphs 18–23 ;…. [ 78 ] Justice Marc Noël (as he then was), writing for the majority in Kandola v.

Canada (Citizenship and Immigration) , 2014 FCA 85 , [2015] 1 F.C.R. 549 ( Kandola ), adopted the same view as Justice Stratas and held that the Supreme Court’s decision in Agraira had conclusively determined the issue and therefore that the presumptive application of the reasonableness standard applies to ministerial decisions (at paragraph 40). [ 79 ] Thus, both Justice Stratas in Takeda and Justice Noël in Kandola found that the presumption of reasonableness applies to ministerial decisions or to decisions made by their delegates.

Both, however, went on to note that the presumption may be rebutted by analysing the four factors discussed in Dunsmuir : (1) the presence or absence of a privative clause; (2) the purpose of the tribunal as determined by

interpretation of enabling legislation; (3) the nature of the question at issue; and (4) the expertise of the tribunal. [ 80 ] In light of the division in the Federal Court of Appeal on this issue, I agree with the Attorney General that Takeda , Suzuki , Toledo , Prescient , Bartlett and Sheldon are not binding on me. [ 81 ] Moreover, as Justice Noël noted in Kandola , decisions of the Supreme Court of Canada issued subsequent to Suzuki and Takeda foreclose the application of the correctness standard to decisions of ministerial delegates by reason of the mere identity of the decision maker. [ 82 ] In this regard, in Agraira , the Supreme Court of Canada was faced with a decision of the Minister of Public Safety and Emergency Preparedness denying relief from a determination of inadmissibility on security grounds, which involved the

interpretation of the term “national interest” in subsection 34(2) [now repealed by S.C. 2013, c. 16, s. 13 ] of the Immigration and Refugee Protection Act , S.C. 2001, c. 27. Despite this, the Court determined that the reasonableness standard of review was applicable. Justice LeBel, writing for the Court, stated as follows (at paragraph 50): The applicability of the reasonableness standard can be confirmed by following the approach discussed in Dunsmuir . As this Court noted in that case, at para. 53, “[w]here the question is one of fact, discretion or policy, deference will usually apply automatically”.

Since a decision by the Minister under s. 34(2) is discretionary, the deferential standard of reasonableness applies. Also, because such a decision involves the

interpretation of the term “national interest” in s. 34(2), it may be said that it involves a decision maker “interpreting its own statute or statutes closely connected to its function, with which it will have particular familiarity” ( Dunsmuir , at para. 54 ). This factor, too, confirms that the applicable standard is reasonableness. [ 83 ] Subsequently, in CN , the Supreme Court was faced with the review of an order by the Governor in Council, who had interpreted subsection 120.1(1) of the Canada Transportation Act . Once again, the Supreme Court held that the reasonableness standard of review was applicable.

Justice Rothstein, writing for the Court, found that the Dunsmuir framework applies to administrative decision makers generally, including the Governor in Council, and not just to administrative tribunals. He stated as follows (at paragraph 62):

In this case, the Governor in Council was interpreting the CTA , legislation closely related to its economic regulation review function. This issue of statutory

interpretation does not fall within any of the categories of questions to which a correctness review applies. As such, the applicable standard of review is reasonableness. [ 84 ] Thus, the fact that the decision to issue the NOC to Teva in this case was made by officials at the OPML and involved an implicit

interpretation of the PMNOC Regulations does not of itself translate to a need to apply the correctness standard of review as the case law from the Federal Court of Appeal is divided on the issue and the more recent jurisprudence of the Supreme Court of Canada indicates that the reasonableness standard is presumptively applicable to these sorts of decisions. C.

The Impact of the Decision of the Supreme Court in CN [ 85 ] In terms of the final principle at issue with respect to the standard of review, the Attorney General argues that in CN the Supreme Court of Canada moved its standard of review jurisprudence forward and determined there is now a firm rule that the reasonableness standard applies to the review of an administrative decision maker’s

interpretation of its constituent statute or a statute or regulation closely connected with its function except where the decision involves a constitutional question, a true jurisdictional issue, the determination of the bounds of jurisdiction between two administrative tribunals or a question of law of general importance to the legal system as a whole that is outside the administrative decision maker’s expertise.

Thus, according to the Attorney General, unless the decision involves one of the four foregoing types of issues, the reasonableness standard must be applied where the decision maker interprets its constituent statute or a statute or regulation that is closely connected with its function. [ 86 ] In support of this argument, the Attorney General points to the fact that in CN , in determining whether the presumption of reasonableness was rebutted, Justice Rothstein looked only to whether the issue that was determined by Cabinet fell within one of the four foregoing categories to which correctness applies.

The Attorney General points in particular to paragraphs 59–62 of the decision, where Justice Rothstein wrote as follows: The presumption of deference is not rebutted here. The question at issue does not fall within one of the established categories of questions to which correctness review applies. In the present case, there is no issue of constitutionality or competing jurisdiction between tribunals. This is also not a question of central importance to the legal system as a whole. The question at issue centres on the

interpretation of s. 120.1 of the CTA . The question is particular to this specific regulatory regime as it involves confidential contracts as provided for under the CTA and the availability of a complaint-based mechanism that is limited to shippers that meet the statutory conditions under s. 120.1(1) . This question does not have precedential value outside of issues arising under this statutory scheme.

To the extent that questions of true jurisdiction or vires have any currency, the Governor in Council’s determination of whether a party to a confidential contract can bring a complaint under s. 120.1 does not fall within that category. This is not an issue in which the Governor in Council was required to explicitly determine whether its own statutory grant of power gave it the authority to decide the matter (see Dunsmuir , at para. 59 ). Rather, it is simply a question of statutory

interpretation involving the issue of whether the s. 120.1 complaint mechanism is available to certain parties. This could not be a true question of jurisdiction or vires of the Governor in Council — the decision maker under review in this case. In this case, the Governor in Council was interpreting the CTA , legislation closely related to its economic regulation review function. This issue of statutory

interpretation does not fall within any of the categories of questions to which a correctness review applies. As such, the applicable standard of review is reasonableness. [ 87 ] The Attorney General argues that the foregoing passage indicates that the Supreme Court abolished the existence of a presumption

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