Pfizer Canada Inc. v. Canada (Health)

Pfizer Canada Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2014-12-19
Neutral citation
2014 FC 1243
File numbers
T-1703-13
Notes
A correction was made on February 13, 2015.
Reported Decision
Decision Content
Date: 20141219
Docket: T-1703-13
Citation: 2014 FC 1243
Ottawa, Ontario, December 19, 2014
PRESENT: The Honourable Madam Justice Gleason
BETWEEN:
PFIZER CANADA INC.
Applicant
and
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL OF CANADA AND TEVA CANADA LIMITED
Respondents
JUDGMENT AND REASONS
[1] In this application for judicial review the applicant, Pfizer Canada Inc. [Pfizer], seeks an order setting aside the decision of the Minister of Health, 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 Pfizer produces and holds patent rights for under a patent listed on the Patent Register established under sections 3 – 4 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [the PMNOC Regulations].
[2] The Minister of Health issued the NOC in question to Teva pursuant to amendments to its Guidance Document, Patented Medicines (Notice of Compliance) Regulations [the Guidance Document]. These amendments purport to allow the Minister of Health 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.
[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, CRC 1978, c 870 [the FDA Regulations], promulgated under the Food and Drugs Act, RSC 1985, c F-27, and the PMNOC Regulations, promulgated under section 55.2 of the Patent Act, RSC 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:
(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
[…]
a) une drogue qui est constituée d’une substance ou renferme une substance, sous forme d’ingrédient actif ou inerte, de véhicule, d’enrobage, d’excipient, de solvant ou de tout autre constituant, laquelle substance n’a pas été vendue comme drogue au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l’innocuité et l’efficacité de ladite substance employée comme drogue
[…]
[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:
(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.
(1) Le fabricant d’une drogue nouvelle peut déposer à l’égard de celle-ci une présentation abrégée de drogue nouvelle ou une présentation abrégée de drogue nouvelle pour usage exceptionnel si, par comparaison à un produit de référence canadien :
a) la drogue nouvelle est un équivalent pharmaceutique du produit de référence canadien;
b) elle est bioéquivalente au produit de référence canadien d’après les caractéristiques pharmaceutiques et, si le ministre l’estime nécessaire, d’après les caractéristiques en matière de biodisponibilité;
c) la voie d’administration de la drogue nouvelle est identique à celle du produit de référence canadien;
d) les conditions thérapeutiques relatives à la drogue nouvelle figurent parmi celles qui s’appliquent au produit de référence canadien.
[10] A “Canadian Reference product” is defined in paragraph C.08.001.1(a) of the 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:
(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;
[…] and
(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 the matters 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 those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters.
(1) […] il est interdit de vendre une drogue nouvelle à l’égard de laquelle un avis de conformité a été délivré à son fabricant et n’a pas été suspendu aux termes de l’article C.08.006, lorsqu’un des éléments visés au paragraphe (2) diffère sensiblement des renseignements ou du matériel contenus dans la présentation de drogue nouvelle, la présentation de drogue nouvelle pour usage exceptionnel, la présentation abrégée de drogue nouvelle ou la présentation abrégée de drogue nouvelle pour usage exceptionnel, à moins que les conditions ci-après ne soient réunies :
a) le fabricant de la drogue nouvelle a déposé auprès du ministre un supplément à la présentation;
[…]
b) le ministre a délivré au fabricant un avis de conformité relativement au supplément;
d) le fabricant de la drogue nouvelle a présenté au ministre, sous leur forme définitive, des échantillons de toute étiquette — y compris une notice jointe à l’emballage, un dépliant et une fiche sur le produit — destinée à être utilisée pour la drogue nouvelle, dans le cas où la modification d’un des éléments visés au paragraphe (2) nécessite un changement dans l’étiquette.
(2) Pour l’application du paragraphe (1), les éléments ayant trait à la drogue nouvelle sont les suivants :
[…]
b) sa marque nominative ou le nom ou code sous lequel il est proposé de l’identifier;
[…]
g) les étiquettes à utiliser pour la drogue nouvelle;
[…]
(3) Le supplément à toute présentation visée au paragraphe (1) contient, à l’égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, suffisamment de renseignements et de matériel pour permettre au ministre d’évaluer l’innocuité et l’efficacité de la drogue nouvelle relativement à ces éléments.
[14] As is apparent from the forgoing provisions (and from the FDA Regulations in their entirety), the role of the Minister of Health in issuing an NOC under these Regulations is to assess the safety and efficacy of drugs to be sold in Canada. Indeed, that this is the purpose 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 SCR 533 [Biolyse] at para 13; AstraZeneca Canada Inc. v Canada (Minister of Health), 2006 SCC 49, [2006] 2 SCR 560 [AstraZeneca] at para 12; Harris v GlaxoSmithKline Inc., 2010 ONCA 872, 78 CCLT (3d) 52 at para 8; Teva Canada Ltd. v Canada (Minister of Health), 2011 FC 507, 95 CPR (4th) 423 at para 23).
B. The PMNOC Regulations [15] The PMNOC Regulations were passed when Parliament abolished the previous system for compulsory licensing of generic drug manufacturers and enacted section 55.2 of the Patent Act. This section allows generic companies to “early work” a product, without infringing an innovator company’s patents for the drug, in order to develop a generic version of the drug and make it available as soon as possible following expiry of the relevant patents. As counsel for the Attorney General premised much of her arguments on section 55.2 of the Patent Act, the relevant portions of the section are reproduced; they provide as follows:
(1) It is not an infringement of a patent for any person to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province or a country other than Canada that regulates the manufacture, construction, use or sale of any product.
(2) and (3) [Repealed, 2001, c. 10, s. 2]
(4) The Governor in Council may make such regulations as the Governor in Council considers necessary for preventing the infringement of a patent by any person who makes, constructs, uses or sells a patented invention in accordance with subsection (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 any product to which a patent may relate may be issued to a patentee or other person under any Act of Parliament that regulates the 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 is issued or to be issued to a person other than the patentee may take effect and respecting the manner in which that date is to be 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 or other 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 and orders it may make; and
(e) generally governing the issue of a notice, certificate, permit or other document referred to in paragraph (a) in circumstances where the issue of that notice, certificate, permit or other document might result directly or indirectly in the infringement of a patent.
(1) 55.2 (1) Il n’y a pas contrefaçon de brevet lorsque l’utilisation, la fabrication, la construction ou la vente d’une invention brevetée se justifie dans la seule mesure nécessaire à la préparation et à la production du dossier d’information qu’oblige à fournir une loi fédérale, provinciale ou étrangère réglementant la fabrication, la construction, l’utilisation ou la vente d’un produit.
(2) et (3) [Abrogés, 2001, ch. 10, art. 2]
(4) Afin d’empêcher la contrefaçon d’un brevet d’invention par l’utilisateur, le fabricant, le constructeur ou le vendeur d’une invention brevetée au sens du paragraphe (1), le gouverneur en conseil peut prendre des règlements, notamment :
a) fixant des conditions complémentaires nécessaires à la délivrance, en vertu de lois fédérales régissant l’exploitation, la fabrication, la construction ou la vente de produits sur lesquels porte un brevet, d’avis, de certificats, de permis ou de tout autre titre à quiconque n’est pas le breveté;
b) concernant la première date, et la manière de la fixer, à laquelle un titre visé à l’alinéa a) peut être délivré à quelqu’un qui n’est pas le breveté et à laquelle elle peut prendre effet;
c) concernant le règlement des litiges entre le breveté, ou l’ancien titulaire du brevet, et le demandeur d’un titre visé à l’alinéa a), quant à la date à laquelle le titre en question peut être délivré ou prendre effet;
d) conférant des droits d’action devant tout tribunal compétent concernant les litiges visés à l’alinéa c), les conclusions qui peuvent être recherchées, la procédure devant ce tribunal et les décisions qui peuvent être rendues;
e) sur toute autre mesure concernant la délivrance d’un titre visé à l’alinéa a) lorsque celle-ci peut avoir pour effet la contrefaçon de brevet.
[16] The PMNOC Regulations, unlike the FDA Regulations, are not aimed at protecting the public from unsafe or inefficacious drugs but, rather, are aimed at protecting the patent rights of innovator companies and balancing those rights with the timely entry of lower priced generic competitors into the market place. The Regulatory Impact Analysis Statement [RIAS] published in the Canada Gazette Part II on October 18, 2006, when a number of amendments were made to the PMNOC Regulations, notes in this regard that the PMNOC Regulations are designed to “balance the effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors”. It elaborates as follows:
… while early-working is intended to promote the timely market entry of generic drugs by allowing them to undergo the regulatory approval 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 or innovator considers justified having regard to the generic company’s allegation. Despite their seemingly competing policy objectives, it is important that neither instrument be considered in isolation as the intended policy can only be achieved when the two operate in a balanced fashion.
[17] The case law confirms the PMNOC Regulations are aimed at protecting the rights of patentees while ensuring that generic versions of patented medicines are available to the public as early as possible (see e.g. Biolyse at paras 45-47; Nu-Pharm Inc. v Canada (Attorney General) (1997), 73 CPR (3d) 510, [1997] FCJ No 624 at para 22, aff’d (1998), 80 CPR (3d) 74, [1998] FCJ No 274 (FCA) [Nu-Pharm 1]; Apotex Inc. v Merck & Co., 2009 FCA 187, 76 CPR (4th) 1 at para 60; Apotex Inc. v Canada (Minister of Health), 2009 FC 721, 79 CPR (4th) 23 at para 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 a generic version of the patented drug onto the Canadian market until the patents expire, the innovator company consents to the generic company’s producing the drug or this Court determines that the generic company’s allegation of non-infringement or invalidity is justified. This is accomplished through the combined effect of sections 5–7 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 for an NOC that directly or indirectly compares or references its product to that of a “first person” (typically the innovator company) whose patent(s) is listed on the Patent Register, must either (1) wait for patent expiry before receiving an NOC, or (2) serve an NOA upon the first person alleging invalidity and/or non-infringement of the listed patents. Subsection 5(1) of the PMNOC Regulations, which is the key 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 indirectly compares the drug with, or makes reference to, another drug marketed in Canada under a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the second person shall, in the submission, with respect to each patent on the register in 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 the medicinal ingredient would be infringed by the second person making, constructing, using or selling the drug for which the submission is filed.
5. (1) Dans le cas où la seconde personne dépose une présentation pour un avis de conformité à l’égard d’une drogue, laquelle présentation, directement ou indirectement, compare celle-ci à une autre drogue commercialisée sur le marché canadien aux termes d’un avis de conformité délivré à la première personne et à l’égard de laquelle une liste de brevets a été présentée — ou y fait renvoi —, cette seconde personne doit, à l’égard de chaque brevet ajouté au registre pour cette autre drogue, inclure dans sa présentation :
a) soit une déclaration portant qu’elle accepte que l’avis de conformité ne sera pas délivré avant l’expiration du brevet;
b) soit une allégation portant que, selon le cas :
(i) la déclaration présentée par la première personne aux termes de l’alinéa 4(4)d) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n’est pas valide,
(iv) elle ne contreferait aucune revendication de l’ingrédient médicinal, revendication de la formulation, revendication de la forme posologique ni revendication de l’utilisation de l’ingrédient médicinal en fabriquant, construisant, utilisant ou vendant la drogue pour laquelle la présentation est déposée.
[20] Under section 6 of the PMNOC Regulations, the first person (i.e. the innovator company) who receives an NOA may seek an order of prohibition from this Court to prevent the Minister of Health from issuing an NOC to the second person (i.e. the generic company). Where this occurs, the Court is called upon to determine if the NOA is substantiated. If the Court determines that the NOA is not substantiated, a prohibition order will issue, preventing the Minister from issuing an NOC to the generic company until the expiry of the 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 of the following events: (1) the second person complies with section 5 of the PMNOC Regulations; (2) the patents at issue expire; (3) 45 days elapse after the service of the NOA and the first person has not filed a prohibition application with the Court; (4) the Court dismisses a prohibition application; (5) the first person consents to the making, constructing, using or selling of the drug in Canada by the 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 a second company an NOC until the latest of the events described in the foregoing paragraph has occurred. It provides in relevant part:
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 any patent 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).
Le ministre ne peut délivrer un avis de conformité à la seconde personne avant la plus tardive des dates suivantes :
[…]
b) la date à laquelle la seconde personne se conforme à l’article 5;
c) […] la date d’expiration de tout brevet inscrit au registre qui ne fait pas l’objet d’une allégation;
d) […] la date qui suit de quarante-cinq jours la date de réception de la preuve de signification de l’avis d’allégation visé à l’alinéa 5(3)a) à l’égard de tout brevet ajouté au registre;
e) […] la date qui suit de 24 mois la date de réception de la preuve de présentation de la demande visée au paragraphe 6(1);
f) la date d’expiration de tout brevet faisant l’objet d’une ordonnance rendue aux termes du paragraphe 6(1).
[23] By virtue of the foregoing provisions, innovator drug companies possess the ability to enjoin generic companies from entering the Canadian market with a competing version of a patented drug for 24 months or a shorter period if the prohibition application is dismissed, 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 as “a submission that does not require scientific review (for example [e.g.] changes in manufacturer or product name)”.
[28] Another Health Canada policy, the Change in Manufacturer’s Name and/or Product Name Policy, details the requirements for an administrative drug submission and the circumstances in which such a submission can be utilized. This policy provides 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 Limited, 2007 FCA 163, 59 CPR (4th) 416).
[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:
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. 2,409,059 [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 pre-date 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’ p