Takeda Canada Inc. v. Canada (Health)

Takeda Canada Inc. v. Canada (Health)
Court (s) Database
Federal Court of Appeal Decisions
Date
2013-01-18
Neutral citation
2013 FCA 13
File numbers
A-9-12
Notes
Reported Decision
Decision Content
Date: 20130118
Docket: A-9-12
Citation: 2013 FCA 13
CORAM: PELLETIER J.A.
DAWSON J.A.
STRATAS J.A.
BETWEEN:
TAKEDA CANADA INC.
Appellant
and
THE MINISTER OF HEALTH and
ATTORNEY GENERAL OF CANADA
Respondents
Heard at Ottawa, Ontario, on June 11, 2012.
Judgment delivered at Ottawa, Ontario, on January 18, 2013.
REASONS FOR JUDGMENT BY: DAWSON J.A.
CONCURRED IN BY: PELLETIER J.A.
DISSENTING REASONS BY: STRATAS J.A.
Date: 20130118
Docket: A-9-12
Citation: 2013 FCA 13
CORAM: PELLETIER J.A.
DAWSON J.A.
STRATAS J.A.
BETWEEN:
TAKEDA CANADA INC.
Appellant
and
THE MINISTER OF HEALTH and
ATTORNEY GENERAL OF CANADA
Respondents
REASONS FOR JUDGMENT
STRATAS J.A. (Dissenting reasons)
[1] The appellant, Takeda Canada Inc., appeals from the judgment dated September 12, 2011 of the Federal Court (per Justice Near): 2011 FC 1444. The Federal Court dismissed Takeda’s application for judicial review of a decision of the respondent Minister.
[2] The Minister refused to list Takeda’s drug, DEXILANT, on the Register of Innovative Drugs and provide data protection under section C.08.004.1 of the Food and Drug Regulations, C.R.C. c. 870, as amended by the Regulations Amending the Food and Drug Regulations (Data Protection), SOR/2006-241.
[3] The Minister refused to list DEXILANT based on her interpretation of the definition of “innovative drug” in subsection C.08.004.1(1) of the Regulations. The Federal Court agreed with the Minister’s interpretation, found that DEXILANT was not an “innovative drug” under the subsection, and dismissed Takeda’s application for judicial review. Takeda appeals to this Court.
[4] For the reasons set out below, I find that the Minister wrongly interpreted the term “innovative drug” under subsection C.08.004.1(1) of the Regulations. Properly interpreted, the definition of “innovative drug” under the subsection can include a drug such as DEXILANT.
[5] Therefore, I would allow Takeda’s appeal, with costs, and remit to the Minister for redetermination the issue whether DEXILIANT is an “innovative drug” entitled to data protection.
A. The data protection regulations: section C.08.004.1 of the Regulations
[6] The provisions contained in Section C.08.004.1 of the Regulations are frequently described as the “data protection regulations.” The data protection regulations protect an innovator who submits undisclosed data in support of an application for approval to market certain drugs in certain circumstances, described below. For a period of time, it prevents others from using the innovator’s data in support of their own submissions for drug approval.
[7] Before the enactment of the data protection regulations, one of the impediments to a generic drug manufacturer’s ability to obtain approval of the right to market a generic drug was the existence of an unexpired patent. After the enactment of the data protection regulations, generic drug manufacturers cannot obtain approval for their generic drug until the period of market exclusivity of the innovative drug has expired, even where there is no patent protection for that drug.
[8] The data protection regulations read as follows:
C.08.004.1 (1) The following definitions apply in this section.
“abbreviated new drug submission” includes an abbreviated extraordinary use new drug submission. (présentation abrégée de drogue nouvelle)
“innovative drug” means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (drogue innovante)
“new drug submission” includes an extraordinary use new drug submission. (présentation de drogue nouvelle)
“pediatric populations” means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. (population pédiatrique)
(2) This section applies to the implementation of Article 1711 of the North American Free Trade Agreement, as defined in the definition "Agreement" in subsection 2(1) of the North American Free Trade Agreement Implementation Act, and of paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the World Trade Organization Agreement, as defined in the definition "Agreement" in subsection 2(1) of the World Trade Organization Agreement Implementation Act.
(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,
(a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and
(b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.
(4) The period specified in paragraph (3)(b) is lengthened to eight years and six months if
(a) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and
(b) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would thereby provide a health benefit to members of those populations.
(5) Subsection (3) does not apply if the innovative drug is not being marketed in Canada.
(6) Paragraph (3)(a) does not apply to a subsequent manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the subsequent manufacturer before the end of the period of six years specified in that paragraph.
(7) Paragraph (3)(a) does not apply to a subsequent manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.
(8) Paragraph (3)(b) does not apply to a subsequent manufacturer if the innovator consents to the issuance of a notice of compliance to the subsequent manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).
(9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4).
C.08.004.1 Les définitions qui suivent s’appliquent au présent article.
« drogue innovante » S’entend de toute drogue qui contient un ingrédient médicinal non déjà approuvé dans une drogue par le ministre et qui ne constitue pas une variante d’un ingrédient médicinal déjà approuvé tel un changement de sel, d’ester, d’énantiomère, de solvate ou de polymorphe. (innovative drug)
« population pédiatrique » S’entend de chacun des groupes suivants : les bébés prématurés nés avant la 37e semaine de gestation, les bébés menés à terme et âgés de 0 à 27 jours, tous les enfants âgés de 28 jours à deux ans, ceux âgés de deux ans et un jour à 11 ans et ceux âgés de 11 ans et un jour à 18 ans. (pediatric populations)
« présentation abrégée de drogue nouvelle » S’entend également d’une présentation abrégée de drogue nouvelle pour usage exceptionnel. (abbreviated new drug submission)
« présentation de drogue nouvelle » S’entend également d’une présentation de drogue nouvelle pour usage exceptionnel. (new drug submission)
(2) Le présent article s’applique à la mise en œuvre de l’article 1711 de l’Accord de libre-échange nord-américain, au sens du terme « Accord » au paragraphe 2(1) de la Loi de mise en œuvre de l’Accord de libre-échange nord-américain, et du paragraphe 3 de l’article 39 de l’Accord sur les aspects des droits de propriété intellectuelle qui touchent au commerce figurant à l’annexe 1C de l’Accord sur l’Organisation mondiale du commerce, au sens du terme « Accord » au paragraphe 2(1) de la Loi de mise en œuvre de l’Accord sur l’Organisation mondiale du commerce.
(3) Lorsque le fabricant demande la délivrance d’un avis de conformité pour une drogue nouvelle sur la base d’une comparaison directe ou indirecte entre celle-ci et la drogue innovante :
a) le fabricant ne peut déposer pour cette drogue nouvelle de présentation de drogue nouvelle, de présentation abrégée de drogue nouvelle ou de supplément à l’une de ces présentations avant l’expiration d’un délai de six ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante;
b) le ministre ne peut approuver une telle présentation ou un tel supplément et ne peut délivrer d’avis de conformité pour cette nouvelle drogue avant l’expiration d’un délai de huit ans suivant la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante.
(4) Le délai prévu à l’alinéa (3)b) est porté à huit ans et six mois si, à la fois:
a) l’innovateur fournit au ministre la description et les résultats des essais cliniques concernant l’utilisation de la drogue innovante dans les populations pédiatriques concernées dans sa première présentation de drogue nouvelle à l’égard de la drogue innovante ou dans tout supplément à une telle présentation déposé au cours des cinq années suivant la délivrance du premier avis de conformité à l’égard de cette drogue innovante;
b) le ministre conclut, avant l’expiration du délai de six ans qui suit la date à laquelle le premier avis de conformité a été délivré à l’innovateur pour la drogue innovante, que les essais cliniques ont été conçus et menés en vue d’élargir les connaissances sur l’utilisation de cette drogue dans les populations pédiatriques visées et que ces connaissances se traduiraient par des avantages pour la santé des membres de celles-ci.
(5) Le paragraphe (3) ne s’applique pas si la drogue innovante n’est pas commercialisée au Canada.
(6) L’alinéa (3)a) ne s’applique pas au fabricant ultérieur dans le cas où l’innovateur consent à ce qu’il dépose une présentation de drogue nouvelle, une présentation abrégée de drogue nouvelle ou un supplément à l’une de ces présentations avant l’expiration du délai de six ans prévu à cet alinéa.
(7) L’alinéa (3)a) ne s’applique pas au fabricant ultérieur s’il dépose une demande d’autorisation pour vendre cette drogue nouvelle aux termes de l’article C.07.003.
(8) L’alinéa (3)b) ne s’applique pas au fabricant ultérieur dans le cas où l’innovateur consent à ce que lui soit délivré un avis de conformité avant l’expiration du délai de huit ans prévu à cet alinéa ou de huit ans et six mois prévu au paragraphe (4).
(9) Le ministre tient un registre des drogues innovantes, lequel contient les renseignements relatifs à l’application des paragraphes (3) et (4).
[9] As the above section shows, data protection is available for “innovative drugs.” This term is defined in subsection C.08.004.1(1) of the Regulations.
[10] There are two components to the definition of “innovative drug” in subsection C.08.004.1(1). In order to be an “innovative drug,” the drug must:
● “[contain] a medicinal ingredient not previously approved in a drug by the Minister”; and
● not “[be] a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.”
B. The basic facts
[11] DEXILIANT is a “new drug” under Canada’s drug approval regulatory regime. It is used in the treatment of gastroesophageal reflux disease, a common, recurring problem affecting 10%-20% of the Canadian population.
[12] The medicinal ingredient in DEXILIANT is dexlansoprazole. The parties agree that dexlansoprazole has not been previously approved in a drug by the Minister.
[13] The dispute between the parties concerns whether dexlansoprazole is a “variation.” If it is, it cannot qualify as an “innovative drug.”
[14] The parties agree that lansoprazole, a medicinal ingredient previously approved by the Minister, is a racemic mixture of two enantiomers, one of which is dexlansoprazole.
[15] Therefore, the question whether the enantiomer dexlansoprazole is a “variation” boils down to this. Under subsection C.08.004.1(1), is an enantiomer of a medicinal ingredient previously approved by the Minister automatically a “variation”? In her decision under review, and in her submissions in the Federal Court and in this Court, the Minister answers that question in the affirmative.
C. Takeda’s request for data protection and the Minister’s decision
[16] On July 16, 2009, Takeda requested data protection for DEXILANT. In support of its request, Takeda advised the Minister that it had to conduct an extensive clinical program to establish DEXILANT’s efficacy and safety. According to Takeda, the resulting clinical data, appearing in the new drug submission delivered to the Minister, was generated only as a result of its considerable efforts. In Takeda’s view, the granting of data protection for DEXILANT was consistent with the wording of the data protection regulations, the purpose behind the data protection regulations, and Canada’s treaty obligations that prompted the enactment of the data protection regulations.
[17] The Minister disagreed. While she granted regulatory approval (a notice of compliance) to DEXILANT, she rejected Takeda’s request for data protection. In her view, DEXILANT was not an “innovative drug” because its medicinal ingredient, dexlansoprazole is an enantiomer of lansoprazole. In her view, drugs containing any of the listed variations of a previously approved medicinal ingredient (here an enantiomer) can never be an “innovative drug,” regardless of the innovator’s effort in developing the drug. Any drug containing a medicinal ingredient that is an enantiomer of a previously approved medicinal ingredient is automatically a “variation.”
[18] For the Minister, that was the end of the matter: DEXILANT could not qualify as an “innovative drug” and receive data protection.
D. Proceedings in the Federal Court
[19] Takeda sought judicial review of the Minister’s decision.
[20] Takeda’s submissions focused on the word “variation” in the definition of “innovative drug” in subsection C.08.004.1(1). It submitted that the five categories of substances listed in the subsection – salts, esters, enantiomers, solvates or polymorphs – were only examples of what might be considered to be a “variation.”
[21] The Federal Court reviewed the Minister’s decision, in particular its interpretation of subsection C.08.004.1(1), on a correctness standard. It dismissed Takeda’s judicial review, substantially agreeing with the Minister’s interpretation of the subsection.
[22] Takeda notes, however, that the reasons of the Court do contain some ambiguity. At one point, the Federal Court describes the five categories of substances as “presumed” variations (at paragraphs 32 and 36), perhaps implying that they are not automatically excluded from the definition of “innovative drug.” But at another point, the Federal Court finds that the five categories of substances are “excluded from the outset” (paragraph 37). Takeda now appeals to this Court.
E. Proceedings in this Court
[23] Before us, the Minister defends her decision, relying upon a literal reading of subsection C.08.004.1(1). To her, the words are clear: the five categories of substances listed in the subsection are automatically excluded, cannot qualify as “innovative drugs,” and thus cannot benefit from data protection.
[24] Takeda repeats many of the submissions it made in the Federal Court. In its view, the Minister takes too literal a reading of the text of the subsection. Takeda suggests that the words “variation…such as a[n]…enantiomer” do not mean that all enantiomers are “variations.”
[25] Takeda encourages this Court to adopt a contextual and purposive interpretation of the term “variation,” one which requires the Minister to assess the nature and extent of the data required to get approval for the drug. In its view, the subsection protects clinical and pre-clinical data necessary for regulatory approval if generating that data required “considerable effort.”
F. Analysis
(1) The standard of review
[26] In this Court, both parties agree that the Federal Court adopted the correct standard of review, correctness. I agree that the standard of review is correctness.
[27] This Court has not previously decided the issue of the standard of review of Ministerial interpretations of the data protection provisions under the Food and Drug Regulations. The interpretation of subsection C.08.004.1(1) arose in the recent case of Teva Canada Limited v. Canada (Health), 2012 FCA 106. However, this Court did not decide the standard of review issue because the Minister had correctly interpreted the Regulations (at paragraph 9).
[28] The Supreme Court has spoken of a presumption that the standard of review is reasonableness for the legislative interpretations of administrative decision-makers: Alberta (Information and Privacy Commissioner) v. Alberta Teachers' Association, 2011 SCC 61, [2011] 3 S.C.R. 654 at paragraph 34. But that is a rebuttable presumption that can be overcome upon an analysis of the four relevant factors discussed in Dunsmuir.
[29] In my view, the presumption is overcome. All of the factors relevant to determining the standard of review lean in favour of correctness review. In this case, the nature of the question is purely legal. There is no privative clause. The Minister has no expertise in legal interpretation. There is nothing in the structure of the Act, this regulatory regime or this particular legislative provision that suggests that deference should be accorded to the Minister’s decision. This analysis of the factors mirrors that in Canada (Fisheries and Oceans) v. David Suzuki Foundation, 2012 FCA 40 at paragraphs 101-105 (sometimes also referred to as “Georgia Strait”); Sheldon Inwentash and Lynn Factor Charitable Foundation v. Canada, 2012 FCA 136 at paragraphs 18-23.
[30] I am comforted in this conclusion by the application of the correctness standard to Ministerial interpretations of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133: Bristol-Myers Squibb Co. v. Canada (Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533 at paragraph 36; AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] 2 S.C.R. 560; Purdue Pharma v. Canada (Attorney General), 2011 FCA 132 at paragraph 13. Although different regulations are involved in this case, both concern Minister-administered regimes governing the period before drugs are authorized for sale. It would be anomalous if the standards of review differed.
[31] Before leaving the standard of review issue, I wish to address the view of my colleague, Justice Dawson, that Alberta Teachers’ Association does not apply to this case because of this Court’s decision in Georgia Strait.
[32] In this case, Parliament empowered the Governor in Council to establish through regulation an administrative scheme that provides for data protection. Parliament could have given this matter to courts, but it did not. Due to this primary indication of Parliamentary intention, the presumption of reasonableness review of administrative decision-makers’ decisions in Alberta Teachers’ Association should apply. However, this presumption can be rebutted in particular cases by examining the normal standard of review factors which shed more light on the matter. This approach, which I shall call the Alberta Teachers’ Association approach, is the one I have followed.
[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 at paragraphs 18-23; see also earlier expressions of uncertainty concerning the standard of review of Ministerial decision-making in Global Wireless Management v. Public Mobile Inc., 2011 FCA 194, [2011] 3 F.C.R. 344 at paragraph 35 (leave denied, April 26, 2012) and Toussaint v. Canada (Attorney General), 2011 FCA 213, 420 N.R. 213 at paragraph 19 (leave denied, April 5, 2012).
[34] In any event, I do not see the Alberta Teachers’ Association approach as being much different from the approach actually followed in Georgia Strait. Indeed, in this case, the two lead to the same result, as I agree with my colleague that the standard of review in this case is correctness.
(2) The interpretation issue
[35] For the reasons set out below, Takeda’s interpretation of subsection C.08.004.1(1) is to be preferred. The Minister’s interpretation is too literal and runs counter to the context surrounding and the purpose underlying the data protection regulations.
[36] In brief, my interpretation of subsection C.08.004.1(1) is as follows.
[37] A drug that contains an enantiomer of a previously approved medicinal ingredient is not automatically excluded from data protection under subsection C.08.004.1(1) of the Regulations. The listed substances in the definition of “innovative drug” – salts, esters, enantiomers, solvates or polymorphs – are examples of substances that may be “variations,” depending on the circumstances, and invite special scrutiny.
[38] Whether an enantiomer is a “variation” of a previously approved medicinal ingredient depends on the circumstances surrounding the data that had to be submitted to get regulatory approval. In particular, if regulatory approval for the drug required the submission of confidential data generated by considerable effort – e.g., new and significant evidence bearing upon the safety and efficacy of the drug – and the medicinal ingredient in the drug is “new” in the sense that it has qualities of safety and efficacy materially different from a previously approved medicinal ingredient, then it is not a “variation” of that previously approved medicinal ingredient.
[39] I offer several reasons for my conclusion. I begin first with a discussion of principles pertaining to the textual, contextual and purposive approach to legislative interpretation. Then I examine the textual, contextual and purposive considerations in this case. Some of these considerations, such as the text of the subsection, are merely consistent with the conclusion I have reached. Others, such as the implementation of Canada’s international obligations, more strongly point in favour of the conclusion I have reached. But, taken together, they confirm that subsection C.08.004.1(1) should be interpreted in the way I have suggested.
– I –
[40] Our starting point is the now classic approach to the interpretation of legislative provisions. This approach requires careful attention to the text, context and purpose surrounding the provisions:
Today there is only one principle or approach, namely, the words of an Act are to be read in their entire context and in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act, and the intention of Parliament.
(Bell ExpressVu Limited Partnership v. Rex, 2002 SCC 42, [2002] 2 S.C.R. 559 at paragraph 26, citing Elmer Driedger, Construction of Statutes (2nd ed. 1983) at page 87. See also Rizzo & Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27 at paragraphs 20-23, and in the area of pharmaceutical legislation, see AstraZeneca Canada Inc. v. Canada (Minister of Health), 2006 SCC 49, [2006] 2 S.C.R. 560 at paragraph 26.)
[41] In interpreting subsection C.08.004.1(1), this Court has followed this approach to statutory interpretation: Teva Canada, supra. Further, in the seminal case of Bayer Inc. v. Canada (Attorney General), [1999] 1 F.C. 553 (approved by this Court on this point at (1999), 87 C.P.R. (3d) 293), Evans J. (as he then was) went beyond the literal wording of subsection C.08.004.1(1), examining, as he was bound by the authorities to do, “the context of the overall scheme” and the “overall purposes of the statutory scheme.”
[42] In the Federal Court and in this Court, the Minister’s submissions are founded upon what it considers to be clear text. In addressing the Minister’s submissions, it is apposite to examine the impact in the interpretive exercise of apparently clear text.
[43] If the words of the legislative provision are truly clear, they will predominate in the interpretive exercise. As the Supreme Court has said,
When the words of a provision are precise and unequivocal, the ordinary meaning of the words plays a dominant role in the interpretive process. On the other hand, where the words can support more than one reasonable meaning, the ordinary meaning of the words plays a lesser role.
(Canada Trustco Mortgage Co. v. Canada, 2005 SCC 54, [2005] 2 S.C.R. 601 at paragraph 10.)
[44] In some cases, however, “[e]ven where the meaning of particular provisions may not appear to be ambiguous at first glance, statutory context and purpose may reveal or resolve latent ambiguities”: Canada Trustco, supra at paragraph 47; Placer Dome Canada Ltd. v. Ontario (Minister of Finance), 2006 SCC 20, [2006] 1 S.C.R. 715 at paragraph 22. So even where the text has some clarity, as the Minister emphasizes here, regard must still be paid to context and purpose, “reading the provisions of [the] Act as a harmonious whole”: Canada Trustco, supra at paragraph 10.
– II –
[45] Turning to the text of subsection C.08.004.1(1), the Minister submits that the wording of the subsection is perfectly clear.
[46] That is not the case.
[47] Subsection C.08.004.1(1) does not define “variation” precisely or exhaustively. Instead, the subsection offers only a loose definition, described by five listed categories of substances: “a salt, ester, enantiomer, solvate or polymorph.”
[48] Are all substances falling within these categories automatically “variations”?
[49] The words of subsection C.08.004.1(1) do not answer that question clearly. In particular, the words “such as a salt, ester, enantiomer, solvate or polymorph” [my emphasis] inject uncertainty into the matter.
[50] If it were intended that all substances falling within those five categories are automatically “variations,” “variations” would have been defined as “any salt, ester, enantiomer, solvate or polymorph” or “all salts, esters, enantiomers, solvates or polymorphs.”
[51] Instead, subsection C.08.004.1(1) uses the words “such as” – words that differ from “any” or “all,” and lend a more open meaning to the subsection.
[52] The more open meaning imported by the words “such as” can be shown by an example. Suppose a particular regulation is aimed at reducing emissions that pollute. The regulation applies to “vehicles such as cars, trucks and buses.” Are all cars caught by the regulation? It may be that electric cars or hybrid cars are not covered by the regulation. Although they are literally “cars,” they may not be “vehicles” for the purposes of the emissions regulation because they do not emit pollution or emit much less pollution than other cars.
[53] In my view, the case before us is exactly like this example. Recourse must be had to context and purpose in order to understand what qualifies as a “variation” because the wording of the subsection is not perfectly clear: Canada Trustco, supra at paragraph 47. The plain text of the subsection opens up the possibility that only some salts, esters, enantiomers, solvates or polymorphs can qualify as “variations” in a particular case, or that some substances falling into categories other than the five listed categories of substances might constitute a variation. It is necessary to examine the context and purpose of the data protection regulations in order to see whether this possibility is a reality. Before examining the context and purpose of the data protection regulations, however, further observations about the plain text of the subsection need to be made.
– III –
[54] The somewhat open-ended nature of the plain text of the subsection is confirmed by the Regulatory Impact Analysis Statement issued concurrently with the data protection regulation.
[55] As the Supreme Court has acknowledged, such statements are commonly used as an aid in the interpretation of regulatory provisions:
…a Regulatory Impact Analysis Statement, which accompanies but does not form part of the regulations, reveals the intention of the government and contains “…information as to the purpose and effect of the proposed regulation.”
(Bristol-Myers Squibb Co., supra at paragraph 156, citing McGillis J. in Merck & Co. v. Canada (Attorney General) (1999), 176 F.T.R. 21 at paragraph 51 (T.D.), aff’d (2000), 5 C.P.R. (4th) 138 (F.C.A.). See also Bayer Inc. v. Canada (Attorney General) (1999), 87 C.P.R. (3d) 293 at paragraph 10 (F.C.A.).)
[56] In this case, the Regulatory Impact Analysis Statement envisages that some substances falling into other categories of substances might constitute a variation. In particular, it confirms that the five categories of substances in the subsection are “not exhaustive”: Canada Gazette, Part II, vol. 140, no. 21, page 1496. Elsewhere, the RIAS concedes that whether or not “arguable variations” outside of the five express categories of substances fall within the definition of “innovative drug” depends on whether approval for the “arguable variations” is “being sought primarily on the basis of previous submitted clinical data” or “new and significant clinical data”: ibid. This shows that “variations” are not defined solely by the five categories that follow, namely “salt, ester, enantiomer, solvate or polymorph.”
[57] While the RIAS does state that the five categories “give examples of the types of variations not considered for protection,” the Minister herself has declined to apply the five categories in a closed-minded way, preferring instead to see “variation” as the controlling idea in the subsection. This is seen in her treatment of certain drugs that contain medicinal ingredients that are esters or enantiomers, such as TORISEL, PRECEDEX and AVAMYS. The Minister has regarded these as qualifying or potentially qualifying as “innovative drugs” under subsection C.08.004.1(1): see Appeal Book, Tabs 10-12.
[58] This shows that in practice the Minister interprets the five categories in the subsection as identifying substances that will normally regarded as variations. But even in the case of those substances, the Minister can go on to consider whether, in fact, the substance is more than a “variation” and, thus, eligible for data protection under the subsection.
[59] The Minister’s particular interpretations of the subsection in other cases are not determinative. Indeed, under a correctness standard of review, courts have the final word and can impose their interpretation of the subsection over that of the Minister. But the Minister, like the courts, is responsible for interpreting the subsection and her interpretations can sometimes provide confirmation of a court’s view of the subsection, if not direct guidance. The Minister’s interpretations of the subsection in the cases of TORISEL, PRECEDEX and AVAMYS confirm the view, expressed above, that the subsection is somewhat open-ended and that the controlling idea in the subsection is whether or not a medicinal ingredient is a “variation,” not whether the medicinal ingredient falls within the five categories of substance.
– IV –
[60] So what, then, is a “variation”?
[61] Neither subsection C.08.004.1(1) nor the data protection regulations define the term “variation” precisely. There is expert evidence that “variation” does not have a specific scientific meaning: Jubran cross-examination, Q. 216; Appeal Book, page 475.
[62] “Variation” is a common word with a common meaning. Its dictionary definition is a “minor change” or a “slight difference”: Oxford English Dictionary (New York: Oxford University Press, 2004), 11th ed., at page 1599, cited by the Federal Court at paragraph 33 of its reasons.
[63] Here again, the Regulatory Impact Analysis Statement is useful. The RIAS confirms that “variations” of previously approved medicinal ingredients are excluded from the definition of “innovative drugs” in order to prevent “the granting of an additional eight years of protection where an innovator seeks approval for a minor change to a drug [my emphasis]”: Canada Gazette, Part II, vol. 140, no. 21, page 1496.
[64] The Federal Court found that salts, esters, and the other listed items “are widely recognized chemical variations” (at paragraph 37). This suggests that salts, esters, and the other listed items are automatically minor changes and, thus, excluded from data protection. But there is no evidence in the record to support this finding. As mentioned above, “variation” does not have a specific scientific meaning.
[65] Indeed, there is some scientific evidence to show that some enantiomers are quite different. This is an important element of context that assists our interpretive task. According to the Minister, some enantiomers, although just mirror images of other substances, can sometimes significantly differ from those substances in terms of pharmacokinetics, pharmacodynamics, toxicity, and protein binding: Health Canada, Guidance for Industry: Stereochemical Issues in Chiral Drug Development (February 14, 2000), at page 2; Appeal Book, page 84. These are all characteristics that can potentially bear upon the safety and efficacy of a drug.
[66] For example, different enantiomers of thalidomide differ significantly in their safety: Jubran cross-examination, QQ. 107-110; Appeal Book, page 468. One causes birth defects, the other does not.
[67] Thus, from the standpoint of safety and efficacy, enantiomers which comprise a racemic mixture may differ from one another or from the racemic mixture. Often, others may be similar, hence the listing of enantiomers as an example of a substance that may be a variation. Because of the possibility they may be different, Health Canada takes the position that the drug submission requirements for a single enantiomer of a marketed racemate are the same as those for any new active substance. Testing must be done.
[68] If the safety and efficacy of an enantiomer is established after only a little testing, there is a sense in which it is not all that different from the previously approved medicinal ingredient. If, on the other hand, much testing has to be done, there is a sense in which it is quite different or new when compared with the previously approved medicinal ingredient. These concepts – considerable effort in testing and difference/newness – lie at the heart of the concept of what is and is not a minor variation under subsection C.08.004.1(1).
[69] This, and my earlier conclusion that the plain text is somewhat open-ended, is confirmed by the purpose behind the data protection regulations, a matter to which I now turn.
– V –
[70] So what is the purpose of the data protection regulations?
[71] As this Court noted in Apotex Inc. v. Canada (Minister of Health), 2010 FCA 334 at paragraph 114, the background to the data protection regulations is key to understanding their purpose. The data protection regulations were prompted by two international obligations accepted by Canada: Article 1711 of the North American Free Trade Agreement, 17 December 1992, Can. T.S. 1994 No. 2, 32 I.L.M. 289 (entered into force 1 January 1994) and paragraph 3 of Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property Rights as set out in Annex 1C to the Marrakesh Agreement Establishing the World Trade Organization, 15 April 1994, 1867 U.N.T.S. 154, 33 I.L.M. 1144 (entered into force 1 January 1996).
[72] Article 1711 of the North American Free Trade Agreement provides as follows:
1. Each Party shall provide the legal means for any person to prevent trade secrets from being disclosed to, acquired by, or used by others without the consent of the person lawfully in control of the information in a manner contrary to honest commercial practices, in so far as:
(a) the information is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons that normally deal with the kind of information in question;
(b) the information has actual or potential commercial value because it is secret; and
(c) the person lawfully in control of the information has taken reasonable steps under the circumstances to keep it secret.
2. A Party may require that to qualify for protection a trade secret must be evidenced in documents, electronic or magnetic means, optical discs, microfilms, films or other similar instruments.
3. No Party may limit the duration of protection for trade secrets, so long as the conditions in paragraph 1 exist.
4. No Party may discourage or impede the voluntary licensing of trade secrets by imposing excessive or discriminatory conditions on such licenses or conditions that dilute the value of the trade secrets.
5. If a Party requires, as a condition for approving the marketing of pharmaceutical or agricultural chemical products that utilize new chemical entities, the submission of undisclosed tests or other data necessary to determine whether the use of such products is safe and effective, the Party shall protect against disclosure of the data of persons making such submissions, where the origination of such data involves considerable effort, except where the disclosure is necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use.
6. Each Party shall provide that for data subject to paragraph 5 that are submitted to the Party after the date of entry into force of this Agreement, no person other than the person that submitted them may, without the latter's permission, rely on such data in support of an application for product approval during a reasonable period of time after their submission. For this purpose, a reasonable period shall normally mean not less than five years from the date on which the Party granted approval to the person that produced the data for approval to market its product