Date: 20050518
Dockets: A-536-04
A-535-04
Citation: 2005 FCA 189
SHARLOW J.A.
MALONE J.A.
A-536-04
BETWEEN:
ASTRAZENECA CANADA INC.
Appellant
and
THE MINISTER OF HEALTH, THE
ATTORNEY GENERAL OF CANADA and
APOTEX INC.
Respondents
A-535-04
BETWEEN:
ASTRAZENECA CANADA INC.
Appellant
and
THE MINISTER OF HEALTH, THE
ATTORNEY GENERAL OF CANADA
Respondents
and
APOTEX INC.
Intervener
Heard at Ottawa, Ontario, on February 8, 2005.
Judgment delivered at Ottawa, Ontario, on May 18, 2005.
REASONS FOR JUDGMENT BY: NOËL J.A.
CONCURRED IN BY: MALONE J.A.
DISSENTING REASONS BY: SHARLOW J.A.
Date: 20050518
Dockets: A-536-04
A-535-04
Citation: 2005 FCA 189
CORAM: NOËL J.A.
SHARLOW J.A.
MALONE J.A.
A-536-04
BETWEEN:
ASTRAZENECA CANADA INC.
Appellant
and
THE MINISTER OF HEALTH, THE
ATTORNEY GENERAL OF CANADA and
APOTEX INC.
Respondents
A-535-04
BETWEEN:
ASTRAZENECA CANADA INC.
Appellant
and
THE MINISTER OF HEALTH, THE
ATTORNEY GENERAL OF CANADA
Respondents
and
APOTEX INC.
Intervener
REASONS FOR JUDGMENT
[1] AstraZeneca Canada Inc. (AstraZeneca) appeals from an order of the Federal Court dismissing its applications for judicial review of a decision of the Minister of Health (the Minister) to issue a Notice of Compliance (NOC) to Apotex Inc. (Apotex) for omeprazole 20 mg and 40mg capsules without requiring Apotex to address Canadian Patents Nos. 2,284,470 ('470) and 2,186,037 ('037) under the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (NOC Regulations) (Docket No. A-536-04); and not to require second persons generally to address the '470 and '037 patents listed in respect of LOSEC 20 mg capsules (Docket No. A-535-04).
[2] The Minister advised at the beginning of the hearing that no issue remained with respect to the 40 mg capsules as the related NOC had been issued to Apotex in error. Nothing further will be said with respect to this NOC.
Background and Facts
[3] The facts are set out in the decision under appeal (AstraZeneca Inc. v. Canada (Minister of Health) (2004), 36 C.P.R. (4th) 819 (F.C.)) and need not be repeated. It is sufficient for present purposes to provide the following summary.
[4] Sometime prior to September 1996, Apotex filed a submission for a NOC comparing its proposed drug (Apo-Omeprazole 20 mg capsules), to AstraZeneca's drug (LOSEC 20 mg capsules). LOSEC 20 mg capsules had been marketed in Canada pursuant to one or more NOCs from 1989 to September of 1996, when it was taken off the market and replaced by omeprazole magnesium tablets.
[5] By the time Apotex had satisfied all the safety and efficacy requirements contemplated by the Food and Drug Regulations, S.R.C., c. 870 (FD Regulations) and the Minister was ready to issue Apotex its NOC, the '470 and '037 patents had been added to the Patent Register (on March 8, 2002 and February 27, 2003 respectively). The '470 and '037 patents claim a new formulation and a new therapeutic use for omeprazole (the treatment of gastrointestinal disorders).
[6] NOCs had been sought and obtained pursuant to supplementary new drug submissions (SNDS) filed in June of 1999 and October of 2000. For present purposes, we are only concerned with the SNDS filed January 22, 1999 and the corresponding NOC issued June 4, 1999 which authorizes the sale of LOSEC 20 mg capsules for a new therapeutic use.
[7] On January 27, 2004, the Minister issued Apotex its NOC for Apo-Omeprazole capsules despite the fact that the '470 and '037 had been properly listed and had not been addressed. Up to then, it had been the position of the Minister that where a second person files a submission for a NOC in respect of a drug and compares that drug to another drug belonging to a first person which has been marketed in Canada, the NOC Regulations require the second person to address all the patents listed on the Patent Register in respect of that other drug.
[8] In this instance, the Minister decided, and the applications Judge agreed, that Apotex did not have to address the '470 and '037 patents because, although AstraZeneca's LOSEC 20 mg capsules had been marketed in Canada pursuant to one or more NOCs, no drug had been marketed pursuant to the specific NOC in respect of which these patents had been listed.
[9] The Minister also refused to accept that AstraZeneca marketed LOSEC 20 mg capsules pursuant to this particular NOC by reference to four individual sales transactions which took place between May 14, 2002 and January 15, 2004.
[10] AstraZeneca brought two judicial review applications alleging that the Minister erred in issuing Apotex its NOC without requiring that the '470 and '037 patents be addressed by Apotex (T-261-04) or by anyone (T-262-04).
[11] AstraZeneca contended in support of these applications that the marketing of LOSEC 20 mg capsules in Canada pursuant to one or more NOCs between 1989 and 1996 was sufficient to trigger the application of the NOC Regulations with respect to the '470 and the '037 patents. The requirement that the drug be marketed pursuant to the particular NOC with respect to which these patents were listed was said to be extraneous to the NOC Regulations.
[12] In the alternative, AstraZeneca argued that LOSEC 20 mg capsules were marketed pursuant to this particular NOC when regard is had to the four sales transactions which took place after May 14, 2002. AstraZeneca further argued that it was not provided with an adequate opportunity to know and respond to the case against it with respect to the legal characterization of these four sales.
Decision Under Review
[13] Leaving aside "for the moment" the post May 14, 2002 sales of LOSEC 20 mg capsules (paragraph 37), the applications Judge first addressed the meaning of subsection 5(1) of the NOC Regulations and in particular the interpretation of the marketing requirement set out therein. This provision, with emphasis on the relevant words, provides:
|
5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug, |
5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue: |
|
(a) state that the 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 pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed. [emphasis added] |
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 faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité. [mon emphase] |
[14] The applications Judge recognized that, on a plain and ordinary reading of the words, there was only a requirement that a drug be marketed in Canada pursuant to a NOC and in respect of which a patent list had been submitted (paragraph 38). It is common ground that LOSEC 20 mg capsules were so marketed. However, relying on the holistic approach to statutory interpretation proposed in Biolyse Pharma Corp. v. Bristol-Myers Squibb Co. (2003), 24 C.P.R. (4th) 417 (F.C.A.), (S.C.C. appeal pending), he held (paragraph 40):
Reading subsection 5(1) in its entire context and its words in their grammatical and ordinary sense harmoniously with the scheme of the Act, the object of the Act and the intention of Parliament, I have concluded that:
(1) the patented drug with which the generic drug compares itself for the purpose of demonstrating bio equivalence, must be a drug which is on the market and available for comparative purposes. In the case at bar, that patented drug could not be a drug manufactured and sold pursuant to patents listed on the Patent Register after the applicant stopped marketing LOSEC omeprazole 20 mg capsules in 1996; and,
(2) the words in subsection 5(1):
and that other drug has been marketed in Canada pursuant to a Notice of Compliance issued to a first person and respect of which a patent list has been submitted ...
can only refer to a drug marketed in Canada pursuant to a Notice of Compliance in respect of which the patent in question has been listed. Since the marketing ceased in 1996, since the patents were added to the Register on March 8, 2002 and February 27, 2003, and since the NOCs for these patents were issued on June 4, 1999 and October 24, 2000, the applicant's LOSEC 20 mg omeprazole capsules could not have been "marketed" in Canada since the NOCs were issued after 1996 and since the patents were added after 1996.
[15] He reiterated in the next paragraph that a generic drug cannot be compared to a drug which is not available on the Canadian market as the generic drug manufacturer cannot obtain such a drug (paragraph 41).
[16] The applications Judge concluded this aspect of his reasons by saying (paragraph 42):
... a patent drug company should not be able to use the Regulations to delay a generic drug by listing new patents for a drug no longer sold in Canada. That would be an abuse of the Regulations, and contrary to the object and intent of the Regulations.
[17] The applications Judge proceeded to dismiss AstraZeneca's alternative contention that in any event, its drug had been marketed pursuant to the NOC issued on June 4, 1999 (paragraphs 45 to 51). He held that it was open to the Minister to hold that the four isolated sales of LOSEC 20mg capsules after May 14, 2002, did not support a finding that the drug was "marketed" within the meaning of subsection 5(1) of the NOC Regulations. He further held that the Minister had provided AstraZeneca with a full opportunity to be heard on this issue.
Position of the Parties
[18] AstraZeneca argues that, under the guise of a contextual interpretation, the applications Judge effectively rewrote subsection 5(1), and inserted a requirement which the drafter did not intend nor contemplate (Biolyse, supra, paragraphs 32 to 35).
[19] With respect to the post May 14, 2002 sales, AstraZeneca submits that the applications Judge applied the wrong standard of review and erred in holding that these sales did not meet the marketing requirement embodied in subsection 5(1). It maintains that the Minister did not provide it with an adequate opportunity to be heard and that the applications Judge erred in holding otherwise.
[20] In response, Apotex argues that the applications Judge gave subsection 5(1) the correct interpretation. It submits that subsection 5(1) should be read in context, with particular regard to subsections 4(3), 4(4) and 4(5), which deal with patent lists. In this respect, Apotex argues that timing is an important element under subsection 4(4) (when read with subsection 4(6)), as a patent list must be submitted within the stated timeframe.
[21] It adds that under subsection 4(5), the opportunity given to a first person to add a patent to a patent list is linked to a particular submission. Hence, Apotex submits that the marketing requirement in subsection 5(1) must be read as applying to the specific NOC with respect to which the '470 and '037 patents were listed. Otherwise, the linkage contemplated by subsection 4(5) would become meaningless.
[22] As to the post May 14, 2002 sales, Apotex argues that the applications Judge correctly held that the four sales in question did not meet the marketing requirement embodied in subsection 5(1) of the NOC Regulations. It adds that no breach of the duty of fairness has been shown in the Minister's handling of this issue.
[23] The Minister takes the position that AstraZeneca is attempting to keep generic competitors out of a market that it is not itself occupying. Although he has advocated the contrary position in the past, the Minister argues that this unique and unusual case requires that subsection 5(1) be construed as applying only if AstraZeneca's drug was marketed pursuant to the specific NOC with respect to which the '470 and the '037 patents were listed.
[24] As the record reveals that AstraZeneca's LOSEC 20 mg capsules were never marketed pursuant to this NOC, the Minister contends that Apotex has no obligation to address these patents.
Analysis and Decision
[25] The applications Judge, in addressing the standard applicable to his review held, properly in my view, that the interpretation of the "critical words" in subsection 5(1) of the NOC Regulations "and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted" gave rise to a question of law to be assessed against a standard of correctness. In contrast, the alternative question whether the four isolated sales which took place after May 14, 2002 were sufficient to support a conclusion that LOSEC 20 mg capsules were "marketed", was one of fact which called for a standard of "patent unreasonableness" (paragraph 33).
[26] Considering the matter from this Court's perspective, questions of law, such as the issue of statutory construction identified by the applications Judge, invite an appellate court to form its own opinion and to provide for the correct answer, if it has not been given, and findings of fact belong to the decision maker at first instance in the absence of a palpable and overriding error (Housen v. Nikolaisen, [2002] 2 S.C.R. 235). I now turn to the issue of statutory construction.
[27] Subsection 5(1) refers to an "other drug [that] has been marketed in Canada pursuant to a notice of compliance issued to a first person". It does not refer to a drug that has been marketed in Canada pursuant to a particular notice of compliance issued to the first person. The difference is significant and, in my opinion, is crucial to the outcome of the appeal.
[28] The link that is made under subsection 4(5) between the addition of a patent list, and the particular submission to which it relates, is not reflected in subsection 5(1). This is not an oversight, but is consistent with the notion that once a second person compares its proposed drug to a first person's drug, every patent on the Patent Register with respect to that drug is given the protection afforded by subsection 5(1).
[29] Reading subsection 5(1) in accordance with the ordinary and grammatical use of the words, all the conditions requiring Apotex to address the '470 and '037 have been met, i.e.: Apotex filed a submission for its Apo-Omeprazole 20 mg capsules; Apotex compared its proposed drug to AstraZeneca's LOSEC 20 mg capsules; LOSEC 20 mg capsules had been marketed in Canada from 1989 until 1996 pursuant to one or more NOCs issued to AstraZeneca and the '470 and '037 patents had been properly added to the Register in respect of LOSEC 20 mg capsules.
[30] Since the '470 and '037 patents had been added to the Register in respect of LOSEC 20 mg capsules after Apotex filed its submission, but before the NOC was issued, Apotex was required to address these patents pursuant to subsection 5(2):
|
5(2) Where, after a second person files a submission for a notice of compliance but before the notice of compliance is issued, a patent list or an amendment to a patent list is submitted in respect of a patent pursuant to subsection 4(4), the second person shall amend the submission to include, in respect of that patent, the statement or allegation that is required by subsection (1) or (1.1), as the case may be. [emphasis added] |
5(2) Lorsque, après le dépôt par la seconde personne d'une demande d'avis de conformité mais avant la délivrance de cet avis, une liste de brevets ou une modification apportée à une liste de brevets est soumise à l'égard d'un brevet aux termes du paragraphe 4(4), la seconde personne doit modifier la demande pour y inclure, à l'égard de ce brevet, la déclaration ou l'allégation exigées par les paragraphes (1) ou (1.1), selon le cas. [mon emphase] |
[31] This construction, which gives effect to the ordinary and grammatical meaning of the words, should prevail unless it can be shown that the words can reasonably bear a different meaning that better accords with the purpose of the NOC Regulations (Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] F.C.J. No. 75; 2003 F.C.A. 24, at paragraph 29).
[32] The applications Judge read subsection 5(1) as requiring both that a patent list be submitted in respect of a NOC (rather than a drug) and that AstraZeneca's "other drug" must be a drug that has been "marketed" pursuant to the specific NOC in respect of which the '470 and the '037 patents have been listed.
[33] In my respectful view, the first part of this reading contradicts the wording of the provision and the second requires significant legislative redrafting.
[34] Dealing with the first, while the English text of subsection 5(1) is gender neutral (as the English language does not ascribe gender to things inanimate), the French language is not. According to the French text, the word "laquelle (in respect of which a patent list has been submitted)" necessarily refers to the "autre drogue (the other drug)" and not the masculine "un avis de conformité ... (a notice of compliance issued to a first person)".
[35] This shows that the drafters had to put their mind to the question whether the link is to the "... other drug [that] has been marketed in Canada ..." or to the notice of compliance, and the language chosen indicates without any possible ambiguity that the link is to the drug. Reading this provision in accordance with the gender of the words goes to the essence of the French language, which provides for a meaning that is unescapable. This is not a matter of words that are capable of bearing a broad or narrow meaning as the only possible link is to the drug, a result embraced by both linguistic texts.
[36] The second part of the applications Judge's reading requires that this "other drug" must not only have been marketed in Canada pursuant to a NOC, but pursuant to the specific NOC in respect of which the '470 and '037 patents have been listed.
[37] The NOC Regulations do not bear this requirement. What is required is that the "other drug" (which forms the subject matter of the comparison) "has been marketed in Canada pursuant to a NOC issued to a first person".
[38] In this case, AstraZeneca's LOSEC 20 mg capsules were marketed in Canada from 1989 to 1996, and Apotex compared its proposed drug to samples of LOSEC 20 mg capsules obtained during that period (Memorandum of Fact and Law of the Minister, paragraph 56).
[39] Under the FD Regulations, a second person may only compare its drug to a "Canadian reference product" (section C.08.002.1). The definition of "Canadian reference product" provides in part (section C.08.001.1):
|
"Canadian reference product" means
(a) a drug in respect of which a notice of compliance is issued pursuant to section C.08.004 and which is marketed in Canada by the innovator of the drug,
(b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued pursuant to section C.08.004 cannot be used for that purpose because it is no longer marketed in Canada,
(c) ... [emphasis added] |
« _produit de référence canadien_ » Selon le cas:
a) une drogue pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 et qui est commercialisée au Canada par son innovateur;
b) une drogue jugée acceptable par le ministre qui peut être utilisée pour la détermination de la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, lorsqu'une drogue pour laquelle un avis de conformité a été délivré aux termes de l'article C.08.004 ne peut être utilisée à cette fin parce qu'elle n'est plus commercialisée au Canada;
c) ... [mon emphase] |
[40] What is required in order for a second person to be able to rely on a first person's pre-approved drug is that a first person's drug has been marketed in Canada pursuant to a notice of compliance. Those are the words of subsection 5(1) of the NOC Regulations, and this is the basis on which the comparison took place in this instance. Once a first person's drug has been marketed in Canada, it qualifies as a "Canadian reference product" and becomes available to a second person for comparative purposes. This is why subsection 5(1) of the NOC Regulations refers to a first person's drug that "has been marketed in Canada".
[41] In a related proceeding involving the same parties, the same drug, but a different patent (Apotex Inc. v. Canada (Minister of Health), [2004] F.C.J. No. 790; 2004 FC 650), Apotex attempted to overcome this obstacle by arguing that a first person's drug when approved for a new use, is a "new drug" for purposes of the NOC Regulations.
[42] In so stating, Apotex was relying on subsection C.08.001 of the FD Regulations which provides inter alia:
|
C.08.001. For the purposes of the Act and this Division, "new drug" means
...
(c) a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug. |
C.08.001. Pour l'application de la Loi et du présent titre, "drogue nouvelle" désigne:
[...]
c) une drogue pour laquelle le fabricant prescrit, recommande, propose ou déclare un usage comme drogue ou un mode d'emploi comme drogue, y compris la posologie, la voie d'administration et la durée d'action, et qui n'a pas été vendue pour cet usage ou selon ce mode d'emploi au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de cet usage ou de ce mode d'emploi pour ladite drogue. |
[43] Apotex there argued that this definition of "new drug" should be imported into the NOC Regulations. As according to this definition, AstraZeneca's "new drug" had never been marketed for its newly authorized use, Apotex contended that subsection 5(1) was not triggered.
[44] O'Keefe J. disposed of this argument as follows:
[71] [...] Based on the definition of a new drug in the Food and Drug Regulations, supra, Apotex claims that because the patent issued for a new use of the drug, it became a new drug. As I read subsection 5(1) of the NOC Regulations, it simply refers to "drug" and does not deal with uses of the drug. I agree with AstraZeneca's submission that subsection 5(1) refers to a physical product, not the uses or new uses of a product.
[72] I am of the view that the drug in question is Losec 20 mg capsules which is the drug to which Apotex compared its 20 mg Apo-Omeprazole capsules. Accordingly, subsection 5(1) applies to Apotex. [emphasis added]
[45] An appeal was brought against this decision, but Apotex withdrew it before it could be heard on its merit (Apotex Inc. v. AbHassle et al., A-291-04 (January 31, 2005)).
[46] In my respectful view, O'Keefe J. reached the correct conclusion when he held that the "new drug" definition in the FD Regulations is incompatible with the meaning of the word "drug" in subsection 5(1) of the NOC Regulations. As is apparent from the applications Judge's reasons in this instance, it is the actual drug, from which samples can be taken and used for comparative purposes, that is relevant to the application of subsection 5(1) of the NOC Regulations.
[47] I would add that in my view, the extended meaning of "drug" by reference to a "new use" in the FD Regulations (as quoted in paragraph 42 above) is no more than a deeming provision intended to insure that no drug can be sold for a new use without being tested and approved for that particular use. Aside from the limited purpose of controlling the safety and efficacy of new uses, the "drug" remains the physical substance in the form in which it is authorized to be sold.
[48] The Minister further argued that mere "technical compliance" with the NOC Regulations is not sufficient to provide first persons with the benefit which they provide (Bristol Myers Squibb v. Canada, [2001] F.C.J. No. 51; Ferring Inc. v. Canada, 2003 FCA 274; Toba Pharma Inc. v. Canada, 2002 FCT 927).
[49] Ignoring the post May 14, 2002 sales for the moment, I can identify no step or action taken by AstraZeneca which can be labelled as "technically compliant" within the meaning ascribed by the case law. It is common ground that the marketing of LOSEC 20 mg capsules took place in the normal course of business; the '470 and '037 patents protect a novel formulation and a novel therapeutic use which required approval under the FD Regulations and the NOC with which we are concerned was issued in relation to this particular use (see Abbott Laboratories et al. v. Minister of Health et al., 31 C.P.R., (4th) (F.C.A.) 321 at paragraphs 27, 28 and 29).
[50] In two related decisions released May 12 and 13, 2005 respectively (Hoffman-LaRoche Limited v. Minister of Health et al., A-595-04, 2005 FCA 140, AstraZeneca v. Minister of Health, A-334-04, 2005 FCA 175), this Court has held that while a SNDS relating to so called "administrative changes" (i.e., a change in the name of a drug or of a drug manufacturer, or a charge in a manufacturing site) can procure no benefit to a first person under the NOC Regulations, an SNDS pertaining to the formulation of the drug or its use do procure such benefits, because these changes are rationally connected to the purpose of the NOC Regulations (i.e., the prevention of patent infringement).
[51] The only possible criticism which the Minister can level against AstraZeneca is that it had not, as of the time the decision in issue was made (January 27, 2004), marketed its LOSEC 20 mg capsules in conformity with the June 4, 1999 NOC. According to the Minister:
In the situation to which the provisions most clearly apply, a drug would be marketed at and after the time that its related patent was listed on the Register (Minister's Memorandum of Fact and Law at paragraph 55). (emphasis added)
[52] This may be so, but there is no requirement under the FD Regulations that a new drug, or a new use for a drug, once approved, be followed by its immediate marketing. A NOC, when issued, remains valid whether or not the approved drug is marketed and the manufacturer is free to market the drug at the time of its choice. The only requirement is that notification be given when a decision is made to market the drug or to withdraw it from the market (see sections C.01.014.3 and C.01.014.7 respectively).
[53] When regard is had to the FD Regulations, a first person cannot be faulted for obtaining a NOC for a new drug, or a new use, even if it has no immediate plans to market the drug.
[54] Finally, I see no merit in the Minister's submission that the NOC Regulations were not intended to prevent a second person from entering a market which the first person does not occupy. The fact that a first person does not presently occupy the market has no bearing on the question whether a second person's proposed drug will infringe. It would be a simple matter to provide for a requirement that the drug be currently marketed if, indeed, it was intended to apply (see for example the Regulatory Impact Analysis Statement published December 11, 2004 in the Canada Gazette Part I at page 3724, which proposes a so called "anti-avoidance" provision which limits the application of subsection 5(1) to drugs with respect to which a drug identification number remains in force under the FD Regulations). However, as the NOC Regulations read, the current occupation of the market by the first person's drug is not a relevant consideration.
[55] I therefore conclude that subsection 5(1) of the NOC Regulations applies where a second person compares its proposed drug to a first person's drug that "has been marketed in Canada pursuant to a notice of compliance." As in this case, it is common ground that AstraZeneca's drug was so marketed between 1989 and 1996, and as the other requirements for the application of subsection 5(1) have also been met, the Minister was bound to require Apotex to address the '470 and '037 patents.
[56] Having so concluded, it is not necessary to deal with AstraZeneca's alternative contention that its drug was marketed pursuant to the relevant NOC after May 14, 2002.
[57] For these reasons, I would allow the appeals, set aside the decision of the applications Judge and giving the order which ought to have been given, I would quash the NOC issued
January 27, 2004 with respect to Apo-Omeprazole and compel the Minister to require a second person to address the '470 and '037 patents where the second person files a submission for a NOC in respect of a drug and compares the drug with LOSEC 20 mg capsules, with costs in favour of the appellant here and below.
"Marc Noël"
J.A.
"I agree.
B.Malone J.A."
SHARLOW J.A. (dissenting reasons)
[58] I have read in draft the reasons of Noël J.A. I must respectfully disagree with him. I would dismiss this appeal, for the reasons that follow.
[59] From 1989 to September of 1996, Astrazeneca marketed Losec 20 mg capsules in Canada pursuant to a NOC issued in 1989. In September of 1996, that product was taken off the market in Canada and replaced with omeprazole magnesium tablets, which were marketed pursuant to a different NOC. Astrazeneca retains the right to market Losec 20 mg capsules in Canada pursuant to the 1989 NOC.
[60] The 470 and 037 patents both relate to new formulations for omeprazole. The filing date of the 470 patent is November 10, 1998, and it was issued on February 26, 2002. The filing date of the 037 patent is February 9, 1996, and it was issued on April 16, 2002.
[61] It is to Astrazeneca's advantage to have the 470 patent and the 037 patent included on a patent list in relation to Losec 20 mg capsules, whether that product is being marketed or not. If they are so listed, and thus are on the patent register, a drug manufacturer who seeks approval for a similar drug based on specified comparisons to Losec 20 mg capsules must give Astrazeneca notice of the comparison in the form of a "notice of allegation" (NOA) pursuant to subsection 5(1) of the NOC Regulations, addressing the listed patents. Astrazeneca then has the right to apply to the Federal Court for an order under section 6 of the NOC Regulations prohibiting the Minister from issuing a NOC to Apotex until after the expiration of the relevant patents. The filing of such an application automatically precludes the Minister from issuing the NOC to the generic manufacturer for up to 24 months. That is because of the automatic "stay" provided in section 7 of the NOC Regulations. Thus, advance notice may result in a further advantage, in the form of a delay in the issuance of a NOC to a potential competitor.
[62] By virtue of subsection 4(3) of the NOC Regulations, a patent list must be submitted at the same time as a submission for a NOC (a new drug submission, or NDS). Subsection 4(4) permits a patent list to be submitted after the related NDS to include newly issued patents. It also permits an existing patent list to be amended to include patents issued after the date of the NDS. In either case, however, the filing date of the new patent must precede the date of the NDS to which the patent list relates (subsection 4(4) of the NOC Regulations).
[63] It has long been established that a supplementary NDS (SNDS) for a drug is a "submission" that may support the filing of a new patent list for that drug: Apotex Inc. v. Minister of Health (1999), 87 C.P.R. (3d), 371 (F.C.T.D., per Justice McGillis), affirmed 11 C.P.R. (4th) 538 (F.C.A.). Relying on that interpretation Astrazeneca could, by filing a SNDS for Losec 20 mg capsules after the filing date of the 470 and 037 patents, have an opportunity to have the 470 and 037 patents included on a patent list in relation to Losec 20 mg capsules, once those patents were issued.
[64] On January 22, 1999, Astrazeneca filed a SNDS to seek authorization for the sale of Losec 20 mg capsules for a new indication, the treatment of H. Pylori. A patent list was filed with that SNDS. On June 4, 1999, the Minister issued a NOC to Astrazeneca in response to that SNDS. Losec 20 mg capsules were not on the market on January 22, 1999, when Astrazeneca filed its SNDS. Nor did Astrazeneca return them to the market after the issuance of the corresponding NOC. However, it is not suggested that this affects the validity of the January 22, 1999 SNDS, or the corresponding NOC issued June 4, 1999.
[65] Once the 470 and 037 patents were issued in 2002, Astrazeneca was entitled to and did apply to include those patents on the patent list submitted with the January 22, 1999 SNDS. On March 8, 2002 and February 27, 2003, respectively, the 470 and 037 patents were added to that patent list. It is common ground that the decision to permit those patents to be listed is correct.
[66] Prior to September 1996, Apotex filed an abbreviated NDS (ANDS) for a NOC comparing its proposed drug (Apo-Omeprazole 20 mg capsules), to Astrazeneca's Losec 20 mg capsules. The Minister formed the view that subsection 5(1) of the NOC Regulations did not require Apotex to address the 470 and 037 patents because (1) those patents had been added to the patent list that was submitted with the January 22, 1999 SNDS, and (2) Astrazeneca had not marketed Losec 20 mg capsules pursuant to the June 4, 1999 NOC, which had been issued in response to the January 22, 1999 SNDS. The Minister issued a NOC to Apotex for Apo-Omeprazole 20 mg capsules on January 27, 2004.
[67] Astrazeneca brought two judicial review applications alleging that the Minister erred in issuing a NOC to Apotex without requiring the 470 and 037 patents to be addressed by Apotex (T-261-04) or by anyone (T-262-04). Astrazeneca argued, among other things, that Apotex had such an obligation because Losec 20 mg capsules had at one time been marketed pursuant to a NOC. As indicated above, both applications were dismissed, leading to these appeals.
[68] There was a dispute in the Federal Court as to whether Astrazeneca had marketed Losec 20 mg capsules between May 14, 2002 and January 15, 2004. Astrazeneca had provided the Minister with evidence of four relatively small sales of Losec 20 mg capsules that occurred between May 14, 2002 and January 15, 2004. The Minister concluded that those transactions did not amount to "marketing" Losec 20 mg capsules within the meaning of the NOC Regulations. The Judge treated that conclusion as primarily one of fact, and he declined to disturb it because he found it not to be patently unreasonable. In this appeal, Astrazeneca argued that this aspect of the Judge's decision should be reversed. In my respectful view, the Judge made no error in accepting the Minister's determination on this factual point.
[69] I will deal with the remaining issues on the basis that Astrazeneca did not market Losec 20 mg capsules at all after September of 1996. The Judge considered those remaining issues to be reviewable on the standard of correctness because they are essentially questions of statutory interpretation. I agree with the Judge on that point.
[70] The principal issue is the correct interpretation of the opening words of subsection 5(1) of the NOC Regulations, which establish the circumstances in which a particular patent must be addressed by a drug manufacturer in connection with an ANDS. The opening words of subsection 5(1) read as follows:
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5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug ... |
5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue ... |
[71] The nub of the debate is whether this provision should be given a broad interpretation, as advocated by Astrazeneca, or the narrower interpretation advocated by the Minister and Apotex.
[72] It is useful first to consider the language of subsection 5(1). I find it helpful to treat subsection 5(1) as asking a number of questions, each of which must receive a positive answer before Apotex is obliged to address the 470 and 037 patents.
[73] The first question asked by subsection 5(1) is this: did Apotex file a submission for a NOC in respect of a drug, comparing its drug with another drug for one of the purposes stipulated in subsection 5(1)? The answer is yes. Apotex filed an ANDS for Apo-Omeprazole 20 mg capsules, in which it made the requisite comparison to Losec 20 mg capsules.
[74] The second question asked by subsection 5(1) is this: is Astrazeneca a "first person" in relation to a NOC pursuant to which Losec 20 mg capsules have been marketed? The answer is yes, but there are two ways to reach that answer.
[75] The term "first person" is defined in the NOC Regulations to mean "the person referred to in subsection 4(1)" ("la personne visée au paragraphe 4(1)"). Subsection 4(1) reads as follows:
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4(1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug. |
4(1) La personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à l'égard de la drogue, accompagnée de l'attestation visée au paragraphe (7). |
[76] The word "submission" in subsection 4(1), as explained above, means either a NDS or a SNDS. Astrazeneca has filed a number of submissions, and has received a number of NOCs, for Losec 20 mg capsules. It is possible that the answer to this question should be yes, simply because of that history.
[77] However, the same answer would result from a narrower interpretation of the provision. This case relates to the scope of subsection 5(1) and the obligation of Apotex, if any, to address the 470 and 037 patents that appear on a particular patent list. It seems to me arguable that for the purposes of this case, Astrazeneca's status as a "first person" should derive from the NOC that corresponds to the SNDS that supported the inclusion of those patents on a patent list. That would be the NOC issued on June 4, 1999 in response to the SNDS filed by Astrazeneca on January 22, 1999. As will be seen, that would tend to support the narrower interpretation of subsection 5(1) proposed by the Minister and Apotex.
[78] The third question asked by subsection 5(1) is this: have Losec 20 mg capsules been marketed in Canada pursuant to a NOC issued to Astrazeneca and in respect of which a patent list has been submitted? I refer to this as the marketing question or the marketing condition. The answer to the marketing question varies depending on whether subsection 5(1) is read broadly, as Astrazeneca contends, or narrowly, as the Minister and Apotex contend.
[79] Astrazeneca would interpret the marketing question expansively, as though the question is intended to refer to any marketing pursuant to any NOC. For a certain period of time between 1989 and 1996, Losec 20 mg capsules were marketed pursuant to the NOC issued in 1989. On that basis, Astrazeneca argues that the answer to the marketing question is yes.
[80] However, the Minister and Apotex propose a narrower view. Their interpretation is that the marketing question is intended to refer to marketing pursuant to the NOC that corresponds to the only SNDS that could possibly support the listing of the 470 and 037 patents. Only the January 22, 1999 SNDS could have supported the listing of the 470 and 037 patents, and as the Losec 20 mg capsules have never been marketed pursuant to the corresponding NOC, the answer to the marketing question is no.
[81] I pause here to make three observations about the marketing question. First, it is undisputed that "marketing" is a precondition to the application of subsection 5(1) of the NOC Regulations. Why is that condition imposed? It is not a condition that can have anything to do with the prevention of patent infringement, because patent infringement can occur even if the infringed patent is never exploited commercially by its holder. I infer that the marketing condition is included to ensure that the advantages of the NOC Regulations are not conferred on patent holders whose products are, for whatever reason, not generally available to consumers. Translating that notion to the context of the NOC Regulations, the general policy behind the marketing condition is that a patent holder who obtains a NOC, but does not use it, should not be entitled to rely on that NOC to obtain collateral advantages because of the NOC Regulations. That would tend to support the narrow interpretation of subsection 5(1) proposed by the Minister and Apotex.
[82] Second, a drug cannot be marketed lawfully in Canada except pursuant to a NOC. Why then does subsection 5(1) of the NOC Regulations include the qualifying language, "pursuant to a notice of compliance"? It may be that the qualifying phrase is intended to compel a reference to the marketing of Losec 20 mg capsules pursuant to a particular NOC. That would also tend to support the narrower interpretation proposed by the Minister and Apotex.
[83] Third, why is it stated as a precondition that a patent list must be submitted? It seems to be axiomatic that the "second person" would have no patents to address unless there is at least one patent list. There is other language in subsection 5(1) which specifically requires the second person to address "each patent on the register in respect of the other (comparator) drug". It may be that the imposition of a further precondition as to the submitting of a patent list is intended to refer to a particular patent list. Subsection 4(5) of the NOC Regulations requires each patent list to identify the NDS or SNDS to which it relates. Therefore, it makes sense to infer that the preconditions of subsection 5(1) are intended to limit its application to the patent list that contains the patent sought to be addressed. This is yet another consideration that would tend to favour the interpretation proposed by the Minister and Apotex.
[84] I turn now to the phrase:
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... pursuant to a notice of compliance and in respect of which a patent list has been submitted ... |
... aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise ... |
To understand this phrase, it is necessary to consider what a patent list is submitted "in respect of". Because of the mechanics of the NOC Regulations, each patent list necessarily relates to a particular NDS or SNDS (subsection 4(5) of the NOC Regulations), and thus to the NOC that corresponds to that NDS or SNDS. In my view, that would suggest that the word "which" in the underlined phrase is intended to refer to the one NOC that corresponds to the one NDS (or SNDS) that supported the filing of the patent list that includes the patents in issue. That would tend to support the narrow interpretation of the subsection proposed by the Minister and Apotex.
[85] The French version of subsection 5(1) of the NOC Regulations uses "laquelle" as the equivalent of "which", and so must be referring to a feminine noun ("cette autre drogue") rather than a masculine noun ("avis de conformité"). That makes a link between the patent list referred to in the marketing question, and the drug Losec 20 mg capsules. This aspect of the French version tends to support the broad interpretation proposed by Astrazeneca. On balance, a consideration of the French and English versions together would tend to support the narrow interpretation proposed by the Minister and Apotex.
[86] In considering whether to accept the broad interpretation or the narrow interpretation of subsection 5(1) of the NOC Regulations should be accepted, I do not consider it conclusive that subsection 5(1) does not expressly refer to a particular NOC. I repeat what I said in Merck & Co. v. Nu-Pharm Inc. (2000), 254 N.R. 68, 5 C.P.R. (4th) 138 (F.C.A.):
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[36] ... it is always open to a court to give the words of a statute or regulation the broadest meaning or the narrowest meaning that its words can bear. The choice will depend on the application of the principle of statutory interpretation adopted by the Supreme Court of Canada in numerous recent cases, including Rizzo & Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27. That principle is encapsulated in the much quoted words of Elmer Driedger in Construction of Statutes (2nd ed., 1983) at 87: |
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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. |
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[37] There is little to be gained by elaborating on this statement. It is enough to say that when it is properly applied, the resulting interpretation is consistent with both the words and the objective of the legislation. |
[87] This seems to me to be a case where the statutory language is capable of bearing two different meanings, a broad one (advocated by Astrazeneca) and a narrow one (advocated by the Minister and Apotex). The problem is to determine which of two possible interpretations is more consistent with the statutory objective.
[88] While the ultimate objective of the NOC Regulations is to prevent patent infringement, they were enacted as a counter balance to other statutory provisions that are intended, among other things, to encourage the development of generic drug products in a manner that ensures that they will be available on the market on a reasonably timely basis. Thus, while patent holders gain significant advantages from the Regulations, that advantage comes only if the preconditions are met: they must adhere to certain procedural restrictions in relation to the filing and amendment of patent lists, and they must actually market their products.
[89] Taking all of these considerations into account, I find myself in agreement with the Minister and Apotex that the provisions in question should be given the narrow interpretation that they propose. I would dismiss this appeal.
"K. Sharlow"
J.A.
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-535-04
STYLE OF CAUSE: ASTRAZENECA CANADA INC. v. MINISTER OF HEALTH ET AL
APPEAL FROM AN ORDER OF KELEN, J. DATED SEPTEMBER 20, 2004, FILE NO. T-262-04
DOCKET: A-536-04
STYLE OF CAUSE: ASTRAZENECA CANADA INC. v. MINISTER OF HEALTH ET AL
APPEAL FROM AN ORDER OF KELEN, J. DATED SEPTEMBER 20, 2004, FILE NO. T-261-04
PLACE OF HEARING: OTTAWA, ONTARIO
DATE OF HEARING: FEBRUARY 8, 2005
REASONS FOR JUDGMENT BY: NOËL J.A.
CONCURRED IN BY: MALONE J.A.
DISSENTING REASONS BY: SHARLOW J.A.
DATED: MAY 18, 2005
APPEARANCES:
Mr. Gunars A. Gaikis FOR ASTRAZENECA CANADA INC.
Mr. J. Sheldon Hamilton
Ms. Nancy Pei
Mr. F.B. Woyiwada FOR THE MINISTER OF HEALTH AND THE ATTORNEY GENERAL OF CANADA
Mr. H.B. Radomski FOR APOTEX, INC.
Mr. Andrew Brodkin
SOLICITORS OF RECORD:
Smart & Biggar FOR ASTRAZENECA CANADA INC.
Toronto, Ontario
John H. Sims, Q.C. FOR THE MINISTER OF HEALTH AND THE
Attorney General of Canada ATTORNEY GENERAL OF CANADA
Goodmans LLP FOR APOTEX, INC
Toronto, Ontario