Pfizer Canada Inc. v. Canada (Attorney General) (C.A.) [2003] 4 F.C. 95
Date: 20030314
Docket: A-442-02
(T-1103-01)
A-443-02
(T-1120-01)
Neutral citation: 2003 FCA 138
CORAM: STRAYER J.A.
NADON J.A.
PELLETIER J.A.
BETWEEN:
PFIZER CANADA INC.
Appellant
(Applicant)
and
ATTORNEY GENERAL OF CANADA
Respondent
(Respondent)
and
THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION
Intervener
Docket: A-445-02
(T-1104-01)
BETWEEN:
SCHERING CANADA INC.
Appellant
and
ATTORNEY GENERAL OF CANADA
Respondent
and
THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION
Intervener
Heard at Toronto, Ontario, Wednesday, January 29, 2003
JUDGMENT delivered at Ottawa, Ontario, Friday, March 14, 2003
REASONS FOR JUDGMENT BY: STRAYER J.A.
CONCURRED IN BY: NADON J.A.
PELLETIER J.A.
Date: 20030314
Docket: A-442-02
(T-1103-01)
A-443-02
(T-1120-01)
Neutral citation: 2003 FCA138
CORAM: STRAYER J.A.
NADON J.A.
PELLETIER J.A.
BETWEEN:
PFIZER CANADA INC.
Appellant
(Applicant)
and
ATTORNEY GENERAL OF CANADA
Respondent
(Respondent)
and
THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION
Intervener
Docket: A-445-02
(T-1104-01)
BETWEEN:
SCHERING CANADA INC.
Appellant
and
ATTORNEY GENERAL OF CANADA
Respondent
and
THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION
Intervener
REASONS FOR JUDGMENT
STRAYER J.A.
[1] These three appeals were heard at the same time. They are from the same order of Blanchard J. dismissing applications for judicial review of the decision of the Minister of Health refusing to list certain Canadian patents on the patent lists pursuant to section 4 of the Patented Medicines (Notice of Compliance) Regulations ("the Regulations") (SOR/93-133 as amended by SOR/98-166).
[2] In each of these cases the sequence of relevant events was as follows.
1. Filing of a U.S. patent application for a drug.
2. Filing in Canada, of a submission for that drug in order to obtain a Notice of Compliance ("NOC").
3. Filing in Canada of a patent application in respect of the same drug.
4. Issue in Canada of an NOC in respect of the drug.
5. Issue of the Canadian patent.
6. Submission to the Minister of National Health and Welfare of the Canadian patent within 30 days of its issue for addition to a patent list under subsection 4(1) of the Regulations.
[3] In each case the Minister refused to list the Canadian patents because the filing date of the applications for those Canadian patents did not precede the filing date for submissions for NOCs.
[4] (It is not explained in the material who applied for the U.S. patents nor the relationship of those applicants to the Canadian appellants in these appeals. Nothing appears to turn on this detail.)
[5] Section 4 of the Regulations provides in part as follows.
| 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. |
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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). |
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| (2) A patent list submitted in respect of a drug must
(b) set out any Canadian patent that is owned by the person . . . that contains a claim for the medicine itself or a claim for the use of the medicine and that the person wishes to have included on the register . . . . |
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(2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants :
b) tout brevet canadien dont la personne est propriétaire . . . qui comporte une revendication pour le médicament en soi ou une revendication pour l'utilisation du médicament, et qu'elle souhaite voir inscrit au registre . . . |
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| (4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2). (Emphasis added). |
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(4) La première personne peut, après la date de dépôt de la demande d'avis de conformité et dans les 30 jours suivant la délivrance d'un brevet qui est fondé sur une demande de brevet dont la date de dépôt est antérieure à celle de la demande d'avis de conformité, soumettre une liste de brevets, ou toute modification apportée à une liste de brevets, qui contient les renseignements visés au paragraphe (2). (Mon soulignement).
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[6] The Minister takes the position that, pursuant to subsection (4), he can only list a Canadian patent where an application was made for such patent prior to the filing of a submission for an NOC. In all of these cases there had been an application for a U.S. equivalent patent prior to the filing of a submission, but in each case the application for the Canadian patent was not made until after the filing of NOC submissions.
[7] The appellants all sought judicial review of the Minister's refusals. In one set of reasons and identical orders the applications judge, Blanchard J., dismissed these applications.
[8] The argument which the appellants made before the applications judge and made in this Court is that the term "filing date" in subsection 4(4) of the Regulations is not confined to the date an application is filed for a Canadian patent but instead means the "priority date" of a Canadian patent based on as, in these cases, the date of filing applications in the U.S. for patents which in each case preceded the date of filing submissions under the Regulations for notices of compliance.
[9] The applications judge, correctly in my view, held that the standard of review of the Minister's decision was correctness, the issue being a question of law.
[10] His main conclusion was as follows:
[51] I therefore conclude that the words "a filing date", read in their entire context and in their grammatical and ordinary sense, harmoniously with the scheme of the Act and the intention of Parliament, should be interpreted to be exhaustive and refer solely to the filing date for an application for patent in Canada.
He did consider the argument that there was ambiguity in subsection 4(4) of the Regulations because the English version refers to "a filing date" preceding the drug submission while the French version speaks of "la date de dépôt" of the application. He concluded that the French version was narrower and must be taken to refer to "the" filing date which in context must be confined to one possible date, the date of filing of an application for a Canadian patent. He chose this meaning as the one common to both versions, being the narrower meaning. However, he also said (para. 43) that determination of the main issue would not turn simply on the use of a definite or indefinite article: "it is a fact to be considered". He then went on to find that looking at the Patent Act and Regulations as a whole, the meaning of "an application date" was clear and unambiguous, referring only to the application filed in Canada for a Canadian patent. In the light of this conclusion he found that he did not have to resort to international conventions as aids to interpretation, as urged to do by the appellants. He observed, however, that he could find no conflict between his interpretation of subsection 4(4) and the international instruments relied on by them.
[11] The appellants argued before us that the applications judge was in error on all of these conclusions.
Issues
[12] I believe the essential issues are:
(1) Does the reference to "a filing date" in subsection 4(4) of the Regulations include a priority date based on an earlier foreign filing, or is the provision at least ambiguous?
(2) Should international conventions be resorted to in order to determine the meaning of "a filing date", and if so are they determinative?
Analysis
(1) Intrinsic meaning of "a filing date" in subsection 4(4)
[13] I am satisfied, like the applications judge, that the meaning of "a filing date" in subsection 4(4) is amply clear and that it refers to the filing date of an application for a Canadian patent.
[14] If one reads section 4 (supra) as a whole it is clear that it deals with a patent list confined to Canadian patents. Paragraph 4(2)(b) makes it clear that only Canadian patents may be included. Subsection 4(4) provides that the patentee may
within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list . . . . (Emphasis added).
It is obvious that all of these references to a "patent" are to the same patent and, as we know that only a Canadian patent can be on such a list, they must refer to the application for, and issuance of, a Canadian patent.
[15] The appellants argue that there are other uses of "filing date" in the Patent Act where the term includes a foreign filing. They cite subsections 28.4(2), 28.4(4), paragraph 28.1(1)(b), and subsection 10(1). Suffice it to say that in the first three provisions it is clear from the context of these provisions that a previous foreign filing is being referred to. I do not understand the reference in their factums to subsection 10(1) which is said to use the term "filing date" twice. I cannot find the phrase in that subsection.
[16] On the other hand, the term "claim date" is defined as follows:
| "claim date" means the date of a claim in an application for a patent in Canada, as determined in accordance with section 28.1. |
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Il n'y a pas de version française disponible. |
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Section 28.1 provides that the date of a claim in a Canadian application is the filing date of that application unless the applicant asserts priority of its claim on the basis of previously filed applications in Canada or abroad in respect of the same subject-matter. This further confirms the view that where the term "filing date" is used alone without qualification it refers to the date of filing an application in Canada.
[17] I find it unnecessary to consider the difference in language between the two official language versions. I believe the meaning is the same in both because of the context of the Regulations and Act.
[18] For these reasons I am satisfied the meaning of "filing date" in subsection 4(4) is clear and unambiguous and is confined to the filing of an application in Canada in conformity with the Patent Act.
(2) Must international conventions nevertheless be consulted and given effect?
[19] The appellants resort to three international instruments which, they say, prohibit this interpretation of subsection 4(4) in the total context of the Patent Act.
Paris Convention for the Protection of Industrial Property
| Article 2
(1) Nationals of any country of the Union shall, as regards the protection of industrial property, enjoy in all the other countries of the Union the advantages that their respective laws now grant, or may hereafter grant, to nationals; all without prejudice to the rights specially provided for by this Convention. Consequently, they shall have the same protection as the latter, and the same legal remedy against any infringement of their rights, provided that the conditions and formalities imposed upon nationals are complied with. |
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Article 2
(1) Les ressortissants de chacun des pays de l'Union jouiront dans tous les autres pays de l'Union, en ce qui concerne la protection de la propriété industrielle, des avantages que les lois respectives accordent actuellement ou accorderont par la suite aux nationaux, le tout sans préjudice des droits spécialement prévus par la présente Convention. En conséquence, ils auront la même protection que ceux-ci et le même recours légal contre toute atteinte portée à leurs droits, sous réserve de l'accomplissement des conditions et formalités imposées aux nationaux. |
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| Article 4
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B. Consequently, any subsequent filing in any of the other countries of the Union before the expiration of the periods referred to above shall not be invalidated by reason of any acts accomplished in the interval, in particular, another filing, the publication or exploitation of the invention, the putting on sale of copies of the design, or the use of the mark, and such acts cannot give rise to any third-party right or any right of personal possession. Rights acquired by third parties before the date of the first application that serves as the basis for the right of priority are reserved in accordance with the domestic legislation of each country of the Union. |
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Article 4
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B. En conséquence, le dépôt ultérieurement opéré dans l'un des autres pays de l'Union, avant l'expiration de ces délais, ne pourra être invalidé par des faits accomplis dans l'intervalle, soit, notamment, par un autre dépôt, par la publication de l'invention ou son exploitation, par la mise en vente d'exemplaires du dessin ou du modèle, par l'emploi de la marque, et ces faits ne pourront faire naître aucun droit de tiers ni aucune possession personnelle. Les droits acquis par des tiers avant le jour de la première demande qui sert de base au droit de priorité sont réservés par l'effet de la législation intérieure de chaque pays de l'Union. |
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North American Free Trade Agreement
| Article 1701
2. To provide adequate and effective protection and enforcement of intellectual property rights, each Party shall, at a minimum, give effect to this Chapter and to the substantive provisions of:
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(c) the Paris Convention for the Protection of Industrial Property, 1967 (Paris Convention) . . . .
Article 1702
A Party may implement in its domestic law more extensive protection of intellectual property rights than is required under this Agreement, provided that such protection is not inconsistent with this Agreement. |
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Article 1701
2. Pour assurer une protection efficace et suffisante des droits de propriété intellectuelle ainsi que le respect de ces droits, chacune des Parties devra, à tout le moins, donner effet au présent chapitre et aux dispositions de fond des instruments suivants:
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c) la Convention de Paris de 1967 pour la protection de la propriété industrielle (Convention de Paris). . . .
Article 1702
Une Partie pourra mettre en oeuvre dans sa législation intérieure une protection plus large des droits de propriété intellectuelle que ne le prescrit le présent accord, à condition que cette protection ne soit pas incompatible avec les dispositions de l'accord. |
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This agreement has been implemented by the North American Free Trade Agreement Implementation Act (S.C. 1993, c.44). Section 3 of this Act provides:
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3. For greater certainty, this Act, any provision of an Act of Parliament enacted by Part II and any other federal law that implements a provision of the Agreement or fulfils an obligation of the Government of Canada under the Agreement shall be interpreted in a manner consistent with the Agreement. |
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3. Il est entendu que la présente loi, les dispositions d'une loi fédérale édictées par la partie II et tout autre texte législatif fédéral qui met en oeuvre une disposition de l'Accord ou vise à permettre au gouvernement du Canada d'exécuter une obligation contractée par lui aux termes de l'Accord s'interprètent d'une manière compatible avec celui-ci. |
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It will be noted that it is a federal law which "implements" or "fulfils an obligation of the Government of Canada" which shall be interpreted consistently with NAFTA. This falls far short of making NAFTA part of domestic law. It also leaves open the question as to which laws can be said to implement or fulfil a NAFTA obligation. Nowhere in the Regulations nor in the Regulatory Import Analysis Statements issued in 1993 or 1998 is such an intention stated. While section 19.3 of the Patent Act specifically authorises the Governor in Council to make regulations to implement Article 1720 of NAFTA, that Article is not invoked by the appellants here and appears to involve only transitional provisions. This also suggests that the Governor in Council was not given a general mandate to implement NAFTA by regulations ("expressio unius est exclusio alterius") and it further puts in doubt the appellants' assumption that subsection 4(4) of the Regulations must be interpreted as legislation for implementing NAFTA generally or some other convention.
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) (1994)
| Article 2
Intellectual Property Conventions
1. In respect of Parts II, III and IV of this Agreement, Members shall comply with Articles 1 through 12, and Article 19, of the Paris Convention (1967).
Article 3
National Treatment
1. Each Member shall accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection of intellectual property, subject to the exceptions already provided in, respectively, the Paris Convention (1967), the Berne Convention (1971), the Rome Convention or the Treaty on Intellectual Property in Respect of Integrated Circuits. . . .
Article 4
Most-Favoured-Nation Treatment
With regard to the protection of intellectual property, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members. . . . |
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Article 2
Conventions relatives à la propriété intellectuelle
1. Pour ce qui est des Parties II, III et IV du présent accord, les Membres se conformeront aux articles premier à 12 et à l'article 19 de la Convention de Paris (1967).
Article 3
Traitement national
1. Chaque Membre accordera aux ressortissants des autres Membres un traitement non moins favorable que celui qu'il accorde à ses propres ressortissants en ce qui concerne la protection de la propriété intellectuelle, sous réserve des exceptions déjà prévues dans, respectivement, la Convention de Paris (1967), la Convention de Berne (1971), la Convention de Rome ou le Traité sur la propriété intellectuelle en matière de circuits intégrés. . . .
Article 4
Traitement de la nation la plus favorisée
En ce qui concerne la protection de la propriété intellectuelle, tous avantages, faveurs, privilèges ou immunités accordés par un Membre aux ressortissants de tout autre pays seront, immédiatement et sans condition, étendus aux ressortissants de tous les autres Membres. . . . |
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[20] First, I am of the view that there is no need to resort to these instruments in this case. I base this conclusion on the long-established jurisprudence that while Parliament is presumed not to intend to legislate contrary to international treaties or general principles of international law, this is only a presumption: where the legislation is clear one need not and should not look to international law. (See, e.g. Daniels v. White and the Queen [1968] SCR 517 at 541; Schreiber v. Canada 2002 SC 62 at para. 50). The appellants nevertheless say this principle has been modified by the Supreme Court in National Corn Growers et al v. Canadian Import Tribunal [1990] 2 SCR 1324. They take that case to mean that "international treaties are always a proper aid to be used to interpret domestic legislation". But in that case Gonthier J. put it thus:
If the convention may be used on the correct principle that the statute is intended to implement the convention then, it follows, the latter becomes a proper aid to interpretation, and, more especially, may reveal a latent ambiguity in the text of the statute even if this was 'clear in itself' . . . . (pages 1371-2)
(See also Pushpanathan v. Minister of Citizenship and Immigration [1998] 1 SCR 982 at para. 51)
In that case the Court was interpreting the Special Import Measures Act SC 1984 which, it was agreed by the parties, was specifically intended to implement the General Agreement on Tariffs and Trade ("GATT"). Therefore resort was had to the GATT in interpreting the powers given to the tribunal under the Act.
[21] That is not the situation in the present case. It has not been demonstrated to me that the Patented Medicine (Notice of Compliance) Regulations were adopted for the purpose of implementing any of the international instruments on which the appellants rely as set out above.
[22] If I should be in error in this respect, however, I am also of the view that none of the instruments relied on, even if applied directly to override the clear language of the Regulations, would dictate the result insisted upon by the appellants.
[23] Some of these instruments require "national treatment", that is treatment as favourable for nationals of other parties to the conventions as is accorded to a member's nationals by that member. This is the essence of Article 2, section (1) of the Paris Convention and Article 3.1 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (1994) ("TRIPS"). Subsection 4(4) of the Regulations as the applications judge has interpreted it in no way conflicts with this obligation. The requirement which it imposes on an originator, to file a patent application in Canada before making a submission for an NOC, is in no way tied to nationality. It applies equally to Canadian originators as to originators from any of the countries who are members of the Paris Convention or TRIPS. Indeed the appellants who complain herein are all Canadian companies. Similarly the most-favoured-nation treatment required by Canada under Article 4 of TRIPS is in no way denied by subsection 4(4) of the Regulations, for the same reason. Its provisions apply to all "first persons" who want to make submissions for NOC in Canada, regardless of nationality.
[24] The other important international obligation invoked by the appellants is found in article 4.B of the Paris Convention. This is based on the right of priority established by Article 4.A. A person filing an application for a patent in any member country enjoys a right of priority for its patent, based on the date of original filing, in respect of any subsequent filing (within prescribed time limits) in another member state. Article 4.B (quoted in full supra) goes on to provide in part:
| Article 4
B. Consequently, any subsequent filing in any of the other countries of the Union . . . shall not be invalidated by reason of any acts accomplished in the interval, in particular, another filing, the publication or exploitation of the invention, the putting on sale of copies of the design design, or the use of the mark, and such acts cannot give rise to any third-party right . . . . |
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Article 4
B. En conséquence, le dépôt ultérieurement opéré dans l'un des autres pays de l'Union . . . ne pourra être invalidé par des faits accomplis dans l'intervalle, soit, notamment, par un autre dépôt, par la publication de l'invention ou son exploitation, par la mise en vente d'exemplaires du dessin ou du modèle, par l'emploi de la marque, et ces faits ne pourront faire naître aucun droit de tiers ni aucune possession personnelle. . . . |
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By Articles 1701.2 of NAFTA, Canada is obliged to give effect to this Convention and is bound to comply with these articles by Article 2.1 of TRIPS.
[25] Now subsection 4(4) of the Regulations as interpreted by the applications judge in no way "invalidates" a patent first filed in another member of the Union where that patent is invoked for purposes of priority in a filing for a Canadian patent. That priority is specifically protected by section 28.1 of the Patent Act. Nor do the Regulations give rise to any third-party patent rights that could detract from the priority based on a foreign filing. The owner of a foreign patent can prosecute his Canadian patent application with his priority recognized, as long as he does it within one year. He has access to our courts to withstand challenges to his application, to object to other conflicting applications, and to seek redress for infringement of his patent once it is issued in Canada.
[26] Instead, the Regulations provide an extra administrative process tied to the protection of public health, designed, on the one hand, to assist the development and preparation for marketing of generic drugs at a time prior to issue of an NOC when their sale would still be an infringement of a current patent. At the same time it gives patentees extra protection: by merely applying for prohibition they can normally prevent the issue of an NOC to a generic for 24 months. This system is, not surprisingly, confined to the protection of patents which have, or will have, force in Canada. The universe of special remedies is confined to existing or potential Canadian patents. But this in no way detracts from the priority to which Convention member patents are entitled in Canada in respect of the prosecution of Canadian patent applications. All that is required to achieve recognition in the Canadian regulatory system under consideration is to file a Canadian patent application prior to filing a submission for a notice of compliance. The appellants were at liberty to file such patent applications in Canada prior to filing their submissions but they did not do so.
[27] In spite of what the appellants seem to imply, the Paris Convention does not, as I understand it, confer immediate enforceability in Canada of a patent applied for or obtained in another member country. While it gives certain priorities to its holder in prosecuting a Canadian patent application, that holder or its affiliate must still apply in Canada for a patent before being able to enforce it here. The Regulations are in no way inconsistent with this principle. Article 1702 of NAFTA provides that a party may provide more extensive protection of patents than already required (by e.g. the Paris Convention), and such protection "must not be inconsistent with this Agreement" (inter alia inconsistent with the Paris Convention incorporated by Article 1701.2(c)). While arguably the Regulations represent "more extensive protection", there is nothing inconsistent with the Paris Convention in requiring the holder of a Convention patent to apply for the same patent in Canada before being able to enjoy the extra enforcement rights under the Regulations just as he has to do to exercise enforcement rights under the Patent Act generally.
[28] Therefore even if resort should be had to the international conventions to interpret subsection 4(4), that provision is correctly understood to require the filing of a Canadian patent application prior to delivery by a first person of a submission for a notice of compliance.
Conclusion
[29] I am therefore satisfied that the applications judge correctly interpreted subsection 4(4) of the Regulations. The appeals should all be dismissed with one set of costs to the respondent. The appeals having been dismissed as sought by the intervener there is no need to deal with its request for grant of status to seek leave to appeal in the Supreme Court.
"B.L. Strayer"
J.A.
I agree
"M. Nadon" J.A.
I agree
"J.D. Denis Pelletier" J.A.
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-442-02
A-443-02
STYLE OF CAUSE: Pfizer Canada Inc. v. Attorney General of Canada and the Canadian Drug Manufacturers' Association
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: Wednesday, January 29, 2003
REASONS FOR JUDGMENT BY: Strayer J.A.
CONCURRED IN BY: Nadon, Pelletier J.J.A.
DATED: March 14, 2003
APPEARANCES
Mr. A. Creber
Mr. François Grenier FOR THE APPELLANT
Mr. F. Woyiwada FOR THE RESPONDENT
Mr. E. Hore FOR THE INTERVENER
SOLICITORS OF RECORD
Gowling, Lafleur Henderson, LLP
Ottawa, Ontario FOR THE APPELLANT
Morris Rosenberg
Department of Justice
Ottawa, Ontario FOR THE RESPONDENT
Hazzard & Hore
Toronto, Ontario FOR THE INTERVENER
DOCKET: A-445-02
STYLE OF CAUSE: Schering Canada Inc. v. Attorney General of Canada and The Canadian Drug Manufacturers' Association
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: Wednesday, January 29, 2003
REASONS FOR JUDGMENT BY: Strayer J.A.
CONCURRED IN BY: Nadon, Pelletier J.J.A.
DATED: March 14, 2003
APPEARANCES:
Mr. A. Creber
Mr. François Grenier FOR THE APPELLANT
Mr. F. Woyiwada FOR THE RESPONDENT
Mr. E. Hore FOR THE INTERVENER
SOLICITORS OF RECORD:
Gowling Lafleur Henderson, LLP
Ottawa, Ontario FOR THE APPELLANT
Morris Rosenberg
Department of Justice
Ottawa, Ontario FOR THE RESPONDENT
Hazzard & Hore
Toronto, Ontario FOR THE INTERVENER