Date: 19990611
Docket: T-667-99
BETWEEN:
PFIZER INC. and
PFIZER CANADA, INC.
Plaintiffs
- and -
HER MAJESTY THE QUEEN,
THE MINISTER OF HEALTH and
APOTEX INC.
Defendants
REASONS FOR ORDER
LEMIEUX J.:
[1] The Canadian Drug Manufacturers Association, an industry association representing Canada's generic drug manufacturers (CDMA), pursuant to rule 109 of the Federal Court Rules, 1998 (the Rules), seeks leave to intervene in an action, and more specifically, in an interlocutory injunction proceeding set down for hearing on July 14, 1999, initiated by the plaintiffs Pfizer Inc. and Pfizer Canada Inc. (Pfizer) in which Her Majesty the Queen, the Minister of Health (the Federal Government) are defendants with Apotex Inc. recently being added as a party defendant.
[2] Pfizer opposes the CDMA's application. The defendants do not oppose.
A. BACKGROUND AND CONTEXT
[3] Pfizer, in its action launched on April 15, 1999, seeks a declaration from this Court that the expiry date of Canadian Letters Patent No. 1,130,815 (the 815 patent), is October 30, 2000. The 815 patent relates to the compound sertraline hydrochloride marketed by Pfizer across Canada under the trademark Zoloft, a medicine indicated for the treatment of, inter alia, depression.
[4] The current expiry date for the 815 patent is August 31, 1999.
[5] There is in place a much litigated regime arising out of amendments made in section 55.2 of the Patent Act and the enactment of the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Regulations provide for a statutory stay prohibiting the Minister of Health from issuing a notice of compliance (NOC) to a second person (usually a generic drug company) who has issued a notice of allegation to a first person (usually a patented medicine holder or licensee such as Pfizer) who has initiated prohibition proceedings under the Regulations. Pfizer is currently engaged in such prohibition proceedings in this Court affecting its drug Zoloft.
[6] An NOC is issued by the Minister of Health pursuant to the Food and Drug Regulations which provide that no person can market a drug in Canada without an NOC.
[7] The Regulations, however, enable the Minister of Health to issue an NOC to the second person at the expiration of any patent on the patent register maintained pursuant to the Regulations. Generally speaking, in practical terms, in this case after August 31, 1999, the Minister of Health could issue an NOC to a generic drug company in respect of sertraline hydrochloride who made a new drug submission and cleared the regulatory path prescribed under the Food and Drug Act in terms of safety and effectiveness.
B. NATURE OF THE PROCEEDING
[8] Pfizer, in its action, claims a declaration of an expiry date of October 30, 2000 on the basis of Canada's agreed to and implemented obligations arising out of article 33 of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) part of the Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations as reflected in the Marrakesh Agreement Establishing the World Trade Organization which Canada approved and implemented by its enactment of the World Trade Organization Implementation Act, S.C. 1994, c. 47 (the WTO Implementation Act).
[9] Pfizer says section 33 of the TRIPS Agreement requires Canada to provide a minimum term of protection for all patents that is not less than twenty years from the filing date of the application for the patent.
[10] Pfizer, as part of its action, seeks an interlocutory injunction to be heard on July 14, 1999 in the following terms:
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Interim and interlocutory injunction enjoining the Minister of Health or his officials from issuing, without the consent of Pfizer, a notice of compliance pursuant to the Food and Drug Regulations and the Patented Medicines (Notice of Compliance) Regulations to any other drug manufacturer with respect to the drug for which patent lists including the 815 patent have been filed with the Minister, until the trial of this action. |
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[11] The Federal Government recently filed a motion to strike the Pfizer action on the grounds, inter alia, it discloses no reasonable cause of action, is frivolous and vexatious or otherwise constitutes an abuse of process. The Federal Government relies upon the no cause of action clauses in sections 5 and 6 of the WTO Implementation Act. Pfizer is likely to attack the validity of those sections on constitutional law grounds. The motion to strike will be heard by this Court on June 25, 1999.
[12] In its grounds for intervention, CDMA says its members, who are virtually all major generic drug manufacturers in Canada, are directly affected by the issues in the Pfizer action and interlocutory proceedings, and that intervention is necessary to ensure that all matters in dispute are effectively and completely determined. CDMA's motion and affidavit in support deposed to by James Keon, President of the CDMA, speak to the impact the expiry date of patented medicines has on a wide range of pharmaceutical preparations and the date of entry into the marketplace of generic drugs. Mr. Keon's affidavit points out that the interlocutory injunction sought by Pfizer would enjoin the Minister of Health from granting an NOC to "any other drug manufacturer" until the trial of the action. Mr. Keon says there is no single issue that more directly affects generic drug companies than the expiry date of pharmaceutical patents.
[13] Mr. Keon further claims the following effects of the Pfizer action and orders sought in the interlocutory proceedings: casts doubt on the validity and effect of section 45 of the Patent Act, extends patent protection not only for sertraline but also for many other pharmaceutical patents, rewrites the Patent Act, causes irreparable harm to the generic pharmaceutical industry, and delays the introduction of low cost drugs.
[14] Mr. Keon was cross-examined on his affidavit on June 3, 1999. Counsel for Pfizer probed or obtained answers touching on the following areas: irreparable harm in the context of Apotex being an added party and the impact on other generic drug manufacturers of being the first generic on the marketplace; the position of sertraline in the Canadian marketplace; the effect of the injunction on drugs other than sertraline, the first-hand knowledge of CDMA of the generic drug business contrasted with the Minister of Health's knowledge, the nature of the order which this Court might make to eliminate confusion and amend the patent register, and the impact of the order sought on drug entry planning and development.
[15] The CDMA claims that its interests diverge from that of the Federal Government; it may wish to provide evidence which the Federal Government (and now Apotex) may be unable or unwilling to provide citing as examples a recent WTO complaint proceeding and the CDMA's participation in the 1997 Parliamentary review of the Patent Act.
[16] The scope of the intervention rights sought by CDMA is the entire panoply: right to produce evidence, cross-examine, participate in discovery, in all motions and at trial, with right of appeal.
C. PRINCIPLES FOR GRANTING INTERVENTION
[17] Rule 109 reads:
| 109. (1) The Court may, on motion, grant leave to any person to intervene in a proceeding.
(2) Notice of a motion under subsection (1) shall
| (a) set out the full name and address of the proposed intervener and of any solicitor acting for the proposed intervener; and |
| (b) describe how the proposed intervener wishes to participate in the proceeding and how that participation will assist the determination of a factual or legal issue related to the proceeding. |
(3) In granting a motion under subsection (1), the Court shall give directions regarding
| (a) the service of documents; and |
| (b) the role of the intervener, including costs, rights of appeal and any other matters relating to the procedure to be followed by the intervener. |
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109. (1) La Cour peut, sur requête, autoriser toute personne à intervenir dans une instance.
(2) L'avis d'une requête présentée pour obtenir l'autorisation d'intervenir :
| a) précise les nom et adresse de la personne qui désire intervenir et ceux de son avocat, le cas échéant; |
| b) explique de quelle manière la personne désire participer à l'instance et en quoi sa participation aidera à la prise d'une décision sur toute question de fait et de droit se rapportant à l'instance. |
(3) La Cour assortit l'autorisation d'intervenir de directives concernant :
| a) la signification de documents; |
| b) le rôle de l'intervenant, notamment en ce qui concerne les dépens, les droits d'appel et toute autre question relative à la procédure à suivre. |
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[18] Rule 109 is new; under the former Rules, there was no general provision governing intervention before the Court: there were several rules governing different subject-matters or proceedings and the gap rule was used to cover other situations.
[19] I note that rule 109 does not as such codify the previous case law on this subject. However, on the other hand, new rule 109 requires a proposed intervenor to "indicate how that participation will assist the determination of a factual or legal issue related to the proceeding" signalling that this factor is an important criteria in terms of evaluating whether intervention should be permitted or not.
[20] I was referred to several authorities, many of which related to the criteria for being added as a party. Being added as a party is not the same as being added as an intervenor although the two become blurred if the intervenor seeks the full scope of intervention rights.
[21] The line of authority which, in my opinion, fits the situation here, is exemplified in Rothmans, Benson & Hedges Inc. v. Canada (Attorney General), [1990] 1 F.C. 74 (T.D.), (in respect of the intervention of the Canadian Cancer Society); [1990] 1 F.C. 84 (in respect of the intervention of the Institute of Canadian Advertising); and [1990] 1 F.C. 90, reporting the decision of the Federal Court of Appeal which dismissed an appeal from the granting of the intervention of the Canadian Cancer Society but allowed the appeal of the Institute of Canadian Advertising.
[22] Hugessen J.A. at page 92 specifically endorsed the criteria enunciated by Rouleau J.; acknowledged that the area of the law relating to intervention is rapidly evolving particularly with the advent of the Charter. In my view, the Supreme Court of Canada's decision in Canadian Council of Churches v. Canada, [1992] 1 S.C.R. 236, cutting back situations where public interest standing to commence proceedings will be granted also impacts on developments in this area of the law in favour of granting intervention rights to public interest organizations or industry associations in appropriate circumstances, where public interest and public law issues of importance are at stake.
[23] What the Federal Court of Appeal endorsed was set out by Rouleau J. in the following lines at pages 79 and 80 of the reported case:
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There can be no doubt as to the evolution of the jurisprudence in "public interest litigation" in this country since the advent of the Charter. The Supreme Court appears to be requiring somewhat less by way of connection to consider "public interest" intervention once they have been persuaded as to the seriousness of the question. |
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In order for the Court to grant standing and to justify the full participation of an intervenor in a "public interest" debate, certain criteria must be met and gathering from the more recent decisions the following is contemplated: |
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(1) Is the proposed intervenor directly affected by the outcome? |
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(2) Does there exist a justiciable issue and a veritable public interest? |
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(3) Is there an apparent lack of any other reasonable or efficient means to submit the question to the Court? |
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(4) Is the position of the proposed intervenor adequately defended by one of the parties to the case? |
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(5) Are the interests of justice better served by the intervention of the proposed third party? |
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(6) Can the Court hear and decide the cause on its merits without the proposed intervenor? |
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[24] Prior to setting out the contemplated criteria, Rouleau J. had said this at page 79:
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Generally speaking, the interest required to intervene in public interest litigation has been recognized by the courts in an organization which is genuinely interested in the issues raised by the action and which possesses special knowledge and expertise related to the issues raised. |
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[25] The Federal Court of Appeal specifically endorsed this statement of Rouleau J. at page 92.
[26] At page 82, Mr. Justice Rouleau indicated not every application by a private or public interest group which can bring a different perspective should be allowed adding that the Supreme Court of Canada and other courts have permitted intervention by persons or groups of persons who possess an interest in public law issues and, in some cases, the ability of a proposed intervenor to assist the court in a unique way will overcome the absence of a direct interest. He added the following at page 82:
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What the Court must consider in applications such as the one now before it is the nature of the issue involved and the likelihood of the applicant being able to make a useful contribution to the resolution of the action, with no injustice being imposed on the immediate parties. |
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[27] This Court and the Federal Court of Appeal on other occasions had an opportunity to consider the proper scope of intervention criteria (see in particular, Holiday Park Developments Ltd. v. Canada (1994), 75 F.T.R. 76, endorsed on appeal 170 N.R. 351; Heïltsuk Indian Band et al. v. Canada (1990), 107 N.R. 187 (F.C.A.).
[28] In a case not much different than the case at bar, Simpson J., in Apotex v. Canada et al. (1994), 79 F.T.R. 235, after setting out her formulation of intervention criteria, allowed the intervention of the Pharmaceutical Manufacturers Association of Canada, the CDMA's counterpart for drug manufacturers holding patent rights, in a case involving the validity of the Regulations.
D. CONCLUSION
[29] The CDMA, in oral argument, scaled back the scope of its intervention. It sought intervention rights only in respect of the interlocutory proceedings scheduled for July 14, 1999, recognizing perhaps it was too late to intervene in a motion to strike proceedings. In respect to other aspects of the action, the CDMA said its intervention could be determined later.
[30] Moreover, counsel for the CDMA undertook to abide by the scheduling of filing of evidence, cross-examination, filing of application records geared to interlocutory injunction proceedings.
[31] Balancing the factors identified in the jurisprudence, I conclude that the CDMA should be granted intervention in the interlocutory injunction proceedings brought by Pfizer. In my view, even without a possible attack by Pfizer on the constitutionality of sections 5 and 6 of the WTO Implementation Act, the nature of this litigation raises broad public law issues going beyond the private or commercial interest of the participants.
[32] CDMA is an industry association representing the generic drug companies who are directly affected. Future rights to obtain an NOC are involved. The proceedings will have a substantial impact on them, either way. CDMA can, in its evidence, bring a perspective different than that of the Federal Government and even Apotex itself such that its participation will be of assistance to the Court. CDMA's intervention will not delay proceedings and, in my view, will not materially affect any other party in the conduct of the proceeding.
[33] Counsel for Pfizer relied upon the tri-partite test expressed by Rothstein J. (as he then was), in Canadian Council of Professional Engineers v. Memorial University of Newfoundland (1997), 75 C.P.R. (3d) 291, where leave to intervene was denied to the Association of Universities and Colleges of Canada (AUCC) in a case involving one or more of its members in respect of the use of the word "engineer" or "engineering" in university faculties or departments. The considerations which led Rothstein J. to deny intervention to AUCC are not present here. It is clear how the rights of CDMA or its members will be affected. CDMA has shown how it will bring a point of view different than Apotex. CDMA has satisfied me generally that its proposed evidence can be of a different nature and kind than that of the Federal Government and Apotex and that such proposed evidence will be different and useful. By saying this, I am not endorsing the relevance of CDMA's proposed evidence set out in Mr. Keon's affidavit nor am I limiting CDMA in that evidence nor the evidence which it can bring forward always subject to relevancy and other rules of evidence.
[34] For all of these reasons, CDMA is granted leave to intervene in Pfizer's interlocutory injunction proceedings with the following rights to be exercised in accordance with a schedule proposed between the plaintiffs and the defendants, yet to be approved by the Court and for the purposes of such scheduling, CDMA to be viewed in the same slot as the defendants:
| (a) right of cross-examination of Pfizer's affidavit evidence; |
| (b) right to file affidavit evidence and right of Pfizer to cross-examine on such; |
| (c) right to file a motion record; |
| (d) right to present argument at the hearing of Pfizer's interlocutory injunction; |
| (e) no right of appeal from the interlocutory decision of this Court; |
| (f) not to be awarded or be liable to costs. |
"François Lemieux"
J U D G E
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