Date : 20000224
Docket : T-2074-99
BETWEEN:
APOTEX INC.
Applicant
- and -
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER
McGILLIS J.
[1] The four motions in this matter raise questions concerning, among other things, the rights of a party and the test to be applied on a motion for intervention under Rule 109 of the Federal Court Rules, 1998.
[2] Apotex Inc. ("Apotex") instituted an application on November 24, 1999 in which it sought various forms of relief as a result of the failure of the Minister of Health ("Minister") to process its abbreviated new drug submission for the unnamed product X. In its application, Apotex alleged, among other things, that it was not required to comply with section 5 of the Patented Medicines (Notice of Compliance) Regulations , SOR/93-133 as amended. In its submission for a notice of compliance, Apotex used a foreign product not sold in Canada as the Canadian reference product. The Minister refused to process the submission on the basis that Apotex was required to comply with section 5 of the Patented Medicines (Notice of Compliance) Regulations by sending a notice of allegation to the patentee of the Canadian approved product.
[3] Several innovator drug companies and a national association learned of Apotex" application in relation to product X and brought motions to be added as parties or interveners. Shortly before the return of those motions, Apotex disclosed that product X was pravastatin sodium. Apotex consented to the addition of Bristol-Myers Squibb Canada Inc. ("Bristol-Myers"), the patentee of pravastatin sodium, as a party respondent in the proceeding. However, Apotex limited its consent by taking the position that Bristol-Myers was a proper party only in relation to the relief sought in paragraphs 3 to 5 inclusive of the application and not in relation to paragraphs 1, 2, 6, 7 and 8.
[4] There were four motions before the Court: a motion by Bristol-Myers, Glaxo Wellcome Inc., Janssen-Ortho Inc., Novartis Pharmaceuticals Canada Inc., and Schering Canada Inc. seeking, among other things, to be added as parties or interveners; a motion by Pfizer Canada Inc. and Amgen Canada Inc. seeking, among other things, to be added as parties or interveners; a motion on behalf of Canada"s Research-based Pharmaceutical Companies ("Rx & D") seeking, among other things, to be added as an intervener; and, a motion on behalf of Merck & Co., Inc. and Merck Frosst Canada & Co. ("Merck") seeking, among other things, to be added as parties or interveners. At the return of the motions, Bristol-Myers limited its submissions to the question of whether it was entitled to participate fully as a party in the proceeding. All other applicants in the motions sought only to intervene in the proceeding. These Reasons for Order apply to all of those motions.
i) extent of participation by Bristol-Myers as a party
[5] Counsel for Apotex was unable to cite any authority to support the proposition that the participation of a party in a proceeding may be limited. In my opinion, the assertion that the participatory right of a party may be limited by the wording used to describe the relief sought in an application is unsupported by the Federal Court Rules, 1998 and the jurisprudence. Bristol-Myers is either a proper or necessary party or it is not. In the present proceeding, Bristol-Myers is clearly and unquestionably a proper party due to its status as the patentee of the drug in question. Under the Federal Court Rules, 1998, there is no provision permitting the Court to limit the rights of a person who is a proper or necessary party. To the contrary, the Federal Court Rules, 1998 accord specific procedural rights to all parties. As a party, Bristol-Myers is therefore entitled to participate fully in exercising all of the rights that accrue to a party in a proceeding [See also Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1997), 72 C.P.R. (3d) 187 at 191 (F.C.T.D.); aff"d (1997), 72 C.P.R. (3d) 517 (F.C.A.)]. Finally, the notion that it is somehow appropriate to limit the participatory rights of a party is undesirable in that it would encourage unnecessary interlocutory motions.
[6] Alternatively, in the event that I have erred in concluding that the participatory rights of a party may not be limited, it is necessary to consider the question in the context of the relief
sought in the notice of application. The relevant provisions of the application state as follows:
| THE APPLICANT MAKES APPLICATION FOR |
| (1) a Declaration that the Respondent, Minister of Health ("Minister"), unlawfully refused to the process the Apotex Abbreviated New Drug Submission for product X ("Apotex ANDS") in accordance with the provisions of Division 8, Part C, of the Food and Drug Regulations ("FDA Regulations") following its filing with the Minister on December 23, 1998; |
| (2) an Order directing the Minister forthwith to review and process the Apotex ANDS in such manner as to place the Apotex ANDS in the position it would have been in had the Minister lawfully carried out his duties under Division 8, Part C, of the FDA Regulations and processed the Apotex ANDS upon its receipt on December 23, 1988, and more particularly: |
| (i) review the ANDS forthwith and in any event within 14 days; and |
| (ii) in the event that the Minister finds that there are any deficiencies requiring response, forthwith to provide such deficiencies to Apotex and to review any response thereto within 7 days of receipt. |
| (3) a Declaration that, as at December 23, 1998, the date of submission of the Apotex ANDS, Apotex was not required to comply with section 5 of the Patented Medicines (Notice of Compliance) Regulations ("Patent Regulations"); |
| (4) a Declaration that Apotex has a vested right to have the Apotex ANDS processed by the Minister in accordance with the provisions of Division 8, Part C, of the FDA Regulations and without regard to the Patent Regulations, and more particularly, a declaration that the amendments to the Patent Regulations made October 1, 1999 are not applicable to the Apotex ANDS; |
| (5) an Order directing the Minister to issue Apotex its Notice of Compliance (''NOC') for product X immediately upon satisfactory review and processing of the Apotex ANDS pursuant to Division 8, Part C, of the FDA Regulations; |
| (6) a Declaration that, by refusing to process the Apotex ANDS on the basis that Apotex was required to comply with the Patent Regulations, the Minister acted arbitrarily and unlawfully discriminated against Apotex; |
| (7) a Declaration that, by persistently ignoring and refusing to respond to Apotex' complaint that there was no basis upon which to distinguish the status and processing of the Apotex ANDS from other cases, the Minister acted unfairly, high-handedly and in bad faith; |
| (8) costs of this application on a solicitor and client basis. |
[7] In his effort to limit the right of Bristol-Myers to participate as a party in the proceeding, counsel for Apotex submitted that paragraphs 1, 2, 6 and 7 were not relevant to Bristol-Myers as patentee in that they raised issues relating to the Food and Drug Regulations, C.R.C., c. 870 as amended, and not the Patented Medicines (Notice of Compliance) Regulations. I cannot accept that submission. All of those paragraphs, with the possible exception of paragraph 7, will require the Court to interpret section 5 of the Patented Medicines (Notice of Compliance) Regulations, as well as the relevant provisions of the Food and Drug Regulations, in order to determine whether the Minister erred in refusing to process the abbreviated new drug submission for pravastatin sodium. This case is simply the next variation on the issues considered in Nu-Pharm Inc. v. Canada (Attorney General) (1998), 80 C.P.R. (3d) 74 (F.C.A.) and Merck & Co. v. Canada (Attorney General), [1999] F.C.J. No. 1825, T-398-99 (November 23, 1999) (T.D.). In the circumstances, I am satisfied that the participation of Bristol-Myers as a party in the proceeding ought not to be limited in any manner.
ii) motion for intervention under Rule 109
[8] Rule 109 of the Federal Court Rules, 1998 governs interventions. That Rule provides as follows:
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[9] Prior to the enactment of Rule 109 in the Federal Court Rules, 1998, the procedure to be followed under the previous Federal Court Rules on a motion for intervention varied depending on the nature of the proceeding [See Pfizer Inc. v. Canada (1999), 1 C.P.R. (4th) 349 at 355 (F.C.T.D.)]. None of the rules governing interventions under the previous Federal Court Rules outlined any criteria or other matters to be considered by the Court on a motion for intervention. As a result, the criteria to be applied on a motion for intervention under the previous Federal Court Rules were developed in the jurisprudence.
[10] For present purposes, it is unnecessary to conduct an exhaustive review of all previous cases dealing with interventions. Suffice it to say that the criteria outlined in the cases varied somewhat, but reflected certain common elements. The criteria typically applied by the Court, both in public interest cases and otherwise, included matters such as the interest of the proposed intervener in the outcome, the effect on the rights of the proposed intervener, the interests of justice, the ability of the Court to hear and determine the matter on its merits without any intervention, and whether the proposed intervener had a different view to bring to the case [See, for example, Canadian Wildlife Federation Inc. v. Canada (Minister of Environment) (1989), 26 F.T.R. 241 at 243 (T.D.); Rothmans, Benson & Hedges Inc. v. Canada (Attorney General), [1990] 1 F.C. 74 at 79-80 (T.D.); aff"d on that point [1990] 1 F.C. 90 at 92; Canadian Council of Professional Engineers v. Memorial University of Newfoundland (1997), 75 C.P.R. (3d) 291 at 293 (F.C.T.D.)]. In Apotex Inc. v. Canada (Attorney-General) (1994), 56 C.P.R. (3d) 261 (F.C.T.D.), Simpson J. expanded on the criteria to be applied under former Rule 1611 on a motion for intervention. At page 266, she stated as follows:
| I have concluded that the following factors are relevant to the exercise of my discretion: |
| (i) The status of the case. What is the procedural and substantive development of the matter to date? How well have the issues been defined? |
| (ii) The impact of the decision. Who will be affected? Are the issues of interest to the parties, to a broader group such as an industry or to the public at large? |
| (iii) The nature of the rights which the moving parties assert. Are they direct or remote? Are they substantive, procedural, economic? |
| (iv) The nature of the evidence the proposed parties or interveners are in a position to adduce and whether it will assist the court in reaching its decision. |
| (v) The ability of the existing parties to adduce all the relevant evidence and their apparent enthusiasm for the task. |
In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), supra, MacKay J. cited the decision in Apotex Inc. v. Canada (Attorney-General), supra, but relied primarily in his analysis on the evidence and arguments that the proposed interveners could bring before the Court, given that their interests were divergent from those of the existing parties. In short, as is apparent from a brief overview of the jurisprudence, the criteria to be applied in determining whether to permit an intervention varied somewhat.
[11] The procedure governing interventions was simplified and streamlined in the Federal Court Rules, 1998, in that a single rule now governs all motions for intervention, regardless of the nature of the proceeding. Furthermore, Rule 109(2)(b) requires an applicant on a motion for intervention to "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". None of the rules pertaining to interventions in the previous Federal Court Rules contained a provision analogous to Rule 109(2)(b). The new requirement that a proposed intervener must indicate in the notice of motion the manner in which the described participation "...will assist in the determination of a factual or legal issue..." therefore clearly signals that the Court will focus on that issue in determining whether an intervention should be permitted. In Pfizer Inc. v. Canada, supra , Lemieux J. recognized the significance of the requirement in Rule 109(2)(b), noting at page 355 that it "...is an important criteria [sic ] in terms of evaluating whether intervention should be permitted or not". In my respectful opinion, it is more than an important criterion; it is the fundamental question to be determined on a motion for intervention. In short, the issue to be addressed on a motion for intervention under Rule 109 is whether the participation of the proposed intervener will assist the Court in determining a factual or legal issue related to the proceeding. Given the shift in focus indicated by the wording of Rule 109 in the Federal Court Rules, 1998, the approach taken in the jurisprudence concerning interventions under the various rules in the previous Federal Court Rules should be approached with caution. However, some of the factors outlined in the previous jurisprudence continue to be relevant, on a motion for intervention under Rule 109, in assessing whether the participation of the proposed intervener will assist the Court in determining a factual or legal issue related to the proceeding. For example, the Court may consider, among other things, the nature of the evidence to be adduced, the ability of the existing parties to adduce all of the relevant evidence or to adequately advance the position of the proposed intervener, and whether the Court can hear and decide the case on its merits without the assistance of the proposed intervener.
[12] To date, reasons have been rendered on three motions for intervention under Rule 109. Pfizer Inc. v. Canada, supra at 355-357 and Bayer v. Canada (Attorney General) (1999), 85 C.P.R. (3d) 175 at 182-183 (F.C.T.D.) applied the criteria enunciated in Rothmans, Benson & Hedges Inc. v. Canada (Attorney-General) and Apotex Inc. v. Canada (Attorney-General), supra. In Yale Indian Band v. Aitchelitz Indian Band, [1998] F.C.J. No. 1060, T-776-98 (June 24, 1998) (Proth.), the criteria outlined in Canadian Wildlife Federation Inc. v. Canada (Minister of Environment), supra were applied. I simply wish to note that, in Bayer v. Canada (Attorney General) and Yale Indian Band v. Aitchelitz Indian Band, supra, the impact of the wording used in Rule 109(2)(b) of the Federal Court Rules, 1998, was not addressed.
iii) motions to add innovator companies as interveners
[13] As indicated previously, Glaxo Wellcome Inc., Janssen-Ortho Inc., Novartis Pharmaceuticals Canada Inc., Schering Canada Inc., Pfizer Canada Inc., Amgen Canada Inc. and Merck ("innovator companies") have brought motions requesting intervener status in this proceeding. I have concluded, in the exercise of my discretion, that those three motions ought to be dismissed. In arriving at my decision, I have carefully considered all of the materials submitted on those motions, as well as the detailed submissions made by all counsel. The central issue to be determined in this proceeding is clearly yet another variation on the question of the interpretation of section 5(1) of the Patented Medicines (Notice of Compliance) Regulations in circumstances where a drug other than the patented drug is named in the abbreviated new drug submission. I am not satisfied, on the basis of the evidence adduced, that the participation of the innovator companies will assist the Court in determining the factual or legal issues related to the proceeding. At the time the innovator companies filed their evidence on the motion, Apotex had not disclosed the identity of product X. As a result, the innovator companies were seeking status as parties, and in the alternative were requesting to be added as interveners. Most of the evidence adduced by the innovator companies related to concerns raised as a result of the refusal of Apotex to identify product X. Now that Apotex has disclosed the identity of product X, the evidence adduced on that issue is irrelevant. However, I have carefully considered the evidence of each innovator company in its entirety. In my opinion, the evidence tendered by each innovator company concerning its proposed participation in the proceeding is couched largely in generalities and is not sufficient to establish that its participation will assist the Court in determining a factual or legal issue related to the proceeding. Furthermore, I am satisfied that the respondents, namely the patentee Bristol-Myers and the Minister, are able to adduce all of the relevant evidence necessary to assist the Court in determining the factual or legal issues related to the proceeding. I have therefore concluded, in the exercise of my discretion, that the innovator companies ought not to be added as interveners.
iv) motion to add Rx & D as intervener
[14] The proposed intervener Rx & D is a national association representing over 19,000 Canadians who work for more than 60 member companies of Canada"s research based pharmaceutical companies. The Rx & D members include all of the innovator companies proposed as interveners in this proceeding. In its materials filed on the motion, Rx & D has indicated that it wishes to tender the evidence of its president, Murray Elston, concerning consultations between Rx & D and Industry Canada during August and September 1999 in relation to the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations , SOR/99-379 which came into force on October 1, 1999. In his affidavit, Mr. Elston stated that, given his "experience in consulting with Industry Canada" in relation to those Regulations, he was "...in a position to provide evidence as to the applicability of these amendments to the Apotex [abbreviated new drug submission] that could not be put forward by either of the current parties to this proceeding". At the time Mr. Elston swore his affidavit, only Apotex and the Minister were parties to the proceeding. However, Bristol-Myers is now a party. In the event that the evidence of Mr. Elston is relevant, Bristol-Myers can certainly tender it. Rx & D has therefore failed to adduce any evidence to establish that its participation will assist the Court in determining a factual or legal issue related to the proceeding. In the circumstances, I have concluded, in the exercise of my discretion, that Rx & D ought not to be added as an intervener.
DECISION
[15] The motion of Bristol-Myers to participate as a party is granted with costs. The motions of the other innovator companies and Rx & D to intervene in the proceeding are dismissed with costs.
| D. McGillis |
| Judge |
OTTAWA
February 24, 2000
| (vi) |