Date: 20010212
Docket: T-1212-00
Neutral Citation: 2001 FCT 56
BETWEEN:
ELI LILLY CANADA INC.
Applicant
- and -
THE MINISTER OF HEALTH
Respondent
- and -
APOTEX INC.
Proposed Intervener
REASONS FOR ORDER AND ORDER
BLAIS J.
[1] This is a motion brought by Apotex Inc. seeking leave to intervene in this proceeding (T-1212-00) pursuant to Rule 109 of the Federal Court Rules, 1998.
FACTS
Nature of the proceeding
[2] By this application, the applicant seeks judicial review in respect of a decision of the Minister dated June 8, 2000 to remove Canadian Letters Patent 1,249,969 (the "`969 Patent") from the Patent Register administered pursuant to the Patented Medicines (Notice of Compliance) Regulations (the "Regulations") in relation to 500 mg, 1g and 6g/vial powder for solution for IV or IM administration in relation to TAZIDIME ceftazidime ("TAZIDIME") and 1g, 2g/vial powder for solution for IV or IM administration for TAZIDIME ADD-VANTAGE ceftazidime ("TAZIDIME ADD-VANTAGE").
[3] The question to be determined in this proceeding is whether a patent which includes claims to a medicine that is different than the drug for which a notice of compliance has already been issued should be included in the Patent Register in respect of such drug.
[4] The applicant filed its evidence in this proceeding on or before August 9, 2000 and the respondent filed its evidence on or before September 7, 2000.
[5] The cross-examinations of the applicant's and the respondent's witnesses were completed by November 10, 2000.
[6] The applicant filed its memorandum of fact and law on December 1, 2000. The applicant also filed its requisition for hearing on December 1, 2000. The hearing date had been set for April 9, 2001.
Nature of Apotex' interest
[7] Apotex is an Ontario Corporation and carries on business principally as a manufacturer of generic pharmaceutical products.
[8] The generic pharmaceutical products Apotex manufactures and sells are therapeutically equivalent to drug products manufactured and sold by other drug manufacturers.
[9] Apotex is frequently a party to proceedings in this Court brought pursuant to the Regulations and, more particularly, is a party to many proceedings which involve question in respect of the Minister's maintenance of the Patent Register.
The proposed intervener's position
[10] The proposed intervener submits that this Court has held that intervener status should be granted where party can bring a different perspective to the proceeding which might assist the Court. The proposed intervener alleges that it will bring a perspective to the proceeding which is different from that of the current parties.
[11] This Court will also evaluate whether the person who seeks to intervene has sufficient knowledge or expertise to assist the Court in its determination. Specifically, this Court will examine whether the participation of the proposed intervener will assist the Court in determining a factual or legal issue related to the proceeding.
[12] The proposed intervener alleges that, as Canada's largest generic drug manufacturer, it will be able to provide to this Court an informed additional perspective as to the interpretation of the Regulations and, in particular, the implications of an interpretation and application of the Regulations which would allow for the `969 Patent to be re-listed on the Patent Register.
[13] The proposed intervener submits that this Court has recognized that patentee and generic drug companies are the "real litigants" in proceedings which bring into question the interpretation and application of the Regulations.
[14] In this respect, it is submitted that the applicant will approach this proceeding in a partisan fashion and will urge this Court to interpret the Regulations in a manner most beneficial to its interest. Conversely, the respondent will almost certainly approach the proceeding in a more neutral fashion consistent with the fact that his property rights will not be affected by the outcome of the proceeding. For this reason, the proposed intervener contends that it will bring a perspective to this proceeding, namely that of a generic drug manufacturer, which otherwise will be missing. This perspective will be necessary to ensure that an appropriate balance is struck and that all pertinent issues are fully canvassed.
[15] The proposed intervener further alleges that the applicant has submitted that the decision of the respondent to remove the `969 Patent from the Patent Register is contrary to established case law, basing its submissions almost exclusively on the decision of Madam Justice McGillis in Apotex v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.).
[16] In particular, the applicant has made submissions in its affidavit evidence about the content of the arguments presented to Madam Justice McGillis and the content of her decision. The applicant further submitted that the respondent is taking the same position taken by the proposed intervener's counsel in the case.
[17] It is further submitted that the proposed intervener is uniquely positioned to assist this Court in evaluating the content of the arguments presented to Madam Justice McGillis, including whether the Minister is taking the same position taken by the proposed intervener's counsel in Apotex v. Canada (Minister of Health), supra.
[18] In determining whether to allow the participation of an intervener, this Court will also consider whether there would be any prejudice to the parties as a result of the intervention. It is submitted that the intervention of the proposed intervener would not prejudice the parties in any manner.
THE APPLICANT'S POSITION
[19] The applicant notes that the decision in Apotex Inc. v. Canada (Minister of Health) was appealed by the proposed intervener and was heard on January 29, 2001. The Court has been advised by the proposed intervener that Justice McGillis' decision was maintained by the Federal Court of Appeal.
[20] The applicant notes that pursuant to Rule 109(2)(b) the intervener must "describe how the proposed intervener wishes to participate in the proceeding and how that participation will assist the determination on a factual or legal issue related to the proceeding". This has been identified as "the fundamental question to be determined on a motion for intervention".
[21] The applicant submits that given that none of the rules pertaining to intervention in the previous Federal Court Rules contained a provision analogous to Rule 109(2)(b) under the 1998Federal Court Rules, the jurisprudence concerning interventions under the various rules in the previous Federal Court Rules should be approached with caution.
[22] The applicant relied on the three part-test for intervener status set out in Abbott v. Canada (T.D.) (March 29, 2000), T-1168-96 (Fed. Proth.) (unreported). The test is stated as follows:
| (a) the applicant for intervention must have an interest in the outcome; |
| (b) the rights of the applicant will be seriously affected by the outcome of the litigation; |
| (c) the applicant, as intervener, will bring a different perspective to the proceedings. |
[23] The applicant alleges that the proposed intervener has not clearly identified its interest and that an interest in the Minister's maintenance of the Patent Register, as alleged by the proposed intervener, does not address the narrow issue of law in this proceeding.
[24] The applicant also notes that the Court's reference to the patentee and generic drug companies as the "real litigants" in David Bull Laboratories (Canada Inc.) v. Pharmacia Inc. (C.A.) [1995], 1 F.C. 588 (C.A.), is in the context of proceedings under the Regulations, specifically where a generic company is seeking a notice of compliance and has served a notice of allegation with respect to an innovator's product.
[25] The applicant contends that the proposed intervener has not provided a notice of allegation with respect to the medicine ceftazidime nor has it adduced any evidence that it has filed an ANDS for ceftazidime. Furthermore, the applicant notes that this is not a proceeding for a notice of compliance under the Regulations.
[26] The issue of law before the Court is narrow and focusses on whether the applicant's `969 Patent was properly delisted by the respondent. The proposed intervener should not be considered a "real litigant" for the purpose of this proceeding and therefore, has no interest in this proceeding.
[27] The applicant also explains that the case Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1997), 72 C.P.R. (3d) 187 (F.C.T.D.) relied upon by the proposed intervener, was different from this proceeding since in that case, the issue was the respondent's decision to remove all process patents from the Patent Register. As such, any generic company holding process patents would have been affected.
[28] The applicant also submits that the proposed intervener has no interest in the main proceeding. It has no interest in the medicine to which the `969 Patent is relevant. At best, it is only affected by the outcome of this proceeding on a jurisprudential basis. The proposed intervener's evidence does not identify any rights that would be seriously affected by the outcome of this proceeding.
[29] The applicant alleges that the proposed intervener's perspective will not assist the Court in a manner sufficient to warrant intervention.
[30] The applicant further alleges that the proposed intervener's position is not "unique" with respect to the decision of Madam Justice McGillis in Apotex Inc. v. Canada (Minister of Health), supra, since the respondent participated fully in the hearing before McGillis J. and the respondent is also a party to the main proceeding. Thus, the respondent is also positioned to assist the Court in evaluating the issues canvassed at that proceeding. The jurisprudence clearly states that interpreting the jurisprudence for the Court is not sufficient to be considered "a different perspective". Furthermore, the proposed intervener has appealed the decision of McGillis J. and has had an opportunity to present its interpretation of the issues at the appeal.
[31] The applicant submits that the proposed intervener cannot offer a perspective that is different from the respondent. Also, this is not a case where the proposed intervener is intimately linked to its interest and it is not affected in any way by the respondent's decision to delist the applicant's `969 Patent.
ISSUE
[32] Should the proposed intervener be granted intervener status in this proceeding (T-1212-00)?
ANALYSIS
Should the proposed intervener be granted intervener status in this proceeding (T-1212-00)?
[33] Rule 109 (1) of the Federal Court Rules, 1998 states:
| The Court may, on motion, grant leave to any person to intervene in a proceeding. |
La Cour peut, sur requête, autoriser toute personne à intervenir dans une instance. |
[34] Rule 109(2) further states:
| 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. |
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. |
| [35] In Apotex Inc. c. Canada (Minister of Health), [2000] F.C.J. No. 248 (F.C.T.D.), McGillis J. held: |
| 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 or 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. |
| [36] In Abbott v. Canada (T.D.), [2000] 3 F.C. 482, Prothonotary Hargrave indicated: |
| There are three basic conditions which are to be read conjunctively: |
| 1. The applicant for intervention must have an interest in the outcome; |
| 2. The rights of the applicant will be seriously affected by the outcome of the litigation; and |
| 3. The applicant, as intervener, will bring a different perspective to the proceedings. |
| This test, its origins and applications, are briefly surveyed in Yale Indian Band v. Aitchelitz Indian Band et al. (1998), 151 F.T.R. 36 (F.C.T.D.), at pages 43-44. However I would also suggest that the law on intervention has not remained static. For example it has been modified by the concept that there be a balancing of the conditions and here I would refer to M. v.H. (1994), 20 O.R. (3d) 70, at page 78, a decision of the Ontario General Division. There Mr. Justice Epstein spoke of the "requirement that the court examine and try to balance the possible advantages of intervention with the disruption that may be caused" and that [at page 77] the "court's focus should be on determining whether the contribution that might be made by the intervenors is sufficient to counterbalance the disruption caused by the increase in the magnitude, timing, complexity and costs of the original action.". Mr. Justice Epstein added a caution to the effect that the discretion to add parties ought to be exercised cautiously, for to easily grant the status of intervener to the first person applying might result in a precedent so that there would be no principled way of excluding subsequent interveners, to the detriment of the whole common law system. |
[37] In the case at bar, the proposed intervener submits that its interest in the proceeding is as a manufacturer of generic pharmaceutical products and that as such it is frequently a party to proceedings in this Court brought pursuant to the Regulations and, more particularly is a party to many
proceedings which involve questions in respect of the Minister's maintenance of the Patent Register.
[38] The proposed intervener submitted its proposed memorandum of facts and law which would be filed should it be granted status as an intervener. The memorandum relates to the interpretation to be given to the decision of McGillis J. in Apotex, supra. It outlines the distinction to be made between that case and the present proceeding.
[39] The proposed intervener has failed to show in its evidence that it has an interest in the outcome of this proceeding and that its rights would be seriously affected by the outcome of the litigation. It is my conclusion that the proposed intervener has an interest only in relation to the interpretation of jurisprudence. This is not sufficient for it to be granted intervener status. Furthermore, the Apotex case, rendered by McGillis J. was heard by the Court of Appeal and the proposed intervener had the chance to make its submission in regard to that decision.
[40] This motion is dismissed with costs in favour of the applicant. The costs of the hearing before Prothonotary Lafrenière in Toronto is granted in favour of the applicant.
Pierre Blais
Judge
OTTAWA, ONTARIO
February 12, 2001