Date: 20000908
Docket: T-994-00
BETWEEN:
WARNER-LAMBERT CANADA INC. and
WARNER-LAMBERT COMPANY
Applicants
- and -
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER AND ORDER
HENEGHAN J.
[1] Apotex Inc. wishes to participate in the application for judicial review commenced by Warner-Lambert Canada Inc. ("W-L Canada") and Warner-Lambert Company ("W-L Company") against the Minister of Health (the "Minister"). Apotex Inc. filed a notice of motion seeking an order that it be granted status as a party pursuant to rules 104(1)(b) and 303(1)(a) of the Federal Court Rules, 1998 (the "Rules") or alternatively, that it be permitted to participate as an intervener pursuant to rule 109(1) of the Rules.
[2] W-L Canada and W-L Company have applied for judicial review of a decision of the Minister made on May 24, 2000, which decision was made pursuant to section 3(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended (the "Regulations"). In the decision, the Minister decided that:
| (1) The patent list for Canadian Patent No. 1297023 (the "023 Patent") and Canadian Patent No. 1297024 (the "024 Patent"), submitted by the Applicant Warner-Lambert Canada Inc. ("W-L Canada") along with a Supplemental New Drug Submission ("the SNDS") will not be added to the patent register maintained by the Minister pursuant to s. 3(1) of the Regulations; and |
| (2) the `023 and `024 Patents will be removed from the Patent Register in respect of the W-L Canada's quinapril hydrochloride 5, 10, 20 and 40 mg oral tablets and quinapril hydrochloride/hydrochlorothiazide 10/12.5 mg, and 20/12.5 mg and 20/25 mg oral tablets. |
[3] In the application for judicial review the applicants seek the following relief:
| (1) a declaration that the Minister erred in law in rendering the Decision; |
| (2) an order quashing the Decision; |
| (3) an order prohibiting the Minister from removing the `023 and `024 Patents from the Patent Register in respect of W-L Canada's quinapril hydrochloride 5, 10, 20 and 40 mg oral tablets and quinapril hydrochloride/hydrochlorothiazide 10/12.5 mg, and 20/12.5 mg and 20/25 mg oral tablets; |
| (4) or, in the alternative to (3), if, at the date of disposition of this application the `023 and `024 Patents have been removed from the Patent Register in respect of W-L Canada's quinapril hydrochloride 5, 10, 20 and 40 mg oral tablets and quinapril hydrochloride/hydrochlorothiazide 10/12.5 mg, and 20/12.5 mg oral tablets, an order requiring the Minister to reinstate the `023 and `024 Patents to the Patent Register in respect thereto; |
| (5) an order requiring the Minister, upon issuing a Notice of Compliance in respect of the SNDS to add the patent list for the `023 and `024 Patents submitted with the SNDS to the Patent Register; |
| (6) an interlocutory stay, pursuant to s. 18.2 of the Federal Court Act, of the Minister's decision to remove the `023 and `024 Patents from the Patent Register in respect of the W-L Canada's quinapril hydrochloride 5, 10, 20 and 40 mg oral tablets and quinapril hydrochloride/hydrochlorothiazide 10/12.5 mg and 20/12.5 mg and 20/25 mg oral tablets; |
| (7) costs of this application; and |
| (8) such other order as this honourable court deems just. |
[4] Apotex is an Ontario Corporation engaged in the manufacture of generic pharmaceutical products. It is a competitor of the applicants. It claims that it is directly interested in and affected by the Minister's decision concerning the W-L Canada patents. The W-L Canada patents relate to quinapril hydrochloride oral tablets and quinapril hydrochloride/hydrochlorothiazide oral tablets. Apotex says that it is fundamentally interested in the Minister's determination concerning these patents because it is in the process of developing a generic version of quinapril hydrochloride for which it will, in the near future, file an abbreviated new drug submission ("ANDS") seeking a Notice of Compliance relative to its product Apo-quinapril. Apotex says that in its ANDS, it will compare its product to the quinapril product currently sold by W-L Canada under the trade name Accupril.
[5] If granted standing to participate in this application for judicial review, Apotex intends to oppose the application, in other words to support the position of the Minister.
[6] There are practical aspect to the request by Apotex to participate in the present proceedings. First, if W-L Canada is unsuccessful in having patents 23 and 24 recorded on the Patent Register, then the field is open for Apotex to proceed with production of its version of quinapril hydrochloride and Apotex would not be required to comply with the requirements of subsections 5(1) and (3) of the Regulations respecting that drug.
[7] There is a second practical consequence to the participation of Apotex in this application. If granted party status, Apotex will be entitled to access the materials and information now subject to the protective order which was issued in this proceeding on June 23, 2000.
[8] W-L Canada and W-L Company oppose the motion brought by Apotex. The applicants say that Apotex has mischaracterized the issue to be determined on the application for judicial review. The applicants say that the issue to be addressed in the application for judicial review is a question of statutory interpretation, particularly the meaning of subsections 4(1), 4(2) and 4(7) of the Regulations. The applicants submit that Apotex has not specified why it is a necessary party to this proceeding nor has Apotex identified what it can contribute to the application for judicial review that the parties themselves, that is W-L Canada, W-L Company and the Minister, cannot contribute. Furthermore, the applicants argue that Apotex has no independent standing to commence this application for judicial review and in consequence, Apotex should not be joined as a party.
[9] The applicants also resist the motion by Apotex to participate as an intervener. The applicants rely upon rule 109 of the Rules and argue that Apotex has failed to disclose the evidence or arguments which it could present upon the hearing of the application for judicial review. The applicants say that the present parties, including the Minister, have filed sufficient affidavit materials to establish the necessary factual foundation for a full adjudication of the application for judicial review. According to the affidavits filed by W-L Canada and W-L Company in connection with this notice of motion, the applicants and the respondent have agreed that there will be no cross-examination on the affidavits which have been filed to date and that they are ready to proceed with the conduct of the application for judicial review in accordance with the Rules.
[10] Apotex submits that it is a necessary party in these proceedings because it will present a view different from that expressed by the applicants and a view which will be less neutral than that anticipated to be expressed by the Minister.
[11] Apotex brings this motion pursuant to rules 104(1)(b), 303(1)(a) and 109(1) of the Rules. Rule 104(1)(b) is the general rule concerning joinder of a party and rule 303(1)(a) deals with parties to an application. These rules provide as follows:
| 104. (1) At any time, the Court may : [...] (b) order that a person who ought to have been joined as a party or whose presence before the Court is necessary to ensure that all matters in dispute in the proceeding may be effectually and completely determined be added as a party, but no person shall be added as a plaintiff or applicant without his or her consent, signified in writing or in such other manner as the Court may order. |
104. (1) La Cour peut, à tout moment, ordonner : [...] b) que soit constituée comme partie à l'instance toute personne qui aurait dû l'être ou don't la présence devant la Cour est nécessaire pour assurer une instruction complète et le règlement des questions en litige dans l'instance; toutefois, nul ne peut être constitué codemandeur sans son consentement, lequel est notifié par écrit ou de telle autre manière que la Cour ordonne. |
| 303. (1) Subject to subsection (2),an applicant shall name as arespondent every person (a) directly affected by the order sought in the application, other than a tribunal in respect of which the application is brought; or |
303. (1) Sous réserve du paragraphe (2), le demandeur désigne à titre de défendeur : a) toute personne directement touchée par l'ordonnance recherchée, autre que l'office fédéral visé par la demande; |
[12] The thrust of rule 104(1)(b) is that a person who is necessary for the effective and complete adjudication of a matter should be joined as a party. It is not sufficient that a person could merely adduce relevant evidence; see Stevens v. Canada (Commissioner, Commission of Inquiry) [1998] 4 F.C. 125. Apotex has not demonstrated that its presence is required to ensure the effective and complete adjudication of the matters in dispute between the applicants and the Minister.
[13] Rule 303(1)(a) of the Rules directs that for an applicant for judicial review shall name as a respondent any person who is "directly affected" by the order sought in the application. However, this application for judicial review is framed in terms of a question of statutory interpretation of certain regulations considered by the Minister in making a decision affecting the rights of a current patent holder, that is W-L Company.
[14] In my view, Apotex is no more "directly affected" by this application for judicial review than is any other pharmaceutical manufacturer. Accordingly, the notice of motion seeking an order to grant Apotex status as a party in this application for judicial review is dismissed.
[15] I turn now to the request that Apotex be allowed to participate as an intervener pursuant to rule 109(1) of the Rules. This rule provides as follows:
| 109. (1) The Court may, on motion, grant leave to any person to intervene in a proceeding. |
109. (1) La Cour peut, sur requête, autoriser toute personne à intervenir dans une instance. |
[16] Apotex has not shown that it has a present interest in these proceedings. From the evidence presented, Apotex has not yet taken steps to seek a Notice of Compliance in relation to its proposed pharmaceutical product. The affidavit of Dr. Bernard Sherman indicates at paragraph 9 as follows:
| 9. Apotex is in the progress of developing a generic version of quinapril hydrochloride. In this respect, Apotex will, in the near future, file an Abbreviated New Drug Submission ("ANDS") with the Minister seeking a NOC in respect of its Apo-Quinapril product and will, in its ANDS, compare its product to the quinapril product currently sold by Warner-Lambert under the trade name Accupri. |
[17] This portion of Dr. Sherman's affidavit is indicative of the present intention to carry out an act in the future. If Apotex indeed takes the steps referred to in this paragraph, the situation concerning its interest may change but at the moment and having regard to the evidence before me, I am not persuaded that Apotex has such an interest in these proceedings that it should be joined as a party.
[18] In Apotex Inc. v. Canada (Minister of Health) [2000] F.C.J. No. 248, Madam Justice McGillis comprehensively reviewed the matters to be considered upon a motion to grant intervener status. She said, in respect of an application by a proposed intervener, as follows, at paragraph 11:
| [...] 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.[...] |
[19] Apotex has provided no detail or specifics with respect to the type of evidence or nature of the legal arguments which it would advance if granted intervener status in this proceeding. In my view, Apotex has failed to meet the requirements of rule 109(1) of the Rules.
[20] Having regard to these factors, I decline to exercise my discretion to grant intervener status to Apotex, and the motion is dismissed with costs.
"ELIZABETH HENEGHAN"
J.F.C.C.