Date: 20010627
Docket: T-493-01
Neutral citation: 2001 FCT 708
BETWEEN:
APOTEX INC.
Applicant
- and -
THE ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
HENEGHAN J.
[1] AstraZeneca (the "moving party") proceeds by Notice of Motion to seek an order requiring Apotex Inc. (the "Applicant") to disclose whether its drug product Apo-X is an omeprazole or omeprazole magnesium product. If this is the situation, then the moving party seeks a further order allowing it to participate in this application for judicial review as a party or alternatively, as an intervener.
[2] Both the Applicant and the Respondent Minister of Health (the "Minister") oppose the motion and deny that the moving party should receive any of the relief sought.
[3] The moving party is a drug manufacturer. Formerly known as AstraPharma Canada Inc., it has approval from the Minister for various omeprazole and omeprazole magnesium products and has patents on the Patent Register in respect of these products. According to the moving party, there have been several proceedings to date involving the Applicant, the moving party and either omeprazole or omeprazole magnesium, which proceedings have involved the Patented Medicine (Notice of Compliance) Regulations, SOR/93-133, (the "Patented Medicine Regulations"). At least two proceedings involving these parties, one or other of the omeprazole products, and the Patented Medicine Regulations, remain outstanding.
[4] The moving party filed the Affidavit of Mr. Gunar Gaikis in support of its motion. Mr. Gaikis, a partner in the law firm of Smart and Bigger, the solicitors for the moving party, recounts the history of certain proceedings involving the Applicant, the moving party and omeprazole. He also alludes to a belief that the Applicant's product may involve omeprazole or omeprazole magnesium. This belief is apparently shared by a senior corporate officer of the moving party. In this regard, Mr. Gaikis deposes as follows:
9. Based on the information disclosed in the Notice of Application herein, I believe that Apo-X may involve omeprazole or omeprazole magnesium and if so, such an application must also involve patent matters under the Regulations, including the right of AstraZeneca to receive an allegation or to have a pending allegation adjudicated. I have also discussed this possibility with Karen Feltmate, Vice-President of Regulatory Affairs, AstraZeneca, who has advised me and I verily believe that she has also read the Notice of Application and cannot rule out the possibility that Apo-X involves omeprazole or omeprazole magnesium.
[5] The moving party claims that it should be joined as a party to the Applicant's application because its patents for omeprazole and omeprazole magnesium give rise to a legal interest in the development of a new drug which may contain these products. The moving party also submits that the current outstanding legal proceedings, involving a dispute about its products and to which the Applicant is a party, further support its claim to have a legal interest in this Application and that the disposition of this Application "directly affects" its rights.
[6] The moving party submits that it has only a narrow interest to protect in this Application, that is the compliance by the Applicant with the Regulations, but if it is granted party status it will be able to address all issues arising from the underlying application for judicial review. Naturally, if granted party status, it will also be in a position to review any materials which are presently subject to a confidentiality order.
[7] Insofar as the moving party seeks the alternative relief of being allowed to participate as an intervener, again it argues that it will only pursue the narrow issue of the Applicant's compliance with the Regulations.
[8] As noted above, both the Applicant and the Minister oppose this motion. In the first place, the Applicant argues that it is unnecessary.
[9] When the moving party filed its Notice of Motion on May 23, 2001, the Applicant was seeking an Order requiring the Minister to issue a Notice of Compliance ("NOC") in relation to Apo-X. However, prior to the hearing of the motion and to the knowledge of the moving party, the Applicant had obtained an Order, with the consent of the Minister, to amend the application for judicial review. The amendment specifically related to the issuance of a NOC, to delete that prayer for relief, and to substitute the following:
3. An Order requiring the Minister to process the Apo-X submission forthwith in accordance with the Regulations and any Order issued by this Honourable Court.
The Order allowing this amendment was issued on June 6, 2001.
[10] Reference to paragraph 1(d) of the Applicant's Application make it clear that the "Regulations" mentioned in paragraph 3 are the Food and Drug Regulations, C.R.C., c. 870 (the "Food and Drug Regulations") and that this proceeding is unrelated to the Patented Medicine Regulations relied on by the moving party in its Notice of Motion and its submission.
[11] Second, the Applicant takes the position that it is under no obligation to disclose the subject of its New Drug Submission ("NDS"). It argues that no one, except the Minister and a submitting drug manufacturer, has any right to know what is the subject of the filing, and this includes competitors of a submitting manufacturer.
[12] The Applicant says that the jurisprudence recognizes that the discharge by the Minister of his obligation to ensure the safety of new drug products does not include a responsibility to consider the commercial interests of the competitors of a submitting drug manufacturer and that essentially, the moving party is seeking status to participate in this application as a means of protecting its own competitive position. The Applicant relies on the following jurisprudence in support of this argument: Pfizer Canada Inc. v. Minister of National Health & Welfare et al. (1986), 12 C.P.R. (3d) 438 at 440 (F.C.A.); Merck Frosst Canada Inc. v. Canada (Minister of Health) (1997), 80 C.P.R. (3d) 550 at 557 (F.C.T.D.); aff'd. (1999) 3 C.P.R. (4th) 77 (F.C.A.); Glaxo Canada Inc. v. Minister of National Health & Welfare et al. (1987), 18 C.P.R. (3d) 206 at 214-215 (F.C.T.D.), aff'd. (1990), 31 C.P.R. (3d) 29 (F.C.A.).
[13] The Applicant submits that the parties who are necessary for a complete adjudication of the issues raised in its application are only the Applicant and the Minister, and both are presently before the Court. The application for judicial review involves review of a decision of the Minister's refusal to approve the drug Apo-X as safe and effective under the Food and Drug Regulations. It is a review on the record and the moving party is in no position to contribute to that record.
[14] In the result, any evidence that could now be produced by the moving party, which was not before the Minister, is irrelevant. Here, the Applicant relies on Hoffmann-LaRoche Ltd. v. Canada (Minister of National Health and Welfare et al) (1996), 67 C.P.R. (3d) 484 at 492 (F.C.T.D.); Ismaili v. Canada (Minister of Citizenship and Immigration) (1995), 100 F.T.R. 139 at 143 (F.C.T.D.); and Lemiecha et al. v. Minister of Employment and Immigration (1993), 72 F.T.R. 49 at 51 (F.C.T.D.).
[15] Next, the Applicant argues that the moving party has failed to adduce evidence to support its request to participate as an intervener and relies on three recent decisions of the Federal Court of Appeal where the Court determined that, in considering a request by a party to intervene, the Court must consider whether the proposed intervener would be "directly affected" by the result of the proceeding. The Court also stated that additionally, a proposed intervener must explain why its "position" in the proceeding is not already adequately presented by one of the parties to the proceeding.[1]
[16] As noted above, the Minister also opposes this motion. Counsel for the Minister appeared at the hearing and endorsed the submissions made by the Applicant, in addition to the concise relevant arguments filed as part of his motion record. In particular, the Minister argues that the decision which is the subject of the application pursuant to the Food and Drugs Act, R.S., c. F-27, and the Regulations passed under that Act, lies wholly within the discretion of the Minister and does not require the participation of the moving party, in any guise, to ensure a full adjudication.
[17] This motion is governed by rules 104(1)(b), 303(1)(a) and 109(1) of the Federal Court Rules, 1998 (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:
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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.
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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.
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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
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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;
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[18] 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. The moving party has presented no evidence to show that its presence is required to ensure the effective and complete adjudication of the matters in dispute between the Applicant and the Minister and has not met the requirements of rule 104(b).
[19] 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.
[20] In my view, neither has the moving party shown that it is "directly affected" by this application for judicial review. There is nothing substantial in the Affidavit of Mr. Gaikis to support such a conclusion. Accordingly, the motion to be granted party status is dismissed.
[21] I turn now to the request that the moving party be allowed to participate as an intervener pursuant to rule 109(1) of the Rules. This rule provides as follows:
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109. (1) The Court may, on motion, grant leave to any person to intervene in a proceeding.
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109. (1) La Cour peut, sur requête, autoriser toute personne à intervenir dans une instance.
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[22] In Apotex Inc. v. Canada (Minister of Health), (2000), 4 C.P.R. (4th) 421, 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 pages 428-429:
[...] 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.[...]
[23] The moving party has provided no evidence with respect to the type of evidence or nature of the legal arguments which it would advance if granted intervener status in this proceeding. The supporting Affidavit of Mr. Gaikis says nothing about these matters. In my view, the moving party has failed to meet the requirements of rule 109(1) of the Rules and that part of the motion is also dismissed.
[24] Since I have declined to exercise my discretion to allow the moving party status as a party or an intervener, I see no basis to order the Applicant to disclose the identification of the subject of its NDS. The moving party has no present right to know this information.
[25] The motion is dismissed with costs to the Applicant and the Minister. It is highly questionable whether this motion should have been pursued at this time and the award of costs should so reflect. Accordingly, costs will be assessed on the basis of the high end of Column IV, Tariff B of the Rules, plus travelling expenses and disbursements, the costs so assessed to be payable forthwith.
ORDER
[26] The motion is dismissed with costs to the Applicant and the Minister, costs to be assessed on the high end of Column IV, Tariff B of the Federal Court Rules, 1998, plus travelling expenses and disbursements, the assessed costs to be payable forthwith.
"E. Heneghan"
J.F.C.C.
Toronto, Ontario
June 27, 2001
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
DOCKET: T-493-01
STYLE OF CAUSE: APOTEX INC.
- and -
THE ATTORNEY GENERAL OF CANADA and THE MINISTER OF HEALTH
DATE OF HEARING: TUESDAY, JUNE 12, 2001
PLACE OF HEARING: OTTAWA, ONTARIO
REASONS FOR ORDER
AND ORDER BY: HENEGHAN J.
DATED: WEDNESDAY, JUNE 27, 2001
APPEARANCES: Mr. Andrew R. Brodkin
For the Applicant
Ms. Marie Crowley
For the Respondents
Mr. J. Sheldon Hamilton
Mr. Filko Prugo
For the Proposed Respondent (Astrazeneca Canada Ltd.)
SOLICITORS OF RECORD: Goodmans LLP
Barristers & Solicitors
250 Yonge Street, Suite 2400
Toronto, Ontario
M5B 2M6
For the Applicant
.../2
Page: 2
SOLICITORS OF RECORD:
(Cont'd) Department of Justice
284 Wellington,
East Memorial Building
Ottawa
For the Respondents
Smart and Biggar
Barristers & Solicitors
483 University Avenue
Suite 1500
Toronto, Ontario
M5G 2K8
For the Proposed Respondent
(Astrazeneca Canada Ltd.)
FEDERAL COURT OF CANADA
Date: 20010627
Docket: T-493-01
BETWEEN:
APOTEX INC.
Applicant
- and -
THE ATTORNEY GENERAL OF
CANADA and THE MINISTER OF
HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1] Canadian Union of Public Employees (Airline Division) v. Canadian Airlines International Ltd., [2000] F.C.J. No. 220 (F.C.A.); Benoit v. Canada 2001 FCA 71, [2001] F.C.J. No. 518 and Eli Lilly Canada Inc. v. Canada (Minister of Health) 2001 FCA 108, [2001] F.C.J. No. 613.
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