Date: 20010420
Docket: A-576-00
Neutral citation: 2001 FCA 116
CORAM: NOËL J.A.
SEXTON J.A.
SHARLOW J.A.
BETWEEN:
APOTEX INC.
Appellant
- and -
WARNER-LAMBERT CANADA INC. and
WARNER-LAMBERT COMPANY
Respondents
- and -
THE MINISTER OF HEALTH
Respondent
Heard at Ottawa, Ontario, Friday, April 20, 2001
Judgment delivered from the Bench at Ottawa, Ontario, Friday, April 20, 2001
REASONS FOR JUDGMENT: NOËL J.A.
Date: 20010420
Docket: A-576-00
Neutral citation: 2001 FCA 116
CORAM: NOËL J.A.
SEXTON J.A.
SHARLOW J.A.
BETWEEN:
APOTEX INC.
Appellant
- and -
WARNER-LAMBERT CANADA INC. and
WARNER-LAMBERT COMPANY
Respondents
- and -
THE MINISTER OF HEALTH
Respondent
REASONS FOR JUDGMENT
(Delivered from the Bench at Ottawa, Ontario
on Friday, April 20, 2001)
NOËL J.A.
[1] This is an appeal from the decision of Heneghan J. (reported at (2000) 8 C.P.R. (4th) 302) dismissing Apotex' motion to participate in the proceeding between the respondents Warner-Lambert Canada Inc. and Warner-Lambert Company ("Warner-Lambert") and the Minister of Health (the "Minister").
[2] On May 24, 2000, the Minister made the following decisions, pursuant to subsection 3(1) of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"):
1. not to add the Patent list for Canadian Patents Nos. 1297023 (the "023 patent") and 1297024 (the "024 patent") submitted, along with a Supplemental New Drug Submission by Warner-Lambert, to the patent register it maintains pursuant to subsection 3(1) of the Regulations;
2. to remove the 023 and 024 patents from the patent register in respect of Warner-Lambert's quinaprol hydrochloride 5, 10, 20 and 40 mg oral tablets and quinapril hydrochlorie-hydrochlorothiazide 10-12.5 mg and 20-12.5 mg and 20-25 mg oral tablets.
Warner-Lambert sought judicial review of the Minister's decision, and Apotex brought a motion seeking to be joined as a party respondent to the proceedings, or in the alternative, to be granted leave to intervene.
[3] In support of its motion, Apotex claimed that it was directly affected by the Minister's decision because it is in the process of developing a generic version of quinapril hydrochloride for which it intends to file an abbreviated new drug submission ("ANDS") seeking a Notice of Compliance ("NOC") relative to its product, Apo-quinapril. The ANDS to be submitted by Apotex will bear a comparison with the quinapril product currently sold by Warner-Lambert.
[4] According to Apotex this establishes a sufficient interest to justify it being joined as a party respondent in the proceeding between the respondents and the Minister. Alternatively, Apotex argued that it should be granted leave to intervene. Apotex submitted that its experience in the field of drug manufacturing gives it an informed perspective into the interpretation and application of the Regulations and its participation in the proceedings will offer the court a valuable additional perspective of the interests of generic drug manufacturers.
[5] As to the first motion, the motions judge concluded that Apotex had failed to demonstrate that its presence was required to ensure the effective and complete adjudication of the matters in dispute between the respondents and the Minister as Federal Court Rule 104(1) contemplates. The motions judge added that Apotex was no more directly affected by the respondents' application for judicial review than any other pharmaceutical manufacturer.
[6] With respect to the motion in the alternative, the motions judge held that Apotex had failed to demonstrate how its intervention would assist the court in the determination of the issue between the respondents and the Minister.
[7] Counsel for Apotex contends that the motions judge erred in law and made palpable and overriding errors in her appreciation of the evidence in concluding that Apotex did not have a sufficient interest in the outcome of the proceeding to justify its participation as a party, and in concluding that it had not sufficiently demonstrated that it could assist the court as an intervenor.
[8] We are all of the view that this appeal must fail.
[9] While the motions judge after having acknowledged that Apotex intended to seek an NOC for its quinapril product could not equate Apotex' interest in the proceeding below with that of any other pharmaceutical manufacturer, the conclusion that she reached remained within the proper exercise of her discretion.
[10] A present intent to seek an NOC, corroborated as it was by steps taken towards that end, does not establish that an NOC will be sought; unforseen circumstances or difficulties dictating a different course of action cannot be ruled out. It was therefore open to the motions judge to hold that at this juncture Apotex' interest was not sufficient to justify the order sought. This is particularly so when regard is had to the confidentiality order which is in place in the proceeding between the respondents and the Minister.
[11] As to the motion to intervene, the burden was on Apotex to show that its intervention would be of assistance to the court. In this regard, Apotex, beyond asserting that it could present the additional perspective of the generic drug manufacturer, had to demonstrate what this perspective would bring to the debate and how it would assist the court in the determination of the issue between the respondents and the Minister. The motions judge concluded that this burden had not been met and we can detect no error in that regard.
[12] The appeal will be dismissed with cost.
"Marc Noël"
J.A.
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