Date: 20011026
Docket: T-1104-01
Neutral Citation: 2001 FCT 1167
BETWEEN:
SCHERING CANADA INC.
Applicant
- and -
ATTORNEY GENERAL OF CANADA
Respondent
- and -
THE CANADIAN DRUG MANUFACTURERS' ASSOCIATION
Proposed Intervener
REASONS FOR ORDER AND ORDER
KELEN J.
[1] The Canadian Drug Manufacturers' Association ("CDMA"), an industry association representing generic drug manufacturers, seeks leave to intervene in this proceeding pursuant to Rule 109 of the Federal Court Rules. This application was heard together with two parallel applications, Court File Numbers T-1103-01 and T-1120-01, for leave to intervene. The applications raise the same issues so that the disposition of the three applications is the same.
[2] The three applications for judicial review are of decisions by the Minister of Health ("the Minister") dated May 22 and 23, 2001. All three decisions were refusals by the Minister to add certain Canadian patents held by the parties Pfizer Canada Inc. and Schering Canada Inc. to the Patent Register under the Patented Medicines (Notice of Compliance) Regulations ("Regulations").
Applications for Judicial Review
[3] The CDMA succinctly defines the issue in the applications as follows:
"The issue in the three applications is the same: whether the term "filing date" of a patent in s. 4(4) of the Regulations includes a priority date. Section 4(4) provides that a first person, after the filing of a submission, and within 30 days after issuance of a patent, may submit a patent list containing a patent that was issued
on the basis of an application that has a filing date that precedes the date of filing of the submission.
If the relief sought by the applicant[s] is granted, the number of patents that may be listed on the patent register will be expanded. More patents will be listed, leading to further litigation and more delays in the market entry of generic drugs as a result of the automatic stay imposed by s.7 of the Regulations."
Three Criteria for Intervener Status
[4] The criteria for receiving intervener status is set out in Eli Lilly Canada Inc. v. Canada (Minister of Health)(2000) 10 C.P.R.(4th) 310 (FCTD), upheld at the Federal Court of Appeal, 2001 F.C.A. 108. Blais, J. referred to the criteria as set out by Prothonotary Hargrave in Abbott v. Canada [2000] 3 F.C. 482:
"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.
Jurisprudential Interest is not a Factor
[5] The applicant for intervener status must have an interest of more than a "jurisprudential" nature. Canadian Union of Public Employees (Airline Division) v. Canadian Airlines International Ltd., [2000] F.C.J. No. 220 (FCA) at page 5:
"It seems clear that at its highest PSAC's interest is "jurisprudential" in nature; it is concerned that the decision of the Tribunal, if allowed to stand, may have repercussions on litigation involving pay equity issues in the future. It is well established that this kind of interest alone cannot justify an application to intervene."
Factors to be Considered by Motions Judge
[6] The Federal Court of Appeal elaborated upon the factors to be considered by the Motions Judge in an application for intervener status in Canadian Airlines (supra). At page 4, Noël J.A. held:
"It is fair to assume that in order to grant the intervention the motions Judge would have considered the following factors which were advanced by both the appellants and PSAC as being relevant to her decision:
1) Is the proposed intervener directly affected by the outcome?
2) Does there exist a justiciable issue and a veritable public interest?
3) Is there an apparent lack of any other reasonable or efficient means to submit the question of the Court?
4) Is the position of the proposed intervener adequately defended by one of the parties to the case?
5) Are the interests of justice better served by the intervention of the proposed third party?
6) Can the Court hear and decide the cause on its merits without the proposed intervener?
CDMA Involved with Decision Subject to Judicial Review
[7] The decisions of the Minister, which are the subject of the applications for judicial review, involved the CDMA. The Minister initially decided that the patent could not be added to the Patent Register due to the Canadian filing date of the patent application. The applicant commenced a proceeding in the Federal Court for judicial review. The Minister reconsidered whether the words "filing date" include the priority filing date and announced that he would hold the decision pending a "policy consultation". At that time, the applicant withdrew its application for judicial review on the basis that the decision would be made subsequent to a policy review.
[8] Then the Minister made a request for submissions in respect of the policy consultation on the issue. The request to the industry was entitled "Proposed amendment ... to allow for the use of priority filing date as the patent application filing date".
[9] The CDMA made a significant submission to Health Canada regarding the proposed amendment.
[10] Upon consideration of the submissions, the Minister decided that the patents could not be added to the Patent Register on the basis that the words "a filing date" in subsection 4(4) of the Regulations mean only the Canadian filing date. The Minister enclosed with his decision a document entitled "Issue Analysis", the Minister's interpretation of the words "a filing date".
[11] The submission by the CDMA and the "Issue Analysis" is part of the record before this Court in the judicial review application.
Treaty Interpretation
[12] In the application for judicial review of the Minister's decision, the applicant states that the interpretation given by the Minister is contrary to Canada's international obligations under the Paris Convention and contrary to NAFTA.
Position of the Respondent
[13] The respondent does not object to the CDMA being granted intervener status.
Conclusion
[14] The position of the CDMA is before the Court, on the record, and relevant. The Minister sought comments from the CDMA before making the decision. In other cases before the Court with respect to the Regulations and intervener status, the Minister did not involve the proposed intervent in the process leading to the Minister's decision. In this case, the Minister invited the advice of the CDMA inter alia before making his decision.
[15] I find that the following criteria and factors warrant intervener status in this case:
1. The CDMA members are directly affected by the outcome of this application;
2. There exists a justiciable and veritable public interest evidenced by:
1. the Minister requiring input from the public on an important issue of interpretation;
2. the Minister released a public policy document with the decision; and,
3. the decision involves the interpretation of the internation of international treaties.
3. It is uncertain whether the respondent will advance CDMA's position at the hearing of this application. There is no other reasonable or efficient means for the CDMA position to be submitted;
4. The interests of justice are served by the intervention of the CDMA in this case. The Court would be better served to have the proposed intervener explain its written submissions which are already on the Court's record with respect to the interpretation of section 4 of the Regulations;
5. The CDMA is already part of this case at the invitation of the Minister; and,
6. The CDMA intervention will not delay the proceedings.
ORDER
[16] Accordingly, this application for leave to intervene is allowed without costs.
"Michael A. Kelen"_________________________
JUDGE
OTTAWA, ONTARIO
October 26, 2001
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