Date: 19990521
Docket: T-174-99
BETWEEN:
MERCK & CO., INC. and
MERCK FROSST CANADA & CO.
Applicants
- and -
THE ATTORNEY GENERAL OF CANADA
THE MINISTER OF HEALTH
and NU-PHARM INC.
Respondents
REASONS FOR ORDER AND ORDER
ARONOVITCH P.:
[1] The Respondents bring a motion to dismiss the Applicant"s proceeding to prohibit the Minister of Health ("The Minister") from issuing a Notice of Compliance ("NOC") to Nu-Pharm in connection with Nu-Enalapril (the "prohibition proceeding") on the grounds the prohibition proceeding has become moot.
[2] In the alternative the Respondents seek to dismiss or permanently stay the within proceedings. The Respondents, the Attorney General of Canada and the Minister join in the motion made by the Respondent Nu-Pharm Inc. ("Nu-Pharm") and concur with the representations made by Nu-Pharm in support of the motion.
[3] Nu-Pharm"s grounds for the motion are as follows: The Applicants Merck & Co. Inc. and Merck Frosst Canada Co. ("Merck") commenced the within prohibition proceeding with respect to the issuance of an NOC to Nu-Pharm by notice of application dated February 5, 1999.
[4] On February 25, 1999, the Minister issued an NOC to Nu-Pharm in respect of its Nu-Enalapril tablets ("Nu-Enalapril"). The prohibition proceeding accordingly became moot which Nu-Pharm submits was recognized by Merck, in that Merck later commenced proceeding T-398-99, to quash the decision of the Minister to issue the NOC to Nu-Pharm ("the certiorari proceeding").
[5] The following is the fuller chronology of events and context within which these proceedings were taken.
[6] On September 11, 1997, Nu-Pharm submitted an Abbreviated New Drug Submission ("ANDS") to the Minister seeking an NOC for drug X (Nu-Enalapril). The Minister having refused to process the ANDS , Nu-Pharm, on November 24, 1997, applied to set aside the decision of the Minister and sought an order directing the Minister to process the applicant"s ANDS pursuant to the Food and Drug Regulations ("the F & D Regulations") and issue an NOC to Nu-Pharm in accordance with the same.
[7] The Minister"s refusal, (which is not in evidence in these proceedings) was due to Nu-Pharm"s failure to reference the innovator manufacturer"s drug as the "Canadian Reference Product". Indeed Nu-Pharm , which for the purpose of the ANDS was required to make a comparison to a Canadian Reference Product did not make a comparison to Merck" s drug but to that of another manufacturer Apotex Inc. ("Apotex") and claimed that Nu-Enalapril was identical to Apotex"s product as the Canadian Reference Product.
[8] On November 19, 1997 Mr. Justice Cullen, issued an Order setting aside the Minister"s refusal to process Nu-Pharm"s application and referring the matter back to the Minister for determination having concluded that Nu-Pharm"s comparison to Apotex"s product was proper and complied with the F & D Regulations.
[9] Merck, having become aware of the proceeding before Mr. Justice Cullen to which neither Merck nor Apotex were parties, on February 4, 1999, brought an application before Mr. Justice Blais in which Merck sought to be joined to the proceedings as a party and moved for a reconsideration of the order of Mr. Justice Cullen, or in the alternative to appeal the same.
[10] In that proceeding, Merck alleges that Nu-Enalapril was a drug under generic manufacture for which Merck is the innovator manufacturer and that as such, Nu-Pharm was required to make a comparison to Merck"s product thus triggering the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations"). These latter regulations would, moreover, have required Nu-Pharm to serve a notice of allegation on Merck as a precondition to the Minister issuing an NOC pursuant to the NOC Regulations.
[11] On February 5, 1999 Merck also took out the within prohibition proceeding seeking inter alia the following:
| a) An Order in accordance with Section 6(1) of the NOC Regulations prohibiting the Minister from issuing an NOC under Section C.08.004 of the F & D Regulation to Nu-Pharm in connection with Enalapril or any other pharmaceutical compound within the scope of the claims of Merck"s "349 Patent" until after its expiration on October 16, 2007; |
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| b) An order prohibiting the Minister from issuing and Nu-Pharm from seeking or using anNOC; |
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c) An Order to produce any portion of the submissions filed by Nu-Pharm;
| d) An order prohibiting the Minister from processing the Nu-Pharm drug submission or issuing an NOC pursuant to the provisions of the NOC Regulations; |
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| e) An order prohibiting the Minister from accepting an Abbreviated new drug submission filed by Nu-Pharm unless said ANDS relies upon the drug of the innovator manufacturer (Merck) as the Canadian Reference Product; |
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| f) In the further alternative, an Order prohibiting the Minister from processing any new drug submission of Nu-Pharm in respect of a drug formulated from the said medicines until a notice of allegation is served on Merck. (emphasis added) |
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[12] On February 17, 1999, Mr. Justice Blais, having heard Merck"s submissions in relation to Mr. Justice Cullen"s Order, concluded that the question of compliance with the NOC Regulations should have been raised and argued but, in fact, was not addressed before Mr. Justice Cullen and accordingly, ordered that Merck be added to the proceedings and extended the time for Merck to appeal the decision of Mr. Justice Cullen.
[13] Shortly thereafter, on February 25, 1999, notwithstanding Merck"s prohibition proceedings the Minister issued an NOC to Nu-Pharm for its Enalapril pursuant to the F & D Regulations.
[14] On March 5, 1999 Merck commenced the certiorari proceedings T-398-99. In these proceedings Merck applies for judicial review of the Minister"s issuance of the NOC pursuant to the F & D Regulations and inter alia, for an order quashing the decision of the Minister and an order setting the decision aside. Merck also seeks an order prohibiting the Minister subsequent to the aforesaid orders from processing Nu-Pharm"s ANDS or issuing an NOC relating to Nu-Enalapril except pursuant to the provisions of the NOC Regulations. Merck seeks as well, an order compelling the Minister to disclose to the Court the identity of the manufacturer of the medicine.
[15] Merck has appealed the order of Mr. Justice Cullen and in that proceeding seeks to quash the NOC issued to Nu-Pharm. The appeal is scheduled to be heard on June 15 and 16, 1999.
MOOTNESS
[16] I shall deal first with the issue of mootness. Merck"s principal argument is that Nu-Pharm"s motion is premature in that the issue can not be dealt with on an interlocutory basis but must await the hearing of the prohibition application on its merits. In that connection the applicant relies on the following remarks of Justice Sopinka in Borowski1 :
| The doctrine of mootness is an aspect of a general policy or practice that a court may decline to decide a case which raises merely a hypothetical or abstract question. The general principle applies when the decision of the court will not have the effect of resolving some controversy which affects or may affect the rights of the parties. If the decision of the court will have no practical effect on such rights, the court will decline to decide the case. This essential ingredient must be present not only when the action or proceeding is commenced but at the time when the court is called upon to reach a decision. Accordingly if, subsequent to the initiation of the action or proceeding, events occur which affect the relationship of the parties so that no present live controversy exists which affects the rights of the parties, the case is said to be moot. |
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(emphasis added)
[17] While I agree that the dismissal of a judicial review application for mootness may rarely be appropriate at an interlocutory stage, it may, in my view, nevertheless be granted where the application is found to be "bereft of any possibility of success". David Bull Laboratories (Canada) Inc. v. Pharmacia Inc. (1995), 58 C.P.R. (3d) 209 at 217 (F.C.A.); Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1997), 72 C.P.R. (3d) 148 at 150; Labbé v. Canada (1997), 146 D.L.R. (4th) 180 (F.C.T.D.).
[18] As for Borowski having regard to the above statement as a whole, I do not construe the words "when the court is called upon to reach a decision" to exclude an interlocutory decision providing there are no subsisting or "live" issues at the time of its disposition.
[19] Having said that, I find that, as a question of fact, Nu-Pharm"s herein motion is premature having regard to the particular and complex circumstances of this case. In particular there remain certain imponderables by reason of the appeal of Mr. Justice Cullen"s decision which puts the Minister"s decision in question.
[20] The dismissal of an application as being moot is radical relief which, the jurisprudence demonstrates, a Court will only exercise discretion to grant where it is satisfied that the proceeding can no longer be of consequence or effect. Despite Nu-Pharm"s very able arguments regarding the possible outcomes of the appeal and the fact that the certiorari proceeding should provide a complete answer to Merck whatever the outcome of the appeal, I am not satisfied that the prohibition proceeding in these circumstances is spent and cannot either in part or in whole have a subsisting effect.
[21] Then too, Merck"s submission that the relief it seeks under section 6(1) of the NOC Regulations cannot be obtained in the context of its application to quash and is relief which is still available to it in the circumstances, while strongly disputed by Nu-Pharm, remains a subsisting issue for determination. I find therefore, that Nu-Pharm"s motion is premature and untimely at this juncture.
STAY
[22] I now turn to Nu-Pharm"s arguments that the prohibition proceeding should be dismissed or stayed because it deals with subject matter identical to the proceeding to quash and raises the same factual and legal issues, it being an abuse of process to litigate the same issues in two proceedings. In applying for a stay, Nu-Pharm relies on section 3 and 50(1) of the Federal Court Act ("the Act"). Indeed Nu-Pharm makes its abuse of process argument almost exclusively in the context of the stay application.
[23] As Nu-Pharm is not prepared to argue irreparable harm, it relies solely section 50(1)(a) of the Act which authorizes the Court to stay any matter on the ground that the claim is being proceeded with "in another Court or jurisdiction". Nu-Pharm is unable to direct the Court to any authority for the proposition that a claim "in another Court" includes two same actions in the same Court. Rather, the respondent invites the Court to consider an argument whereby section 3 of the Act may be used to remedy that "gap".
[24] Nu-Pharm argues that by virtue of section 3 of the Act, the Court has inherent jurisdiction and control over its process which it may exercise where parties have recourse to redundant or inappropriate proceedings. Therefore, given the Court"s authority and powers pursuant to section 3 of the Act it cannot be, that the Court may stay an action which is being proceeded with in another Court but not two same claims which are proceeding in the same Court. This proposition of course begs the question as to whether the two applications are in fact identical.. In any case, I decline the invitation to so construe the sections and will not extend the meaning and scope of section 50(1)(a) of the Act to include two applications in the same Federal Court.
[25] In sum, I concur with the Plaintiff that no significant prejudice accrues to the Respondents nor indeed to the Court in allowing the two applications to wind their way through the system such that Merck can, in due course, and following the Court of Appeal decision, select the remedy which may be the most appropriate in the circumstances. If it does not make its election, I speculate that it will either have to defend another and more timely application for mootness or have to answer to issue estoppel or costs or a combination thereof.
[26] Accordingly Nu-Pharm"s motion to dismiss or stay the within application is denied.
[27] The Respondents shall have thirty (30) days from the date of this order to file their affidavit evidence. Costs in the cause.
"R. ARONOVITCH"
Prothonotary
Ottawa, Ontario
May 21, 1999
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1 Borowski v. Canada (Attorney General) [1989] 1 S.C.R. 342 at 353
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