Date: 19990329
Docket: T-398-99
| IN THE MATTER OF Sections 18, 18.1 and 18.2 of the Federal |
Court Act., R.S.C. 1985, Chapter, F-7.
AND IN THE MATTER OF the Food and Drugs Act, R.S.C. 1985,
Chapter F-27 and Division 8 of the Regulations thereunder.
AND IN THE MATTER OFSection 55.2(4) of the Patent Act
and the Patented Medicines (Notice of Compliance)Regulations
SOR/93/133
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
GIBSON J.:
[1] By Notice of Application filed the 5th of March, 1999, the applicants seek the following reliefs:
| A. An Order quashing the decision of the Minister of Health ("Minister") to issue a Notice of Compliance ("NOC") under Section C. 08.004 of the Food and Drug Regulations to Nu-Pharm Inc. ("Nu-Pharm") in respect of Nu-Enalapril in 2.5, 5, 10 and 20 mg dosage strengths ("the drug") which contains as an active ingredient a pharmaceutical compound identified as enalapril maleate, which is within the scope of claims 1 to 5, 8 to 17 of Canadian Letters Patent No. 1,275, 349 ("the medicine") issued on October 16, 2007 (""349 Patent"); |
| B. An Order declaring the Minister"s decision to issue the NOC in relation to Nu-Enalapril to be unlawful and to set aside the Minister"s decision in that regard; |
| C. An Order prohibiting the Minister subsequent to an Order under Paragraphs A or B aforesaid from processing the Respondent Nu-Pharm"s New Drug Submission ("NDS"), including amendments thereto, or issuing an NOC relating to the drug except pursuant to the provisions of the Patented Medicines (Notice of Compliance) Regulations ("Patented Medicines Regulations"); |
| D. An Order prohibiting the Minister subsequent to an Order under Paragraphs A or B aforesaid from taking any step in processing any NDS, including amendments thereto, of the Respondent Nu-Pharm in respect of enalapril maleate unless said Respondent has served a Notice of Allegation on Merck Frosst, the first person who had submitted a patent list identifying the "349 patent; |
| E. An Order in accordance with Section 6(7) of the Patented Medicines Regulations that Nu-Pharm produce to the Applicants any portion of the submission for a NOC filed by Nu-Pharm with the Minister of health relevant to the disposition of the issues herein and any changes made therein, including any New Drug Submissions and Drug Master Files referred to, relied upon or incorporated into said New Drug Submissions, relating to the drug in the possession of Nu-Pharm or the Minister and an Order for the Minister to verify that any portion of the said submissions produced by Nu-Pharm corresponds fully to the information in the submission; |
| F. An Order prohibiting the Minister from issuing, and Nu-Pharm from seeking and using, a NOC which would authorize Nu-Pharm to manufacture, use and/or sell the medicines within the scope of claims 1 to 5 of the "349 Patent and formulate, use and/or sell the drug, formulated from the medicines, within the scope of claims 8 to 15 of the "349 Patent, in infringement of one or more of the claims of the "349 Patent; |
| G. An Order compelling the Minister and/or Nu-Pharm to disclose to the Court and to the Applicants", the identity of the manufacturer of the medicine and the drug; |
| H. An interim Order pursuant to section 18.2 of the Federal Court Act suspending the NOC issued on February 25, 1999 to Nu-Pharm for Nu-Enalapril in 2.5, 5, 10 and 20 mg dosage strength and enjoining Nu-Pharm from selling or advertising Nu-Enalapril, which is the drug defined aforesaid, until the Court finally determines this proceedings; |
| I. Such further and other relief as the Court may deem just; and |
| J. Costs of the application. |
[2] By motion filed the 8th of March, 1999, the motion to which these reasons relate, Merck seeks the interim relief as set out in paragraph H just quoted, together with costs.
[3] The respondent the Minister of Health (the "Minister") first determined to refuse to process the respondent Nu-Pharm Inc."s ("Nu-Pharm" "s) Abbreviated New Drug Submission and issue a Notice of Compliance to Nu-Pharm in respect of the drug Nu-Enalapril. Nu-Pharm"s Abbreviated New Drug Submission ("ANDS") was filed without reference to six patent lists submitted to the Minister pursuant to subsection 4(1) of the Patented Medicines (Notice of Compliance) Regulations by Merck, each of which included Canadian Letters Patents No. 1,275,349 valid until the 16th of October, 2007 (the ""349 Patent") owned by Merck & Co., Inc. and under which Merck Frosst Canada & Co. is the sole licensee. The "349 Patent relates to enalapril and its salt, enalapril maleate. Further, the ANDS was submitted in such a manner that it was impossible to identify from public records that the drug was Nu-Enalapril, the drug to which it was compared, and the manufacturer of that drug.
[4] No Notice of Allegation arising out of Nu-Pharm"s ANDS was sent to Merck. In the result, Merck was unaware of Nu-Pharm"s ANDS and of the refusal by the Minister to process it.
[5] Nu-Pharm applied to this Court for judicial review of the decision of the Minister to refuse to process its ANDS and to issue a Notice of Compliance. Once again, Merck was unaware of this application.
[6] By Order dated the 19th of November, 1998,1 Mr. Justice Cullen ordered that the Minister"s decision be set aside and that Nu-Pharm"s ANDS be referred back to the Minister for redetermination based on Mr. Justice Cullen"s reasons. At the conclusion of his reasons, Mr. Justice Cullen wrote:2
Subsection 18.1(3) of the Federal Court Act sets out the remedies available once an applicant successfully establishes a legitimate ground for review. Subsection (a) permits the Court to order the decision maker to perform the act that "...it has unlawfully... refused to do...", which is essentially a licence to issue mandamus. The applicant [Nu-Pharm] urges the Court to order the respondent [the Attorney General of Canada and the Minister of Health] to issue a NOC for its version of drug X [enalapril maleate]. The detailed regulation of the issuance of NOCs, which includes the submission of complicated scientific evidence for review by qualified technicians and scientists accounts for my reluctance to comply with the applicant"s request. Instead, I rely on paragraph 18.1(3)(b ) of the Federal Court Act to set aside the Minister"s refusal to process the application and to refer this matter back to the Therapeutic Products Directorate of the Department of National Health and Welfare for determination based on the foregoing reasons.
[7] Merck alleges that it first became aware of the proceeding resulting in Justice Cullen"s order and reasons just referred to on the 26th of January, 1999. Merck applied to be added as respondents in that proceeding, or for leave to intervene, to extend the time for Merck to appeal the order of Mr. Justice Cullen, for a stay of the order of Mr. Justice Cullen pending the hearing and determination of an appeal and for other and alternative relief.
[8] Merck"s application was heard by Mr. Justice Blais on the 4th of February, 1999. From the bench, Mr. Justice Blais added Merck as party respondents on file T-2552-97, and granted an extension of time for Merck to file an appeal of Justice Cullen"s Order but refused to stay that Order on the ground that Merck had not established that it would suffer irreparable harm if Mr. Justice Cullen"s decision were not stayed. In reasons issued the 17th of February, 1999, Mr. Justice Blais referred to a decision of Mr. Justice Richard, as he then was, in Nu-Pharm v. Attorney General of Canada et al.3 and of the Court of Appeal affirming the decision of Mr. Justice Richard4 which, Merck urged before me, were directly on point on the issues before Mr. Justice Cullen, were not cited before him, and would, once again in Merck"s submission, have led to a different conclusion by Mr. Justice Cullen. Mr. Justice Blais wrote:
Since Mr. Justice Cullen did not have a chance to review these decisions and that it was not in the interest of Nu-Pharm to bring these rulings to the attention of the judge, Mr. Justice Cullen granted the judicial review, based exclusively on the approach suggested by Nu-Pharm and the question of compliance with the Patented Medicines (Notice of Compliance) Regulations was not addressed.
As for counsel for the Minister of Health, respondent in the application for judicial review, he did not raise the matter either at the hearing before Mr. Justice Cullen.
[9] Having been added as a party defendant in the proceedings on file T-2552-97, Merck sought an opportunity to appear before Mr. Justice Cullen to seek a variation of his order. By letter dated the 24th of February, 1999, counsel for Merck was advised that Mr. Justice Cullen refused to reopen the matter. Mr. Justice Cullen directed as follows:
Blais J."s Order offered two alternatives, reconsideration or appeal of my decision. I am not going to reconsider my decision as it would place me in a position of bias because I have already made a decision. The parties will have to appeal my decision.
[10] Counsel for Merck then sought from the Associate Chief Justice, the appointment of another judge to hear a motion to vary the decision of Justice Cullen. The Associate Chief Justice declined to appoint another judge.
[11] On the 25th of February, 1999, the Minister granted an NOC to Nu-Pharm in respect of Nu-Enalapril. The evidence before me indicates that Merck first became aware of this decision of the Minister on the 4th of March, 1999. The application before me was filed some four (4) days later.
[12] At the hearing before me, I was advised that Merck has filed an appeal of the Order of Mr. Justice Cullen.5
[13] Against this strange and elaborate background, Merck seeks interlocutory relief against the decision of the Minister to issue the NOC to Nu-Pharm. Such relief is essentially the same relief sought through an application for reconsideration of the order of Mr. Justice Cullen. Mr. Justice Cullen refused the request to reconsider. The Associate Chief Justice refused to appoint another judge to hear the request to reconsider. Mr. Justice Blais refused to grant a stay of the order of Mr. Justice Cullen.
[14] I conclude that I am, in effect, being invited once again to reconsider the order of Mr. Justice Cullen or to reconsider the determination of Mr. Justice Blais not to grant a stay of Justice Cullen"s order. That invitation has, in various forms, already been refused three times by this Court. In all of the foregoing circumstances, I am not prepared to exercise my discretion in favour of Merck. To do so would be, in my perception, a significant preemption of the appeal of the order of Mr. Justice Cullen, a failure to respect the determination of my colleague Mr. Justice Cullen not to reopen the matter before him, a failure to respect the decision of the Associate Chief Justice not to appoint another judge to reopen the decision of Mr. Justice Cullen, and a failure to respect the order of my colleague Justice Blais not to grant a stay of Mr. Justice Cullen"s order.
[15] Prior to the adoption of the Federal Court Rules, 1998,6 effective the 25th of April, 1998, it was the practice of this Court for the Trial Division to consider applications to stay orders and judgments of the Trial Division where an appeal thereof had been filed or was about to be filed. That practice has now been changed where an appeal has been filed. Rule 398(1) reads as follows:
| 398. (1) On the motion of a person against whom an order has been made,
|
398.(1) Sur requête d"une personne contre laquelle une ordonnance a été rendue:
|
[16] Now that an appeal has been filed in respect of the order of Mr. Justice Cullen, I am further satisfied that, to grant the relief here requested by Merck, would be to subvert the principle underlying the transfer to the Appeal Division of the authority to grant a stay. What is being sought before me is, by its very nature, a stay with the difference that, because following the order of Mr. Justice Cullen, the Minister has complied with that order and, in accordance with his authority, granted an NOC, what is sought to be stayed is the NOC itself rather than the order of Mr. Justice Cullen.
[17] For the foregoing reasons, this application has been dismissed. Costs have been ordered to be in the cause.
____________________________
Frederick E. Gibson
Ottawa, Ontario
March 29, 1999
__________________1 See: Nu-Pharm Inc. v. Attorney General of Canada and Minister of Health, Court File T-2552-97 (F.C.T.D.).
2 [1998] F.C.J. No. 1721. (Q.L.).