Date: 1999-02-17
Docket: T-2552-97
BETWEEN:
NU-PHARM INC.
- and -
THE ATTORNEY GENERAL OF CANADA
and THE MINISTER OF HEALTH
REASONS FOR ORDER AND ORDER
BLAIS J.
- [1] The notice of motion made on behalf of Merck & Co. Inc. ("Merck") and Merck Frosst Canada & Co. ("Merck Frosst") is seeking:
| - an order under Rules 104(1)(b) and 303(1) of the Federal Court Rules adding Merck and Merck Frosst as Respondents to this proceeding; |
| - alternatively, an order under Rule 109(1) of the Federal Court Rules granting leave to Merck Frosst and Merck to intervene in the proceeding; |
| - an order under section 27(2) of the Federal Court Act extending the time for Merck and Merck Frosst to appeal the order of Mr. Justice Cullen dated November 19, 1998, to a date following the order extending the said time for appealing the said order; |
| - an order identifying drug X and manufacturers A and B under conditions to be agreed upon by the parties or ordered by the Court; |
| - an order pursuant to Sections 18.2 and 50 of the Federal Court Act staying the order of Mr. Justice Cullen dated November 19, 1998, pending the hearing and determination of an appeal from the said order of Mr. Justice Cullen; |
| - alternatively, an order pursuant to Rules 399(1) and (2) of the Federal Court Rules setting aside or varying the order of Mr. Justice Cullen dated November 19, 1998. |
| [2] Nu-Pharm Inc. ("Nu-Pharm") has submitted to the Minister of Health ("Minister") an Abbreviated New Drug Submission ("ANDS") seeking a notice of compliance ("NOC") for drug X. The Minister rejected Nu-Pharm"s application for a NOC by letter dated November 12, 1997. |
| [3] The decision of the Minister itself is not part of the record, save for the reference made in the affidavit of Mr. Robert Quesnel at page 179 of Tome II of the applicant"s record, paragraph 48, where a reference is made to the letter sent by Dann M. Michols indicating that "the Therapeutics Products Directorate would be returning Nu-Pharm"s Abbreviated New Drug Submission under separate cover as Nu-Pharm"s product X did not compare or make reference to the other brand of product X manufactured by manufacturer B for which a Notice of Compliance had also been issued by the Minister pursuant to section C.08.004 of the Food and Drug Regulations". |
| [4] Upon receipt of the interlocutory decision by the Minister, Nu-Pharm filed an application for judicial review dated November 24, 1997, seeking a declaration that the Minister"s refusal to process Nu-Pharm"s ANDS was unlawful and should be set aside. |
| [5] On November 19, 1998, Mr. Justice Cullen ordered that the Minister"s refusal to process the application be set aside and that the matter be referred back to the Minister for redetermination. |
| [6] Merck and Merck Frosst allege that drug X is in fact a drug under generic manufacturer A and for which Merck and Merck Frosst are the innovator manufacturer B. |
| [7] It is submitted that the order of Justice Cullen is having the effect of circumventing section 5 of the Patented Medicines (Notice of Compliance) Regulations by requiring the Minister of Health to issue a NOC for drug X without issuing and serving a notice of allegation on innovator manufacturer B of drug X, the first person in respect of which a patent list had been submitted. Therefore, Merck and Merck Frosst sustain that they should be allowed in on the within proceeding to defend their rights. In particular, Merck and Merck Frosst are requesting an extension of time to appeal the decision rendered by Mr. Justice Cullen once they are granted status to intervene or permission to be added as respondents. |
| [8] Merck and Merck Frosst rely mainly upon two decisions; one rendered by the Honourable Mr. Justice Richard in Nu-Pharm v. Attorney General of Canada et al. (1997) 73 C.P.R. (3d) 510, and the other one by the Court of Appeal in Nu-Pharm Inc. v. Canada (Attorney General) (1998) 80 C.P.R. (3d) 74. |
| [9] In the decisions of Mr. Justice Richard and the Court of Appeal, the Court held that no notices of compliance may be issued by the Minister, unless the requirements of the Food and Drug Regulations and the requirements of the Patented Medicines (Notice of Compliance) Regulations are met. One should not lose sight of the objective of the Patented Medicines (Notice of Compliance) Regulations which were drafted in order to protect the research and development initiatives of innovator pharmaceutical companies. |
| [10] It would appear from the reading of the two decisions that an applicant for a notice of compliance must satisfy the requirements established by both regime of Regulations concurrently to be approved. |
| [11] In the case at hand, Nu-Pharm submits that the Minister based its refusal to process its application for a NOC exclusively on the basis that Nu-Pharm did not comply with the Food and Drug Regulations and that accordingly the only issue before Mr. Justice Cullen was whether the Minister committed an error of law by concluding that the applicant"s drug was not a "Canadian reference product" as defined in the Food and Drug Regulations . |
| [12] On the other hand, Merck and Merck Frosst submit that the decision issued by the Minister which underwent judicial review before Mr. Justice Cullen should have been reviewed on the basis of compliance of the NOC with both the Food and Drug Regulations and the Patented Medicines (Notice of Compliance) Regulations. Particularly, the two decisions of Mr. Justice Richard and of the Court of Appeal should have been brought to the attention of Mr. Justice Cullen upon judicial review. |
| [13] 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. |
| [14] 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. |
| [15] Attending the hearing today, was counsel for Minister of Health. Counsel mentioned that he did not have any submissions on behalf of the Minister but confirmed that the decision of the Minister only dealt with the Food and Drug Regulations and that accordingly the requirements of the Patented Medicines (Notice of Compliance) Regulations was not an issue raised before Mr. Justice Cullen. |
| [16] The Court hereby grants the motion to allow Merck and Merck Frosst to be added in the proceeding as respondents. The Court also grants an extension of time of thirty (30) days from the date of this order for Merck and Merck Frosst to either appeal the decision of Mr. Justice Cullen dated November 19, 1998, or to make a motion to the Court pursuant to Rule 399 of the Federal Court Rules, 1998, requesting that Justice Cullen reconsider his order. |
| [17] As for the requested order for a stay of Mr. Justice Cullen"s order, the motion is dismissed. The Court is not satisfied that an irreparable harm exists warranting the granting of such an order. Furthermore, the nature of the motion was not in the nature of an injunction against the Minister of Health, but rather presupposed that Mr. Justice Cullen"s decision be maintained in order that the new respondents may take action upon it. |
| [18] Costs of the motion in the amount of $2,000 are awarded to the applicant. |
| [19] The representative for the Minister of Health confirmed to the Court that the Minister of Health would not interrupt his revision of the application before him pursuant to the order of Mr. Justice Cullen and that the Minister would comply with the decision of this Court. |
Pierre Blais
Judge
OTTAWA, ONTARIO
FEBRUARY 17, 1999
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