Date: 20030626
Docket: T-711-02
Citation: 2003 FCT 790
Toronto, Ontario, June 26th, 2003
Present: The Honourable Madam Justice Heneghan
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and GENPHARM INC.
Respondents
REASONS FOR ORDER AND ORDER
[1] Abbott Laboratories and Abbott Laboratories Limited (the "Applicants") seek an order extending the period of time within which the Minister of Health is prohibited pursuant to section 7(1)(e) of the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 ("NOC Regulations") from issuing a Notice of Compliance ("NOC") to Genpharm Inc. ("Genpharm"). The Applicants seek an extension of ten months beyond the date of May 2, 2004. The Applicants also seek their costs of this motion.
[2] The Applicants base their motion on section 7(5)(b) of the NOC Regulations which provides as follows:
7(5) If the court has not yet made an order under subsection 6(1) in respect of an application, the court may
...
(b) extend the time limit referred to in paragraph (1)(e) on consent of the first and second persons or, if the court finds that the second person has failed, at any time during the proceeding, to reasonably cooperate in expediting the application.
7(5) Lorsque le tribunal n'a pas encore rendu d'ordonnance aux termes du paragraphe 6(1) à l'égard d'une demande, il peut :
...
b) proroger le délai visé à l'alinéa (1)e) avec le consentement de la première personne et de la seconde personne, ou s'il conclut que la seconde personne n'a pas, au cours de l'instance relative à la demande, collaboré de façon raisonnable au règlement expéditif de celle-ci.
[3] The Applicants filed a lengthy motion record including a number of pieces of correspondence exchanged with counsel for Genpharm, purportedly asking for disclosure of information relating to the matters raised in the Notice of Allegation ("NOA") dated March 13, 2002. The motion record also includes an Order made on October 22, 2002, in which Genpharm was ordered to produce specific information and materials. The balance of this material was provided by Genpharm in March 2003 and Genpharm argued that some of the material had been disclosed by it to the Applicants prior to the Order of October 22, 2002.
[4] The Applicants now argue that they need an extension of time to prepare their case in this proceeding by reason of the delay of Genpharm first, in failing to disclose requested material without an Order of the Court and second, by failing to comply with that Order for a period of nearly five months. The Applicants say that they initially requested disclosure by a letter dated May 17, 2002. Because Genpharm did not deliver that information, the Applicants were required to bring a motion before the Court for an Order; the Order was granted on October 22, 2002, some five months after the initial request for disclosure.
[5] The Applicants rely on the decision of the Federal Court of Appeal in AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.) where the Court addressed the obligations of each party in a prohibition proceeding pursuant to the NOC Regulations to expedite the conclusion of the proceeding. The Aplicants also rely on the decision of the Federal Court of Appeal in Merck Frosst Canada Inc. v. Apotex Inc., [1997] 2 F.C. 561 (C.A.) where the Court commented on the significance of the legislative stay granted under the NOC Regulations and the relevance of the conduct of the parties when a variation of that legislative stay is sought.
[6] Genpharm opposes the Applicants' motion. It acknowledges that there were delays but says that the delays are not wholly attributable to it. For example, Genpharm argues that the original request for disclosure from the Applicants was in very general language and no specific request was received from the Applicants until August 8, 2002. On that date counsel for the Applicants sent a letter to counsel for Genpharm with a detailed request for production. By this time, that is August 8, 2002, the Applicants had already filed a Notice of Motion seeking an Order for production but that motion had been postponed several times and ultimately came on for hearing on October 21, 2002.
[7] Genpharm argues that the delay in obtaining certain information that was the subject of the Order made on October 22, 2002 was due to the fact that certain information was beyond its control. The production of that information required a further Protective Order. That Order required execution of an affidavit by a person beyond the jurisdiction of the Court and that Order was not obtained until March 2003.
[8] Genpharm submits that certain time-lines have been put in place that will require the parties to file all necessary affidavits before October 6, 2003. It may be possible for the parties to complete and file affidavits before that deadline. Genpharm says that the present motion to extend the period of the statutory stay is premature.
[9] The test for deciding whether to extend the time for the statutory stay is set out in section 7(5)(b) of the NOC Regulations. In David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588 (C.A.) at paragraph 12, the Court said:
The Patented Medicines (Notice of Compliance) Regulations further indicate an intention that this particular kind of application for judicial review should be disposed of expeditiously. Section 7(1) of the regulations provides that normally a notice of compliance should not be issued until 30 months have elapsed from the filing of the application for prohibition, unless the court has in the meantime dismissed the application. Section 7(5), however authorizes the court to abbreviate or extend the 30-month period where it has not yet reached a decision on the application but where it finds that a party to the application "failed to reasonably cooperate in expediting the application". Thus if, for example, the applicant unduly delays in bringing the matter on for hearing on the merits, the respondent can move to have the court shorten the time-limit for the issue of a notice of compliance.
Accordingly, the real question arising from the Applicants' motion is whether Genpharm has "failed to reasonably cooperate in expediting the application".
[10] As noted above, the Applicants produced many pieces of correspondence as part of the motion record. They argue that these letters show that Genpharm has acted in a manner designed to delay the progress of this application and that the time should be extended to allow them to fully prepare the evidence in support of the application for an order of prohibition.
[11] In my view, the Applicants have not produced evidence to show that Genpharm has failed to reasonably expedite the conclusion of this proceeding. As I read section 7(5)(b) of the NOC Regulations, the Applicants carry this burden. The evidence produced by the Applicants, that is the extracts from correspondence exchanged with counsel for Genpharm, shows that there has been delay, contributed to by both parties. There is merit in Genpharm's argument that the Applicants did not make a clearly defined request for specific information until August 8, 2002, nearly three months after the initial generalized request for disclosure. Although the Applicants filed a motion on July 24, 2002 to compel disclosure, they did not proceed with that motion until October 21, nearly three months later.
[12] I note, from the file, that this proceeding was subject to a Notice of Status Review in February 2003. Joint submissions were made by the parties in response to that Notice and the matter was ordered to be continued. By an Order that was dated April 30, 2003, the proceeding was made subject to special management. By further order dated June 12, 2003, as part of the case management of this file, a time-line was established by Prothonotary Lafrenière for the completion of the affidavits to be relied on by the parties. It is clear that this proceeding is subject to guidance in the completion of the remaining steps.
[13] I acknowledge that the parties are subject to time restraints, in light of the NOC Regulations. At the same time, it is not clear that the parties will be unable to finalize their respective cases in time to obtain a hearing prior to the expiry of the twenty-four month statutory stay, that is May 2, 2004. In my opinion, the present motion is premature, having regard to the fact that slightly more than ten months remain of that legislative stay period and the parties are to finalize their respective affidavits by October 6, 2003.
[14] Proceedings pursuant to the NOC Regulations are intended to be summary. They are not meant to be full-blown trials. The application records should be prepared with a hard assessment of the matters really in issue. The parties here, by their own actions, have each contributed to the time pressures now prevailing. They should concentrate on completing the affidavits in accordance with the time-lines set out in the Order of June 12, 2003. If necessary, the issue of an extension of time can be raised after Genpharm has served and filed its affidavits, on or before October 6, 2003.
[15] The motion is dismissed without prejudice to a future request for an extension of time; costs in the cause.
ORDER
The motion is dismissed without prejudice to a future request for an extension of time; costs in the cause.
"E. Heneghan"
J.F.C.C.
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
DOCKET: T-711-02
STYLE OF CAUSE: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
- and -
THE MINISTER OF HEALTH and
GENPHARM INC.
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: MONDAY JUNE 23, 2003
REASONS FOR ORDER
AND ORDER BY: HENEGHAN J.
DATED: JUNE 26, 2003
APPEARANCES BY: Mr. Steve Mason, and
Mr. Marcus Klee
For the Applicants
Ms. Barbara Murchie
For the Respondent, Genpharm
SOLICITORS OF RECORD: McCarthy & Tetrault
Barristers & Solicitors Toronto, Ontario
For the Applicants
Sim, Hughes, Ashton & McKay LLP.
Barristers & Solicitors
Toronto, Ontario For the Respondent, Genpharm
FEDERAL COURT OF CANADA
Date:20030626
Docket: T-711-02
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
- and -
THE MINISTER OF HEALTH and GENPHARM INC.
Respondents
REASONS FOR ORDER
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