Date: 20050421
Docket: T-2137-04
Citation: 2005 FC 545
Toronto, Ontario, April 21st, 2005
Present: Roger R. Lafrenière, Esquire
Prothonotary
BETWEEN:
PFIZER CANADA INC. and PFIZER INC.
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1] The only issue to be determined is whether the Respondent, Apotex Inc. ("Apotex") should be granted an additional period of time in which to serve and file its affidavits and documentary exhibits pursuant to Rule 307 of theFederal Courts Rules ("the Rules").
[2] The schedule for completion of procedural steps that governs this proceeding was fixed by Order of Justice de Montigny dated January 21, 2005 (the "Scheduling Order") following a motion for extension of time by the Applicants, Pfizer Canada Inc. and Pfizer Inc. (hereinafter referred to in the singular as "Pfizer") to serve and file its affidavit evidence. At the hearing of Pfizer's motion, Apotex consented to serve and file its affidavit evidence within 45 days of service of Pfizer's evidence. Apotex now moves for an additional three months to file its affidavit evidence, and an equivalent extension of time to complete subsequent steps in the proceeding.
[3] Apotex submits that an extension of time is justified in light of the voluminous nature and complexity of Pfizer's evidence, as well as the busy schedules of its experts who will be considering the evidence. Pfizer opposes the motion on the grounds that it would be prejudiced by any delay in the proceeding, and that Apotex ought not be entitled to resile from its position that 45 days is sufficient.
Background
[4] By way of background, Apotex provided its Notice of Allegation ("NOA") pursuant to the Regulations in respect of Canadian Letters Patent No. 2,044,748 ("'748 Patent") in October 18, 2004, alleging that the '748 Patent was invalid, void and of no force and effect. In support of its NOA, Apotex referred to 83 prior art references.
[5] Pfizer commenced the within proceeding in response to the NOA, seeking an Order pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations ("the Regulations") that would prohibit the Minister of Health from issuing a Notice of Compliance to Apotex for its sildenafil product.
[6] Pfizer subsequently brought a motion in December 2004 seeking, among other relief, an extension of time of three months beyond the time provided in the Rules for service and filing of its affidavit evidence. In the context of that motion, Pfizer gave notice of the nature and extent of the evidence it intended to adduce in the proceeding. Pfizer specifically advised that it expected to present evidence from cardiologists and medical chemists, pharmacologists with expertise in cardiology, respirology, ophthalmology, gastro-interology, and PDE inhibitors generally. Pfizer also disclosed that over 100 prior art references had already been identified and were potentially at issue, beyond those already listed in Apotex's NOA.
[7] Pfizer's request for extension of time was vigorously opposed by Apotex. Counsel for Apotex characterized the extension of time requested by Pfizer as "extraordinary" and "unparalleled in proceedings under the Regulations". At the hearing of the motion, counsel consented to delivery of Apotex's evidence within 45 days of service of Pfizer's evidence.
[8] Justice de Montigny decided to grant Pfizer an extension to March 1, 2005 to serve and file its evidence after taking into account the complexity of the issues raised and the number of allegations made by Apotex. The Scheduling Order also granted Apotex an extension of 15 days beyond the time provided in Rule 308 to serve and file responding affidavit evidence.
[9] The present motion is supported by the affidavit of Mr. Ivor Hughes, who is co-counsel to Apotex. According to Mr. Hughes, it became apparent to Apotex that the 45 day period it had agreed to before Justice de Montigny would be insufficient when counsel received Pfizer's affidavit evidence on March 1, 2005. Pfizer's evidence consisted of 7 expert affidavits and 6 volumes of references, comprising over 160 additional references in addition to the 83 references referred to by Apotex in its NOA. Apotex requested Pfizer's consent to an extension of time of the same duration as the one provided to Pfizer in order to complete and file its evidence, however Pfizer would not agree to any extension.
[10] Mr. Hughes deposes that, due to the breadth of the evidence filed by Pfizer, the deadlines contemplated by the current timetable would be impossible to meet. He then refers to communications between counsel for Apotex and seven experts it retained to review the material. All are of the view that 45 days is insufficient time to meaningfully consider Pfizer's evidence and to prepare a sufficient response.
[11] Attached as an exhibit to Mr. Hughes' affidavit is an e-mail from Dr. D.H. Maurice, one of the experts retained by Apotex. Dr. Maurice briefly comments on the "mass of evidence" he received, and suggests that it would be "almost impossible" to meet the April 15 deadline. Dr. Maurice concludes his e-mail by inquiring whether it would be possible to obtain a 60 day extension. In another e-mail from second expert, Dr. Jackie Corbin, a similar extension is requested, essentially for the same reasons.
Analysis
[12] In Canada (AG) v. Hennelly (1999), 244 NR 399, the Federal Court of Appeal set out four factors that the Court should take into account when exercising its discretion. An applicant is generally required to establish:
(a) a continuing interest to pursue the application;
(b) that the application has some merit;
(c) that no prejudice results from the delay; and
(d) a reasonable explanation for the delay.
[13] The parties agree that the underlying consideration for the Court in deciding whether to grant an extension of time is that justice be done between the parties. In the search for justice, it is often necessary to balance the relevant factors.
[14] Counsel for Pfizer took no position regarding Apotex's continued intention to oppose the application. He also abandoned his objection that Apotex failed to establish an arguable case in oral argument. He maintained, however, that the last two criteria for exercise of the Court's discretion to extend the time have not been established by Apotex.
[15] With respect to prejudice, Apotex has failed to establish that Pfizer would not be negatively impacted by a further delay of three months. First, the delay is quite significant and could jeopardize the timely hearing of the prohibition application within the 24 month legislative stay period under section 7(1)(e) of the Regulations. Second, Pfizer would remain exposed to a claim for damages for any further period of delay under section 8. The potential and real prejudice to Pfizer therefore militates against granting an extension of time.
[16] As for the explanation provided by Apotex for the delay, I find it less than satisfactory. At paragraph 16 of his affidavit, Mr. Hughes states that a period of 45 days is not enough time for Apotex's experts to meaningfully consider Pfizer's evidence and to prepare a sufficient response. His assessment is largely based, however, on hearsay statements made by a number of experts retained by Apotex, which is wanting in many respects.
[17] In particular, it is unclear whether Apotex's experts had previous knowledge of the additional references cited by Pfizer's experts, or whether the references were unanticipated. Nor is there any evidence to explain why there is a need for each expert to review all the evidence delivered by Pfizer. In addition, by the tone of the e-mails of Drs. Maurice and Corbin, it seems that Apotex's experts were not alive to the fact that prohibition applications must proceed expeditiously.
[18] Turning to the length of the extension of time requested, the evidence adduced by Apotex fails to clearly explain why 60 days are required by the experts to review Pfizer's materials and a further 30 days for counsel to prepare the affidavits. Apotex argues that it does not seek any more time than that afforded to Pfizer to file its evidence. This is a rather hollow argument. The fact Pfizer was granted an extension of time may be indicative of the complexity of the proceeding, but does not establish that a corresponding extension of time should be granted to Apotex. Each case must be decided on its own merits.
[19] Finally, in order to succeed on this motion, Apotex was not only required to establish that further time is required to file its evidence, but also that the 15 day extension of time granted by Justice de Montigny proved insufficient by reason of a matter arising or discovered subsequent to the Scheduling Order.
[20] One cannot ignore the fact that an extension of time of 15 days has already been granted to Apotex. Apotex vigorously opposed Pfizer's request for an extension of time, characterizing it as unparalleled, extraordinary and unprecedented. In what appears to be an attempt to downplay the nature and scope of Pfizer's evidence and to convince Justice de Montigny that Pfizer's request for an extension of time was unreasonable, Apotex agreed to a 45 day period of time in which to serve its own responding evidence.
[21] In his affidavit, Mr. Hughes declares that Apotex did not know or could not anticipate that Pfizer would be filing the evidence of 7 expert witnesses and 6 volumes of references. Mr. Hughes' assertion is somewhat surprising taking into account the fairly detailed evidence adduced by Pfizer in its earlier motion.
[22] In my view, Apotex were given fair notice of the approximate number of expert affidavits it would receive from Pfizer, as well as the number of articles to which the experts would be referring. I conclude that Apotex was fully aware of the nature and scope of the evidence that the Applicants were intending to adduce, and ought therefore not be permitted to resile from its position, absent a material change in circumstances, which has not been established.
[23] The Court is placed in an awkward position by Apotex's late request for an extension of time. Apotex's motion was filed on April 5, 2005 and made returnable on April 11, 2005, four days before the expiration of the Court-ordered deadline. Although I find that improper tactics were used by Apotex in this and the previous motion, which I consider to be a failure to reasonably cooperate in expediting the application, I am also of the view that to deny Apotex an opportunity to file responding evidence would be too draconian a consequence. A party committing a procedural default should not be denied an opportunity to respond to a proceeding unless there is prejudice to the other side which cannot be compensated by costs, or otherwise.
[24] In the exercise of my discretion as case management prothonotary, I consider that a liberal approach is in order, and indeed necessary, to do justice between the parties. I would therefore grant Apotex an extension of time to May 31, 2005. Any prejudice to Pfizer can be avoided or addressed by a concurrent disposition which extends the statutory stay by a period equivalent to the extended period, prevents Apotex from claiming damages during the same period, and grants Pfizer its costs of the motion.
ORDER
THIS COURT ORDERS that
1. The Respondent, Apotex Inc., be granted an extension of time to May 31, 2005 in which to serve and file affidavits and documentary exhibits pursuant to Rule 307 of the Federal Courts Rules.
2. The 24 month statutory stay prescribed by section 7(1)(e) of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") shall be extended, pursuant to section 7(5)(b) of the Regulations, for the period of Apotex's extension to serve and file its affidavits and documentary exhibits, namely, 46 days.
3. Apotex is prevented from claiming any loss pursuant to section 8 of the Regulations for the period of the extension, namely, April 15 to May 31, 2005.
4. The remainder of the timetable is extended as follows:
(a) the Applicants shall serve and file any motion for leave to file reply evidence within 21 days of service of the Respondents' evidence;
(b) in the absence of any motion for leave to file reply evidence, cross-examinations shall be conducted within 90 days of the time for expiry set out in (a) above;
(c) the Applicants' application record shall be served and filed within 30 days of the conclusion of cross-examinations; and
(d) the Respondents' application records shall be served and filed within 40 days of service of the Applicants' application record.
5. Costs of this motion shall be payable by Apotex to the Applicants in any event of the cause.
"Roger R. Lafrenière"
Prothonotary
FEDERAL COURT
Names of Counsel and Solicitors of Record
DOCKET: T-2137-04
STYLE OF CAUSE: PFIZER CANADA INC. AND PFIZER INC.
and
APOTEX INC. AND THE MINISTER OF
HEALTH
DATE OF HEARING: APRIL 11, 2005
PLACE OF HEARING: TORONTO, ONTARIO
REASONS FOR ORDER
AND ORDER BY: LAFRENIÈRE P.
DATED: APRIL 21, 2005
APPEARANCES BY:
Mr. Andrew McIntosh FOR THE APPLICANTS
Mr. David E. Lederman FOR THE RESPONDENTS
SOLICITORS OF RECORD:
BERESKIN & PARR
Barristers & Solicitors
Toronto, Ontario FOR THE APPLICANTS
GOODMANS LLP
Barristers & Solicitors
Toronto, Ontario FOR THE RESPONDENTS