Date: 20040729
Docket: T-1035-02
Citation: 2004 FC 1049
BETWEEN:
ABBOTT LABORATORIES and
ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and
PHARMASCIENCE INC.
Respondents
APPLICATION UNDER Section 55.2 of the Patent Act, Section 6 of the Patented Medicines (Notice of Compliance) Regulations, am. by the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations.
INTRODUCTION
[1] These reasons follow the hearing of an appeal by Pharmascience Inc. ("Pharmascience") and a cross-appeal by Abbott Laboratories and Abbott Laboratories Limited ("Abbott") from an Order of Prothonotary Aronovitch in which she granted, in part, Abbott's motion for extension of the twenty-four (24) month period specified in paragraph 7(1)(e) of the Patented Medicines (Notice of Compliance) Regulations[1], by one hundred and five (105) days to the 18th of October, 2004 and dismissed Pharmascience's motion to shorten the same twenty-four (24) month period. The Order under appeal is dated the 25th of June, 2004. On its appeal, Pharmascience once again seeks the shortening of the twenty-four (24) month period. On its cross-appeal, Abbott seeks to vary the Order of the learned Prothonotary, by lengthening the one hundred and five (105) day extension of the 24-month period "...to allow the application to be heard and determined, such that Abbott's counsel of choice is available to argue the case".
[2] The relevant provisions of the Patented Medicines (Notice of Compliance) Regulations (the "PMNOC Regulations") read as follows:
7. (1) The Minister shall not issue a notice of compliance to a second person before the latest of
(a) [Repealed, SOR/98-166, s. 6]
(b) the day on which the second person complies with section 5,
(c) subject to subsection (3), the expiration of any patent on the register that is not the subject of an allegation,
(d) subject to subsection (3), the expiration of 45 days after the receipt of proof of service of a notice of any allegation pursuant to paragraph 5(3)(b) or (c) in respect of any patent on the register,
(e) subject to subsections (2), (3) and (4), the expiration of 24 months after the receipt of proof of the making of any application under subsection 6(1), and
(f) the expiration of any patent that is the subject of an order pursuant to subsection 6(1).
7. (1) Le ministre ne peut délivrer un avis de conformité à la seconde personne avant la plus tardive des dates suivantes :
a) [Abrogé, DORS/98-166, art. 6]
b) la date à laquelle la seconde personne se conforme à l'article 5;
c) sous réserve du paragraphe (3), la date d'expiration de tout brevet inscrit au registre qui ne fait pas l'objet d'une allégation;
d) sous réserve du paragraphe (3), la date qui suit de 45 jours la date de réception de la preuve de signification de l'avis d'allégation visé aux alinéas 5(3)b) ou c) à l'égard de tout brevet inscrit au registre;
e) sous réserve des paragraphes (2), (3) et (4), la date qui suit de 24 mois la date de réception de la preuve de présentation de la demande visée au paragraphe 6(1);
f) la date d'expiration de tout brevet faisant l'objet d'une ordonnance rendue aux termes du paragraphe 6(1).
...
...
(5) If the court has not yet made an order under subsection 6(1) in respect of an application, the court may
(a) shorten the time limit referred to in paragraph (1)(e) on consent of the first and second persons or if the court finds that the first person has failed, at any time during the proceeding, to reasonably cooperate in expediting the application; or
(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.
[emphasis added]
(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 :
a) abréger 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 première personne n'a pas, au cours de l'instance relative à la demande, collaboré de façon raisonnable au règlement expéditif de celle-ci;
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.
[Je souligne]
[3] Subsections 7(2), (3) and (4) are not relevant for the purposes of this matter. In the absence of the Order made by Prothonotary Aronovitch, the twenty-four (24) month period specified in paragraph 7(1)(e) of the PMNOC Regulations would have expired on the 5th of July, 2004.
[4] The Minister of Health filed no materials before Prothonotary Aronovitch, nor did he appear before her. Similarly the Minister filed no materials on this appeal and did not appear on the hearing.
BACKGROUND
[5] This proceeding was commenced by Notice of Application filed on behalf of Abbott on the 5th of July, 2002, in response to a Notice of Allegation served on Abbott by Pharmascience on the 21st of May, 2002.
[6] By Order dated the 25th of October, 2002, my colleague Justice Layden-Stevenson ordered production by Pharmascience of specific portions of its Abbreviated New Drug Submission and a related Drug Master File that underlay its Notice of Allegation.
[7] On the 6th of December, 2002, a Confidentiality Order issued facilitating disclosure. Disclosure nonetheless proceeded rather slowly, in part by reason of a motion by Pharmascience for reconsideration of Justice Layden-Stevenson's Order of the 25th of October, 2002 and related appeals.
[8] On the 7th of January, 2003, the Court ordered the parties to provide a timetable for completion of the remaining steps in this matter. Less than a month earlier, on the 18th of December, 2002, a case management judge was appointed with Prothonotary Aronovitch appointed to assist.
[9] On the 17th of February, 2003, Pharmascience served a motion to strike this matter. On the 29th of January, 2004, the motion to strike was granted. In the meantime, this matter had been set down for hearing in March of 2004. The Order striking the matter was promptly appealed by Abbott. While the appeal was pending, the hearing dates in March, 2004 went by.
[10] On the 19th of April, 2004, the Federal Court of Appeal allowed the appeal from the Order striking this matter and thus, it was reinstated.
[11] Only on the 21st of May, 2004, did Abbott file its Application Record.
[12] Once again, only on the 2nd of June, 2004, did Abbott serve its Notice of Motion leading in part to the Order under appeal. On the 16th of June, 2004, Pharmascience filed its cross-motion.
[13] In the absence of a disposition of Abbott's motion for an extension of the twenty-four (24) month period and Pharmascience's cross-motion for a shortening of the same period, and in anticipation of the expiration of the twenty-four (24) month period on the 5th of July, 2004, by Order or Direction dated the 22nd of June, 2004, the hearing of this matter was set down for three (3) days at Ottawa, Ontario commencing on Monday the 28th of June, 2004.
[14] On Friday, the 25th of June, 2004, Prothonotary Aronovitch's Order extending time issued. The Order included an extensive endorsement in explanation of the substance of the Order. That endorsement is attached as Exhibit A to these reasons.
[15] The same day, by teleconference, the Court consulted with counsel regarding "next steps". Following the teleconference, an Order issued adjourning the hearing of this matter then scheduled for the 28th of June, 2004 to three (3) days at Toronto commencing the 12th of July, 2004 and fixing the morning of the 8th of July, 2004, at Toronto, for the hearing of any appeal or appeals from Prothonotary Aronovitch's order. The appeal and cross-appeal here at issue followed and, with the cooperation of counsel, those appeals were heard as scheduled. On the 9th of July, 2004, an order issued dismissing the appeal and cross-appeal and indicating that reasons would follow. These are those reasons.
[16] The hearing on the merits of this application for prohibition took place as scheduled at Toronto on the 12th, 13th and 14th of July, 2004.
THE DECISION UNDER APPEAL
[17] Prothonotary Aronovitch's decision that is under appeal is earlier briefly described in these reasons. In addition, her endorsement in support of her decision is annexed hereto as a Schedule.
THE STANDARD OF REVIEW ON THIS APPEAL
[18] The standard of review to be applied by a motions judge to a discretionary decision of a prothonotary was clearly established in Canada v. Aqua-Gem Investments Ltd. (C.A.)[2], where Justice MacGuigan, on behalf of the majority, wrote at pages 462-3:
...Following in particular Lord Wright in Evans v. Bartlam, ..., and Lacourcière J.A. in Stoicevski v. Casement ..., discretionary orders of prothonotaries ought not to be disturbed on appeal to a judge unless:
a) they are clearly wrong, in the sense that the exercise of discretion by the prothonotary was based upon a wrong principle or upon a misapprehension of the facts, or
(b) they raise questions vital to the final issue of the case.
Where such discretionary orders are clearly wrong in that the prothonotary has fallen into error of law (a concept in which I include a discretion based upon a wrong principle or upon a misapprehension of the facts), or where they raise questions vital to the final issue of the case, a judge ought to exercise his own discretion de novo. [citations omitted]
[19] In a footnote to the reference in the foregoing quotation to "...the final issue of the case", Justice MacGuigan wrote:
It should be noted that Lord Wright's phrase "the final issue of the case" is quite different from "the final issue in the case." Lord Wright means "vital to the result of the case" rather than "vital to the ultimate issue on the merits of the case." [emphasis in original]
[20] The foregoing formulation of the appropriate test was endorsed by the Supreme Court of Canada in Z.I. Pompey Industrie v. Ecu-Line N.V.[3]
[21] In Merck & Co. v. Apotex Inc.[4], the Federal Court of Appeal reformulated the Aqua-Gem test without impacting its substance. Justice Décary, for the Court, wrote at paragraph [19]:
To avoid the confusion which we have seen from time to time arising from the wording used by MacGuigan J.A., I think it is appropriate to slightly reformulate the test for the standard of review. I will use the occasion to reverse the sequence of the propositions as originally set out, for the practical reason that a judge should logically determine first whether the questions are vital to the final issue: it is only when they are not that the judge effectively needs to engage in the process of determining whether the orders are clearly wrong. The test would now read:
Discretionary orders of prothonotaries ought not be disturbed on appeal to a judge unless:
a) the questions raised in the motion are vital to the final issue of the case, or
b) the orders are clearly wrong, in the sense that the exercise of discretion by the prothonotary was based upon a wrong principle or upon a misapprehension of the facts.[5]
[22] Finally on the question of standard of review, Justice Rothstein for the Federal Court of Appeal, wrote in Sawridge Band v. Canada[6] at paragraph [11]:
We would take this opportunity to state the position of this Court on appeals from orders of case management judges. Case management judges must be given latitude to manage cases. This Court will interfere only in the clearest case of a misuse of judicial discretion. This approach was well stated by the Alberta Court of Appeal in Korte v. Deloitte, Haskins and Sells ..., and is applicable in these appeals. We adopt these words as our own.
This is a very complicated lawsuit. It is subject to case management and has been since 1993. The orders made here are discretionary. We have said before, and we repeat, that case management judges in these complex matters must be given some "elbow room" to resolve endless interlocutory matters and move these cases on to trial. In some cases, the case management judge will have to be innovative to avoid having the case bog down in a morass of technical matters. Only in the clearest cases of mis-use of judicial discretion will we interfere. In this case, the carefully crafted orders made by the case management judge display a sound knowledge of the rules and the related case law. In particular, the order contains a provision that the parties are free to return to the case management judge for relief from the imposition of any intolerable burden imposed by the order. No clear error has been shown and we decline to interfere. While there may be some inconvenience to some of the parties, this does not translate into reversible error. We are not here to fine tune orders made in interlocutory proceedings, particularly in a case such as this one.
[citation omitted]
[23] Under the Rules of this Court, a Prothonotary appointed to assist a case management judge, as Prothonotary Aronovitch was in this matter, is herself or himself a "case management judge".
APPLICATION OF THE AUTHORITIES ON STANDARD OF REVIEW TO THE FACTS OF THIS CASE
[24] There can be no question but that the order under appeal is a discretionary order. In the result, unless it can be said to be vital to the final issue of the case, or clearly wrong, in the sense that the exercise of discretion was based upon a wrong principle or upon a misapprehension of the facts, then it is deserving of great deference. But for the weight of authority to the contrary, I would find it to be worthy of great deference in any event. Who other than a case management judge who has been intimately involved in all facets of a complicated lawsuit such as this over the greater part of the life of that lawsuit, is in a better position to judge whether the twenty-four (24) month guillotine that hangs over proceedings such as this should be extended or shortened, and if so by how much, based upon a test of reasonable cooperation in expediting the proceeding? Certainly not a judge such as I who encounters the proceeding for the first time less than two (2) weeks before the guillotine falls.
[25] The foregoing being said, with regret, I am satisfied that I must conclude that the facts that were before Prothonotary Aronovitch and on which she adjudicated were vital to the final issue of the case. If she had determined to shorten the twenty-four (24) month period, the proceeding would have been determined against the Applicant without any consideration on its merits. If she had determined not to vary the twenty-four (24) month period, the matter might conceivably have been determined on its merits within the period but certainly in very unfavourable circumstances. By determining to extend the period, based upon her view of the relative degrees of cooperation of the parties in moving the proceeding forward, she allowed for its determination on the merits, on a more rational schedule, albeit one that was substantially disruptive of the summer schedule of both counsel and the Court. There can be no doubt that, among the options open to the learned Prothonotary, at least one would not only have been vital to the result of the case, it would have been absolutely determinative without any consideration on the merits.
[26] In the result, with great regret because, whatever time counsel and I were jointly able to devote to this matter, I am satisfied that the learned Prothonotary was in a better position to evaluate the whole course of events then I ever could be, I undertook this appeal on a de novo basis.
DE NOVO REVIEW AND CONCLUSION
[27] Counsel for the parties placed before Prothonotary Aronovitch very extensive materials. In advance of the hearing of this appeal, I reviewed those materials in toto. Of course, I also reviewed the Order that was under appeal before me and the related endorsement. Given the limited time between the date of Prothonotary Aronovitch's Order and the hearing of this appeal, counsel did an admirable job in providing me with synthesized material which, again, I reviewed. At the half-day hearing of the appeal, counsel did another admirable job of synthesizing the course of events since this matter commenced. Having taken all of the foregoing into account, I find no basis whatsoever for reaching a conclusion different from that reached by Prothonotary Aronovitch. Further, I find no basis whatsoever to vary from the length of the extension of the twenty-four (24) month period that she determined to provide. In the result, by Order dated Friday, the 9th of July, 2004, I dismissed the appeal and the cross-appeal that were before me.
[28] I was tempted to adopt Prothonotary Aronovitch's reasons as my own, but I decline to do so. They reflect a familiarity with the process and claims and counter-claims of responsibility for delay that I could not hope to emulate without her degree of hands-on familiarity.
A POSTSCRIPT
[29] When the Aqua-Gem test was propounded, this Court was not in the business of case management in any formalized way, such as it has been since the complete revision of the Court's Rules in 1998. In the perception of this judge, this change in the practice of the Court might warrant a revisiting of the Aqua-Gem test, at least on facts equivalent to those giving rise to these reasons. The decision of the Federal Court of Appeal in Sawridge Band, supra, might provide a first step, and indeed a springboard, for such a review. Any such review would, of course, be for others to conduct.
______________________________
J.F.C.
Ottawa, Ontario
July 29, 2004
EXHIBIT
(see paragraph [17] of the reasons)
ENDORSEMENT
I am seized of the above-noted motions argued on the basis of the same evidence and will deal with each in turn, starting with Abbott's. As a preliminary matter, at the hearing of the motion Abbott abandoned its objections to Ms. Hitchman's affidavit, a matter I will accordingly not deal with below.
As to the substance of the motion, I find for Abbott on two bases; one, Pharmascience's delay in making disclosure including its haltingly incremental, and piecemeal compliance with the disclosure orders of the Court. The other basis for concluding that Pharmascience has failed, in this instance, to reasonably cooperate in expediting the proceeding is in its delay in bringing Pharmascience's motion to strike.
There is the usual abundance of motions in the course of this application, all of them accompanied by recriminations from the responding party as to their necessity and effect in protracting the proceedings.
Indeed there is rarely a piece of correspondence in this long record that does not reproach the party opposite with delaying the prosecution of the application. So much so, that one can draw no conclusions as to the vice or virtue of either party from the stream of correspondence containing what can only be characterized as stock complaints of delay.
Evidently the best evidence is of what the parties did rather than what they have said. In the same vein I have considered the various motions brought by the parties in light of the direction of Strayer J.A. that "Interlocutory motions indulged in by a party will be assessed by their outcome, to determine whether they were brought or opposed unreasonably". (Merck Frosst Canada Inc. v. Apotex Inc., (1997), 72 C.P.R. (3d) 170 (F.C.A.)) ("Merck")
Abbott says that Pharmascience began by serving a deficient, bare bones, NOA and thereafter took roughly ten months from July 25, 2002 to May 6, 2003 to make full and final disclosure of its process details. By contrast says Abbott, the remainder of what is a complex application took only seven months to complete.
To begin, given Abbott's allegation that Pharmascience's NOA was deficient, I do not accept Pharmascience's response that Abbott ought to have argued the prohibition on the sole basis of the deficiencies and not sought the details of the process used to make the allegedly non-infringing clarithromycin. In other words, that it was an unnecessary "indulgence" on the part of Abbott to pursue production rather than simply seek to prohibit issuance of the NOC on the basis that Pharmascience has not advanced any facts to support its allegations of non-infringement (AB Hassle v. Canada (Minister of National Health and Welfare) [2000] F.C.J. No. 855 and Proctor & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health) (C.A.) [2003] 1 F.C. 402 ).
This was not an "indulgence" on the part of Abbott who was well within its rights to seek disclosure pursuant to subsection 6(7) of the NOC Regulations, a right endorsed by the Court of Appeal in Novartis AG et al. v. Abbott Laboratories Ltd. et al. 7 C.P.R. (4th) 264, ("Novartis") reversing 4 C.P.R. (4th) 379, and applied inter alia, in AB Hassle v. Apotex (July 16, 2001) T-1747-00 (F.C.T.D.). In Novartis the Court clarified the standard to be applied and acknowledged that by the enactment of s. 6(7) of the NOC Regulations, the Governor in Council, had intended further disclosure to be made than previously ordered by the Court in the context of summary NOC proceedings.
In light of that finding, it does not lie with Pharmascience to argue that Abbott, whether by dint of the motion for disclosure or the later motion for compliance with the disclosure order, may be said to have unnecessarily protracted the proceeding and caused it to take on "the ponderous character of a patent action" (Merck, supra).
Indeed, in applying the standard approved by the Court of Appeal in Novartis, Justice Layden-Stevenson in her Order of October 25, 2002 found Abbott to be fully entitled to the disclosure of Pharmascience's process information, from its ANDS, as well as details from its supplier Teva's DMF. Layden-Stevenson J. agreed with Abbott that s. 6(7) permits an order for disclosure of information from a DMF that is cross-referenced or incorporated by reference into the ANDS filed by Pharmascience.
Pharmascience then brought a motion for reconsideration rather than appeal. This, in the face of a clear and unambiguous order, as later determined by the Court of Appeal. In Pharmascience Inc. v. Minister of Health et al. 28 C.P.R. (4th) 27 Sharlow J.A. said of it, "I do not accept that the order is ambiguous or that Pharmascience could reasonably have believed that it did not express the judge's true intention". Notwithstanding that the appeal was moot, the Court went on to elucidate the onus on a generic manufacturer when dealing with the information of a third party, as follows:
31. Having said that, I agree with Pharmascience to a certain extent. If it is established by credible evidence that a generic manufacturer has filed an abbreviated new drug submission that includes cross-referenced third party information that the generic manufacturer does not have, that it has tried and failed to obtain, and that it has no legal right to obtain, it would be an error of law for a judge to order production of the cross-referenced information. That would not be because the information is outside the scope of s. 6(7), but because a party cannot be ordered to do something that it cannot do. However, even if there is such evidence, it would be open to a judge to order the generic manufacturer to use its best efforts to obtain the information, and to insist on a credible explanation if those best efforts fail. ...
32. In this case, there was no evidence before the judge that Pharmascience did not have the Teva information, or that Pharmascience had tried and failed to obtain the Teva information, or that it had no legal right to obtain the information. On the contrary, there was an affidavit from Dr. A.J. Liston, a chemist with many years experience as an official of Health Canada dealing with new drug submissions. He deposed that Pharmascience would have the Teva information or could get it from Teva. His affidavit was not contradicted, and he was not cross-examined. ... (emphasis mine)
Ostensibly the delay in complying with the Court's Order of October had little to do with any confidentiality order. As late as November 12, 2002, Ms. Hitchman wrote to Abbott that Pharmascience did not have access to the Teva DMF and could not provide it, simpliciter. No evidence is adduced on this motion as to the efforts Pharmascience made to procure disclosure of the DMF information; certainly not for the period from August 30, 2002, when it was served with Abbott's notice of motion for disclosure specifically requesting relevant portions of the ANDS and its suppliers' DMF, until December 13, 2002, when PMS finally sent its letter to Abbott disclosing portions of the DMF, though partially redacted.
It is most especially in its failure to meet that onus that Pharmascience, in my view, has failed to reasonably cooperate to expedite the proceedings in that period. Pharmascience hardly took a more cooperative or expeditious approach with its own information. It was not until November 19, 2002 that pages of Pharmascience's own ANDS were being sent to Abbott on the basis of Abbott's agreement to be bound by a draft protective order which essentially had been agreed to earlier in October and had originally been sought by Abbott in August 2002.
Pharmascience's counsel makes the point that parties can not be said to be uncooperative simply by resisting requests for disclosure. It is not intended, says Pharmascience, that they should capitulate to every request.
The record is not kind to Pharmascience in this regard. There is nothing to suggest that Pharmascience was prepared, at any time, to cooperate to meet some if not all of Abbott's requests even in respect of its own documents. It remained consistently and unconditionally opposed to any disclosure of its process information, running the clock down in the process.
As I have said, Abbott maintains that the period during which Pharmascience ought to be held not to have cooperated is of some ten months, including the period during which Abbott was compelled to bring its motion for compliance with the Order of Justice Layden-Stevenson. While that motion, its outcome, and the unsuccessful appeal from it, display Pharmascience's incrementalist approach, I have chosen to accept Pharmascience's contention that disclosure was substantially made by December 13, 2002. Even so, I find that the disclosure to that date was unnecessarily protracted by Pharmascience in its uncompromising opposition to the disclosure and its apparent lack of best efforts in gaining Teva's support in the period between August 30, 2002 and December 13, 2002.
I note that in Abbott Laboratories v. Canada (Minister of Health) 28 C.P.R. (4th) 79 this Court has found that a somewhat longer period than 10 months in making disclosure did not constitute a lack of cooperation to expedite the proceeding. I would distinguish the case on its facts.
On the second ground of this motion, I also find unacceptable that Pharmascience brought its motion to strike roughly 7 months into the proceeding. Pharmascience does not claim that the facts on which it moved were unknown to it until then. There is no explanation of Pharmascience's delay. Abbott's contention in this respect is that all of the facts on which Pharmascience relied when it moved to strike were known to it even before Pharmascience served its NOA.
The impact of the motion to strike was profound. The application was struck out on January 29, 2004 a day before Abbott was to perfect its application by serving its record with the ensuing loss of the dates set aside for the hearing of the application on the merits.
Pharmascience says that it brought its motion as early as the other generic manufacturers being; Novopharm, Apotex and Ratiopharm. Indeed I am not inclined to draw any inferences adverse to Pharmascience on the basis that the timing of the motion to strike by the four generic manufacturers (the three others being involved in similar applications by Abbott) was tactical, with Pharmascience a participant in a strategy of the four to jointly delay the various proceedings. I agree with Pharmascience that the conduct of the parties in each of the applications has to be considered separately and on its own facts and merits. However, while there is clearly good reason to have consolidated the motions, there is none to explain Pharmascience's delay in bringing the motion.
Section 6(1) proceedings, being summary in nature, and framed as they are by what is essentially a 24 month statutory injunction, parties have to be accountable not only for bringing and resisting motions unnecessarily, but for unreasonable delay in moving for relief once the factual basis for so doing has been ascertained. What may constitute such delay is a question to be determined on the particular facts of the case. Seven months without explanation however, is surely beyond the bounds of reason.
That said, while Pharmascience has provided no evidence on point, in the absence of an evidentiary basis for Abbott's assertions in that regard, I am not prepared to allow any extension of the 24 months on that account.
I would add that it matters not that in this instance, parties had been proceeding separately with the application, with the motion to strike essentially moving on a separate track. Nor do I accept Pharmascience's assertion in this regard that all other things being equal, the results in this proceeding would have been the same at whatever juncture the motion was brought. That is a baseless assertion and an explanation after the fact.
Turning to Pharmascience's motion to shorten the 24 months, with one exception, I find no merit in the motion as I find no basis in the facts to conclude that Abbott has been uncooperative or has unreasonably delayed.
I will therefore not address Pharmascience's allegations in detail as for the most part I concur with and adopt the submissions of Abbott in response.
The evidence does support Pharmascience's contentions in one respect. I agree that Abbott ought to have moved to serve and file its application record within a couple of weeks of the Court of Appeal decision of April 19, 2004, as it held out it would. Instead, it served only on May 21, 2004 and filed on June 3, 2004. I take that delay of roughly two weeks to constitute a lack of cooperation to expedite the proceedings on the part of Abbott.
I would add however that I find Pharmascience's motion opportunistic and brought almost as an afterthought. While Abbott has for some time complained of the lack of timely disclosure and has on numerous occasions put the Court and Pharmascience on notice that it would move for an extension of the twenty-four months arising from the delays in disclosure, Pharmascience while all the while complaining of delays, did not move to shorten the 24 months until June 17, 2004, on the eve of the hearing of Abbott's motion, apparently to foreclose any possibility that the application might be heard before July 5, 2004. In the circumstances I will exercise my discretion in favour of denying Pharmascience the contraction of the 24 month period by the roughly two weeks I noted above.
A final point, at the hearing of its motion and therefore prior to the issuance of the direction setting the application down for hearing on June 28, 2004, Abbott argued that it was variously prejudiced; by reason of being deprived of its day in Court, and having its application dealt with on the merits, by losing its right to obtain prohibition for the life of the patent, and by being rendered "automatically" liable to damages under s. 8 of the NOC Regulations. Pharmascience, it argued in any case, is not in a position to obtain its NOC due to the other pending applications and would not be prejudiced by the extension.
Pharmascience in the context of its own motion, has adduced the affidavit of Ms. Bremner speaking to Pharmascience's prejudice should the hearing on the merits proceed on June 28, 2004.
Counsel are ad idem that subject to establishing as a threshold issue conduct that meets the criteria of s. 7(5) of the Regulations, the Court retains broad discretion pursuant to the section such that it may take prejudice into consideration. Given my disposition above I need not decide the issue. I would say however that I was unable to follow how Pharmascience's difficulties in attending at the hearing on the merits should weigh as prejudice sufficient to shorten the 24 months thereby affecting the substantive rights of Abbott. Surely Pharmascience's remedy in that regard is more appropriately a motion to stay the direction or adjourn the hearing of June 28, 2004, which I understand will be done as a preliminary matter at the commencement of the hearing.
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1035-02
STYLE OF CAUSE: ABBOTT LABORTORIES ET AL v. MINISTER OF HEALTH ET AL
PLACE OF HEARING: Toronto, Ontraio
DATE OF HEARING: July 8, 2004
REASONS FOR ORDER: Gibson J.
APPEARANCES:
|
Mr. Steven G. Mason Mr. Marcus Klee |
FOR THE APPLICANT
|
|
|
FOR THE RESPONDENT |
SOLICITORS OF RECORD:
|
Toronto, Ontario |
FOR THE APPLICANT |
|
Toronto, Ontario |
FOR THE RESPONDENT |
[1] SOR/93 - 133.
[2] [1993] 2 F.C. 425 (C.A.).
[3] [2003] 1 S.C.R. 450 at page 461.
[4] (2003), 30 C.P.R. (4th) 40.
[5] NOTE: In reviewing the chronology that I have set out above, I should take a close look at pages 67, 68 and 69 of Abbott's responding and cross-motion record filed July 5, 2004. It is a document #221 in this matter.
[6] [2002] 2 F.C. 346.