Date: 20030117
Docket: T-2282-01
Neutral Citation: 2003 FCT 40
OTTAWA, ONTARIO, this 17th day of January 2003
PRESENT: The Honourable Madam Justice Snider
BETWEEN:
PFIZER CANADA INC.
and PFIZER INC.
Applicants
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER AND ORDER
SNIDER J.
[1] This is a motion brought by the respondent, Apotex Inc. ("Apotex"), seeking to set aside the Order of Prothonotary Aronovitch dated December 16, 2002 which dismissed a motion brought by Apotex for production of certain documents and materials by the applicants ("Pfizer"), which Apotex alleges are required to prepare its responding affidavit evidence. An extension of the schedule in this matter was also refused.
Background
[2] By letter dated November 12, 2001, Apotex provided a Notice of Allegation ("NOA") pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended ("Regulations") in respect of azithromycin tablets for oral administration 250 mg strength. In the NOA, Apotex alleged, inter alia, that no claim for the medicine itself and no claim for the use of the medicine in Canadian Patent No. 1,314,876 ("'876 Patent") would be infringed by the making, constructing, using or selling by Apotex of its azithromycin tablets.
[3] Pfizer owns the '876 Patent which claims exclusive rights to the product crystalline azithromycin dihydrate.
[4] By application dated December 27, 2001, Pfizer applied in accordance with subsection 6(1) of the Regulations to prevent the issuance of a Notice of Compliance ("NOC").
[5] The main issue in respect to the section 6 application is whether, in making, using or selling of the Apotex product, any azithromycin dihydrate will be made or formed.
[6] Pursuant to an Order and Reasons for Order of O'Keefe J., dated May 3, 2002, Apotex provided portions of its Abbreviated New Drug Submission ("ANDS") and Drug Master File as well as samples of the bulk material and tablets that it filed with the Minister of Health ("Minister").
[7] The evidence of Pfizer was filed on October 25, 2002. The substance of the motion heard and decided by Prothonotary Aronovitch arises from affidavits that form part of that evidence.
Issues Before Prothonotary Aronovitch
[8] In its motion to Prothonotary Aronovitch, Apotex expressed concern that the evidence of Dr. Stahly and Dr. Bugay did not disclose the specific steps, details or methodologies of the experiments and tests that they carried out. Apotex argued that samples of the end and intermediate products and full disclosure of the procedures used by the experts and other information related to the process were required for it to prepare its evidence. At present, the evidence of Apotex is to be filed by January 17, 2003.
[9] Before Prothonotary Aronovitch, Apotex relied on Rule 3 of the Federal Court Rules, 1998 as justification for the production of the materials and documents sought. Apotex, however, acknowledged that the Federal Court Rules, 1998 provide no specific entitlement to seek production of documents prior to filing a responding party's affidavit evidence.
[10] Apotex also acknowledged that it would be entitled to test the affidavits and request the particulars on cross-examination, which would take place after Apotex has filed its affidavit evidence. Pursuing this sequence would, in Apotex' view, not be the most efficient way of proceeding. Further, Apotex argued that "it would be unjust to permit the applicants to rely upon evidence to which Apotex cannot properly respond".
[11] Pfizer opposed the motion.
Decision of Prothonotary Aronovitch
[12] The endorsement in the Order of Aronovitch P. sets out the reasons for her Order to dismiss as follows:
I will dismiss the motion, substantially on the grounds set out in the submissions of the applicants.
I accept that the applicants rely on cases that predate the amendment to the NOC Regulations that added section 6(7). That amendment allows greater disclosure of documentation than had previously been available. While infringement is at issue, and there is reason to have more fulsome evidence before the Court, the nature of the proceeding is not thereby transformed. Brought pursuant to 55.2(4) of the Patent Act and section 6 of the NOC Regulations, the within application for judicial review remains a summary proceeding, governed by applicable Federal Court Rules that are meant to expedite the process and is further subject to the critical time constraints imposed under the NOC Regulations.
Apotex' argues that being provided with this production in advance of putting in its own evidence will, in fact result in expediting matters. Apotex' argument, as I understand it is, two fold. First, that in these circumstances, it is appropriate to partially dispense with, the order of events under the Rules because Apotex does not have the information necessary to adequately respond to the evidence adduced by Pfizer. Second, as a corollary, should Apotex have to wait for cross-examinations to get the required information, further motions for leave to file supplementary evidence, will invariably follow.
I am not satisfied on the basis of the evidence and arguments made, that Apotex ought to have the production it seeks, out of sequence. In the circumstances, it cannot be said that Apotex does not know the case it has to meet or is precluded from putting in its evidence, in support of the underlying application. It is of course for Apotex to determine the evidence it wishes to adduce, but it does not argue a paucity of evidence, including knowledge of the additional steps or conditions that Apotex says must be followed to avoid production and conversion to dihydrate.
I also do not accept that motions to adduce further evidence will invariably ensue. That will surely depend on the evidence adduced by Apotex, and the extent to which Apotex can justify on proper affidavit evidence, the necessity for further evidence.
As to the "fairness" argument, in the circumstances, it favours the applicants as much, if not more than Apotex.
Analysis
[13] The standard of review on an appeal from a decision of a prothonotary in a case such as this was set out in Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425 at 463 (C.A.) by MacGuigan J.A.:
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.
[14] The Order does not raise questions vital to the final issue of the case. Accordingly, to succeed, Apotex must demonstrate that the Prothonotary's decision was based upon a wrong principle or upon a misapprehension of the facts.
[15] In my view, for the reasons that follow, Prothonotary Aronovitch did not base her decision upon a wrong principle or upon a misapprehension of the facts. Accordingly, there is no basis on which to interfere with the Order.
Nature of Proceeding
[16] A proceeding under section 6 of the Regulations is, in effect, a judicial review proceeding. It is not an action for the infringement of a patent where oral and documentary discovery would be available. This was recognized in the endorsement of Prothonotary Aronovitch when she stated that "... the within application for judicial review remains a summary proceeding."
[17] As agreed by the parties, there is no specific Federal Court rule allowing for disclosure. Apotex argues, however, that the Court needs to ensure that the non-testing party (in this case, Apotex) has a real and fair opportunity to respond to the tests. This, in the submission of Apotex, requires that the Court allow disclosure as part of its inherent jurisdiction to ensure fairness. In the absence of a specific rule, Rule 3 should, in the opinion of Apotex, apply in this instance. Rule 3 of the Federal Court Rules, 1998 states:
| These Rules shall be interpreted and applied so as to secure the just, most expeditious and least expensive determination of every proceeding on its merits. |
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Les présentes règles sont interprétées et appliquées de façon à permettre d'apporter une solution au litige qui soit juste et la plus expéditive et économique possible. |
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[18] With respect to these arguments, I note first that Rules 3 is a rule of interpretation and not a general procedural "catch all". As agreed by the parties, there is no specific rule to be interpreted; there is a complete absence of such rule. Accordingly, it is difficult to understand the use of Rule 3 in this context.
[19] Even if Rule 3 is applicable, its application to a situation would be discretionary. I have read and listened to the submission of Apotex and I am convinced that Prothonotary Aronovitch exercised her discretion correctly. More specifically:
1. I do not agree that it is "virtually impossible" for Apotex to file "meaningful responsive evidence". At this stage of the proceedings, it is possible for Apotex to file its evidence showing that its process and product will not make or contain dihydrate. This point is discussed further in paragraphs 20 to 22.
2. Given the nature of these summary proceedings, any discretion that may arise from Rule 3 should be used sparingly, particularly where the exercise of that discretion would result in a substantial change to the character of the proceedings. In this case, with a right of disclosure, the nature of these proceedings would be moving toward one that resembles an action for patent infringement. Indeed, I note that most of the cases raised by Apotex arose in the context of patent infringement actions. There are clear procedural differences between patent infringement cases and NOC Regulations cases. Those differences should be respected to the greatest extent possible.
3. In the normal sequence, Apotex will file its evidence and the parties will then proceed to cross-examination. At this stage, it is possible (although not necessarily a "virtual certainty") that Apotex may apply to introduce further evidence. In this way, the rights of Apotex to a fair process continue to be protected.
Inability of Apotex to Adequately Respond
[20] Apotex argued that Prothonotary Aronovitch's Order constituted an error in principle and a misapprehension of the facts. The issue, in Apotex' submission, "is not Apotex' ability to file its own positive evidence, but rather, the ability of Apotex to coherently respond to the evidence filed by the applicants".
[21] In my view Prothonotary Aronovitch responded correctly to that argument when she stated:
... In the circumstances, it cannot be said that Apotex does not know the case it has to meet or is precluded from putting in its evidence, in support of the underlying application. It is of course for Apotex to determine the evidence it wishes to adduce, but it does not argue a paucity of evidence, including knowledge of the additional steps or conditions that Apotex says must be followed to avoid production and conversion to dihydrate.
[22] I agree. It is up to Apotex to craft its evidence as it deems necessary. Completion of this "positive or affirmative" evidence is completely in the control of Apotex. To the extent that it provides conflicting results from those of Pfizer, such evidence will be responsive. Further, I cannot accept that there is no meaningful response possible to the evidence filed by Pfizer. Although this response may not be as complete or detailed as Apotex would like, this is not sufficient reason for changing the nature of this summary proceeding.
Lengthening of the Proceedings
[23] Apotex argues that Prothonotary Aronovitch "failed to recognize that her Order would result in further delay to the application and further unnecessary interlocutory motions". In my view, this is merely speculation on the part of Apotex. One could equally speculate that cross-examination on the affidavits will provide clear responses to the concerns now raised by Apotex or that production of the requested materials will cause even more interlocutory motions. In these circumstances, I am not persuaded that varying the well-established procedures for summary matters is justified.
Relevance of Subsection 6(7) of the Regulations
[24] Subsection 6(7) of the Regulations is as follows:
| (7) On the motion of a first person, the court may, at any time during a proceeding, (a) order a second person to produce any portion of the submission for a notice of compliance filed by the second person relevant to the disposition of the issues in the proceeding and may order that any change made to the portion during the proceeding be produced by the second person as it is made; and (b) order the Minister to verify that any portion produced corresponds fully to the information in the submission. |
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(7) Sur requête de la première personne, le tribunal peut, au cours de l'instance : a) ordonner à la seconde personne de produire les extraits pertinents de la demande d'avis de conformité qu'elle a déposée et lui enjoindre de produire sans délai tout changement apporté à ces extraits au cours de l'instance;
b) enjoindre au ministre de vérifier que les extraits produits correspondent fidèlement aux renseignements figurant dans la demande d'avis de conformité. |
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[25] Apotex argues that the introduction of subsection 6(7) in 1998, which allows for production in some circumstances, made some of the existing jurisprudence irrelevant. Specifically, Apotex referred to those cases that clearly established that parties to an action under section 6 of the Regulations do not have recourse to discovery. (See, for example, Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1994] F.C.J. No. 662 (.C.A.) (QL); Hoffman-La Roche Ltd. v. Canada (Minister of National Health and Welfare), [1996] F.C.J. No. 348 (F.C.T.D.) (QL)).
[26] I agree with Prothonotary Aronovitch, who concluded that by the introduction of subsection 6(7), "the nature of the proceeding is not thereby transformed". The exceptional instances in which production is required are clearly set out in that subsection and ought not to be expanded without clear legislative direction.
Conclusion
[27] The Order of Prothonotary Aronovitch is not, in my view, clearly wrong and ought to stand.
ORDER
THIS COURT HEREBY ORDERS THAT:
1. The motion of Apotex is dismissed;
2. Apotex will have until January 22, 2003 to serve and file its evidence;
3. Costs shall be costs in the cause.
J.F.C.C.
Ottawa, Ontario
January 17, 2003