Date: 20040416
Docket: T-1633-03
Citation: 2004 FC 572
BETWEEN:
PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC
and PARKE, DAVIS & COMPANY LLC
Applicants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
INTRODUCTION
[1] These reasons follow consideration by the Court of a Notice of Motion under Rule 369 of the Federal Court Rules, 1998[1] (the "Rules"), brought on behalf of the Respondent Apotex Inc. ("Apotex") for an Order under Rule 106(b) that the relief sought pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations[2] (the "Regulations") in respect of Notices of Allegation dated the 18th, 22nd, and 24th of July and the 11th of August, 2003, served by Apotex upon the Applicant, Pfizer Canada Inc. ("Pfizer Canada"), be pursued in separate proceedings. Apotex also seeks its costs of the motion.
[2] For ease of reference, the opening words of Rule 106 and paragraph b) of that Rule read as follows:
106. Where the hearing of two or more claims or parties in a single proceeding would cause undue complication or delay or would prejudice a party, the Court may order that
...
(b) one or more claims be pursued separately;
...
106. Lorsque l'audition de deux ou plusieurs causes d'action ou parties dans une même instance compliquerait indûment ou retarderait le déroulement de celle-ci ou porterait préjudice à une partie, la Cour peut ordonner :
...
b) qu'une ou plusieurs causes d'action soient poursuivies en tant qu'instances distinctes;
...
BACKGROUND
[3] By letter dated the 18th of July, 2003, Apotex served a Notice of Allegation pursuant to subsection 5(3) of the Regulations on Pfizer Canada in respect of Apotex's Apo-Quinapril tablets in which Apotex alleged that none of the relevant claims of Canadian Patent 1,291,999 (the " '999 Patent") and Canadian Patent 1,331,615 (the " '615 Patent") would be infringed because, inter alia, the process claims of the '999 and '615 Patents are not relevant under the Regulations and further, Apotex's tablets would not comprise any of the compounds set out in the relevant claims of the '999 and '615 Patents.
[4] By letter dated the 22nd of July, 2003, Apotex served a distinct Notice of Allegation on Pfizer Canada, again in respect of its Apo-Quinapril tablets, in which Apotex alleged that all of the relevant claims of a different patent, Canadian Patent 1,300,510 (the " '510 Patent"), would not be infringed, inter alia because its product would not contain two (2) of the three (3) requisite elements of the pharmaceutical composition claimed by the '510 Patent.
[5] By letter dated the 24th of July, 2003, Apotex served another distinct Notice of Allegation on Pfizer Canada, once again in respect of Apotex's Apo-Quinapril tablets in which Apotex alleged that all of the relevant claims of Canadian Patent 1,341,330 (the " '330 Patent") are invalid on various grounds.
[6] Finally, by letter dated the 11th of August, 2003, Apotex served another distinct Notice of Allegation on Pfizer Canada, once again in respect of Apotex's Apo-Quinapril tablets, in which Apotex alleged that all of the relevant claims of Canadian Patent 1,297, 023 (the " '023 Patent") and Canadian Patent 1,297,024 (the " '024 Patent") would not be infringed given that Apotex's product would not contain any ingredient that is or contains ascorbic acid or any salt or derivative of ascorbic acid.
[7] By Notice of Application dated the 5th of September, 2003, the Applicants commenced one application under the Regulations in response to all four (4) of the Notices of Allegation by Apotex that are previously referred to. Within the Notice of Alleagtion, the Applicants' argument is divided into four (4) distinct elements, each a separate and virtually stand-alone element and each dealing with one of Apotex's four (4) Notices of Allegation.
[8] By Notice of Motion dated the 29th of September, 2003, Apotex sought an order dismissing this proceeding and, in the alternative, relief equivalent to the relief sought on the motion now before the Court. Apotex's motion was heard by Prothonotary Tabib on the 2nd of October and the 14th of November, 2003. Prothonotary Tabib dismissed Apotex's motion. In recitals to her Order, Prothonotary Tabib noted that:
Nothing prevents the first person [the Applicants] from bringing a single notice of application for a prohibition order in respect of several allegations or in respect of allegations included in several notices, provided the notice of application be served and filed within the required time frame (and that it relate to the same submission for a NOC).
Prothonotary Tabib also recited:
As regards the Respondent's [Apotex's] motion to sever the notice of application in respect of each notice of allegation pursuant to Rule 106 of the Federal Court Rules, 1998, the motion is premature. [emphasis added]
[9] Following Prothonotary Tabib's Order, the Applicants' evidence was filed. It is extensive, consisting of nine (9) affidavits of nine (9) separate affiants. A scheduling order was also sought, on consent, and eventually issued, providing the Respondents to the 14th of May, 2004 to file their evidence. No Respondents' evidence has yet been filed.
[10] By Notice of Motion dated the 11th of December, 2003, Apotex appealed Prothonotary Tabib's Order. By Order dated the 19th of February, 2004, I dismissed Apotex's appeal but further ordered:
If a fresh motion to sever the application herein on the Record as it now stands or as it may be further supplemented, is filed within fourteen (14) days from the date of this Order, to be dealt with under Rule 369 or, if the Court considers it more appropriate, by teleconference or in Court, then this judge will remain seized of that motion.
[11] The Notice of Motion now before the Court was filed as provided in the foregoing quoted paragraph and thus has come forward before me. Filings on the motion were completed on the 25th of March last. While both Apotex and the Applicants filed relatively pro forma affidavits in support of the motion, no cross-examination was conducted.
[12] The Respondent the Minister of Health filed no materials.
POSITION OF APOTEX
[13] Apotex, with the support of an affidavit of one of counsel for Apotex, alleges that Rule 106(b) provides authority for the relief that it is seeking and that it will be severely prejudiced if severance is not granted. In particular, Apotex alleges that prejudice will flow from its inability to seek summary dismissal pursuant to subsection 6(5) of the Regulations. It alleges that it will further suffer prejudice by reason of inevitable protraction and complication, and thus delay, in the proceedings if all four (4) Notices of Allegation are dealt with in a single proceeding.
POSITION OF THE APPLICANTS
[14] In response, the Applicants urge that the motion should be heard orally, that there are severe defects in Apotex's affidavit in support of its motion that should lead either to the affidavit being struck or alternatively to it, or critical portions of it, being given little or no weight, that the test for severance has not been met, that the motion has already been argued and dismissed and that there is no credible evidence of prejudice to Apotex if the Application proceeds as presently constituted in that the evidence of complexity and thus delay is almost entirely speculative. Further, the Applicants note that Apotex did not place the Applicants' evidence on the Application before the Court and, impliedly at least, urge that therefore it should not be considered by the Court on this motion.
[15] In what I consider to be an alternative argument, the Applicants urge that, if severance is to be accorded, it should only be accorded in respect of the second and fourth Notices of Allegation in that the '615 Patent and the '999 Patent will have to be construed in the proceeding concerning the '330 Patent and such patents should all be construed by the same judge, at the same time, on the same evidence and therefore in the same proceeding to avoid any risk of inconsistent results which of itself would present significant prejudice to the parties.
[16] The Applicants seek dismissal of Apotex's motion with costs of the motion in any event of the cause, determined at the highest level of Column V of Tariff B. Finally, the Applicants urge that, if Apotex is to any extent successful, a case conference should be convened, presumably before the Case Management Judge or Prothonotary, to resolve a number of procedural matters arising out of severance.
APOTEX'S REPLY
[17] In reply, it is urged on behalf of Apotex that the material before the Court is "...more than sufficient to allow the Court to disposed of [the] motion", that Apotex's affidavit filed on the motion is not only permissible but indeed necessary given that a motion for severance is necessarily prospective in nature, that the Applicants in their own affidavit and Memorandum of Argument themselves engage in "...repeated rampant speculation..." and that therefore the motion should be granted. It is worthy of note that Apotex's reply submissions do not address the Applicants' submissions that, if severance is to be granted, it should only be partial severance.
ANALYSIS
a) Preliminary matters
[18] I adopt without reservation the submissions on behalf of Apotex responding to the Applicants' assertion that the motion before the Court has already been argued and dismissed. Prothonotary Tabib's recitals earlier referred to only indicated that the motion for severance was premature, not without merit. The Applicants' evidence has since been filed and is indeed extensive and complex . That a severance motion might not now be premature was recognized in my Order of the 19th of February, 2004, which specifically contemplated a fresh severance motion such as that now before the Court. That order was not appealed.
[19] While the affidavit filed on behalf of Apotex is indeed sworn by one of counsel for Apotex and contains extensive speculation and argument, once again I agree with the submission on behalf of Apotex that, given the nature of the motion before the Court, it is of some utility and is attested to by one of a very limited number of persons with knowledge of all of the relevant factual background. I will not strike the affidavit. Rather, I will give it and its various provisions such weight as I consider it and they deserve in all of the circumstances.
[20] With regard to the submission that the motion before the Court should be heard orally, once again I agree with the position urged on behalf of Apotex that the Court has sufficient material before it, and sufficient background understanding derived from an earlier oral hearing before the Court, to fully and fairly deal with the motion without oral hearing. My Order of the 19th of February, 2004 provides that the motion should be brought under Rule 369 and would only be dealt with by teleconference or in Court "...if the Court considers it more appropriate..." . The Court as constituted does not consider a hearing in open court or by teleconference to be "more appropriate".
[21] Finally, the Court notes that the Applicants' extensive evidence is before the Court, notwithstanding that it was not specifically placed before the Court in respect of this motion. The Court is entitled to access the totality of the file before it on a motion such as this. The Court has briefly reviewed and taken note of the Applicants' affidavit evidence.
b) The substance of the motion
[22] Paragraph 106(b) of the Rules is quoted earlier in these reasons. It provides authority to the Court to order that one or more claims be pursued separately where to deal with those claims in a single proceeding would "...cause undue complication or delay or would prejudice a party...".
[23] In Sawridge Indian Band et al v. Canada[3], Justice Hugessen wrote at paragraph [9] of his reasons:
The Federal Court Rules, 1998 are very liberal in their treatment of joinder of parties and causes of action and they are intended to be untechnical and to facilitate the just resolution of actions in the most expeditious, efficient and least costly manner.
[24] Justice Hugessen continued at paragraph [11] of his reasons:
Giving the matter the best consideration of which I am able, I have concluded that while there are common issues of law and fact in this matter, by far the more important and burdensome issues will be separate ... and that the establishment by each plaintiff of the asserted aboriginal rights and the extent thereof is very likely to occupy a far greater proportion of trial time than such common issues of law and fact as may arise, most of which, in my view, are likely to be matters relating to the extent of infringement or to possible defences which may be asserted. As a consequence, I think that joinder will cause undue complication and delay and I am going to order that the two claims of the two remaining Bands be separately asserted.
[25] While the facts before Justice Hugessen were certainly very different than those now before the Court, I am satisfied that his reasoning applies equally here. There are undoubtedly common issues of law and fact on the four (4) Notices of Allegation that have here been made the subject of a single Notice of Application. That being said, the "...far... more important and burdensome issues", at least in respect of the second and fourth Notices of Allegation, are far more important and are very likely to occupy a far greater proportion of hearing time than are the common issues of fact and law flowing from those two (2) Notices of Allegation on the one hand and the first and third Notices of Allegation on the other.
[26] Perhaps more importantly, separate proceedings in respect of the second and fourth Notices of Allegation may well be amenable to summary disposition under subsection 6(5) of the Regulations and it was not in dispute before me that, if those Notices of Allegation continue to be amalgamated within a single proceeding, summary disposition would not be available in respect of either of them[4].
[27] With regard to the first and third Notices of Allegation, I am satisfied that they should continue on in a single proceeding. Apotex in its submissions did not suggest that it could obtain summary determination under subsection 6(5) of the Regulations in respect of those two (2) allegations. Further, the allegation of double patenting in the third allegation will require that the '999, '615, and '330 patents be construed together.
[28] In G.D. Searle & Co. et al. v. Merck & Co. et al[5], my colleague Justice Heneghan wrote at paragraph [103]:
Where segregating a claim and counterclaim into separate actions would result in the duplication of some evidence as well as give rise to the possibility of inconsistent judgments, the action and counterclaim should not be separated; see R. v. Central Tobacco Mfg. (1980) Ltd., [1985] 1 C.T.C. 357 (F.C.T.D.).
[29] While what is at issue here is not segregating of a claim and counterclaim, I am satisfied that segregating a Notice of Application in respect two (2) separate Notices of Allegation, where the consideration of each would give rise to the interpretation of the same Patents, should be subject to the same principle. The possibility of inconsistent judgments should be minimized where circumstances permit. Here, the circumstances certainly permit given that the two (2) Notices of Allegation at issue have already been joined in a single application.
[30] Apotex, in its reply submissions, essentially did not dispute this outcome in respect of the first and third allegations.
CONCLUSION
[31] In the result, Apotex will succeed in part in its motion. The second and fourth Notices of Allegation at issue, that is to say those served on Pfizer Canada by letters dated the 22nd of July, 2003 and the 11th of August, 2003 shall be severed from the current proceeding and made the subject of separate proceedings, assuming the Applicants choose to pursue them before this Court. The subject matter of the first and third Notices of Allegation, that is to say those served on Pfizer Canada by letters dated the 18th of July and 24th of July, 2003 shall remain the subject matter of the current proceeding. In the result, Apotex's motion to severe one (1) of those Notices of Allegations into a separate proceeding will be dismissed.
[32] As urged by the Applicants in their responding motion record now before the Court, counsel should forthwith contact the Case Management Prothonotary in respect of this proceeding to urge the convening of a case conference to discuss and resolve the modalities for achieving the outcome flowing from the Court's order herein with a minimal disruption of the schedule currently in place for steps to bring the current proceeding to hearing. To the extent possible, the same schedule should be maintained for any severed proceedings.
COSTS
[33] In light of the divided success on the motion before the Court, there will be no order as to costs of the motion.
_____________________________
J.F.C.
Ottawa, Ontario
April 16, 2004
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
COURT FILE NO.: T-1633-03
STYLE OF CAUSE: PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC and PARKE, DAVIS & COMPANY LLC
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: NONE
REASONS FOR ORDER: The Honourable Mr. Justice Gibson
DATED: April 16, 2005
APPEARANCES:
Mr. Andrew Shaughnessy for the Applicant
Mr. Andrew Bernstein
Mr. Andrew Brodkin for the Respondent
Ildiko Mehes
SOLICITORS OF RECORD:
Torys LLP for the Applicant
Toronto, Ontario
Goodmans LLP for the Respondent
Toronto, Ontario