Toronto, Ontario, November 1, 2005
PRESENT: THE HONOURABLE MR. JUSTICE KELEN
BETWEEN:
and WARNER-LABMERT COMPANY, LLC
and
and RANBAXY LABORATORIES LIMITED
REASONS FOR ORDER AND ORDER
[1] This is an appeal by the applicants Pfizer Canada Inc. and Warner-Lambert Company, (collectively referred to as "Pfizer") from the Order of Prothonotary Milczynski dated June 29, 2005 dismissing Pfizer's motion under Rule 385 of the Federal Courts Rules, SOR/98-106 for an order directing both the applicants and the respondent Ranbaxy Laboratories Ltd. ("Ranbaxy") refrain from relying on, leading, or otherwise filing evidence in relation to statements in Ranbaxy's Notice of Allegation ("NOA") on the grounds that they are irrelevant, have no reasonable chance of success or are vague or overly broad.
FACTS
[2] This appeal is in the context of Pfizer's application for prohibition under the Patented Medicines (Notice of Compliance) Regulations SOR/93-133 ("PMNOC"). By letter dated January 31, 2005 Ranbaxy provided Pfizer with a 54-page NOA in relation to the alleged infringement of Canadian Patents Nos. 1,268,768 (the '768 patent) and 2,021,546 (the '546 patent) relating to the pharmaceutical product atorvastatin calcium, the drug called Lipitor®. Pfizer's Notice of Application filed on March 17, 2005 was amended October 17, 2005 so that it seeks an order to prohibit the Minister of Health from issuing an NOC to Ranbaxy in respect of two patents. The original NOA dealt with six Pfizer patents. Only 21 pages of the NOA are now in issue.
[3] By way of motion dated May 20, 2005 Pfizer sought an order that no parties be entitled to rely on, lead, or otherwise file evidence in response to, or in support of the following statements occurring in Ranbaxy's NOA:
(a) at pages 8 and 9 under the heading "Other Evidence Confirms the 768 Patent is restricted to Racemates";
(b) the statement made at the bottom of page 20, "Ranbaxy relies on the non-confidential transcript of the evidence given by Dr. Scallen at the US trial of Pfizer, Inc. et al. v. Ranbaxy Laboratories Limited at [sic] al., Court File No. 03-209-JJF, on December 3, 2004;
(c) the first two paragraphs on page 21 relating to Dr. Scallen; and
(d) the statement on pages 48-49, "Ranbaxy refers you to the decision of the European Patent Office respecting corresponding European Patent application no. 96 924 553-9 dated July 29, 2003 and incorporates herein the evidence submitted by Opposers in that Opposition."
At the hearing of this appeal, Pfizer advised that only paragraphs (a) and (c) are still in issue following the amendment to its Notice of Application.
STANDARD OF REVIEW
[4] The standard of review to be applied by the Court in reviewing a decision of a prothonotary was set out by the Federal Court of Appeal in Canada v. Aqua-Gem Investments Ltd., [1993] F.C.J. No. 103 and affirmed by the Supreme Court of Canada in Z.I. Pompey Industrie v. ECU-Line N.V., [2003] 1 S.C.R. 450. The test was modified by the Federal Court of Appeal in Merck & Co. v. Apotex Inc., [2004] 2 F.C.R. 459, where Décary J.A. wrote for the Court at paragraph 19:
[...] 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] Even if the Court would have come to a different conclusion than that of the Prothonotary, difference of view is not sufficient to ground the Court's intervention. However, if the Prothonotary's decision was clearly wrong, the Court must set aside the Prothonotary's decision and exercise its own discretion de novo.
ISSUES
[6] The issue in this appeal is whether the Prothonotary was clearly wrong in dismissing the motion for directions pursuant to Rule 385 of the Federal Courts Rules, SOR/98-106. Pfizer submits that the learned Prothonotary:
1. erred in law in concluding that the Court could not grant the relief sought by Pfizer on a motion for directions; and
2. misapprehended the facts in characterizing Pfizer's motion as one for an order to strike certain portions of the NOA, rather than as a motion for directions.
ANALYSIS
[7] The NOA alleges that the patents are restricted to racemates, and not a single enantiomer. Ranbaxy alleges that its drug is a single enantiomer, not a racemate, and for that reason does not infringe Pfizer's patents. The NOA relies upon, inter alia, "file wrappers" from foreign patent prosecutions by Pfizer for the same drug, and the transcript of evidence presented at a US trial by a Dr. Sallen which showed some of Pfizer's evidence is not accurate. Pfizer sought a direction from the Prothonotary that "file wrapper" evidence was not relevant, and that Dr. Sallen's US evidence was inadmissible so that Pfizer need not adduce evidence with respect to these two subjects.
(a) The Scope of Rule 385
[8] In my view it was not clearly wrong for the Prothonotary to conclude that Rule 385 does not empower her to effectively strike out or restrict sections of the respondent's NOA.
[9] Rule 385 provides, in part:
Powers of case management judge
385. (1) A case management judge or a prothonotary assigned under paragraph 383(c) shall deal with all matters that arise prior to the trial or hearing of a specially managed proceeding and may
(a) give any directions that are necessary for the just, most expeditious and least expensive determination of the proceeding on its merits;
[...]
[10] Pfizer submits that it is neither just nor expeditious to require a patentee to respond to issues that are clearly irrelevant or based on inadmissible evidence. Pfizer submits the Prothonotary erred in concluding she had no jurisdiction to grant the order sought. The relevant portion of her order states at page 3:
The Applicants may or may not have a legitimate complaint with the form or substance of the impugned portions of the NOA. It is not, however, a proper subject for a motion for directions to determine what parts of the NOA should or should not be addressed by the parties in their subsequent filings with the Court in either their evidence or argument. I must agree with the submissions of the respondent, Ranbaxy that the relief sought on this motion for directions is in effect, an order to strike certain portions of the NOA. The Applicants seek to limit or eliminate certain issues at the outset that they submit have no chance of success. The jurisprudence is clear, however, on this point - the NOA is beyond the jurisdiction of this Court. Whether the allegations are without merit is a matter for the hearings judge. I also agree with the Respondent Ranbaxy's submissions that to the extent evidence is filed that goes beyond the NOA or raises issues of admissibility, the appropriate motion may be brought at that time. The Court cannot, in the circumstances limit the evidence before it is even adduced.
[Emphasis added]
[11] In support of Pfizer's submission that the Prothonotary erred in her finding of jurisdiction, it submits this Court recently made such an order in GlaxoSmithKline Inc. v. Canada (Minister of Health), 2004 FC 116. In that case, a prothonotary granted an order limiting the number of documents, cited in a schedule to an NOA, upon which the respondent could rely in support of its allegation of patent invalidity. However, it is clear that part of that order was on consent so that it is not a precedent.
[12] In Merck & Co. v. Apotex Inc., (2003) 312 N.R. 273, 2003 FCA 438, the Federal Court of Appeal interpreted the ambit of Rule 385(1)(a) in case management proceedings and held that justice is not to be subordinated to expedience, per Strayer J.A. at paragraph 13:
¶ 13 [...] I do not understand Rule 385 to authorize a case management judge or prothonotary, in giving directions that are necessary for the "just, most expeditious and least expensive determination of the proceeding on its merits" to enable them to deny a party the legal right to have questions answered on examination for discovery which are relevant to the issues in the pleadings. That right ... is clearly spelled out in Rule 240 and I do not take the general words of Rule 385(1)(a) or of Rule 3 to be sufficient to override that specific right. I would also observe that the word "just" which appears in both these rules relied on by the respondents and the decision-makers below confirms that justice is not to be subordinated to expedition. A person who is a party to a civil action is entitled to ask any question on discovery that is relevant to the issue: that is a matter of justice to him, subject of course to the discretionary power of the prothonotary or a judge to disallow the question where it is abusive for one of the reasons mentioned above.
[Emphasis added]
While the issue before the Court of Appeal in that case was the right to discovery on relevant issues the comments of Strayer J.A. apply to the substantive issue in the case at bar. In my view, the Court of Appeal has given clear guidance that relief sought under the case management Rule 385 should not derogate from a party's substantive right in preference of alleviating another's procedural burden.
[13] In the case at bar paragraph 5(3)(a) of the PMNOC Regulations imposes an obligation on the second person to provide a detailed and factual statement in support of its allegations. I conclude that Rule 385(1)(a) should not operate so as to override that NOA. To find otherwise may limit the scope within which the respondent may file evidence. In my view Rule 385 contemplates that evidence filed outside the relevancy or admissibly parameters is appropriately dealt with at that time, and not before such evidence is filed. In this way Pfizer seeks its relief prematurely.
(b) Issues of relevancy and inadmissibility
[14] Issues of relevancy and inadmissibility are not issues which the Prothonotary could have dealt with at this point. I cannot conclude at this point that the "foreign wrapper" evidence is clearly irrelevant or inadmissible. Ranbaxy does not concede that the only issue is how the patent claims are to be construed such that the rule stopping extrinsic evidence for the purpose of defining the patent claims would not apply.
(c) This motion seeks to break new ground
[15] Both parties agree that there is no jurisprudence which has allowed a party obtain a direction from the Court limiting the type of evidence on a PMNOC application before the respondent has filed its evidence. A NOA is not a court document. In this case, the NOA may be providing "reasons" in too broad a fashion. As a result, references may be vague, lacking in the precision required of proper evidence. But the NOA is not the evidence upon which the Court will decide. As indicated above, it is premature to judge the admissibility of the evidence before it is filed. Moreover, its relevancy may not be ascertainable except by the hearing judge because the complex matter may require the understanding only a hearing judge can deliver.
CONCLUSION
[16] For these reasons, I am not persuaded the learned Prothonotary was clearly wrong in deciding the substantive issues. Accordingly, it is not necessary to decide whether the Prothonotary misapprehended the facts in characterizing the motion as one to strike parts of the NOA, rather than as a motion for directions.
ORDER
THIS COURT ORDERS that
This appeal is dismissed with costs in the cause.
"Michael A. Kelen"
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-507-05
STYLE OF CAUSE: PFIZER CANADA INC.
and WARNER-LAMBERT COMPANY, LLC
Applicants
and
THE MINISTER OF HEALTH
and RANBAXY LABORATORIES LIMITED
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: OCTOBER 31, 2005
REASONS FOR ORDER
AND ORDER BY: KELEN J.
DATED: NOVEMBER 1, 2005
APPEARANCES:
Peter Wilcox
W. Grant Worden FOR THE APPLICANTS
Angela Furlanetto
David Reid FOR THE RESPONDENTS
SOLICITORS OF RECORD:
Torys LLP
Toronto, Ontario FOR THE APPLICANTS
John H. Sims, Q.C.
Deputy Attorney General of Canada FOR THE RESPONDENTS