Ottawa, Ontario, June 21, 2006
PRESENT: The Honourable Mr. Justice Mosley
BETWEEN:
WARNER-LAMBERT COMPANY, LLC
Applicants
and
THE MINISTER OF HEALTH and NOVOPHARM LIMITED
Respondents
REASONS FOR ORDER AND ORDER
[1] Novopharm Limited has brought two related motions arising from proceedings under the Patented Medicines (Notice of Compliance) Regulations. The motions were heard together in Toronto on June 12, 2006. In the first motion, under Rule 51 of the Federal Courts Rules, 1998, Novopharm appeals from a Prothonotary's decision to strike an affidavit from the record and, in the second motion, seeks leave under Rule 312 to serve and file the same affidavit.
[2] In the underlying proceedings, the applicants, hereafter referred to as Pfizer, seek an Order prohibiting the Minister from issuing a Notice of Compliance to Novopharm for its atorvastatin calcium 10, 20, 40, and 80 mg tablets, which Pfizer compares to its atorvastatin calcium tablets marketed under the name of Lipitor. Pfizer has listed Canadian Letters Patent No. 2,021,546 (the '546 Patent) in relation to Lipitor on the Patent Register. Novopharm's Notice of Allegation and Detailed Statement alleges, among other things, that the relevant claims of the '546 Patent are invalid.
[3] Pfizer served its affidavits pursuant to Rule 306 on August 19, 2005. Novopharm served its responding affidavits, pursuant to Rule 307, on December 15, 2005. Pfizer brought a motion dated February 1, 2006 seeking leave to serve and file certain affidavits in reply under Rule 312. By order dated March 3, 2006, Prothonotary Milczynski granted Pfizer's motion. The order gave Novopharm leave to serve and file sur-reply evidence in response to Pfizer's reply affidavits, which were served and filed on March 7, 2006.
[4] On March 17, 2006, Novopharm served and filed sur-reply affidavits including the affidavit of James M. Brophy, M.D., Ph.D., sworn March 10, 2006. Dr. Brophy's affidavit addresses the subject matter of a paper he co-authored which was published in the January 2006 Canadian Journal of Cardiology. The paper is attached as an exhibit to his affidavit. Two other affidavits submitted by Novopharm in sur-reply also reference and attach the Brophy paper.
[5] Pfizer brought a motion dated March 30, 2006 for an order striking the Brophy affidavit. By order dated April 24, 2006, Prothonotary Lafrenière granted Pfizer's motion finding that the affidavit was not proper sur-reply and was outside the scope of Prothonotary Milczynski's March 3, 2006 order. It is that decision which is the subject of Novopharm's Rule 51 appeal. Should the appeal not succeed, Novopharm seeks leave under Rule 312 to serve and file the Brophy affidavit as additional evidence.
[6] Cross-examinations on the affidavits submitted by both parties have largely been completed. Dr. Brophy's cross-examination is scheduled for July 5, 2006, subject to the outcome of these proceedings. The hearing of the NOC application is scheduled for November 2006.
ISSUES
[7] Novopharm has raised a number of issues with respect to Prothonotary Lafrenière's decision on the Rule 51 appeal. These issues can be summarized as questioning whether the Prothonotary erred in deciding the matter rather than leaving it for the applications judge to decide, and in making the decision, whether he erred in concluding that the Brophy affidavit was improper sur-reply and not within the terms of Prothonotary Milczynski's March 3rd order.
[8] The standard of review on the appeal of a prothonotary's decision is that set out in Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425, 149 N.R. 273 (F.C.A.), as clarified in Merck & Co. v. Apotex Inc., [2004] 2 F.C.R. 459, 2003 FCA 488. Novopharm concedes that the question raised by its motion is not vital to the final issue of the case. Thus, Prothonotary Lafrenière's discretionary decision may only be reviewed de novo if it was clearly wrong in the sense that it was based upon wrong principles or upon a misapprehension of the facts: Z.I. Pompey Industrie v. ECU-Line N.V. [2003] 1 S.C.R. 450 at 461, 2003 SCC 27.
[9] With respect to the motion under Rule 312, the issue is whether the Court should exercise its discretion to grant leave to Novopharm to file the Brophy affidavit. Related to that is the question of whether Novopharm should have sought leave under Rule 84(2) as the cross-examination of nine of Pfizer's ten affiants has already been completed.
ANALYSIS
Did the Prothonotary err in making an interlocutory decision on the admissibility of the affidavit?
[10] Novopharm submits that Prothonotary Lafrenière ought to have left the decision whether to strike the Brophy affidavit to the applications judge as there were no special circumstances, such as clear evidence of prejudice to Pfizer, to justify striking an affidavit on an interlocutory motion in an application for judicial review: Sawridge Band v. Canada, [2000] F.C.J. No.192 (F.C.) (QL).
[11] Pfizer acknowledges that the general rule is that a determination of the admissibility of an affidavit should be made by the judge hearing the application. However, there are well-established exceptions to the rule, including "where a party has to obtain leave to admit evidence and it is obvious in the view of the court that it is inadmissible": Ginter v. Canada (Attorney General) (1999), 178 F.T.R. 156 at 158 (F.C.T.D.). Moreover, says Pfizer, the need to move to strike evidence at the preliminary stage is apparent in light of the Court's reluctance to declare evidence inadmissible at a hearing where no interlocutory motion has been brought: Novartis A.G. v. Apotex Inc. (2001), 212 F.T.R. 161 , 2001 FCT 1129(F.C.T.D.) [Novartis].
[12] As Pfizer's argument goes, in this instance Novopharm required leave of the Court to adduce additional evidence. It could have brought a motion under Rule 312 for that purpose but has not done so until now. Novopharm was granted leave in Prothonotary Milczynski's March 3rd order to file sur-reply in response to the Pfizer Rule 312 affidavits. The Brophy affidavit was not proper sur-reply but new evidence outside the scope of the March 3rd order and was, therefore, correctly the subject of an interlocutory motion to strike: AB Hassle v. Canada(Minister of National Health and Welfare) (2000), 190 F.T.R. 264 at para. 15 (F.C.T.D) [AB Hassle].
[13] I doubt that Novartis stands for the proposition for which it has been cited by Pfizer. In that case, Justice Blais concluded at an NOC hearing that an objection to the introduction of new prior art in one of the respondent's affidavits should have been brought by interlocutory motion. However, this ruling arose in the context of the particular procedural history of the case. Two years earlier, the applicants had responded to Apotex's new prior art by seeking leave to file reply affidavits, for which leave was granted. At the hearing, the applicants sought to take advantage of a decision by the Court of Appeal in the interim to the effect that an adequate notice of allegation should contain the complete list of prior art relied upon by the responding second person. It was in that context that Justice Blais found that raising the objection at the hearing was then unfair to the respondent as it had been led to believe that its evidence would stand.
[14] AB Hassle is more on point. In that decision, Justice MacKay upheld a prothonotary's decision to strike an affidavit on the ground that it did not conform to a court order. The respondent had been granted leave, on consent, to file reply evidence on the issue of non-infringement only. The evidence before the prothonotary was that the impugned affidavit went to validity rather than to non-infringement. Justice MacKay held, at paragraph 15, that the terms of the order granting leave must be met absent exceptional circumstances that would warrant variation of the process established earlier by the Court.
[15] Applying the approach taken by Justice MacKay, I conclude that if the Brophy affidavit was outside the scope of the leave granted by Prothonotary Milczynski's March 3rd order, it was not wrong in principle for Prothonotary Lafrenière to deal with the issue of admissibility by way of interlocutory order rather than to leave the question to the applications judge at the hearing. It remains to be determined whether, in concluding, that the affidavit was not proper sur-reply, Prothonotary Lafrenière was clearly wrong in that he misapprehended the facts or applied the wrong principles.
Was the Brophy affidavit improper sur-reply?
[16] A considerable amount of evidence had been filed in these proceedings before the matter came before Prothonotary Milczynski. Pfizer's Rule 306 evidence consisted of eleven affidavits. Novopharm delivered its responding evidence on December 15, 2006 through ten affidavits. Pfizer then brought its motion dated February 1, 2006 for leave to serve and file six affidavits in reply acknowledging that, if the motion were granted, Novopharm should also be given leave to serve and file sur-reply evidence.
[17] In deciding the motion, Prothonotary Milczynski held that it was not necessary to parse those portions of the affidavits to which Novopharm had taken or did not take issue. She did not, therefore, address Novopharm's objections to certain of the Pfizer reply evidence. Adopting a broad and principled approach, she concluded that the evidence as a whole satisfied the factors which the Court must consider in determining whether to exercise its discretion pursuant to Rule 312 namely: that the additional evidence would serve the interests of justice; that it would assist the Court in making its final determination; and that there would be no substantial or significant prejudice to the responding party: Abbot Laboratories v. Canada (Minister of Health) (2003), 29 C.P.R. (4th) 450, 2003 FC 1512.
[18] Prothonotary Milczynski noted that the hearings judge at the application would not normally preside over the adducing of evidence and that it would assist the Court to have all of the relevant evidence at one time in the record before the hearing of the application has commenced. Moreover, there was no evidence submitted of prejudice to Novopharm. To the extent that the Order sought would also grant leave to Novopharm to file sur-reply evidence, she concluded, "Novopharm shall have the final word."
[19] Novopharm submits that in seeking to have that final word, its sur-reply evidence should have been subjected to the same standards as were applied to Pfizer's reply. Prothonotary Lafrenière's reasons for concluding that the Brophy affidavit was not proper sur-reply were as follows:
The Brophy Affidavit is clearly not responsive to the Applicants' reply evidence, neither in form nor in content. Dr. Brophy simply restates certain conclusions from a January 2006 paper that he authored and discusses his prescription patterns in his clinical practice, without making any reference to the Applicants' reply evidence. In the circumstances, the Brophy Affidavit does not comply with the letter or the spirit of the Order of Prothonotary Milczynski dated March 3, 2006. Moreover, the fact that the Applicants have not sought to strike the evidence of two other Novopharm deponents who have attached the Brophy paper to their affidavit does not operate to prevent them from objecting to the direct evidence of Dr. Brophy. Being substantially in agreement with paragraphs 16 to 22 of the Applicants' written representations, I am satisfied that the Court should intervene at this stage to prevent the introduction of clearly inadmissible evidence.
[20] The reference to paragraphs 16-22 of Pfizer's written representations does not add content to Prothonotary Lafrenière's reasons. Pfizer's argument before him, essentially, was that Dr. Brophy's affidavit is not responsive on its face or in substance to the Pfizer reply affidavits and was therefore outside the scope of Prothonotary Milczynski's Order. Pfizer advanced no evidence or submissions that it would be seriously prejudiced by the reception of the affidavit.
[21] Pfizer did not contest two other sur-reply affidavits filed by Novopharm that reference and attach the Brophy paper. Novopharm submits that Pfizer should have been prevented for that reason alone from challenging the Brophy affidavit. Prothonotary Lafrenière dismissed that argument, correctly I believe, on the basis that the failure to object to the other affidavits did not operate to prevent Pfizer from objecting to Dr. Brophy's direct evidence.
[22] Novopharm submits that it would be a triumph of form over substance if Prothonotary Lafrenière's decision were to be interpreted as holding that sur-reply affidavits must expressly state that the affiant has reviewed the reply evidence and is responding to statements therein. While that may be a common and helpful practice in drafting such affidavits, there is no requirement in law that to be proper reply or sur-reply, an affidavit must on its face refer to the preceding evidence and identify precisely that with which issue is taken. Such defects in form, if that is what they are, should not disqualify an affidavit that is in fact responsive, upon a fair reading, to the evidence tendered by the opposing party.
[23] Apart from perceived defects in form, it is evident from Prothonotary Lafrenière's reasons that he also concluded that the Brophy affidavit was not, in substance, responsive to the Pfizer reply evidence. I find that in doing so, he relied upon a misapprehension of the facts and was clearly wrong. The affidavit is, in my view, responsive to Pfizer's reply concerning one of the issues in the NOC proceedings and should not have been struck from the record.
[24] The additional evidence that Pfizer was accorded leave to serve and file by the March 3rd order covered a broad range of issues, including Novopharm's allegation that the patent in dispute was invalid for obviousness. In responding to that allegation, Pfizer wished to rely in part upon the commercial success of its product as a secondary indication of innovation. Several of the reply affidavits tendered by Pfizer include assertions by its affiants that Lipitor's success, as measured by its selection as the statin of choice by prescribing physicians, was due to its proven superior safety and efficacy.
[25] The gist of Dr. Brophy's affidavit is that factors other than scientific evidence may account for the growth in Lipitor prescriptions. In essence, Brophy suggests, marketing rather than science was the major factor in Lipitor's success as the random clinical trials demonstrating its safety and efficacy had not been conducted when much of the growth in market share took place. This is, in my view, factual evidence clearly responsive to the Pfizer reply evidence on this point and would assist the Court in weighing the value of the evidence of commercial success.
[26] Pfizer suggests that Novopharm will not suffer by the exclusion of the Brophy affidavit as his paper is referenced and attached in the two other Novopharm affidavits submitted as sur-reply and to which Pfizer has not objected. However, from my reading of the affidavit, its content is more than simply a restatement of the conclusions from Dr. Brophy's peer reviewed study but a clear explanation of why the study was performed and what it means. This explanation would be helpful to the applications judge.
[27] I accept that where affidavit evidence clearly falls outside the scope of the court order under which a party seeks to file it, as in AB Hassle, evidence of prejudice to the moving party will not be necessary. The party tendering the evidence must conform to the order, unless, as Justice MacKay stated, there is some exceptional reason to justify a variance from the previously determined process. Where, as I have found here, the evidence is within the scope of the prior order, it should not be excluded unless significant prejudice can be shown. Pfizer has shown none. Moreover, as the cross-examination of Dr. Brophy has already been scheduled for July 5th, no delay would be occasioned by the reception of his affidavit.
[28] There is a disturbing tendency for the parties in NOC proceedings to file an ever increasing volume of evidence and to seek leave for additional evidence in reply, sur-reply and even, I gather, sur-sur-reply. I don't wish to encourage that tendency through this ruling. If there had been any basis upon which to conclude that Novopharm was attempting to split its case or could reasonably have been expected to identify Dr. Brophy as a potential witness prior to the publication of his paper in January, I would have declined to intervene. However, having satisfied myself during the hearing of this motion that neither concern applies, it would be unfair in my view to deny Novopharm the opportunity to tender and rely on this relevant evidence.
[29] Accordingly, I am satisfied that Novopharm's appeal of the April 24, 2006 decision should succeed and considering the matter, de novo, Pfizer's motion to strike the Brophy affidavit should be dismissed. The affidavit will remain on the record.
[30] With this result on the appeal motion, I do not need to render a decision on the motion seeking leave under Rule 312 to serve and file the Brophy affidavit as additional evidence. However, I will indicate for the benefit of any subsequent proceedings over this matter that if I had concluded that the April 24, 2006 decision was not "clearly wrong" I would have exercised my discretion under Rule 312 to grant leave to serve and file the Brophy affidavit by reason of the factors cited by Prothonotary Milczynski in her March 3rd order: namely that the additional evidence would serve the interests of justice; that it would assist the Court in making its final determination; and that there would be no substantial or significant prejudice to the responding party.
ORDER
THIS COURT ORDERS that the motion pursuant to Rule 51 Federal Courts Rules, 1998, is granted and the appeal from the Prothonotary's April 24, 2006 Order is allowed. Considering the matter de novo, the applicants' motion to strike the affidavit of James M. Brophy, M.D., Ph.D., sworn March 10, 2006, is dismissed.
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-560-05
STYLE OF CAUSE: PFIZER CANADA INC. and
WARNER-LAMBERT COMPANY, LLC
and
THE MINISTER OF HEALTH and
NOVOPHARM LIMITED
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: June 12, 2006
APPEARANCES:
| Grant Worden Damien McCotter
|
|
| Jonathan Stainsby Andy Radhakant |
SOLICITORS OF RECORD:
| GRANT WARDEN DAMIEN McCOTTER Torys LLP Toronto, Ontario
|
|
| JONATHAN STAINSBY ANDY RADHAKANT Heenan Blaikie Toronto, Ontario |
|