Date: 20041028
Docket: T-1633-03
Citation: 2004 FC 1526
BETWEEN:
PFIZER CANADA INC., WARNER-LAMBERT COMPANY LLC
and PARKE, DAVIS & COMPANY LLC
Applicants
and
THE MINISTER OF HEALTH
and APOTEX INC.
Respondents
REASONS FOR ORDER
(Confidential Reasons for Order issued on October 14, 2004)
HENEGHAN J.
INTRODUCTION
[1] Pfizer Canada Inc., Warner-Lambert Company LLC and Parke, Davis & Company LLC (the "Applicants" or "Pfizer") and Apotex Inc. (the "Respondent" or "Apotex") both appeal from certain paragraphs of the Order of Prothonotary Lafrenière made on August 18, 2004. Pfizer appeals from paragraphs 3 and 5 of that Order, and Apotex appeals against paragraphs 1 and 2.
BACKGROUND
[2] This is an application pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. As of the date of the appeals this prohibition proceeding relates to two Notices of Allegation ("NOAs") served by Apotex. The first, dated July 18, 2003, alleges non-infringement of Canadian Patents 1,331,615 (the " '615 patent") and 1,291,999 (the " '999 patent"). The second, dated July 24, 2003, alleges that Canadian Patent 1,341,330 (the " '330 patent) is invalid.
[3] On September 5, 2003, Pfizer commenced this proceeding to seek an order prohibiting the Minister of Health (the "Minister") from issuing a notice of compliance to Apotex for apo-quinapril.
[4] Pfizer served and filed its evidence, consisting of several affidavits, on January 15, 2004. By consent, the date for Apotex to serve and file its evidence was May 14, 2004. That evidence also consisted of several affidavits.
[5] By motion dated June 30, 2004, Pfizer sought an Order striking out some of the affidavit evidence filed by Apotex, as follows:
1. An Order striking out certain of the following evidence filed by the Respondent, Apotex Inc. ("Apotex"), on May 14, 2004 in this proceeding, namely:
(a) The affidavit of Jianguo Wang, sworn May 13, 2004 and filed under seal;
(b) The affidavit of Michael J. Cima, sworn May 13, 2004 and filed under seal;
(c) The affidavit of Regis Leung-Toung, sworn April 22, 2004 and filed under seal;
(d) The affidavit of Matthew Buck, sworn May 4, 2004 and filed under seal;
(e) The affidavit of Sergei Danilov, sworn April 28, 2004 and filed under seal;
(f) Paragraphs 6 to 9, and exhibit B, of the affidavit of John Hems, sworn May 12, 2004, and filed under seal;
(g) Paragraphs 93 to 108 of the affidavit of Garland Ross Marshall, sworn May 11, 2004;
(h) Paragraph 23 of the affidavit of Robert McClelland, sworn May 12, 2004 and filed under seal;
[6] As well, Pfizer sought variation, in the following terms, of the Protective Order that had been issued in this proceeding on November 25, 2003:
(a) amending section 11(f) to permit the Applicants to disclose confidential information to Drs. Topliss, Hoefle, Blankley and Mr. Klutchko, who are neither employees of Pfizer nor experts, but rather witnesses and inventors of two of the patents at issue; and
(b) section 20 thereof, to permit the Applicants to use confidential information received by Apotex in the manner set out in Confidential Schedule "A" filed herewith under seal.
[7] The motion was argued before Prothonotary Lafrenière who issued an Order on August 18, 2004, granting partial relief to Pfizer in the matter of the affidavits of Dr. Wang and Dr. McClelland but otherwise, dismissing the motion. Paragraphs 1, 2, 3 and 5 of the Order are the subject of these appeals and provide as follows:
1. Paragraphs 33 to 38 of the affidavit of Jianguo Wang, sworn May 13, 2004 and filed under seal are hereby struck.
2. The first sentence of paragraph 23 of the affidavit of Robert McClelland, sworn May 12, 2004 and filed under seal is hereby struck.
3. The balance of the motion to strike is dismissed, without prejudice to the right of the Applicants to raise any argument relating to the admissibility of any evidence or the insufficience of the notices of allegation to the judge hearing the application.
...
5. The balance of the motion to vary the Protective Order is dismissed, without prejudice to the right of the Applicants, should the Applicants initiate judicial review proceedings against the Minister, to renew their motion, or initiate a motion in that new proceeding, for an Order varying the Protective Order.
PFIZER'S APPEAL
[8] Pfizer argues that the Prothonotary erred in fact or in law by refusing its motion to strike the affidavit evidence of Apotex or to vary the Protective Order as requested. It submits that the impugned affidavits improperly try to supplement the NOAs that were served by Apotex. The Federal Court of Appeal in AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172 has clearly stated that the NOA must set out the legal and factual basis upon which a second person relies. Pfizer says that the Prothonotary was clearly wrong in refusing to strike the affidavits in question.
[9] Likewise, Pfizer argues that the Prothonotary was clearly wrong in refusing to vary the Protective Order which would allow Pfizer to commence an independent judicial review proceeding. Pfizer argues that the Prothonotary was already in error when he said, in the accompanying endorsement, that it could first commence its application for judicial review and then seek variation of the Protective Order.
[10] In reply, Apotex argues that paragraphs 3 and 5 of the Order are essentially discretionary decisions that do not attract a de novo standard of review, according to the decision in Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425 (F.C.A.).
[11] Apotex says that the Prothonotary followed a long line of authority when he exercised his discretion not to strike certain affidavits, as requested by Pfizer, and that the Prothonotary correctly decided that the issue of filing affidavits should not be dealt with on an interlocutory basis but should be left to the trial judge. Apotex submits that the Prothonotary made no reviewable error in this regard.
[12] Apotex also argues that, in any event, the Prothonotary should not have entertained Pfizer's motion to strike the affidavits since that motion was not filed on a timely basis. Apotex says that the Prothonotary should not have accepted Pfizer's explanation for the delay in bringing its motion to strike.
[13] As for the Prothonotary's refusal to vary the Protective Order, Apotex submits that this decision was also made in the proper judicial exercise of discretion. There is no basis in law for Pfizer to have access to confidential material in order to ground an independent application for judicial review and Apotex relies on the decision of the Federal Court of Appeal in Merck Frosst Canada Inc. v. Canada (1994), 55 C.P.R. (3d) 302 where the Court, at page 322, stated that the public health and safety issues that are engaged in an application for a notice of compliance concern only the Minister, not potential commercial competitors.
APOTEX APPEAL
[14] As noted above, Apotex also appeals against the Prothonotary's Order of August 18, 2004 specifically paragraphs 1 and 2 by which the Prothonotary struck out certain portions of the Wang and McClelland affidavits, respectively. Apotex argues that the Prothonotary erred in law by improperly striking paragraphs 33 to 38 of the Wang affidavit and the first sentence of paragraph 23 of the McClelland affidavit on the grounds of being hearsay evidence.
[15] Apotex submits that these provisions of the Order are wrong because the impugned paragraphs and sentence do not meet the test for hearsay evidence as discussed in P.S. Partsource Inc. v. Canadian Tire Corp. (2001), 267 N.R. 135 or in R. v. Lavallee, [1990] 1 S.C.R. 852. In particular, insofar as the Wang affidavit is concerned, Apotex argues that the Prothonotary confused the admissibility of the affidavit with the weight to be given to that evidence.
[16] Pfizer, in reply argues that the Prothonotary applied the proper test in determining the impugned parts of the Wang and McClelland affidavits to be impermissible hearsay evidence. Paragraph 4 of his endorsement shows that he applied the correct test.
[17] Pfizer concedes that paragraphs 33 and 38 of the Wang affidavit are not hearsay but in the absence of paragraphs 34, 35 and 36, these paragraphs make no sense. It says that the contents of paragraphs 34, 35 and 36 are prejudicial and were properly struck out by the Prothonotary.
[18] As for the first sentence of paragraph 23 of the McClelland affidavit, Pfizer argues that the Prothonotary considered the test and in light of Lavallee, supra, Apotex cannot show that he was clearly wrong.
DISCUSSION
[19] The applicable test in reviewing a decision of a prothonotary upon appeal is set out in Canada v. Aqua-Gem Investments, supra at p. 454, as follows:
... I am of the opinion that such orders ought to be disturbed on appeal only where it has been made to appear that
(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) in making them, the prothonotary improperly exercised his discretion on a question vital to the final issue of the case.
[20] In the present case, Pfizer argues that the Prothonotary was clearly wrong in dismissing the greater part of its motion, pursuant to paragraphs 3 and 5, and as such, a de novo standard of review would be invoked. I do not accept the submissions of Pfizer in this regard.
[21] Insofar as the Prothonotary found that the prevailing jurisprudence directs that a decision to strike affidavits in an application for judicial review should be left to the trial judge, he correctly interpreted and applied the law. I refer to Lominadze v. Canada (Minister of Citizenship and Immigration) (1998), 143 F.T.R. 310, Sawridge Band v. Canada [2000] 3 F.C. D-11 and Dupuis v. Canada (1998), 152 F.T.R. 82 (Proth.). The Prothonotary committed no reviewable error in his decision in this regard.
[22] I am likewise satisfied that the Prothonotary committed no reviewable error in the manner with which he dealt with Pfizer's motion to vary the Protective Order that has been issued in this proceeding. Pfizer did not cite any authority in support of this prayer for relief.
[23] However, I am satisfied that the jurisprudence referred to by Apotex, including Glaxo Canada Inc. v. Canada (1987), 18 C.P.R. (3d) 206 at 217 (F.C.T.D.); aff'd (1990), 31 C.P.R. (3d) 29 (F.C.A.), Apotex Inc. v. Canada (Attorney-General) (1993), 48 C.P.R. (3d) 296 at 302-3, 305 (F.C.T.D.) and Merck Frosst Canada Inc., supra, squarely support the view that materials filed with the Minister in an application for a notice of compliance are not generally to be made available to third parties to such an application.
[24] The Prothonotary recognized the law and properly applied it. Furthermore, he gave Pfizer the opportunity to commence its "other" application for judicial review and to then seek variation of the Protection Order, without foreclosing the possibility that such an Order may be made.
[25] For these reasons, I dismiss Pfizer's appeal.
[26] I turn now to the matter of the Apotex appeal. Again, the moving party is arguing that the applicable standard is that of a review de novo, on the grounds that the Prothonotary erred in law in classifying the affidavit evidence in issue as impermissible hearsay evidence.
[27] In my opinion, the appropriate standard relative to the Apotex appeal is the de novo standard since the admissibility of evidence involves a question of law, rather than the exercise of discretion. I refer to R. v. Gaich, [1956] O.W.N. 616 (Ont. C.A.) at p. 617 where the Court said as follows:
With respect to grounds 7 and 8, the admissibility of evidence depends upon its character and not upon its weight: McLaren v. Canadian Central Railway (1884), C.R. [14] A.C. 259, 21 C.L.J. 114 at 117 (sub nom. Canadian Central Railway Company v. McLaren). If the particular piece of evidence is reasonably relevant and not obnoxious to any exclusionary rule, it is admissible although its weight may not be very great: Rogers v. London and Canadian Loan and Agency Company, Limited (1908), 18 O.L.R. 8.
[28] The question, then, is whether the impugned paragraphs of the Wang affidavit and the first section in paragraph 23 of the McClelland affidavit, respectively, are impermissible hearsay evidence.
[29] Apotex relies on the test set out in P.S. Partsource, supra at page 140, as follows:
Nonetheless, I would emphasize that motions to strike all or parts of affidavits are not to become routine at any level of this Court. This is especially the case where the question is one of relevancy. Only in exceptional cases where prejudice is demonstrated and the evidence is obviously irrelevant will such motions be justified. In the case of motions to strike based on hearsay, the motion should only be brought where the hearsay goes to a controversial issue, where the hearsay can be clearly shown and where prejudice by leaving the matter for disposition at trial can be demonstrated.
[30] According to paragraph 4 of his endorsement, it appears that the Prothonotary considered these factors when he said as follows:
Finally, I agree with the Applicants that the first sentence of paragraph 23 of the affidavit of Dr. McClelland and the statements by Dr. Wang about the results of certain tests constitute inadmissible hearsay and should be struck at this stage. To begin with, neither affiant has identified the source of the information, or the grounds for their belief. More particularly, the results referred to by Dr. Wang were not undertaken by him, nor has he been able to locate any written results. There is no dispute that the hearsay statements go to controversial issues. Accordingly, the Applicants will be prejudiced since they will be unable to effectively cross-examine in respect to the hearsay statements.
[31] The question, then, is whether the Prothonotary correctly applied the test in finding the paragraphs and sections here in issue constitute inadmissible hearsay evidence. With respect, I conclude that he did not, at least in part.
[32] First, with respect to the Wang affidavit, the learned Prothonotary erred in describing Dr. Wang's evidence addressing certain test results. That witness deposes to the occurrence of certain steps, in paragraphs 33 to 35. In paragraphs 36 and 37, he expresses an opinion. In paragraph 38, he says that he was unable to locate copies of the "above noted spectra from my archived files" at the time of swearing his affidavit.
[33] This is not "inadmissible hearsay" evidence, in my opinion. The affidavit addresses matters that are in issue in the proceeding and to that extent, there is controversy between the parties. This evidence may not be very strong but that is a matter of weight, not of its admissibility. Weight of the evidence is a matter for the trial judge. If it is found to be weak, the consequences of that lie with the producing party.
[34] As for the opening sentence of paragraph 23 of the McClelland affidavit, I am satisfied that the Prothonotary correctly characterized this as inadmissible hearsay. There is no declared source of the information in this section and therefore no basis upon which to draw the distinction inherent in the test set out by Sopinka J. in Lavallee, supra.
[35] In the result, Apotex's appeal is allowed in part and paragraphs 33 to 38 of the Wang affidavit are re-instated. The appeal in relation to paragraph 2 of the Order is dismissed.
[36] Apotex has been substantially successful on this appeal and shall have its taxed costs.
(Sgd.) "E. Heneghan"
J.F.C.
VANCOUVER, BRITISH COLUMBIA
October 28, 2004
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
STYLE OF CAUSE: PFIZER CANADA INC., WARNER-LAMBERT
COMPANY LLC and PARKE, DAVIS & COMPANY
LLC
Applicants
and
THE MINISTER OF HEALTH and APOTEX INC.
Respondents
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: September 13, 2004
REASONS FOR ORDER: HENEGHAN J.
DATED: Confidential Reasons for Order filed October 14, 2004 and public Reasons for Order filed October 28, 2004
APPEARANCES:
Andrew Bernstein
Grant Warden FOR APPLICANTS
Andrew Brodkin FOR RESPONDENT,
APOTEX INC.
no appearance FOR RESPONDENT,
MINISTER OF HEALTH
SOLICITORS OF RECORD:
Torys LLP
Goodmans LLP
Toronto, ON FOR RESPONDENT,
APOTEX INC.
Morris Rosenberg
Deputy Attorney General of Canada FOR RESPONDENT,
MINISTER OF HEALTH