Date: 20031222
Docket: T-1133-02
Citation: 2003 FC 1512
Ottawa, Ontario, this 22nd day of December, 2003
Present: The Honourable Madam Justice Heneghan
BETWEEN:
ABBOTT LABORATORIES and
ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and
APOTEX INC.
Respondents
REASONS FOR ORDER AND ORDER
INTRODUCTION
[1] Abbott Laboratories and Abbott Laboratories Limited ("Abbott") appeal from the Order of Prothonotary Aronovitch, dated October 7, 2003. In her Order, the Prothonotary struck certain paragraphs from the further affidavits filed by Apotex Inc. ("Apotex") pursuant to an earlier Order dated May 28, 2003.
BACKGROUND
[2] This is an application pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended (the "Regulations). On May 31, 2002 Apotex served Abbott with a Notice of Allegation ("NOA"). In its NOA, Apotex alleged that its proposed pharmaceutical product clarithromycin will not infringe the patent enjoyed by the Applicants, that is Canadian Patent 2,261,732 (the " '732" patent) for clarithromycin, on the grounds that the '732 patent is invalid.
[3] On July 18, 2002, Abbott commenced proceedings pursuant to section 6 of the Regulations, seeking an order prohibiting the Respondent Minister from issuing a Notice of Compliance ("NOC") to Apotex for clarithromycin tablets until after the expiry of the '732 patent. The parties then proceeded to file their evidence in accordance with a schedule set forth in an order dated September 9, 2002.
[4] On May 28, 2003, Prothonotary Aronovitch, in her capacity as a case management judge, issued an Order on consent pursuant to a notice of motion filed by Abbott, seeking leave to file additional evidence pursuant to the Federal Court Rules, 1998 (the "Rules"), Rule 312. The Order of May 28, 2003 provides as follows:
UPON MOTION made by the Applicant Abbott Laboratories, Ltd. ("Abbott"), for an Order permitting Abbott to file the additional Affidavits of Dr. Stephen Byrn, Dr. Allan Myerson, Dr. Jerry Atwood and Dr. Leonard J. Chyall pursuant to Rule 312.
ON READING the Consent of Abbott and Apotex Inc., filed:
THIS COURT ORDERS that Abbott shall have leave to file the affidavits of Dr. Stephen Byrn dated April 1st, 2003, Dr. Allan Myerson dated April 1st, 2003, Dr. Jerry Atwood dated April 2nd, 2003, and Dr. Leonard J. Chyall dated April 1st, 2003.
THIS COURT ORDERS that Apotex may file additional evidence on or before June 15, 2003, provided that such evidence would be proper reply to the abovementioned affidavits.
THIS COURT ORDERS that in the event of any dispute about the propriety or scope of any additional evidence filed by Apotex pursuant to paragraph 2, above, such dispute shall be resolved upon motion to the Court prior to the hearing of the application herein.
THIS COURT ORDERS that costs of this motion be in the cause.
[5] Abbott filed the affidavits of Dr. Stephen Byrn, Dr. Allan S. Myerson and Dr. Jerry L. Atwood, pursuant to this Order of May 28, 2003. Apotex filed, as reply affidavits, the affidavits of Dr. Robert Allan McClelland, Dr. Robert S. Brown and Dr. Nicholas A. Taylor.
[6] Abbott objected to certain passages in these affidavits filed by Apotex and filed a Notice of Motion on August 1, 2003, seeking an Order to strike out portions of the reply affidavits of Dr. Brown and Dr. McClelland, and portions of the affidavit of Dr. Taylor, on the ground that these affidavits were not proper reply evidence. Abbott sought the alternative relief that if portions of these affidavits were not stricken out, that it be granted leave to file reply to those affidavits filed by Apotex.
[7] The motion was argued, on a contested basis, before Prothonotary Aronovitch on August 7, 2003. She issued an Order together with reasons by way of endorsement, on October 7, 2003, in the following terms:
1. The motion is granted as follows, and is otherwise denied.
2. Apotex shall produced [sic] Dr. Ray for cross-examination as to the contents of paragraphs 28 of Brown #2 and paragraph 34 of McClelland #2, to be cross-examined as though the above statements were his own. As to paragraph 30 of Brown #2, Apotex shall produce for cross-examination an individual with first hand or direct knowledge of the use of the "vacuum" referred to therein.
3. Paragraphs 4 through 10 of Brown #2, and 4 through 12 of McClelland #2 are struck out without prejudice to the right of Apotex to address the subject matter of these paragraphs in their cross-examination on Abbott's affidavits on the merits. Apotex shall serve and file affidavits, amended accordingly, by no later than October 10, 2003.
4. Apotex shall produce a representative of BCI to affirm that they have provided to Brown and McClelland any of their tests referred to in Brown #2 and McClelland #2.
5. If the parties cannot agree as to costs they may be separately spoken to.
SUBMISSIONS
[8] Abbott argues that the Prothonotary erred in law in allowing the impugned affidavits to stand, notwithstanding the provisions of her Order that struck out certain paragraphs from both the Brown and McClelland affidavits. Abbott says that the Apotex affidavits do not meet the criteria of the May 28, 2003 Order as "proper reply". As well, Abbott argues that the Prothonotary failed to ask herself whether the last three categories of objectionable affidavit material identified by the Applicants, constitute "proper reply" and says that in this regard, the Prothonotary's order is unsupported by reasons.
[9] Abbott submits that the Prothonotary's decision involved a question of law and is reviewable on a de novo basis. It says that the motion was not one engaging the exercise of discretion in the course of case management. Relying on the recent decision of Justice Pelletier in Halford v. Seed Hawk Inc., [2003] FCT 141, the Applicants submit that the Prothonotary failed to apply the proper legal test in assessing the reply affidavits submitted by Apotex.
[10] Abbott classified the objectionable evidence under four headings:
1. new test results;
2. new analyses of prior tests;
3. re-assertions or argument about matters already addressed in the initial affidavits filed by Apotex;
4. entirely new subject matter.
[11] According to Abbott, the Prothonotary addressed the first category of challenged evidence in the following paragraph of her endorsement:
I will next deal with experiments or data arising from tests conducted (by BCI) on behalf of Apotex, not previously produced by it, but sought to be produced now in surreply. Paragraphs 15 and 33 of McClelland #2 and 27, 33 and 36 of Brown #2 inter alia, are objected to on that basis.
I shall consider as an example the x-ray diffraction data for ARC-I-19-1, newly attached by way of "Exhibit 3" to McClelland #2, purportedly in reply to paragraph 28 of the Myerson affidavit. Certainly Myerson does not merely state as a fact that certain tests have not been provided to him but opines as the construal to be given to the absence of the data and conclusions that are proper to draw accordingly, (In the same vain [sic] see paragraph 47 of Myerson). While the evidence is newly sought to be adduced, in the circumstances, I take it to be properly in reply to the evidence of Myerson. The same may be said of the other similarly impugned evidence.
[12] As for the remaining categories, she made the following observations:
As to other impugned matters having to do with re-statements or fresh analysis, there is again no expert evidence adduced on the motion, for example, as to the applicants' inability to do the same analysis done by Apotex, or as to prejudice.
[13] Abbott argues that the Prothonotary further erred in dismissing the motion on the basis of lack of expert evidence as to any alleged prejudice to the Applicants, flowing from the introduction of the Apotex affidavits, at this time.
[14] Apotex takes the position that there is no reviewable error in the Prothonotary's Order, that its affidavits are responsive to the matters raised in the additional affidavits filed by Abbott and that the admissibility of its affidavits in this proceeding was a question involving the discretionary jurisdiction of the Prothonotary pursuant to Rule 312 of the Rules.
[15] As well, Apotex refers to the nature of this proceeding as a summary proceeding pursuant to both the Regulations and the Rules. It is not a trial and the rules relating to the admissibility of evidence in a trial do not strictly apply here. The Applicants' motion before the Prothonotary was a motion to strike affidavits. Such a motion involves the exercise of discretion. There is no basis for reversing the Order in issue.
DISPOSITION
[16] This appeal involves a narrow point. Did the Prothonotary err in her disposition of Abbott's motion such that this Court should exercise its discretion on a de novo basis, pursuant to the test set out in Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425 (F.C.A.). In my opinion, she did not.
[17] I will not identify the specific details of the affidavits to which the Applicants object, in view of the fact that the materials filed in this matter are subject to a confidentiality order and in any event, the details are known to the parties.
[18] The affidavits in question are responsive to matters raised in the Applicants' affidavits. This is admitted by Abbott but they argue that Apotex's affidavits do not meet the test of "proper reply" evidence as discussed in Halford, supra. There the Court said as follows at paragraph 15:
Consequently, I believe that the following principles govern the admissibility of reply evidence:
1 - Evidence which is simply confirmatory of evidence already before the court is not be allowed [sic].
2 - Evidence which is directed to a matter raised for the first time in cross examination and which ought to have been part of the plaintiff's case in chief is not be allowed [sic]. Any other new matter relevant to a matter in issue, and not simply for the purpose of contradicting a defence witness, may be allowed.
3 - Evidence which is simply a rebuttal of evidence led as part of the defence case and which could have been led in chief is not be be [sic] admitted. [Emphasis in original]
[19] In my opinion, the strict test characterizing reply evidence in a trial does not necessarily apply in respect of proceedings taken under the Regulations. Such proceedings are dealt with by way of application; see Bayer AG v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 377. They are governed by Part 5 of the Rules .
[20] Those Rules are silent about filing reply evidence but Rule 312 provides for the filing of additional affidavits. The issue was considered in the context of the former Rules of the Federal Court in Eli Lilly Co. v. Apotex Inc. (1997), 76 C.P.R. (3d) 15 where the Court identified three factors that will be considered when a party seeks to file additional affidavit evidence: will the further evidence serve the interests of justice, will it assist the Court and will it cause substantial or serious prejudice to the other parties.
[21] Abbott here is attempting to impose a technical, legalistic meaning on the words "proper proceeding reply evidence" which is unwarranted. This is an application for judicial review, it is not a trial and the general rules concerning admissibility of evidence do not apply. The Prothonotary was adjudicating a motion to introduce further affidavits and in my opinion, she considered the appropriate factors as established in the existing jurisprudence.
[22] One of those factors is the question of prejudice. The Prothonotary did not require expert evidence as to prejudice, per se. In my opinion, the reference to the lack of expert evidence on behalf of Abbott in responding to the motion must be read in relation to absence of expert evidence as to its inability to conduct the same testing carried out by Apotex.
[23] In the result, I see no error in the manner in which the Prothonotary exercised her discretion pursuant to the Rules, in particular Rule 312, and there is no basis for reversing the Order. The appeal is dismissed, with costs to Apotex.
[24] If unsuccessful on this motion, as it is, Abbott sought the opportunity to file reply to the Apotex affidavits. The Prothonotary did not grant such leave. Likewise, I see no need to grant such leave but the matter may be raised before the case management judge if necessary.
ORDER
The appeal is dismissed, with costs to Apotex.
"E. Heneghan"
J.F.C.
FEDERAL COURT
Names of Counsel and Solicitors of Record
DOCKET: T-1133-02
STYLE OF CAUSE: ABBOTT LABORATORIES ET AL
Applicant
- and -
THE MINISTER OF HEALTH ET AL
Respondent
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: NOVEMBER 26, 2003
REASONS FOR ORDER
AND ORDER BY: HENEGHAN J.
DATED: DECEMBER 22, 2003
APPEARANCES BY: Mr. Andrew Reddon / Ms. Meghan Leon
For the Applicant
Mr. Andrew Brodkin / Mr. David Lederman
For the Respondent (Apotex)
SOLICITORS OF RECORD: McCarthy Tétrault
Barristers & Solicitors
Toronto, ON
For the Applicant
Goodmans
Barristers & Solicitors
Toronto, ON
For the Respondent (Apotex)
Morris Rosenberg
Deputy Attorney General of Canada
FEDERAL COURT
Date: 20031222
Docket: T-1133-02
BETWEEN:
ABBOTT LABORATORIES ET AL
Applicant
- and -
THE MINISTER OF HEALTH ET AL
Respondent
REASONS FOR ORDER
AND ORDER
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