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                                                                                          Date: 20030721

Docket: T-1878-02

Citation: 2003 FC 903

Toronto, Ontario, July 21st, 2003

Present:           Roger R. Lafrenière, Esquire

Prothonotary

BETWEEN:

                                                AB HASSLE, ASTRAZENECA AB and

ASTRAZENECA CANADA INC.

                                                                                                                                                      Applicants

                                                                                 and

APOTEX INC. and THE MINISTER OF HEALTH

                                                                                                                                               Respondents

REASONS FOR ORDER AND ORDER

Overview


[1]                 These reasons deal with the scope of cross-examination on an affidavit filed in support of a motion for leave to adduce reply evidence. The Respondent, Apotex Inc. ("Apotex), has moved for an Order requiring Dr. Jörgen Lindquist to re-attend in Toronto at the expense of the Applicants for cross-examination on his affidavit dated May 6, 2003 and to answer certain refusals given during his cross-examination. Apotex's motion arises out of a motion by the Applicants to file reply evidence, namely the Lindquist affidavit, in support of their application under the Patented Medicines (Notice of Compliance) (the "PMNOC Regulations"). Apotex submits that the questions that were refused to be answered at the cross-examination of Dr. Linquist prevented Apotex from testing Dr. Linquist's qualifications and the Applicants' assertions that Dr. Lindquist's evidence would assist the Court in making its determination in the main proceeding.

[2]                 The parties agree that the matters at issue on the motion must be determined by reference to the test for admitting reply evidence, as set out by MacKay J. in Bayer AG v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 377 (F.C.T.D.) MacKay J. noted that although the Federal Court Rules, as they then were, did not specifically provide for affidavits to be filed in reply, the Court had discretion to allow reply evidence where it will serve the interests of justice, will assist the Court and will not seriously prejudice the other party. This statement was cited with approval by Rouleau J. in AB Hassle v. Canada (Minister of National Health and Welfare) (1995), 61 C.P.R. (3d) 492 (F.C.T.D.), aff'd (1995), 64 C.P.R. (3d) 78 (F.C.A.). Apotex submits that the refused questions ought to have been answered since they are relevant to the second factor, that is, whether Dr. Lindquist's evidence will be of assistance to the Court.

History of the Proceeding


[3]                 This proceeding was initiated by Notice of Application dated November 8, 2002 pursuant to the PMNOC Regulations for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of omeprazole magnesium tablets 10 and 20 mg until after the expiration of Canadian Patents 1,292,693, 1,302,891, 2,166,483 ("Patents").

[4]                 The Applicants served their evidence on January 10, 2003. Apotex served its affidavit evidence on April 2, 2003, including an affidavit from Dr. Michael J. Cima ("Professor Cima"). A Protective Order was subsequently issued at the request of Apotex.

[5]                 The Applicants then brought a motion, returnable on May 12, 2003, to strike out certain portions of Apotex's affidavit evidence. In the event the Applicants were unsuccessful in striking portions of the affidavit of Professor Cima,, they also requested as alternative relief leave to file a reply affidavit from Dr. Lindquist. The proposed Lindquist affidavit was relied upon, in part, to support the Applicants' motion. On May 12, 2003, counsel appeared before me to jointly request an adjournment to allow for cross-examination of Dr. Lindquist, and to make submissions on the scope of permissible cross-examination. After hearing counsel, I adjourned the motion for two weeks and issued the following directions:

AND UPON the parties seeking directions of the Court regarding the scope of cross-examination of Dr. Jürgen Lindquist on his Affidavit filed in support of the motion;

Rule 83 provides for cross-examination as of right on Affidavits filed in a motion. Consequently, the Respondent, Apotex Inc., may cross-examine Dr. Jürgen Lindquist on any matters relevant to the determination of the issues on the motion. The cross-examination should not extend, however, to all matters at issue in the application: see Imperial Chemical Industries PLC v. Apotex Inc. (1989) 23 C.P.R. (3d) 363 (F.C.T.D.)


[6]                 A dispute subsequently arose between the parties regarding the scheduling of Dr. Lindquist's cross-examination. Taking the position that the Applicants were refusing to produce Dr. Lindquist for cross-examination, Apotex brought a motion to strike out the affidavit of Dr. Lindquist from the Applicants' motion.

[7]                 Prior to the return date of Apotex's motion to strike, a conference call was convened before me. On May 22, 2003, Apotex's motion to strike was adjourned sine die, without prejudice, and the Applicants' motion was adjourned to the general sittings in Toronto on June 2, 2003. The following directions were also issued with respect to Dr. Lindquist's cross-examination:

3.              Dr. Lindquist shall be produced for cross-examination, for the purposes of Applicants' pending motion, by telephone either on Friday, May 23, 2003 or Tuesday, May 27, 2003, at such time as may be agreed to by the parties, or as directed by the Court. The Respondent, Apotex Inc., may at its option, elect to cross-examine Dr. Lindquist in person, in London, England on May 27, 2003.

4.              Counsel for Apotex shall advise counsel for Applicants by 12:00 noon on Friday, May 23, 2003, as to when, and in what manner the cross-examination of Dr. Lindquist shall proceed.

[8]                 Counsel for Apotex elected to proceed with the cross-examination of Dr. Lindquist in person in London, England on May 27, 2003. In response to Apotex's earlier request in this regard, counsel for the Applicants gave notice that the cross-examination of Dr. Lindquist would be limited to questions of timing of Dr. Lindquist's involvement and his credential as an expert. Accordingly, a number of substantive questions put to Dr. Lindquist at his cross-examination were refused.


[9]                 The parties subsequently appeared before me on June 3, 2003 on the Applicants' motion. Counsel for Apotex advised that its motion to strike would be withdrawn. After hearing the submissions of counsel, Apotex was ordered to serve and file further evidence to correct certain deficiencies in its affidavits, failing which portions of the Cima affidavit would be struck out. The Applicants' motion for alternative relief was adjourned pending compliance by Apotex with the Order dated June 3, 2003.

[10]            On June 4, 2003, Apotex brought the present motion to compel the re-attendance of Dr. Lindquist. By Order dated June 10, 2003, O'Reilly J. adjourned the motion on the following terms:

In the event that the Applicants' motion to file the Lindquist Affidavit is made returnable, Apotex' motion shall be heard, and disposed of, on a date prior to the date for the hearing of the Applicants' motion for leave to file the Lindquist Affidavit.

Legal Principles: Proper Questions on Cross-examination

[11]            Rule 83 of the Federal Court Rules, 1998 provides for cross-examination as of right on affidavits filed in a motion. Although Rule 83 is silent as to the scope of cross-examination, in general, cross-examination may cover any matters relevant to the determination of the issues on the motion in respect of which the affidavit is filed.

[12]            In Merck Frosst Canada Inc. v. Canada (Minister of Health) (1997), 80 C.P.R. (3d) 550 (F.C.T.D.), upheld by the Court of Appeal (2000), 249 N.R. 15, Hugessen J. stated that cross-examination differs from examination for discovery in several important respects and, more particularly, that the rules of relevance are more limited. He considered the principal issue to be relevance.

For present purposes, I think it is useful to look at relevance as being of two sorts: formal relevance and legal relevance.


Formal relevance is determined by reference to the issues of fact which separate the parties. In an action those issues are defined by the pleadings, but in an application for judicial review, where there are no pleadings (the notice of motion itself being required to set out only the legal as opposed to the factual grounds for seeking review), the issues are defined by the affidavits which are filed by the parties. Thus, cross-examination of the deponents of an affidavit is limited to those facts sworn to by the deponent and the deponent of any other affidavits filed in the proceeding.

Over and above formal relevance, however, questions on cross-examination must also meet the requirement of legal relevance. Even when a fact has been sworn to in the proceeding, it does not have legal relevance unless its existence or non-existence can assist in determining whether or not the remedy sought can be granted.

Objections on Dr. Lindquist's Cross-examination

[13]            According to the Applicants, the Lindquist affidavit responds to certain matters in the affidavit of Dr. Cima and the testing techniques employed by Dr. Cima. Apotex seeks to question Dr. Lindquist with respect to his qualifications and his criticism of Dr. Cima regarding sample preparation, raman spectroscopy, fluorescence microscopy and the use of an acetone wash.

[14]            Counsel for Apotex asked questions bearing upon the qualifications of Dr. Lindquist to be giving the opinion contained his affidavit. Although a number of questions regarding Dr. Lindquist's credentials were answered, others, categorized by Apotex as relating to the qualifications of Dr. Lindquist, were refused. The Applicants' objections were, in my view, entirely proper.


[15]            The questions numbered 1, 2 and 3 in Schedule "A" (Question Nos. 267, 268 and 269 from the transcript) all relate to why Dr. Lindquist did not give evidence in ongoing U.S. proceedings involving corresponding U.S. patents, and why another witness provided such evidence. These questions are wholly irrelevant to the question of Dr. Lindquist's qualifications. It is inappropriate to assess the qualifications of Dr. Lindquist by comparing him to another witness in another jurisdiction who was not selected in the present case and whose qualifications are not before the Court. The fact that Dr. Lindquist did not provide evidence in other litigation is not pertinent to his ability to provide expert evidence in this proceeding. The proper approach to qualifying (or disqualifying) an expert is to ask him questions on his experience and expertise. However, attempts to draw inferences on the basis of why someone else was selected to give evidence on another case is improper, and wholly irrelevant to the issues on this motion.

[16]            Question 4 does not relate in any fashion to Dr. Lindquist's qualifications, but instead relates to possible differences between the present case and the case decided by this Court in RhoxalPharma (AB Hassle v. Canada (Minister of National Health and Welfare) 2000 10 C.P.R. (4th) 38, affirmed 18 C.P.R. (4th) 558 (F.C.A.)), in which Dr. Lindquist was accepted as an expert.

[17]            Similarly, Question 5 seeks production of a copy of the affidavit of Dr. Lindquist used in RhoxalPharma, his cross-examination transcript, the affidavit of Dr. Cartilier (a witness proferred by RhoxalPharma) and his cross-examination. Counsel for Apotex provided no explanation as to how Dr. Lindquist's testimony, or the evidence of an expert on behalf of another party's testimony is relevant. Moreover, the evidence in that case is not relevant to the issues in the present motion, or to the qualifications of Dr. Lindquist.


[18]            The questions in Categories 2 to 5, identified by counsel for Apotex under separate headings of sample preparation, raman spectroscopy, fluorescence microscopy and acetone wash, are also irrelevant to the issues on the motion. While such questions may be appropriate in a cross-examination on the merits, they are clearly irrelevant to the narrow issues in play on the present motion. Apotex seeks to have the Court, in deciding whether to admit the evidence of Dr. Lindquist, evaluate and determine the factual issues raised by the Lindquist affidavit. This is clearly the function of the hearing judge dealing with the matter on the merits, and not that of a motions judge.

[19]            Apotex argues that it is entitled to question Dr. Lindquist on these issues, presumably on the basis that they speak to whether the evidence will assist the Court. However, in deciding whether the material will assist the Court, it is not necessary, or appropriate, to engage in a detailed assessment of expert evidence. Such an exercise would be a mis-allocation of the resources of the parties and the Court, and would unduly complicate and lengthen the proceeding.

[20]            The Federal Court of Appeal has repeatedly stated that the Court has a duty to deal expeditiously with proceeding under the PMNOC Regulations. Motions within motions ought therefore be discouraged, particularly motions such as these, dealing with questions refused in cross-examination of an affidavit filed in support of a motion. The more efficient and proper procedure, in my view, is for the aggrieved party to file a respondent's record, re-attend at the return of the opposing party's motion, and request relief under Rule 97, which provides that where a person refuses to answer a proper question, the Court may order the person to re-attend for cross-examination, require the person to answer the question that was improperly refused or strike all or part of the person's affidavit.


Conclusion

[21]            Apotex has confused the threshold issue of whether Dr. Lindquist's evidence will assist the Court with the issue of the weight to be attributed to the evidence on the merits. The latter issue is reserved for determination by the trial judge. In assessing whether Dr. Lindquist's evidence will assist the Court, the only issue is whether it fairly responds to matters raised in Apotex's evidence. Consequently, I conclude that the questions raised by Apotex are wholly irrelevant to the issue on the motion, namely whether the Applicants ought to be permitted to file further evidence.

[22]            The present motion is ill-founded, and none of the questions refused will be ordered answered.

                                                  ORDER

THIS COURT ORDERS that

1.                    The motion is dismissed, with costs to be paid by the Respondent, Apotex Inc., to the Applicants in any event of the cause.

"Roger R. Lafrenière"

                                                                                               Prothonotary                    


             FEDERAL COURT OF CANADA

TRIAL DIVISION

    NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                                  T-1878-02

STYLE OF CAUSE:                  AB HASSLE, ASTRAZENECA AB and

    ASTRAZENECA CANADA INC.

                                                                                                   Applicants

    and

   APOTEX INC. and THE MINISTER OF HEALTH

                                                                                                Respondents

PLACE OF HEARING:                      TORONTO, ONTARIO

DATE OF HEARING:           JULY 14, 2003   

REASONS FOR ORDER

AND ORDER BY:                  LAFRENIÈRE P.

DATED:                          JULY 21, 2003

APPEARANCES BY:             Mr. Gunars A. Gaikis

                                                             For the Applicants

Mr. Andrew R. Brodkin

For the Respondent, Apotex Inc.

Ms. Nathalie Butterfield

For the Respondent, Apotex Inc.

SOLICITORS OF RECORD:        Smart & Biggar

Barristers & Solicitors

Toronto, Ontario

For the Applicants                        

Goodmans LLP

Barristers & Solicitors

Toronto, Ontario

For the Respondent, Apotex Inc.

Morris Rosenberg

Deputy Attorney General of Canada

For the Respondent, The Minister of Health


FEDERAL COURT OF CANADA

TRIAL DIVISION

             Date:20030721

       Docket: T-1878-02

BETWEEN:

AB HASSLE, ASTRAZENECA AB and

ASTRAZENECA CANADA INC.

                                              Applicants

and

APOTEX INC. and THE MINISTER OF HEALTH

                                       Respondents

                                                   

REASONS FOR ORDER

AND ORDER

                                                   

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