ASTRAZENECA CANADA INC. Applicant - v. -, 2003 FCT 370

Date: 20030327 Docket: T-660-02 Neutral citation: 2003 FCT 370 Ottawa, Ontario, this 27th day of March, 2003 PRESENT: THE HONOURABLE MR. JUSTICE JOHN A. O'KEEFE BETWEEN: ASTRAZENECA CANADA INC.

Applicant - and - APOTEX INC., TAKEDA CHEMICAL INDUSTRIES LTD. and THE MINISTER OF HEALTH Respondents REASONS FOR ORDER AND ORDER O'KEEFE J. [ 1 ] This is a motion by the respondent, Apotex Inc. ("Apotex") for an order setting aside the order of Prothonotary Lafrenière made orally on October 21, 2002 and issued on October 24, 2002. [ 2 ] The underlying proceeding in this matter is an application by the applicant, AstraZeneca Canada Inc. ("AstraZeneca"), pursuant to the Patented Medicines (Notice of Compliance) Regulations , S.O.R./93-133 (the " Regulations "). [ 3 ] In support of their application, the applicant filed evidence on May 22, 2002.

In response, Apotex filed the evidence of Dr. Bernard Sherman on June 24, 2002. The time for conducting cross-examinations on his affidavit expired on July 13, 2002. [ 4 ] Dr. Sherman was cross-examined on his affidavit on July 9, 2002. [ 5 ] By motion dated August 2, 2002, AstraZeneca requested answers to questions which were refused to be answered at the cross-examination of Dr. Sherman. The applicant also asked for an extension of time for completion of the cross-examination. [ 6 ] The motion was heard by Prothonotary Lafrenière on October 21, 2002.

He granted an extension of time for the completion of the cross-examination and his order read as follows: 1. Dr. Sherman is ordered to provide answers to Questions 55, 110 and 111 set out in

Schedule "A" to the Notice of Motion dated August 2, 2002 and to provide an answer to the undertaking given at Question 141. 2. Any further cross-examination of Dr. Sherman shall be completed within 2 weeks of receipt of Apotex's answers to Questions 55, 110, 111 and 141. 3. The balance of the

schedule shall proceed in accordance with the time limits prescribed by the Federal Court Rules, 1998 . 4. Costs of this motion shall be in the cause. [ 7 ] Issue Did the Prothonotary make a reviewable error? [ 8 ] Standard of Review The law followed by this Court when reviewing or deciding appeals from a discretionary decision of a Prothonotary was set out by MacGuigan J.A. in Canada v.

Aqua-Gem Investments Ltd. , 1993 CanLII 2939 (FCA) , [1993] 2 F.C. 425 (C.A.) at pages 462 to 463: I also agree with the Chief Justice in part as to the standard of review to be applied by a motions judge to a discretionary decision of a prothonotary. Following in particular Lord Wright in Evans v. Bartlam , [1937] A.C. 473 (H.L.) at page 484, and Lacourcière J.A. in Stoicevski v. Casement (1983), 1983 CanLII 1679 (ON CA) , 43 O.R. (2d) 436 (Div. Ct.), discretionary orders of prothonotaries ought not to be disturbed on appeal to a judge unless: (

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) they raise questions vital to the final issue of the case. Where such discretionary orders are clearly wrong in that the prothonotary has fallen into error of law (a concept in which I include a discretion based upon a wrong principle or upon a misapprehension of the facts), or where they raise questions vital to the final issue of the case, a judge ought to exercise his own discretion de novo . And at pages 464 to 465: In Canada v.

"Jala Godavari" ( The ) (1991), 40 C.P.R. (3d) 127 (F.C.A.) , this Court in an obiter dictum stated the rule the other way around, seeking to emphasize the necessity for the exercise of the Judge's discretion de novo , in contradistinction to the view that was at that time gaining acceptance in the Trial Division that the prothonotary's discretion should be followed unless he had committed error of law.

Jala Godavari should not, I think, be read as meaning that the prothonotary's discretion should never be respected, but rather that it is subject to an overriding discretion by a judge where the question involved is vital to the final issue of the case. (Error of law is, of course, always a reason for intervention by a judge, and is not in any way in controversy). Now, in the case at bar, what kind of interlocutory order was in question?

The appellant urged this Court to follow Stoicevski , but was unable to explain in argument why the prothonotary's decision here was not on a question vital to the final issue of the case. The formulations both of Lord Wright and Lacourcière J.A. underline the contrast between " routine matters of pleading" (Lord Wright) and "a routine amendment to a pleading" (Lacourcière J.A.) [italics added] and questions vital to the final issue of the case, i.e., to its final resolution.

The question before the prothonotary in the case at bar can be considered interlocutory only because the prothonotary decided it in favour of the appellant. If he had decided it for the respondent, it would itself have been a final decision of the case: A-G of Canada v. S.F. Enterprises Inc. et al. (1990), 90 DTC 6195 (F.C.A.) at pages 6197-6198 ; Ainsworth v. Bickersteth et al. , 1947 CanLII 122 (ON CA) , [1947] O.R. 525 (C.A.).

It seems to me that a decision which can thus be either interlocutory or final depending on how it is decided, even if interlocutory because of the result, must nevertheless be considered vital to the final resolution of the case. Another way of putting the matter would be to say that for the test as to relevance to the final issue of the case, the issue to be decided should be looked to before the question is answered by the prothonotary, whereas that as to whether it is interlocutory or final (which is purely a pro forma matter) should be put after the prothonotary's decision.

Any other approach, it seems to me, would reduce the more substantial question of "vital to the issue of the case" to the merely procedural issue of interlocutory or final, and preserve all interlocutory rulings from attack (except in relation to errors of law). [ 9 ] In this case, since the Prothonotary ruled that the questions need to be answered because the questions were relevant, his decision must be correct because relevancy is a question of law (see Reading & Bates Construction Co. v. Baker Energy Resources Corp. , [1988] F.C.J. No. 1025 (QL) (T.D.) ).

With respect to the Prothonotary's ruling on an extension of time to complete cross- examination, this ruling is not a matter vital to the final issue of the case so on this issue, I must determine whether or not the decision of the Prothonotary was clearly wrong in the sense that the Prothonotary's exercise of discretion was based upon a wrong principle or upon a misapprehension of the facts. [ 10 ] In his order, Prothonotary Lafrenière's first decision was to order Dr. Sherman to provide answers to Questions 55, 110 and 111 set out in

Schedule A to the notice of motion and to provide an answer to the undertaking given at Question 141. This appeal deals only with Questions 55, 110 and 111. [ 11 ] Question 55 reads as follows: Could we also have you produce a copy of your monograph for the Apo-Omeprazole tablets referred to in the current NOA? The Prothonotary's reasons for allowing this question to be asked were: (

b) Question 55 is relevant to the issue whether the allegation of non-infringement is justified. Although no affidavit evidence was filed in support of the request, from reading the transcript of the cross-examination of Dr. Sherman, information contained in the product monograph may assist the Applicant in establishing that Apotex's tablets contain a sodium salt. It is not open to Apotex to refuse to produce the document simply because it has provided its formulation particulars. The Applicant need not simply accept the evidence tendered and is fully entitled to inquire further.

I am of the opinion that the Prothonotary was correct in his finding. Apotex's concern about confidentiality can be dealt with by taking steps to ensure that the document is kept confidential once it is produced. [ 12 ] Question 110 is as follows: Could you make enquiries and let me know if Apotex has any other matter - - you mentioned cefuroxime - - if Apotex has any other matter, any other medicine in respect of which it went to a hearing on the merits in circumstances when it did not have a new drug submission pending in respect of the allegation - - the subject of that hearing on the merits?

The Prothonotary's reason for allowing this question to be answered was: Question 110 goes to the issue of Dr. Sherman's credibility on a material assertion and is therefore relevant. The Applicant is entitled to test Dr. Sherman's answer to Question 96 that the earlier proceedings were withdrawn as premature by inquiring whether Apotex has previously taken a contrary position. If the circumstances in other proceedings that may have been withdrawn by Apotex as premature were significantly different than those at bar, Dr. Sherman can so indicate.

I agree with the Prothonotary's conclusion with respect to Question 110. AstraZeneca is entitled to test the credibility of Dr. Sherman. The Prothonotary was correct. [ 13 ] Question 111 reads: Going back to the difficulties alleged to have been encountered by Apotex, what I'd like to do is to ask you to produce the documents that show when and how the alleged difficulties were overcome. The Prothonotary's reason for allowing the question to be answered was: Question 111 is relevant to the issue of abuse of process. The Applicant is entitled to inquire whether the formulation difficulties referred to by Dr.

Sherman in his affidavit provided a legitimate basis for withdrawing the allegation. The question as to when and how those difficulties were subsequently overcome by Apotex, giving rise to the new allegation, is clearly relevant. I have reviewed the record and I agree with the Prothonotary. The issue of what the formulation difficulties were and when they were overcome is relevant to determining whether the filing of a new Notice of Allegation is an abuse of process. The Prothonotary was correct in his conclusion. [ 14 ] The Prothonotary also ordered that any further cross-examination of Dr.

Sherman shall be completed within two weeks of receipt of Apotex's answers to Questions 55, 110, 111 and 141. Apotex submitted that the Prothonotary made errors of law and misapprehended the facts in granting the extension of time to complete the cross-examination. The examination of Dr. Sherman was completed on July 9, 2002 and AstraZeneca was provided with Apotex's position on matters outstanding from the cross-examination on July 26, 2002 (this did not relate to the refusal to answer questions in issue)" AstraZeneca brought its motion for an order to have the questions answered on August 2, 2002.

The Prothonotary, in the

preamble to his order stated at paragraph 4: AND UPON reading the motion records filed on behalf of the Applicant and Apotex, and hearing the oral submissions of counsel on October 21, 2002; AND UPON being satisfied that the Applicant moved promptly in bringing this motion and that the Respondents have not been prejudiced by the brief delay; I am not persuaded that the Prothonotary was clearly wrong in granting the extension of time for further cross-examination after the questions in issue were answered.

I am not persuaded, on the facts of this case, that a delay from July 9, 2002 until August 2, 2002 would result in a finding that AstraZeneca did not move promptly. [ 15 ] The appeal of the Prothonotary's decision is dismissed. [ 16 ] Costs shall be costs in the cause. ORDER [ 17 ] IT IS ORDERED that: 1. The appeal (motion) of Apotex is dismissed. 2. Costs shall be costs in the cause. "John A. O'Keefe" J.F.C.C. Ottawa, Ontario March 27, 2003 FEDERAL COURT OF CANADA TRIAL DIVISION NAMES OF COUNSEL AND SOLICITORS OF RECORD DOCKET: T-660-02 STYLE OF CAUSE: ASTRAZENECA CANADA INC. - and - APOTEX INC., TAKEDA CHEMICAL

INDUSTRIES LTD.and THE MINISTER OF HEALTH PLACE OF HEARING: Toronto, Ontario DATE OF HEARING: Monday, November 18, 2002 REASONS FOR ORDER AND ORDER OF O'KEEFE J. DATED: March 27, 2002 APPEARANCES : Mr. Gunars A. Gaikis Ms. D. Lancombe FOR APPLICANT Ms. Julie Perrin FOR RESPONDENT, Apotex Inc. SOLICITORS OF RECORD : Smart & Biggar Suite 1500, Box 11 438 University Avenue Toronto, Ontario M5G 2K8 FOR APPLICANT Goodmans LLP Suite 2400 250 Yonge Street Toronto, Ontario M5B 2M6 FOR RESPONDENT