[1] The appellant, Apotex Inc., challenges an order of a judge of the Federal Court (judge) who allowed the respondent's (Astra) appeal against an order from a Prothonotary dated May 12, 2004. Astra had made a motion, which the Prothonotary dismissed, to file affidavit evidence of an expert, Dr. Lindquist. Pursuant to the production by the appellant of samples of its omeprazole magnesium tablets, Dr. Lindquist analysed their contents to determine whether the appellant's claim of non-infringement of Astra's patents was founded. Astra wanted to file such evidence to demonstrate infringement of its patents by the appellant. This procedural incident occurred in the context of an application for an order prohibiting the Minister of Health (minister) from issuing to the appellant a Notice of Compliance.

[2] The hearing on the seeking of a prohibition order was scheduled for August 17, 2004. As a result of the present proceedings, the hearing date which had been fixed by priority has now been postponed to next December. In the meantime, the cross-examination of Dr. Lindquist has been suspended pending this appeal. Also in issue is the appellant's claim to a right to produce rebuttal evidence if Astra's evidence is allowed to be filed. I am stating these facts to stress the urgency in ruling on this appeal. Therefore, I will issue short reasons in support of the decision.

[3] Upon hearing the parties and reviewing the material, I believe that, save for the appellant's right to file rebuttal evidence, the judge has come to the right conclusion although I endorse it for different reasons.

[4] The Prothonotary dismissed Astra's motion to file evidence on the basis that the motion was not brought promptly in proceedings under the Patent Medicines (Notice of Compliance) Regulations (Regulations) where celerity is of great importance. He held Astra and the other applicants accountable for their failure, in particular, to bring a timely motion to compel production of samples for testing. At paragraph 37 of his reasons, he wrote:

The Applicants are seeking leave to file further affidavit evidence eighteen months after the commencement of the proceedings in Court File No. T-1878-02, and almost one year after the commencement of the proceedings in Court File No. T-766-03. Although the period of delay between the commencement of the proceeding and the filing of the Apotex's evidence has been satisfactorily explained, I am not satisfied that the applicants have accounted for their subsequent inaction and, in particular, their failure to bring a timely motion to compel production of samples for testing.

[5] Astra sought production of the appellant's product after cross-examination of Dr. Sherman who, as an expert, filed an affidavit on behalf of the appellant relating to the analysis of the tablets conducted by the appellant. The Prothonotary saw in this waiting period by Astra a strategy that he found perplexing and unacceptable as it resulted in unnecessary delays: see paragraphs 39, 40 and 41 of his decision. He was of the view that Astra should have sought production of the samples, proceeded to their analysis and made a motion to file the resulting affidavit evidence prior to scheduling cross-examinations: id., paragraph 40.

[6] With respect, the Prothonotary misstated the law when he so concluded. Subsection 6(7) of the Regulations allows a party to compel the production of samples where such samples have been filed with the minister as part of an applicant's regulatory submissions (NDS). Since the appellant did not submit samples of its product to the minister, Astra could not exercise the right conferred by subsection 6(7) and compel production.

[7] As the Prothonotary rightly observed, proceedings under the Regulations must be prosecuted expeditiously: Bayer AG v. Canada (1993), 51 C.P.R. (3d) 329, at page 337 (F.C.A.); AB Hassle v. Canada (2000), 7 C.P.R. (4^th) 272, at paragraph 27 (F.C.A.); Pharmacia Inc. v. Canada (1994), 58 C.P.R. 209, at page 215 (F.C.A.). Discovery and powers to compel disclosure are limited. The Prothonotary has cited no authority, and I know of none, to support his conclusion that Astra could and should have sought production of the samples at an earlier stage than it did and, therefore, should be blamed for the delay which resulted from its failure to do so. Astra did request the needed samples from the appellant, but all in vain. The appellant finally produced them on February 19, 2004 during the cross-examination of its expert witness because their production had then become compellable as part of the witness' testimony.

[8] In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare (1994), 55 C.P.R. (3d) 302, at page 320 (F.C.A.), this Court stressed the limited scope for discovery in these proceedings. In Hoffmann-La Roche Ltd. et al. v. Minister of National Health and Welfare et al. (1996) 67 C.P.R. (3d) 484, at page 497 (F.C. T.D.), Reed J. concluded that her Court had no authority to compel the production of evidence in applications pursuant to subsection 6(1) of the Regulations and that there is no oral or documentary discovery. She went on to assert, as an example, that the Court could not require that the respondent "provide samples of the drug it proposes to market to the applicant". In Pfizer Canada v. Apotex Inc. (2002), 18 C.P.R. (4^th) 323, at paragraphs 28 and 29, O'Keefe J. expressed the view that the production of the samples could be compelled only if they had been provided to the minister. In that case, Apotex Inc. opposed successfully the motion to compel production of its samples on the authority of the decision in Hoffmann-La Roche Ltd. v. Canada, supra: see paragraphs 27 and 28. It is the same Apotex Inc. who, in the present proceedings, claims that Astra should have sought, at an earlier stage, the production of the samples by way of motion.

[9] Finally, in Pfizer Canada Inc. v. Apotex Inc. (2003), 24 C.P.R. (4^th) 259, Apotex Inc. sought by motion the production of documents which it alleged were necessary to prepare its responding affidavit evidence. It acknowledged at paragraph 9 that the Federal Court Rules, 1998 provided no specific entitlement to seek production of documents prior to filing a responding party's affidavit evidence. At pages 265-266, Snider J. ruled that, if ever there is authority to order disclosure of material referred to in an affidavit prior to cross-examination on the affidavit, the issuance of the order would be discretionary.

[10] In the actual state of the law, I do not think that Astra can be blamed for having waited until the cross-examination of the appellant's witness to compel the production of the samples. At best, the law is unclear and uncertain on the issue. At worst, Astra had no right to compel the production of the samples prior to cross-examination.

[11] The appellant was under no obligation to file its samples with the minister and to produce them to Astra. That said, however, it was just a matter of time before it could be compelled to produce them once it had filed affidavit evidence concerning the results of their testing. In my view, in circumstances where the disclosure process envisaged in subsection 6(7) of the Regulations cannot be resorted to because the samples have not been provided to the minister and where the second person proceeds to their testing and file affidavit evidence of the results of these tests in the prohibition proceedings, expediency, fairness and the overall interest of justice give the first person the right to, immediately after such filing, seek by motion the production of these samples for a testing of its own. This should remedy the unfortunate delay encountered in the present proceedings. The first person can then be held accountable for its failure to proceed promptly.

[12] It is clear upon reading the decision of the Prothonotary, that he felt that Astra had failed to act with due diligence in seeking the production of the samples and that the motion to file the Lindquist affidavit would result in further delay to the prejudice of the appellant. At paragraphs 43 and 44, he writes:

Finally, Apotex complains that the Applicants chose to delay an additional two months after Apotex voluntarily produced its samples prior to bringing the within motion. Were it not for the substantial delay from the time Apotex filed its responding affidavit evidence to the date of cross-examination of Dr. Sherman, I would have been inclined to excuse this period of delay in light of the explanation provided, and the assistance the Lindquist Affidavit would give the Court in reaching its determination on the merits of the application.

In conclusion, the Applicants have unreasonably delayed in seeking to compel samples. Since Apotex would be prejudiced by any further delay in this proceeding, I do not consider it is in the interests of justice to grant the relief requested.

(Emphasis added)

Were it not for his misapprehension of the law relating to the forced production of samples, he would have granted Astra's motion and allowed the affidavit evidence to be filed. On appeal, the judge should have intervened on that basis since the judicial discretion was exercised on a wrong principle: see Merck & Co. v. Apotex Inc., 2003 FCA 488, at paragraph 19.

[13] At paragraph 28 of his decision, the learned judge, in light of the tight time frame governing the proceedings at the time, did not see the necessity in allowing the appellant to introduce further counter-evidence on testing because this would result in further delays. The hearing has now been adjourned to December 2004 and the time frame has changed.

[14] Furthermore, in an Order dated May 12, 2004, the Prothonotary dismissed as moot a motion by the appellant to be authorized to file responding affidavit evidence if Astra was granted leave to file the Lindquist affidavit. However, he dismissed the motion without prejudice to the appellant's right to bring a motion seeking leave to file responding evidence if Astra is "successful on any appeal seeking leave to file the Affidavit of Dr. Jörgen Lindquist sworn April 15, 2004". This Order is still in force. In the circumstances, I would authorize the appellant, if it so wishes pursuant to that Order, to file in a timely fashion a motion seeking leave to file responding evidence to the Lindquist affidavit.

[15] For these reasons, I would dismiss the appeal with costs throughout payable to the respondents AB Hassle, Astrazeneca AB and Astrazeneca Canada Inc., without prejudice to the appellant's right to bring a motion pursuant to the Order of the Prothonotary dated May 12, 2004. The respondents AB Hassle, Astrazeneca AB and Astrazeneca Canada Inc. will be entitled to their disbursements in file A-289-04 in which a copy of these reasons will be filed.

"Gilles Létourneau"

"I agree J.A.

K. Sharlow J.A."

"I agree

B. Malone J.A."

FEDERAL COURT OF APPEAL

NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET: A-288-04/A-289-04

STYLE OF CAUSE: APOTEX INC. v. AB HASSLE et al.

PLACE OF HEARING: Vancouver, British Columbia

DATE OF HEARING: June 22, 2004

REASONS FOR JUDGMENT: LÉTOURNEAU J.A.

CONCURRED IN BY: SHARLOW J.A.

MALONE J.A.

DATED: July 7, 2004

APPEARANCES:

Mr. Andrew Brodkin

Ms. Nathalie Butterfield

FOR THE APPELLANT

Mr. Sheldon Hamilton

Ms. Yoon Kang

FOR THE RESPONDENT

SOLICITORS OF RECORD:

Goodman LLP

Toronto, ON

FOR THE APPLICANT

Smart & Biggar

Toronto, ON

FOR THE RESPONDENT

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Apotex Inc. v. AB Hassle, 2004 FCA 255

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2004 FCA 255