Ottawa, Ontario, October 14th, 2005
PRESENT: THE HONOURABLE MR. JUSTICE LEMIEUX
BETWEEN:
and
REASONS FOR ORDER AND ORDER
A. INTRODUCTION
[1] Apotex appeals Prothonotary Tabib's decision of May 20, 2005 refusing, pursuant to subsection 84(2) of the Federal Court Rules, (the Rules) leave to Apotex to file the supplementary affidavit of Dr. Bernard Sherman sworn on March 18, 2005.
[2] Dr. Sherman's supplementary affidavit sets out test results conducted by Apotex contrasting impurity levels in tablets of Apo-X containing medicine X and tablets of medicine X currently sold in Canada. Dr. Sherman concludes the comparisons demonstrate the position taken by the Minister of Health for Canada (the Minister) is not only arbitrary but is discriminatory.
[3] Dr. Sherman's proposed evidence is in support of Apotex's motion of November 12, 2004 for an Order from this Court finding the Minister has unlawfully refused to comply with the Order of Justice Pinard dated June 2, 2004 by treating Apotex's Apo-X tablets as a new drug and requiring that Apotex' drug identification number (DIN) applications for those tablets be processed as an abbreviated new drug submission (ANDS) to obtain a Notice of Compliance (NOC). Apotex' November 12, 2004 motion (the compliance motion) also seeks an Order from this Court the Minister forthwith issue DINs for Apo-X tablets to Apotex.
[4] Justice Pinard's Order was issued with the consent of the Minister. His Order was issued in the context of a judicial review application launched by Apotex on April 14, 2004 for an Order compelling the Minister to forthwith process Apotex' DIN applications for Apo-X tablets in accordance with the provisions of the Food and Drugs Act and the Regulations and to issue Apotex a DIN for each dosage strength applied for.
[5] The material part of Justice Pinard's consent Order provides that:
The Minister shall forthwith process the DIN Applications in accordance with the provisions of the Food and Drugs Act and the Food and Drug Regulations for each dosage strength of the Apo-X drug product.
[6] In March 2003, Apotex had filed with the Therapeutic Products Directorate of Health Canada (TPD), pursuant to Division 1 of the Food and Drug Regulations (the Regulations), applications to obtain drug identification numbers for its Apo-X tablets in various strength. Apotex was of the view DINs were sufficient authority to market its Apo-X tablets because medicine X, the active ingredient in the tablets, was an old drug which had been sold on the Canadian market since the 1930s. In this context, applications for DINs are to be contrasted with applications made pursuant to Part C of Division 8 of the Regulations for a Notice of Compliance (NOC), which must be supported by ANDS or a new drug submission (NDS).
[7] Apotex' April 14, 2004 judicial review application was initiated after it had received a letter dated February 17, 2004 from the Director General of the TPD explaining the delay associated with the screening of Apo-X's DIN applications was a consequence of internal deliberations regarding the need to regulate medicine X in accordance with the standards imposed under Part C, Division 8 of the Regulations.
[8] Subsequent to Justice Pinard's Order, the TPD on July 9, 2004, advised Apotex that its DIN applications for Apo-X had been administratively changed to a NDS and would be reviewed as such. The TDP told Apotex the Minister had notified all drug manufacturers of its decision to regulate medicine X as a new drug pursuant to Part C, Division 8 of the Regulations in order to ensure safety, efficacy and quality are adequately assessed at the pre-approval stage and appropriately monitored throughout the product life-cycle.
[9] On August 30, 2004, the TPD notified Apotex its DIN applications did not comply with the requirements of Part C, Division 8 of the Regulations. Several deficiencies were identified including deficiencies related to drug substance specifications and test methods, namely, excessive impurity levels.
[10] Before turning to a consideration of Prothonotary Tabib's reasons for refusing leave to file Dr. Sherman's supplementary affidavit, I will touch briefly on the procedural history behind Apotex' compliance motion.
[11] When Apotex launched its compliance motion on November 12, 2004, it supported that motion with the affidavit of Bernard Sherman sworn November 11, 2004.
[12] The Minister's counsel immediately responded to Apotex' compliance motion by filing the affidavit of Dr. Anna Melnyk sworn on November 18, 2004 on which she was cross-examined February 16, 2005.
[13] Before that cross-examination took place, Apotex responded by filing a second affidavit in support of its compliance motion. The purpose of Dr. Sherman's second affidavit was to respond point by point to statements contained in Dr. Melnyk's affidavit.
B. THE PROTHONOTARY'S DECISION
[14] Prothonotary Tabib prefaced her analysis by stating (Applicant's Record, vol. 1, p. 17) that "the parties are ad idem that the factors to be taken into account in exercising the discretion conferred by Rule 84(2) of the Federal Courts Rules to allow the filing of an affidavit after cross-examinations are not a list of criteria to be met, but factors to be weighed".
[15] The factors she considered were relevance, availability and prejudice:
[16] On relevance, she wrote as follows:
Despite the able submissions of counsel for the Applicant at the hearing, I remain persuaded that any relevance the proposed evidence might have to the motion before the Court is tenuous at best. The issue before the Court on the Applicant's motion to compel compliance with the order of June 2, 2004 is whether the manner in which the Respondent processed the Applicant's DIN application, including its decision to regulate the product as a "new drug", constitute proper compliance with this Court's order. With respect, whether the decision to regulate the product as a "new drug" is applied with the same rigour to other manufacturers and whether it is justified are not obviously relevant to the issue to be determined. The comparative purity of the Applicant's and its competitors' products is even further removed from possible relevance. [emphasis mine]
[17] She touched upon another aspect of relevance stemming from Dr. Melnyk's cross-examination. She stated:
Finally, nothing in the cross-examination of the Respondent's affiant has made the relevance of the actual impurity levels of the respective products more immediate or apparent than it was prior to cross-examinations, as, contrary to the Applicant's assertions, it has not been established in cross-examination that the other manufacturers on the market have indeed submitted an NOC or safety data in relation to their product. All that has been established is that these manufacturers have submitted a response to the Minister, which response could simply consist of a request for additional time to comply. [emphasis mine]
[18] With respect to availability of Dr. Sherman's proposed evidence in the supplementary affidavit sought to be filed, Prothonotary Tabib wrote:
Furthermore, the proposed evidence was not only available to the Applicant prior to cross-examinations but the Applicant was, at the time, clearly alive to its potential relevance - such as it is. Indeed, the affidavit of Bernard Sherman affirmed December 17, 2004 specifically raises concerns as to the ability of other manufacturers on the market to comply with the newly imposed impurity limits and the alleged discriminatory or uneven treatment of the Applicant in comparison to other manufacturers who, it is alleged, continue to be able to market their product without having provided the required data as to their safety (see for example paragraphs 32 and 40 of Dr. Sherman's affidavit of December 17, 2004). [emphasis mine]
[19] After expressing her views on relevance and availability, Prothonotary Tabib stated in view of her comments, it was difficult to see how the proposed new evidence could be of assistance to the Court in determining the issues before it or how a departure from Rule 84 could, in this case, serve the interest of justice.
[20] Finally, on prejudice, Prothonotary Tabib wrote:
While the Respondent does not dispute that allowing the filing of the proposed evidence would not cause prejudice to the Respondent, absence of prejudice alone does not, in my view, counterbalance the findings I have made in respect of the other factors to be weighed. [emphasis mine]
C. THE STANDARD OF REVIEW
[21] The Federal Court of Appeal in Merck & Co. Inc. v. Apotex, [2004] 2 F.C.R. 459 reaffirmed the standard of review expressed by Mr. Justice MacGuigan in that Court's decision of Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425 but reversed the sequencing of the two propositions of the two-part test. The test now reads:
Discretionary orders of prothonotaries ought not be disturbed on appeal to a judge unless: (a) the questions raised in the motion are vital to the final issue of the case, or (b) the orders 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.
[22] Counsel for Apotex did not argue I should exercise the discretion found in subsection 84(2) of the Rules de novo because the evidence in Dr. Sherman's supplementary affidavit was vital to the final issue of the case. In my view, he was correct in not advancing that point because the circumstances of this case would not meet the standard of "vitality" expressed by Justice Décary in Merck, supra at paragraphs 23 to 28.
[23] Rather, counsel for Apotex argued that Prothonotary Tabib's decision not to grant leave to file Dr. Sherman's supplementary affidavit was clearly wrong because her decision was based upon a wrong principle and/or a misapprehension of the facts.
[24] Specifically, counsel for Apotex argues:
1) On relevance, she erred in three ways:
a) She failed to appreciate the relevance of Apotex' proposed evidence and its legal implications. According to counsel, it was only on cross-examination that Apotex discovered that all drug manufacturers of tablets with medicine X were held to the same standard of purity, i.e. those drug manufacturers now on the market and Apotex who was seeking to come on the market. Apotex' proposed evidence shows this is not the case;
b) The Prothonotary found that Apotex' proposed evidence may be relevant, yet she ruled Apotex failed to meet the relevance factor; and
c) She erred in concluding that leave to file evidence ought not to be permitted where a party was alive to its potential relevance prior to cross-examination.
2) On prejudice, she erred in concluding that the absence of any prejudice does not in itself justify the granting of leave.
3) She erred in concluding it was not in the interest of justice to allow the supplementary affidavit. The Court should have before it the complete evidentiary record. Without the supplementary affidavit being in the record, the judge hearing the compliance motion will be required to determine Apotex' rights based on incomplete information. He states the treatment of Apotex in comparison to others lies at the root of the dispute and the judge hearing the compliance motion ought, at the very least, know that the manufacturers who continue to sell their X tablets on the market are not only being required to obtain NOCs, but are violating the proposed requirements the TPD has set with respect to purity limitations that have allegedly kept Apotex out of the market.
4) Prothonotary Tabib misapprehended the evidence garnered on cross-examination since she found that it had not been established in cross-examination that other manufacturers on the market had indeed submitted a NOC or safety data in relation to their product. That was not Apotex' assertion. Apotex' assertion was that on cross-examination, it learned that all manufacturers or proposed manufacturers of X-tablets were being subjected to the requirements of a NDS including the same purity standards.
D. CONCLUSIONS
[25] After reviewing the entire record, including Dr. Sherman's second affidavit sworn on December 17, 2004, which was handed to me at the hearing of this motion but without its voluminous exhibits, I conclude that Apotex' appeal from Prothonotary Tabib's decision must be dismissed.
[26] When reviewing the decision of a prothonotary or other decision-makers, I am reminded of the caution raised by Justice Laskin, as he then was, in Boulis v. Canada (Minister of Manpower and Immigration), [1974] S.C.R. 875 at 885 that "reasons are not to be read microscopically and the record is always available as a check on conclusions".
[27] Critical to the analysis of the Prothonotary's decision is the nature of the relief sought in Apotex' compliance motion and the nature of the evidence proposed to be tendered by Dr. Sherman in his supplemental affidavit.
[28] Apotex seeks an Order from this Court that the Minister has unlawfully refused to comply with Justice Pinard's Order by treating its Apo-X tablets as a new drug and a further Order that the Minister forthwith issue DINs for those tablets.
[29] As noted, Dr. Sherman's proposed evidence sets out comparative impurity results between Apotex's tablet not on the market and tablets containing medicine which are on the market.
[30] In my view, Apotex's appeal should be dismissed for the following reasons.
[31] First, on relevance, I cannot agree with counsel for Apotex that Prothonotary Tabib erred in the ways he suggested. When her reasons are read as a whole and not microscopically, it is clear she concludes that Dr. Sherman's proposed evidence is not relevant to the compliance motion. (See Justice O'Reilly's decision in Biovail Corp. v. Canada(Minister of National Health & Welfare), 2005 FC 1135.)
[32] As to the availability of the proposed evidence to be introduced through Dr. Sherman's supplementary affidavit, the Prothonotary's finding such evidence was available is grounded in the evidence. Apotex raised with the TPD as far back as March 29, 2004, the issue of discrimination (Applicant's Record, volume 1, page 258) and subsequently raised the treatment given TPD to a competitor (Applicant's Record, volume 1, page 280) and Dr. Sherman's second affidavit at paragraph 32(d). As noted by the Prothonotary, Apotex had long formed the view that no Canadian manufacturer could meet the standards which TPD required of Apotex (see Dr. Sherman's second affidavit at paragraph 40).
[33] Counsel for Apotex criticizes Prothonotary Tabib's statement "that the Applicant was, at the time, clearly alive to its potential relevance - such as it is". He says this statement runs afoul of Mr. Justice MacKay's decision in Bayer AG et al. v. Canada (Minister of National Health and Welfare) et al. (1994), 58 C.P.R. (3d) page 377.
[34] I do not accept his submission. He reads Prothonotary Tabib's words microscopically and out of context. She is simply saying Apotex was aware of the issue well before Dr. Melnyk's cross-examination and is not making a finding as to relevance which is clearly apparent by the use of the words "such as it is". In any event, I do not accept counsel for Apotex' contention that it was only during the cross-examination of Dr. Melnyk that Apotex was tipped off on the issue whether manufacturers were already complying with the new safety requirements. The evidence cited in these reasons shows that Apotex was well aware of that issue before Dr. Melnyk's cross-examination. (See Inverhuron & District Ratepayers' Association v. Canada(Minister of the Environment), [2000] F.C.J. No. 59.)
[35] In terms of the interest of justice I can find no fault in the Prothonotary's finding that the proposed new evidence would not be of assistance to the Court in determining the issues before it in the compliance motion and thus serve the interest of justice.
[36] Finally, on the issue of prejudice, Prothonotary Tabib recognized that the Minister would not be prejudiced by the filing of the supplementary affidavit. Counsel for Apotex suggests that absence of prejudice trumps all other factors. I do not read the relevant jurisprudence as supporting this proposition. Absence of prejudice is but one factor amongst others all of which must be weighed which is precisely what the Prothonotary did.
ORDER
THIS COURT ORDERS that the applicant's appeal be dismissed with costs.
JUDGE
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-761-04
STYLE OF CAUSE: APOTEX INC. v. MINISTER OF HEALTH
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: September 8, 2005
APPEARANCES:
| Mr. Andrew Brodkin
|
|
| Mr. F. B. Woyiwada
|
SOLICITORS OF RECORD:
| Goodmans LLP
|
|
| Deputy Attorney General of Canada
|