Date: 20030702
Docket: T-1236-02
Citation: 2003 FC 821
Toronto, Ontario, July 2nd, 2003
Present: The Honourable Madam Justice Heneghan
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and NOVOPHARM LIMITED
Respondents
REASONS FOR ORDER AND ORDER
[1] Abbott Laboratories and Abbot Laboratories Limited (the "Applicants") bring a motion to strike portions of the affidavits filed by Novopharm Limited (the "Respondent") on May 20, 2003 and further, for an order that the Respondent not be able to rely at the hearing of this application on the prior art or secondary sources identified in the affidavits in question.
[2] The Applicants' challenge is directed to the four affidavits identified in its Motion Record as Exhibits "D", "E", "F" and "G". I will refer to the affidavits by the Exhibit references since the motion materials were filed on a confidential basis and the motion was held in camera.
[3] Generally, the Applicants seek to strike the affidavits recorded on the Exhibits referred to above on the grounds that they are based on inadmissible hearsay evidence, contrary to the Federal Court Rules, 1998, SOR/98-106, specifically Rule 81. In the case of Exhibit "G", the Applicants further complain that the statements on the affidavits improperly seek to expand the allegations of fact set out in the Notice of Allegation ("NOA") underlying this application pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. The Applicants argue that the Respondent is attempting to introduce evidence of prior art that was not referred to in the NOA. The Applicants also argue that the contents of Exhibit "H" are based on hearsay, and therefore inadmissible, evidence.
[4] Generally, the Respondent argues that the evidence set out in Exhibits "D", "E" and "F" meets the test for the admissibility of hearsay evidence, that is, the test of reliability and necessity. In this regard, the Respondent relies on R. v. Khan, [1990] 2 S.C.R. 531, R. v. Smith, [1992] 2 S.C.R. 915 and R. v. Starr, [2000] 2 S.C.R. 144.
[5] The Applicants rely on P.S. Partsource Inc. v. Canadian Tire Corporation, Limited (2001), 267 N.R. 135 (F.C.A.) where the Federal Court of Appeal stated the test for striking affidavits prior to the hearing of an application, as follows at paragraph 18:
Nonetheless, I would emphasize that motions to strike all or parts of affidavits are not to become routine at any level of this Court. This is especially the case where the question is one of relevancy. Only in exceptional cases where prejudice is demonstrated and the evidence is obviously irrelevant will such motions be justified. In the case of motions to strike based on hearsay, the motion should only be brought where the hearsay goes to a controversial issue, where hearsay can be clearly shown and where prejudice by leaving the matter for disposition at trial can be demonstrated.
[6] The decisions referenced to by the parties provide the legal context which governs the motion brought by the Applicants and I turn now to the affidavits in issue.
[7] Exhibit "D" deals with a computer database that is owned and maintained by IMS Health. The deponent describes that database, the manner in which and from where IMS obtains the information which is contained in the database. The deponent, however, has no personal knowledge about the database except his experience of working with it.
[8] I am not persuaded that the entirety of Exhibit "D" is hearsay evidence. The deponent can be cross-examined in a meaningful way. In my opinion, only paragraph 4 of the affidavit raises problems since it deals with how IMS obtains its data. However, this is one thing to be explored on cross-examination and ultimately, the affidavit and any cross-examination can be the subject of argument as to weight.
[9] At the hearing of the motion, the Applicants focussed on paragraphs 32, 33 and 34 of the affidavit filed as Exhibit "E" to the affidavit filed in support of this motion.
[10] Paragraph 33 is clearly hearsay and should be struck out. I am not persuaded that paragraphs 32 and 34 are equally vulnerable.
[11] These paragraphs are relevant to the issue of prior art and should remain.
[12] The affidavit submitted as Exhibit "F" is impugned both on the basis of being hearsay evidence and an expansion of the factual basis set out in the NOA served by the Respondent. The Applicants argue that in order to claim the benefit of the decision in AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 256 N.R. 172, they must challenge any alleged expansion of the NOA before filing reply evidence. In this regard, the Applicants rely on Novartis AG et al v. Apotex Inc. et al (2001), 15 C.P.R. (4th) 417 (F.C.T.D.), appeal dismissed for mootness (2002), 22 C.P.R. (4th) 450 (F.C.A.).
[13] In the Novartis case, the first person sought and obtained leave to file additional evidence to respond to further documents submitted by Apotex through its affiant, Dr. Langer. At the hearing of the application for an order of prohibition, Novartis sought to challenge the further evidence from Dr. Langer notwithstanding its previous successful motion to file further evidence in response to Apotex's affidavit evidence. At paragraphs 72 to 75, the Court said as follows:
Apotex submits therefore that Novartis had clearly waived any right to complain about the impugned documents.
In my view, Novartis should have raised that question by way of motion before the hearing. Raising it as this moment could be unfair to the respondent, Apotex, who was led to believe that following the granting of the motion by Novartis to file further evidence, the material that was already in the file after the decision by the Court dated November 17, 1999, would stand.
As mentioned earlier, Novartis refers to the decision in AB Hassle, supra of the Court of Appeal. This decision was rendered on June 12, 2000 and Stone J.A. writing for the majority found that [page 439] adequate notice of allegation should contain the complete list of prior art on which a second person intends to rely at the time the notice of allegation is sent and that a second person cannot subsequently introduce prior art by way of an affidavit [at p. 288 C.P.R.]:
I am of the view, however, that paragraph 5(3)(a) does not contemplate such possibility. The intent appears to be that the entire factual basis be set forth in the statement rather than be revealed piecemeal when some need happens to arise in a section 6 proceeding. This Court has cautioned persons in the position of the respondent that they assume a risk that ta particular allegation may not be in compliance with the Regulations and that the deficiency cannot be cured by the Court in a section 6 proceeding.
Nevertheless, the interlocutory decision of this Court was rendered on November 17, 1999, months before the decision of the Court of Appeal and, in my view, I do not think that it would be reasonable for the Court to allow the applicants to raise that question now when a decision was already rendered in regards to the exact question by the Court two years ago.
[14] In my opinion, it is not clear that the affidavit at Exhibit "F" offends the rule set out by the Federal Court of Appeal in AB Hassle, supra, as being an expansion of the factual grounds set out in the NOA and the matters addressed in this affidavit are relevant to the ultimate issues in this prohibition application. It is preferable to leave the question of sufficiency of the NOA to the trial judge who will hear this application.
[15] The trial judge will have a complete record and be in a better position to assess the admissibility of the evidence and the sufficiency of the NOA. Further, there will be no unfairness to Novopharm if the affidavit at Exhibit "F" is ultimately struck out by the trial judge since this motion clearly alerts Novopharm to that possibility. Accordingly, in the exercise of my discretion, I decline to strike the affidavit at Exhibit "F" either on the ground of being hearsay evidence or as improperly expanding the NOA. This finding is clearly without prejudice to the right of the Applicants to raise these objections before the trial judge.
[16] Finally, I turn to Exhibit "G". This is clearly an affidavit based on hearsay and without much explanation as to why the information sought to be entered was not otherwise available.
[17] In conclusion, I grant the Applicants' motion in part and the following affidavits and portions of affidavits will be struck out on the basis that they contravene Rule 81 of the Federal Court Rules, 1998:
i) Exhibit "E", paragraph 33;
ii) Exhibit "G" in its entirety.
[18] The Applicants shall be at liberty to challenge the remaining affidavits and to raise arguments concerning the sufficiency of the NOA, in relation to the affidavit at Exhibit "F", upon the full hearing of this matter. In the exercise of my discretion, costs of this motion will be dealt with by the trial judge.
ORDER
THIS COURT ORDERS that the motion is allowed in part and paragraph 33 of the affidavit at Exhibit "E" of the Applicants' Motion Record and the affidavit at Exhibit "G" will be struck in its entirety. The costs of this motion are reserved to the trial judge.
"E. Heneghan"
J.F.C.C.
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
DOCKET: T-1236-02
STYLE OF CAUSE: ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH
and NOVOPHARM LIMITED
Respondents
PLACE OF HEARING: TORONTO, ONTARIO
DATE OF HEARING: JUNE 23, 2003
REASONS FOR ORDER
AND ORDER BY: HENEGHAN J.
DATED: JULY 2, 2003
APPEARANCES BY: Mr. Steve Mason
Mr. Marcus Klee
For the Applicants
Mr. Anthony Prenol
Mr. Michael Vaillancourt
For the Respondent
SOLICITORS OF RECORD: McCarthy & Tetrault
Toronto, Ontario
For the Applicants
Blake Cassels & Graydon LLP
Toronto, Ontario
For the Respondent
FEDERAL COURT OF CANADA
Date: 20030702
Docket: T-1236-02
BETWEEN:
ABBOTT LABORATORIES and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH and NOVOPHARM LIMITED
Respondents
REASONS FOR ORDER
AND ORDER