Pfizer Canada Inc. v. Apotex Inc., 2002 FCT 152

                                                                                                                                          Date:    20020211

                                                                                                                                     Docket:    T-2096-00

                                                                                                                Neutral citation: 2002 FCT 152

Ottawa, Ontario, this 11^th day of February, 2002

PRESENT: THE HONOURABLE MR. JUSTICE BLANCHARD

BETWEEN:

                                             PFIZER CANADA INC. and PFIZER INC.

                                                                                                                                                      Applicants

                                                                              - and -

                                     APOTEX INC. and THE MINISTER OF HEALTH

                                                                                                                                               Respondents

                                               REASONS FOR ORDER AND ORDER

[1]                 This is a motion by the respondent Apotex Inc. ("Apotex") appealing the Order of Prothonotary Aronovitch dated December 11, 2001, in which the Prothonotary restricted the use of documentary evidence (prior art references) at the hearing of this matter. The respondent Apotex was ordered not to rely on the five impugned documents for the purpose of arguing the validity of the Patent.

[2]                 The respondent Apotex's notice of allegations of invalidity were supported by 96 prior art references. In response to the notice of allegation, the applicants commenced this proceeding seeking an order prohibiting the respondent Minister of Health ("Minister") from issuing a notice of compliance to Apotex in respect of the medicine sertraline. In support of their application, the applicants filed four affidavits, three of which were expert affidavits, citing numerous prior art references as exhibits. In reply, the respondent Apotex also filed four affidavits, three of which were experts affidavits. All of the affiants were cross-examined. During the cross-examinations of two of the applicants' experts, the respondent Apotex's counsel challenged the experts' evidence by referring to and producing various prior art references which were not included in the notice of allegation.

[3]                 In her order, the Prothonotary made the following endorsement:

I conclude that while the rights of the parties on cross-examination in the context of s.6 proceeding are preserved, these must be exercised subject to the admonition of AB Hassle, supra. Thus while the disputed documents may be relied upon for the purpose of proper cross-examination, they cannot be used to add to the prior art. To find otherwise would defeat the restrictions placed on the respondent in adducing evidence in s.6 proceedings and preclude the applicant from challenging or replying to the expanded evidence of prior art.

[4]                 The Prothonotary therefore applied the Federal Court of Appeal decision in A. B. Hassle v. Canada (2000), 7 C.P.R. (4th) 272 (F.C.A.) ("Hassle"), and ordered that the respondent could not rely on the documents adduced by the respondent on cross-examination for the purposes of arguing in the application, that the Patent is invalid.

[5]                 In Hassle, supra, the second person as defined in the Patent and Medicines (Notice of Compliance) Regulations, SOR/93-133, filed its expert evidence which relied upon and appended as exhibits dozens of prior art references not previously listed in the notice of allegation. The Court held that these prior references sought to expand the factual basis of the allegation made beyond that set out in the notice of allegation and could not be relied upon, since the detailed statement of allegation must be such as to make the patentee fully aware of the grounds for the claim, otherwise the patentee would be unable to decide whether or not to initiate section 6 proceedings.

[6]                 In the case before me, the respondent Apotex argues that the documents were relevant and otherwise satisfied all known prerequisites for admissibility and that their use should be permitted for the purpose of arguing the validity of the Patent. The respondent Apotex submits that the Prothonotary erred in that she misconstrued pertinent jurisprudence, created a dichotomy foreign to the law of evidence by disallowing evidence for the purpose of arguing the validity of the Patent while allowing the evidence on cross-examination for the purpose of challenging opposing expert testimony and, finally, usurped the role of the hearing judge.

[7]                 The respondent Apotex argues that the documents at issue were introduced, not as exhibits to the respondent Apotex's expert affidavits to expand or alter the factual basis of the allegations of invalidity set out in the notice of allegation as was the case in Hassle, supra, but rather, put to the applicants' witnesses on cross-examination in order to test their expert opinions and to impeach their credibility consistent with the factual bases and state of the art at the relevant time previously asserted in the notice of application. The respondent Apotex contends, consequently, that the Hassle case, supra, is inapplicable.

[8]                 The respondent Apotex further contends that the Prothonotary should have followed the Court of Appeal decision in Abbott Laboratories, Ltd. v. Nu-Pharm Inc. (1998), 83 C.P.R. (3d) 441 at para. 10, (Abbott). In that case, the Court commented as follows:

The evidence relating to patent ‘272, and indeed to patent ‘558 as well, was introduced not to challenge the validity of such patents, but merely to establish the state of the knowledge of a person skilled in the art at the time of the filing of patent ‘151.           

[9]                 I am of the view that the prior art references at issue in the case before me do more than establish the state of the knowledge of the person skilled in the art at the time of the filing of the patent. These documents expand the factual basis of the allegations made beyond that set out in the notice of allegation. The Court of Appeal in Hassle , supra, held that this was not permissible. A first person must have an opportunity to respond to or comment upon this evidence. I therefore conclude that, in the circumstances of this case, the Prothonotary did not err in applying the principles set out in Hassle to the impugned prior art evidence.

[10]            With respect to the remaining grounds of appeal advanced by Apotex, namely the alleged evidentiary dichotomy not known to law and usurping the role of the hearing judge, I am not persuaded that the respondent Apotex has demonstrated that the Prothonotary made an error of law in her conclusions that would justify the intervention of this Court.

[11]               In my view, it was open to the Prothonotary to limit the use of prior art properly used in a cross-examination and preclude its introduction in argument on the validity of the Patent in the application. Arguably, the Court of Appeal in Abbott, supra, recognized the different purposes for which the same evidence can be used in the same proceeding. In Abbott, the Court found the evidence admissible for the purpose of establishing the state of the knowledge of the expert, but not admissible for the purpose of challenging the validity of the Patent. I am therefore of the view that the argument put forward by the respondent Apotex of this alleged unworkable evidentiary dichotomy has no merit.

[12]            Similarly, I cannot accept the respondent Apotex's contention that, by ruling as she did, the Prothonotary usurped the authority of the hearing judge. I am substantially in agreement with and adopt the arguments set forth in the applicants' written representations, and conclude that the Prothonotary did not commit an error of law in considering the applicants' motion and in concluding as she did. The Prothonotary was not clearly wrong in the exercise of her discretion.

[13]            For the above reasons, this appeal will be dismissed.

                                                                            ORDER

THIS COURT ORDERS that:

1.         This motion by the respondent Apotex appealing the Order of Prothonotary Aronovich dated December 11, 2001, is dismissed with costs to the applicants.

                                                                                                                               "Edmond P. Blanchard"                       

                                                                                                                                                               Judge                         

                                                       FEDERAL COURT OF CANADA

                                                                    TRIAL DIVISION

                         NAMES OF SOLICITORS AND SOLICITORS ON THE RECORD

COURT FILE NO.:                        T-2096-00

STYLE OF CAUSE:                      Pfizer Canada Inc., and Pfizer Inc.    v.    Apotex Inc. and The            Minster of Health

NOTICE OF MOTION DISPOSED OF IN WRITING

REASONS FOR ORDER AND ORDER OF THE HONOURABLE MR. JUSTICE BLANCHARD

DATED:                                           February 11, 2002

WRITTEN SUBMISSIONS:

Mr. Anthony CreberFOR APPLICANT

Mr. Andrew R. BrodkinFOR RESPONDENT (APOTEX)

Mr. W.B. Woyiwada                                                       FOR RESPONDENT (MINSTER       OF                                              HEALTH)                                             

SOLICITORS OF RECORD:

Gowling Lafleur Henderson LLPFOR APPLICANT

GoodmansFOR RESPONDENT (APOTEX)

Mr Morris Rosenberg                                                        FOR RESPONDENT (MINSTER     OF Deputy Attorney General of Canada                                        HEALTH)