Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2004 FC 389

Date: 20040316

Docket: T-668-03

Citation: 2004 FC 389

Ottawa, Ontario, this 16^th of March, 2004

Present:           The Honourable Justice James Russell

BETWEEN:

                                          SANOFI-SYNTHELABO CANADA INC. and

SANOFI-SYNTHELABO

                                                                                                                                                      Applicants

                                                                              and

                                     APOTEX INC. and THE MINISTER OF HEALTH

                                                                                                                                               Respondents

REASONS FOR ORDER AND ORDER

MOTION

[1]                 This Appeal Motion is for:

1.          an Order setting aside the Order of Madam prothonotary Tabib dated February 12, 2004 wherein she denied, inter alia, the Applicants' motion for leave to file the Affidavit of Dr. Hans Schroeder;

2.          an Order permitting the Applicants to serve and file the Affidavit of Dr. Hans Schroeder within two (2) days of the date of the Order;

3.          if leave is granted to file the Affidavit of Dr. Hans Schroeder, an Order that any cross-examination of Dr. Hans Schroeder is to be completed by March 26, 2004;

4.          the Applicants' costs of this motion; and

5.          such further and other relief as this Honourable Court may deem just.

BACKGROUND

[2]                 On March 10, 2003, Apotex delivered to the Applicants a Notice of Allegation ("NOA") pursuant to the Patented Medicines (Notice of Compliance) Regulations ("Regulations") in respect of Canadian Patent No. 1,336,777 ("777 Patent").

[3]                 The NOA indicated that Apotex had filed a submission for a Notice of Compliance ("NOC") with the Minister of Health ("Minister") for a tablet for oral administration comprising clopidogrel bisulphate in a dosage amount of 75 mg for inhibiting platelet aggregation.

[4]                 In the NOA, Apotex alleged that claims 6, 7, 8 and 9 of the '777 Patent are irrelevant for the purposes of the Regulations because they do not contain a claim for the medicine itself or a claim for the use of the medicine. Apotex also alleged that it would not infringe claims 2, 4 and 5 of the '777 Patent. Apotex further alleged that claims 1, 3, 10 and 11 (as well as claims 2, 4 and 5 if asserted as being infringed) of the '777 Patent are invalid.

[5]                 In support of its allegations of invalidity, Apotex relied upon a series of prior art documents, including Apotex Document number 5, for, inter alia, the purpose of demonstrating that claims 1, 3, 10 and 11 (as well as claims 2, 4 and 5 if asserted as being infringed) are invalid on the basis of obviousness. More particularly, Apotex alleged that, by reasons of the state of the art publicly available as of the priority date of the '777 Patent, a person of ordinary skill in the art would have been led directly and without difficulty to the claimed invention.

[6]                 By Notice of Application dated April 28, 2003 ("Notice of Application"), the Applicants sought an order, on various grounds, in accordance with ss. 6(1) of the Regulations, prohibiting the Minister from issuing a NOC to Apotex in connection with 75 mg strength oral tablets of the drug clopidogrel bisulphate until after the expiration of the '777 Patent.

[7]                 Despite advancing various ground in support of the relief requested, the Applicants did not specifically assert that documents that were relied upon by Apotex were either not publicly available or not locatable by a person of ordinary skill.

[8]                 In their Written Representations filed in support of this Appeal Motion, the Applicants state that, in response to the NOA, they relied upon the statutory presumption of validity contained in s. 43 of the Patent Act.

[9]                 On or about June 12, 2003, the Applicants filed their evidence in support of the Application. This evidence did not challenge Apotex's documents as not being publicly available at the pertinent time or reasonably locatable notwithstanding that Apotex's NOA had been served over three months earlier.

[10]            On August 1, 2003, Apotex served upon the Applicants several affidavits, including the Affidavit of Samuel Tekie, sworn July 30, 2003 ("Tekie Affidavit"). Mr. Tekie was cross-examined on November 7, 2003.

Notice of Status Review

[11]            On November 21, 2003, the Court issued a Notice of Status Review requiring the Applicants to show cause, by written submissions, why the within Application should not be dismissed for delay. By letter dated December 5, 2003, almost one month after cross-examining Mr. Tekie, the Applicants responded to the Notice of Status Review.

[12]            The Applicants proposed a schedule for the completion of pre-hearing interlocutory steps. No mention was made of an intention to file further evidence.

[13]            By Order dated January 21, 2004, Madam Prothonotary Tabib ordered that the within proceeding continue as a specially managed proceeding and endorsed the schedule proposed by the Applicants in their December 5, 2003 letter.

Order of Prothonotary Tabib under Appeal

[14]            By Notice of Motion dated January 19, 2004, the Applicants sought to compel Mr. Tekie to re-attend for cross-examination and provide answers to questions for which purported "undertakings" had been given. The premise for the motion before Prothonotary Tabib was that Mr. Tekie had given evidence to the effect that he had located Apotex Document number 5 by reading a U.S. Patent that made reference to it. As Mr. Tekie did not know the specific identity of the U.S. Patent, the Applicants asserted that they had obtained an undertaking from Mr. Tekie that he would obtain this information and provide it to them. By this same motion, the Applicants sought leave to file the Schroeder Affidavit.

[15]            By Order dated February 12, 2004, Prothonotary Tabib dismissed the Applicants' motion in its entirety. Prothonotary Tabib held that, upon a careful consideration of the transcript of the Tekie cross-examination, no undertaking to identify the U.S. Patent that cited Document 5 was sought by the Applicants nor given by Mr. Tekie.

[16]            Prothonotary Tabib next went on to question the relevance of the Applicants' proposed affidavit and specifically noted that the evidence sought to be adduced was not directed to the manner in which a search for Document 5 had been made, but simply to the fact that it was present as part of a U.S. Patent at a particular time.

[17]            Finally, Prothonotary Tabib held that the Applicants had failed to establish that the "new" information sought to be filed was not available to them prior to the cross-examinations. Prothonotary Tabib specifically noted, in this regard, that the Applicants knew which databases had been searched and what prior art was claimed to have been available in them.

The Appeal

[18]            In this Appeal the Applicants urge the Court to consider the matter de novo because Madam Prothonotary Tabib was clearly wrong in principle and in misapprehending the facts, and because questions vital to the final issue of the case are involved, all within the meaning of the well-known test in Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425 at 463 (C.A.).

[19]            In essence, the Applicants say that Prothonotary Tabib was clearly wrong to conclude that the evidence which the Applicants seek to file in their reply affidavit could have been discovered by any search of the United States Patent and Tradesmark Office database at the relevant date. The Applicants also say that Prothonotary Tabib was clearly wrong to conclude that, as a matter of law, the reply affidavit should not be filed because the evidence was available prior to cross-examination. In accordance with the decision of this Court in Robert Mondavi v. Spagnol's Wine & Beer Making Supplies Limited (2001), 10 C.P.R. (4^th) 331, the Court is not barred from exercising its discretion to allow a party to file affidavit evidence containing information that was available before cross-examination.

[20]            Finally, the Applicants argue that the question in this appeal is vital to the final issue in the case because if the evidence of Dr. Schroeder is not admitted then there is a good possibility that the Court will find that Mr. Tekie's search was conducted properly and that Reference 5 is admissible.

[21]            Having reviewed the decision of Prothonotary Tabib against the Applicants submissions, I find that this is not a matter that the Court should hear de novo in that she was not clearly wrong on the facts or the law and that she exercised her discretion appropriately. Nor do I find that this appeal raises a question vital to a final issue of the case as that concept is defined by the jurisprudence. See, for example, the recent decision of O'Keefe J. in AstraZeneca AB v. Apotex Inc., [2004] F.C.J. No. 54. A question is only vital to the final issue of a case when it means that a decision on that question will conclusively decide a final issue. That is not the case here.

[22]            Even if I should be wrong on this point and consider the Applicants submissions de novo, Rule 84(2) of the Federal Court Rules, 1998, preclude the filing of an affidavit after cross-examining the deponent of an affidavit filed in the application without the consent of the parties or leave of the court.    Before granting leave, the Court should consider the various factors outlined in Salton Appliances (1985) Corp. v. Salton Inc. (2000), 4 C.P.R. (4^th) at 496-498 (F.C.T.D.) and Robert Mondari Winery v. Spagnot's Wine & Beer Making Supplies Ltd. (2001), 14 C.P.R. (4^th) 269 (F.C.T.D.). These factors are, generally, relevance, assistance to the Court, availability prior to the conduct of the cross-examination, prejudice and the overall interests of justice.

[23]            On the facts of the present case, the relevance is questionable at best when the grounds advanced by the Applicant for challenging the NOA are examined. I am not convinced that, on the issue of relevance, the Schroeder affidavit will assist the Court on the matter before it. Nor, it seems to me, does the affidavit directly address the skilled workman/reasonable and diligent search issue. The Applicants have not provided me with convincing evidence that the information was not discoverable beforehand through reasonable diligence. And, given the present state of the proceedings, I believe that the prejudice and justice issues favour Apotex rather than the Applicants.

[24]            Hence, even if the matter were considered de novo, the Court comes to the same conclusion as Prothonotary Tabib.

ORDER

THIS COURT ORDERS that

1.          The Motion is dismissed.

2.          Apotex shall have the costs of the motion payable immediately and irrespective of the cause.

   "James Russell"

_____________________________________

                                                                                                 JFC

FEDERAL COURT

Names of Counsel and Solicitors of Record

DOCKET:T-668-03

STYLE OF CAUSE:SANOFI-SYNTHELABO CANADA INC.

                                                          and SANOFI-SYNTHELABO

Applicant

             and

    APOTEX INC. and THE MINISTER OF HEALTH Respondents

PLACE OF HEARING:                        TORONTO, ONTARIO

DATES OF HEARING:                       MARCH 8^TH, 2004

REASONS FOR ORDER

AND ORDER BY:                                 RUSSELL, J.

DATED:                                                   MARCH 16^TH, 2004

APPEARANCES BY:                          

Mr. Jamie Mills                                                                FOR THE APPLICANT

Ms. Cristin Wagner                                                     FOR THE APPLICANT

Mr. Andrew Brodkin                                                      FOR THE RESPONDENT

SOLICITORS OF RECORD:                 

Gowling Lafleur Henderson LLP

Ottawa, Ontario                                                         FOR THE APPLICANTS

Goodmans LLP                                                           FOR THE RESPONDENT      

Toronto, Ontario                                           

Ms. Barbara Jackman                                                     FOR THE RESPONDENT

Toronto, Ontario

                          FEDERAL COURT

Date:

Docket:DES-1-00

BETWEEN:

SANOFI-SYNTHELABO CANADA INC. and

                  SANOFI-SYNTHELABO                                                       

                                                                                                                                               Applicants

and

APOTEX INC.. and THE MINISTER OF HEALTH

Respondents

REASONS FOR ORDER AND ORDER