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Date: 19980127


Docket: T-2494-96

BETWEEN:

     HOFFMANN-LA ROCHE LIMITED, and

     SYNTEX PHARMACEUTICALS

     INTERNATIONAL LIMITED

     Applicants

     - and -

     THE MINISTER OF NATIONAL HEALTH AND WELFARE

     and NOVOPHARM LIMITED

     Respondents

     Docket: T-2807-96

BETWEEN:

     HOFFMANN-LA ROCHE LIMITED, and

     SYNTEX PHARMACEUTICALS

     INTERNATIONAL LIMITED

     Applicants

     - and -

     THE MINISTER OF NATIONAL HEALTH AND WELFARE

     and NOVOPHARM LIMITED

     Respondents

     REASONS FOR ORDER AND ORDER

JEROME, A.C.J.

[1]      This application came for hearing before me at Toronto on November 4th, 1997. At the opening of Novopharm's response the applicants advised that they would not oppose the dismissal of the application in respect of the '735, '318, '319, '646, '338 and '627 Patents, the respondent so moved and it was so ordered. The Court reserved on the dismissal of the application in respect of claims 1-26 and 28-29 of the '660 Patent and claims 1-26 and 28-31 of the '717 Patent as the applicants have left in issue in this matter claim 27 of CP 2,131,660 and claim 27 of CP 1,135,717.

[2]      I accept the submission of the respondent that these claims are to intermediates used in the process of making an active ingredient for pharmaceutical use, then under the jurisprudence as found by this Court and by the Federal Court of Appeal and therefore binding on this Court, such claims are not claims for the medicine itself or its use. Furthermore these precise patents have already been considered by our Court, and not only do I agree with the following comments by my colleague Madame Justice Reed:

                 Many aspects of the issues originally raised in the present applications have been settled, at least, insofar as the Trial Division is concerned. This is the result of decisions such as: Deprenyl Research Ltd. v. Apotex Inc. (1994), 55 C.P.R. (3d) 171 (F.C.T.D.); affirmed (1995), 60 C.P.R. (3d) 501 (F.C.A.) (process claims are not claims which contain a claim for the medicine itself); Eli Lilly and Co. v. Apotex Inc. (1995), 63 C.P.R. (3d) 245 (F.C.T.D.) (process claims for intermediate substances are not claims for the medicine itself); Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58; affirmed A-389-95, December 5, 1995 [reported 67 C.P.R. (3d) 25] (composition or formulation claims for the medicine itself).                 

The order of Madame Justice Reed was affirmed by the Federal Court of Appeal, (1996) 70 C.P.R. (3d) 1. At page 2 Stone J.A. cites the argument of the appellants in those proceedings, (i.e. the applicants in this proceeding) as follows:

                 "In paragraph 19 and 25 of their written argument, the Appellants make the following submissions:                 
                 19. In view of this Court's decision in Deprenyl ... (where this Court held that process claims were not covered by the Regulations) and in Eli Lilly and Co. ... (where this Court held that claims for an intermediate were not covered by the Regulations), and the fact that the 660, 717, 627 and 338 patents contain only claims to processes and intermediates, the Appellants will not oppose the dismissal of the appeal as regards these patents, without prejudice to any rights of appeal. ... "(emphasis added).                 

[3]      As I not only agree with both decisions, but I am bound by them and I have not been persuaded that the facts it the case at bar are sufficiently to warrant the relief sought, the application for prohibition is dismissed on the ground that the claims of the '660 and '717 patents are claims to intermediates and are not claims for the medicine itself nor claims for the use of the medicine.

[4]      The respondents are also entitled to costs forthwith after taxation on party basis.

                             "JAMES A. JEROME"

                                 A.C.J.

Toronto, Ontario

January 27, 1998

     FEDERAL COURT OF CANADA

     Names of Counsel and Solicitors of Record

DOCKET:                      T-2494-96

STYLE OF CAUSE:                 
                         HOFFMANN-LA ROCHE LIMITED, and SYNTEX PHARMACEUTICALS INTERNATIONAL LIMITED
                         - and -
                         THE MINISTER OF NATIONAL HEALTH AND WELFARE and NOVOPHARM LIMITED
                         AND     

     Docket: T-2807-96

                         BETWEEN:
                         HOFFMANN-LA ROCHE LIMITED, and
                         SYNTEX PHARMACEUTICALS
                         INTERNATIONAL LIMITED
                         - and -
                         THE MINISTER OF NATIONAL HEALTH AND WELFARE and
                         NOVOPHARM LIMITED

                    

DATE OF HEARING:              NOVEMBER 3, 1997

PLACE OF HEARING:              TORONTO, ONTARIO

REASONS FOR JUDGMENT BY:          JEROME, A.C.J.

DATED:                      JANUARY 27, 1998


     - 2 -

APPEARANCES:                 

                         Mr. Guinars Gaikis

                         Mr. Sheldon J. Hamilton

                            

                             For the Applicants

                         Mr. Donald N. Plumley, Q.C.

                         Mr. Mark Mitchell

                             For the Respondent

                             (Novopharm Ltd.)

                        

SOLICITORS OF RECORD:         

                         Smart & Biggar

                         Barristers & Solicitors

                         2300 - 439 University Avenue

                         Toronto, Ontario

                         M5G 1Y8

                             For the Applicants

                         Ridout & Maybee

                         Barristers & Solicitors

                         2400 - One Queen Street East

                         Toronto, Ontario

                         M5L 3B1

                             For the Respondent

                             (Novopharm Ltd.)

                         George Thomson

                         Deputy Attorney General

                         of Canada

                             For the Respondent


                          FEDERAL COURT OF CANADA


Date: 19980127


Docket: T-2494-96

                         BETWEEN:

                        

                         HOFFMANN-LA ROCHE LIMITED, and

                         SYNTEX PHARMACEUTICALS

                         INTERNATIONAL LIMITED

     Applicants

                         - and -

                         THE MINISTER OF NATIONAL HEALTH AND WELFARE and NOVOPHARM LIMITED

     Respondents

                         AND

     Docket: T-2807-96

                         BETWEEN:

                         HOFFMANN-LA ROCHE LIMITED, and
                         SYNTEX PHARMACEUTICALS
                         INTERNATIONAL LIMITED

     Applicants

                         - and -
                         THE MINISTER OF NATIONAL HEALTH AND WELFARE and NOVOPHARM LIMITED

     Respondents

    

                        

            

                         REASONS FOR ORDER

                        


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