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Date: 20050209

Docket: A-537-04

Citation: 2005 FCA 58

CORAM:        NOËL J.A.

SHARLOW J.A.

MALONE J.A.

BETWEEN:

                                                  ASTRAZENECA CANADA INC.

                                                                                                                                            Appellant

(Applicant)

                                                                           and

                                               THE MINISTER OF HEALTH, THE

ATTORNEY GENERAL OF CANADA and

APOTEX INC.

                                                                                                                                      Respondents

(Respondents)

                                         Heard at Ottawa, Ontario, on February 9, 2005.

                    Judgment delivered from the Bench at Ottawa, Ontario, on February 9, 2005.

REASONS FOR JUDGMENT OF THE COURT BY:                                                       NOËL J.A.


Date: 20050209

Docket: A-537-04

Citation: 2005 FCA 58

CORAM:        NOËL J.A.

SHARLOW J.A.

MALONE J.A.

BETWEEN:

                                                  ASTRAZENECA CANADA INC.

                                                                                                                                            Appellant

(Applicant)

                                                                           and

                                               THE MINISTER OF HEALTH, THE

ATTORNEY GENERAL OF CANADA and

APOTEX INC.

                                                                                                                                      Respondents

(Respondents)

                                     REASONS FOR JUDGMENT OF THE COURT

                      (Delivered from the Bench at Ottawa, Ontario, on February 9, 2005)

NOËL J.A.

[1]                This is an appeal from a decision of Kelen J. ([2004] F.C.J. No. 1546; 2004 F.C. 1278) sitting in judicial review of a prior decision of the Minister of Health to issue a notice of compliance to Apotex Inc. for omeprazole 20 milligrams capsules.


[2]                Assuming without deciding that judicial review did lie from the decision of the Minister, we are of the view that Kelen J. applied the correct standard in assessing the Minister's decision. We are also of the view that applying that standard (reasonableness), it was open to Kelen J. based on the evidence before him, to hold that the Minister had acted reasonably in issuing a NOC to Apotex for its revised formulation without requiring Apotex to file a new allegation in relation to patents '693 and '891.

[3]                The appeal will be dismissed with costs to both the Minister and Apotex.

                    "Marc Noël"                    

J.A.


                                                  FEDERAL COURT OF APPEAL

                            NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                          A-537-04

AN APPEAL OF THE FEDERAL COURT OF KELEN J. DATED SEPTEMBER 20, 2004

STYLE OF CAUSE:                          AstraZeneca Canada Inc. v. The Minister of Health, the Attorney General of Canada and Apotex Inc.

PLACE OF HEARING:                    Ottawa, Ontario

DATE OF HEARING:                      February 9, 2005

REASONS FOR JUDGMENT OF THE COURT:              Noël J.A.

Sharlow J.A.

Malone J.A.

DELIVERED FROM THE BENCH BY:                             Noël J.A.

APPEARANCES:

Mr. Gunars A. Gaikis

Mr. J. Sheldon Hamilton

Ms. Nancy Pei

For AstraZeneca Canada Inc.

Mr. F.B. Woyiwada

For the Minister of Health and the Attorney General of Canada

Mr. H.B. Radomski

Mr. Andrew Brodkin

For Apotex Inc.

SOLICITORS OF RECORD:

Smart and Biggar

Toronto, Ontario

For AstraZeneca Canada Inc.

Mr. John Sims, Q.C.

Deputy Attorney General of Canada

Ottawa, Ontario

For the Minister of Health and the Attorney General of Canada

Goodmans LLP

Toronto, Ontario

For Apotex Inc.



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