Federal Court of Appeal Decisions

Date: 20070516

Docket: A-58-07

Citation: 2007 FCA 195

CORAM:       SEXTON J.A.

                        SHARLOW J.A.

                        MALONE J.A.

BETWEEN:

PFIZER CANADA INC. and PFIZER INC.

Appellants

and

APOTEX INC. and THE MINISTER OF HEALTH

Respondents

Heard at Toronto, Ontario, on May 16, 2007.

Judgment delivered from the Bench at Toronto, Ontario, on May 16, 2007.

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

Date: 20070516

Docket: A-58-07

Citation: 2007 FCA 195

CORAM:       SEXTON J.A.

                        SHARLOW J.A.

                        MALONE J.A.

BETWEEN:

PFIZER CANADA INC. and PFIZER INC.

Appellants

and

APOTEX INC. and THE MINISTER OF HEALTH

Respondents

REASONS FOR JUDGMENT OF THE COURT

(Delivered from the Bench at Toronto, Ontario, on May 16, 2007)

SHARLOW J.A.

[1]               This is an appeal from the judgment of the Federal Court (2007 FC 26) dismissing the application of Pfizer Canada Inc. and Pfizer Inc. (collectively, “Pfizer”) under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. for its sildenafil tablets until after the expiry of Canadian Patent No. 2,044,748.

[2]               The first issue is whether the Judge misinterpreted the notice of allegation, leading him to reach a conclusion on the utility of claim 6 of the 748 patent that was not raised in the notice of allegation. We are not persuaded that the Judge made an error in his interpretation of the notice of allegation. In our view, the notice of allegation did allege that the compounds of the 748 patent including sildenafil had not, in the words of paragraph 65 of the Judge’s reasons, been “shown, or soundly predicted, to be potent and selective cGMP PDE inhibitors”.

[3]               The second issue is whether the doctrine of sound prediction applies at all to a claim for a new compound. In our view, it does. This point was most clearly addressed by Justice Binnie in Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, in particular at paragraphs 46 and 80.

[4]               The third issue is whether the Judge made a palpable and overriding error in finding no evidence that sildenafil was a potent and selective cGMP PDE inhibitor. Our review of the record and the written submissions discloses no such error. We accept the submission of Apotex that the two articles cited by Pfizer as being evidence on this point do not support Pfizer’s position.

[5]               In light of these conclusions, it is unnecessary to deal with Pfizer’s fourth argument relating to the sufficiency of the disclosure in the patent.

[6]               For these reasons, this appeal will be dismissed with costs.

                                                                                                    “K. Sharlow”

FEDERAL COURT OF APPEAL

NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                                           A-58-07

APPEAL TO THE FEDERAL COURT OF APPEAL, FROM AN ORDER OF THE HONOURABLE MR. JUSTICE O’REILEY OF THE FEDERAL COURT, DATED JANUARY 12, 2007, IN COURT FILE NO. T-2137-04.

STYLE OF CAUSE:                          PFIZER CANADA INC. and PFIZER INC. v. APOTEX

                                                            INC. and THE MINISTER OF HEALTH

PLACE OF HEARING:                    TORONTO, ONTARIO

DATE OF HEARING:                      MAY 16, 2007

REASONS FOR JUDGMENT

OF THE COURT BY:                       (SEXTON, SHARLOW, & MALONE JJ. A)

DELIVERED FROM THE

BENCH BY:                                       SHARLOW J.A.

APPEARANCES:

SOLICITORS OF RECORD: