Apotex Inc. v. Merck & Co. and Merck Frosst Canada Ltd., (1993) 66 F.T.R. 245 (TD)

• Judge: Gibson, J.
• Court: Federal Court (Canada)
• Case Date: July 23, 1993
• Jurisdiction: Canada (Federal)
• Citations: (1993), 66 F.T.R. 245 (TD)

Apotex Inc. v. Merck & Co. (1993), 66 F.T.R. 245 (TD)

MLB headnote and full text

Apotex Inc. (applicant) v. Attorney General of Canada, and The Minister of National Health and Welfare (respondents) and Merck & Co. Inc. and Merck Frosst Canada Inc. (respondents)

(T-3099-92, T-427-93)

Indexed As: Apotex Inc. v. Merck & Co. and Merck Frosst Canada Ltd.

Federal Court of Canada

Trial Division

Gibson, J.

July 27, 1993.

Summary:

Apotex Inc. applied for an order of mandamus to compel the Minister of National Health and Welfare to issue a Notice of Compliance (NOC) respecting a generic drug. The respondents Merck applied for an order prohibiting the Minister from issuing the NOC on the ground that the new regime under the Patent Act protected its patent in the drug. The required review of Apotex's New Drug Submission had been completed and the issuance of a NOC was recommended, but the Minister delayed issuance from uncertainty of his legal position in the face of the impending new patent protection regime under which a NOC could not be issued until the patent expired.

The Federal Court of Canada, Trial Division, in a decision reported 66 F.T.R. 36, allowed Apotex's application for mandamus and dismissed Merck's application. Merck appealed and applied for a stay pending appeal.

The Federal Court of Canada, Trial Division, allowed the application and granted a stay pending appeal.

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compliance - Issuance of - [See Practice - Topic 8952 ].

Food and Drug Control - Topic 1112

Drugs - New drugs - Approval of generic drugs - [See Practice - Topic 8952 ].

Practice - Topic 8952

Appeals - Stay of proceedings pending appeal - When appellant entitled to stay - Apotex Inc. successfully applied for an order of mandamus to compel the Minister to issue a Notice of Compliance (NOC) respecting a generic drug to which Merck held that patent - Merck appealed - The Federal Court of Canada, Trial Division, issued a stay pending appeal - The parties agreed that there was a serious question to be tried; if no stay were granted and Merck were successful on appeal, the appeal would be rendered nugatory (irreparable harm) and the balance of convenience favoured preservation of the status quo.

Practice - Topic 8959

Appeals - Stay of proceedings pending appeal - Considerations - The Federal Court of Canada, Trial Division, stated that the power to grant a stay should only be exercised sparingly and only in the clearest of cases - The three elements of the test were (1) whether there is a serious question to be tried, as opposed to a frivolous or vexatious claim; (2) whether irreparable harm, that is harm not susceptible or difficult to be compensated in damages, would result if the stay were not granted; and (3) the balance of convenience, i.e., which party would suffer the greater harm from the grant or refusal of the stay.

Practice - Topic 8965

Appeals - Stay of proceedings pending appeal - Appeals respecting prerogative relief and injunctions - [See Practice - Topic 8952 ].

Cases Noticed:

Aztec Aviation Consulting Ltd. v. Canada et al. (1990), 35 F.T.R. 203 (T.D.), refd to. [para. 9].

Metropolitan Stores (MTS) Ltd. v. Manitoba Food and Commercial Workers Union, Local 832 and Labour Board (Man.), [1987] 1 S.C.R. 110; 73 N.R. 341; 46 Man.R.(2d) 241; 38 D.L.R.(4th) 321; 18 C.P.C.(2d) 273; 25 Admin. L.R. 20, refd to. [para. 14].

Varnum v. Canada (Minister of National Health and Welfare), Director of Bureau of Dangerous Drugs and College of Physicians and Surgeons (B.C.) (1987), 12 F.T.R. 34 (T.D.), refd to. [para. 18].

American Cyanamid Co. v. Ethicon Ltd., [1975] A.C. 396; [1975] 1 All E.R. 504; [1975] 2 W.L.R. 316 (H.L.), refd to. [para. 21].

Air Atonabee Ltd. v. Toronto Harbour Commissioners (1991), 135 N.R. 118 (F.C.A.), refd to. [para. 21].

Gauthier v. Canada Employment and Immigration Commission and Canada (Attorney General) (1986), 8 F.T.R. 162 (T.D.), refd to. [para. 29].

Statutes Noticed:

Federal Court Act, R.S.C. 1985, c. F-7, sect. 52(b)(i) [para. 27].

Federal Court Rules, C.R.C. 1978, c. 663, rule 341A, rule 1909 [para. 13].

Counsel:

Harry Radomski, for the applicant, Apotex Inc.;

Donald J. Rennie, for the respondents, Attorney General of Canada, and the Minister of National Health and Welfare;

Ian Binnie, Q.C., for the respondents, Merck & Co. and Merck Frosst Canada Inc.

Solicitors of Record:

Goodman & Goodman, Toronto, Ontario, for the applicant, Apotex Inc.;

John C. Tait, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondents, Attorney General of Canada, and the Minister of National Health and Welfare;

McCarthy, Tétrault, Toronto, Ontario, for the respondents, Merck & Co. and Merck Frosst Canada Inc.

This case was heard on July 23, 1993, at Ottawa, Ontario, before Gibson, J., of the Federal Court of Canada, Trial Division, who delivered the following judgment on July 27, 1993.