Apotex Inc. v. Merck & Co. and Merck Frosst Canada Inc., (1993) 161 N.R. 157 (FCA)

• Judge: Mahoney, Robertson and MacDonald, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: September 01, 1993
• Jurisdiction: Canada (Federal)
• Citations: (1993), 161 N.R. 157 (FCA)

Apotex Inc. v. Merck & Co. (1993), 161 N.R. 157 (FCA)

MLB headnote and full text

Apotex Inc. (appellant) v. Attorney General of Canada and Minister of National Health and Welfare (respondents) and Merck and Co. Inc. and Merck Frosst Canada Inc. (respondents)

(A-484-93)

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

Federal Court of Appeal

Mahoney, Robertson and

MacDonald, JJ.A.

September 1, 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 an 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 an 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, in a decision reported 66 F.T.R. 245, allowed the application and granted a stay pending appeal. Apotex appealed.

The Federal Court of Appeal allowed the appeal and set aside the stay.

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 - The trial judge granted Apotex Inc. an order of mandamus to compel the Minister to issue a Notice of Compliance (NOC) respecting a generic drug to which Merck held the patent - Merck appealed - The Federal Court of Canada, Trial Division, granted a stay pending appeal, concluding that the appeal would be rendered nugatory if no stay were granted and Merck were successful on appeal - Apotex appealed - The Federal Court of Appeal set aside the stay - The trial judge correctly found that issuance of the NOC would not result in irreparable harm; accordingly, staying the order was an error in principle.

Practice - Topic 8957

Appeals - Stay of proceedings pending appeal - Appeal of order granting a stay - [See Practice - Topic 8952 ].

Practice - Topic 8959

Appeals - Stay of proceedings pending appeal - Considerations - [See Practice - Topic 8952 ].

Practice - Topic 8965

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

Counsel:

Harry Radomski and Richard E. Naiberg, for the appellant;

No one appeared for the respondent, At­torney General of Canada and Minister of National Health and Welfare;

W. Ian C. Binnie, Q.C., and William H. Richardson, for the respondent, Merck and Co. Inc. and Merck Frosst Canada Inc.

Solicitors of Record:

Goodman & Goodman, Toronto, Ontario, for the appellant;

Tory, Tory, DesLauriers and Binnington, Toronto, Ontario, for the respondent, Attorney General of Canada and Minister of National Health and Welfare;

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

This appeal was heard on September 1, 1993, at Ottawa, Ontario, before Mahoney, Robertson and McDonald, JJ.A., of the Federal Court of Appeal. On September 1, 1993, Mahoney, J.A., delivered the following judgment for the court.