Apotex Inc. v. Merck & Co. and Merck Frosst Canada Inc., (1993) 66 F.T.R. 36 (TD)

• Judge: Dubé, J.
• Court: Federal Court (Canada)
• Case Date: July 16, 1993
• Jurisdiction: Canada (Federal)
• Citations: (1993), 66 F.T.R. 36 (TD)

Apotex Inc. v. Merck & Co. (1993), 66 F.T.R. 36 (TD)

MLB headnote and full text

Apotex Inc. (applicant) v. Attorney General of Canada and Minister of National Health and Welfare, 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 Inc.

Federal Court of Canada

Trial Division

Dubé, J.

July 16, 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' 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, ordered the Minister to issue the NOC, ruling that once the review process was complete under the old regime and the issuance of a NOC recommended, the Minister's discretion was exhausted and he was bound to issue the NOC.

Administrative Law - Topic 3705

Judicial review - Mandamus - Mandamus to government and executive - Ministers of the Crown - [See Food and Drug Control - Topic 1106 ].

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compliance - Issuance of - Apotex Inc. 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 the patent - The required review of Apotex' New Drug Submission had been completed and the issuance of a NOC was recommended, but the Minister delayed issuance in the face of the impending, but not yet proclaimed, new patent protection regime under which a NOC could not be issued until the patent expired - The Federal Court of Canada, Trial Division, ordered the Minister to issue the NOC, ruling that once the review process was complete under the old regime, the Minister's discretion was exhausted and he was bound to issue the NOC.

Food and Drug Control - Topic 1112

Drugs - New drugs - Approval of generic drugs - [See Food and Drug Control - Topic 1106 ].

Statutes - Topic 4945

Operation and effect - Enabling acts - Powers - General - Extent or scope of discretionary power - [See Food and Drug Control - Topic 1106 ].

Cases Noticed:

Massey Manufacturing Co., Re (1886), 11 O.R. 444 (C.P.), affd. 13 O.A.R. 446 (C.A.), appld. [para. 18].

Ontario (Provincial Board of Health) v. Toronto (City) (1920), 51 D.L.R. 444 (Ont. C.A.), appld. [para. 18].

Scott v. College of Physicians and Surgeons (Sask.), [1993] 1 W.W.R. 533; 100 Sask.R. 291; 18 W.A.C. 291 (C.A.), appld. [para. 19].

Galloway v. London Corp. (1866), L.R. 1 H.L. 34 (H.L.), appld. [para. 20].

Glaxo Canada Inc. v. Canada (Minister of National Health and Welfare) and Apotex Inc. et al. (No. 5) (1987), 16 F.T.R. 81; 18 C.P.R.(3d) 206 (T.D.), appld. [para. 20].

Apotex Inc. v. Canada (Attorney General and Minister of National Health and Welfare)(No. 1) (1986), 1 F.T.R. 310; 9 C.P.R.(3d) 193 (T.D.), appld. [para. 20].

Pfizer Canada Inc. v. Canada (Minister of National Health & Welfare) et al. (1986), 12 C.P.R.(3d) 438 (F.C.A.), appld. [para. 20].

Woodglen & Co. v. North York and Building Inspector for North York (Uzumeri) (1984), 5 O.A.C. 313; 47 O.R.(2d) 614 (Div. Ct.), appld. [paras. 21, 74].

Wolfond v. North York (City) Building Commissioner (1990), 74 O.R.(2d) 466 (Dist. Ct.), appld. [para. 22].

Spooner Oils Ltd. v. Turner Valley Gas Conservation Board, [1933] S.C.R. 629, appld. [para. 23].

Gustavson Drilling (1964) Ltd. v. Minister of National Revenue, [1977] 1 S.C.R. 271; 7 N.R. 401, appld. [para. 23].

Hutchins v. National Parole Board et al. (1993), 63 F.T.R. 263 (T.D.), revd. 156 N.R. 205 (F.C.A.), appld. [para. 24].

Noel & Lewis Holdings Ltd. v. R. (1983), 1 Admin. L.R. 290 (F.C.T.D.), appld. [para. 25].

H.T.V. Ltd. v. Price Commission, [1976] I.C.R. 170 (C.A.), appld. [para. 25].

Roncarelli v. Duplessis, [1959] S.C.R. 121, appld. [para. 25].

Apotex Inc. v. Ontario (Attorney General) et al. (1984), 47 O.R.(2d) 176 (H.C.), appld. [para. 25].

Mensinger v. Minister of Employment and Immigration, [1987] 1 F.C. 59; 5 F.T.R. 64 (T.D.), appld. [para. 30].

Cyanamid Canada Inc. v. Canada (Minister of National Health and Welfare) (1992), 148 N.R. 147; 45 C.P.R.(3d) 390 (F.C.A.), appld. [para. 31].

Sandoz Ltd. v. Commissioner of Patents et al. (1991), 42 F.T.R. 30; 34 C.P.R.(3d) 543 (T.D.), appld. [para. 31].

Engineers' and Managers' Association et al. v. Advisory, Conciliation and Arbitration Service and United Kingdom Association of Professional Engineers, [1980] 1 W.L.R. 302; [1980] 1 All E.R. 896 (H.L.), appld. [para. 33].

Commission de protection du territoire agricole (Qué.) v. Venne et al., [1989] 1 S.C.R. 880; 95 N.R. 335; 24 Q.A.C. 162, appld. [para. 40].

R. v. Smith (Howard) Paper Mills Ltd. et al., [1957] S.C.R. 403, appld. [para. 43].

Québec (Procureur général) v. Office national de l'énergie, [1991] 3 F.C. 443; 132 N.R. 214 (F.C.A.), appld. [para. 44].

Merck & Co. v. Sherman & Ulster Ltd. et al. (1971), 65 C.P.R. 1 (Ex.), appld. [para. 47].

R. v. Ali, [1980] 1 S.C.R. 221; 27 N.R. 243; 21 Nfld. & P.E.I.R. 361; 56 A.P.R. 361, appld. [para. 47].

Ottawa (City) et al. v. Boyd Builders Ltd. (1965), 50 D.L.R.(2d) 704 (S.C.C.), dist. [para. 48].

Canadian Petrofina Ltd. v. Martin and St. Lambert (1959), 18 D.L.R.(2d) 761 (S.C.C.), appld. [para. 48].

Toronto Corp. v. Roman Catholic Separate Schools Trustee, [1926] A.C. 81 (P.C.), appld. [para. 48].

Hammond et al. v. Hamilton (City), [1954] O.R. 209 (C.A.), appld. [para. 48].

Harju v. Thunder Bay (City) et al. (1974), 4 O.R.(2d) 61 (Div. Ct.), appld. [para. 48].

Overcomers Church et al. v. Toronto (City) et al. (1973), 1 O.R.(2d) 123 (Div. Ct.), appld. [para. 48].

Apotex Inc. v. Canada (Attorney General) et al. (1993), 59 F.T.R. 85 (T.D.), appld. [para. 53].

Jamieson (C.E.) & Co. (Dominion) Ltd. et al. v. Canada (Attorney General) (1987), 12 F.T.R. 167 (T.D.), appld. [para. 63].

Statutes Noticed:

Food and Drugs Act, R.S.C. 1985, c. F-27, generally.

Food and Drugs Act Regulations (Can.), C.R.C. 1978, c. 870, Div. 8, sect. C.08.001(a), sect. C.08.002(1)(a), sect. C.08.002(1)(b), sect. C.08.002(2), sect. C.08.004(1)(a) [para. 4].

Interpretation Act, R.S.C. 1985, c. I-21, sect. 10 [para. 40]; sect. 43 [para. 46].

Patent Act, R.S.C. 1985, c. P-4, sect. 55.2 [para. 10]; sect. 55.2(5) [para. 35].

Patent Act Regulations (Can.), Patented Medicine (Notice of Compliance) Regulations, sect. 5(1) [para. 37]; sect. 5(2) [para. 38]; sect. 7(1) [para. 33].

Authors and Works Noticed:

de Smith, S.A., Judicial Review of Administrative Action (3rd Ed.), p. 498 [para. 48].

Halsbury's Laws of England (4th Ed.), vol. 44, p. 571, para. 922 [para. 23].

Counsel:

Harry B. Radomsky, Graham Smith and Richard Naiberg, for the applicant;

H. Lorne Morphy, Q.C., for the respondents, Attorney General of Canada and Minister of National Health and Welfare;

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

Solicitors of Record:

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

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

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

This case was heard on June 21 and 22, 1993, at Ottawa, Ontario, before Dubé, J., of the Federal Court of Canada, Trial Division, who delivered the following decision on July 16, 1993.