Merck & Co. et al. v. Canada (Attorney General) et al., (1999) 176 F.T.R. 21 (TD)

• Judge: McGillis, J.
• Court: Federal Court (Canada)
• Case Date: September 19, 1999
• Jurisdiction: Canada (Federal)
• Citations: (1999), 176 F.T.R. 21 (TD)

Merck & Co. v. Can. (A.G.) (1999), 176 F.T.R. 21 (TD)

MLB headnote and full text

Temp. Cite: [1999] F.T.R. TBEd. DE.086

In The Matter Of Sections 18, 18.1 and 18.2 of the Federal Court Act, R.S.C. 1985, Chapter F-7;

And In The Matter Of the Food and Drugs Act, R.S.C. 1985, Chapter F-27 and Division 8 of the Regulations thereunder;

And In The Matter Of Section 55.2(4) of the Patent Act and the Patented Medicines (Notice of Compliance) Regulations, SOR/93/133.

Merck & Co., Inc. and Merck Frosst Canada & Co. (Applicants) and The Attorney General of Canada, The Minister of Health and Nu-Pharm Inc. (Respondents)

(T-398-99)

Indexed As: Merck & Co. et al. v. Canada (Attorney General) et al.

Federal Court of Canada

Trial Division

McGillis, J.

November 23, 1999.

Summary:

Nu-Pharm filed an abbreviated new drug submission (ANDS) and sought a notice of compliance for Nu-Enalapril. In its submission, Nu-Pharm compared Nu-Enalapril with Apotex's Apo-Enalapril, the generic version of Merck's patented drug Vasotec. Nu-Pharm made no comparison with Vasotec. The Minister of Health refused to process Nu-Pharm's ANDS. Nu-Pharm applied for judicial review seeking an order declaring that the Minister's refusal was unlawful and requiring the Minister to process Nu-Pharm's ANDS and issue a Notice of Compliance.

The Federal Court of Canada, Trial Division, per Cullen, J., in a decision dated November 19, 1998 and reported 159 F.T.R. 68, allowed the application. Merck, who became aware of the proceedings on January 26, 1999, took various procedural steps, in both the Trial Division and the Court of Appeal, to have Cullen, J's decision reconsidered or appealed. Merck was not successful. See [1999] F.T.R. Uned. 260; 164 F.T.R. 68; 246 N.R. 386 and 247 N.R. 227. On February 25, 1999, the Minister issued a Notice of Compliance to Nu-Pharm. Merck applied to quash the Minister's decision.

The Federal Court of Canada, Trial Division, allowed the application.

Food and Drug Control - Topic 1102

Drugs - New drugs - Legislation, re - The Federal Court of Canada, Trial Division, discussed the legislative scheme governing the procedure to be followed for obtaining approval to sell a new drug in Canada - The court also discussed the interpretation to be given to the legislation - See paragraphs 35 to 67.

Food and Drug Control - Topic 1108

Drugs - New drugs - Notice of compliance - Judicial review - [See Food and Drug Control - Topic 1109 ].

Food and Drug Control - Topic 1109

Drugs - New drugs - Notice of compliance - New drug submission - Nu-Pharm filed an abbreviated new drug submission (ANDS) and sought a notice of compliance for Nu-Enalapril - In its submission, Nu-Pharm compared Nu-Enalapril with Apotex's Apo-Enalapril, the generic version of drug innovator Merck's patented drug Vasotec - Nu-Pharm made no comparison with Vasotec - As a result of prior court proceedings, the Minister accepted Apo-Enalapril as a Canadian reference product, within the meaning of s. C.08.001.1(c) of the Food and Drug Regulations - The Minister determined that the relevant provisions of the Patented Medicines (Notice of Compliance) Regulations, did not apply where Nu-Pharm had not compared Nu-Enalapril with Vasotec - The Minister issued a notice of compliance to Nu-Pharm without Nu-Pharm complying with s. 5(1) of the Patented Medicines (Notice of Compliance) Regulations - The Federal Court of Canada, Trial Division, applying the standard of correctness, quashed the Minister's decision - Using a purposive approach, the court interpreted s. 5(1) to mean that where a person filed an ANDS in which the Canadian reference product was a drug acceptable to the Minister under s. C.08.001.1(c), the innovator's drug constituted the drug to which a comparison had to be made for the purposes of s. 5(1).

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compliance - Practice - [See Food and Drug Control - Topic 1109 ].

Cases Noticed:

Eli Lilly & Co. et al. v. Novopharm Ltd. et al., [1998] 2 S.C.R. 129; 227 N.R. 201, consd. [para. 43].

Rizzo & Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1, consd. [para. 47].

Chartier v. Chartier, [1999] 1 S.C.R. 242; 235 N.R. 1; 134 Man.R.(2d) 19; 193 W.A.C. 19, refd to. [para. 48].

R. v. Gladue (J.T.), [1999] 1 S.C.R. 688; 238 N.R. 1; 121 B.C.A.C. 161; 198 W.A.C. 161, refd to. [para. 48].

Novak et al. v. Bond, [1999] 1 S.C.R. 808; 239 N.R. 134; 122 B.C.A.C. 161; 200 W.A.C. 161; 45 C.C.L.T.(2d) 1, refd to. [para. 48].

M & D Farm Ltd. et al. v. Manitoba Agricultural Credit Corp. (1999), 245 N.R. 165; 138 Man.R.(2d) 161; 202 W.A.C. 161; 176 D.L.R.(4th) 585 (S.C.C.), refd to. [para. 48].

Baker v. Canada (Minister of Citizenship and Immigration) (1999), 243 N.R. 22; 174 D.L.R.(4th) 193 (S.C.C.), refd to. [para. 48].

Best v. Best (1999), 242 N.R. 1; 123 O.A.C. 1; 174 D.L.R.(4th) 235 (S.C.C.), refd to. [para. 48].

Winters v. Legal Services Society (B.C.) (1999), 244 N.R. 203; 128 B.C.A.C. 161; 208 W.A.C. 161; 177 D.L.R.(4th) 94 (S.C.C.), refd to. [para. 48].

Francis v. Baker (1999), 246 N.R. 45; 125 O.A.C. 201; 177 D.L.R.(4th) 1 (S.C.C.), refd to. [para. 48].

Smithkline Beecham Pharma Inc. et al. v. Apotex Inc. et al. (1999), 179 F.T.R. 109 (T.D.), refd to. [para. 51].

Teal Cedar Products (1977) Ltd. v. Canada, [1989] 2 F.C. 135; 19 F.T.R. 35 (T.D.), refd to. [para. 51].

Bayer Inc. v. Canada (Attorney General) et al. (1999), 243 N.R. 170; 87 C.P.R.(3d) 293 (F.C.A.), refd to. [para. 51].

Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 53].

ICN Pharmaceuticals Inc. et al. v. Patented Medicine Prices Review Board et al. (1996), 200 N.R. 376; 68 C.P.R.(3d) 417 (F.C.A.), refd to. [para. 53].

Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 53].

Bayer AG and Miles Canada Inc. v. Canada (Minister of Health and Welfare) and Apotex Inc. (1993), 163 N.R. 183; 51 C.P.R.(3d) 329 (F.C.A.), refd to. [para. 53].

Merck & Co. et al. v. Canada (Minister of Health) et al. (1999), 249 N.R. 110 (F.C.A.), consd. [para. 54].

Nu-Pharm Inc. v. Canada (Attorney General) et al. (1998), 224 N.R. 386; 80 C.P.R.(3d) 74 (F.C.A.), consd. [para. 65].

Merck Frosst Canada Inc. v. Minister of National Health and Welfare et al. (1996), 71 C.P.R.(3d) 156 (F.C.T.D.), refd to. [para. 66].

Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982; 226 N.R. 201, refd to. [para. 68].

Statutes Noticed:

Food and Drugs Act Regulations (Can.), Food and Drugs Regulations, C.R.C. 1978, c. 870, sect. C.08.001.1 [para. 38]; sect. C.08.002(1) [para. 37]; sect. C.08.002.1(1), sect. C.08.002.1(2) [para. 38].

Food and Drugs Regulations - see Food and Drugs Act Regulations (Can.).

Interpretation Act, R.S.C. 1985, c. I-21, sect. 12 [para. 49].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93/133, sect. 2 [para. 41]; sect. 4(1) [para. 44]; sect. 5(1) [para. 45]; sect. 7(1) [para. 46].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Authors and Works Noticed:

Canada, Food and Drug Act Regulations Regulatory Impact Analysis Statement, Canada Gazette, Part II, vol. 127, no. 6, pp. 1388 [para. 51]; 1389 [para. 52].

Counsel:

G.A. Macklin, Q.C., for the applicants;

F.B. Woyiwada, for the respondent, Attorney General of Canada;

H.B. Radomski and Ms. Bassan, for the respondent, Nu-Pharm Inc.

Solicitors of Record:

Gowling, Strathy & Henderson, Ottawa, Ontario, for the applicants;

Department of Justice, Ottawa, Ontario, for the respondent, Attorney General of Canada;

Goodman, Phillips & Vineberg, Toronto, Ontario, for the respondent, Nu-Pharm Inc.

This application was heard at Ottawa, Ontario, on September 19, 1999, by McGillis, J., of the Federal Court of Canada, Trial Division, who delivered the following decision at Ottawa, Ontario, on November 23, 1999.