Adria Laboratories of Canada Ltd. et al. v. Canada (Minister of National Health and Welfare) et al., (1995) 182 N.R. 313 (FCA)

• Judge: Stone, Robertson and McDonald, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: May 03, 1995
• Jurisdiction: Canada (Federal)
• Citations: (1995), 182 N.R. 313 (FCA)

Adria Laboratories v. Can. (1995), 182 N.R. 313 (FCA)

MLB headnote and full text

Novopharm Limited (appellant/respondent) v. Adria Laboratories of Canada Ltd. and Farmitalia Carlo Erba S.R.L. (respondents/applicants) and the Minister of National Health and Welfare (respondent/respondent)

(A-318-94)

Indexed As: Adria Laboratories of Canada Ltd. et al. v. Canada (Minister of National Health and Welfare) et al.

Federal Court of Appeal

Stone, Robertson and

McDonald, JJ.A.

May 3, 1995.

Summary:

Novopharm proposed to market a particu­lar drug and filed a notice of allegation under s. 5 of the Patented Medicines (Notice of Compliance) Regulations, alleging that no claim for the medicine itself and no claim for the use of the medicine would be infringed. Adria Laboratories et al. (the applicants) applied for an order prohibiting the issuance of a notice of compliance. Novopharm subsequently applied to file four affidavits in reply to affidavit evidence filed by the applicants. The applicants consented to the filing of one of the affidavits, but objected to the filing of the remaining three.

The Federal Court of Canada, Trial Divi­sion, in a decision reported 82 F.T.R. 61, dismissed Novopharm's application to tender reply evidence, except with respect to the affidavit which would be filed on the con­sent of the parties. Novopharm appealed.

The Federal Court of Appeal allowed the appeal and permitted Novopharm to file the three reply affidavits.

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of com­pliance - Issuance of - [See Patents of Invention - Topic 5676 ].

Food and Drug Control - Topic 1111

Drugs - New drugs - Notice of com­pliance - Affidavits - [See Patents of Invention - Topic 5676 ].

Patents of Invention - Topic 5666

New substances licences - Application - Amendment of - General - [See Patents of Invention - Topic 5676 ].

Patents of Invention - Topic 5676

New substances licences - Application - Evidence - Novopharm filed a notice of allegation under the Patented Medicines (Notice of Compliance) Regulations indi­cating that the drug proposed to be mar­keted did not contain an agent contained in a patented drug - Adria Laboratories et al. (Adria) sought an order prohibiting the issuance of a notice of compliance - Novopharm subsequently filed a "Detailed Statement" in which it altered its approach by alleging that it would purchase the agent from a supplier whose licence allowed Novopharm to resell the agent in Canada - Adria filed expert evidence con­cerning the licence - Novopharm applied to admit three affidavits in reply - Adria opposed the application and submitted that the notice of allegation could not be amended by a "Detailed Statement" - The Federal Court of Appeal, permitted Novo­pharm to file the affidavits.

Cases Noticed:

Friends of the Oldman River Society v. Canada (Minister of Transport and Minister of Fisheries and Oceans), [1992] 1 S.C.R. 3; 132 N.R. 321, consd. [para. 7, footnote 2].

Proctor & Gamble Co. v. Nabisco Brands Ltd. (1985), 62 N.R. 364; 5 C.P.R.(3d) 417 (F.C.A.), refd to. [para. 7, footnote 2].

Pharmacia Inc. et al. v. Bull (David) Laboratories (Canada) Inc. (1994), 175 N.R. 334; 58 C.P.R.(3d) 207 (F.C.A.), refd to. [para. 8].

Pharmacia Inc. et al. v. Bull (David) Laboratories (Canada) Inc. (1994), 182 N.R. 158; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 8].

Pharmacia Inc. v. Canada (Minister of National Health and Welfare) - see Pharmacia Inc. et al. v. Bull (David) Laboratories (Canada) Inc.

Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 163 N.R. 183; 51 C.P.R.(3d) 329 (F.C.A.), refd to. [para. 8].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Wel­fare) et al. (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 8].

DRG Inc. v. Datafile Ltd. and Registrar of Copyrights (1987), 14 F.T.R. 219; 16 C.P.R.(3d) 155 (T.D.), folld. [para. 12].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 5(1)(b), sect. 5(3)(a) [para. 2]; sect. 6 [para. 1].

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

Counsel:

Donald N. Plumley and Carol Hitchman, for the appellant;

Gunar Gaikis and Peter R. Wilcox, for the respondents, Adria Laboratories of Canada Ltd. and Farmitalia Carlo Erba S.R.L.;

No one appearing on behalf of the respon­dent, Minister of National Health and Welfare.

Solicitors of Record:

Ridout & Maybee, Toronto, Ontario, for the appellant;

Smart & Biggar, Toronto, Ontario, for the respondents, Adria Laboratories of Canada Ltd. and Farmitalia Carlo Erba S.R.L.

This appeal was heard at Toronto, Ontario, on April 25, 1995, before Stone, Robertson and McDonald, JJ.A., of the Federal Court of Appeal.

On May 3, 1995, Stone, J.A., delivered the following judgment for the Court of Appeal.