Pfizer Canada Inc. v. Nu-Pharm Inc.
T-1352-93
McKeown J.
24/12/93
10 pp.
Application for order requiring Minister of National Health and Welfare to produce portions of Nu-Pharm's New Drug Submission (NDS) relating to fluconazole tablets and Drug Master File (DMF) filed by Nu-Pharm's supplier pursuant to Food and Drug Regulations, Division 8 -- Nu-Pharm seeking Notice of Compliance (NOC) (marketing approval) for NDS -- Pfizer has patent for product made by process -- Nu-Pharm filing NDS and Notice of Allegation (pursuant to Patented Medicines (Notice of Compliance) Regulations) stating its manufacture, use or sale of tablets infringing neither medicine itself nor use thereof in Pfizer patent -- Pfizer applying under Regulations, s. 6(1) for order prohibiting Minister from issuing NOC on grounds Nu-Pharm's Notice of Allegation lacking description of process, not justified because fluconazole to be sold by Nu-Pharm same chemical composition as fluconazole described in patent -- Application dismissed -- S. 6(1) contemplating quick procedure -- Onus on Pfizer to show relevance of material sought -- Important given summary nature of proceedings -- Applicants entitled to sufficient information to define issues -- Sufficient material in NDS to meet requirements of Food & Drug Regulations, Division 8, ss. C.08.002 to C.08.004 -- No evidence of any relationship between information sought and process of manufacture -- Applicants not entitled to go on fishing expedition -- To resolve main action (infringement) Court will examine drug supplier's process, compare chemicals set out therein with patented claims and determine if chemical equivalence -- Information sought not essential to main application -- DMF belonging to third party (drug supplier) not involved in litigation and who could be wrongfully affected by disclosure -- Applicants have sufficient information to define issues -- No further part of NDS and no part of DMF made available -- Food and Drugs Act, R.S.C., 1985, c. F-27 -- Food and Drug Regulations, C.R.C., c. 870, ss. C.08.002 to C.08.004 -- Patent Act, R.S.C., 1985, c. P-4, ss. 55.1 (as enacted by S.C. 1993, c. 2, s. 4), 55.2 (as enacted idem) -- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1) -- Patent Act Amendment Act, 1992, S.C. 1993, c. 2 -- Federal Court Act, R.S.C., 1985, c. F-7, ss. 18 (as am. by S.C. 1990, c. 8, s. 4), 18.1 (as enacted idem, s. 5), 18.4 (as enacted idem) -- Federal Court Rules, C.R.C., c. 663, RR. 1612 (as enacted by SOR/92-43, s. 19), 1613 (as enacted idem).