Apotex Inc. v. Canada ( Attorney General )
T-3099-92 / T-427-93
Dubé J.
16/7/93
28 pp.
[cp85d,93d]Application for mandamus directing Minister to issue notice of compliance (NOC) in respect of each dosage of its drug, Apo-Enalapril -- Respondents seeking order prohibiting Minister from issuing NOC -- Merck exclusive licensee of drug enalapril under valid patent prohibiting unauthorized manufacture of drug -- Before selling new drug, pharmaceutical manufacturer must obtain NOC from Minister -- Must submit new drug submission (NDS) -- If satisfactory, Minister issuing NOC -- Apotex applied for NOC in respect of Apo-enalapril in 1990 -- In 1991 respondent commenced patent infringement action -- On February 3, 1993 review of NDS complete, issuance of NOC recommended -- On February 4, day issuing authority receiving NOC for signature, Patent Act Amendment Act, 1992 receiving Royal Assent -- Most provisions proclaimed in force February 15 -- Regulation-making authority provision coming into force March 12 -- Regulations made thereunder radically changed process for obtaining NOC -- Essentially prohibiting Minister from granting NOC for patented drug until expiry of all patents pertaining thereto -- Issuing authority and Minister obtaining legal advice on how to proceed -- Application for mandamus allowed; application for prohibition denied -- Although Minister having discretion in NDS approval process under Food and Drug Regulations, discretion not unfettered -- Scope of discretion limited strictly to consideration of factors relevant to purposes of FDR as relate to process of approval of new drugs to be marketed in Canada -- Limited to decision as to whether Health Protection Branch (HPB) review of NDS establishing safety, effectiveness of drug -- Once answered in affirmative, any other extraneous consideration irrelevant -- Minister not entitled to refuse to issue NOC based on anticipated changes to legislation -- NDS approval process geared toward determining safety, effectiveness of drug under consideration -- Suggestion NDS which has passed muster with HPB officials as safe, effective may then be refused NOC on basis content still not satisfactory to Minister on grounds other than safety, effectiveness inconsistent with scheme of FDR, and defeating purpose -- FDR not contemplating or authorizing broad scope of ministerial discretion in NDS approval process -- Neither Minister nor delegate having discretion to refuse to issue NOC to Apotex on other grounds -- Consistent with views expressed in Glaxo Canada Inc. v. Canada (Minister of National Health & Welfare), [1988] 1 F.C. 422 (T.D.) and Pfizer Canada Inc. v. Minister of National Health & Welfare et al. (1986), 12 C.P.R. (3d) 438 (F.C.A.) -- Minister ought to have been concerned primarily with matters within jurisdiction, rather than waiting for legal advice on extra-departmental matters -- Legal advice justification potentially endless -- Minister having no assurance Regulations would be promulgated March 12 -- In theory Regulations might not yet have come into effect -- Fact Parliament not providing explicitly for NOC application completed during transition period reinforcing view NOC should have been dealt with under FDR -- From February 4 to March 12 FDR in place, Apotex NOC ready for signature, whereas regulation-making provision not -- Minister's delay in issuing NOC not warranted -- Food and Drugs Act, R.S.C., 1985, c. F-27 -- Food and Drugs Regulations, C.R.C., c. 870, s. C.08.001, C.08.002, C.08.004 (as am. by SOR/88-42, s. 1) -- Patent Act, R.S.C., 1985, c. P-4, s. 55.2 (as enacted by S.C. 1993, c. 2) -- Patent Act Amendment Act, 1992, S.C. 1993, c. 2, s. 12 -- Patented Medecine (Notice of Compliance) Regulations, SOR/93-133, ss. 4, 5, 7 -- Interpretation Act, R.S.C., 1985, c. I-21, s. 43.