Apotex Inc. v. Canada ( Attorney General )
T-3099-92 / T-427-93
McGillis J.
5/5/93
15 pp.
Application to compel answers to questions posed during cross-examination on affidavits, for production of documents, of Apotex's new drug submission for drug "apo-enalapril" and of Health Protection Branch's record relating thereto, or to prohibit use of affidavits -- Merck owner and exclusive licensee of drug "enalapril" under patent valid until 2007 -- Apotex, generic manufacturer and distributor, applied for notice of compliance for new drug apo-enalapril -- Merck commenced patent infringement action -- Apotex instituting application for judicial review seeking order to compel issuance of notice of compliance on ground Minister discriminating against Apotex by delaying processing of new drug submissions and by expediting and according preferential treatment to its competitors -- New drug submission filed in support of application for issuance of notice of compliance for apo-enalapril approved February 3, 1993 and submitted for signature February 4 -- Not yet signed -- Amendments to Patent Act receiving Royal Assent February 4 -- S. 55.2 providing for exceptions to patent infringement, making of regulations and paramountcy of section and its regulations, effective March 12 -- Regulations made under authority of s. 55.2 concerning issuance of notices of compliance for patented medicines also coming into force March 12 -- Regulations radically altering procedures for obtaining notice of compliance -- Essentially prohibiting Minister from granting such notice in relation to patented drug until expiry of patent -- Merck commenced application for judicial review to restrain Minister from issuing notice of compliance for enalapril based on government's failure to proclaim s. 55.2 in force, absence of evidence of safety and efficacy of apo-enalapril, patent infringement -- Filed affidavit evidence showing safety and efficacy questionable -- Apotex bringing motion for judgment directing Minister to issue notice of compliance for apo-enalapril or for determination of whether Minister entertained irrelevant considerations in refusing to grant notice of compliance for apo-enalapril -- Merck added as respondent to Apotex' judicial review application and two applications consolidated -- Attorney General filing supplementary affidavits indicating review of chemistry and manufacturing sections of new drug conducted as result of affidavits filed by Merck alleging instability of apo-enalapril, and Apotex found to have complied with all applicable regulations pertaining to issuance of notice of compliance and satisfying Minister of safety and efficacy of apo-enalapril -- Application dismissed -- (1) Concern of competitor as to safety and efficacy of drug not raising question of law and not justiciable: Glaxo Canada v. Minister of National Health & Welfare et al. (1987), 18 C.P.R. (3d) 206 (F.C.T.D.); affd (1990), 31 C.P.R. (3d) 29 (F.C.A.) -- Court would have to review merits of Minister's regulatory decision, necessitating analysis of sufficiency of evidence before Minister -- Court not to review in consolidated review application technical and scientific conclusions of departmental experts leading to recommendation notice of compliance issue for enalapril -- Cross-examination on safety and efficacy of drug irrelevant -- Alternatively, no evidence establishing attack on safety and efficacy of apo-enalapril within grounds of review specified in Federal Court Act, s. 18.1(4) and not justiciable -- (2) Allegations pertaining to patent infringement and passing off not within enumerated grounds for judicial review specified in s. 18.1(4) -- Questions relating thereto irrelevant -- (3) Whether privilege attaches to confidential information provided by drug manufacturer need not be decided in view of general evidentiary principles concerning relevance -- As safety and efficacy, patent infringement and passing off issues not justiciable in consolidated review proceedings, evidence obtained from confidential information filed by Apotex with Department of National Health and Welfare irrelevant -- Merck on massive fishing expedition in hopes of uncovering evidence to justify argument safety and efficacy, patent infringement and passing off within ground enumerated in s. 18.1(4) -- (4) Use of affidavits of certain witnesses not prohibited -- To do so would leave unanswered on public record allegations concerning safety and efficacy of apo-enalapril and failure of Minister to satisfy himself in this regard -- Patent Act, R.S.C., 1985, c. P-4, s. 55.2 (as am. by S.C. 1993, c. 2, s. 4) -- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 -- Federal Court Act, R.S.C., 1985, c. F-7, s. 18.1(4) (as am. by S.C. 1990, c. 8, s. 5).