Merck Frosst Canada Inc. v. Canada ( Minister of National Health and Welfare )
T-339-94
Tremblay-Lamer J.
4/7/96
12 pp.
Application to quash Minister's decision to issue notice of compliance (NOC) to Nu-Pharm Inc. for medicine famotidine-NuPharm filing new drug submission (NDS) seeking NOC February 16, 1993-Nu-Pharm NDS cross-referenced to earlier NDS by Apotex Inc. for same medicine in respect of which NOC previously issued-Cross-referenced application relies on same information regarding composition, analysis, testing, submitted by another applicant in support of earlier successful NDS for same medicine-NOC not issued unless Health Protection Branch (HPB) satisfied as to safety, efficacy of drug-Nu-Pharm NDS review, conclusion complied with Food and Drug Regulations verified and documentation for NOC forwarded to Director for issuance of NOC March 9, 1993-Director determining application involving patent linkage concerns arising from coming into force of Bill C-91 on February 4, 1993 and pending regulations thereunder-Application forwarded to Assistant Deputy Minister (ADM) on March 10, 1993 together with completed NOC for signature-ADM away until late March 11-On March 12, 1993 Patented Medicines (Notice of Compliance) Regulations coming into force-Prohibiting issuance of NOC, in respect of patentlinked drugs-On June 1, 1993 Merck Frosst beginning proceedings to prohibit Minister from issuing NOC to Nu-Pharm in respect of famotidine-NOC issued January 14, 1994 after ruling in Apotex Inc. v. Canada (Attorney General), [1994] 1 F.C. 742 (C.A.) neither patent linkage concerns nor pending prohibition application should have delayed or prevented issuance of NOC-Application dismissed-Minister having duty to act in accordance with law-No choice but to apply Apotex, which determined under which statute Minister had to exercise discretion-Apotex relied upon to decide Minister's jurisdiction as to which regime applied-Apotex merely confirming that according to Interpretation Act, if vested right acquired, change in legislation not affecting right-If vested right to NOC, subsequent enactment of Regulations not invoked-Apotex identifying issues relevant to determination of whether vested right to NOC: scope of Minister's discretion; relevance of "pending legislative policy"; whether matter reaching Minister for consideration-Scope of Minister's discretion limited to factors concerning drug safety, efficacy-Pending legislative policy not relevant consideration unilaterally invoked by Minister-Applicant may acquire right to NOC notwithstanding Minister's failure to render decision because Minister's discretion restricted to safety, efficacy interests-Where safety and efficacy concerns satisfied, and application procedurally ready for decision, applicant having vested right-Where right to NOC vested before new Regulations coming into force, NOC must issue, even if issuance would occur after Regulations in force and application for prohibition instituted under them-Application met all statutory requirements, ready for decision March 10, 1993-Determination to issue NOC should have been made March 10, 1993-Nu-Pharm had vested right to NOC-Food and Drug Regulations, C.R.C., c. 879, s. C.08.004(1)(a) (as am. by SOR/85-142, s. 1; 88-257, s. 1)-Patented Medicine (Notice of Compliance) Regulations, SOR/93-133, s. 7-Food and Drug Act, R.S.C., 1985, c. F-27-Interpretation Act, R.S.C., 1985, c. I-21, s. 43(c).