Decision to issue notice of compliance was reasonable

Miscellaneous

Decision to issue notice of compliance was reasonable

Reasonableness. Minister of Health made decision to issue notice of compliance (NOC) to TC Inc. for exemestane tablet, which was generic version marketed by PC Inc.. Minister of Health made decision to issue NOC to HH Inc. for its 100 mg/vial inflixmab powder solution, which was generic version marketed by J Inc. . PC Inc. brought application to challenge issuance of NOC. Federal judge found that standard of review of minister’s decision was correctness, that minister’s interpretation of regulations was incorrect and thus, decision to issue NOC was set aside. J Inc. also brought application to challenge issuance of NOC and on consent of parties, federal judge set aside decision to issue NOC. PC Inc. and J Inc. appealed and appeals were consolidated. Appeal allowed. Federal judge erred by reviewing minister’s decisions on standard of correctness. Applying standard of reasonableness, decision to issue NOC was reasonable. Contextual analysis did not rebut presumption of reasonableness. While regulations were enacted pursuant to Patent Act which fell under Ministry of Industry, not Health, this was too narrow of view of prevailing jurisprudence . Presumption of reasonableness applied when administrative decision-maker was interpreting not just its home statute, but also when decision-maker was interpreting “statutes closely connected to its function” which applied equally to regulations that were closely connected to function of Minister of Health.
Teva Canada Ltd. v. Pfizer Canada Inc. (2016), 2016 CarswellNat 5051, 2016 FCA 248, Eleanor R. Dawson J.A., Wyman W. Webb J.A., and Donald J. Rennie J.A. (F.C.A.); reversed (2014), 2014 CarswellNat 5409, 2014 CarswellNat 7072, 2014 FC 1243, 2014 CF 1243, Mary J.L. Gleason J. (F.C.).