Merck Frosst Canada Inc. v. Canada ( Minister of National Health and Welfare )
T-1502-96
Campbell J.
18/12/98
26 pp.
Judicial review seeking order prohibiting Minister from issuing notice of compliance (NOC) to Apotex for antibiotic norfloxacin until expiry of Merck's patent protecting process for production of anti-bacterial agents, including norfloxacin (patent 961)-Proceedings under Patented Medicines (Notice of Compliance) Regulations s. 6(1) for order prohibiting Minister from issuing Notice of Compliance (NOC) until after expiration of patent by way of judicial review-Party initiating proceedings (Merck) must disprove allegations in NOC-When determining whether allegations justified, Court must decide whether, based on facts as assumed or proven, allegations would give rise in law to conclusion patent would not be infringed by respondent-Respondent (Apotex) required to adduce evidence to support position process non-infringing-If respondent's supporting evidence weak, easier for applicant to displace such evidence-Merck must prove, on balance of probabilities, Apotex's allegation of non-infringement not justified; lower bar than hurdle of proving infringement-Burden on applicant to prove evidence provided by respondent not justifying allegation, not allegation having no merit-Apotex serving NOC claiming norfloxacin made by non-infringing process-Two differences between two processes at issue: starting compounds not identical; Apotex's process requiring two additional steps-No weight attached to evidence of one of Apotex's expert witnesses as not neutral-Apotex's other key witness relying on four patents to establish evidence upon which formulating opinion-Patents issued subsequent to filing of application for patent 961 irrelevant for purpose of proving prior art, except patent 466 whose relevance established in Abbott Laboratories, Ltd. v. Nu-Pharm Inc., [1998] F.C.J. No. 1393 (C.A.) (QL)-As improvement patent, respecting prior art, no weight placed on difference between patent 466 and patent 961-As result no weight given to second expert's opinion relied upon by Apotex-Contents of new drug submission regarding Apotex's application for NOC irrelevant to these proceedings: Smithkline Beecham Pharma Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1997), 138 F.T.R. 310 (F.C.T.D.)-As objective of exercise to test, determine strength of allegation, must consider evidence according to established patent infringement considerations-Necessary to construe scope of claims of patent 961-Text of claims, state of art at time of filing application for 961, conveying intention to provide broad protection-As to whether Apotex's process within scope of claims of patent 961: (1) variant having no material effect upon way invention working; (2) this would have been obvious at date of publication of patent to reader skilled in art; (3) reader skilled in art would not have understood from language of claim patentee intended strict compliance with primary meaning essential requirement of invention-Apotex's primary opinion evidence weak-Merck discharging burden to prove allegation of non-infringement not justified-Application allowed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5 (as am. by SOR/98-166, s. 4), 6 (as am. idem, s. 5).