Apotex Inc. v. Canada ( Minister of National Health and Welfare )
T-1237-95
Jerome A.C.J.
25/4/97
11 pp.
Application for mandamus, declaratory relief-Eli Lilly & Company owning Canadian patents pertaining to nizatidine used in treatment of peptic ulcers-Was issued notice of compliance (NOC)-Apotex filing new drug submission (NDS) for NOC in respect of own brand of nizatidine-Filing notice of allegation alleging would sell free of infringement pursuant to licence-Eli Lilly obtaining order prohibiting Minister from issuing NOC pursuant to Patented Medicines (Notice of Compliance) Regulations, s. 6(1)-Apotex submitting second notice of allegation alleging Apotex would only use nizatidine manufactured by means of noninfringing process-Eli Lilly not applying within forty-five days for prohibition order pursuant to s. 6-Apotex submitting issue before Court in application pursuant to s. 6 not whether in general terms generic should ever receive NOC, but whether allegation contained in notice of allegation not justified-Reasoning any prohibition order relating only to particular allegation found on balance of probabilities not to be justified-Arguing Court can make no determination as to whether other allegations not placed before it would be justified-Submitting doctrine of res judicata not applicable as no final determination binding in all circumstances for all time-Nothing in Regulations or in law establishing prohibition order in respect of one allegation rendering generic company permanently incapable of advancing non-infringing claim on alternate basis-Apotex submitting Court should follow AB Hassle v. Canada (Minister of National Health and Welfare), [1997] F.C.J. No. 10 (T.D.) (QL)-Minister submitting notice of compliance cannot issue because of prohibition order-Eli Lilly submitting order prohibiting Minister from issuing NOC to Apotex until after expiry of patents-Arguing even if Court permitted to go behind order, and even if Minister not restricted by s. 7 from issuing NOC, second notice merely duplication of matter resolved in Eli Lilly's favour by prohibition order-Stating second notice res judicata-Application allowed-Case law recognizing multiple notices of allegation can be filed, provided subsequent notice of allegation not essentially same as one previously filed-First and second notices not essentially same-First notice based on existence of licence-Second notice claimed non-infringing process would be utilized-Principle of res judicata in narrow sense i.e. issue already determined by Court, only applicable if essentially same notice of allegation before Court as already determined not to be justified: AB Hassle-Eli Lilly's arguments concerning contents of NDS, res judicata not convincing-Contents of NDS, evaluation part of parallel process pursuant to Food and Drug Regulations, related to health, safety concerns-Contents of NDS not before Court directly-Court's task to determine whether notice of allegation justified-Extraordinary to interpret prohibition order as dealing with anything more than that before Court for hearing-Court unable to rule prospectively in respect of issues, evidence of which not seized-As Eli Lilly not commencing application for prohibition order, upon expiry of 45 days Minister under no restriction to issue NOC to Apotex-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5, 6, 7-Food and Drug Regulations, C.R.C., c. 870.