Bayer AG v. Canada ( Minister of National Health and Welfare )
A-389-93
Mahoney J.A.
25/10/93
9 pp.
Appeal from refusal of special order for directions as to conduct of Trial Division proceeding -- Proceeding seeking to prohibit issuance of notice of compliance under Food and Drug Regulations to respondent Apotex, in respect of medicine for which Bayer owns subsisting patent and Miles licensee and holder of notice of compliance (NOC) -- Apotex alleging since patent claims monopoly in respect of medicine made in accordance with processes covered by process claims of patent, patent could not be infringed by making medicine by different process -- Undertaking not to make medicine by patented process until patent expiring -- Issue whether process by which medicine to be produced by or for Apotex so different from that patented as to result in medicine not infringing Bayer's patent -- Direction sought concerning filing and service of affidavit evidence by Apotex, provision of samples and particulars of process, filing and service of affidavit evidence in reply, personal knowledge of affiants, cross-examination anf re-examination of affiants, hearing of interlocutory motions, preparation and filing of memoranda of fact and law prior to hearing, restriction of evidence to affidavits and transcripts of cross-examinations and re-examinations, order of argument at hearing, role of Minister -- Trial Judge dismissing application upon determining Part V.1 Rules governing application for judicial review ought to be followed -- Whether Part V.1 Rules apply depending on whether proceeding taken under Federal Court Act, s. 18.1 -- Regulations, s. 6(1) authorizing application to court for order prohibiting Minister from issuing NOC -- Clearly application within contemplation of Federal Court Act, s. 18(1)(b) -- Application required by s. 18(3) to be made under s. 18.1 and prescribed procedures found in Part V.1 of Rules -- Trial Judge correctly holding proceedings governed by Part V.1 Rules -- Part III Rules also apply except to extent of any conflict -- Part V.1 Rules also dictating timetable for expeditious conduct of proceedings -- Person claiming patent rights must commence proceeding within 45 days of being served with notice of allegation -- Court expected to resolve matter within 30 months after proceeding commenced -- When extension of time that might delay final resolution of application beyond 30 months sought, Court will have to consider impact of Patent Act, s. 55.2(4)(e) and Regulations, s. 7(5) on discretion provided by R. 1614 -- By merely commencing proceeding, applicant obtaining tantamount to interlocutory injunction for up to 30 months without having satisfied any of criteria Court would require before enjoining issuance of NOC -- No liability as to damages arising from application as would be imposed by undertaking any court would require before making interlocutory injunction -- Duty of court to deal with application expeditiously -- Given that, in scheme of Regulations, patentee having both carriage of proceeding and interest in its dilatory prosecution, departures from schedule imposed by Part V.1 Rules should be exceptional -- Regulations, s. 5(3)(a) requiring applicant for NOC to provide detailed statement of basis in fact and law for statement of allegation -- Intending patentee be fully aware of grounds on which applicant alleging issuance of NOC will not lead to infringement of patent before deciding whether to apply to court for determination -- Such disclosure would define issues at very early stage -- Such purpose confirming intention proceedings be expeditiously conducted -- Not workable in case where ground provided by s. 5(1)(b)(iv) invoked -- Apotex not complying here -- Applicant for NOC alleging different process cannot be expected to make full disclosure without protective order -- Confidentiality cannot be assured until proceeding in court -- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2, 4, 5, 6, 7, 8 -- Food and Drug Regulations, C.R.C., c. 870, s. C.08.004 (as am. by SOR/85-143, s. 1; 88-257, s. 1) -- Patent Act, R.S.C., 1985, c. P-4, ss. 55.1 (as enacted by S.C. 1993, c. 2, s. 4), 55.2 (as enacted idem) -- Federal Court Act, R.S.C., 1985, ss. 18.1 (as enacted by S.C. 1990, c. 8, s. 5), 18.4 (as enacted idem) -- Federal Court Rules, C.R.C., c. 663, R. 1614 (as enacted by SOR/92-43, s. 19).