Bayer AG v. Canada ( Minister of National Health and Welfare )
T-1192-93
Rouleau J.
23/7/93
5 pp.
Dismissal of issue of "question of law" respecting onus together with imposition of directions, under appeal -- Rouleau J. previously ordering accelerated schedule with respect to matters under appeal -- Pursuant to Patented Medicines (Notice of Compliance) Regulations, ss. 6, 7 all challenges to applications for notices of compliance prohibit Minister from issuing notice until patent expires or Court declaring either allegations submitted not justified or under s. 7(2)(b) no claim for use of medicine would be infringed -- Department expecting Federal Court to render decisions on invalidity of patent; or to determine if alternative process submitted by generic non-infringing -- Judicial review process not proper method by which to determine applications -- Each situation will require lengthy trials, viva voce evidence -- Patentee by simply completing application obtaining order prohibiting Minister from issuing notice of compliance for interim period of 30 months -- Effectively issuing interlocutory injunction -- Regulations contemplating Court, on affidavit evidence only, should be able to resolve validity of patent in medicine or determine if application submitted by generic as to its manufacture and process non-infringing -- Although Regulations contemplating proceeding by way of judicial review, appropriate to direct these applications proceed by way of action in accordance with Federal Court Act, R.S.C., 1985, c. F-7, s. 18.4(2) (as enacted by S.C. 1990, c. 8, s. 5) -- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5, 6, 7.