Apotex Inc. v. Canada ( Minister of National Health and Welfare )
T-2070-97
Gibson J.
29/7/98
19 pp.
Application for judicial review to require Minister maintain Register in accordance with Regulations and case law-Applicants seek mandamus to maintain Patent Register under Patented Medicines (Notice of Compliance) Regulations in accordance with Regulations; injunction requiring Minister not to list on Register patents containing only claims for processes or intermediates or otherwise irrelevant claims; mandamus requiring Minister to delete any patent now listed on Register containing only claims for processes or intermediates or otherwise irrelevant claims; mandamus requiring Minister to amend current "Form IV" under Regulations so that patentee must certify patent containing claim for medicine or use of medicine-Reference to background and facts set out in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1997] 3 F.C. 752 (T.D.)-Present application representing, to some extent, converse of application in latter case-Applicants concerned process of purging of Register that Minister engaged in did not go far enough as did not purge all patents containing only process claims-Further, Minister made no attempt to purge patents containing only intermediate claims-Application dismissed-Subject matter of application not properly subject of judicial review-Matter sought to be reviewed described as course of conduct of Minister in maintenance of Register, not program-Minister's course of conduct more amenable to review through public consultation and political process-Parliament, in enacting Patent Act, s. 55.2(4), and Governor in Council, in enacting pursuant to that provision regulatory scheme of which Register component, could not have contemplated judicial review of Minister's course of conduct in maintenance of Register-Applicants, generic drug manufacturers, not directly affected by Minister's course of conduct in maintaining Register, within meaning of Federal Court Act, s. 18.1-Applicants not "second persons" with identifiable direct interests at stake under Regulations under which Minister maintains Register-Insufficient that applicants have general interest in manner in which Minister maintains Register, must establish direct effect-Applicants have other effective ways to bring matter before Court when specific patent in new drug submission involved and proceeding commenced against them as provided in Regulations-Therefore, even if subject matter of application proper subject of judicial review, applicants nevertheless lack standing to bring application-Although unnecessary to do so, substantive issue raised by application and question of appropriate relief will be considered-On basis of evidence presented, difficulty and cost of conducting full purging of Register could not be major considerations-Absence of evidence on behalf of Minister leading to inference Minister could not provide evidence to establish decision not to fully purge Register in accordance with decisions of this Court based upon proper considerations and not extraneous grounds-In light of advice of patent examiner in Canadian Intellectual Property Office that it would take only 15 to 20 working days to check entire Register and in absence of evidence on behalf of Minister, in absence of considerations previously addressed in reasons, applicants would be entitled to relief-As to appropriate relief, if any-Minister's duty under Regulations, s. 3 to maintain Register of information submitted under s. 4, public duty-Duty owed to public, not exclusively or even primarily to first or second persons-Minister's duty purely administrative and ministerial in nature-Applicants have adequate alternative remedies-Compelling performance of Minister's duty not something for which mandamus should issue in favour of applicants on facts of this matter-Same conclusion, for essentially same reasons, in respect of prohibition-If applicants were found to have standing in respect of judicially reviewable matter, relief would be declaration Minister required to maintain Register in accordance with law and, on evidence, not doing so-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 3 (as am. by SOR/98-166, s. 2), 4 (as am. idem, s. 3)-Federal Court Act, R.S.C., 1985, c. F-7, s. 18.1 (as enacted by S.C. 1990, c. 8, s. 5)-Patent Act, R.S.C., 1985, c. P-4, s. 55.4 (as enacted by S.C. 1993, c. 2, s. 4).