Glaxo Wellcome Inc. v. Canada ( Minister of National Health and Welfare )
T-388-96 / T-793-96
Teitelbaum J.
19/8/97
18 pp.
Applications for judicial review concerning medicine acyclovir-Applicants seek orders to prohibit respondent from issuing Notices of Compliance to respondent Apotex-Proceedings hinge on criteria for issuing NOC-Requirements for NOC include overall safety and efficacy of drug and non-infringement of certain patents embodied in drug-Applicants owners or licencees of four patents in respect of acyclovir (patent no. 1,172,169 (169 patent) relating to acyclovir in topical cream or ointment form; patent no. 1,062,257 (257 patent) relating to more general claims of acyclovir; patents nos. 1,096,863 (863 patent) and 1,096,864 (864 patent) for methods and processes of manufacture of acyclovir and its intermediates)-In current proceedings, Apotex, generic drug manufacturer, sent two NOCs to applicants-On February 19, 1996, in action T-388-96 (388 proceeding), applicants responded to Apotex's NOC by issuing originating notice of motion for judicial review-On February 21, 1996, Apotex sent second NOC to applicants concerning medicine acyclovir in tablet form, and applicants responded, in action T-793-96 (793 proceeding), by issuing second originating notice of motion-Burden on applicants to establish on balance of probabilities Apotex's allegations of non-infringement in its NOCs not justified-Two overriding issues: first issue concerning expiry and relevancy of certain of applicants' patents; second centering on question of whether drug manufacturer must mention in NOC all of patents found on Patent Register for particular drug-Applications dismissed-No need for order of prohibition in 388 proceeding as patents at issue have either expired (257 patent) or contain claim not encompassed under Regulations-Would be height of futility if Court had to prohibit Minister from issuing NOC on basis of expired patent (257 patent)-Justification for allegations not frozen in time; time of hearing optimum period for determining justification of allegation-Applicants also conceded 863 and 864 patents did not contain claims encompassed by Regulations: in original notice of motion, applicants stated they did not rely upon these two patents in present proceedings-Therefore, irrelevant-But, even without express statement in originating notice of motion, these two patents describe methods and processes for manufacture of acyclovir and intermediates, and such method or process patents not type of patents encompassed by term "medicine or use of medicine" in Regulations, s. 4(2)-In 793 proceeding, Court should not issue order of prohibition in relation to patents whose claims do not fall under purview of Regulations-Process only patent conferring no rights on patent-holder in context of Regulations-In circumstances, Court has to go beyond contents of notice of allegation and decided whether it should grant order of prohibition based on 863 and 864 patents-Order of prohibition should not be issued as relating to 863 and 864 patents because such method or process patents have no bearing on medicine or use of medicine acyclovir under Regulations-388 proceeding therefore dismissed-No conclusion reached as to validity of Apotex's arrangement with Medichem, which holds compulsory licence for acyclovir, to obtain acyclovir or whether arrangement constituting sub-licence or transfer of compulsory licence by Medichem to Apotex-As to whether drug manufacturer must mention in NOC all of patents found on Patent Register for particular drug, Apotex must only give allegation with respect to every patent on patent list in respect of particular form of drug for which it seeks NOC-Apotex did not have to cite 169 patent as latter containing claims for acyclovir in topical cream or ointment form whereas Apotex was seeking NOC for oral tablet form of acyclovir in varying dosages-Failure to cite 169 patent irrelevant to issue of justified allegations of noninfringement-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4(2).