Merck Frosst Canada Inc. v. Canada ( Minister of National Health and Welfare )
T-1306-93
Simpson J.
20/12/95
9 pp.
Judicial review seeking order prohibiting Minister from issuing Notice of Compliance (NOC) to Apotex for antibiotic Norfloxacin until after expiry of patent in 2001-Apotex opposing application-Apotex manufacturing, distributing generic pharmaceutical products-Merck Frosst Canada Inc. sole sublicencee for patent-Only holder of NOC for Norfloxacin-Notice of Allegation (Notice) served by Apotex alleging non-infringement on basis Apotex will obtain Norfloxacin in bulk from Novopharm-Alleged to be non-infringing activity because Novopharm holding valid compulsory licence for Norfloxacin-Licence subject to prohibitions arising under Patent Act, ss. 39.11, 39.14-Not entitled to import Norfloxacin for sale for consumption in Canada until 1996; produce Norfloxacin for sale for consumption in Canada until 1993-At date of Notice, Novopharm entitled to import bulk Norfloxacin for formulation and export without NOC-Application allowed-Allegations of infringement premature-Notice of allegation (1) serves as application for NOC and (2) if prohibition proceedings commenced, creates cause of action-Because NOC issued to permit marketing in Canada, question of whether issuance will cause infringement in Canadian market relevant-On forty-sixth day after service of Notice, when NOC could theoretically have been issued, no non-infringing activity possible under NOC due to prohibitions-When NOC requested and could have been issued, all purposes for which NOC required prohibited-Allegation of non-infringement not justified-Because NOC at issue, infringement to be considered only in respect of activities for which NOC required i.e. Canadian sales of Norfloxacin-As prohibited both at date of Notice and at date NOC could have issued, allegations of infringement premature-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1)-Patent Act, R.S.C., 1985, c. P-4, s. 39.11 (as enacted by R.S.C., 1985 (3rd Supp.), c. 33, s. 15; rep. by S.C. 1993, c. 2, s. 3), 39.14 (as enacted idem; as am. idem).