PATENTS |
Eli Lilly Canada Inc. v. Canada (Minister of Health)
T-1212-00
2002 FCT 28, Hansen J.
10/1/02
19 pp.
Application for judicial review of decision by Minister of Health to remove applicant's Canadian Letters Patent no. 1,249,969 from Patent Register--969 patent covering claims for pharmaceutical compositions comprised of ceftazidime pentahydrate combined with amorphous lactose, pharmaceuti-cally acceptable base--Audited after Patented Medicines (Notice of Compliance) Regulations amended in 1998-- Applicant submitting Minister applied 1998 amendments to NOC Regulations in reaching decision to delist patent included on Patent Register in 1993--NOC Regulations exist to protect rights of patent holders, at same time to ensure new drugs not impeded from entering market place once shown not to infringe patent rights--Presumption that legislation not intended to have retroactive application well established-- Applicant's allegation Minister erred in applying NOC Regulations retroactively unsupported--Minister, in applying amended NOC Regulations, giving effect to Regulations as they apply to current facts--Minister's decision not amounting to retroactive application of NOC Regulations-- Requisite issuance of notice of compliance with respect to 969 patent in effect under 1993 Regulations--Applicant's argument with respect to retroactivity without merit-- Whether ceftazidime without amorphous lactose meets definition of "the medicine itself"--Tazidime, Tazidime Add-Vantage not containing "the medicine itself" as described in 969 patent--Manufactured by different process, formulation, detailed in confidential New Drug Submission filed with Minister--Medicine claimed in 969 patent not same medicine used in Tazidime, Tazidime Add-Vantage--Minister's interpretation of NOC Regulations correct, decision to remove 969 patent from Patent Register also correct--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (as am. by SOR/98-166).