Nu-Pharm Inc. v. Canada ( Attorney General )
A-389-97
McDonald J.A.
20/2/98
7 pp.
Appeal from dismissal of application for judicial review ((1997), 73 C.P.R. (3d) 510) of Minister's decision not to issue notices of compliance to Nu-Pharm on new drug submission because not meeting requirements of Patented Medicines (Notice of Compliance) Regulations, s. 5-S. 5 setting out requirements to be met where person filing submission for notice of compliance in respect of drug, and comparing that drug with drug marketed in Canada pursuant to notice of compliance in respect of which patent list issued-Nu-Pharm's new drug submission relying on information, materials submitted previously by generic drug manufacturer, which in turn had filed abbreviated drug submission incorporating testing of original patentee of drug-Appeal dismissed-Nu-Pharm must comply with requirements of s. 5 before Minister will issue notice of compliance-Purpose of Regulations to protect research, development initiatives of innovator pharmaceutical companies-S. 5 putting patentee on notice generic drug manufacturer marketing same or similar drug-Permitting patentee to protect interests by ensuring not affected until after notice of compliance expiring or after receiving notice-Person seeking notice of compliance must file allegation, detailed statement of factual, legal basis, and must serve notice of allegation if wishes to compare that drug with drug in respect of which patent list submitted-Nu-Pharm cannot piggy-back its claim on generic drug company who relies on tests of patentee, and then state need not comply with Act because generic company not issuing patent list-Although one step removed, Nu-Pharm relying on tests done by patentees, whom generic company relied upon-While Nu-Pharm claiming to be comparing drug to generic, in essence comparing it to that of original patentee because generic compared its drug to that of patentee-Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1996), 71 C.P.R. (3d) 156 (F.C.T.D.) distinguished-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5.