Nu-Pharm Inc. v. Canada ( Attorney General )
T-2552-97
Blais J.
4/2/99
8 pp.
Motion for order adding Merck, Merck Frosst (Merck) as respondents; extending time to appeal November 19, 1998 order of Cullen J. (setting aside Minister's refusal to process Nu-Pharm's Abbreviated New Drug Submission (ANDS) for drug X: NuPharm Inc. v. Canada (Attorney General), [1999] 1 F.C. 620 (T.D.))-Merck alleging drug X drug under generic manufacturer A, and for which Merck innovator manufacturer B-Submitting Cullen J.'s order circumventing Patented Medicines (Notice of Compliance) Regulations by requiring Minister of Health to issue NOC for drug X without issuing, serving notice of allegation on innovator manufacturer B of drug X, first person in respect of which patent list submitted-Therefore maintaining should be allowed to participate in these proceedings to defend rights-Nu-Pharm Inc. v. Canada (Attorney General) (1997), 73 C.P.R. (3d) 510 (F.C.T.D.) and Nu-Pharm Inc. v. Canada (Attorney General) (1998), 80 C.P.R. (3d) 74 (F.C.A.) holding no notices of compliance may be issued by Minister unless requirements of Food and Drug Regulations and of Patented Medicines (Notice of Compliance) Regulations met-According to those decisions, applicant for notice of compliance must satisfy requirements established by both regime of Regulations concurrently prior to approval-Since these decisions not brought to Cullen J.'s attention, Cullen J. granted judicial review based exclusively on whether Minister committed error of law by concluding applicant's drug not "Canadian reference product" as defined in Food and Drug Regulations, and question of compliance with Patented Medicines (Notice of Compliance) Regulations not addressed-Motions to add Merck as respondents, for extension of time to either appeal Cullen J.'s order or to make motion to Court pursuant to Federal Court Rules, 1998, r. 399 requesting Cullen J. to reconsider order, allowed-Federal Court Rules, 1998, SOR/98-106, r. 399-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133-Food and Drug Regulations, C.R.C., c. 870.