Nu-Pharm Inc. v. Canada ( Attorney General )
T-2030-96
Richard J.
15/5/97
10 pp.
Application under Federal Court Act, s. 18.1 for order (a) declaring refusal by Minister of National Health and Welfare to process applicant's new drug submissions invalid and setting aside Minister's decisions; (b) directing Minister to process applicant's new drug submissions in issue without regard to Patent Regulations, and to issue notices of compliance for applicant's drug products-On August 7, 1996, Nu-Pharm submitted two new drug submissions, one for Drug X in one strength, other for Drug Y in two strengths-Minister advised Nu-Pharm new drug submissions will not be processed until requirements of Patented Medicines (Notice of Compliance) Regulations met-Under Food and Drug Regulations, manufacturer must satisfy Minister new drug safe, effective before notice of compliance permitting it to market new drug in Canada issued-Nu-Pharm not itself manufacturing drugs-Drugs manufactured for Nu-Pharm, identical to previously approved brands to which Nu-Pharm submissions cross-referenced except for branding, labelling changes-Drugs marketed by Nu-Pharm under own label, brand-Person seeking notice of compliance for drug must file allegation, detailed statement of factual, legal basis, must serve notice of allegation if person wishes to compare, or make reference to, drug in respect of which patent list submitted-Failing compliance with requirements, Minister may not issue notice of compliance-Nu-Pharm's new drug submissions providing no new data-Comparing drugs with, making reference to drug marketed in Canada pursuant to notice of compliance issued to first person in respect of which patent list submitted-Medicine in drugs identical-Drugs themselves equivalent although may not be identical by reason of differences in excipients-Minister's decision not invalid, unlawful-Minister having no duty, right to issue notices of compliance in respect of new drug submissions unless requirements of Patented Medicines (Notice of Compliance) Regulations, s. 5 met-Application dismissed-Federal Court Act, R.S.C., 1985, c. F-7, s. 18.1 (as enacted by S.C. 1990, c. 8, s. 5)-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5-Food and Drug Regulations, C.R.C., c. 870.