PATENTS |
Practice |
Reddy-Chemicor, Inc. v. Canada (Attorney General)
T-2294-00
2001 FCT 1065, Lemieux J.
28/9/01
24 pp.
Application by AstraZeneca Inc. for party or intervener status in present proceedings (raising issue of interrelationship between NOC provisions of Food and Drug Regulations (FD Regulations) made under Food and Drugs Act and Patented Medicine (Notice of Compliance Regulations) (NOC Regulations) made under Patent Act) and application for judicial review of Minister of Health's decision not to process applicant's abbreviated New Drug Submission (ANDS) for notice of compliance (NOC) to enable it to market omeprazole capsules--In July 1999, Therapeutic Products Program (TPP) of Health Canada issued a screening deficiency notice to Chemicor on basis medicinal ingredient in omeprazole in its ANDS not pharmaceutically equivalent to that in Canadian reference product (AstraZeneca's Losec tablets; omeprazole magnesium); that its ANDS not acceptable; and that Chemicor would have to proceed by way of New Drug Submission (NDS)--That decision affirmed by A/Director General of TPP--AstraZeneca's application for party or intervener status dismissed with costs--Test herein for determination whether AstraZeneca ought to be granted party status whether it has shown that, in judicial review proceedings initiated by Reddy-Chemicor, matter arises which affects AstraZeneca's patent protection rights provided for in NOC Regulations; answer thereto determining whether AstraZeneca directly affected by Court's decision in that proceeding or ought to have been joined as party--Herein, AstraZeneca not directly affected by judicial review proceedings launched by Chemicor nor is its presence necessary to ensure that all matters in dispute in that proceeding may be effectually and completely determined--AstraZeneca's alternative request for intervener status also rejected as no need for its presence as intervener to assist Court--No relevant evidentiary gap--Food and Drug Regulations, C.R.C., c. 870--Food and Drugs Act, R.S.C., 1985, c. F-27--Patented Medicines (Notice of Compliance Regulations), SOR/93-133--Patent Act, R.S.C., 1985, c. P-4.