Digests

AstraZeneca Canada Inc. v. Canada (Minister of Health)

T-1954-02

2004 FC 736, Heneghan J.

20/5/04

21 pp.

AstraZeneca Canada Inc. (applicant or AstraZeneca) seeking judicial review of Minister of Health's (Minister) refusal to add Canadian Patent No. 2186037 (037 patent) to patent register relative to "Losec" (omeprazole) delayed-release capsule in 40-mg dosage--037 patent issued in April 2002-- On May 14, 2002, applicant requested listing of 037 patent on register--Referenced earlier Supplemental New Drug Submission (SNDS) dated July 2000, for company name change--Listing refused on ground earlier submission filed for change in manufacturer name not sufficient to permit listing of patent--Food and Drug Regulations (Regulations) requiring Notice of Compliance (NOC) to be obtained after submission made to Minister--Various types of submissions, in particular, "new drug submission" (NDS) pursuant to Regulations, s. C.08.002(1)(a), "abbreviated new drug submission" (ANDS) pursuant to s. C.08.002.1(1), and "Supplement" (SNDS) to either NDS or ANDS pursuant to s. C.08.003(1)(a)--Regulations not requiring any particular information to be provided about manufacturer's name or change in manufacturer's name--Regulations require manufacturer to submit new submission when significant change in respect of any of matters identified in s. C.08.003(2), including description of new drug, brand name or identifying name or code, and specifications of ingredients --Definition of NOC in Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) incorporates definition in Regulations--For purposes of NOC Regulations, "submission for notice of compliance" is NDS, ANDS, supplement to either of them--Whether NOC issued in response to something other than NDS, ANDS or SNDS allows holder of NOC to submit patent list pursuant to NOC Regulations, s. 4(4)--According to evidence, applicant filed submission to Minister relative only to change of its name, in accordance with policy concerning change of manufacturer's name--Submission not relating to any change in composition of drug or any of constituent components--SNDS in issue not addressing different indication for applicant's pharmaceutical product--Patent list can be submitted either at time person files submission for NOC (NOC Regulations, s. 4(3)) or within 30 days after issuance of patent issued on basis of application that has filing date predating date of filing submissions (s. 4(4))--Applicant claims to meet requirements of s. 4(4) and says it is entitled to have patent list included on patent register--Minister has complete discretion to accept or reject patent list--Time-lines for submitting patent list critical factor in making decision--Purpose of NOC Regulations to balance effective enforcement of patent rights and earliest possible entry of generic drugs into market, after issuance of NOC--Operation of NOC Regulations connected with assessment of safety and efficacy of pharmaceutical products, pursuant to Regulations--Reasonable to conclude underlying submission for patent list be related to purpose of regulatory scheme--Here, relationship not apparent--Underlying submission only for administrative change in record of manufacturer's name--Minister correctly interpreted Regulations in refusing to list 037 patent--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4 (as am. by SOR/98-166, s. 3)--Food and Drug Regulations, C.R.C., c. 870, ss. C.08.002 (as am. by SOR/93-202, s. 24; 95-411, s. 4), C.08.002.1 (as enacted idem, s. 5), C.08.003 (as am. idem, s. 6).