PATENTS |
Bristol-Myers Squibb Co. v. Canada (Attorney General)
T-1898-01
2002 FCT 1205, Blanchard J.
22/11/02
21 pp.
Judicial review of decision by Minister of Health to issue notice of compliance under Patented Medicines (Notice of Compliance) Regulations to Biolyse in relation to new drug submission for "Paclitaxel for injection"--Whether Regulations, s. 5(1), (1.1) engaged by facts of case-- Applicant Bristol--Myers Squibb Co. owner of two Canadian patents in relation to 6mg/ml injectable paclitaxel solutions-- Drug marketed under name "Taxol"-- Person making allegation under Regulations, ss. 5(1)(b), (1.1)(b) must provide detailed statement of legal, factual basis for allegation, serve notice of allegation on first person-- Expertise of Minister not engaged for proper construction of Regulations, s. 5--Minister would arguably have no greater expertise on issue than Court--Factors set out in Pushpanathan v. Canada (Minister of Citizenship and Immigration), [1998] 1 S.C.R. 982, requiring consideration-- Decision to grant NOC made under Regulations warranting low level of deference on judicial review--Appropriate standard of review applicable to issue of whether Regulations, s. 5 engaged on facts of application correctness--Finding based on "pragmatic or functional analysis"--Respondent Biolyse arguing applicants lack standing for application under Federal Court Act, s. 18.1 as failed to show "directly affected" --Applicants proceeding not under Patented Medicines (NOC) Regulations, but under Federal Court Act, s. 18.1-- Appropriate proceeding for remedies applicants sought-- Applicants' interest in so far as patents concerned "directly affected" by new drug submission (NDS)--Finding based on Minister's determination submitted drug contains same medicine found in applicants' drug "Taxol" namely, paclitaxel --Determinative issue on applicability of s. 5(1) whether Biolyse compared, referenced "Taxol" on basis of pharmaceutical characteristics-- Comparative analysis under s. 5(1) twofold: (1) to establish bioequivalence with another drug with objective to demonstrate safety, efficacy of drug; (2) to verify for patent infringement--Biolyse did not compare drug, make reference to another drug for purpose of demonstrating bioequivalence --Biolyse's submission not one to which s. 5(1) applies-- Attorney General of Canada arguing s. 5(1.1) should apply only where NDS relies on comparisons with another drug as basis for approval--Court disagreeing with this interpretation of s. 5(1.1)--Latter triggered when drug for which NOC sought contains "a medicine found in another drug that has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted"--Plain reading of s. 5(1.1) consistent with purposive approach to interpretation of Patented Medicines (NOC) Regulations--Regulations intended to prevent infringement of patent rights--Drug for which Biolyse sought NOC containing medicine, paclitaxel, found in another drug, "Taxol", marketed in Canada pursuant to NOC issued to first person, BMS--S. 5(1.1) engaged on facts of application--Minister erred by failing to require notice of allegation be served on applicants in compliance therewith-- Misinterpreted s. 5(1.1) in deciding only submissions based on comparative studies trigger s. 5(1.1)--Committed reviewable error in determining s. 5(1.1) does not apply to Biolyse NDS-- Erred in issuing NOC to respondent Biolyse until first person, BMS, served with notice of allegation--Application allowed-- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(1) (as am. by SOR/99-379, s. 2), 5(1.1) (as enacted idem)--Federal Court Act, R.S.C., 1985, c. F-7, s. 18.1 (as enacted by S.C. 1990, c. 8, s. 5; 2002, c. 8, s. 27).