Merck Frosst Canada Inc. v. Canada ( Minister of Health )
T-1663-97 / T-1258-97
Teitelbaum J.
26/3/99
28 pp.
Applications for judicial review under Patent Act, s. 55.2, Patented Medicines (Notice of Compliance) Regulations, s. 6, R. 1600-Applicants seeking order of prohibition precluding respondent Minister of Health from issuing to respondent Nu-Pharm Inc. in file T-1258-97, and to respondent Pro Doc Limited in file T-1663-97, notice of compliance (NOC) for medicine lovastatin until after expiry of Canadian Patent No. 1,161,380-Applicant Merck & Co. owner of Canadian Patent No. 1,161,380 (_380 Patent) granted on January 1, 1984 in respect of lovastatin-Medicine lovastatin hypocholesteremic drug effective in treatment of people with elevated blood cholesterol-Respondents Pro Doc, Nu-Pharm Canadian generic drug manufacturers-Merck Frosst receiving Pro Doc's notice of allegation (NOA) dated June 17, 1997, Nu-Pharm's NOA dated April 23, 1997, for lovastatin, alleging non-infringement of _380 Patent-On June 10, 1997, applicants commenced prohibition proceedings in respect of aforementioned NOAs in files T-1663-97, T-1258-97 raising virtually identical issues-Legal burden in prohibition proceedings under Regulations considered at length in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] F.C.J. No. 1882 (T.D.) (QL)-Regulations stipulating requirements must be complied with before Minister may issue NOC-Compliance with requirements matter for determination of Minister as part of administrative process leading to issuance of NOC-Minister in position to issue NOC where New Drug Submission (NDS) filed with allegation and where first person served with NOA, detailed statement-Where this has been done, failure to file proof of service should not vitiate entire process-Consistent with Parliament's intent in enacting Regulations as part of new patent scheme to ensure Minister of Health attest to health, safety, efficacy of drugs prior to issuance of NOC, to give first persons protection over proprietary rights by permitting them to challenge generic manufacturers' allegations of non-infringement-Given nature of proceedings, not for Court to scrutinize every shred of evidence to determine whether infringement-Nature of prohibition proceedings requiring determination be made on whether, on balance of probabilities, allegations of noninfringement justified-Applicants' challenge to allegations of non-infringement based on speculative theory of contamination-Weight of evidence adduced by way of affidavit not showing contamination more likely than not occurred-Applicants unable to show respondents' allegations of non-infringement, on balance of probabilities, with respect to intended use of lovastatin provided by Apotex Fermentation Inc., not justified-Filing of NDS, proof of service of NOA upon first person with Minister matters falling in realm of administrative process leading to issuance of NOC by Minister, not relevant to prohibition proceedings-In prohibition proceedings, Court concerned with allegations, first person in position to challenge it where served with NOA, detailed statement-Applications dismissed-Patent Act, R.S.C., 1985, c. P-4, s. 55.2 (as enacted by S.C. 1993, c. 2, s. 4)-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6-Federal Court Rules, C.R.C., c. 663, R. 1600.