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Hoffmann-La Roche Ltd. v. Canada ( Minister of National Health and Welfare )

T-970-98

Reed J.

26/1/99

12 pp.

Application for order prohibiting Minister of National Health and Welfare from issuing Notice of Compliance (NOC) to Genpharm Inc. for medicine naproxen until after expiry of Canadian patents 1,131,660 (_660) and 1,135,717 (_717)-Respondent Genpharm sending applicant Hoffmann-La Roche Ltd. (Roche) letter dated March 20, 1998 containing Notice of Allegation (NOA) regarding naproxen tablets as required by Patented Medicines (Notice of Compliance) Regulations, s. 5-Regulations amended March 12, 1998 to require service of NOA occur no earlier that at time new drug submission (NDS) filed-Genpharm sending NDS to Minister on same day, March 20, 1998-Contemporaneous sending by registered mail of NOA to Roche and of NDS to Minister meeting requirements of Regulations, s. 5(3)(c)(i)-Substance of Genpharm's allegation patents on which Roche relies not ones claiming medicine itself or use thereof and, therefore, sale of Genpharm's naproxen will not infringe any such claim-No vagueness, ambiguity-Genpharm's allegation sufficiently delineated issue, provided basis from which Roche could seek to disprove allegations contained in it-Genpharm not establishing proof of service on Roche provided to Minister-However, applicant cannot use failure to provide Minister with proof of service as grounds for seeking order Minister lacks jurisdiction to issue relevant NOC-Provision requiring proof of service to be filed on Minister for Minister's benefit, not applicant's-Roche patents relating to naproxen subject of other NOC proceedings in Court-Parties agreeing decisions in Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 67 C.P.R. (3d) 484 (F.C.T.D.) (the Apotex case) and in Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1998), 79 C.P.R. (3d) 486 (F.C.T.D.) (the Novopharm case) cannot be treated as rendering issue herein res judicata-Nor can they constitute issue estoppel-Applicant same in all three cases but not respondent-Evidence filed herein not filed in either of earlier cases-Applicant not adducing sufficient evidence to establish claim 27 of _660 patent, claim 27 of _717 patent claims for medicines-Roche's evidence not sufficient to establish mixtures described in respective claims 27 medicines-No claim in _660 patent mixture therapeutically active-Application dismissed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5 (as am. by SOR/98-166, s. 4).

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