PATENTS |
Infringement |
Pfizer Canada Inc. v. Apotex Inc.
T-1325-00
2002 FCT 805, Heneghan J.
19/7/02
27 pp.
Application for order pursuant to Patented Medicines (Notice of Compliance) Regulations, s. 6(2) prohibiting Minister of Health from issuing notice of compliance (NOC) to Apotex in relation to 250 mg azithromycin capsules for oral administration until applicant Pliva d.d.'s patent expired--Respondent served notice of allegation (NOA) because wants to obtain NOC for its version of azithromycin prior to expiry of patent in order to apply for listing on provincial formularies (lists maintained by provinces of all drug products approved by provincial Ministries of Health)--Application allowed-- Statement in NOA (basically that would not make, construct, use or sell capsules other than as deemed to be non-infringing pursuant to Patent Act, s. 55.2(1), (2) sufficient to meet requirement that respondent state legal foundation for its NOA --Fact respondent abandoning reliance upon Act, s. 55.2, referred to in NOA, not amounting to rewriting of NOA as exemption in Act, s. 55.2(2) no longer available, by operation of Parliament, matter beyond respondent's control--As to whether NOA justified, question whether issuance of NOC to respondent, for purpose of its application for listing on provincial formularies, falling within exemption of deemed non-infringement created by Act, s. 55.2(1)--Answer dependent upon interpretation of Act, s. 55.2(1), Regulations, s. 5(1)(b)(iv), in comparison with provincial legislation governing interchangeability and payment for pharmaceutical products--According to relevant Regulatory Impact Analysis Statement, patentee's exclusive rights to use, enjoy its patent now limited by ability of generic manufacturers to use otherwise protected material in making submission for regulatory approval, such as applying for NOC--According to evidence herein, all provinces require pharmaceutical manufacturer to hold NOC before drug product listed on provincial formulary--However, respondent cannot rely on provincial legislative regime over interchangeability of drug products, inclusion in provincial drug plans to justify its application for NOC--Provincial legislation serving regulatory purpose over use, sale of drug products but only after federal process has been engaged, completed--Provincial regimes subordinate to federal scheme mandated by Food and Drug Act, Regulations--Respondent cannot succeed as argument (characterizing provincial legislation as regulating use, sale of drug products) contrary to regulatory scheme affecting both approval of drug product, protection of patent rights-- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(2)--Patent Act, R.S.C., 1985, c. P-5, s. 55.2(1) (as enacted by S.C. 1993, c. 2, s. 4), (2) (as enacted idem; 2001, c. 10, s. 2)--Food and Drugs Act, R.S.C., 1985, c. F-27--Food and Drug Regulations, C.R.C., c. 870.