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Pfizer Canada Inc. v. Apotex Inc.

T-2282-01

2002 FCT 498, O'Keefe J.

3/5/02

14 pp.

Motion for order under Patented Medicines (Notice of Compliance) Regulations requiring Apotex Inc. to produce samples of bulk azithromycin used in Apotex' azithromycin tablets, together with samples of such tablets--Apotex providing notice of allegation (NOA) under NOC Regulations in respect of azithromycin tablets for oral administration in strengths of 250 mg--Alleging no claim for medicine itself, no claim for use of medicine in Canadian Patent No. 1,314,876 would be infringed by making, constructing, using, selling by Apotex of azithromycin tablets--Applicants owner of 876 patent--Apotex filed patent application 2,245,398 disclosing method for preparing monohydrate--Whether samples compellable under Patented Medicines (Notice of Compliance) Regulations, s. 6(7) depends upon whether samples provided to Minister as part of submission for notice of compliance--Samples can be compellable only if provided to Minister--Samples provided to Minister, compellable under s. 6(7)--On balance of probabilities, production of requested information, samples necessary to provide evidentiary foundation for Court to assess allegations of non-infringement--Applicants should be provided with opportunity to examine material produced by Apotex, to file further evidence--Granted extension of time to file evidence herein for period of 60 days following production of material by Apotex--Motion granted--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6 (as am. by SOR/98-166, s. 5; 99-379, s. 3).

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