Digests

Pfizer Canada Inc. v. Apotex Inc.

T-2282-01

2003 FC 1428, Snider J.

21/1/04

35 pp.

Application for order prohibiting Minister of Health (respondent) from granting to Apotex Inc. (Apotex) Notice of Compliance (NOC) for tablets of azithromycin until after expiration of Pfizer Canada Inc.'s (Pfizer) patent for crystalline azithromycin dihydrate (dihydrate) (876 patent) --Whether allegation of non-infringement contained in Notice of Allegation (NOA) justified--In examining issue, five questions addressed--First, whether burden of proof shifts to Apotex to show non-infringement once Pfizer requested samples of material produced by Apotex in clinical trials--In proceeding under Patented Medicines (Notice of Compliance) Regulations, s. 6(2), party who has carriage of litigation has burden of proving on balance of probabilities NOA not justified--Further, facts contained in NOA and detailed statement presumed to be true--Clear Pfizer bears legal burden and "cannot expect to be able to make [its] case out of mouth of respondent"--In Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1995), 60 C.P.R. (3d) 328 (F.C.T.D.), affd (1995), 64 C.P.R. (3d) 450 (F.C.A.), Strayer J.A. held generic respondent or second person does have evidential burden in NOC proceedings--Clear Apotex has evidential burden to "put into play" issue of non- infringement by issuing NOA and detailed statement to Pfizer and respondent--However, these documents, if determined adequate, will satisfy evidential burden on a respondent-- Thus, if NOA and detailed statement not deficient, Apotex will have discharged evidential burden--Strayer J.A.'s comments not permitting applicant to expand evidential burden on respondent at its whim--Further, nonsensical to allow one party to state what vexes it, thereby putting issue into play, and then determine other party has burden of providing evidence in support of such vexation--Legal burden rests with Pfizer as does evidential burden with respect to samples requested--Second, whether Apotex's failure to provide requested samples giving rise to common law presumption of infringement--If information "manifestly beyond the power of" party to "discover and prove in evidence", and it pleads, in originating notice of motion, nature of information within exclusive knowledge of generic, it may be able to rely on presumption--However, it must additionally demonstrate information required not in its possession and peculiarly within knowledge of other party-- Case at bar not infringement action--Because of purpose of proceeding and applicable standard of proof, samples not falling within meaning of "required information"--Given disclosure of abbreviated new drug submission (ANDS), not manifestly beyond power of Pfizer to determine whether Apotex's product will contain dihydrate--Common law presumption not available to Pfizer--Third, whether production of samples necessary--Pfizer relied on AB Hassle v. Apotex Inc. (2002), 21 C.P.R. (4th) 173 (F.C.T.D.) to contend insufficient facts provided in respondent's NOA justifying allegation of non-infringement of 876 patent--AB Hassle distinguished--Before commencing this proceeding, Pfizer sought production of "samples of bulk azithromycin used in Apotex's azithromycin tablets, together with samples of such tablets"--O'Keefe J. ordered Apotex to produce requested samples only if Apotex provided such samples to Minister in NOC submissions--Pfizer submitting Court should rely on order of O'Keefe J. as support for position Apotex samples necessary to provide evidentiary foundation for Court to determine whether NOA justified--As only limited evidence before O'Keefe J. inappropriate to be bound by reasons of order or even to give it more than passing reference--As to samples as "best evidence", mere fact sample materials relevant insufficient to order their production or to form basis of successful application by Pfizer--Fourth, whether NOA and detailed statement adequate--In assessing adequacy of NOA, must keep in mind: (1) bald assertion of non-infringement insufficient; (2) permissible for second person to withhold certain information regarding formulation until subsequent to confidentiality order being in place; and (3) NOA adequate if further disclosure elaborates on basis for which allegation of non-infringement made such that sufficient evidence upon which to evaluate allegation--Pfizer submitted Apotex's NOA fatally flawed--Here, Apotex clearly stated "making, constructing, using or selling by us of tablets containing the medicine azithromycin in strengths of 250 mg for oral administration" will not infringe applicant's 876 patent--Sufficient information contained in NOA and detailed statement upon which Pfizer could evaluate allegation --NOA not fatally flawed--Fifth, whether non-infringement allegation in NOA justified--Only claim at issue claim 1 of 876 patent and that its essential element "crystalline azithromycin dihydrate"--Pfizer seeking prohibition order on grounds Apotex will produce dihydrate either as byproduct or as final product and even if final product free of dihydrate, it will nevertheless convert into dihydrate upon storage and scaling up of production--As to manufacturing, Pfizer failed to show Apotex would infringe patent by producing dihydrate either as byproduct or final product--As to storage and scaling up, Pfizer submitted upon storage and scaling up, conversion of IPA monohydrate will occur, thus infringing 876 patent--Pfizer failed to prove conversion upon scaling up production will occur on balance of probabilities-- Evidence not establishing, on balance of probabilities, Apotex's allegation of non-infringement not justified-- Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(2).