SmithKline Beecham Pharma Inc. v. Apotex Inc.
T-1042-99
McGillis J.
12/11/99
15 pp.
Application under Patented Medicines (Notice of Compliance) Regulations, s. 6(7)(a) for order requiring Apotex Inc. to produce all relevant portions of submissions for notice of compliance describing process for preparation of drug paroxetine hydrochloride-SmithKline also applied, under s. 6(7)(b), for order requiring Minister of Health to verify that any documents produced correspond fully to information in submission-First issue production of portions of submission for notice of compliance-SmithKline has established on balance of probabilities disclosure of full process for manufacture of Apotex's paroxetine hydrochloride required to provide proper evidentiary foundation for assessing allegation of non-infringement in relation, at least, to product by process claim in claim 5 of _023 patent-Second issue whether Minister should be required to verify that portion of drug master file produced by Apotex to SmithKline corresponds fully to information filed with him in submission for notice of compliance-In order to determine proper construction of Patented Medicines (Notice of Compliance) Regulations, s. 6(7), principles of statutory interpretation outlined in leading case Rizzo & Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27 must be applied-Basic purpose of Patented Medicines (Notice of Compliance) Regulations to prevent patent infringement-First submission advanced by Minister s. 6(7)(b) "additional or supplementary remedy" that should not necessarily be made following making of order for production under s. 6(7)(a)-Provision in s. 6(7)(b) intended to operate as administrative check, designed to eliminate questions concerning information produced, including matters such as accuracy, completeness, currency-Not intended to be read in isolation as "additional or supplementary remedy", rather intended to constitute integral part of every order made by Court concerning production of confidential information-Sole legislative purpose of s. 6(7)(b) to reduce unnecessary litigation by eliminating uncertainty concerning information produced-Legislative amendment relieving Minister of more onerous burden of actually producing information-Second branch of Minister's argument prior to making order for verification under s. 6(7)(b), applicant should be required to establish material differences may exist between information produced and information filed by Minister-Interpretation proposed by Minister not consistent with legislative intention of reducing litigation, also not consistent with express wording of s. 6(7), when considered in entire context-Application allowed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(7) (as am. by SOR/98-166, s. 5).