PATENTS |
Pfizer Canada Inc. v. Canada (Attorney General)
T-441-03
2004 FC 370, Mosley J.
11/3/04
22 pp.
Judicial review of Minister of Health's decision refusing to add Canadian patent No. 2088376 (376 patent) to Patent Register on grounds patent not containing claim to medicine verapamil hydrochloride, or its use, as required by Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), s. 4(2)(b)--S. 4(2)(b) requiring patent list in respect of drug to set out any Canadian patent that contains a claim for the medicine itself--In particular, refusal based on grounds "dosage form" referred to in patent not claim for "medicine" within meaning of NOC Regulations, s. 4(2)(b)-- Definition of "medicine" in NOC Regulations means "substance intended or capable of being used" for treating, diagnosing or preventing ailments--In Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 67 C.P.R. (3d) 25 (F.C.A.), Court held terms "drug" and "medicine" not intended to be interpreted in "contradistinction"--Objective of 376 patent to provide novel dosage form allowing for particular method of delivery of variety of different drugs--376 patent addresses problem that prior art had not revealed delivery system for administration of drug in tablet form allowing "time-varying patterns of delivery"--No mention of verapamil or verapamil hydrochloride in introductory portions of specification--In fact, "verapamil" only mentioned twice in patent: in claim 2, as one of several possible drugs to use in dosage form described in claim 1, and also in examples 1 and 2 of specification--376 patent not claiming protection for "medicine" found in Pfizer's "Chronovera" tablet--Rather, patent is for delivery system for administration of any one of 27 listed drugs, including verapamil hydrocholride-- "Essential elements" of invention are features of dosage form allowing for time-varying delivery of various drugs--Delivery system protected, not listed drugs--Fact tablets claimed in 376 patent ingested not altering their function in therapeutic process as device for administration of medicine, rather than medicine itself--Correct construction of patent focusses on purpose of patent, and function of invention at issue, being for system of delivery of medicine, over varying time intervals, making therapeutic effect of certain drugs more beneficial --376 patent providing for discrete and separate components of "drug-free" layers, surrounding actual drug dose, and these parts of tablet should not be viewed as inactive ingredients of drug substance itself--Patent describing sustained release and time-varied nature of invention as well as ways of building invention, that is the tablet, using different medicines--But claims in patent not for "the medicine itself", as found in Pfizer's product for which NOC granted--Minister's decision correct and 376 patent not eligible for listing on Patent Register with respect to applicant's "Chronovera" tablets-- Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4(2)(b) (as am. by SOR/98-166, s. 3).