PATENTS
Appeal from Federal Court decision (GlaxoSmithKline Inc. v. Canada (Attorney General), 2004 FC 1725) dismissing appellant’s application for judicial review of Minister of Health’s refusal to list Canadian Letter Patent Nos. 1298479, 2031393 on Register of Patents as including within scope thereof controlled-release tablets of medicine paroxetine hydrochloride—Patents for system for controlled-rate release of active substances, including “pesticides, herbicides, fertilizers, room deodorants, medicaments or any type of substance which requires to be released at a controlled rate into a [sic] aqueous fluid”—Whether patents contain “claim for medicine itself or claim for use of medicine” as prescribed by Patented Medicines (Notice of Compliance) Regulations, s. 4(2)(b)—Motions Judge found within claims of either patent, no explicit claim to either medicine paroxetine hydrochloride or its use—Appeal dismissed—Claims in patent give no guidance as “claim for the medicine itself” (defined term found in NOC Regulations, s. 2), except through use of “active substance”—Wording too imprecise to satisfy requirement of NOC Regulations, s. 4(2)(b)—Expert evidence cannot fill in when terms of claims give insufficient guidance—Pelletier J.A. (concurring reasons): question whether patents must teach method or process for manufacture of paroxetine hydrochloride itself, or if sufficient if patents teach method or process for manufacture of controlled-release version of paroxetine hydrochloride—Proposing new approach based on dichotomy between delivery system and payload: whether patent protecting delivery system or payload—Herein, patents clearly designed to protect delivery system—Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 “claim for the medicine itself”, 4(2)(b) (as am. by SOR/98-166, s. 3).
GlaxoSmithKline Inc. v. Canada (Attorney General) (A-686-04, 2005 FCA 197, Desjardins and Pelletier JJ.A., judgment dated 24/5/05, 18 pp.)