Hoffmann-La Roche Ltd. v. Canada ( Minister of National Health and Welfare )
T-1325-94
Noël J.
21/6/95
19 pp.
Application under Patented Medicines (Notice of Compliance) Regulations for order prohibiting Minister from issuing Notice of Compliance (NOC) for nasal mist proposed to be sold by respondent Nu-Pharm Inc. until expiration of patents owned by applicant Syntex Inc.-Patents in issue prefaced by description of anti-inflammatory properties of chemical flunisolide, which has been subject of public disclosure since 1964 when first patented in United States-Nu-Pharm alleging Regulations only allow patent list to be filed where claims for medicine itself or for use of medicine-Words "drug", "medicine" said to be given distinct meaning-Regulations, s. 5(1)(b)(iv) contemplating comparison between drugs in issue to determine whether claim for medicine itself or use of medicine would be infringed by making and selling of new drug-Resolution of issue raised by notice of allegation turning on meaning, scope of following words as defined in Regulations, s. 2: "claim for the medicine itself", "claim for the use of the medicine", "medicine"-Use of words "drug", "medicine" in Regulations originating from interaction between Food and Drugs Act and Patent Act now existing under Regulations as result of enactment of Patent Act Amendment Act, 1992-Regulations preventing Minister from issuing NOC under Food and Drugs Act to second person when drug with respect to which NOC sought would infringe first person's patent granted under Patent Act-Word "medicine" foreign to Food and Drugs Act-Word "drug" undefined, should be given meaning under Food and Drugs Act subject to necessary modification under Regulations-"Drug that contains a medicine" in Regulations, s. 4(1) framed by reference to drug containing medicine as opposed to drug containing other non-medicinal substance and falling outside scope of Regulations-Pharmaceutical composition can be substance that is medicine-Words "drug", "medicine" in Regulations, s. 4(1) not used in contradistinction, not intended to draw line between active ingredient and preparation or composition including active ingredient-Substances claimed in patents 228, 963, 048 "medicine" within meaning of Regulations as intended or capable of being used for treatment of disorder or disease-Making "claim for the medicine itself" as each patent includes claim for such substances-None of allegations by Nu-Pharm justified with respect to patents 228, 048, 963-Application allowed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2, 4(1), 5(1)(b)(iv)-Patent Act Amendment Act, 1992, S.C. 1993, c. 2-Food and Drugs Act, R.S.C., 1985, c. F-27.