Glaxo Group Ltd. v. Novopharm Ltd.
T-2673-96
Tremblay-Lamer J.
9/2/98
12 pp.
Application for order pursuant to Patented Medicines (Notice of Compliance) Regulations prohibiting Minister from issuing notice of compliance (NOC) to Novopharm in respect of beclomethasone dipropionate inhaler until after expiration of patents-Patents disclosing claims for mechanical devices known as "inhalers", used for administering medicaments to patients suffering from bronchial conditions-Respondent alleging infringement impossible since patents not containing any claims for medicine itself, but solely describe devices for administering medicament-Regulations, s. 2 defining "medicine" as substance capable of being used for diagnosis, treatment, mitigation or prevention of disease, disorder or abnormal physical state-In Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.); affd (1996), 67 C.P.R. (3d) 25 (F.C.A.), Court holding nasal spray composed of active ingredient mixed with inactive ingredients (solvents, gases, other spray components) needed for ideal delivery of active ingredient to affected area, "medicine" because having therapeutic effect; "medicine" not restricted to one substance but would encompass many substances; Regulations neither restricting these substances to active ingredients nor excluding claim for composition or formulation including active ingredient-Presence of inactive ingredients forming integral part of formulation, assisting in delivery of active ingredients to body not removing composition from definition of "medicine"-(1) Whether definition of "medicine" encompassing devices used to administer active substances to patients, but which are not ingested into body-Hoffmann-La Roche specifically dealing with compositions of active, inactive ingredients (such as coatings, inert carriers) physically mixed together, ingested into body as single composition-Not intended to include mechanical device as inactive ingredient-Regulations not extending meaning of "substance" to include mechanical devices made of metal, plastic which cannot be ingested into body-(2) Meaning of "finally dismissed" in Regulations, s. 7(4)-By virtue of s. 7(1), when application under s. 6(1) commenced, Minister automatically prohibited from issuing NOC to generic drug company until "latest of" various listed events, time periods, one of which period of 30 months after application commenced-Under s. 7(4), 30-month period lifted when application withdrawn or "finally dismissed"-Application "finally dismissed" when all appellate procedures completed or when time to appeal expired without any appeal having been launched; otherwise "finally" having no meaning: R. v. Morgentaler, [1988] 1 S.C.R. 30 (interpreting "if finally acquitted" and "if finally found guilty")-Motion for order of prohibition dismissed-30-month period prescribed in s. 7(1)(e) continuing to apply until all appeals exhausted or all appeal periods expired-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 "medicine", 7.