Digests

Novartis Pharmaceuticals Canada Inc. v. Canada (Minister of Health)

A-617-02

2003 FCA 299, Malone J.A.

6/10/03

15 pp.

Appeal from order of MacKay J. (Applications Judge) ((2002), 22 C.P.R. (4th) 361), dated October 7, 2002, dismissing appellant's application for judicial review in relation to Canadian Patent 1300021 (021 patent)-- Applications Judge upheld decision of respondent Minister of Health (Minister) to remove 021 patent relating to Novartis' Estracomb patches from Patent Register--Whether patent claim to system of two patches applied to skin of patient constitutes claim for medicine itself or claim for use of medicine within meaning of Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), s. 4(2)(b)-- Proper test to determine if patches medicine under NOC Regulation whether patches administered to patient or whether patches administer substances to patient--Determination made by Applications Judge that patches not medicine does not conflict with Glaxo Group Ltd. v. Novopharm Ltd. (1999), 244 N.R. 199 (F.C.A.) decision--Underlying theory of Applications Judge's determination patches not administered, but instead administer medicine, direct application of Glaxo decision--Evidence clearly establishes claims of 021 patent similar to those of patent at issue in Glaxo--In Glaxo, inhaler used to administer medicament--Similarly, patches claimed in 021 patent used to administer estradiol or estradiol and norethindrone acetate to patients--Claims of 021 patent in relation to system for administration of substances, not in relation to substances themselves--Accordingly, patent for patches, 021 patent, not eligible for inclusion on Patent Register--Applications Judge correctly distinguished this case from Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.)--Patches different from formulation at issue in Hoffmann--In Hoffmann, patent contained claims to nasal spray composed of active and inactive ingredients physically mixed together in formulation, and administered to patient-- In case at bar, patches claimed in 021 patent not formulations --Layers of patches not mixed with estradiol or estradiol and norethindrone acetate--Rather, patches all discrete and separate components, and only estradiol or estradiol and norethindrone acetate administered to patient-- Other layers of patches never administered--Instead, each of two patches intentionally removed by patient and discarded after 14 days--Accordingly, clear patches never administered, and therefore do not fall within definition of medicine in NOC Regulations--Finally, Applications Judge correct in concluding manner in which Estracomb patches regulated under Food and Drugs Regulations, as drugs and not devices, and by Patented Medicines Prices Review Board not determinative when construing claims of 021 patent--Well established courts will not look at matters extraneous to patent in construing claims of patent--Appeal dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4(2)(b) (as am. by SOR/98-166, s. 3).