Eli Lilly and Co. v. Novopharm Ltd.
T-2210-93
Richard J.
27/4/95
24 pp.
Application for order prohibiting Minister from issuing notice of compliance (NOC) for capsules of fluoxetine hydrochloride until after expiration of applicant's patent -- Issue whether respondent's allegation of non-infringement justified, i.e. whether process used by respondent's suppliers constituting obvious chemical equivalent of process described in applicant's patent-Review of general principles regarding legislative framework provided for in Regulations as examined by Court of Appeal in four decisions: Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329; Apotex Inc. v. Canada (Attorney General), [1994] 1 F.C. 742; Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302; David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588 -- Applicant submitting Act, s. 55.1 statutory presumption applicable to Regulation, s. 6 proceedings -- Whether s. 55.1 word "action" including s. 6 summary application for judicial review, not determinative as s. 55.1 proceedings must be for infringement of patent -- Although s. 6 purpose to prevent infringement of patent, s. 6 not proceeding for declaration of infringement but rather proceeding for an order of prohibition against Minister -- Applicant having overall burden of proof and must discharge burden without assistance of s. 55.1 statutory presumption -- Two approaches developed with respect to infringement test: (1) two-part test; and (2) purposive or realistic construction of claim language -- Two-part test including (a) literal or textual infringement test, and (b) substance or pith and marrow test -- Purposive test requiring determination of whether person skilled in art understanding particular phrase intended to be applied strictly so as to exclude any variant -- Both approaches requiring determination of whether those skilled in art would understand from reading claims particular word or phrase regarded as essential feature of claimed invention -- Substance of invention: formation of fluoxetine hydrochloride; most important part of process: ether formation step -- Ether formation process employed in respondent's process obvious chemical equivalent to ether formation process claimed in applicant's patent -- Respondent's allegation of non-infringement not justified -- Order of prohibition granted-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 -- Patent Act, R.S.C., 1985, c. P-4, s. 55.1 (as enacted by S.C. 1993, c. 2, s. 4; c. 44, s. 193) -- North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United States of America, [1944] Can. T.S. No. 2, Art. 1709(11).