[2013] 1 F.C.R. D-4
Patents
Practice
Appeal from Federal Court decision (2012 FC 2) accepting Minister of Health’s (respondent) position refusing to list Canadian Patent No. 2512475 ('475 patent) on patent register since failing to meet requirements of Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4(2)(b)—Appellant filing new drug submission (NDS) seeking approval of drug for treatment of human immunodeficiency virus infection—NDS stating that drug Complera containing three medicinal ingredients (tenofovir, emtricitabine, rilpivirine)—Appellant also submitting eight patents for listing on patent register in relation to Complera, including '475 patent—Informed that '475 patent not eligible for listing since rilpivirine not mentioned in any of '475 patent claims, that patent not meeting matching requirement—Main issues how to correctly interpret Regulations, ss. 4(2)(a),(b); whether respondent’s decision excluding '475 patent from register reasonable—Federal Court erring in law in applying requirements for eligibility under s. 4(2)(b) rather than 4(2)(a) since claims at issue for new combination of medicinal ingredient—Both Federal Court, Minister failing to give sufficient weight to requirement that formulations contain non-medicinal ingredients, set out particular dosage form—Definition of “formulation” in Regulations, s. 2 clear: must contain both medicinal, nonmedicinal ingredients—Term “medicinal ingredient” must be read in both singular, plural forms—Overall inventive step of '475 patent constituting combination of chemically stable medicinal ingredients—Therefore, '475 patent falling under Regulations, s. 4(2)(a)—However, relevant claims in '475 patent not meeting requirements of s. 4(2)(a) since lacking strict product specificity regarding three medicinal ingredients listed in NDS (i.e. not specifically referring to rilpivirine)—While Federal Court erring in applying Regulations, s. 4(2)(b) to claims at issue, not erring in reasoning under product specificity analysis, that reasoning equally applicable under s. 4(2)(a)—Appeal dismissed.
Gilead Sciences Canada Inc. v. Canada (Health) (A-44-12, 2012 FCA 254, Trudel J.A., judgment dated October 9, 2012, 16 pp.)