[2012] 4 F.C.R. D-7
Patents
Counterclaim for damages by Teva Canada Limited (Teva) pursuant to Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 8 as result of delay caused by Sanofi-Aventis Canada Inc. (Sanofi) exercising rights under Regulations to stay issuance of notice of compliance to Teva to prohibit Teva from selling generic version of drug ramipril—Decision with respect to Sanofi’s claim of invalidity of Regulations, s. 8 rendered under separate reasons (2012 FC 551); second action for damages released concurrently (2012 FC 553)—In assessing award of damages, Court having to consider hypothetical question, or “but for” world, of what would have happened if Sanofi had not brought application for prohibition by determining, inter alia, duration of relevant period, portion of generic market that would have been held by Teva—Parties disputing, inter alia, commencement date of relevant period for computing loss—Teva arguing commencement date prior to certification date, beginning of statutory stay—This argument premised on claim that commencement date to be determined in absence of Regulations, that Teva should be considered only generic manufacturer of ramipril during relevant period—Teva’s claim that start date to be determined “in the absence of these Regulations” overstating effect of that phrase in Regulations, s. 8(1)(a)—Phrase only modifying certification date, referring to absence of Regulations, s. 6 prohibition order, not to absence of Regulations generally—Limiting first person’s liability to some period following commencement of statutory stay not requiring radical re-writing, reading in of Regulations, as s. 8(1) already referencing statutory stay—This interpretation consistent with Apotex Inc. v. Merck & Co. Inc., 2009 FCA 187, [2010] 2 F.C.R. 389—Teva’s interpretation of s. 8(1)(a), effect of words “in the absence of these Regulations” on commencement date rejected—Reading words of s. 8 in their context, grammatical, ordinary sense, harmoniously with scheme, object of Regulations, intention of Parliament resulting in conclusion that liability period cannot predate statutory stay—As to assessment of Teva’s share of generic market, s. 8 requiring consideration of generic competition in hypothetical world—Market share captured by other generics in “but for” world accordingly considered—Court rejecting argument that one “but for” world be established, applied to present case, any other case involving genericization of ramipril—Assessment of damages to be made on facts of each case—Regulations contemplating “multi-generic” universe—Matter referred back to parties to determine final quantum of damages.
Sanofi-Aventis Canada Inc. v. Teva Canada Limited (T-1161-07, 2012 FC 552, Snider J., public reasons for judgment dated May 23, 2012, 133 pp.)