[2013] 3 F.C.R. D-14
Patents
Practice
Judicial review of Patented Medicine Prices Review Board decision ordering applicant to pay Crown amount exceeding $2 million for having sold its Copaxone Syringe in Canadian market at “excessive” price between 2004, 2010 contrary to Patent Act, R.S.C., 1985, c. P-4, s. 83—Applicant challenging Board’s redetermination regarding excessive pricing of Copaxone Syringe; succeeding in first challenge—Applicant marketing medicine Copaxone for use in treatment of multiple sclerosis—First introduced in Canadian market in 2007 in vial format—Applicant later developing, marketing Copaxone as syringe, selling at same price as vial—In 2004, applicant increasing price of Copaxone Syringe, discontinuing vial format—In first judicial review application, Board found to have improperly limited attention to only one of four factors having to be considered under Act, s. 85(1), namely “changes in consumer price index” as stated in s. 85(1)(d); that other factors in s. 85(1) not considered—Whether Board’s decision should be quashed because unreasonable—Contrary to applicant’s argument, Board not unreasonably interpreting or applying term “medicine” as found in Act—While on face, Board carefully considering each factor in Act, s. 85(1), decision only paying lip service to factors stated in ss. 85(1)(b),(c) favouring conclusion that medicine not excessively priced—Treating consumer price index (CPI) found in s. 85(1)(d) as conclusive factor—Board inexplicably assigning less weight to relative price of medicine within domestic market, factor set out in s. 85(1)(b), which clearly favoured applicant’s position—Also unjustifiably placing less significance on relative price of medicine within international market, factor in s. 85(1)(c), which also favoured applicant’s position that medicine not being sold at excessive price in Canada—Board’s decision not indicating how much weight factors in ss. 85(1)(b),(c) given—However, Board making fundamental error in interpreting Act, s. 85(1) generally when giving weight only to CPI factor in s. 85(1)(d); when stating that price increases of medicine exceeding protection Parliament providing—Parliament providing no such “protection”; rather providing protection from “excessive” prices; stating that CPI constituting one factor to consider without being only or determinative factor as Board’s decision suggesting—Board’s error confirmed when Board stating that s. 85(1)(d) providing public protection which complements limits ss. 85(1)(b),(c) placing on relative pricing within marketplace—Act, ss. 85(1)(b),(c) placing no such limits; CPI itself not “limit”—Opening words in s. 85(1) meaning that each of factors listed therein relevant to singular determination: whether medicine sold at “excessive” price—In short, Board erring when considering guidelines, portions thereof dealing with CPI to be binding—Guidelines not binding in accordance with Act, s. 96(4)—Board’s decision therefore unreasonable—Application allowed.
Teva Canada Innovation v. Canada (Attorney General) (T-586-12, 2013 FC 448, Zinn J., judgment dated April 30, 2013, 19 pp.)