Digests

Patents

Judicial review of decisions by Patented Medicines Prices Review Board determining applicant priced its medicine Copaxone excessively, required to pay $2 417 223.29 to Crown—Patent Act, R.S.C., 1985, c. P-4, s. 96(4) providing that Board may issue guidelines with respect to any matter within its jurisdiction, but clearly specifying that such guidelines not binding—Among many things covered in guidelines prepared by Board (Guidelines) is Board’s approach to question of excessive pricing—Guidelines, s. 6 setting out number of “tests”—Guidelines, ss. 7.1, 9 also setting out two presumptions of excessive pricing: (1) if price in Canada exceeding that of all other countries listed in Patented Medicines Regulations, SOR/94-688; (2) if price increase over benchmark price exceeding cumulative consumer price index (CPI) increase during pricing period—Patent Act, s. 85(1) providing that Board shall take into consideration five factors to the extent that information on factors available to Board—Each factor must be given reasonable consideration, no factor can be ignored, nor can any one factor be given such dominance that others essentially irrelevant—Board’s Guidelines, in particular s. 9.1, providing that if price increases exceeding cumulative CPI increase in relevant period, price presumed to be “excessive”—Such presumption effectively ignoring other factors of s. 85(1)—Board only focusing on CPI factor in s. 85(1)(d), no proper weighing of any kind given to other factors (ss. 85(1)(a),(b),(c))—Board acting unreasonably, outside mandate given under Patent Act, ss. 85(1),(2)—Applications allowed.

Teva Neuroscience G.P.-S.E.N.C. v. Canada (Attorney General) (T-470-08, T-939-08, 2009 FC 1155, Hughes J., judgment dated November 12, 2009, 38 pp.)