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On January 6, 2021, the Federal Court issued its decision in two patent infringement actions pursuant to subsection 6(1) of the
Patented Medicines (Notice of Compliance) Regulations involving Teva’s patents pertaining to the drug
glatiramer acetate (Teva’s
GLATECT):
Teva v Pharmascience,2020 FC 1158. Justice Kane found Canadian Patent No. 2,702,437 (437 patent) invalid for obviousness while Canadian Patent No. 2,760,802 (802 patent) was found valid and infringed by Pharmascience if it proceeds to market its product.
COPAXONE 20 mg has been on the market since the mid-1990s for use in treating patients with relapsing-remitting multiple sclerosis (RRMS) and, in 2017, Pharmascience received a notice of compliance for GLATECT 20 mg for daily administration for this indication. COPAXONE 40 mg was approved in 2016 to be administered three times per week to treat patients with RRMS. Pharmascience sought approval for