In Lundbeck Canada v. Minister of Health, 2009 FC 1102, the Federal Court of Canada (FC) dismissed Lundbeck’s prohibition application against Ratiopharm in respect of two patents relating to memantine hydrochloride. Canadian patents 2,014,453 (’453 patent) and 2,426,492 (’492 patent) were listed by Lundbeck on the Patent Register under section 4 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (PMNOC Regulations). The patents relate to memantine, a drug used to treat individuals with Alzheimers. The ’453 patent outlines the mechanism of action for memantine and the ’492 patent suggests a method for combining memantine with other acetylcholine inhibitors (ACE inhibitors) to provide a synergistic effect. Ratiopharm served a Notice of Allegation on Lundbeck alleging that both the ’453 and the ’492 patents were invalid. The FC ruled that Ratiopharm’s allegations of invalidity were justified with respect to both patents. In doing so, the FC employed the tests for anticipation, obviousness, utility and found a lack of good faith prosecution due to the failure to specifically identify adverse material in a disclosed prior art reference. Continue Reading