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. (more…)
Posts Tagged ‘utility’
FC Goes Beyond Specification to Assess Utility and Introduces Deception by Inference into s. 53 of Patent Act
In Ratiopharm Inc. v. Pfizer Limited (2009 FC 711), the Federal Court of Canada (FC) granted a declaration that Canadian Patent 1,321,393 (‘393 Patent) is invalid pursuant to s.60(1) of the Patent Act. The Court accepted all five grounds of invalidity put forward by the generic challenger. In invalidating the ‘393 Patent, the FC reviewed evidence beyond the patent specification to assess the level of utility specifically promised in the disclosure. The FC also indicated that “wilfully mislead”, under s.53 of the Patent Act, could be established by inference. Ratiopharm brought this action after the Federal Court of Appeal (FCA) (2006 FCA 214) rejected similar challenges in litigation under the Patented Medicines (Notice of Compliance) Regulations.
(more…)
Posted in Canada: Patents 
Tags: impeachment, invalidity, patented medicines, utility, wilful misleading 
No Comments »
|