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...)