This document summarizes a judgment where the Federal Court of Canada held that Sanofi-Aventis' ("Sanofi") patent for clopidogrel bisulfate (Plavix®) is infringed by Apotex, but is invalid on the basis of lack of utility.
This decision is one of a series of at least four fairly recent decisions in which patents for drugs were found invalid for lack of utility. This calls into question the validity of many pharmaceutical patents given the very high thresholds for utility in Canada compared to other jurisdictions. These recent decisions from the Federal Court and the Court of Appeal seem to suggest that clinical trial data may be required for new drugs directed to humans.
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