Promise Doctrine

The issue of disclosure requirements with respect to sound prediction was addressed squarely by the Supreme Court in AstraZeneca Canada Inc. v. Apotex Inc., where the Court held that the so-called Promise Doctrine was not good law, in that it conflated the requirement for utility with the requirements for the specification.

March 3, 2015

Physical Stability Experiments did not Adequately Demonstrate or Soundly Predict Utility for Overbroad Eye Drop Patent

Alcon Canada Inc v Cobalt Pharmaceuticals Company, 2014 FC 149 - The Court examined in detail a number of experiments disclosed in the patent that were said to establish the claimed utility, but the experiments did not demonstrate or soundly predict utility for the broad ranges of molecular weight and chemical concentration claimed.
November 21, 2014

FCA Dismisses Apotex Appeal to have the Promise Doctrine Extended

Apotex Inc v Pfizer Canada Inc, 2014 FCA 250 - The Court rejected Apotex’s sweeping argument that any given promise in the patent must be construed as overarching to all of the patent’s claims.
July 29, 2013

FCA Upholds the Plavix Patent, Reverses Lower Court’s “Promise of Patent” and “Obvious to Try” Analyses

Sanofi-Aventis v. Apotex Inc. – 2013 FCA 186 Per Pelletier J.A. (Noel J.A. concurring): Apotex attempted to market a generic version of clopidogrel bisulfate (clopidogrel), sold […]