Tuesday, March 26, 2013

Delayed Release Esomeprazole Not Obvious on the Facts

Astrazeneca Canada Inc. v. Ranbaxy Pharmaceuticals Canada Inc / esomeprazole (NOC) 2013 FC 232 O’Keefe J
            NEXIUM / esomeprazole / 2,170,647

Obviousness was the only point in issue in this NOC proceeding related to a delayed release form of esomeprazole. O’Keefe J’s decision holding that the enteric coating formulation was not obvious, due to the difficulty of actually producing an effective coating, turned entirely on his assessment of the conflicting expert evidence.

The only point of more general interest is a brief review at [80]-[84] of the case law relating to the “motivation” aspect of the obvious to try test. O’Keefe J noted that in Allergan Inc. v Canada (Minister of Health), 2012 FC 767 a finding that there was a strong motivation to solve the problem at hand supported a finding of non-obviousness, on the logic that “If other parties were motivated to find the solution and yet were unable or unwilling to do so prior to the patent being obtained, this factor would point to a solution that was not ‘obvious to try’” [82]. On the other hand, in Janssen-Ortho Inc. v Novopharm Ltd. 2006 FC 1234, a finding that there was “no motivation exhibited by any outside persons to explore Ofloxacin enantiomers,” also supported a holding of non-obviousness, on the basis that absent Daiichi’s motivation, “there may well never have been levofloxacin” [84]. 

Note that in his recent decision in Apotex Inc. v. H. Lundbeck A/S / escitalopram 2013 FC 192 (not mentioned by O’Keefe J), Harrington J remarked that “I am troubled by the concept of motivation. Wishing does not make something come true. Wishing does not make something easier. A motive is defined as that which moves or tends to move a person to a particular course of action (Oxford Dictionary). On the other hand, there may not have been reason to do something at a particular point in time. For instance, there may have been little interest in increasing automobile fuel efficiency in the 1950s. Lack of interest would not give rise to a patent if what was eventually done was obvious” [99]. It seems that significance of motivation in the obvious to try test needs clarification.

O’Keefe J’s reasoning in this case did not ultimately turn on the question of motivation.

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