Novopharm Limited v. Pfizer Canada inc. (2010 FCA 242)

A-292-09

Appeal of PMNOC proceedings decision, Sildenafil, September 24, 2010

Novopharm appealed the decision of the Federal Court to grant an order of prohibition to Pfizer in respect of Novopharm’s generic version of VIAGRA. The Federal Court of Appeal (the “FCA”) dismissed the appeal. Claim 7 of Pfizer’s patent covered sildenafil, the active ingredient in VIAGRA. Two grounds of appeal were raised by Novopharm: insufficiency and inutility. The FCA held that the trial judge was correct to limit the “invention” at issue in this case to that disclosed in claim 7 rather than the patent as a whole. This was because claim 7 constituted its own invention. In respect of the insufficiency allegations, as claim 7 clearly stated the formula for sildenafil the FCA held it to be sufficient. The FCA also confirmed that the “best mode” requirements of section 27(3)(c) of the Patents Act only applies to patents covering machines. In respect of the inutility allegations, the FCA reaffirmed that proof of utility does not need to be included in the patent and that evidence beyond the patent can and will be necessary.