Teva Canada Limited v. Leo Pharma Inc., 2017 FCA 50 Drug: Calcipotriol and betamethasone dipropionate

Teva appealed a decision of the Federal Court ("FC") granting Leo a prohibition order in respect of their psoriasis drug (Decision here; our summary here). The Federal Court of Appeal ("FCA") dismissed the appeal. At issue was whether the FC erred in finding the patent could be soundly predicted, and whether it erred in finding the patent was sufficient.

The FCA held that the application of the AZT test is normally a question of fact, and Teva had not established that there was a palpable and overriding error made by the FC. Thus, there was no basis for the FCA to substitute its assessment of the evidence to determine whether Teva's allegations were justified. Teva argued that there could be no sound prediction because it was not known exactly why a particular combination works. The FCA accepted that this argument may apply in other cases, but in this one, it was rejected on the evidentiary record. Teva also argued that the FC should have used a subjective approach when assessing whether there was a sound prediction and that the patentee needed to produce evidence emanating directly from the inventors. However, the FCA held that AZT does not limit how the facts necessary to apply the doctrine of sound prediction can be established. The FCA in this case saw no difference between an express sentence and conveying the same logic through technical information disclosed in the specification read as a whole.

With respect to the allegations of insufficiency, the FCA held that whether or not a particular disclosure is sufficient depends on what the skilled person would consider sufficient to enable it to work the invention. This is a question of fact. Furthermore, the FCA held that one must always consider the nature of the invention to determine what needs to be included in the description. The FCA also considered Teva's arguments with respect to the SCC decision in Sildenafil and held that in Sildenafil , the problem was that a minor research project was needed to determine the true invention. The FCA held that the SCC had not changed the law that recognizes that some non-inventive trial and error may be required to put a properly disclosed invention into practice. Thus, the appeal was dismissed.