Viagra Did Not Change the Test for Sufficiency

Teva Canada Limited v Leo Pharma Inc 2017 FCA 50 Gauthier JA: De Montigny, Gleason JJA aff’g 2015 FC 1237 Locke J
            2,370,565 / calcipotriol & betamethasone / DOVOBET

In Teva v Leo Pharma the FCA has affirmed the decision of Locke J (blogged here) granting an order of prohibition. Teva raised two arguments on appeal, relating to sound prediction and insufficiency. While the appeal was dismissed largely on the facts, the decision is noteworthy for the FCA’s brief but helpful discussion of Viagra / Sildenafil 2012 SCC 60, which clarifies both what Viagra did and did not hold.

Like Arctic Cat in 2017 FC 207, blogged here, Teva in this case argued that Viagra had changed the standard for sufficiency, so that now, not even a minor research project is permitted [57]. The FCA rejected this with a brief explanation of the true import of Viagra:

[58] The case before us is very different from the one that was before the Supreme Court of Canada in Sildenafil, where the patentee had deliberately omitted essential information, thereby obscuring the fact that only one of the compounds claimed actually worked (Sildenafil at paras 72, 73 and 76) . Thus, the invention itself was not even properly disclosed.

That is, Viagra concerns a situation where the patentee has deliberately obscured the nature of the invention. The FCA continued:

[59] Furthermore, the Supreme Court refers to the factual findings of the Federal Court in Sildenafil which found that in that case, one would require a minor research project to determine the true invention. This statement of Justice Lebel is, as mentioned, perfectly in line with the law as I understand it, not only in Canada but elsewhere, such as the U.K. and Europe, which recognizes that some non-inventive trial and error may be required to put a properly disclosed invention into practice. Had the Supreme Court wished to change the law on this point in Sildenafil, one would have expected a much more fulsome analysis of the issue and discussion of the relevant authorities. In the absence of such a discussion, I do not believe that the Supreme Court changed the law in Sildenafil in the manner Teva argues.

So, Viagra did not change the standard for sufficiency. I agree with Gauthier JA’s holdings on both these points.

Otherwise, Teva was largely trying to re-argue the facts, and the appeal failed for that reason [54].

(A post on the punitive damages issue in Airbus v Bell Helicopter 2017 FC 170 will be forthcoming soon, but I am taking a break from that case to clear up my blogging backlog.)