Monday, July 4, 2011

Mootness on Appeal

Epicept Corporation v. Canada (Health) 2011 FCA 209 Stratas JA: Sharlow, Trudel JJA, dismissing for mootness 2010 FC 956 Near J

In the decision under appeal Near J had held that Epicept’s drug CEPLENE is not an “innovative drug” under the Data Protection Regulations. Epicept appealed, but while the appeal was pending, Epicept withdrew its new drug submission for the approval of CEPLENE. On a motion by the CGPA, the Court of Appeal dismissed the appeal for mootness.

The appeal was clearly moot, and the real question was whether the Court should exercise its discretion to hear a moot appeal [7].
The Court declined to hear the appeal. While the Court did not discuss the three Borowski considerations in detail, its decision is clearly consistent with Borowski [1989] 1 SCR 342. The first consideration is the requirement of an adversarial context. Here, as in Borowski itself, this factor does not seem to weigh strongly against hearing the appeal, unless there was some real question as to Epicept’s willingness to argue the matter fully. While the Court emphasized the “hypothetical context” of the question [12], this is not a strong point, as the matters on appeal were raised and argued in a fully developed factual matrix. More persuasive is the Court’s observation that the issue might not arise again for many years, at which time circumstances might have changed significantly, whether as a result of policy changes by the Minister, or new studies on the drug in question.

The third consideration, described in Borowski as “the need for the Court to demonstrate a measure of awareness of its proper law-making function,” militates against hearing the appeal, in this case as in Borowski. Indeed, this factor operates as a fairly strong presumption against hearing moot appeals generally. In Borowski the Supreme Court remarked that “[p]ronouncing judgments in the absence of a dispute affecting the rights of the parties may be viewed as intruding into the role of the legislative branch.” The courts certainly undertake a measure of law-making whenever they interpret legislation in the context of a live dispute, and it is difficult to see why doing so in the context of an appeal that is moot, though based on a well-developed factual context, is much different. But a line must be drawn somewhere. As the Court of Appeal repeated, “we are really being asked to provide a legal opinion on this issue of interpretation, and nothing else” ([7] and see also [10]).

This will be disappointing to Epicept, which no doubt spent considerable sums at trial and preparing the appeal. This was in part to get CEPLENE listed, but also, presumably, to get clarity on the legal point. This is the flip side of the second Borowski consideration, the need to economize on judicial resources. Refusal to hear a moot appeal economizes on judicial resources while wasting those of the appellant, which will have to argue the issue all over again when the question next arises. (Though refusing to hear the appeal does save resources for the respondent and interveners, as well as the courts.) I wonder what other patentees would wish? Would they prefer to have clarity on this point, at Epicept’s expense? Or would they prefer to try for a better result at their own expense?


  1. The real tragedy is that AML affected in Canada won't have access to a new and effective treatment because of the law prohibit that EpiCept can get the right protection against generic drugs for a certain period.
    EpiCept simply can't take any chances to let through generica for this new and innovative treatment.

    At the expence of possibly not search for an approval in Canada.

    Can't say that I'm very impressed with the Canadian legislation if the result will be no access to new and effective treatments.

    Ceplene have got "orphan drug" protection in both Europe and USA.
    But Canada can't give it because of the law.

    Sad but true...

  2. Epicept have filed another patent on Ceplene that is not yet approved.

    Is that of any applicability to this case? There was a Canadian patent that expired 2010?

    Stil, as you stated above, a tragedy for those who will have a relaps in AML in Canada.