Epicept Corporation v. The Minister of Health, 2011 FCA 209 (June 22, 2011)

The Court of Appeal allowed an intervener's motion dismissing for mootness Epicept's appeal of Justice Near, who affirmed a decision of the Minister of Health denying "innovative drug" status for Epicept's product CEPLENE histamine dihydrochloride.

CEPLENE is used for remission maintenance therapy in acute myeloid leukemia.  Epicept sought to have their product designated as an "innovative drug" pursuant to subsection C.08.004.1(1) of the Food and Drug Regulations, so that it would benefit from an eight year term of market exclusivity under the data protection provisions.  The Minister of Health denied their request, advising that the medicinal ingredient has been previously approved in several drugs and the definition of "innovative drug" contemplates that medicinal ingredients not previously approved in "any drug" are to be considered in the assessment of eligibility of data protection, and not just those drugs that receive a NOC.  Justice Near agreed with the Minister of Health on judicial review (2010 FC 956).

Before the appeal was heard, Epicept withdrew its new drug submission for CEPLENE.  The Canadian Generic Pharmaceutical Association, acting as an intervener, brought a motion to dismiss the appeal as moot.  The Court agreed, and declined to use its discretion to hear the appeal.  There was uncertainty that Epicept would re-file their new-drug submission and the Court did not want to make the decision on a hypothetical.

However, the Court of Appeal made it clear that by dismissing the appeal for mootness, they did not rule on whether Epicept would have been entitled to data protection, leaving that issue for another day.

The full text of the decision can be found at: