Drug: CEPLENE histamine dihydrochloride
The intervener, the Canadian Generic Pharmaceutical Association (CGPA), brought a motion to dismiss the appeal by Epicept on the basis of mootness. The underlying judicial review application relates to a finding that CEPLENE is not an “innovative drug” for the purposes of data protection. The Federal Court decision is summarized here.
The CGPA brought the motion to dismiss as Epicept withdrew its New Drug Submission (NDS) for approval of CEPLENE. The Court of Appeal found the appeal to be moot, but then considered whether to hear the appeal in any event. The Court of Appeal refused to exercise its discretion to hear the appeal based on the circumstances of the case. Further, the Court of Appeal refused Epicept’s cross-motion to stay or adjourn the appeal until such time as it re-files its NDS.