The May 2011 edition of Rx IP Update provided a case-law update on data protection. Further updates on two of the cases reported are as follows.
First, we had previously reported that the Court of Appeal would soon be considering the meaning of "innovative drug" in the context of prior "approvals" based on applications for a Drug Identification Number and under the Natural Health Products Regulations in connection with EpiCept's appeal of Justice Near's decision in Epicept Corporation v. Canada (Health), 2010 FC 956. However, on June 22, 2011, the Court of Appeal dismissed EpiCept's appeal as moot: Epicept Corporation v. Canada (Health), 2011 FCA 209. The Minister found that EpiCept was not entitled to data protection for CEPLENE (EpiCept's histamine dihydrochloride). EpiCept sought judicial review and Justice Near dismissed the application. EpiCept appealed, and the Canadian Generic Pharmaceutical Association ("CGPA") and Canada's Research-Based Pharmaceutical Companies ("Rx&D") were granted leave to intervene. Before the appeal was heard, EpiCept had withdrawn its submission for approval of CEPLENE. The CGPA therefore brought a motion to dismiss the appeal as moot. The Court found that the appeal was moot as there was no "practical consequences" left in the appeal. EpiCept submitted that the Court should exercise its discretion to hear the appeal, submitting that it intends to re-file its submission and apply for data protection at that time. On examining the evidence, however, the Court found that there was uncertainty as to whether EpiCept will ever re-file the submission, and any re-filing will not take place for many years. In addition, as a new submission could contain different studies and data, any subsequent decision of the Minister could have additional reasons for refusing data protection, and any review should be considered on the specific bases relied on by the Minister. The Court also noted its reluctance to affect or bind other parties seeking data protection with a decision in a moot appeal.
EpiCept brought a cross-motion to have the appeal stayed until it re-files its submission. The Court, while stressing that a dismissal for mootness is not a decision on whether EpiCept is entitled to data protection, declined to do so, citing the potential length of adjournment and the uncertainty as to whether EpiCept will ever re-file.
Second, as reported previously, Teva challenged data protection for ELOXATIN (sanofi-aventis's oxaliplatin) on the basis of prior approvals under the Special Access Programme between 1999 and 2005. Justice Campbell dismissed Teva's application and Teva appealed (Court File No. A-215-11). Sanofi-aventis has since cross-appealed Justice Campbell's decision not to strike the application. Sanofi-aventis had argued that Teva lacked standing to bring the application and was out of time.
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