Horizon Pharma PLC v. Canada (Health), 2015 FC 744 (Gagné J.)
June 12, 2015
Christopher Van Barr/William Boyer for Horizon Pharma
Sanderson Graham/Leah Garvin for Minister of Health
Horizon brought an urgent motion under ss. 18(1), 18.1, and 18.2 of the Federal Courts Act seeking a stay of the issuance of a Notice of Compliance for its own drug Ravicti. The Minister took no position on the motion.
Horizon sought the stay pending the judicial review of the Minister’s decision to refuse data protection for Ravicti. In its submission Horizon argued that absent a stay it would be forced to withdraw its New Drug Submission (NDS) for Ravicti in order to prevent generic competitors from using the information contained in the NDS to gain a springboard advantage for immediately entering the market when Canadian Patent No. 2,212,047 expires on February 6, 2016.
The Court found that there was a “serious issue” to be tried based upon the potential errors committed by the Minister, as alleged by Horizon. The inability of Horizon to recoup on its investment and the loss of any recourse of means to be compensated in respect of lost sales as a result of the Minster’s decision was considered to meet the test for irreparable harm. In assessing the balance of convenience, the Court found that there was a compelling public interest in granting the stay, in order to ensure that patients continue to have access to what could be a life-saving drug.
The Court ordered that the applicant’s motion be granted, and issuance of the NOC was stayed until the earlier of 10 days following either final judgment on, or discontinuance of, the underlying judicial review application. No costs were awarded on the motion.
By: Etienne de Villiers, Dimock Stratton LLP