Drug: RAVICTI glycerol phenylbutyrate
This is a motion by Horizon for an Order staying the issuance of a Notice of Compliance (NOC) to Horizon for its drug, pursuant to sections 18(1), 18.1 and 18.2 of the Federal Courts Act. Horizon was seeking the stay pending judicial review of the decision of the Minister of Health (Minister) refusing data protection for RAVICTI. The motion was granted, with the Court finding a serious issue to be tried, irreparable harm to the applicant if the stay is not granted, and a balance of convenience favouring the stay.
In the course of considering Horizon’s New Drug Submission (NDS), the Minister initially refused data protection to RAVICTI. However, after negotiations with Horizon, the Minister agreed that RAVICTI was eligible subject to a final review of NOC issues. As a result of regulatory issues, approval of Horizon’s NDS was delayed and prior to the issuance of Horizon’s NOC, a NOC was issued to a generic company for its drug. The Minister then refused data protection to RAVICTI because it was considered an ester variation of the generic company’s drug. As a result, it could no longer be considered an “innovative drug” for the purposes of data protection. Horizon commenced a judicial review of this decision by the Minister.
The Court found that the judicial review proceeding raised serious issues of potential errors by the Minister, and thus the first step for a stay was met. In terms of irreparable harm, Horizon submitted evidence that it will withdraw the NDS if data protection is not provided. The evidence showed that the patent relating to the product expires shortly and Horizon will not be able to recoup sufficient investment in the absence of data protection. The Court found the second part of the test for a stay is met as “the applicant could not recoup its investment and would have no recourse or means to be compensate [sic] in respect of lost sales”. The Court found that it was not necessary to consider whether irreparable harm to third parties, in this case, patients, could be considered for the purposes of the second part of the test but instead considered it as part of determining the balance of convenience. The Court found a compelling public interest in granting the stay, namely access by Canadian patients to this drug. Further, the respondents took no position on the motion for a stay, further supporting the finding by the Court.