Horizon Pharma plc v. Canada (Health)

In Horizon Pharma plc v. Canada (Health), 2015 FC 744, the Federal Court issued a rare interlocutory stay in the context of a judicial review application relating to pharmaceutical data protection.

In December, the Court allowed Horizon’s application, remitting the issue of data protection back to the Minister for redetermination.

The proceeding underlying this decision was an application for judicial review of the Minister’s decision to deny data protection for a new orphan drug called RAVICTI® (glycerol phenylbutyrate) for the treatment of ultra-rare and life-threatening Urea Cycle Disorders (UCDs). Data protection was denied for RAVICTI because Horizon Pharma plc’s (Horizon’s) generic competitor, Medunik Canada, received a Notice of Compliance (NOC) for PHEBURANE, a copy of Horizon’s older drug BUPHENYL® (sodium phenylbutyrate). The NOC for PHEBURANE, which established safety and efficacy by relying on BUPHENYL’s market experience over 10 years, was issued only months before RAVICTI was to receive an NOC. But for the PHEBURANE NOC, RAVICTI would have been granted data protection.

Horizon’s request for an interlocutory stay arose because the Minister was on the verge of issuing an NOC for RAVICTI. If the NOC were to issue without data protection, then RAVICTI would be immediately available for generic drug manufacturers to create their own copied version and seek regulatory approval in Canada. The evidence established that in an early-genericized market Horizon would not be able to recoup its investments into developing RAVICTI.

During discussions with the Minister regarding data protection for RAVICTI, Horizon consistently stated that, without data protection, it would withdraw its New Drug Submission (NDS) before the NOC issued. To maintain its ability to withdraw the NDS, and still proceed with its challenge to the Minister’s refusal of data protection, Horizon brought a motion to stay the issuance of the NOC for RAVICTI pending the outcome of its judicial review application.

Horizon’s biggest hurdle in obtaining the interlocutory stay was establishing that, without the stay, it would suffer irreparable (i.e., non-compensable) harm. This harm was established because of Horizon’s intention to withdraw its NDS for RAVICTI without the stay and, in turn, Horizon would have no recourse or means to be compensated in respect of lost sales. This non-compensable harm alone was sufficient to satisfy the irreparable harm requirement.

On the issue of balance of convenience, the Court noted that “there is a compelling public interest in granting the stay, an important factor: Canadian patients with UCDs will have access to what could be a life-saving drug.” The balance of convenience therefore favoured issuance of the stay.

On December 10, 2015, the Federal Court issued a Judgment allowing the judicial review application and remitting the matter back to the Minister for redetermination. The stay of the issuance of the NOC for RAVICTI was also extended pending the redetermination and any subsequent judicial review application.

Christopher Van Barr and William Boyer of Gowling WLG represented Horizon Pharma plc.

Sanderson Graham and Leah Garvin of Department of Justice Canada represented The Minister of Health.