On June 12, 2015, the Federal Court issued an interlocutory stay
in the context of a data protection application in Horizon
Pharma plc v The Minister of Health et al, 2015 FC 744.
The proceeding underlying the Horizon decision is an
application for judicial review of the minister of health’s
decision to deny data protection for a new orphan drug called
RAVICTI® for the treatment of Urea Cycle Disorders
(“UCDs”). Horizon’s request for an interlocutory
stay arose because the Minister was on the verge of issuing a
Notice of Compliance (“NOC”) for RAVICTI. If the NOC
were to issue, without data protection, RAVICTI would be
immediately available for generic drug manufacturers to create
their own copied version and seek regulatory approval in Canada.
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.
The Court granted the stay based on the RJR MacDonald
Serious Issue to be Tried
The Court noted that the threshold for a “serious
issue” is a low one that will be satisfied “unless it
can be shown that the arguments put forth are frivolous or
vexatious.” Relying on Reckitt Benchiser LLC et al v
Jamieson Laboratories Ltd, 2015 FC 215, aff’d 2015 FCA
104, the Court noted that the question is to be answered on no more
than an extremely limited review of the case.
Notwithstanding, the Court canvassed the law and affidavit evidence
supporting Horizon’s case including whether RAVICTI is an
ester of sodium phenylbutyrate, whether a “second minor
variation” exists as a legal basis to deny data protection
and whether the Minister properly interpreted and applied the
meaning of “variation” in the Data Protection
Upon canvassing the evidence, the Court found that
Horizon’s judicial review application raised a serious issue
to be tried.
Horizon asserted two separate types of irreparable harm:
non-compensable harm to Horizon and irreparable harm to patients
suffering from UCDs.
Regarding non-compensable harm, Horizon argued that if the stay
is not granted, Horizon will withdraw its NDS and will not market
RAVICTI in Canada. Accordingly, it will lose profits that it
otherwise would have generated and will have no recourse to recover
those lost profits.
Although Horizon was not yet in the marketplace, the Court noted
that it can draw inferences that logically flow from the evidence.
In this case, the evidence established that in an early-genericized
market Horizon would not be able to recoup its investments into
developing RAVICTI and would therefore withdraw its NDS for RAVICTI
without the stay. 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
Regarding harm to patients, the evidence established that
RAVICTI was a clinical improvement over other drugs to treat UCDs.
Horizon argued that, if the NDS for RAVICTI were to be
withdrawn, UCD patients would be denied a life-changing and
life-saving drug. These patients would be irreparably
The Court considered the legal question of whether or not third
party harm can be considered at this stage of the test. The Court
noted that this same question was before the Federal Court of
Appeal in Janssen Inc v AbbVie Corporation, 2014 FCA 112,
but the Court in that case did not resolve the issue in light of
its findings that the harm to patients was speculative.
In this case, the Federal Court noted that the harm to patients
was not speculative. However, since the Court found that Horizon
would be irreparably harmed by a refusal to grant the requested
stay, it did not need to consider third party irreparable harm and
left such harm to be canvassed in the context of balance of
Balance of Convenience
At the balance of convenience stage of the test, the Court did
consider harm to the public and noted that, “I find there is
a compelling public interest in granting the stay.” The
Court, citing RJR Macdonald, found that, “public
interest concerns both the concerns of society generally and the
particular interests of identifiable groups.” The
Court’s finding that the balance of convenience favoured a
stay was reinforced by the fact that the Minister of Health took no
position on the motion.
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guide to the subject matter. Specialist advice should be sought
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