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APRIL 2016 37
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ment of ultra-rare and life-threatening Urea
Cycle Disorders (UCDs). Data protection
was denied for RAVICTI because Horizon
Pharma plc's (Horizon's) generic competi-
tor, Medunik Canada, received a Notice of
Compliance (NOC) for PHEBURANE, a
copy of Horizon's older drug BUPHENYL®
(sodium phenylbutyrate). e 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 re-
ceive 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 avail-
able for generic drug manufacturers to create
their own copied version and seek regulatory
approval in Canada. e 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 issu-
ance 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. is 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. is non-compensable
harm alone was sufficient to satisfy the ir-
reparable harm requirement.
On the issue of balance of convenience, the
Court noted that "there is a compelling pub-
lic interest in granting the stay, an important
factor: Canadian patients with UCDs will
have access to what could be a life-saving
drug." e balance of convenience therefore
favoured issuance of the stay.
On December 10, 2015, the Federal Court
issued a Judgment allowing the judicial re-
view application and remitting the matter
back to the Minister for redetermination.
e 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
e Minister of Health.
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