Case:Photocure ASA v Canada (Health),
2015 FC 959 (Court File No. T-1774-14)
Drug: CYSVIEW® (HAL HCl)
Nature of case: Judicial review of Minister of
Health's decision to not grant data protection to a
Successful party: Health Canada
Date of decision: August 10, 2015
Photocure ASA (Photocure) markets HAL HCl in
Canada under the name CYSVIEW® for use as an optical imaging
agent in the detection of non-muscle invasive bladder cancer.
Photocure sought "innovative drug" status for
CYSVIEW® in order to obtain eight years of data protection
under section C.08.004.1 of the Food and Drug Regulations
Minister of Health (Minister) refused to grant
"innovative drug" status to CYSVIEW® because HAL HCl
is an ester of ALA HCl, which was previously approved.
The Federal Court dismissed Photocure's application for
judicial review of the Minister's decision. Justice Kane held
that: (1) affidavit evidence not before the Minister was
inadmissible; (2) the standard of review was reasonableness; and
(3) the Minister's decision to not grant "innovative
drug" status was reasonable.
Before the Minister, Photocure argued that: (a) HAL HCl is a
salt of HAL, which has not been previously approved; and (b) HAL is
an ester of ALA, which has not been previously approved.
Accordingly, HAL HCl is not an "ester" of ALA HCl within
the meaning of "innovative drug" in the FDA
Regulations. The Minister thought otherwise and refused data
protection. Photocure then brought an application for judicial
Affidavits not before decision maker struck
Photocure filed an expert affidavit in support of its
application for judicial review. This affidavit provided scientific
background, argument, and opinion evidence. In response, the
Minister filed affidavit evidence from the individual at Health
Canada who decided that CYSVIEW® was not an "innovative
In general, the Court will not admit evidence that was not
before the decision-maker. Therefore, since Photocure's
affidavit did not fit into any of the recognized exceptions, and
since the Minister's affidavit was in response to
Photocure's, Justice Kane ruled both affidavits
Standard of review is reasonableness
Photocure argued that the standard of review was correctness
because, in interpreting the meaning of "innovative drug"
under the FDA Regulations, the Minister was determining a
question of law. In contrast, the Minister argued that the standard
of review was reasonableness because it was not interpretting the
FDA Regulations; rather it was determining the fact of
whether CYSVIEW® was an ester of ALA HCl.
Justice Kane agreed with the Minister and held that the standard
of review was reasonableness. She found that the issue was a
factual determination as to whether one drug is a variation of
another. Since the Court has no expertise in determining such
matters, it deferred to the decision-maker.
Minister's decision was reasonable
A reasonable decision is one that can withstand a "somewhat
probing examination". Justice Kane found that the
Minister's decision was based on a thorough comparison of the
whole structures of CYSVIEW® and ALA HCl, and determined that
CYSVIEW® was an ester of that previously approved drug. Thus,
Justice Kane upheld the Minister's decision and dismissed
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