Date: 20101221
Docket: T-1372-10
Citation:
2010 FC 1310
Ottawa,
Ontario, this
21st day of December 2010
Present: The Honourable Mr. Justice Pinard
BETWEEN:
APOTEX
INC.
Applicant
and
MINISTER OF HEALTH and
ATTORNEY
GENERAL OF CANADA
Respondents
REASONS FOR ORDER AND ORDER
[1]
The
respondents have brought a motion seeking an Order to strike the underlying
application for judicial review. The respondents identify the following issues
on this motion:
1)
Is the
application out of time contrary to subsection 18.1(2) of the Federal Courts
Act?
2)
Should the
application be struck as it is not limited to a single order contrary to Rule
302 of the Federal Courts Rules?
3)
If the application is
not struck on the above grounds, should the Court strike out further parts of
the application, specifically:
a.
Those parts
related to allegations regarding “vested rights”?
b.
Those parts
regarding “revocation” of the “patent hold” status of Apotex’s submission?
4)
If the
application is to proceed:
a.
Should the proceeding
be specially managed?
b.
Should the
respondents be given additional time to prepare responses to Apotex’s Rule-317
request and the application itself?
1. Factual
background
[2]
In
the underlying application, Apotex Inc. (the applicant) asks this Court to
quash certain decisions made by the Minister of Health related to the granting
of approval for sale of its Apo-Omeprazole tablets. The applicant asks
this Court to compel the Minister to issue a Notice of Compliance (“NOC”) or
alternatively to quash the decisions and proceed in a further review of its
drug submission.
[3]
In
April 2000, the applicant filed a submission for approval for sale of its Apo-Omeprazole
tablets with the Therapeutic Products Directorate (“TPD”). The TPD has the
delegated authority to review new drug submissions. In March 2003 the applicant
was advised that its submission was satisfactory and that the issuance of a NOC
was on “patent hold”. That is, the issuance of the NOC was on hold pending the resolution
of certain applications under the Patented Medicines (Notice of Compliance)
Regulations (the “PMNOC Regulations”). Later, in December 2008, the TPD
notified the applicant by letter that it was revoking the approval status of
the submission. The TPD’s justification for this decision was that the
bioequivalence study filed by the applicant with its Abbreviated New Drug Submission
(“ANDS”) had not been appropriately conducted. The TPD stated that it had newly
discovered that the applicant’s study had been conducted with a “light meal”
and not a “high fat meal” as required.
[4]
The
applicant objected, but the TPD issued a Notice of Non-Compliance Withdrawal
letter. The applicant requested reconsideration of the Notice of Non-Compliance
Withdrawal letter but this was denied by the TPD. The applicant then sought for
the matter to be referred to an external panel; this request was also denied.
[5]
The
applicant subsequently learned of certain facts and documents through an Access
to Information Act request. It alleges that these revelations taint the
Minister’s decision to revoke approval for its Apo-Omeprazole tablets. The
applicant alleges that the Minister’s delegates acted in a way that
demonstrated a reasonable apprehension of bias, and that the TPD had been aware
during the initial review of the 2003 submission that a low fat meal had been
used in the bioequivalence study. The applicant says that this means there was
no basis for the Minister to revoke approvability status in December 2008. The
applicant further alleges that when approvability status was revoked, a
favourable review of the 2003 submission was not disclosed, even throughout the
reconsideration period. The applicant further alleges that the Minister’s
delegates made the decision to revoke approvability status at least six months
before the applicant was advised of this decision. The applicant says this
delay was in contravention of an earlier agreement it had with the Minister
dated May 24, 2005 to “resolve disputes in a fair and timely manner”.
[6]
The
applicant also claims that it learned through this request that the Acting
Director of the Bureau of Pharmaceutical Sciences had secretly instructed staff
involved in the reconsideration not to approve it. The applicant further
alleges that the TPD had initially determined that it would be appropriate to
refer the matter to an external panel, but that this decision was reversed on
May 22, 2009 after an external panel had found in the applicant’s favour in
respect of a nearly identical situation involving its Apo-Lansoprazole
product.
[7]
The
applicant claims that the foregoing allegations constitute a continuing course
of intransigent, disingenuous and seemingly biased conduct by the Minister’s
delegates in respect of its reviews of the Apo-Omeprazole tablet
submission. The applicant claims that this conduct was carried out with a view
to revoking the approvability status of the Apo-Omeprazole submissions
and protecting that revocation from reconsideration. As such, it asserts that
the revocation of approvability status, the issuance of the Non-Compliance
Withdrawal letter, and the refusal to allow independent reconsideration of the
matter constitute a continuing course of conduct that began in early 2008 and
continues to the present.
2. Analysis
[8]
In Odynsky
v. League for Human Rights of B’Nai Brith Canada et al., 2009 FCA 82, the
Federal Court of Appeal conclusively held that in order to succeed on a motion
to strike in the context of an application for judicial review, the moving
party must show that the application is so clearly improper as to be bereft of
any possibility of success. As held by the Federal Court of Appeal, justice is
typically better served by allowing the application judge to deal with all of the
issues raised in a judicial review application, as motions to strike may unduly
or unnecessarily delay the expeditious determination of the issues.
A. Is
the application time-barred?
[9]
The
respondents say that the applicant’s application to review certain decisions
was brought out of time, contrary to the 30-day time limit imposed by
subsection 18.1(2) of the Federal Courts Act, R.S.C. 1985, c. F-7. They
also contend that the instant case is just the sort of exceptional case where a
motion to strike an application on the basis of timeliness ought to be allowed.
On the other hand, the applicant contends that what it seeks to review is not
an “order” or “decision” subject to the time limitation in subsection 18.1(2),
but rather a “matter” which consists of a continuing course of conduct. The
applicant does not agree that there are factors at play in the present case
justifying a departure from the usual practice of leaving limitations issues to
the application judge (Hamilton-Wentworth (Regional Municipality) v. Canada (Minister of the
Environment),
[2000] F.C.J. No. 440 (T.D.), 187 F.T.R. 287).
[10]
As
set out in Krause v. Canada (C.A.), [1999] 2 F.C. 476, and followed by
Justice Michael Phelan in Airth v. The Minister of National Revenue,
2006 FC 1442, where the subject-matter of a judicial review application is a
“matter” rather than a “decision or order”, the 30-day time limit does not
apply: Airth at para 5. A matter is distinguished from a decision or
order by considering whether what is at issue is a “singular decision” or
instead “part of a course of conduct, all of which the Applicant challenges”: Airth
at para 9.
[11]
In
the present case, at this stage, I am not prepared to accept the respondents’
characterization of the underlying application as one that seeks to combine the
review of three discrete decisions. It appears that the applicant is requesting
relief arising out of a number of decisions and other conduct of the same
decision maker, operating under the same statute (the Food and Drug
Regulations), arising out of the same factual matrix (the Apo-Omeprazole
ANDS). Further, as the applicant points out, each action it now challenges
was contingent upon the previous decision that had been made. The Notice of
Application discloses a complex set of facts and an inter-related series of
decisions all concerning Apotex’s ANDS for Apo-Omeprazole. Further, the
applicant has alleged that its decision to now challenge the Minister’s conduct
with regard to its drug submission is motivated by factual revelations produced
through recent Access to Information Requests. The applicant claims that these
new facts reveal a continuing course of seemingly biased conduct on the part of
the Minister’s delegates that both pre-dates and post-dates the individual
“decisions”.
[12]
In
my view, given the Krause, Airth and Hamilton-Wentworth
decisions above, there is certainly a debatable issue as to whether it can be
said that the applicant’s attack in this case is simply on the Minister’s
decision to revoke approval status for the Apo-Omeprazole submission, or
any other individual decision in the parties’ long history with respect to Apo-Omeprazole.
Consequently, I do not see how it can be said that the application is bereft of
any chance of success on the basis that it is out of time. The serious question
of whether the proper approach is to view the underlying application for
judicial review as directed to a “matter” or a continuing course of conduct to
which the 30-day time limit imposed by subsection 18.1(2) of the Federal
Courts Act should not apply ought to be determined by the application
judge.
B. Should
the application be struck as it is not limited to a single order contrary to
Rule 302?
[13]
The
respondents characterize the underlying application as a case where three or
more independently-arising decisions have been “packaged” together. They rely
upon Rule 302 to assert that the applicant’s application should be struck as no
more than one order may be challenged in a single judicial review application.
[14]
In
view of my above conclusion that the subject-matter of the underlying
application is a debatable issue which must be determined by the application
judge, it follows that the question concerning the application of Rule 302 also
ought to be left to the application judge.
C. Does
the applicant have “vested rights” to a NOC?
[15]
According
to the respondents, the applicant has asserted that because its ANDS was on
“patent hold” as of March 2003, it had (a) a “vested right” to the issuance of
a NOC subject only to compliance with the PMNOC Regulations, and (b) a “vested
right” to the subsequent application of the Minister’s procedures on appeals
and reconsiderations, as they existed in March 2003. The respondents say that
the applicant has cited neither law nor facts in support of its claim to any
“vested rights”.
[16]
In
my view, the applicant is correct when it asserts that the respondents are
seeking to litigate the substance of the application, which is improper on a
motion to strike. The Federal Court of Appeal has held that, in light of the
decision in David Bull Laboratories (Canada) Inc. v. Pharmacia Inc.,
[1995] 1 F.C. 588, motions to strike applications for judicial review should
only be brought in exceptional circumstances, given the summary nature of the
proceedings: LJP Sales Agency Inc v. Minister of National Revenue, 2007
FCA 114 at para 8.
[17]
In
this case, the respondents not only say that there is no basis in law for the
applicant’s “vested rights” argument, but further that prior jurisprudence from
both the Supreme Court of Canada and this Court stands for the proposition that
the Minister retains the power to revoke authorization any time prior to the
actual issuance of a NOC: Comeau’s Sea Foods Ltd. v. Canada (Minister of
Fisheries and Oceans), [1997] 1 S.C.R. 12 at paras 39-51, and Ferring
Inc. v. The Minister of Health et al., 2007 FC 300. In my opinion, those
cases do not stand directly contrary to the applicant’s position.
[18]
Comeau’s
Sea Foods Ltd. is
put forward for the general proposition that where a Minister is given a
statutory discretion to issue licenses, the Minister retains the power to
revoke authorization any time prior to the actual issuance of the license.
However, as I understand it, that case was decided in greatly different factual
circumstances and on the basis of a very different statutory scheme than those
at issue in the case at bar. Under the Fisheries Act, the Minister was
given broad discretion to authorize and issue fishing licenses, unfettered by
any regulations until after a license was issued (at paras 36, 40, and 49).
According to the Supreme Court, this allowed the Minister to revoke an
authorization in implementing government policy to address pressing concerns.
By comparison, the Minister’s discretion to issue a NOC under the Food and
Drug Regulations is quite narrow. Subject to the application of the PMNOC
Regulations, section C.08.004 of the Regulations is quite clear that after
completing an examination of the new drug submission the Minister must either
issue a NOC or issue a notice of non-compliance. In my opinion, the Regulations
appear to preclude the type of broad policy-based discretion found by the Court
in Comeau’s Sea Foods Ltd.
[19]
While
the Ferring case cited by the respondents deals with the PMNOC
Regulations, I do not think that it can be taken as a direct authority. As the
applicant points out, the Ferring case deals with whether or not the Minister
is functus officio as to the issue of whether a generic is a second
person pursuant to the PMNOC Regulations. While the Court in that case
determined that the Minister retained discretion, it was the discretion to
re-address whether certain companies were second persons under the PMNOC
Regulations, not the discretion to issue a NOC. As such, I do not think that Ferring
can be taken as an authority that is directly contrary to the applicant’s
position. That said, I would also add that I agree with the respondents’
assertion that the decision of the Federal Court of Appeal in Apotex Inc. v.
Canada (Attorney General), [1994] 1 F.C. 742, cannot
be taken as authority for the existence of such “vested rights” given the
unique factual circumstances in that case. Given the dearth of authorities
directly on point, and the arguably contradictory jurisprudence, I am of the
view that this is an issue that is clearly best left to the application judge
to deal with on the basis of a complete record and full argument.
[20]
Thus
while the Comeau’s Sea Foods Ltd. and Ferring decisions, above, indicate
that there may not be a vested right to a NOC as claimed by the applicant, I do
not believe that it can be said that there is an authority directly contrary to
its position. That is, following LJP Sales Agency Inc., above, neither
party has put forward an authority decided on materially indistinguishable
facts addressing the exact issue in question in this application. Consequently,
I do not think that it can be said that the applicant’s argument with regard to
its alleged “vested rights” is bereft of any possibility of success.
D. Respondents’
alternate requests: case management and extensions of time
[21]
In
the circumstances, I agree with the respondents’ alternate requests.
Accordingly, I will order that the matter continue as a specially managed
proceeding; that counsel shall file with the Registry of the Court, either
jointly or separately, before the expiration of ten (10) days from the date of
the Order supported by these reasons, a document outlining the steps remaining
to be taken in this proceeding, together with a proposed timetable for the
completion of the necessary steps; and that any further directions be issued by
the case management judge.
3. Conclusion
[22]
For
the above-mentioned reasons, the respondents’ motion to strike the underlying
application for judicial review in whole or in part will be dismissed, with
costs in the cause.
[23]
In
response to the respondents’ motion to strike the underlying application, the
applicant, out of an abundance of caution, has brought a motion seeking (a)
leave to amend its Notice of Application, and (b) an order granting an
extension of time to commence the underlying application pursuant to subsection
18.1(2) of the Federal Courts Act.
[24]
At
the hearing before me, counsel for the parties agreed that if the motion to
strike was dismissed, and that a question of the application of subsection
18.1(2) of the Federal Courts Act was left to the application judge, the
applicant’s motion ought also to be dealt with by the application judge. A
distinct Order will be made accordingly.
ORDER
The respondents’ motion to strike the
underlying application for judicial review in whole or in part is dismissed,
with costs in the cause.
This matter will continue as a
specially managed proceeding.
Counsel shall file with the
Registry of the Court, either jointly or separately, before the expiration of
ten (10) days from the date of this Order, a document outlining the steps
remaining to be taken in this proceeding, together with a proposed timetable
for the completion of the necessary steps.
Any further directions will be issued by
the case management judge.
“Yvon
Pinard”
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