Date: 20071107
Docket: T-1351-07
Citation: 2007
FC 1156
Toronto, Ontario, November 7, 2007
PRESENT: Kevin R. Aalto, Esquire, Prothonotary
BETWEEN:
SANOFI-AVENTIS CANADA INC.
Applicant
and
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL OF CANADA and
LABORATOIRE RIVA INC.
Respondents
REASONS FOR ORDER AND ORDER
[1]
This
motion is brought on behalf of the Respondent, Laboratoire Riva Inc. (“Riva”),
for, inter alia, an Order dismissing this Application for Judicial
Review.
[2]
The
Application seeks to judicially review an alleged “decision” of Health Canada contained in a letter dated
June 21, 2007 (the “Letter”) sent by counsel for Health Canada addressed only to counsel for
Riva. The relevant portion of the Letter for purposes of this motion states:
“. . . Health Canada is no longer of the view that Riva
cannot receive a notice of compliance until such time as the Pharmascience
submission to which Riva’s product is ‘cross-referenced’ is itself approved.
As a result, should Riva be ultimately successful in the prohibition
proceedings ongoing in T-127-07, and otherwise meet all of its obligations
under the Patented Medicines (Notice of Compliance) Regulations, it will
be eligible to receive a notice of compliance regardless of whether the
Pharmascience submission has fully complied with the NOC Regulations and received a notice of
compliance. I can also advise that Health Canada will soon be providing Riva
with a letter confirming that this is so.” [emphasis added]
[3]
The
Applicant seeks to quash this “decision” and require the Minister of Health to
advise Riva that a Notice of Compliance (“NOC”) will not issue until such time
as the requirements of Patented Medicines (Notice of Compliance) Regulations
(the “Regulations”) are met and Pharmascience receives a NOC in respect of its abbreviated new drug
submission (“ANDS”) for rampiril 2.5, 5, and 10 mg. capsules.
[4]
Riva
brings this motion to dismiss the Application and is supported by the Minister
of Health (“Minister”) and the Attorney General of Canada. In essence, there
are two grounds which are put forward in support of the motion. First, the Letter
does not contain a decision of a federal board, commission or tribunal which
gives rise to the remedy sought. Second, there is no duty owed by the Minister
to the Applicant and the Applicant has no standing because it is not directly
affected by the Minister’s position.
[5]
The Court
may strike out a Notice of Application and dismiss the Application where it is
“plain and obvious” that the application cannot succeed or the application is
“so clearly improper as to be bereft of any possibility of success [see Pharmacia
Inc. v. Canada (Minister of National Health
and Welfare),
[1994] F.C.J. No. 1629 (F.C.A.)]. This is such a case.
The “Decision”
[6]
In my
view, the Letter does not contain a “decision” in the sense that is referred to
in the jurisprudence. It is a Letter from counsel to the Minister addressed only
to counsel for Riva in the context of other proceedings not involving this
Applicant. The Letter simply advises Riva what the Minister may do if certain
events transpire. It is speculative to the extent that the hurdles which Riva
must overcome in order to obtain a NOC may not occur. Further, it is not a
final decision of the Minister but merely an advance indication of a
ministerial position. Such an indication has been held not to be subject to
judicial review [see, Rothmans, Benson & Hedges Inc. v. M.N.R.,
[1998] 148 F.T.R. 3 (T.D.)]. As noted in the Written Representations of the
Minister:
“Of course, what Sanofi [the Applicant] seeks
to accomplish in this application is prevention of the issuance of a Notice of
Compliance to Riva. Setting aside any issue of standing for the moment,
Sanofi’s opportunity to bring a challenge to such a decision would arise with
the actual issuance of a Notice of Compliance by the Minister. By bringing the
present application speculatively and prematurely, Sanofi seeks to prevent the
Minister from exercising his lawful discretion to issue Notices of Compliance
pursuant to the terms of the Food and Drug Regulations.”
[7]
If I am
wrong in my determination that the Letter does not contain a judicially
reviewable “decision” the other arguments of Riva and the Minister provide
ample support for the proposition that this Application is bereft of any
possibility of success.
Does the Applicant Have Standing?
[8]
The answer
to this question is - no. There is ample jurisprudence in this Court to the
effect that judicial review is not available to a party that is not directly
affected by the decision at issue. Section 18.1 of the Federal Courts Act
provides as follows:
|
18.1 (1) An application for judicial
review may be made by the Attorney General of Canada or by anyone directly
affected by the matter in respect of which relief is sought.
|
18.1 (1) Une
demande de contrôle judiciaire peut être présentée par le procureur général
du Canada ou par quiconque est directement touché par l’objet de la demande.
|
[9]
Here, the
Applicant is not directly affected by the position of the Minister as set out
in the Letter. To be directly affected, the matter involved must be one that
affects the Applicant’s legal
rights or imposes legal obligations on it or prejudices it
directly [see, Apotex Inc. v. Canada (Governor in Council), [2007] F. C. J. No. 312
par. 20 and cases cited therein].
[10]
Potentially,
the commercial interest of the Applicant may be affected. However, a
commercial advantage conferred on a third party by the government does not give
rise to standing to commence a judicial review application [see, Rothmans of
Pall Mall Canada Ltd. V. M.N.R., [1976] 2 F.C. 500 (C.A.); (1976),
67 D.L.R. (3d) 505]. In that case, Justice Le Dain noted:
“The appellants do not contend, nor is
there any evidence to suggest, that they themselves had any interest in marketing
a cigarette with a tobacco portion of less than four inches but an overall
length, including the filter tip, of more than four inches. They do not seek
the interpretation which they contend to be the correct one in order to permit
them to do anything in particular that they are not able to do now, but rather
to prevent the respondent companies from doing something which is thought to
give the latter a commercial advantage.
I am in agreement with the learned trial
Judge that such an interest is not sufficient to give the appellants the
required status
or locus standi to obtain any of
the relief sought in their application. The appellants do not have a genuine
grievance entitling them to challenge by legal proceedings the interpretation
which the respondent officials have given to the definition of “cigarette” in
s. 6
of the Excise Act for purposes of
their administrative application of the Act. Such interpretation does not
adversely affect the legal rights of the appellants nor impose any additional
legal obligation upon them. Nor can it really be said to affect their
interests prejudicially in any direct sense. . . .
. . . I know of no authority which
supports a general duty, when considering a change of administrative policy to
be applied in individual cases, to notify and offer anyone who may be
interested an opportunity to make representations.” [emphasis added]
[11]
As in the Rothmans
case, the Applicant here may be affected in its commercial interests if, in
fact, Riva successfully overcomes all of the hurdles necessary in order to be
granted a NOC for its rampiril product.
This commercial interest of the Applicant is insufficient to ground this
application for judicial review.
[12]
The
Applicant argues that the position set out in the Letter is one of
interpretation of the Regulations which impacts on potential liability of the
Applicant under the Regulations and therefore it has standing. Alternatively,
the Applicant argues it should be granted public interest standing. For the
reasons outlined above, I am not persuaded by the arguments of the Applicant
that it has standing as it is not directly affected by the position of the
Minister as set out in the Letter.
[13]
Counsel
for the Applicant argued that the decision of the Federal Court of Appeal in Ferring
Inc. v. Apotex Inc., [2007] FCA 276, supported its position that it
had standing. In that case, Chief
Justice Richard observed at par. 5: [i]n our view, Ferring
Inc. did have standing to challenge that decision because it was made by
the Minister in the course of his administration of the NOC Regulations.”
[14]
However,
the “decision” of the Minster in that case was very different than the position
articulated by counsel for the Minister in the Letter. In the decision of
Justice Hughes [Ferring Inc. v. Canada (Minister of Health), [2007] F.C.J. No. 429] from
which the appeal was taken, Ferring argued that it had standing to seek
judicial review of a Minster’s decision relating to the issuance of a NOC to a
generic. The standing issue related to whether Ferring could seek judicial
review of the Minister’s decision that Novopharm was not a “second party” as
defined in s. 5(1) of the Regulations, whereby Novopharm received the NOC it sought without engaging the
provisions of the Regulations [par. 98]. Justice Hughes determined that this
decision i.e. that Ferring had no right to be given notice or an opportunity to
be heard before the Minister made a determination that the generic, in its
particular circumstances, did not have to engage the Regulations, was
insufficient to afford Ferring the right to judicially review the matter [par.
102].
[15]
It can be
seen that the issue raised by the Applicant in the Ferring case is very
different than the position taken by the Minister in the Letter which is
central to this case. Here, the Regulations are not engaged while the interpretation
and application of the Regulations was put directly in issue in the Ferring case.
Here, the decision of whether and how the Minister’s discretion is exercised in
deciding whether an ANDS meets the requirements of the Food and Drug
Regulations does not put the interpretation, application nor administration
of the Regulations in issue and thus does not directly affect the interests of
the Applicant.
[16]
As for the
alternative argument that the Applicant meets the criteria for public interest
standing, again this also fails. A party seeking public interest standing must
demonstrate, inter alia, that it has a direct or genuine interest in the
matter [see, Canadian Generic Pharmaceutical Association v. Canada
(Governor in Council), [2007] F.C.J. No. 202]. For the reasons noted
above,
the Applicant does not meet this requirement nor the other
criteria that there is a serious issue to be tried and that there is no other
reasonable and effective manner in which the issue to court.
[17]
The
application will be dismissed with costs to the Respondents. If the parties
are unable to agree on the disposition of costs they may make submissions as to
costs, limited to three pages, within thirty days of the date of this
decision.
[17]
ORDER
THIS COURT ORDERS that:
1. This application is dismissed.
2. The parties may submit written
representations with respect to the disposition of costs, limited
to three pages, within thirty days of the date of this
Order.
“Kevin R. Aalto”
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