Date: 20110622
Docket: A-397-10
Citation: 2011 FCA 209
CORAM: SHARLOW
J.A.
TRUDEL
J.A.
STRATAS
J.A.
BETWEEN:
EPICEPT CORPORATION
Appellant
and
CANADA’S RESEARCH-BASED
PHARMACEUTICAL COMPANIES
Intervener
and
THE MINISTER OF HEALTH
Respondent
and
CANADIAN GENERIC PHARMACEUTICAL
ASSOCIATION
Intervener
REASONS FOR ORDER
STRATAS J.A.
[1]
In this appeal, the intervener, Canadian Generic
Pharmaceutical Association (CGPA), moves, among other things, for an order
dismissing this appeal for mootness. If the CGPA succeeds in convincing us that
the appeal is moot and should not be heard, the appellant asks us to stay the
appeal rather than dismiss it.
[2]
The facts giving rise to the mootness issue
before us are as follows.
[3]
The appellant filed a new drug submission with
the respondent Minister concerning a drug known as Ceplene. In its submission,
the appellant requested the Minister to grant Ceplene “innovative drug status”
prohibiting the Minister from granting approval for any generic equivalent drug
for at least eight years from the date of issuance of a notice of compliance to
Ceplene under section C.08.004.1 of the Food and Drug Regulations,
C.R.C., c. 870, as amended by S.O.R./2006-241.
[4]
Based on her interpretation of section
C.08.004.1 of the Regulations, the Minister decided that Ceplene was not an “innovative drug” because its active
ingredient, histamine dihydrochloride, had been previously approved by the
Minister in other drugs.
[5]
The appellant challenged the Minister’s decision
in an application for judicial review. The Federal Court dismissed the
application, agreeing with the Minister’s interpretation of section C.08.004.1
of the Regulations: 2010 FC 956. The appellant now appeals to this Court.
[6]
In November 2010, while this appeal was pending,
the appellant withdrew its new drug submission for approval of Ceplene.
[7]
Originally, this appeal mattered because the
appellant believed it was entitled to and needed protection for the data
contained in the new drug submission before the Minister. Now that it has
withdrawn the new drug submission, that protection is no longer needed. There
is no new drug submission for Ceplene before the Minister, and nothing left for
the Minister to decide, whatever this Court decides. With no practical
consequences left in this appeal, we are really being asked to provide a legal
opinion on this issue of interpretation, and nothing else.
[8]
In our view, for the foregoing reasons, this
appeal is moot. However, we can hear a moot appeal: Borowski v. Canada (Attorney General), [1989] 1 S.C.R. 342.
[9]
In its written submissions, the appellant says
that it intends to re-file its new drug submission for Ceplene and it says that
it will apply for data protection at that time. Therefore, says the appellant,
the issue in this appeal will arise again so we might as well hear the appeal
now.
[10]
However, the evidence shows that there is
uncertainty regarding whether the appellant will ever re-file its new-drug
submission. Indeed, if this Court hears this appeal and dismisses it, the
appellant says that it will not re-file its new drug submission. Further, on
cross-examination on this motion, the appellant’s Chief Executive Officer
admitted that financing problems, the results of a new study being conducted,
or both might cause the appellant not to re-file. These considerations
underscore our concern that we are really being asked to provide a legal
opinion that, in the end, will not be of any practical use.
[11]
Even if the appellant does re-file, the
re-filing will not take place for many years, in part due to the new study,
mentioned above. The appellant is conducting this study to support a new drug
application filed with the United States Food and Drug Administration. After
the years to complete this study, the provisions of the Regulations may no
longer be the same. Further, the new drug submission will contain different
studies and different data and the Minister might have additional reasons for
refusing data protection under the Regulations. Any future decision made by the
Minister, if challenged on judicial review, should be considered by the Federal
Court on the specific bases relied upon by the Minister, and then, if
necessary, appealed to this Court.
[12]
In the meantime, there may be other parties in
the Federal Court and this Court seeking protection for the data in their new
drug submissions and they may well raise in this Court the issue of
interpretation that we have in this appeal. If we were to hear and decide the
issues in this appeal today in this hypothetical context, we might well affect
or even bind parties not before this Court today who will wish to argue those
issues in a concrete context.
[13]
In these circumstances, for the foregoing
reasons, we would exercise our discretion against hearing and deciding this
moot appeal.
[14]
The appellant asks us to “stay” this appeal
until it re-files its new drug submission with the Minister. The parties
founded their submissions upon the classic three part test for a court staying
other bodies’ proceedings pending an appeal or other matter, or for an
injunction: RJR-MacDonald Inc. v. Canada (Attorney General), [1995] 3
S.C.R. 199. This is not what is being sought here. In reality, the appellant is
seeking a long-term adjournment of this appeal. Whether or not such an
adjournment is to be granted is a matter of discretion, taking all of the
circumstances into account.
[15]
Many of the facts, canvassed above, concerning
whether we should hear the moot appeal are relevant to our discretion whether
to adjourn this appeal.
[16]
The appellant is concerned that if this appeal
is dismissed, rather than “stayed,” this Court might be taken to have affirmed
the order made by the Federal Court. That is not the case. This Court’s
dismissal of the appeal for mootness is not a decision on whether the appellant
is entitled to data protection.
[17]
On the facts of this case, we would not grant
the appellant’s request to adjourn this appeal. The potential length of the
adjournment, possibly for several years, and the overall uncertainty regarding
whether the appellant will ever re-file a new drug submission weigh heavily in
our exercise of discretion.
[18]
Accordingly, we will grant the CGPA’s motion to
dismiss the appeal for mootness, with costs of the motion payable by the
appellant to the CGPA. We will also dismiss the appellant’s cross-motion for a
stay or adjournment, with costs. The respondent Minister shall have her costs
of the appeal, payable by the appellant.
"David
Stratas"
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