Date:
20111117
Docket:
A-344-11
Citation: 2011 FCA 312
Present: STRATAS J.A.
BETWEEN:
MYLAN
PHARMACEUTICALS ULC
Appellant
and
ASTRAZENECA CANADA, INC.
ASTRAZENECA UK LIMITED, and
THE MINISTER OF HEALTH
Respondents
REASONS
FOR ORDER
STRATAS J.A.
[1]
Mylan Pharmaceuticals ULC appeals from a decision of the Federal
Court: 2011 FC 1023.
The appeal is yet to be heard.
[2]
Two motions have been brought in this Court, one telling us to go
slow and the other telling us to go fast:
·
AstraZeneca Canada, Inc. and AstraZeneca UK Limited move for an
order staying the appeal until after the Supreme Court of Canada has rendered
its decision in Teva Canada Limited v. Pfizer Canada Inc., et al.
(S.C.C. file no. 33951).
·
Mylan moves for an order expediting the appeal.
A. Astra
Zeneca’s motion for an order staying the appeal
(1) The
applicable legal test
[3]
AstraZeneca submits that the legal test is whether, in all the
circumstances, it is in the interests of justice to order the stay. It submits
that this test emanates from section 50 of the Federal Courts Act, R.S.C.
1985, c. F-7. That section empowers this Court to stay proceedings where “it is
in the interests of justice that the proceeding be stayed.”
[4]
On the other hand, Mylan submits that AstraZeneca must satisfy the
tripartite test set out in RJR-MacDonald Inc. v. Canada (Attorney General),
[1994] 1 S.C.R. 311.
[5]
In considering this issue, the relief AstraZeneca seeks must be
characterized. AstraZeneca is not asking this Court to enjoin another body from
exercising its jurisdiction. Rather, it is asking this Court not to hear this
appeal until some time later. There is a material difference between these two
things and different considerations apply:
·
This Court enjoining another body from
exercising its jurisdiction. When we do this, we are
forbidding another body from going ahead and exercising the powers granted by
Parliament that it normally exercises. In short, we are forbidding that body
from doing what Parliament says it can do. As the Supreme Court recognized in RJR-MacDonald
Inc., this is unusual relief that requires satisfaction of a demanding
test. Two parts of that test are particularly demanding. First, there must be
persuasive, detailed and concrete evidence of irreparable harm: Stoney First Nation v. Shotclose, 2011 FCA 232 at paragraphs 47-49; Laperrière v. D. & A. MacLeod Company Ltd., 2010 FCA 84 at paragraphs 14-22. Second,
there must be a demonstration, through evidence, of inconvenience that
outweighs public interest considerations, such as the right of the other body
to discharge the mandate given to it by Parliament: RJR-MacDonald Inc., supra
at pages 343-347.
·
This Court deciding not to exercise its jurisdiction until some
time later. When we do this, we are exercising a jurisdiction that is not
unlike scheduling or adjourning a matter. Broad discretionary considerations
come to bear in decisions such as these. There is a public interest
consideration – the need for proceedings to move fairly and with due dispatch –
but this is qualitatively different from the public interest considerations
that apply when we forbid another body from doing what Parliament says it can
do. As a result, the demanding tests prescribed in RJR-MacDonald do not
apply here. This is not to say that this Court will lightly delay a matter. It
all depends on the factual circumstances presented to the Court. In some cases,
it will take much to convince the Court, for example where a long period of
delay is requested or where the requested delay will cause harsh effects upon a
party or the public. In other cases, it may take less.
[6]
The conclusion that the RJR-MacDonald test does not apply
in cases where the Court is deciding not to exercise its jurisdiction until
some time later is supported by other cases in this Court: Boston Scientific
Ltd. v. Johnson & Johnson Inc., 2004 FCA 354; Epicept Corporation v.
Minister of Health, 2011 FCA 209.
[7]
Mylan cites another authority of this Court and says that it is to
the contrary: D & B Companies of Canada Ltd. v. Canada
(Director of Investigation and Research) (1994), 58
C.P.R. (3d) 342 (F.C.A.).
[8]
In D & B Companies, a party asked the Competition
Tribunal to delay its proceedings. The Competition Tribunal refused. It held
that the factors relevant to its discretion to delay its proceedings were the
same as those set out in RJR-Macdonald. A motion was then brought in
this Court to stay the Competition Tribunal’s proceedings. As an attempt to
have this Court enjoin another body from carrying out its mandate, the test in RJR-Macdonald
was properly applied and the stay was refused.
[9]
In the course of its reasons in D & B Companies, this
Court observed that the Competition Tribunal was right to apply the test in RJR-MacDonald
in order to determine whether it should delay the hearing before it. Mylan
relies on this observation.
[10]
There are three considerations that reduce the authority of this
observation. First, in D & B Companies, this Court had to apply the
test in RJR-Macdonald anyway. So its observation must be seen as obiter.
Second, D & B Companies can be seen as one where, in the particular
circumstances of that case, the Competition Tribunal saw the factors normally
canvassed under the RJR-MacDonald test to be relevant to the exercise of
discretion before it. Third, D & B Companies may be explained as a
decision by a specialist administrative tribunal – not this Court – about what
factors ought to apply to such matters before it, and, in making its
observation, this Court appropriately deferred to the tribunal’s decision.
[11]
Because of these three considerations, the observation made by
this Court in D & B Companies should not be seen as a statement of
general principle, binding in all future cases.
[12]
As a result, I do not agree with the reasoning of certain Federal
Court cases cited by Mylan that follow the observation in D & B
Companies: Sawridge Band v. Canada, 2006 FC 1218 and Re Zündel,
2004 FC 198.
[13]
In any event, the reasoning in Epicept and Boston
Scientific are preferable to that in D & B Companies. As
explained above, cases such as Epicept, Boston Scientific and
this case do not involve forbidding another body from doing what Parliament
says it can do. As explained above, in such cases the RJR-MacDonald test
is inapt.
[14]
Therefore, as Astra-Zeneca is asking this Court not
to hear this appeal until some time later, the RJR-Macdonald test does not
apply. Rather, we are to ask ourselves whether, in all the circumstances, the
interests of justice support the appeal being delayed.
(2) Application
of the test to the circumstances of this case
[15]
AstraZeneca submits that the decision of the Supreme Court of
Canada in Teva Canada Limited v. Pfizer Canada Inc., et al. (S.C.C. file
no. 33951) has such a bearing on this appeal that this Court should exercise
its discretion in favour of waiting until the Supreme Court has released its
decision.
[16]
Mylan disagrees. It emphasizes that if this Court waits until the
Supreme Court has decided the Teva appeal, the wait will be a very long
one. It also suggests that the decision of the Supreme Court may not have any
bearing on the outcome of this appeal.
[17]
Mylan is correct about the possible length of the wait. The Teva
appeal is scheduled to be heard on February 8, 2012. The most recent statistics
of the Supreme Court of Canada, filed before me, show that the average time
required by that Court to issue a decision after hearing an appeal is 7.7
months. There are recent cases, albeit rare, where it has taken 18 months after
a hearing to issue a decision: Reference re
Assisted Human Reproduction Act, 2010 SCC 61, [2010] 3 S.C.R. 457; Ontario
(Public Safety and Security) v. Criminal Lawyers' Association, 2010 SCC 23, [2010] 1 S.C.R. 815. Of course, a number of
others are released well below the 7.7 month average.
[18]
The parties helpfully filed the
memoranda of the parties in the Teva appeal. The
issues appear to be of considerable complexity. Added to whatever time the
Supreme Court takes must be the time for the parties to file their memoranda of
fact and law in this Court and to get a hearing. This means that AstraZeneca’s
request that this Court wait until the Supreme Court has released
its decision is really a request that this Court not hold its appeal hearing
until, perhaps, the spring of 2013.
[19]
This is a request for a long wait. Only a very direct nexus
between the issues in the Teva appeal and this appeal might warrant an
exercise of discretion in favour of that wait.
[20]
Upon reviewing the memoranda of the parties in the Teva
appeal, I am not convinced that such a direct nexus exists.
[21]
The Teva appeal involves an allegation made by Teva under
the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133
that a patent, which claims the use of sildenafil in the treatment of erectile
disfunction, is invalid for insufficient disclosure. Teva’s allegation of
insufficient disclosure is based on a particular feature of this patent: it is
said that this particular patent does not reveal which of 260 quintillion
compounds disclosed was observed to induce erections in men. In this case, the
patent at issue, unlike the patent at issue in the Teva appeal, only
claims a single compound, anastrozole. Mylan is not arguing that the patent in
issue in this case is invalid because it conceals the identity of anastozole
among numerous other compounds.
[22]
In this case, both Mylan and the Federal Court relied on a
particular statement made by this Court in its decision on the Teva
appeal. AstraZeneca says that the validity of that statement is one of the
issues before the Supreme Court in the Teva appeal. That is true, but
the Supreme Court may never decide that issue: many other arguments against the
sufficiency and utility of the patent at issue are before it.
[23]
AstraZeneca expresses concern that if this Court does not delay
the appeal, this Court may decide the appeal against it on a basis that turns
out to be wrong in light of the later decision of the Supreme Court in the Teva
appeal. It points to the unlikelihood of the Supreme Court granting it leave to
appeal in such a circumstance.
[24]
AstraZeneca overlooks that in that situation the Supreme Court has
the power to remand the case back to this Court and “order any
further proceedings that would be just in the circumstances,” such as a
redetermination of the matter based on its decision in the Teva appeal:
Supreme Court Act, R.S.C. 1985, c. S-26, subsection 43(1.1). This can be
done without granting leave to appeal: see the words “notwithstanding
subsection [43](1)” at the beginning of subsection 43(1.1). In light of this
available avenue of relief, the concern expressed by AstraZeneca is
insignificant.
[25]
I also point out that it may be possible for the parties to intervene
in the Teva appeal and make submissions on issues that could conceivably
affect them later in any remand proceedings ordered under subsection 43(1.1):
see Rules 55-59 of the Rules of the Supreme Court of Canada,
SOR/2002-156, and see also Rule 6 on extensions of time. This
option becomes attractive if, contrary to the view I take of the matter, there
is in fact a very direct nexus between the issues in the Teva appeal and
this appeal. An application for intervention in circumstances such as these is
not without precedent: the Mounted
Police Members’ Legal Fund successfully applied to the Supreme Court to
intervene in Ontario (Attorney General) v.
Fraser, 2011 SCC 20, [2011] 2 S.C.R. 3. The
application was partly on the basis that the Supreme Court’s decision
might affect an appeal from a case in which it was a party (Mounted
Police Association of Ontario v. Canada (Attorney General)
(2009), 96 O.R. (3d) 20 (S.C.J.)): see Supreme Court of Canada, Bulletin
of Proceedings, November 13, 2009 at page 1589 and the intervention
materials filed with the Court.
[26]
For the foregoing reasons, I shall dismiss the motion for an order
staying the appeal, with costs.
B. Mylan’s
motion to expedite the appeal
[27]
Mylan offers two reasons for expediting this appeal.
[28]
First, Mylan is concerned that if the appeal is not decided before
the expiry of the ’420 Patent on October 24, 2012, it may be considered moot. I
reject this. AstraZeneca has undertaken not to argue that the appeal is moot.
It is true that, on its own motion, this Court could raise the issue of
mootness at the hearing of the appeal and dismiss the appeal on that basis.
However, the current state of the hearing list is such that this appeal will be
heard long before October 24, 2012, most likely in March-May, 2012.
[29]
Second, Mylan suggests that if the appeal is expedited, Mylan may
gain a first-to-market advantage over other generics, assuming that the appeal
is decided before expiry of the patent and Mylan is successful on the appeal. I
reject this as well. In my view the evidence is purely speculative as to
whether Mylan would get a first-to-market advantage if this appeal were
allowed.
[30]
In any event, I would exercise my discretion against expediting
the appeal. Those who seek expedition should themselves expedite. That has not
happened here. Mylan took 25 days to issue its eight page notice of appeal,
another 27 days to file the agreement as to the contents of the appeal book,
and another 27 days to file the appeal book. All three of these procedural
steps took close to the maximum time permitted under the Federal Courts
Rules. The uneventful pace at which the appeal is being prosecuted belies
any need for an expedition order.
[31]
Therefore, for the foregoing reasons, I shall dismiss the motion
to expedite, with costs.
"David Stratas"
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