Docket: A-501-15
Citation:
2016 FCA 196
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CORAM:
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NOËL C.J.
STRATAS J.A.
RENNIE J.A.
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BETWEEN:
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AMGEN CANADA INC.
and AMGEN INC.
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Appellants
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and
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APOTEX INC.
and THE
MINISTER OF HEALTH
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Respondents
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REASONS
FOR ORDER
STRATAS J.A.
[1]
Apotex moves for an order dismissing this appeal
because it has become moot. For the following reasons, I would grant the motion
and dismiss this appeal with costs.
A.
Basic facts
[2]
In the Federal Court, Amgen applied for an order
under the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133 prohibiting the Minister of Health from issuing a notice of
compliance to Apotex for its Grastofil pharmaceutical product. The Federal
Court (per Hughes J.) dismissed Amgen’s application: 2015 FC 1261. Amgen
appeals.
[3]
In its motion, Apotex says this appeal is now
moot. After the Federal Court’s judgment, the Minister—not subject to
prohibition and free to act—issued a notice of compliance to Apotex for its
product. Apotex says that the subject-matter of the appeal—whether the Federal
Court should have prohibited the Minister from issuing the notice of
compliance—is moot. There is no longer anything to prohibit. Thus, this Court
should not hear the appeal and, instead, should dismiss it.
[4]
Amgen opposes the motion. In its first written
representation on the motion, Amgen pointed out that the notice of compliance
the Minister issued concerned one dosage strength of pharmaceutical product but
not another. It submitted that whether a notice of compliance should be granted
for that other dosage strength was still live.
[5]
Apotex was granted the opportunity to file an
affidavit in reply to address that point: Amgen Canada Inc. v. Apotex Inc.,
2016 FCA 121. Cross-examinations took place on that affidavit. In later written
representations, the parties advise that there were disputes during the
cross-examinations. Although the Court made it clear in advance that it would
be willing to resolve such disputes, no party asked the Court to do so. In a
later written representation, counsel for Amgen suggested that if the Court “forms the view that Amgen should bring a motion on refusals
to sort out the underlying facts, Amgen is, of course, willing to do so.”
But this Court does not read materials and advise parties about whether they
should bring a motion. The evidentiary record on this motion is as it stands
now.
[6]
Based on that evidentiary record, I find that
the other dosage strength raised by Amgen is not before the Minister. The
Minister could not be the subject of a prohibition application concerning that
product. Thus, it is not within the ambit of this appeal. This appeal concerns
only the dosage strength of Grastofil for which the Minister has issued a
notice of compliance.
B.
Should this matter be determined now or be left
for the panel hearing the appeal?
[7]
This motion has been brought as an interlocutory
matter before the hearing of the appeal. But just because it has been brought
now does not mean it must be decided now. This motion could be adjourned and
left for the panel hearing the appeal.
[8]
When to determine a motion is a matter of
discretion: Association of Universities and Colleges of Canada v. Canadian
Copyright Licensing Agency (Access Copyright), 2012 FCA 22, 428 N.R. 297 at
paragraph 11. The discretion is guided by Rule 3 of the Federal Courts Rules,
SOR/98-106: the need to “secure the just, most expeditious and least expensive
determination of every proceeding on its merits.” In applications for
judicial reviews, the commandment in subsection 18.4(1) of the Federal
Courts Act, R.S.C. 1985, c. F‑7—that they be “heard and determined
without delay and in a summary way”—may
also bear upon the discretion.
[9]
This Court usually determines motions on the
basis of written material filed by the parties: Rule 369. However, where there
are certain ambiguities or complexities or where otherwise appropriate, this
Court can request oral submissions. In these circumstances, judicial economy
may favour leaving the motion to the appeal panel, unless for some reason time
is of the essence or other considerations favour immediate determination.
[10]
Where the motion is clear-cut or obvious, it
might as well be decided right away. Efficiency and judicial economy support
this: Collins v. Canada, 2014 FCA 240, 466 N.R. 127 at paragraph 6; Canadian Tire Corp.
Ltd. v. P.S. Partsource Inc., 2001 FCA 8, 267 N.R. 135. However, if reasonable minds might
differ on the outcome of the motion, the ruling should be left to the panel
hearing the appeal: McKesson Canada Corporation v. Canada, 2014
FCA 290, 466 N.R. 185 at paragraph 9; Gitxaala Nation v. Canada, 2015
FCA 27 at paragraph 7.
Sometimes the novelty, quality or incompleteness of the submissions may make it
sensible to leave the motion for the appeal panel to determine: Gitxaala
Nation, above at paragraphs 9-12.
[11]
Here, I am of the view that the motion should now
be determined. As will be seen, the result of the motion is clear-cut and
obvious: the facts and the law impel me to a firm conclusion. All of the
parties to this motion submit that it can and should be decided now and have
offered complete submissions. Further, this Court has determined interlocutory
mootness motions similar to this before the appeal hearing: see, e.g., Janssen
Inc. v. Teva Canada Limited, 2015 FCA 36. Finally, deciding this motion now—rather
than at a hearing some months away—advances judicial economy.
C.
Is this appeal moot?
[12]
This appeal is moot. The facts above show that
there is no longer a live controversy. An order prohibiting the Minister from
issuing the notice of compliance would serve no purpose. She has already issued
the notice of compliance.
[13]
There are many cases to this effect. A good
example is Apotex Inc. v. Bayer AG, 2004 FCA 242, 325 N.R. 289. In that
case, Apotex appealed to this Court from a decision by the Federal Court not to
prohibit the Minister from issuing a notice of compliance. Before the appeal
was heard, the Minister issued a notice of compliance. This Court held that the
appeal became moot. The live controversy—whether the Minister should be stopped
from issuing a notice of compliance—had disappeared. This is the situation
here.
[14]
In Janssen, above, this Court put it this
way (at paragraph 7):
Asking a court to
prohibit a notice of compliance after it has issued is like asking someone to
close the barn door after the horses have escaped. A long and unquestioned line
of authority from this Court “establishes that an appeal from an order
dismissing an application for a prohibition order under the [Regulations] becomes
moot when the notice of compliance is issued”: Biovail
Corporation v. Canada, 2006 FCA 92, 348 N.R. 117 at
paragraph 5. This is because “once the notice of compliance is issued…it is no
longer possible for the Court to prohibit the Minister from issuing the notice
of compliance”: Janssen Inc. v. Mylan
Pharmaceuticals ULC, 2011 FCA 16, 88 C.P.R. (4th)
379 at paragraph 1.
D.
Should the Court exercise its discretion to hear
this moot appeal?
[15]
Although there is no longer a live matter before
the Court, the Court may nevertheless exercise its discretion to hear and
decide it: Borowski v. Canada (Attorney General), [1989] 1 S.C.R. 342 at
pages 358-62.
[16]
To guide that discretion, the Supreme Court in Borowski
offered three considerations:
1.
The absence of adversarial parties. If there are no longer parties on opposing sides that are keen to
advocate their positions, the Court will be less willing to hear the matter.
2.
Lack of practicality; wasteful use of
resources. If a proceeding will not have any
practical effect upon the rights of the parties, it has lost its primary
purpose. The parties and the Court should no longer devote scarce resources to
it. Here, the concern is judicial economy. However, in exceptionally rare
cases, the need to settle uncertain jurisprudence can assume such great
practical importance that a court may nevertheless exercise its discretion to
hear a moot appeal: M. v. H., [1999] 2 S.C.R. 3, 171 D.L.R. (4th) 577 at paragraphs 43-44.
3.
The court exceeding its proper role. In some cases, pronouncing law in a moot appeal in the absence of a real
dispute is tantamount to making law in the abstract, a task reserved for the
legislative branch of government not the judicial branch.
[17]
Amgen says that these considerations should
cause this Court to exercise its discretion in favour of hearing the appeal. It
says that if it succeeds in the appeal, it will not be exposed to damages under
section 8 of the Regulations.
[18]
On this, Amgen is correct. Under subsection 8(1)
of the Regulations, a damages claim arises only if, among other things, the
prohibition application under the Regulations is “dismissed.”
In this case, the Federal Court dismissed Amgen’s prohibition application,
triggering Apotex’s right to bring a section 8 claim. If, however, in this
appeal this Court were to rule that the Federal Court should have granted the
prohibition application, Apotex’s right to bring a section 8 claim would
disappear. So, according to Amgen, a decision on this appeal will determine
whether Apotex can bring a section 8 claim.
[19]
Amgen also points to a new development it
disclosed in a last-minute affidavit, received by the Court without objection
from Apotex. The new development is that Apotex has issued a statement of claim
in the Federal Court seeking section 8 damages. The section 8 claim is now not
just a possibility but a reality. Amgen says this development underscores the
real, practical effect this appeal will have on the parties’ rights.
[20]
This Court has held that the mere possibility of
a section 8 claim is not enough to keep an appeal such as this alive. A mere
possibility affects rights only in a “remote” or
“speculative” sense. See, e.g., Sanofi-Aventis
Canada Inc. v. Apotex Inc., 2006 FCA 328, 53 C.P.R. (4th) 447 at paragraph
18. But here, a live section 8 claim is now on the table. If Amgen succeeds in
this appeal—i.e., this Court rules that the Federal Court should have
granted the prohibition application—Apotex’s section 8 claim in the Federal
Court will immediately end.
[21]
Apotex does not take any serious issue with this
analysis. Rather, it notes that Amgen, as a patentee, “retains
its right to commence an infringement action and to defend [the] section 8 [claim]
with its patent.” Thus, Apotex submits that the dismissal of this appeal
will not affect Amgen’s rights in any practical sense. Hearing this appeal
would only squander the resources of the Court and the parties. Therefore, Apotex
urges us to not to hear this moot appeal.
[22]
My discretion must be guided by both the Borowski
considerations and the previous authorities of this Court that follow Borowski
and bear substantial similarity to the facts here. Absent demonstration of
manifest error in these authorities or a principled basis upon which they can
be distinguished—and no demonstration has been seriously attempted here—I must
follow them: Miller v. Canada (Attorney General), 2002 FCA 370, 220
D.L.R. (4th) 149. These authorities all say—on facts virtually identical to these—that
in a matter arising under the Regulations, this Court should not entertain an
appeal from a denial of prohibition where the patentee can bring an action for
patent infringement and can assert its patent against the section 8 claim: see,
e.g., Pfizer Canada Inc. v. Apotex Inc. (2001), 11 C.P.R. (4th)
245 at page 253 (F.C.A.); Apotex Inc. v. Bayer AG, above; Sanofi-Aventis, above at
paragraph 17; Janssen Inc. v. Mylan Pharmaceuticals
ULC, 2011 FCA 16, 88 C.P.R. (4th) 379. According to all these authorities and even others, the pending appeal loses its practical utility in circumstances such as these and, if it is
heard, would serve only to waste the resources of the Court and the parties. Judicial
economy will not be served.
[23]
The fact that a section 8 claim is on the table is
not a principled basis for distinguishing these authorities. That fact answers only
the objection that rights are affected only in a “remote”
or “speculative” sense and, thus, not in a real
and practical way. It does not answer the objection that the patentee can raise
patent infringement and so the appeal has no real or practical effect on the
parties’ rights. Overall, it does not answer the objection that hearing and
determining this appeal would be inconsistent with judicial economy.
[24]
The Borowski considerations and the
authorities of this Court applying these considerations to facts substantially
similar to those here are front of mind in determining this motion. They prompt
me to exercise my discretion against the continuance of this appeal. Looking at
the particular facts of this case and assessing how they will likely play out,
I am not persuaded that the continuance of this appeal will further judicial
economy. Quite the opposite.
E.
Proposed disposition
[25]
For the foregoing reasons, I would grant Apotex’s
motion and dismiss this appeal with costs.
“David Stratas”
“I agree
Marc Noël C.J.”
“I agree
Donald J. Rennie J.A.”
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