Docket: A-270-14
Citation: 2014 FCA 176
Present: STRATAS
J.A.
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BETWEEN:
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JANSSEN INC.
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Appellant
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and
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ABBVIE CORPORATION, ABBVIE DEUTSCHLAND GMBH & CO. KG AND
ABBVIE BIOTECHNOLOGY LTD.
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Respondents
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REASONS
FOR ORDER
STRATAS J.A.
[1]
Janssen moves for a stay of an injunction the
Federal Court issued on May 22, 2014 (per Justice Hughes) (2014 FC 489)
until this Court determines three appeals. Janssen also moves for an order
consolidating and expediting the appeals.
A. The
appeals
[2]
The three appeals arise from AbbVie’s action
against Janssen in the Federal Court. In the action, AbbVie claimed that
Janssen’s drug product, Stelara, infringes claims 143 and 222 of Canadian
patent 2,365,281.
[3]
The Federal Court divided the action into a
liability phase and a remedial phase: Order of Prothonotary Aalto dated
September 26, 2011.
[4]
During the liability phase of the action, the
Federal Court refused Janssen’s motion to amend its pleadings: 2013 FC 1148.
Janssen has appealed that refusal (file A-380-13).
[5]
Following a trial on the liability phase, the
Federal Court found infringement: 2014 FC 55. Janssen has appealed that finding
(file A-95-14).
[6]
After the Federal Court’s finding of liability,
it embarked upon the remedial phase. First, it considered AbbVie’s request that
Janssen be enjoined from certain infringing conduct. It granted the injunction:
2014 FC 489. Janssen has appealed the injunction (file A-270-14). The next part
of the remedial phase concerns the issues relating to damages. These issues
will not be tried until autumn 2015.
B. Consolidating
and expediting the appeals
[7]
Janssen requests consolidation of the appeals.
Consolidation achieves two purposes: reducing the amount of paper that needs to
be filed and allowing all appeals to be heard together. The alternative remedy
of hearing the appeals together achieves only the second purpose. Either remedy
is appropriate where, as here, the appeals are factually and legally related.
[8]
In these circumstances, where the appeals are
related but most of the paper for the appeals has already been filed, the
appropriate remedy is to order that the appeals be heard together.
[9]
Janssen also requests that the appeals be
expedited. The pleadings appeal (file A-380-13) and the liability appeal (file
A-95-14) are ready for hearing but no date has been set. In the ordinary
course, without an expedition order, the injunction appeal (file A-270-14) will
be ready for hearing in October 2014.
[10]
The parties have advised the Court of their
availability at that time. An order will issue setting down the appeals to be
heard together on October 8 and 9, 2014.
C. Staying
the injunction until the appeals are determined
(1) Janssen’s earlier request for a stay in
this Court
[11]
Following the Federal Court’s finding of
infringement, Janssen moved in this Court for a stay of the remedial phase of
the action. Applying the settled principles in RJR-MacDonald
v. Canada (Attorney General), [1994] 1 S.C.R. 311, this Court dismissed the motion: Janssen Inc. v. AbbVie Corporation, 2014 FCA 112.
[12]
Among other things, this Court found that
Janssen had suffered no irreparable harm because the Federal Court had not yet
granted AbbVie any remedy. This Court recognized that if the Federal Court were
to issue an injunction, the circumstances might be different and so Janssen
could reapply to this Court for a stay: 2014 FCA 112 at paragraph 2.
[13]
The injunction has now issued and Janssen has
moved to stay it.
(2) Janssen’s request for a stay
from the Federal Court
[14]
In this Court, AbbVie submits that Janssen is
barred by the doctrine of abuse of process from so moving. Janssen
unsuccessfully requested a “stay” of the injunction
in the Federal Court. In its appeal from the injunction, Janssen does not
impugn this aspect of the Federal Court’s decision. AbbVie submits that
Janssen, having failed to appeal the denial of the “stay,”
cannot now ask this Court for one.
[15]
I reject this submission. To show why, some
further background is needed.
[16]
During the Federal Court’s hearing into whether
Janssen should be enjoined from certain conduct, Janssen submitted that if the
Federal Court were minded to issue such an order, it should “stay” it until the determination of the appeals. The
Federal Court rejected the submission. Its injunction took immediate effect.
[17]
Although Janssen phrased its request to the
Federal Court as a “stay,” in reality it was just
a request that the Federal Court delay when its own order should take effect.
[18]
There is a difference between that sort of
request – one made to the court making its own order – and a request that a
court stay the order of another body. The former
attracts a broad “interests of justice” test while the latter attracts the tougher RJR-MacDonald test: Mylan Pharmaceuticals ULC v. AstraZeneca
Canada, Inc., 2011 FCA 312, 426 N.R. 167; Epicept Corporation v. Canada (Health), 2011 FCA 209, 425
N.R. 353 at paragraph 14; Korea Data Systems (USA), Inc. v. Aamazing Technologies Inc.,
2012 ONCA 756 at paragraphs 17-19. In this
case, the Federal Court decided that its own order should take effect
immediately.
[19]
The stay motion presently before this Court is
in no way an appeal from the Federal Court’s decision concerning when its order
should take effect. Rather, it seeks to invoke this Court’s own jurisdiction to
stay an order on appeal. That jurisdiction arises from this Court’s power to
make an order addressing its own inability to determine the appeal in time to
prevent an appellant from suffering irreparable harm. It is just one example of
this Court’s broad original jurisdiction to make orders necessary for its own
process: Canada (Human
Rights Commission) v. Canadian Liberty Net, [1998] 1 S.C.R. 626; Canada (National Revenue) v. RBC Life Insurance Company, 2013 FCA
50. Section 50 of the Federal Courts Act, R.S.C. 1985, c. F-7 and
Rule 398(1)(b) of the Federal Courts Rules, SOR/98-106 are
further sources of this original jurisdiction. Orders made by the Federal Court
in related matters cannot oust this Court’s original jurisdiction to make
orders necessary for its own process.
[20]
While this Court is not barred from considering
Janssen’s stay motion, it must acknowledge that the Federal Court has found in
this case that Janssen will not suffer undue harm if the injunction takes
immediate effect. As mentioned, Janssen has not appealed that finding.
[21]
It seems to me that in an appropriate case this
Court might give weight to a finding made by the Federal Court on a related
issue that has not been appealed to this Court, especially in the absence of
satisfactory submissions to the contrary. This might be such a case, as the
record before this Court on this motion does overlap somewhat with the record
that was before the Federal Court when it made its finding.
[22]
That hypothesis, however, need not be explored
further or definitively answered here. For the reasons below, Janssen has
failed to establish unavoidable irreparable harm and, thus, is not entitled to
a stay of the injunction: RJR-McDonald, supra.
[23]
Janssen proffers evidence of irreparable harm in
several categories: legal and other expenses, non-monetary burdens associated
with complying with the injunction, injury to its reputation, damage to its
market share, and damage arising from the ambiguity of the terms of the
injunction. Janssen must show that this harm is likely to arise over the next
few months until this Court determines its appeals.
[24]
Legal and other expenses without “abnormal, harsh consequences beyond the norm” do not
qualify as irreparable harm, as these can be quantified in damages: Laperrière v. D. & A. MacLeod Company Ltd., 2010 FCA 84
at paragraph 21.
[25]
In this case, the non-monetary burdens
associated with complying with the injunction – training personnel, changing
communications, etc. – are the sorts of administrative inconvenience
that, without more, cannot support suspending the injunction: Laperrière,
supra at paragraph 20; Janssen, supra, at paragraphs 20-26
(on the importance of the binding effect of orders). Further, although
non-monetary on the surface, the burdens identified here may well be
quantifiable in monetary terms.
[26]
Janssen is concerned about its reputation with
doctors who prescribe Stelara. I am not persuaded on this record that these
doctors will think less of Janssen or Stelara because of this intellectual
property dispute. In accordance with the terms of the injunction, Janssen
remains free to explain to physicians the dispute. As well, physicians
understand the frequency of intellectual property litigation among
pharmaceutical companies. If Stelara is helpful to their patients and if the
physicians, themselves, are not involved in the dispute – and on this record
they are not – they will continue to prescribe Stelara. Accordingly, Janssen’s
long term reputation as a reliable supplier of good pharmaceutical products
will not be hurt. See the similar observations in Hoffman-La
Roche Ltd. v. Canada (Minister of National Health and Welfare) (1999), 168
F.T.R. 24 at paragraph 19 (T.D.) (per Evans J. as he then was)
and Novopharm Ltd. v. Janssen-Ortho Inc., 2006 FCA 406 at
paragraph 11 (per Sharlow J.A.).
[27]
Janssen’s related concern that it will lose
market share is unpersuasive. On this record, it appears that treating
physicians in this area know Stelara well and, as mentioned in the preceding
paragraph, they will continue to prescribe it. The injunction allows doctors to
prescribe Stelara to new patients and allows Janssen to supply it to them.
Evidence shows that doctors learn about the usefulness of Stelara from many
sources of readily available information and, thus, are poised to introduce
Stelara to new patients. Against this concrete backdrop, the evidence only
shows general and speculative assertions about loss of market share, unsupported
by particularity. Further, like Justice Rothstein in Apotex
Inc. v. Wellcome Foundation Ltd., 2000 CarswellNat 4299 at paragraph
13 (Fed. C.A.), I suspect that, despite the obiter statement of the
Supreme Court in RJR-MacDonald to the contrary, any such loss nevertheless
might be quantifiable in monetary terms.
[28]
Finally, Janssen submits that it is suffering
and will continue to suffer irreparable harm because of ambiguities in certain
terms of the injunction. It focuses upon certain wording in the injunction,
such as the prohibition in paragraph 2 against “influencing”
physicians. It alleges that certain paragraphs of the injunction conflict.
[29]
These ambiguities, it says, force it to take
very restrictive views of the meaning of the terms of the injunction, resulting
in over-compliance. Further, the ambiguities create the spectre of contempt
proceedings arising from breaches of the injunction, a most serious matter.
Janssen points out that AbbVie has threatened such proceedings arising from a
specific, recent incident.
[30]
Janssen says that it has attempted in the
Federal Court to address the ambiguities but the Federal Court rebuffed it. In
particular, soon after the Federal Court issued the injunction, Janssen sought
direction and guidance from the Federal Court concerning some of the
injunction’s terms and whether certain activities would be caught.
[31]
The Federal Court refused to give any direction
or guidance. It advised that if Janssen wanted specific relief concerning the
injunction, it would have to bring a motion.
[32]
In response to that invitation, Janssen brought
a motion to clarify the terms of the injunction. The Federal Court dismissed
that motion.
[33]
In these circumstances, Janssen says that
further recourse to the Federal Court would not assist it. In its view, only
this Court can rescue it from the real harm caused by the ambiguities in the
terms of the injunction.
[34]
I disagree. If ambiguities in the terms of the
injunction cause it real harm, Janssen can seek a variation of the terms of the
injunction from the Federal Court. The Federal Court is an adequate,
alternative forum for that relief and Janssen has not properly sought that
relief to date. This is demonstrated by an examination of the Federal Courts
Rules, supra and the Federal Court’s reasons dismissing Janssen’s
motion.
[35]
The general principle here is functus officio: an order, once made,
cannot be revisited by the Court that made it. However, limited exceptions to
this principle exist. In the Federal Courts, Rules 397-399 of the Federal
Courts Rules express those exceptions. Two are in play here, Rule 397 and
Rule 399.
[36]
The scope of Rule 397 is set by its strict text.
Under Rule 397, the Federal Court may correct the terms of an order if “the order does not accord with any reasons given,” “a matter that should have been dealt with has been overlooked
or accidentally omitted,” or the order
contains “[c]lerical mistakes, errors or
omissions.” To paraphrase, Rule 397 is available only for slips, errors
and oversights in the preparation of the document expressing the Court’s order.
It is not a means by which the Court can revisit any part of the substance of
its decision.
[37]
In support of its motion to the Federal Court to
clarify the terms of the injunction, Janssen invoked only Rule 397 of the Federal
Courts Rules. The Federal Court dealt with it strictly on that basis. In
its reasons dismissing the motion, the Federal Court noted that “there is no clerical error in [the] Judgment [setting out the
injunction]” and the parties made “no comment…as
to any amendment to [the] Judgment.”
[38]
I have no doubt that in bringing its motion to
clarify the terms of the injunction, Janssen hoped that the Federal Court might
supply more specific wording and direction supplementing, modifying or
replacing the terms of the injunction. However, that goes beyond slips, errors
and oversights in the preparation of the document expressing the Court’s order
– i.e., the subject-matter of the rule Janssen invoked, Rule 397. The
Federal Court properly dismissed Janssen’s motion.
[39]
However, another route was – and still is –
available to Janssen to try to gain the clarity it says it needs. Under Rule
399(2)(a), the Federal Court may set aside or vary an order “by reason of a matter that arose…subsequent to the making of
the order.”
[40]
Janssen has had experience working under the
injunction and today alleges that ambiguity in its terms is causing real
difficulties. These real difficulties, if true and if proven satisfactorily,
can potentially qualify as “a matter that
arose…subsequent to the making of the order.” Janssen can ask the
Federal Court to supplement, modify or replace what it says are unclear terms
with clear terms.
[41]
If Janssen brings a motion in the Federal Court
under Rule 399(2)(a), it will be for that Court to determine whether the
real difficulties alleged by Janssen constitute “a matter
that arose…subsequent to the making of the order.” The Federal Court
could take the view that the difficulties were fully canvassed before the
injunction was made and the wording of the injunction represents its final
solution to them. In oral argument, Janssen appears to be taking the position
that many of the difficulties it says are now happening were unforeseen and
unaddressed at the time the Court set the terms of the injunction. To the
extent that is true, a motion under Rule 399 is open to it. The Federal Court
has said nothing foreclosing Janssen’s resort to one of the exceptions to functus officio – a Rule 399 motion
supported by detailed, concrete and proper evidence.
[42]
In argument before me, the spectre of constant,
repetitive Rule 399 motions was raised. This is unpersuasive. Only concrete
matters of such significance warranting a change to the terms of the injunction
can qualify, and that threshold is quite high: Ayangma v.
Canada, 2003 FCA 382, 313 N.R. 312; Pfizer
Canada Inc. v. Canada (Minister of Health), 2007 FCA 407, 371 N.R. 174.
An even higher threshold must be met to set aside all of an injunction or a key
part of it: Del Zotto v. Canada (M.N.R.), [1996] 2
C.T.C 22, 195 N.R. 74 at paragraph
12 (F.C.A.); UHA Research Society v. Canada (Attorney General), 2014 FCA 134 at paragraph 9. Further, the Federal
Court has the power to prevent relitigation, among other things by ordering
(following brief written submissions) that an improperly filed notice of motion
be removed from the court file under Rule 74: in analogous circumstances, see Rock-St Laurent v. Canada (Citizenship and Immigration), 2012
FCA 192.
[43]
In a situation such as this, a party moving for
variation of the injunction under Rule 399 would have to present specific,
particularized evidence of significant, unforeseen difficulty in following its
terms. Absent significantly changed circumstances later, it would likely be
limited to only one kick at the can.
[44]
Quite aside from Janssen’s ability to pursue a
motion under Rule 399 to clarify any ambiguities – as yet unpursued – Janssen’s
stay motion in this Court must fail for another reason. Its evidence of
irreparable harm falls short of the mark. It has not presented evidence of
sufficient particularity concerning what actions, activities, plans or
communications have been or will be affected by the injunction’s ambiguity.
[45]
General assertions cannot establish irreparable
harm. They essentially prove nothing:
It is
all too easy for those seeking a stay in a case like this to enumerate
problems, call them serious, and then, when describing the harm that might
result, to use broad, expressive terms that essentially just assert – not
demonstrate to the Court’s satisfaction – that the harm is irreparable.
(Stoney First Nation v. Shotclose, 2011 FCA 232 at paragraph 48.)
Accordingly, “[a]ssumptions,
speculations, hypotheticals and arguable assertions, unsupported by evidence,
carry no weight”: Glooscap Heritage
Society v. Minister of National Revenue, 2012 FCA
255 at
paragraph 31.
[46]
Instead, “there must be
evidence at a convincing level of particularity that demonstrates a real
probability that unavoidable irreparable harm will result unless a stay is
granted”: Glooscap, supra at paragraph 31. See also Dywidag Systems International, Canada, Ltd. v. Garford Pty Ltd.,
2010 FCA 232 at paragraph 14; Canada (Attorney
General) v. Canada (Information Commissioner), 2001 FCA 25, 268 N.R. 328
at paragraph 12; Laperrière, supra at paragraph 17.
[47]
The main affidavit offered by Janssen on
irreparable harm says that “extremely complicated
questions” are arising about the scope of the injunction and these
questions are “difficult to answer” as they have “many grey areas of uncertainty”: Motion Record at page
9. But the Court is told neither the questions nor the areas of uncertainty.
[48]
The affidavit says that “[c]omplications
in drawing the line between permitted and non-permitted activities” are
arising with “potential risk”: Motion Record at
page 16. But specifics regarding the complications are missing.
[49]
A communication plan is being developed in the
face of “difficulties” but has not been
implemented: Motion Record at pages 11-13. But even if Janssen had settled on
its communication plan and disclosed it to the Court – in other words, even if
the matter were not premature – it is unclear what the “difficulties”
are.
[50]
“Practical problems” are said to arise when Janssen’s representatives discuss another
drug with clients (Motion Record at page 13), but it is unclear what those problems
are and no specific examples are offered.
[51]
Disseminating medical information might run
afoul of the prohibition in paragraph 2 of the injunction against Janssen “influencing” physicians (Motion Record at page 16), but
exactly what information might be disseminated is unclear.
[52]
In oral argument, Janssen emphasized this
last-mentioned point, stressing the breadth and vagueness of the word “influencing” in paragraph 2 of the injunction. Arising
from that one fuzzy word, Janssen hypothesized all sorts of potential harm that
might arise.
[53]
But the word “influencing”
must be seen in its context. Paragraph 1 of the injunction prohibits “making, using, selling, offering for sale or promoting”
any infringing product, such as Stelara. Paragraph 2 operates as an exception.
It allows Janssen to continue to provide Stelara to patients already using it
under a physician’s prescription or to provide Stelara to new patients whose
physician “has determined that [it] is necessary for that
purpose.” But that is subject to one condition: Janssen “shall not communicate directly or indirectly with any such
physician for the purpose of influencing the decision to initiate or continue
such treatment.” Seen in its actual context, “influencing”
does not sit in isolation with a sprawling meaning poised to trap Janssen. It
is qualified. And practical steps available to Janssen qualify it further:
Janssen can protect itself against harm by documenting all its contacts with
physicians and memorializing the purpose and content of any communications.
Nothing in Janssen’s evidence proves that irreparable harm will arise in the
face of these qualifications.
[54]
Moving from the terms of the injunction to the
nature of the harm that Janssen says it will suffer, Janssen’s motion is again
flawed. Much of the harm identified by Janssen is the sort of inconvenience
suffered by any party when it must comply with an injunction – issues of
interpretation, judgment calls and practical implementation. Undoubtedly these
can create burdens, uncertainties and risks.
[55]
But an injunction cannot be suspended just
because it creates usual or normal burdens, uncertainties or risks. Otherwise,
injunctions that, as here, are intended to take immediate effect would almost
always be suspended as a matter of course. That would conflict with the consistent
thread running through the RJR-MacDonald test for a stay – the need to engage in a careful, case-by-case,
fact-specific balance between fairness and the principle of legality: see Janssen,
supra, at paragraphs 19-26. A moving party seeking to suspend an
injunction pending appeal must adduce evidence showing unusual or abnormal
burdens, uncertainties and risks. Here, that evidence is missing.
[56]
Overall, for the reasons set out above, despite
the very able submissions of Janssen’s counsel, irreparable harm has not been
established.
[57]
Therefore, for the foregoing reasons, I shall
dismiss Janssen’s stay motion with costs. As mentioned, the appeals shall be
heard together and set down for hearing in October, 2014.
[58]
I thank all parties’ counsel, including junior
counsel, for their excellent submissions and high-quality written materials.
"David Stratas"
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