Date: 20101005
Docket: A-252-10
Citation: 2010 FCA 258
Present: EVANS
J.A.
BETWEEN:
NOVOPHARM LIMITED
Appellant
and
PFIZER CANADA INC.,
WARNER-LAMBERT COMPANY,
WARNER-LAMBERT COMPANY LLC,
NORTHWESTERN UNIVERSITY and
THE BOARD OF REGENTS FOR THE
UNIVERSITY OF OKLAHOMA
Respondents
REASONS FOR ORDER
EVANS J.A.
[1]
The motion
before me arises from a prohibition proceeding brought by Pfizer Canada Inc.
under the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133, (Regulations) to restrain the Minister of Health from issuing a
Notice of Compliance (NOC) to Novopharm Limited in respect of its drug
pregabalin, until after the expiry of the patents listed on the patent register
by Pfizer with respect to pregabalin.
[2]
Novopharm
sought a confidentiality order for the Notice of Allegation (NOA) that it had
served on Pfizer, in which it addressed the patents listed in respect of
pregabalin. Prothonotary Milczynski of the Federal Court refused the order
(2010 FC 409). Justice Crampton dismissed Novopharm’s motion appealing from the
Prothonotary’s decision, finding the motion to be improper and vexatious (2010
FC 668). Novopharm has appealed to this Court from Justice Crampton’s decision.
[3]
Novopharm’s
present motion requests two forms of interim relief pending the disposition of
the appeal by this Court, both of which are designed to protect the
confidentiality of its NOA. First, it seeks a stay of Justice Crampton’s order;
second, in the alternative, it seeks an order restraining the parties to the
prohibition proceeding, and the Court’s Registry, from disclosing the NOA to
others.
[4]
Novopharm
alleges that its competitive position as potentially the first or second generic
pharmaceutical company on the market with pregabalin would be prejudiced by the
disclosure of its NOA to its competitors, who could copy Novopharm’s NOA when
applying for their own NOC for pregabalin. In this way, competitors would obtain
for free the benefit of the considerable effort and resources that Novopharm
has devoted to producing its pregabalin NOA.
[5]
The
Regulations are silent on the confidentiality of NOAs filed by generics in
support of their NOC applications. The Court has yet to determine in what circumstances,
if any, NOAs are to be treated as confidential.
[6]
In this
case, Novopharm unilaterally marked its NOA as confidential and treated it as
such. Further, Pfizer agreed to treat it as confidential pending the Federal
Court’s disposition of Novopharm’s motion for a confidentiality order. However,
after Justice Crampton dismissed Novopharm’s appeal from Prothonotary
Milczynski, Pfizer informed Novopharm that it had ceased treating the NOA as
confidential from the date of Justice Crampton’s decision. The copy of
Novopharm’s NOA filed with the Court was under seal pending the determination
of its confidentiality, and remains so.
[7]
The
purpose of a stay of the execution of a Court order is to preserve the status
quo ante pending an appeal. Since Justice Crampton refused to grant
Novopharm a confidentiality order for its NOA, the status quo is that
the confidentiality of the NOA is not protected. Granting a stay of Justice
Crampton’s Order does not therefore achieve the result that Novopharm seeks,
namely, the designation of its NOA as confidential.
[8]
Novopharm
is in effect seeking the relief that Prothonotary Milczynski and Justice
Crampton refused to grant to it. Hence, it has also requested an order restraining
Pfizer and other parties to the prohibition proceeding, as well as the Court’s
Registry, from disclosing the NOA pending the disposition of Novopharm’s
appeal.
[9]
In order
to obtain an interlocutory or interim injunction, an applicant must satisfy the
three-prong test established in RJR-MacDonald Inc. v. Canada (Attorney
General), [1994] 1 S.C.R. 311: the existence of a serious issue to be
tried, whether the applicant will suffer irreparable harm if denied an
injunction, and whether the harm that denying the remedy will cause to the
applicant is outweighed by the harm likely to be caused by granting it.
[10]
Whether an
appeal raises a serious issue is a relatively low threshold for an applicant to
cross. For the reasons outlined in the Federal Court, I entertain considerable
doubt as to whether Novopharm can bring its claim to confidentiality within the
tests established in Sierra Club of Canada v. Canada (Minister of Finance),
2002 SCC 41, [2002] 2 S.C.R. 522. The fact that the confidentiality of an NOA
has never been determined by the Court is not in itself an adequate basis for
concluding that the issue must be a serious one. Nonetheless, for present
purposes, I am prepared to find that Novopharm’s appeal raises a serious
issue.
[11]
However, I
am not satisfied that Novopharm has demonstrated on a balance of probabilities
that it would suffer irreparable harm if not granted an interim injunction.
Novopharm says that if the injunction is not granted, and its NOA is disclosed,
its appeal will become moot and it will effectively have been deprived of its
right to appeal Justice Crampton’s decision.
[12]
That an
appeal may become moot is not in itself sufficient to warrant the award of an
interim injunction pending the appeal: eBay Canada Ltd. v. Canada (Minister of National
Revenue), 2008
FCA 141, 292 D.L.R. (4th) 299 at para. 33. It is still necessary for the party requesting
the injunction to establish that the disclosure of the information that it is
seeking to protect will cause it irreparable harm (at para. 36).
[13]
Prothonotary
Milczynski concluded (at para. 16) that Novopharm had adduced no
evidence that disclosure of its NOA posed a serious risk to its market position
with respect to pregabalin. Novopharm’s allegation of harm is contingent on its
success in defeating the patents listed by Pfizer on the patent register, and
assumes that its competitors would want to copy its NOA. However, there was no
evidence that competitors had copied the first NOA filed in respect of
pregabalin by another generic.
[14]
On appeal,
Justice Crampton agreed (at para. 37) with this analysis, describing
Novopharm’s evidence of harm as “entirely speculative and largely based on bald
assertions and unsupported assumptions.” Two other points about the confidentiality
claim should be noted. First, Novopharm is seeking a confidentiality order for
its entire NOA, and not merely parts which could be redacted. Second, it does
not allege that the NOA contains trade secrets. It is seeking only to protect
its work product from “free riders”.
[15]
In the
absence of evidence in support of this motion materially adding to that
considered in the Federal Court, the findings of Prothonotary Milczynski and
Justice Crampton are equally applicable to the question before me.
Consequently, I am not satisfied that Novopharm has demonstrated on a balance
of probabilities that, if the Court does not grant the interim relief sought,
disclosure of the NOA pending the disposition of the appeal, will cause irreparable
harm to Novopharm’s commercial interest.
[16]
In view of
this finding, it is unnecessary for me to consider where the balance of
convenience lies. There is no harm to be balanced against the harm to the public
interest in the openness of judicial proceedings if relief were granted.
[17]
For these
reasons, Novopharm’s motion is denied, with costs in the lump sum of $4,000 payable
to Pfizer forthwith.
“John M. Evans”
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND
SOLICITORS OF RECORD
DOCKET: A-252-10
STYLE OF CAUSE: NOVOPHARM LIMITED and PFIZER
CANADA INC. et al
MOTION
DEALT WITH IN WRITING WITHOUT APPEARANCE OF PARTIES
REASONS FOR ORDER BY: EVANS
J.A.
WRITTEN REPRESENTATIONS BY:
|
Barbara J. Murchie
Dominique
T. Hussey
Jeilah
Y. Chan
Christopher
D. Heer
|
FOR
THE APPELLANT
|
|
Peter R. Wilcox
|
FOR
THE RESPONDENTS:
PFIZER
CANADA INC., WARNER-LAMBERT COMPANY,WARNER-LAMBERT COMPANY LLC, THE BOARD OF
REGENTS FOR THE
UNIVERSITY
OF OKLAHOMA
|
SOLICITORS OF RECORD:
|
BENNET JONES LLP
Toronto,
Ontario
|
FOR
THE APPELLANT
|
|
TORYS LLP
Toronto,
Ontario
|
FOR
THE RESPONDENTS:
PFIZER
CANADA INC., WARNER-LAMBERT COMPANY,WARNER-LAMBERT COMPANY LLC, THE BOARD OF
REGENTS FOR THE
UNIVERSITY
OF OKLAHOMA
|
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