Date: 20071119
Docket: A-440-07
Citation: 2007 FCA 368
Present: RICHARD
C.J.
SHARLOW
J.A.
RYER
J.A.
BETWEEN:
ABBOTT LABORATORIES
and
ABBOTT
LABORATORIES LIMITED
Appellants
and
APOTEX INC.
and
THE MINISTER
OF HEALTH
Respondents
REASONS FOR ORDER
SHARLOW J.A.
[1]
The
respondent Apotex Inc. has moved for an order dismissing this appeal for
mootness. The appellants (collectively “Abbott”) oppose the motion and have
asked for an oral hearing. The motion arises in circumstances that are routine
in the context of appeals from proceedings under the Patented Medicines
(Notice of Compliance) Regulations (the “NOC Regulations”). I am not
persuaded that an oral hearing would be helpful. I would dispose of this motion
under Rule 369.
[2]
The
relevant circumstances are as follows. Abbott is an innovator drug manufacturer
that markets a drug called Biaxin. Apotex, a generic drug manufacturer, filed
an abbreviated new drug submission seeking a notice of compliance for its
generic version of Biaxin. In order to obtain its notice of compliance, Apotex
was required to address certain listed patents. It did so by serving Abbott
with a notice of allegation raising issues of invalidity and non-infringement.
Abbott commenced an application under the NOC Regulations for an order
prohibiting the Minister of Health from issuing a notice of compliance to
Apotex until after the expiry of the patents in issue. That application was
dismissed by Justice O’Reilly on July 17, 2007 (2007 FC 753). The dismissal of
the application required the Minister to issue a notice of compliance to Apotex
for its generic
version of Biaxin once all conditions relating to safety and efficacy were met
(Apotex Inc. v. Canada (Attorney General) (C.A.), [1994] 1 F.C.
742). Those conditions apparently were met because the notice of compliance was
issued on July 27, 2007. On October 1, 2007, Abbott filed a notice of appeal of the decision of
Justice O’Reilly.
[3]
The only
remedy that could have been be obtained by Abbott in its application in the
Federal Court was an order prohibiting the Minister of Health from issuing a
notice of compliance to Apotex for its generic version of Biaxin. Once the
prohibition application failed and the Minister issued the notice of compliance
that was the subject of that proceeding, the case became moot. That point has
been made in numerous cases, most recently in Eli Lilly Canada Inc. v.
Novopharm Limited, 2007 FCA 359, at paragraph 24. It follows that the
motion to dismiss must be granted unless the Court exercises its discretion to
hear this appeal despite its mootness: Borowski v. Canada (Attorney General), [1989] 1 S.C.R. 542.
[4]
In most
cases involving a moot appeal from the dismissal of a prohibition application under
the NOC Regulations, this Court does not exercise its discretion to hear
the appeal. Usually, the key factor in such cases is judicial economy. A
prohibition application, regardless of its outcome, does not put an end to any
substantive dispute between the parties as to the validity or infringement of
the patent or patents in issue. In practical terms, the effect of a dismissal
of a prohibition application is analogous to the dismissal of an application
for an interlocutory injunction, in the sense that the applicant retains the
right to pursue a claim for infringement.
[5]
The
jurisprudence discloses only one example of a situation in which this Court
exercised its discretion to hear a moot appeal from the dismissal of a
prohibition application: Abbott Laboratories v. Apotex Inc., 2007
FCA 153. Numerous issues were raised in the appeal in that case, including a
question as to whether the principle in Hoffmann-La Roche & Co. Ltd. v.
Commissioner of Patents, [1955] S.C.R. 414, was still good law. The same
point was about to be argued in a number of other prohibition applications in
the Federal Court involving strikingly similar circumstances. The appeal was
heard on that single point (and dismissed).
[6]
In this
case, Abbott is arguing essentially that the decision sought to be appealed may
have a collateral consequence for Abbott that would justify the continuation of
the appeal. The alleged collateral consequence arises from another prohibition
application commenced by Abbott against a generic drug manufacturer, Sandoz, which
has moved under paragraph 6(5)(b) of the NOC Regulations to dismiss that
application as an abuse of process, relying on the decision of Justice O’Reilly
in this case. Abbott argues that it would be unfairly prejudiced in that case
if this appeal is not permitted to continue because the dismissal of its
application in that other case might succeed even though Justice O’Reilly’s
decision in this case is arguably wrong in law. In support of that argument,
Abbott cites Sanofi-Aventis Canada Inc. v. Novopharm Limited, 2007 FCA
163 (leave to appeal refused October 25, 2007, Supreme Court of Canada File No.
32105). Apotex argues that, as it has no interest in the Sandoz proceedings, it
is unfair to Apotex to give the possible outcome of that case any weight in
determining whether this moot appeal should be heard. I agree with Apotex on
that point.
[7]
However,
there is another reason why the argument of Abbott should not prevail. The
apparent premise of Abbott’s argument is that Sanofi-Aventis shifts the
balance of rights under the NOC Regulations. Abbott suggests that,
because Sanofi-Aventis gives generic drug manufacturers an advantage
over innovator drug manufacturers in respect of motions under paragraph 6(5)(b)
of the NOC Regulations to dismiss prohibition applications as an abuse
of process, innovator drug manufacturers should have a corresponding advantage
in the exercise of this Court’s discretion to hear moot appeals from judgments
dismissing prohibition applications.
[8]
I express
no opinion on the merits of the Sandoz dismissal motion. However, I acknowledge
that the jurisprudence of the Federal Court and this Court, culminating in Sanofi-Aventis,
may have caused the remedy in paragraph 6(5)(b) of the NOC Regulations to
appear to be more robust than might have been foreseen by innovator drug
manufacturers. Even if that is the case, the possibility of a successful
paragraph 6(5)(b) motion in another proceeding normally should bear no weight
in the exercise of the discretion of this Court to hear a moot appeal from a
judgment dismissing a prohibition application. On that point I agree with the
decision of this Court in Eli Lilly Canada Inc. (cited above) (see in
particular paragraph 42 of the reasons of Justice Sexton, writing for the
majority).
[9]
For these
reasons, I would grant with costs the motion of Apotex to dismiss this appeal,
and I would dismiss the appeal with costs.
“K.
Sharlow”
“I
agree.
J.
Richard, Chief Justice”
“I
agree.
C.
Michael Ryer J.A.”
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-440-07
STYLE OF CAUSE: Abbott
Laboratories and Abbott Laboratories Limited v.
Apotex Inc. and The Minister of Health
MOTION DEALT WITH IN WRITING WITHOUT
APPEARANCE OF PARTIES
REASONS FOR ORDER BY: SHARLOW J.A.
DATED: November 19, 2007
WRITTEN REPRESENTATIONS BY:
|
William H.
Richardson
Steven Tanner
|
FOR THE APPELLANTS
|
|
Andrew
Brodkin
John Simpson
|
FOR THE RESPONDENT
Apotex Inc.
|
SOLICITORS OF RECORD:
|
McCarthy Tétrault LLP
Toronto, Ontario
|
FOR THE APPELLANTS
|
|
Goodmans LLP
Toronto, Ontario
John H. Sims, Q.C.
Deputy Attorney General of Canada
Ottawa, Ontario
|
FOR THE RESPONDENT
Apotex Inc.
FOR THE RESPONDENT
The Minister of Health
|
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