Date: 20080916
Docket: A-336-08
Citation: 2008 FCA 265
CORAM: DESJARDINS
J.A.
EVANS J.A.
PELLETIER
J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
and
LUNDBECK CANADA INC.
Respondent
(Applicant)
and
THE MINISTER OF HEALTH
Respondent
(Respondent)
and
H. LUNDBECK A/S
Respondent
(Respondent/Patentee)
REASONS FOR JUDGMENT
EVANS J.A.
[1]
This
appeal arises from an interlocutory order made in the course of an
application by Lundbeck Canada Inc. for an order of prohibition, filed on May
31, 2007, under subsection 6(1) of the Patented Medicines (Notice of
Compliance) Regulations, S.O.R./93-133. In this application, the applicant
seeks to prohibit the Minister of Health from issuing a Notice of Compliance to
Apotex Inc. for a proposed new generic drug, until the expiry of Canadian
Patent No. 1,339,452 (’452 patent) held by H. Lundbeck A/S, the parent company
of Lundbeck Canada Inc. The Lundbeck parties will be referred to in these
reasons as Lundbeck.
[2]
Apotex
appeals from a decision of the Federal Court (2008 FC 787) in which Justice
Harrington allowed, in part, an appeal from a decision of Prothonotary Morneau,
dated March 6, 2008. In that decision, the Prothonotary, who is case managing
Lundbeck’s application for an order of prohibition, dismissed a motion by
Lundbeck to strike an affidavit sworn by Dr. Richard Kellogg, together with its
exhibits, and various paragraphs in, and exhibits to, three other affidavits
referring to the Kellogg affidavit.
[3]
Lundbeck
cross-appeals from that part of Justice Harrington’s order dismissing its
appeal from the Prothonotary’s decision to dismiss a second motion by Lundbeck
to strike certain paragraphs and exhibits from four other affidavits. Lundbeck
also requests that, whether or not it succeeds in its motion to strike, it be
granted leave pursuant to rule 312 of the Federal Courts Rules,
SOR/98-106, to file seven reply affidavits.
[4]
Lundbeck’s
application for an order of prohibition has been set down to be heard for five
days commencing December 8, 2008, less than three months from now.
Cross-examination on the 17 affidavits pertaining to the validity of the ’452
patent filed by the parties in this summary proceeding is underway and is expected
to be completed by the end of September.
[5]
I wish to
emphasise at the outset a point reflected in the jurisprudence and often
reiterated by this Court in interlocutory disputes, particularly, but not
exclusively, in connection with those arising from NOC proceedings. Appellate
courts (including courts of first instance when exercising an
appellate function) are
well advised not to interfere with discretionary rulings in interlocutory
matters, especially of the kind in this case, unless satisfied that the issues
in dispute are clearly material to the just disposition of the litigation and
the ruling in question is fundamentally flawed.
[6]
The fact
that the Federal Courts Act, R.S.C. 1985, c. F-7, provides for appeals
as of right in interlocutory matters from a Prothonotary to a Judge of the
Federal Court, and then to the Federal Court of Appeal, is not an open
invitation to subject discretionary decisions at first instance to close
scrutiny. The interests of justice are normally best served in summary and,
indeed, in other proceedings, by minimising delays in the determination of the
substantive matter. Whenever possible, the resolution of ongoing evidential wrangles
(and some
procedural issues) should
be left to be decided by the judge hearing the application, or conducting the
trial.
1. Apotex’s Appeal: the Kellogg Affidavit
Standard of review
[7]
It is common
ground that the order made by the Prothonotary in disposing of Lundbeck’s
motions was discretionary in nature and that the questions raised were not
vital to the final issue in the case. Accordingly, the Judge was only entitled
to intervene, and to exercise his discretion de novo, if satisfied that
the order was clearly wrong, because it was based on a wrong principle or on a
misapprehension of the facts: Merck & Co. v. Apotex Inc. (2003), 30
C.P.R. (4th) 40, 2003 FCA 488 at para. 19. A similar standard of
review applies on an appeal to this Court from a discretionary decision in an
interlocutory matter by a Judge of the Federal Court: Z.I. Pompey Industrie
v. ECU-Line N.V., [2003] 1 S.C.R. 450 at para. 18.
[8]
While I am
not satisfied that the Judge made an error of law in his formulation of the
appropriate standard of review, it is my opinion that he erred in concluding
that the Prothonotary’s order was “clearly wrong” in either of the senses
described above. Hence, he was not entitled to strike the Kellogg affidavit in
the exercise of his discretion and his decision cannot stand.
Issue and Analysis
[9]
In its
lengthy Notice of Allegation (NOA), Apotex alleged that the ’452 patent was
invalid on several grounds, including anticipation. In support of this ground
the NOA stated:
Furthermore, testing results
have confirmed that separation of citalopram using conventional techniques (as
described herein) available prior to June 13, 1987 [i.e. when the ’452 patent
was filed] results in substantially pure (+) – citalopram.
[10]
Lundbeck’s
core objection to the Kellogg affidavit is that Dr. Kellogg’s report was
signed, and some of the tests referred to in it were conducted, after the issue
of Apotex’s NOA. Lundbeck says that Apotex is not permitted to rely on facts
outside the scope of its NOA in order to support an allegation that the patent
is invalid.
[11]
Lundbeck
also says that the statement in the NOA that “testing results have confirmed …”
is insufficient because it does not identify the tests in question. However,
the Prothonotary found that the NOA sufficiently disclosed the existence of
test results on the separation of citalopram. Lundbeck did not ask Apotex for
clarification or for the identity of the person who had conducted the tests,
but was content to file affidavits responding to the NOA. In these
circumstances, I attach no importance to this point.
[12]
Hence, the
question to be decided in this appeal is whether the Prothonotary’s order was
“clearly wrong” because the Kellogg affidavit, and the test procedure and
results described in an exhibit to the affidavit, improperly expand the scope
of the NOA. I am not persuaded that the Prothonotary did so err.
[13]
First, Dr.
Kellogg had produced relevant test results prior to the issue of the NOA.
Second, the results subsequently obtained simply confirmed the earlier results,
and could legitimately have been regarded by the Prothonotary as not being
“additional facts” beyond those set out in the NOA. Third, since it is common
ground that Apotex was not required to include Dr. Kellogg’s report in its NOA,
the fact that it was completed after the NOA was issued does not render it irrelevant
to this proceeding.
2. Lundbeck’s Cross-Appeal
Standard of review
[14]
The part
of the order in dispute in the cross-appeal is also discretionary and does not
pertain to a question vital to the final issue in the case, since it involves
the striking of affidavits, as well as a request by Lundbeck for leave to file
additional affidavits. It is therefore subject to the same standard of review
as the part of the order appealed by Apotex.
[15]
In my
opinion, Justice Harrington was correct to conclude that Prothonotary Morneau
had committed no reversible error in dismissing Lundbeck’s motion.
Issue and Analysis
[16]
Lundbeck
says that the paragraphs in question should be struck because they contain
facts that are beyond the scope of the Apotex’s NOA. However, the Prothonotary
concluded that the disputed paragraphs in the affidavits related to facts
contained in either the NOA or the affidavits filed in support of Lundbeck’s
attempt to disprove the allegation that the ’452 patent is invalid. I am not
persuaded that this conclusion was “clearly wrong” in law or was based on a
misapprehension of the facts. As Justice Heneghan aptly said in GlaxoSmithKline
Inc. v. Genpharm Inc. (2003), 30 C.P.R. (4th) 360, 2003 FC 1248
at para. 59:
The affidavit evidence filed
by the Respondent was responding to the evidence and argument filed by the
Applicants. … [T]his must be permitted to allow for the adversarial process to
function properly.
[17]
Nor am I
satisfied that the Prothonotary made any error warranting the intervention of
this Court in his formulation or application of the criteria for the exercise
of discretion when he
dismissed Lundbeck’s request for leave to file additional
affidavits in response to those of Apotex’s experts. None of the affidavits adduced
before the Prothonotary were “final drafts”, and some were only “partial drafts”.
Cross-examination provides an adequate opportunity for Lundbeck to challenge
the evidence contained in the affidavits filed by Apotex.
[18]
I note
that on both of the above issues, Justice Harrington, exercising his discretion
de novo out of an abundance of caution, concluded that the Prothonotary
was correct.
3. Conclusion
[19]
For these
reasons, I would allow Apotex’s appeal and dismiss Lundbeck’s cross-appeal,
both with costs.
“John M. Evans”
“I agree
Alice Desjardins J.A.”
“I agree
J.D. Denis Pelletier J.A.”
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