Date: 20080623
Docket: T-991-07
Citation: 2008
FC 787
Toronto, Ontario, June
23, 2008
PRESENT: The Honourable Mr. Justice Harrington
BETWEEN:
LUNDBECK CANADA INC.
Applicant
and
THE MINISTER OF HEALTH AND
APOTEX INC.
Respondents
and
H. LUNDBECK A/S
Respondent/Patentee
REASONS FOR ORDER AND ORDER
[1]
This
appeal from an interlocutory order of Prothonotary Morneau puts in issue the
manner in which proof is adduced in applications before this Court, as opposed
to actions. The skirmish is within the context of the Patented Medicines
(Notice of Compliance) Regulations. Lundbeck Canada Inc. has applied for an
order prohibiting the Minister of Health from issuing Apotex a Notice of
Compliance with respect to its submission for tablets comprising Escitalopram
Oxalate until the expiry of H. Lundbeck A/S’s Canadian patent 1,339,452 titled “Etaniomers
of Citalopram and Derivatives Thereof”.
[2]
Pursuant
to rule 300 and following of the Federal Courts Rules, Lundbeck filed
its Notice of Application and then its evidence which takes the form of
affidavits and documentary support. The respondent, Apotex, replied in kind.
The next step, which has yet to take place, is the cross-examination on
affidavits, followed by the filing of both parties’ records, which will include
memoranda of fact and law. The hearing on the merits is scheduled for this
December.
[3]
Although
on notice, the Minister of Health takes no position and has not participated.
[4]
Lundbeck
moved to have some of Apotex’s expert affidavits struck in whole or in part.
Failing that, it asked that it at least be given leave to file affidavits in
reply. Leave is required under rule 312. It also sought leave to reply to
certain paragraphs of the Apotex affidavits notwithstanding that it did not
move that those statements be struck.
[5]
Prothonotary
Morneau dismissed the motions outright. Although Lundbeck appealed the order in
its entirety, at the hearing it resiled with respect to certain paragraphs of
certain affidavits.
THE DECISION UNDER APPEAL
[6]
It bears
mentioning that Lundbeck originally brought on two separate motions. However,
they were heard together by Prothonotary Morneau who issued one order, and so
there is only one appeal before me. In one motion, it sought an order striking
out certain paragraphs and exhibits to the affidavits of Aidan Hollis, Peter
Jenner, John Keana, Robert McCelland and Timothy Ward, or in the alternative
for an order granting leave to file evidence in reply thereto and, in any
event, for an order granting it leave to file evidence in reply to certain
other paragraphs. The basis of the motion is that the parameters of this
application were established by Apotex in the Notice of Allegation (NOA) it
gave under the PM (NOC) Regulations, and that the said affidavit material was neither
responsive to Lundbeck’s own affidavits nor within the scope of the NOA.
[7]
In its
other motion, it sought to strike the affidavit of Dr. Richard Kellogg, and the
two exhibits accompanying same, in their entirety, together with identified
paragraphs and exhibits of other experts called by Apotex who referred to Dr.
Kellogg’s report, more particularly certain paragraphs and exhibits to the
affidavits of Drs. McCelland, Ward and Keana. The test results exhibited
thereto were not listed as prior art in the NOA and in fact were only completed
after the NOA was served.
[8]
Prothonotary
Morneau refused to strike any part of any affidavit and refused to grant
Lundbeck leave to file any further affidavit evidence. He held that the test
for striking out parts of an affidavit under rule 307 is that absent special
circumstances, such as an affidavit being clearly abusive or irrelevant, the
decision to strike should be left to the applications judge. Having reviewed
the material, it was not clear to him that Apotex’s affidavit evidence was an
expansion of the legal and factual basis of its NOA, or that it could not
clearly be considered a reply to the Lundbeck affidavits filed under rule 306.
[9]
As for
granting leave to file reply affidavits under rule 312, he purported to apply Atlantic
Engraving Ltd. v. Lapointe Rosenstein, 2002 FCA 503, 23 C.P.R. (4th)
5 which set out a four-part test: a) the evidence to be adduced will serve the
interests of justice; b) the evidence will assist the Court; c) the evidence
will not cause substantial or serious prejudice to the other side; and d) the
evidence was not available at an earlier date or could not have been
anticipated.
THE REVIEW STANDARD IN APPEAL
[10]
The order
of the Prothonotary was discretionary. It is well established that the Court
should not interfere with such a decision unless: a) the questions raised are
vital to the final issue in the case; or b) the order is “clearly wrong” in the
sense that the exercise of discretion by the Prothonotary was based upon an
incorrect principle of law or upon a misapprehension of the facts. In that
event, the Court must exercise its discretion de novo (Merck &
Co. v. Apotex Inc., [2004] 2 F.C.R. 459, 30 C.P.R. (4th) 40 at paragraph
19; Canada v. Aqua-Gem Investments Ltd., [1993] F.C.J. No. 103, [1993] 2
F.C. 425 at page 454).
[11]
In my
opinion, the order of Prothonotary Morneau was not vital to the outcome of the
case.
[12]
Except in
one respect, I am of the opinion that he based himself neither upon an
incorrect principle of law nor upon a misapprehension of the facts. However, I
cannot agree with his analysis with respect to the affidavit of Dr. Richard
Kellogg, and the exhibits attached thereto.
[13]
Dr. Kellogg’s
affidavit is dated 5 December 2007. In it, he states that he was provided by
one of Apotex’s co-counsel with copy of two U.S. patents and asked to carry out or
supervise certain resolutions and separations based on open literature
available in June 1988. The accompanying notes and report indicate that the
work began 10 April 2007 and finished 21 May 2007.
[14]
The report
was relied upon by other experts called by Apotex to support the following
proposition in Apotex’s NOA where it states:
Furthermore, testing results have
confirmed that separation of Citalopram using conventional techniques (as
described herein) available prior to June 13, 1987 results in substantially
pure (+) – Citalopram.
[15]
That NOA
is dated 20 April 2007. It comprises forty-three (43) pages of text and an
additional seventeen (17) pages of a schedule in which 170 items of “prior art”
are listed.
[16]
Perhaps on
20 April, Apotex had reason to believe the testing then going on would support
its case, but the simple fact remains that the test was not complete, and so
cannot be called “prior art”. It is, at best, “subsequent art”.
[17]
Had Apotex
waited until the report was actually in existence, it could have been invoked.
I agree with the Prothonotary that it would not have been absolutely necessary
to refer to it in the text of its NOA, but it would have had to list it as
prior art. The PM (NOC) Regulations require a detailed statement of the basis
in fact and law to support the allegation that a patent is invalid, or that it
will not be infringed, or whatever other grounds are alleged with a view of
obtaining a Notice of Compliance from the Minister before a listed patent has
expired (Bayer AG v. Canada (MNHW), [1993] F.C.J. No. 1106, 51 C.P.R.
(3d) 329).
[18]
As noted
in AB Hassle v. Canada (MNHW), [2000] F.C.J. No. 855, 7 C.P.R. (4th)
272 at paragraph 23, the entire factual basis is to be set forth in the NOA
rather than be revealed piecemeal as the need arises. To the extent prior art
is relied upon, it must be identified.
[19]
Consequently,
I cannot share the Prothonotary’s opinion that the section of Apotex’s NOA
referred to above sufficiently discloses the existence of test results. If there
are such results, it is certainly not the Kellogg report, which did not exist
at the time.
[20]
To allow
the affidavit to stand, even giving Lundbeck a right to reply, would be to
allow Apotex to split its case. The Kellogg report goes beyond the NOA and it
would be patently unfair to allow it to remain in the record (Mayne Pharma (Canada) Inc. v. Aventis Pharma Inc., 2005 FCA 50, 2005 F.C.J. No.
215).
[21]
I do not
think that this misapprehension of the Kellogg Report permeated the rest of
Prothonotary Morneau’s decision, but to be on the same side I have decided to
consider the matter de novo.
[22]
It is
certainly not at all clear to me whether the remaining affidavits go beyond the
NOA and the Lundbeck affidavits. To the extent that reports are mentioned that
are not listed in the NOA, Apotex must be given a fair opportunity to respond
to Lundbeck’s affidavits. One does not know how the person who has listed a
patent may react to an NOA, and so the issuer thereof cannot fully anticipate
all that might be set out in the applicant’s affidavits. It is not at all clear
to me that the affidavits bring new points into issue, or raise confusion.
[23]
One of the
reasons these matters are usually left to the applications judge is that in the
fullness of time, with the benefit of transcripts of cross-examinations and
argument on all points in issue, that judge is in, at that time, a much better
position to appreciate the relevance of the statements under attack, the weight
which should be given to them, and their context. If Apotex has split its case,
or if some of the allegations in its NOA are too vague, then it is open to the
applications judge, on a full record, to so find, without the need of still
more affidavits.
[24]
Following Atlantic
Engraving, I do not see circumstances which are such that justice would be
better served by permitting further affidavits, which quite possibly would lead
to further motions to file affidavits in reply and more cross-examinations.
Apotex made its bed in its NOA and Lundbeck in its Notice of Application and
its affidavits. They should lie in them.
ORDER
THIS COURT ORDERS that the appeal from the order of
Prothonotary Morneau, dated 6 March 2008, is allowed in part:
1.
The
affidavit of Dr. Richard Kellogg and the two exhibits thereto are struck in
their entirety.
2.
The
following paragraphs and exhibits of the experts called by Apotex who refer to
the Kellogg report are struck:
a. Paragraph 91 and exhibit 2 to
the affidavit of Dr. McCelland;
b. Paragraphs 26-29 and exhibit 3
to the affidavit of Dr. Ward; and
c. Paragraph 117 and exhibits 3
and 4 to the affidavit of Dr. Keana.
3.
The
balance of the appeal is dismissed.
4.
Costs in
the cause.
“Sean Harrington”
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