Date: 20070828
Docket: T-427-06
Citation: 2007
FC 857
Ottawa, Ontario,
August 28, 2007
PRESENT: The Honourable Mr. Justice Blais
BETWEEN:
SOLVAY PHARMA INC. and
ALTANA PHARMA AG
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
This is an
application by Solvay Pharma Inc. and Altana Pharma AG (the applicants) to file
the supplemental affidavit evidence of Dr. Jorg Senn-Bilfinger and the
affidavit of Laura Meucci attaching, as exhibit A, a letter received from
Health Canada on August 2, 2007 pursuant to Rule 312 of the Federal Courts
Rules, SOR/2004-283.
BACKGROUND
[2]
By notice
of application dated March 9, 2006, the applicants commenced the within
proceeding seeking an order pursuant to section 6 of the Regulations
prohibiting the Minister from issuing a Notice of Compliance (NOC) to Apotex
for its pantoprazole product.
[3]
By virtue
of the applicants’ commencement of the application, a 24-month statutory
injunction was imposed on Apotex prior to it being entitled to market and sell
its own enteric-coated tablets comprising pantaprazole sodium. That presumptive
injunction expires on March 9, 2008.
[4]
The
applicants’ evidence in support of their case was due on April 10, 2006.
[5]
The
applicants’ request for a more than six months extension of time was partially
granted as the applicants now had until July 14, 2006 to file their evidence.
[6]
Later on,
by notice of motion dated June 21, 2006, the applicants sought another
extension of time which was denied by Madam Protonotary Milczynski.
[7]
Finally, the
parties agreed that the applicant could get an additional three weeks to serve
and file their evidence. The evidence was filed on August 4, 2006, including an
affidavit of Dr. Jorge Senn-Bilfinger sworn August 1, 2006.
[8]
The applicants
sought another extension of time to file additional evidence which was the
affidavit of Dr. Corbin; Apotex provided its consent and obtained an extension
of time until January 31, 2007 to respond to the evidence of the applicants.
[9]
Apotex
served its evidence upon the applicants on January 30, 2007.
[10]
By notice
of motion dated March 14, 2007, the applicants sought leave to file reply
evidence.
[11]
The
applicants proposed to file ten new affidavits, including one of Dr.
Senn-Bilfinger to be sworn in April 2007 in reply to Apotex’s evidence. The
drafts of all ten affidavits were delivered by the applicants on April 10,
2007, which is, as noted by the respondents, exactly one year after the
applicants’ evidence was first due.
[12]
In the
decision dated June 15, 2007, Madam Prothonotary Tabib granted leave only for a
partial reply evidence for a total of six paragraphs from three of the ten
affidavits. Leave to file any portion of the second Senn-Bilfinger affidavit
was denied.
[13]
By notice
of motion dated July 18, 2007, the applicants again seek leave to file reply
evidence.
[14]
This is
the motion before the Court now.
ANALYSIS
[15]
The third
Senn-Bilfinger affidavit attaches two research reports (Research Report No.
32/91 and Research Report No. 101/91) as exhibits. The third Senn-Bilfinger affidavit
and the reports purport to address Apotex’s allegations concerning sound
prediction.
[16]
It is not
usually permitted to file reply evidence.
[17]
The Court
has established some basic principles to allow such reply evidence. In Wayzhushk
Onigum Nation v. Kakeway (2000), 182 F.T.R. 100, Prothonotary Hargrave held
at paragraphs 5-7:
In my view, the 1998 Federal Court Rule
312 allows the filing of a supplementary affidavit in limited instances and
special circumstances, for to do otherwise would not be in the spirit of
judicial review proceedings which are designed to obtain quick relief through a
summary procedure. While the general test, as reflected in Eli Lily, Abbott
Laboratories and Bayer A.G. (supra) is whether the additional material will
serve the interests of justice, will assist the court and will not seriously
prejudice the other side, it is also important that any supplementary affidavit
neither deal with material which could have been made available at an earlier
date, nor unduly delay the proceedings. To this I would add two further
observations.
First, supplemental material is meant to
provide additional factual evidence to meet the respondent’s case: see for
example Vrabek v. Minister of National Revenue, [1997] N.R. Uned. 39; [1997] 2
C.T.C. 261, at pp. 262-263 (F.C.A.). Moreover, a reply affidavit is to meet the
other sides case, not merely to confirm the deponent’s initial evidence.
Second, a motion to file reply affidavit
evidence ought to be brought promptly, for not only is judicial review, by the
use of an application, a summary procedure designed to get a hearing with a
minimum of delay, but also, and equally important, delay will often be a bar to
a discretionary remedy.
[18]
In an
application under the Patent Medicines Regulations, supplemental
affidavits should be allowed only in very limited circumstances. It cannot be
used to introduce additional legal arguments. Justice Paul Rouleau in Abbott
Laboratories, Ltd. v. Nu-Pharm Inc. et
al. (1998), 82 C.P.R. (3d) 216 at paragraph 11 held:
Judicial review and more particularly the
patent medicines regulations require that these applications are to be
conducted summarily and expeditiously. To allow the respondents to file a third
affidavit from the same expert containing some 62 pages will not contribute in
any way to a better understanding or clarification of the issues.
[19]
The Court
of Appeal also discussed the question of filing reply evidence in Atlantic
Engraving Ltd. v. Lapointe Rosenstein (2002), 23 C.P.R. (4th) 5 at
paragraph 9:
Further, an applicant, in seeking leave
to file additional material, must show that the evidence sought to be adduced
was not available prior to the cross-examination of the opponent’s affidavits.
Rule 312 is not there to allow a party to split its case and a party must put
its best case forward at the first opportunity. […]
[20]
On that
subject, the applicants’ counsel points out that the cross-examinations have
not occurred yet. Nevertheless, the clock is ticking and the hearing of the
case is already fixed for December. There is at least another motion pending
and the time is very limited for cross-examinations on affidavits given the
high number of affidavits that were filed on both sides.
[21]
Madam
Prothonotary Tabib in her decision dated June 15, 2007, held at page 2:
The Applicants have already filed their
evidence pursuant to Rule 306, the affidavit of twelve expert witnesses, while
Apotex has responded with some ten expert witnesses. By their motion, the
Applicants would add supplementary evidence from ten experts, one of whom is a
new expert who has not yet filed any evidence in this case. The proposed
affidavits would add a total of 87 pages of affidavit evidence, excluding
exhibits, to a case that already has a surfeit of expert evidence. The
Applicants’ within motion was filed nearly ten weeks after the delivery of
Apotex’ evidence, in a matter where the parties have already engaged each other
of the issue of delays.
[22]
Suffice it
to say that this large volume of technical evidence already filed is subject to
cross-examination. If the Court allows filing of two other documents, this will
increase the duty of the respondent and somehow limit his capacity to face this
new evidence at the last minute.
[23]
The
applicants are right when they say that the interests of justice are better
served if the Court has all relevant information before it. Nevertheless, it
has to be done pursuant to the rules and there are limits. The affidavit of
Laura Meucci attaching a letter received from Health Canada dated July 30, 2007 is in response to a
letter sent by the applicants on July 17, 2007 referring to other documents
that were not filed. The applicants want to file this document which amounts to
introducing an opinion by an associate director of the office of Patented
Medecines and Liaison. This correspondence was exchanged only a few weeks ago
and the letter cannot, in any way, be considered as evidence. It is not an
affidavit, and the documents referred to in it are unknown. Hence, it is
hearsay. In my view, that is sufficient to reject the application to file this
letter as evidence.
[24]
Regarding
the two reports that the applicants want to introduce, those documents have existed
since 1991. Pursuant to Dr. Senn-Bilfinger’s affidavit, when he signed his
first affidavit on August 1, 2006 he advised counsel that the documents
attached to his initial affidavit were the only ones in his possession. Later
on, Dr. Senn-Bilfinger tried to locate those reports and has been unable to find
them on his own. Pursuant to his affidavit in May 2007, it was only with the
assistance of a company information research specialist that the reports were
finally located. Dr. Senn-Bilfinger now believes that those two researches
would be relevant to these proceedings. Despite the fact that those researches
were located in May 2007, he waited until the end of June when a scheduled meeting with counsel occurred to
bring copies of these reports.
[25]
As
suggested by counsel for Apotex, the documents are not filed nor commented on
by an expert. The detailed scientific nature of the documents and the absence
of expert consideration make me doubt the impact or relevance of the documents
on this case.
[26]
In
addition, I am considering the prejudice that could be created to Apotex if
those documents were filed. Dr. Senn-Bilfinger mentioned that he made a mental
note to himself at the time he wrote the first affidavit; he recalled that the
reports supported certain of his statements in his first affidavit.
Nevertheless, it was not mentioned in the affidavit and it is only when he
finally located them, almost a year later, that he seeks to introduce them. That
is, only a few months before the hearing and just a few weeks before the
cross-examinations would be done. The reports were available at an earlier date;
it is unfortunate that they could not be located earlier.
[27]
I am of
the opinion that Apotex will suffer a prejudice if they now have to take those
reports and ask their experts to examine these documents and see whether there
is an impact and whether they should reply to it in any way or use the
cross-examination process to do that. Given the time constraint they could
suffer a prejudice. We should remember that the 24-month injunction is there
and, not only should the hearing be completed on schedule, but a judgment
should be rendered also in due time to avoid any prejudice to any of the parties.
[28]
Therefore,
I have no hesitation to conclude that this motion to file reply evidence should
be dismissed. Costs in favour of the respondents.
ORDER
THIS COURT ORDERS that
- This motion to file reply evidence
be dismissed.
- Costs in favour of the respondents.
“Pierre
Blais”
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