Date: 20091118
Docket: T-780-08
Citation: 2009 FC 1179
Toronto, Ontario, November 18, 2009
PRESENT: The Honourable Mr. Justice Zinn
BETWEEN:
JANSSEN-ORTHO INC. and
ALZA CORPORATION
Applicants
and
THE MINISTER OF HEALTH
and NOVOPHARM LIMITED
Respondents
REASONS FOR ORDER AND ORDER
[1]
This is an
appeal by Novopharm Limited (Novopharm) from a decision of the case management
Prothonotary dated October 29, 2009. This appeal was heard on November 16,
2009 at the commencement of the hearing of this proceeding which is an
application for an Order under the Patented Medicines (Notice of Compliance)
Regulations prohibiting the Minister from issuing a Notice of Compliance to
Novopharm for its proposed product. After oral submissions, I indicated that
the appeal was being allowed and that Reasons would follow. These are those
Reasons and formal Order.
[2]
Dr. Quinn,
an expert for the Applicants, swore an affidavit in which he makes the
following assertion at paragraph 92:
Along the same vein, I have been known to
say that the clinical significance of the need for ascending plasma
concentrations because of a possible side effect of acute tolerance is
theoretical because it has not been quantified. That too is simply a comment on
the problem of an inability to ethically test to rigorously prove such
significance. The fact remains that psychiatrists generally do recognize that
the prior RITALIN SR® formulation created acute tolerance and that
the newer once a day CONCERTA® formulation due to its sustained
ascending plasma concentration resolves or regulates that problem. On this
topic, I note that the British group of child and adolescent psychiatrists
accept the concept of acute tolerance to Methylphenidate (http://www.rcpsyh.ac.uk).
[3]
It is
accepted that the website referenced by Dr. Quinn is that of the Royal College
of Psychiatrists in the United
Kingdom (the
College). No particular web pages were identified from this site or attached
as an exhibit to Dr. Quinn’s affidavit. Dr. Quinn was not cross-examined on paragraph
92 of his affidavit nor was he asked any questions concerning the website
referenced by him.
[4]
When the
Applicants were cross-examining Dr. Kutcher, an expert witness of Novopharm,
they asked questions of him relating to paragraph 92 of Dr. Quinn’s affidavit
and specifically put to him two pages from the College’s website. Dr. Kutcher
stated that he could neither identify the pages nor authenticate them as he had
not seen them. The pages were marked as Exhibit A for identification purposes
only. The Applicants also asked Dr. McCracken, another Novopharm expert, about
paragraph 92 of Dr. Quinn’s affidavit. He responded that he had not gone to
the website because he didn’t see the relevance “of a group of community
psychiatrists passing judgment on something that I think is determined by the
weight of scientific evidence.”
[5]
The
Applicants filed their Application Record which included Exhibit A marked for
identification purposes on the cross-examination of Dr. Kutcher. Novopharm
objected and brought a motion before the case management Prothonotary seeking
an Order striking the web pages from the Record as well as any reference
thereto. In this respect, it was noted that the Applicants refer to Exhibit A
in paragraph 95 of their Memorandum of Fact and Law wherein they submit as
follows:
Dr. Quinn points out that the United Kingdom’s Royal College of
Psychiatrists’ website has a training manual that specifically references the
Swanson “Acute Tolerance” article that is also referenced in Novopharm’s product
monograph. On the basis of that authority the Association recommends that
acute tolerance to methylphenidate be regulated by use of CONCERTA®’s
ascending methylphenidate plasma attributes.
[6]
The Applicants
resisted the motion and brought a cross-motion seeking leave to serve and file
the affidavit of Marie Mutchler, to which is attached as Exhibits the web pages
that were marked as Exhibit A on the cross-examination of Dr. Kutcher.
[7]
The
learned Prothonotary held that Exhibit A on the cross-examination of Dr.
Kutcher was not in evidence. No appeal was taken by the Applicants from this
finding and I concur with her ruling on this issue which reads as follows:
I am satisfied that the two web pages are
not properly in evidence. They were not included in the affidavits and
documentary exhibits filed by the Applicants pursuant to Rule 306, and they
were not identified or authenticated by any witness on cross-examination.
Reference to the domain or home page for the Royal College of Psychiatrists in
the United
Kingdom by Dr.
Quinn at paragraph 92 of his affidavit does not give adequate or complete
reference to the appropriate source. Providing the web address for the domain
or home page without the balance of the path or address contained in the
complete URL to the specific page would purport to make the entire site and all
of its contents “evidence” in a proceeding, which cannot properly be the case.
Moreover, and in any event, an opposing party is not required to go on a hunt
to try and ferret out the evidence with the hope that they are correct in
finding what might be referred to in an affidavit.
[8]
The Prothonotary
granted the Applicants’ motion and permitted the late filing of the affidavit
of Marie Mutchler, a clerk in the office of counsel for the Applicants, and the
two web pages attached as Exhibits. Accordingly, the Prothonotary found that
“the disposition of Novopharm’s motion to strike the two web pages and
references to them from the Applicants’ Record is rendered moot by the
disposition of the Applicants’ motion for an order to file the two web pages as
additional evidence through the affidavit of Ms. Mutchler.”
[9]
The test
under Rule 84(2) for granting leave to file evidence after having
cross-examined the opposite parties’ deponents is the same as under Rule 312: Pfizer
Canada Inc. v. RhoxalPharma Inc. [2006] 36 C.P.R. (4th) 550
(F.C). As the Prothonotary correctly observed, the filing of additional
evidence may be permitted but only if four requirements are met. The first
three requirements are not relevant, however, the fourth requirement as stated
by her is “whether the further evidence was available and/or could not be
anticipated as being relevant at an earlier date.” The Court of Appeal in Atlantic
Engraving Ltd. v. Lapointe Rosenstein, 2002 FCA 503 at para. 9 stated that this
requirement is included because the Rule permitting the filing of additional evidence
“is not there to allow a party to split its case and a party must put its best
case forward at the first opportunity…”
[10]
The Prothonotary
found and the parties are agreed that the two web pages at issue were available
to the Applicants prior to the cross-examination.
[11]
The
Prothonotary states that while the web pages were available, “it appears that
the Applicants may have erroneously thought that they had properly referenced
them through the web address to the home page of the Royal College of
Psychiatrists, noting that the site has an effective search function.” I can
only conclude that the Prothonotary was of the opinion that due to this
erroneous view, the Applicants could not have anticipated that these pages were
relevant at an earlier date; otherwise the fourth requirement was not met and
the Order permitting the late filing of evidence should not have issued.
[12]
I have
concluded that the Prothonotary acted on a misapprehension of the facts or
erred in law in her application of the fourth requirement of the test. In
order to find that a party requesting leave to file additional evidence could
not have anticipated that the evidence it now wishes to tender was relevant,
one must make that determination by examining the circumstances as they existed
when the party requesting leave first filed its evidence. The question is
whether the moving party knew or ought to have known then that the evidence was
relevant. Here the Applicants knew when it filed its evidence that these pages
were relevant; they were indirectly referenced in an affidavit they filed. The
Applicants tried, without success, to pull themselves up by their bootstraps by
tendering these pages as evidence through Novopharm’s experts but they were
unable so to do. They cannot now tender evidence that was available and known by
them to be relevant when Dr. Quinn swore his affidavit; to permit this would be
to permit the Applicants to split their case.
[13]
Novopharm
also made submissions that the evidence that was to be tendered by Ms. Mutchler
was hearsay evidence and that there was no way the Court could know that these
were the pages that Dr. Quinn was referencing in his affidavit or that they
constituted all of the pages from the College on the issue or that they
reflected the opinion of the College. It was further submitted that they had
not had the opportunity to cross-examine Dr. Quinn on this “new” evidence. The
Applicants submitted that the Court was able to assign whatever weight it saw
fit to the pages after they were allowed into evidence.
[14]
I share
the view of Novopharm that the purported evidence that is now being tendered by
a clerk and not by an expert who is relying on it, is hearsay and had it been
allowed in I would have given it virtually no weight for the reasons advanced
by Novopharm, especially as it had not had an opportunity to cross-examine on
this evidence.
[15]
The
Applicants submitted that Novopharm did have an opportunity to cross-examine
Dr. Quinn on paragraph 92 of his affidavit (and by inference these pages) but
asked him no questions relating to paragraph 92. In my view, it is
disingenuous for the Applicants to suggest that Novopharm had any meaningful
opportunity to cross-examine on two specific pages of a web site when it only
mentions the home page and not the specific pages being relied upon. Perhaps
the Applicants tried to hide the two pages in the forest of the home webpage
rather than attaching them as an Exhibit to the affidavit, which would have
been the proper procedure, or perhaps they merely failed to be more specific
when drafting their expert’s affidavit. Regardless, they are bound by the
choices they made and cannot at this late date tender that evidence.
[16]
Accordingly,
the appeal is allowed and considering Novopharm’s original motion afresh, it is
granted.
ORDER
THIS COURT ORDERS that:
1.
The Order
of Madam Prothonotary Milczynski, dated October 29, 2009, is set aside;
2.
Exhibit A
to the cross-examination of Dr. Stanley L. Kutcher and the affidavit of Marie
Mutchler are struck from the Application Record;
3.
Paragraph
95 of the Applicants’ Memorandum of Fact and Law is struck as are any other references
to the web pages in the Applicants’ Record;
4.
Novopharm
is granted its costs of this appeal and of the motion below.
"Russel
W. Zinn"
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-780-08
STYLE OF CAUSE: JANSSEN-ORTHO INC. and ALZA
CORPORATION v. THE MINISTER OF HEALTH and NOVOPHARM LIMITED
PLACE OF HEARING: TORONTO,
ONTARIO
DATE OF HEARING: NOVEMBER 16-19, 2009
REASONS FOR ORDER
AND ORDER: ZINN J.
DATED: NOVEMBER 18, 2009
APPEARANCES:
Mr.
Neil Belmore FOR
THE APPLICANTS
Ms.
Lindsay Neidrauer
Mr.
Greg Beach
Ms.
Marian Wolanski
Mr. Jonathan Stainsby FOR
THE RESPONDENT
Mr.
Julian Worsley NOVOPHARM
Mr.
Andrew Skodyn
No
Appearance FOR
THE RESPONDENT
MINISTER
OF HEALTH SOLICITORS
OF RECORD:
Belmore
McIntosh Neidrauer LLP FOR THE APPLICANTS
Toronto, Ontario
Heenan Blaikie LLP FOR
THE RESPONDENT
Toronto, Ontario NOVOPHARM
John H. Sims, Q.C. FOR
THE RESPONDENT
Deputy Attorney General of Canada MINISTER
OF HEALTH
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