Date: 20071214
Docket: T-127-07
Citation: 2007 FC 1317
Ottawa, Ontario, December 14, 2007
PRESENT: The Honourable Mr. Justice Shore
BETWEEN:
SANOFI-AVENTIS CANADA LTD. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Applicants
and
LABORATOIRE RIVA INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
OVERVIEW
[1]
After
all cross-examinations had taken place in this application under the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations) and
approximately one week before the applicants’ Application Record was due, the
respondent generic company, Laboratoire Riva Inc. (Riva), brought a motion to
seek leave to file further evidence, namely an affidavit of Mr. Jean-Paul
Lefebvre (Lefebvre Affidavit). The motion was heard on December 3, 2007.
[2]
Leave
was granted, allowing Riva to file the further evidence by Order, dated
December 5, 2007.
[3]
In
so doing, an error occurred in fact, law and/or principle.
FACTS
The Application
[4]
Riva
sent a letter, dated December 5, 2006 (NOA) asserting non-infringement of
Canadian Patents 2,382,549 and 2,382,387 (collectively the “HOPE Patents”).
While the Riva NOA also alleges patent invalidity on several bases, Riva has
abandoned all of its invalidity attacks, and the sole live allegation is non-infringement
of the HOPE Patents which claim the HOPE Indication, the main use for ramipril
in Canada today. (Affidavit of
Guy Pridham (Pridham Affidavit), Exh. C; Sanofi-Aventis’ Motion Record (MR),
Vol. 1, Tab 5, p. 202.)
[5]
In
the NOA, Riva refers (see page 2) to its pending product monograph provided to
Sanofi-Aventis under a Protective Order in another proceeding and asserts (see
page 4) that it will include a disclaimer in a revised product monograph as
follows:
… In its product
monograph, Riva will include a statement that the Riva Product is approved for
only the use and indication for which the NOC is issued, that it should be used
for such uses and indication and that no statement or reference in the product
monograph should be construed or interpreted to be an encouragement, suggestion
or recommendation that the Riva Product is to be used for anything but the
approved use and indication.
(Pridham Affidavit, Exh. C; MR, Vol. 1, Tab 5,
p. 205.)
[6]
In
response to the NOA, Sanofi-Aventis commenced this application by Notice of Application,
dated January 19, 2007, and subsequently filed its evidence on the merits.
[7]
In
September 2007, in response to Sanofi-Aventis’ evidence on the merits, Riva
filed its evidence consisting only of an affidavit of Dr. Guy Pridham (Pridham
Affidavit), portions of which (paras. 7-9 and Exhibit A) are marked
confidential subject to the Protective Order, dated August 10, 2007. The
Pridham Affidavit gives evidence with respect to Riva’s product monograph and
Health Canada’s requirements for
regulatory submissions. (Pridham Affidavit; MR, Vol. 1, Tab 5, p. 128.)
[8]
The
Pridham Affidavit is silent with respect to the disclaimer referred to in
Riva’s NOA.
[9]
Following
the filing of all evidence on the merits, the respective sides proceeded to
complete cross-examinations subject to outstanding questions.
[10]
Dr.
Pridham was cross-examined on November 2, 2007. Prior to his cross-examination,
counsel for Sanofi-Aventis requested that Dr. Pridham bring “all versions of Riva’s proposed product monograph
(PM) for its ramipril capsules” to his cross-examination. The request was
refused. (MR, Vol. 1, Tab 5, p. 250.)
[11]
During
his cross-examination, Dr. Pridham confirmed that the latest version of Riva’s
product monograph had not been produced. Sanofi-Aventis’ request for the
production of the latest product monograph was refused by Riva on the basis
that it was not relevant to the merits. (Transcript for the Cross-Examination
of Guy Pridham, held November 2, 2007 (Pridham Transcript); MR, Vol. 2, Tab 5,
pp. 343-344 (Qs. 367-373).)
[12]
During
his cross-examination, Dr. Pridham also gave answers, which Sanofi-Aventis
submits, materially undermined his affidavit evidence and Riva’s position in
respect of its allegation of non-infringement. In particular, Dr. Pridham was
candid in admitting that Riva will offer pharmacists financial inducements to
add Riva’s ramipril product to their inventories and to remove any other
generic ramipril brand from their inventories. The admissions are relevant to
whether Riva will be inducing or procuring pharmacists and patients to use
Riva’s ramipril for the patented HOPE Indication, not disputed to be the main
use of ramipril. The admissions also appear to contradict Dr. Pridham’s
affidavit evidence to the effect that Riva will not be entering into exclusive
sales agreements with pharmacists. (Pridham Transcript; MR, Vol. 2, Tab 5, pp.
321, 323, 352, 370 (Qs. 282-285, 292-293, 440-441, 475).)
[13]
Sanofi-Aventis
brought a motion to compel production of the latest Riva product monograph and
the Court disagreed with Riva’s position. By Order, dated November 14, 2007, the
Prothonotary ordered Riva’s witness, Dr. Pridham, to “produce Riva’s current
product monograph for Riva-Ramipril”. The Court Order states “[t]he NOA
referred to a draft monograph which has evolved into another version of the
product monograph. This document is relevant to the issue on this Application
and should be produced”. (Order of the Prothonotary, dated November 14, 2007;
MR, Vol. 1, Tab 4, p.p. 110 and 113.)
[14]
On
November 20, 2007, Riva produced its current product monograph with comments
from Dr. Pridham and counsel for Riva. Sanofi-Aventis objected to the comments
and asked that they be deleted. Riva subsequently agreed that the comments
should not properly be included but sought leave to file further evidence. (MR,
Vol. 1, Tab 4, pp. 58, 96, 100, 101.)
[15]
By
Order, dated November 22, 2007, this Court ordered that the hearing of this
application shall take place on January 15, 2008 and that Sanofi-Aventis’
record shall be served and filed on or before December 7, 2007. (Order of the
Prothonotary, dated November 22, 2007; MR, Vol. 1, Tab 4, p. 115.)
Riva’s Motion under
Appeal
[16]
Riva
subsequently moved to seek leave to file the proposed Lefebvre Affidavit,
following the filing of all evidence on the merits and the cross-examination
thereon.
[17]
Mr.
Lefebvre is not an employee of Riva, but is referred to as a Consultant,
Regulatory Affairs for Riva. Mr. Lefebvre gave evidence on behalf of Riva. (Lefebvre
Affidavit; MR, Vol. 1, Tab 4, p. 40, para. 1.)
[18]
The Lefebvre
Affidavit attaches Riva’s most recent draft product monograph, which he confirms
is on file with the Minister. (Lefebvre Affidavit; MR, Vol. 1, Tab 4, p. 40,
para. 2, Exh. “A”.)
[19]
Paragraphs
2 to 6 of the Lefebvre Affidavit indicate that Riva updated reference 17 of its
earlier draft product monograph to refer to Sanofi-Aventis’ product monograph
as of October 24, 2006. (Lefebvre Affidavit; MR, Vol. 1, Tab 4, p. 40-41,
paras. 2-6.)
[20]
The
remainder of the Lefebvre Affidavit addresses Riva’s intention to include the
disclaimer set out in the NOA, dated December 5, 2006, into a further version
of a product monograph, if the “Court deems it necessary”. (Lefebvre Affidavit;
MR, Vol. 1, Tab 4, p.41, paras. 7-8.)
[21]
Consequently,
the Lefebvre Affidavit (1) includes certain comments which Riva attempted to
include in the Court ordered answers, but then agreed could not be properly
included; (2) addresses the content of Riva’s product monograph, including the
disclaimer referred to in Riva’s NOA; but it is not addressed in Riva’s
previous evidence on the merits; and (3) raises a matter not referred to in the
NOA (namely, that the disclaimer will be offered only if required by the
Court).
[22]
The Lefebvre
Affidavit is improper as Riva appears to be “splitting its case” at this late
stage of the litigation after cross-examinations have been completed, and it
raises a new matter not in the NOA. Moreover, it could have a prejudicial
effect to Sanofi-Aventis’ position on the merits because Riva could rely on it
at the hearing on the merits on January 15, 2008. This could affect
Sanofi-Aventis’ evidence and argument in respect of inducing and procuring
infringement of the HOPE Patents by others.
[23]
By Order, dated December 5, 2007, Riva was granted leave
to file the Lefebvre Affidavit and extended the due date for filing
Sanofi-Aventis’ application record by one week to December 14, 2007. (Order
of the Prothonotary, dated December 5, 2007; MR, Vol. 1, Tab 2, p. 11.)
[24]
In brief reasons for the Order, it is noted that
Sanofi-Aventis opposed Riva’s motion to file further evidence on the merits
“arguing that [Riva] is splitting its case, that the evidence was available
earlier and that to permit filing at this time will cause prejudice”. The Order
states that “none of these arguments hold water”. Furthermore, it is noted that
“while the evidence was available earlier, Riva was not relying on it and had
not produced it”, “there is no prejudice to the Applicant” and the evidence
“will assist the interests of justice and assist the Court”. (Order of the
Prothonotary, dated December 5, 2007; MR, Vol. 1, Tab 2, p. 12.)
ISSUE
[25]
The
sole issue on this motion is whether an error occurred in granting Riva leave
to file the Lefebvre Affidavit.
ANALYSIS
Standard of
Review
[26]
On appeal, a judge may disturb a discretionary order of
a Prothonotary, where:
a) the question raised
in the motion is vital to the final issue of the case; or
b) the order is clearly wrong, in the sense
that the exercise of discretion by the prothonotary was based upon a wrong
principle or upon a misapprehension of the facts.
(Merck & Co., Inc.
v. Apotex Inc., 2003 FCA 488, [2003] F.C.J. No. 1925 (QL), para. 19.)
Test
for Filing Further Evidence in an Application under the Regulations
[27]
Additional
affidavits are not permitted in the ordinary course and constitutes
extraordinary relief. In order to file such affidavits, the moving party must
obtain leave of the Court. (Rule 312 of the Federal Courts Rules, SOR/98-106.)
[28]
In
an application under the Regulations, a supplemental affidavit should be
allowed in only very limited circumstances. It cannot be used to introduce
additional arguments. (Solvay Pharma Inc. v. Apotex Inc., 2007 FC 857, [2007]
F.C.J. No. 1129 (QL), para.18; Abbott Laboratories Ltd. v. Nu-Pharm Inc.
(1998), 82 C.P.R. (3d) 216, at 219 (para. 11) (F.C.T.D.).)
[29]
The
Court has distilled the following test for filing further evidence in an
application under the Regulations:
… the Court
may allow the filing of additional evidence if the following requirements are
met:
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;
d)
the evidence was not available at an earlier date.
(Pfizer Canada Inc. v. Canada (Minister of Health), 2006 FC 984, [2006] F.C.J. No. 1243 (QL), para. 22; Purdue
Pharma v. Novopharm Ltd., 2006 FC 385, [2006] F.C.J. No. 497 (QL), para. 13.)
An
error occurred in finding that Riva is not “splitting its case”
[30]
Although
it was correctly acknowledged that the evidence was available earlier, an error
occurred in failing to appreciate that much of the evidence in the Lefebvre
Affidavit was referred to in the NOA; therefore, Riva was previously relying on
it and it was previously relevant to the merits of the application.
[31]
As
previously mentioned, in the NOA, Riva refers to its pending product monograph
provided to Sanofi-Aventis under a Protective Order in another proceeding and
asserts that it will include a disclaimer in a revised product monograph.
Hence, the language of the NOA clearly contemplates that it will revise its
product monograph to include the disclaimer. Riva had the intention in December
2006 to rely on a revised product monograph. The revised product monograph
predates the Pridham Affidavit; therefore, any further evidence on Riva’s
revised product monograph should have been addressed in the Pridham Affidavit.
[32]
As
the Lefebvre Affidavit addresses the content of Riva’s revised product monograph,
including the disclaimer referred to in the NOA, the evidence was previously
relied upon by Riva and was relevant to the merits of the application prior to
the Court ordered production in November, 2007.
[33]
In
fact, the Order, dated November 14, 2007, recognizes that the revised product
monograph was relevant to the issue on this application and should be produced.
(Order of the Prothonotary, dated November 14, 2007; MR, Vol. 1, Tab 4, p.110.)
[34]
A
further error occurred in failing to
appreciate that some of the evidence in the Lefebvre Affidavit went beyond the
NOA which limited the legal and factual basis which could be relied on by Riva.
In particular, the Lefebvre Affidavit led evidence that the disclaimer referred
to in the NOA will be offered only if required by the Court. This evidence is
clearly beyond the NOA and, thus, it is not open to Riva to file this evidence
in an attempt to amend the NOA. (AB Hassle v. Canada (Minister of
National Health and Welfare) (2000), 7 C.P.R. (4th) 272, paras.
21 and 27; Hoffmann-La Roche Ltd. v. Apotex Inc. (1997), 72 C.P.R. (3d)
480, at 485 (F.C.T.D.), aff’d (1998), 82 C.P.R. (3d) 384 (F.C.A.); Aventis
Pharma Inc. v. Apotex Inc., 2005 FC 1381, [2005] F.C.J. No. 1691 (QL),
paras. 12-13.)
[35]
The
facts were misapprehended in concluding that Riva is not “splitting its case”
at this late stage of the litigation or an error in law occurred by incorrectly
applying the applicable jurisprudential test for the filing of further evidence
in a case under the Regulations.
An error occurred in the
finding that, by permitting Riva to file the further evidence at this late
stage of the litigation, it would not cause prejudice to Sanofi-Aventis
[36]
It was not recognized that Riva is “splitting its case” at this
late stage of the litigation which, by its very nature, results in prejudice to
Sanofi-Aventis and that the brief extension granted to Sanofi-Aventis is not
sufficient to alleviate the resulting prejudice to Sanofi-Aventis.
[37]
In a similar situation, this Court has disallowed the filing of
further evidence recognizing that the opposing party could suffer a prejudice
given the time constraint in a case under the Regulations. (Solvay, above,
paras. 26 and 27.)
[38]
This Court has also disallowed the filing of further evidence as
the further late filing would cause prejudice to the opposing party even though
the moving party suggested the Court extend the opposing party the courtesy of
a further reply. (Abbott, above, para. 11.)
[39]
In this case, Riva attempted to file the Lefebvre Affidavit which
could alter the context with respect to Dr. Pridham’s cross-examination
answers; thus, the Lefebvre Affidavit is clearly improper, as Riva, for all
intents and purposes, appears to be “splitting its case” at this late stage of
the litigation and raises a new matter not raised in the NOA. Allowing Riva to
split its case, at this stage, appears prejudicial to Sanofi-Aventis’s position
on the merits.
An error occurred in finding
that the further evidence will assist the interests of justice and the Court
[40]
While the interests of justice are better served if the Court has
all relevant information before it, filing further evidence must be done
pursuant to the rules and there are limits, also, for the very purpose of
ensuring the interests of justice are understood and met. (Solvay,
above, para. 23.)
[41]
It is not in the interests of justice to allow a party to proceed
far into an application and then to change its litigation approach, as is the
case here, because applications under the Regulations are meant to be dealt
with in an expeditious manner. It is not in the overall interests of justice
that leave be granted to file the further evidence in circumstances where,
after the completion of cross-examinations and just before the hearing date,
Riva appears to have changed its litigation strategy to lead evidence with
respect to the proposed revised product monograph referred to in the NOA. (AstraZeneca AB v. Apotex Inc., 2004 FC 71, [2004] F.C.J. No. 54 (QL), paras. 41 and
42.)
[42]
Moreover, with respect to the proposed evidence on the
disclaimer, an error occurred in finding that the evidence will assist the
interests of justice and the Court despite that Riva did not explain, in its
motion materials, how this proposed evidence will serve the interests of
justice and will assist the Court in its determination of the merits. Quite
simply, it clearly does not appear in the interests of justice to permit a
party to split its case.
Brief Extension of Time
without delaying the date of the hearing
for January 15, 2008
[43]
Riva has agreed to make Mr.
Lefebvre available for cross-examination on his affidavit on December 17, 2007.
[44]
Riva agreed to the Applicants’
request for an extension of the deadline for filing its Record on December 21,
2007.
[45]
The Court, pursuant to Rule 53,
extends Riva’s deadline for filing its Application Record, to January 7, 2008.
[46]
Thus, the hearing fixed for
January 15, 2008 will not be delayed and will proceed as scheduled.
CONCLUSION
[47]
In
view of the foregoing, paragraphs 1 and 2 of the Prothonotary’s Order, dated
December 5, 2007, is set aside, with costs.
ORDER
THIS COURT ORDERS that paragraphs 1 and 2 of
the Prothonotary’s Order, dated December 5, 2007, be set aside, with costs.
“Michel M.J. Shore”
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