Date: 20060817
Docket: T-1232-05
Citation: 2006
FC 984
OTTAWA, Ontario, August 17, 2006
PRESENT: The Honourable Mr. Justice Teitelbaum
BETWEEN:
PFIZER
CANADA INC.
Applicant
and
THE
MINISTER OF HEALTH and APOTEX INC.
Respondents
and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondent/Patentee
REASONS FOR ORDER AND ORDER
[1]
The
present motion arises within an application for prohibition under the Patented
Medicines (Notice of Compliance) Regulations. Apotex Inc. (“Apotex”) served
a Notice of Allegation (“NOA”) on June 3, 2005 alleging non-infringement of
Canadian Patent No. 2,023,089, held by Pfizer Canada Inc.’s (“Pfizer”). Apotex
also made arguments as to the patent’s invalidity. Pfizer initiated proceedings
on July 18, 2005 seeking an order prohibiting the Minister of Health from
issuing a Notice of Compliance (“NOC”) to Apotex in respect of its proposed
Apo-Quinapril tablets. Pfizer filed evidence with the Court on November 24,
2005, including a Confidential Affidavit of Dr. Mansoor Husain. Apotex then
served and filed its evidence on April 7, 2006, including a Confidential
Affidavit of Dr. Gordon W. Moe.
[2]
Pfizer
alleges that Dr. Moe’s affidavit aggressively critiques Dr. Husain’s evidence.
Pfizer brought a motion for (among other things) leave to file a reply
affidavit of Dr. Husain pursuant to Rule 312 of the Federal Courts Rules.
Pfizer alleges that the reply affidavit consists exclusively of responses to
Dr. Moe’s criticisms. By Order dated June 16, 2006, Prothonotary Tabib declined
to grant Pfizer leave to file Dr. Husain’s reply affidavit. Pfizer presently
brings a motion requesting that the Court set aside the Prothonotary’s Order
and grant it leave to file the reply affidavit.
II. The Prothonotary’s Decision
[3]
The
Prothonotary’s reasons for declining to grant Pfizer leave to file its reply
affidavit are as follows:
In my view, the decision of this Court in Abbott
Laboratories et al. v. Minister of Health et al., (2003) 29 C.P.R. (4th)
450; 2003, FC 1512, merely confirms that the jurisprudential criteria for the
application of Rule 312 of the Federal Courts Rules also apply to a
motion to strike evidence filed in sur-reply pursuant to an order of the Court.
It does not affect the binding and authoritative nature of the Court of
Appeal’s decision in Atlantic Engraving Ltd. v. Lapointe Rosenstein, (2002)
23 C.P.R. (4th) 5; 2002 FCA 503, which adds to the traditional three
part test the requirement that the evidence sought to be adduced not have been
available or not having been capable of being brought as part of the
Applicant’s case in chief.
I agree with the Applicant that the issues upon which it
seeks to bring reply evidence are critical, and even central, to the issues in
this proceeding. That, however, does not in and of itself suffice to satisfy the
application criteria of Rule 312. Indeed, the critical nature of the issues
underscores the fact that the evidence was available and known to be relevant
at the time the Applicant filed its initial affidavits. The proposed reply
affidavit merely states the basis upon which Dr. Husain disagrees with the
critique leveled by Dr. Moe against his affidavit in chief. It addresses no new
issue raised by Dr. Moe and addresses no issue not already contained in Dr.
Husain’s initial affidavit. Much of the content of the proposed reply affidavit
is argumentative and can likely be brought to light in cross-examination. On
the whole, if such were the kind of reply affidavit contemplated by Rule 312
and its judicial interpretation, then one can expect that for every expert
affidavit filed in an NOC proceeding containing a critique of the Applicant’s
experts, there would be a permissible reply affidavit for the purpose of
refining the argument and rebutting the critique. Such a result would be
contrary to the legislative intent that NOC proceedings should be summary in
nature and proceeded with expeditiously.
In conclusion, I am not satisfied that granting leave to
the Applicant to file the proposed reply affidavit would be in the interests of
justice or would be of assistance to the Court, nor am I satisfied that the
evidence thus proposed to be filed was not available or could not have been
brought as part of the Applicant’s evidence in chief. I should add here that my
decision does not rest on any alleged prejudice to Apotex if the evidence were
allowed. Indeed, I am satisfied that, had leave to file the evidence been
granted, it would not have caused any prejudice to Apotex. I am satisfied that,
in notice of application proceedings, there is no inherent prejudice to a Respondent
in not being the last party to file evidence on any issue.
III. The Applicant’s Submissions
[4]
The
Applicant Pfizer argues that the Prothonotary’s Order is clearly wrong because
the Prothonotary erred by importing a fourth requirement into the three-part
test for granting leave to file reply evidence. Pfizer argues that there is a
three part test for granting leave to file reply evidence in Patented Medicine
(Notice of Compliance) (“PM(NOC)”) proceedings as established by Eli Lilly
and Co. v. Apotex Inc. (1997), 76 C.P.R. (3d) 15 at 20-21 (F.C.T.D.) [“Eli
Lilly”]. The Court has the discretion to grant an Applicant leave to file
reply evidence if the Applicant demonstrates that the evidence it wishes to
file:
a. would serve the interests of
justice;
b. would assist the Court in
making its final determination;
c. would not cause substantial or
serious prejudice to the respondents.
[5]
The
Applicant argues that the three part test has been confirmed in Abbott
Laboratories v. Canada (Minister of Health) (2003), 29 C.P.R. (4th) 450 [“Abbott
Laboratories”], as well as in AstraZeneca AB v. Apotex Inc. (2004), 36 C.P.R. (4th) 48 at para. 25;
2004 FC 1207 [“AstraZeneca”], and in Bayer AG v. Canada (Minister of Health and
Welfare)
(1994), 58 C.P.R. (3d) 377 at 380.
[6]
Pfizer
contends that the Prothonotary erred by importing a fourth requirement into the
test for granting leave to file reply evidence. This fourth requirement,
referred to by Pfizer as the “available in chief” requirement, examines whether
the evidence sought to be filed in reply was available at an earlier date.
Pfizer submits that the Prothonotary erred by importing the “available in
chief” requirement from Atlantic Engraving into the test to grant leave
to file reply evidence in PM(NOC) proceedings. Pfizer notes that the “available
in chief” requirement in Atlantic Engraving applied when a party sought
leave to file reply evidence after cross-examinations had already occurred. In
contrast, cross-examinations have not taken place in the present matter.
Moreover, Atlantic Engraving was a trade-marks appeal, while the present
matter is part of a PM(NOC) proceeding. Pfizer argues that PM(NOC) proceedings
are unique, and that the issues are often only made clear to the applicant
after the respondent has filed its evidence. Pfizer suggests that the Court has
therefore adopted a more permissive approach to allowing reply evidence in
PM(NOC) proceedings, and cites Abbott Laboratories in support of this
claim.
[7]
Pfizer
argues that since the Prothonotary clearly erred in law, the Motions Judge
should hear the matter de novo: Canada v. Aqua-Gem Investments Ltd., [1993]
2 F.C. 425 at 454 (C.A.) [“Aqua-Gem”]; Merck
&Co., Inc. v. Apotex, [2004] 2 F.C.R. 459 at para. 19, 2003 FCA 488 [“Merck”].
Since Apotex did not allege any prejudice at the hearing, Pfizer submits that
the only two remaining issues are whether the proposed evidence is in the
interests of justice and whether it would assist the Court.
[8]
The
Applicant argues that Dr. Husain’s affidavit will service the interests of
justice as granting Pfizer leave to file reply evidence will ensure that both
parties have had fair opportunities to adduce affidavit evidence on the issues
and to respond to issues raised by the other party. Pfizer also claims that
counsel must have the appropriate tools to present their case on behalf of
their client. Pfizer suggests that Dr. Husain’s reply evidence serves the
interest of justice as his reply affidavit will respond to Apotex’s evidence on
substantive issues.
[9]
Pfizer
equally maintains that Dr. Husain’s reply evidence will assist the Court, as it
will assist the Court in making its final determination. The Applicant claims
that it should be permitted to explain and respond to Apotex’s evidence to
ensure that all facts are properly before the Court, and to ensure that the
Court has received a complete, balanced view of the evidence.
[10]
Finally,
while Prothonotary Tabib suggested in her reasons that Pfizer will likely be
able to respond to Dr. Moe’s affidavit in cross-examination, Pfizer argues that
the Court has recognized that cross-examination “is no substitute” for written
reply evidence: AstraZeneca, above, at paragraph 31. Pfizer therefore
submits that on hearing the matter de novo, the Motions Judge should
grant it leave to file Dr. Husain’s reply affidavit.
IV. The Respondent’s Submissions
[11]
Apotex
argues that Prothonotary Tabib was not clearly wrong in deciding to reject the
filing of Dr. Husain’s affidavit, and did not err in law in reaching her
decision. The Respondent claims that reply evidence is not permitted in the
ordinary course, and that it constitutes extraordinary relief that can only be
obtained through leave of the Court. Apotex submits that a party wishing to
file a supplemental affidavit must demonstrate that the material is necessary,
that it was not available at an earlier date, that the evidence could not have
been included in its initial affidavit, and that its inclusion will not delay
the proceeding. It claims that the Court will not grant leave to file a supplemental
affidavit where the subject matter of the affidavit has been or could have been
included in the Applicant’s initial affidavit evidence. In support of this
argument, Apotex relies on Wayzhushk Onigum Nation v. Kakeway (2000),
182 F.T.R. 100 at 101 (F.C.T.D.); Deigan v. Canada (A.G.) (1999), 165
F.T.R. 121 at 123 (F.C.T.D.); and Wright v. Mission Institution (1998),
159 F.T.R. 104 at 105-106 (F.C.T.D.). According to Apotex, Applicant needs to
satisfy the three criteria of the Eli Lilly test once the above criteria
have been met.
[12]
Apotex
submits that Atlantic Engraving did not change the three-part test
applicable to motions under Rule 312. In its view, the Federal Court of Appeal
provided guidance with respect to what factors should be considered when determining
whether the material would serve the “interests of justice”. Apotex suggests
that the Federal Court of Appeal directed lower courts to consider whether the
evidence to be filed was available earlier, and cautioned against filing that
would allow a party to split its case.
[13]
Apotex
argues that Pfizer has failed to distinguish Atlantic Engraving. The
Respondent argues that there is nothing in Atlantic Engraving suggesting
that it should not apply when considering whether to allow the filing of reply
evidence in PM(NOC) proceedings. Although cross-examinations have not started
in the present matter, Apotex argues that the Prothonotary still found that the
evidence was available to Pfizer at an earlier time, and that the interests of
justice would not be served by allowing the evidence to be filed at this stage.
According to Apotex, the Prothonotary did not err by importing a fourth factor
into the three-part test for reply evidence. Rather, she considered the test in
light of the Federal Court of Appeal’s decision in Atlantic Engraving.
[14]
Apotex
submits that the Motions Judge does not need to hear the matter de novo.
It also argues that Pfizer has failed to support its bald assertions that it
has met the three-part test for reply evidence.
V. Standard of Review
[15]
It is
trite law that discretionary Orders of a Prothonotary cannot be disturbed by a
motions judge unless:
a. the question(s) raised in the
motion are vital to the final issue of the case;
b. the orders are clearly wrong,
in the sense that the exercise of discretion by the prothonotary was based upon
a wrong principle or a misapprehension of the facts (Aqua-Gem, above; Merck,
above).
[16]
The
Applicant did not argue that the order under appeal addresses questions that
are vital to the final issue of the case. Although the Prothonotary stated that
certain issues raised in the proposed affidavit of Dr. Husain raise issues that
are critical to the proceedings, it has not been argued that the Applicant’s
ability to raise the issues by way of a reply affidavit is vital to the final
issue of the case. The onus therefore remains on the Applicant to establish
that the Prothonotary’s Order was clearly wrong.
VI. Analysis
[17]
Pfizer
asserts that the Prothonotary’s decision is clearly wrong since the
Prothonotary erroneously imported and applied a fourth component into the test
for determining whether to grant leave to file reply evidence. The Federal
Court appears to be somewhat divided on the question of whether there is a
fourth “availability” component to the test for leave to file reply evidence.
In the case of Abbott Laboratories, above, which Prothonotary Tabib
attempts to distinguish in the reasons of her impugned Order, Justice Heneghan
suggests that the test for leave to file reply evidence is made up of three factors,
as identified by Eli Lilly, above. In contrast, Justice Beaudry recently
held that when the four factors found in Atlantic Engraving are met, the
Court may allow the filing of additional evidence: Purdue Pharma v.
Novopharm [2006] F.C.J. No. 497, 2006 FC 385 at para. 13 [“Purdue”].
Prothonotary Tabib has similarly stated in the reasons for her Order presently
under appeal that Atlantic Engraving adds a requirement to consider
“availability” in addition to the traditional three part test articulated in Eli
Lilly. In the recent decision in Pfizer Canada Inc. v. Canada (Minister
of Health) 2006 FC 790, Justice Lemieux upheld a Prothonotary’s
decision to grant an applicant leave to serve and file a reply affidavit, and
referred to both Eli Lilly and Atlantic Engraving. However,
Justice Lemieux decided to uphold a Prothonotary’s Order to grant leave to file
reply evidence on the basis of the difference between reply affidavits and
supplementary affidavits, and did not conclusively determine whether there are
three or four parts to the test to grant leave to file reply evidence.
[18]
The
confusion as to the test to grant leave to file reply evidence arises out of
attempts to determine the reach of paragraphs 8 and 9 of the Federal Court of
Appeal’s Atlantic Engraving decision. I reproduce the paragraphs below:
¶ 8 Pursuant to rule 306
of the Federal Court Rules, 1998, an applicant has thirty days from the filing
of its notice of application to file its supporting affidavits and exhibits
(appeals under section 56 of the Trade-marks Act fall within Part 5 of the
Rules entitled "Applications" (rules 300 to 334) and therefore must
be commenced by way of a notice of application). By exception, rule 312 allows
a party, with leave of the Court, to file additional affidavits. Under
that rule, the Court may allow the filing of additional affidavits if the
following requirements are met:
i) The
evidence to be adduced will serve the interests of justice;
ii) The
evidence will assist the Court;
iii) The
evidence will not cause substantial or serious prejudice to the other side (see
Eli Lilly and Co. v. Apotex Inc. (1997), 76 C.P.R. (3d) 15 (T.D.); Robert
Mondavi Winery v. Spagnol’s Wine & Beer Making Supplies Ltd. (2001), 10
C.P.R. (4th) 331 (T.D.)).
¶ 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 (see Salton Appliances (1985) Corp. v. Salton
Inc. (2000), 181 F.T.R. 146, 4 C.P.R. (4th) 491 (T.D.); Inverhuron &
District Ratepayers Assn. v. Canada (Min. of Environment) (2000), 180 F.T.R. 314
(T.D.)).
[19]
Pfizer
suggests that the Federal Court of Appeal’s comments in paragraph 9 of Atlantic
Engraving do not apply to PM(NOC) proceedings. There is nothing on the face
of the Federal Court of Appeal’s decision suggesting that its reasons should not
apply with equal force to the PM(NOC) proceedings. Although Atlantic
Engraving was a trade-marks case, in my view the Federal Court of Appeal’s
comments with respect to the rules governing the filing of additional affidavit
apply to all motions brought under Rule 312.
[20]
Pfizer
also attempts to limit the reach of Atlantic Engraving by suggesting
that it only applies to situations where cross-examination has already taken
place. Although cross-examinations already occurred in Atlantic Engraving, the
Federal Court of Appeal’s reasoning in paragraph 9 of its decision suggests
that a party must put its best case forward at the first opportunity and must
not be able to split its case. While this meant that in Atlantic Engraving
a party had to demonstrate that the evidence it sought to adduce was not
available prior to the cross-examination stage, in other cases, a party seeking
to adduce evidence may need to show that its evidence was not available at some
other earlier date (such as at the time of filing its first affidavit
evidence), in order to satisfy the Court that it is not attempting to split its
case or is otherwise failing to put its best case forward at the first
opportunity. I do not read the Federal Court of Appeal’s reasoning as being
limited to cases where cross-examination has already taken place. Rather, I
extract from Atlantic Engraving the general concern that Rule 312 should
not be used to allow a party to split its case or to delay putting its best
case forward.
[21]
In sum, I
believe that the Federal Court of Appeal’s decision of Atlantic Engraving dictates
that the availability of evidence is an additional factor that must be
considered as part of the test for granting leave to file additional affidavit
material. While Pfizer submits that such a factor does not apply to PM(NOC)
proceedings, in my view the availability of evidence plays an important role in
safeguarding the legislative intent, which Prothonotary Tabib accurately
described as being “that NOC proceedings should be summary in nature and
proceeded with expeditiously”.
[22]
I
therefore agree with Justice Beaudry in Purdue, above, that there are
four factors to consider before leave to file additional material can be
granted pursuant to Rule 312:
[12]
Rule 312 of the Federal
Courts Rules, SOR/98-106 gives the Court a discretionary power to allow
parties to file supplementary evidence. In Mazhero v. Canada (Industrial
Relations Board), 2002 FCA 295, [2002] F.C.J. No. 1112 (F.C.A.) (QL),
Justice John M. Evans wrote that applications for judicial review were summary
proceedings that should be determined without undue delay, and that the
discretion of the Court to permit the filing of additional material should be
exercised with great circumspection.
[13]
In Atlantic Engraving
Ltd. v. Lapointe Rosenstein, 2002 FCA 503, [2002] F.C.J. No 1782 (F.C.A.)
(QL), Justice Marc Nadon stated that 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.
[emphasis removed]
[23]
It follows
that the Prothonotary correctly described the test for granting leave to file
reply evidence, and her Order was therefore not clearly wrong on this basis.
[24]
In short,
in my view the Prothonotary did not misconstrue the test for granting leave to
file additional evidence pursuant to Rule 312 of the Federal Courts Rules,
nor did she err in her application of the test.
ORDER
THIS COURT ORDERS that the motion is denied with
costs.
“Max
M. Teitelbaum”
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-1232-05
STYLE OF CAUSE: Pfizer
Canada Inc. v. The Minister of Health and Apotex Inc. and Sanofi-Aventis
Deutschland GmbH
PLACE OF
HEARING: OTTAWA, Ontario
DATE OF
HEARING: July
27, 2006
REASONS FOR ORDER: TEITELBAUM J.
DATED: August
17, 2006
APPEARANCES:
A. Bernstein
A. Houweling
|
FOR THE APPLICANT
|
A. Brodkin
D. Lederman
|
FOR THE RESPONDENTS
|
SOLICITORS
OF RECORD:
TORYS LLP
Barristers and
Solicitors
|
FOR THE APPLICANT
|
GOODMANS LLP
Barristers and
Solicitors
|
FOR THE RESPONDENTS
|