Date: 20070510
Docket: T-507-05
Citation: 2007
FC 506
Toronto, Ontario, May 10, 2007
PRESENT: The Honourable Mr. Justice Mosley
BETWEEN:
PFIZER
CANADA INC. and WARNER-LAMBERT COMPANY, LLC
Applicants
and
THE
MINISTER OF HEALTH and RANBAXY LABORATORIES LIMITED
Respondents
REASONS FOR ORDER AND ORDER
[1]
This is an
appeal from the order of a prothonotary dated April 12, 2007 declining to grant
leave to Pfizer under Rule 312 to file the additional affidavit of Dr. Allan S.
Myerson, sworn on April 5, 2007, in proceedings under the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133. The underlying application
brought by the applicants arises from allegations set out in a letter to them dated
January 31, 2005 from counsel for Ranbaxy Laboratories Limited (the “Ranbaxy
letter”).
[2]
In
December 2006 Pfizer was granted leave by Prothonotary Milczynski, case management
prothonotary for the application, to amend its notice of application to add
responses to Ranbaxy’s allegations relating to two patents, Canadian Patent
Nos. 2,220,018 (018 Patent) and 2,220,455 (455 Patent). These responses had
originally been included in the notice but were deleted on the basis of
Pfizer’s analysis of information voluntarily produced by Ranbaxy which
indicated that the form of atorvastatin calcium for which Ranbaxy sought a
notice of compliance would not infringe the 018 or 455 patents. In another
proceeding, Ranbaxy made further production of information which, upon
analysis, led Pfizer to conclude that infringement would in fact result leading
to the motion to amend.
[3]
In
addition to granting leave to amend, Prothonotary Milczynski also set aside the
scheduled hearing dates in January, extended the 24 month stay provided under
s.7(1) (e) of the Regulations to October 26, 2007 and established a new
schedule for completing the remaining procedural steps. Under the new schedule,
evidence was to be served and filed by March 23rd and
cross-examinations were to be completed by April 30th. The hearing
on the merits was set to begin June 25, 2007 for a duration of three days.
[4]
In
accordance with the new schedule, on February 5, 2007 Pfizer delivered five
affidavits including one by Dr. Allan S. Myerson of Chicago, Illinois. Ranbaxy delivered affidavits on March
23, 2007 from three witnesses including Dr. Ian M. Cunningham and Dr. Mark D.
Hollingsworth. Dates for cross-examination were agreed to by March 30th;
all within the April 30th timeline fixed by the prothonotary. Dr.
Myerson’s cross examination was scheduled for April 13th in Chicago.
[5]
Dr.
Hollingsworth’s affidavit presents the results of calculations he performed
using some of the results reported by Dr. Myerson in his February affidavit.
Dr. Cunningham’s affidavit includes a discussion of his views on the
interpretation of a phrase which appears in the claims of the 455 Patent.
[6]
On April 5th,
late in the day on the Thursday before the Easter holiday weekend, Pfizer
served and filed a motion returnable in Ottawa on April 12th, seeking leave
pursuant to Rule 312 to file additional evidence from Dr. Myerson responding to
the Hollingsworth and Cunningham affidavits.
[7]
Due to the
length of the motions list in Ottawa on April 12th and the fact that
Dr. Myerson’s cross-examination on his first affidavit was to take place the
following day in Chicago, Prothonotary Milczynski
heard the motion by teleconference from Toronto. She delivered her decision and reasons
the same day. In determining whether leave to file additional evidence under
Rule 312 should be granted, Prothonotary Milczynski held that a four part test
must be considered:
-
whether
the further evidence serves the interests of justice;
-
whether
the further evidence will assist the court;
-
whether
granting the motion will cause substantial or serious prejudice to the other
side; and
-
whether
the evidence was not available and/or could not be anticipated as being
relevant at an earlier date. [emphasis mine]
[8]
Applying
these factors and having reviewed the Myerson reply affidavit, Prothonotary
Milczynski reached several conclusions. First, with respect to the proposed
response to Dr. Hollingsworth’s evidence, she found that the reply affidavit
contains comments that are largely discussion relating to or criticism of the
methodology employed by Dr. Hollingsworth. While these could be of assistance
to the Court which would hear the application, they could also be explored in
the cross-examination of Dr. Hollingsworth. Secondly, regarding the proposed
response to Dr. Cunningham, the learned prothonotary concluded that the reply affidavit
raised nothing new or anything that could not have been anticipated. Further, the
issue of claims construction with respect to the 455 Patent was raised and
contained in the Notice of Allegation.
Issues
[9]
The central issue before me is whether the
Prothonotary erred in dismissing Pfizer’s motion for leave such that this Court
should exercise its discretion on a de novo basis pursuant to the test
set out in Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425
(C.A.) and restated in Merck & Co. v. Apotex Inc., 2003 FCA 488 at para. 19 as
follows:
Discretionary
orders of prothonotaries ought not to be disturbed on appeal to a judge
unless:
a) the questions in the motion
are vital to the final issue of the case, or
b) the orders are clearly wrong,
in the sense that the exercise of discretion by the prothonotary was based upon
a wrong principle or upon a misapprehension of facts.
[10]
There is no suggestion that the questions in the motion are vital
to the final issue of the case. Pfizer submits that the exercise of discretion was
based on wrong principles or a misapprehension of facts in that the learned
prothonotary:
1) erred in law by imposing a requirement of
“forseeability” that had been previously absent in the test for reply
evidence;
2) erred in holding that Dr. Myerson could have
foreseen the evidence of Drs. Hollingsworth and Cunningham given his
uncontested evidence in support of the motion to the contrary; and
3) erred in law by holding that the issue of
“claims construction” addressed in the Cunningham affidavit was
raised and contained in the Ranbaxy letter.
Analysis
The test for reply evidence
[11]
Pfizer
submits that long-standing authority in this Court supports a “permissive”
three part test for the filing of reply evidence based on the following three
factors as originally set out in Eli Lilly and Co. v. Apotex Inc.
(1997), 76 C.P.R. (3d) 15 (F.C.T.D.): interests of justice, assistance to the
court, and prejudice to the respondent. Pfizer does not dispute that it could
have tendered the evidence of Dr. Myerson on the points addressed in the
Hollingsworth and Cunningham affidavits in his affidavit in chief but argues
that there was no reason to do so until the issues raised by their evidence was
presented.
[12]
Pfizer
contends further that the additional requirement applied by the prothonotary,
“whether the evidence was not available and/or could not be anticipated as
being relevant at an earlier date”, was specifically rejected by this court in Abbott
Laboratories v. Canada (Minister of Health) (2003), 29 C.P.R. (4th)
450 at para. 20 [Abbott Laboratories].
[13]
The court
in Abbott Laboratories was dealing with an argument that the
restrictive test for allowing reply evidence at trial, as set out in Halford
v. Seed Hawk Inc., 2003 FCT 141 at para. 15 , should be applied to PM(NOC)
proceedings. Justice Elizabeth Heneghan rejected that approach noting that
these applications are intended to be summary in nature and the prothonotary is
vested with considerable discretionary authority to manage the proceedings.
Justice Heneghan noted that the prothonotary had considered the three factors
identified in Eli Lilly in arriving at her decision to allow the reply
evidence: Abbott Laboratories, above at para. 20.
[14]
There is
clear authority for the addition of a fourth element to the test in the
decision of the Federal Court of Appeal in Atlantic Engraving Ltd. v. LaPointe Rosenstein,
2002 FCA 503 [Atlantic Engraving]. The Court of Appeal cited the Eli
Lilly formula at paragraph 8 but went on to say the following 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.
[Citations omitted] [Emphasis mine]
[15]
All “four” parts of the test
were also set out and utilized by the Federal Court of Appeal in Mazhero v. Canada (Industrial Relations Board), 2002 FCA 295 at paragraph 5. The Court of Appeal cited
a decision in which Prothonotary Hargrave, interpreting the then recently
adopted Rule 312, stated:
The
new Federal Court Rules allow the filing of a supplementary affidavit
and of a supplementary record, however such should only be allowed 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 for such
supplementary material 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 and
supplementary record neither deal with material which could have been made
available at an earlier date, nor unduly delay the proceedings. [emphasis
mine]
(Deigan v. Canada (Industry), [1999] F.C.J.
No. 304 (Proth.)(QL), aff'd. [1999] F.C.J.
No. 645 (T.D.)(QL))
[16]
In challenging the notion of a fourth element to
the additional evidence test under Rule 312, Pfizer advances the same
arguments upon which they were unsuccessful last year in a case heard and decided
by my colleague Justice Max Teitelbaum: Pfizer Canada Inc. v. Canada (Minister of Health), 2006
FC 984. The respondent submits that as Pfizer did not appeal that decision, this
motion represents a “collateral attack” on Justice Teitelbaum’s decision. That
in my view is a mischaracterization of the matter as the proceedings are
distinct. Nonetheless, unless I am persuaded that my colleague’s reasons were
clearly wrong, the principle of judicial comity suggests that I should not
depart from Justice Teitelbaum’s reasoning: Glaxo Group Ltd. v. Canada (Minister of National Health and
Welfare), [1995] F.C.J. No.
1430 (T.D.) (QL); Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1283.
[17]
As in the case before Justice Teitelbaum, Pfizer
argues that Atlantic Engraving should be distinguished on two grounds:
first that the Court should only apply what it calls the “available in chief” requirement
when a party has sought leave to file reply evidence after cross-examinations
have already occurred; and second, the requirement was established in a trade
marks case in the context of Atlantic Engraving and PM(NOC) proceedings
are unique.
[18]
Justice Teitelbaum held, at paragraphs 19-21 of
the 2006 decision, that there is nothing on the face of the Federal Court of
Appeal’s decision in Atlantic Engraving to indicate that it would not
apply to Rule 312 motions in PM(NOC) proceedings. Moreover, Justice Teitelbaum
made it clear that the principle that a party must put its best case forward at
the first opportunity and not split its case was not limited to situations in
which cross-examinations had already taken place. This was in keeping, he concluded,
with the legislative intent that these proceedings should be summary in nature
and proceed expeditiously.
[19]
I agree with Justice Teitelbaum and adopt his
reasons as my own.
Whether
the respondent’s evidence could have been anticipated
[20]
Pfizer submits that the prothonotary proceeded
on a misapprehension of the facts as the uncontradicted evidence before her as
stated by Dr. Myerson in his April 5, 2007 affidavit was that he could not have
anticipated the evidence put forward in the Hollingsworth and Cunningham
affidavits for several reasons. I will address the Cunningham affidavit under
the next issue.
[21]
Dr.
Myerson deposes that he could not have anticipated Dr. Hollingsworth’s
“extensive calculations using one of the unit cells obtained from [his] indexing
results…because my analysis was and remains sufficient to conclude that
Ranbaxy’s samples contain crystalline Form 1 atorvastatin.” Dr. Myerson
proceeds to set out several other reasons why he disagrees with Dr.
Hollingsworth’s evidence, but this statement is really the crux of the matter.
While Prothonotary Milczynski agreed that Dr. Myerson’s evidence could be of
assistance to the Court, she considered that these points could also be
explored in the cross-examination of Dr. Hollingsworth.
[22]
Pfizer
relies on the aphorism that “cross-examination is no substitute for evidence”.
While that may be true in many cases, it doesn’t provide a satisfactory answer
for why Dr. Hollingsworth’s evidence could not have been foreseen. The fact
that Dr. Myerson did not think it necessary to perform the same analysis is
not, in my view, proper reply evidence but evidence to supplement his prior
affidavit.
[23]
Prothonotary Milczynski’s Order states that she
reviewed the affidavit for which leave was being sought. In doing so, she had
the benefit of the knowledge gained from having case managed this file for
several months. The conclusions she reached with respect to the proposed
evidence in reply to the Hollingsworth affidavit were, in my view, reasonably
open to her on the evidence submitted as well as that previously filed. The
applicant has not established that she proceeded on a misapprehension of the
facts and was clearly wrong in this respect.
Was
claims construction a live issue?
[24]
With
respect to Dr. Cunningham’s views on the construction of the phrase “removing
the solvent to afford… amorphous atorvastatin” which appears in the claims of
the 455 Patent, Dr. Myerson deposes that he did not discuss this phrase in his
first affidavit because the Ranbaxy letter did not raise the issue. Dr. Cunningham states that based on his reading of the claims, the 455
Patent is limited to evaporative techniques. Dr. Myerson disputes this as he
says that solvents may be removed by other means such as precipitation and
filtration or drying.
[25]
Prothonotary
Milczynski concluded that the issue of claims construction with respect to the
455 Patent was raised and contained in the Notice of Allegation. Pfizer submits
that she erred in law in so finding as there is no discussion of the phrase in
the Ranbaxy letter or indication that Ranbaxy would be relying upon the fact
that its process allegedly does not involve evaporation.
[26]
Ranbaxy argues
that it is axiomatic that an allegation of non-infringement involves claim construction:
Whirlpool Corp. Camco Inc., [2000] 2 S.C.R. 067, 2000 SCC 67 at
paragraph 43. Accordingly, the respondent submits that it was incumbent upon
Dr. Myerson in his first affidavit to properly construe the claims of the 455
Patent. Further, Ranbaxy contends that the issue is clearly identified in the
portions of the Notice of Allegation that describe the process claims of the
455 Patent.
[27]
It is trite law that the first task of an
applications judge in a patent case, including proceedings under the PM (NOC)
Regulations, is to construe the claims. I do not understand that to mean
however that claims construction is put in issue by a bald assertion of
non-infringement. Adequacy of the Notice of Allegation and the accompanying
detailed statement is a matter of law. The test for adequacy is whether the
detailed statement is sufficient to make the patentee fully aware of the
grounds on which the other party claimed that the relevant patent would not be
infringed if a NOC was issued by the Minister: Novopharm Ltd. v. Pfizer Canada
Inc. et al., 2005 FCA 270 at para. 4. This must include an adequate
description of any claim construction grounds.
[28]
I have read the portions
of the Notice of Allegation to which Ranbaxy drew my attention several times
and I am unable to see how they identify the issue that Dr. Cunningham raised
in his construction of the disputed phrase. Accordingly,
I am satisfied that the learned prothonotary erred in law in holding that the issue of
“claims construction” addressed in the Cunningham affidavit was raised and
contained in the Ranbaxy letter.
[29]
Considering
the matter de novo, I am satisfied that those paragraphs of the Myerson
April 5th affidavit that address the Cunningham claim construction
evidence meet the test for the filing of additional evidence under Rule 312
described above. Reception of the evidence will serve the interests of justice
and will assist the Court in making its final determination, as Prothonotary
Milczynski found. There is no evidence or submissions before me that it will
cause substantial or serious prejudice to the respondent, and with respect to
the fourth requirement, in light of my conclusions in the preceding paragraphs,
the evidence could not have been anticipated as being relevant at an earlier
date.
[30]
I will therefore grant leave to file paragraphs 18
to 25 inclusive of the Myerson affidavit as they relate to the Cunningham
evidence. Paragraphs 2 to 17 inclusive of the affidavit will be struck as they
pertain to the Hollingsworth evidence. While the results were somewhat mixed,
in light of the background to this matter and that Ranbaxy had the greater
success on the appeal, costs of the motion here and below in any event of the
cause are payable to the respondent.
ORDER
THIS COURT ORDERS that:
1.
The
applicant’s appeal from the Order of Prothonotary Milczynski dated April 12,
2007 is granted in part.
2.
Paragraphs 18 to 25 inclusive of the affidavit of Dr. Allan S. Myerson
dated April 5, 2007 may be filed as additional evidence under Rule 312.
3.
Paragraphs
2 to 17 inclusive of Dr. Myerson’s April 5, 2007 affidavit shall be struck
before it is filed.
4.
The costs
of this motion here and below are payable to the respondent in any event of the
cause.
“Richard G. Mosley”
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