Date:
20060804
Dockets:
T-156-05
T-787-05
Citation:
2006 FC 953
Ottawa, Ontario, Friday, this 4th
day of August 2006
PRESENT: MADAM PROTHONOTARY MIREILLE
TABIB
BETWEEN:
ELI
LILLY CANADA INC.
Applicant
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
- and -
ELI LILLY AND
COMPANY LIMITED
Respondent/Patentee
REASONS FOR ORDER
[1]
“Be careful what you wish for…”. The motion before me arises out of both parties having wished and
having been granted leave to file reply and sur-reply affidavits without having
first submitted a draft of the proposed affidavits. The result stands as a
cautionary tale for those who would seek leave to file further affidavits,
pursuant to Rule 312 of the Federal Courts Rules, without submitting the
proposed affidavits as part of their motion record.
[2]
The present motion is made in the context of an
application by Eli Lilly Canada Inc. (“Lilly”) for a prohibition order pursuant
to subsection 6(1) of the Patented Medicines (Notice of Compliance)
Regulations, SOR 93-133 (the “Regulations”). By this motion
Lilly seeks to strike a substantial portion of the sur-reply affidavits filed
by Apotex Inc. (“Apotex”) pursuant to an order of this Court. That order, made
on October 24, 2005 upon Lilly’s motion to strike parts of Apotex’s evidence
and for leave to serve reply evidence, granted leave to Lilly to file “proper”
reply evidence in respect of certain specified evidence of Apotex, and further,
granted Apotex leave to file “proper” sur-reply evidence to Lilly’s reply.
[3]
Although Lilly’s motion had identified the
specific paragraphs of Apotex’s evidence which it desired struck or to which it
wished to reply, Lilly had not tendered a draft of the affidavits it proposed
to file in reply, nor, it seems, otherwise specified the scope or precise
nature of the proposed reply. In response, Apotex took the position that if
Lilly were to be permitted to file reply evidence, then it too, should be
granted leave to file sur-reply. Obviously, at that time, Apotex could not
define or circumscribe the issues upon which sur-reply evidence might be needed,
let alone its nature and substance.
[4]
In my opinion, the practice in which both
parties engaged is to be discouraged. Whilst in some cases, the relevance,
necessity and usefulness of additional evidence can appear on the face of the
record, and therefore make it possible for leave to be granted without the
support of the proposed affidavit, it is always far better for the proposed
affidavits to be submitted to the Court on seeking leave. Not only does this
better allow the Court to judge whether the criteria for granting leave have
been met, but as this case demonstrates, it would permit the opposing side to
determine in advance whether sur-reply evidence will be needed, to put before
the Court a focused and precise draft of any proposed sur-reply, and ultimately
would avoid motions to strike reply or sur-reply evidence, along with the significant
waste of time and resources which these increasingly common motions represent.
[5]
As the order of October 24, 2005 shows, the
Court was satisfied that Lilly could not have anticipated Apotex’s evidence or
allegations as adduced or advanced, and granted it leave to file “proper” reply
evidence in respect of specific paragraphs of Apotex’s evidence. Presumably,
in view of the large number of issues and wide scope of the leave granted –
even as limited by reference to specific paragraphs – it was felt by the Court
(and by Lilly whom I understand did not oppose Apotex’s prayer for subsidiary
relief) that there would likely be a need for sur-reply evidence. Again, I
assume that all concerned expected that a motion by Apotex for leave to file
sur-reply affidavits would be avoided if leave to file “proper sur-reply”
evidence were granted in anticipation.
[6]
Pursuant to the order, each party filed nearly
as many affidavits in reply or sur-reply as they had filed in chief; the
additional evidence filed by both parties consists of over 200 pages of
affidavit text only, excluding exhibits. Lilly, having been permitted to reply
to nine affidavits of Apotex, filed nine reply affidavits. While the evidence
contained in these affidavits is generally restricted to what was specifically
permitted by the order of October 24, the strict propriety of some of the
evidence is questionable. There are substantial – and not necessarily
justifiable – reiterations of previous evidence; some witnesses might have
taken the opportunity to enlarge or supplement on prior evidence with little or
tenuous value as “reply”; even if formally permissible, the relevance or
usefulness of some of the evidence tendered is not always readily apparent.
Still, Apotex chose to ignore any possible liberties taken by Lilly and did not
challenge the propriety of any of the evidence tendered. Instead, Apotex filed
11 affidavits in sur-reply.
[7]
Whereas it is arguable that Lilly took liberties
with the authorisation it was given to file reply evidence (a matter I do not
have to determine, as Apotex did not formally object to Lilly’s filing), I find
Apotex’s filings to be a misuse of the privilege granted to it by the order of
October 24, 2005.
[8]
There is something that is inherently
counter-intuitive in the proposition that evidence supposed to be in reply to
something can be more voluminous and lengthy than that to which it purports to
reply. The incongruity is all the greater when one realizes that the scope of
Lilly’s reply was specifically restricted to matters that had been raised for
the first time by Apotex itself and on which Apotex had therefore already had a
say.
[9]
This inherent incongruity is not, however, the
basis upon which I find Apotex’s filings objectionable. The cause is in the
general form and content of the affidavits. Most of Apotex’s sur-reply affidavits,
and more notably, those of Drs. Dordick, Jenike, Nagy, Castagnoli, and Brock,
contain vast swaths of text that, if they refer at all to the evidence to which
they purport to reply, do so in the broadest of terms, such as referring
without discrimination to the affidavits of two or three witnesses, or worse,
in some cases, to “Lilly’s affiants” at large. This leaves the reader at a
loss to understand and identify which of the statements purported to have been
made in the replies are being attacked, where they might be found, and in some
cases, whether they even exist. In the course of the hearing, this has
resulted in several instances of counsel for Apotex leading the Court on a
chase through the evidence in an attempt to pin parts of an affidavit to any
part of Lilly’s reply affidavits. In addition, in many cases, Apotex’s
affiants unnecessarily repeat, quote or restate at length what they have said
in their previous affidavits.
[10]
Good practice would dictate that a party, whose
right to file additional evidence by way of sur-reply is defined solely by the
criteria that it be “proper sur-reply”, would identify with clarity and
precision the exact statements or paragraphs of the reply to which it purports
to sur-reply. To not do so is unfair to the other party and to the Court; Apotex’s
failure in this regard has turned the hearing of this already long and complex
matter into a frustrating game of hide-and-go-seek, and has substantially
increased the time required to hear this matter.
[11]
As a final point to this introduction, I should
mention that the motion before me sought to strike and required the examination
of 168 paragraphs of the sur-reply affidavits of Apotex, that the motion
records comprised of over 800 pages, excluding authorities, that I have spent
over twelve hours of personal preparation time prior to the hearings, have
heard the parties on the merits of the motion (excluding scheduling
conferences) for the equivalent of three full hearing days spread over three
months, and have heard representations from six different counsel. I am
intimately convinced that, had the parties been required to submit their draft
affidavits in order to obtain leave to file them, they would both have been far
more circumspect as to their scope and length, and this wasteful exercise would
not have occurred.
APPLICABLE PRINCIPLES
Should admissibility be deferred to the Application Judge?
[12]
At the outset of the hearing, as in their
respective motion records, the parties’ arguments placed substantial reliance
on some of the principles applicable to preliminary motions to strike affidavit
evidence filed pursuant to Rules 306 and 307, with Apotex urging that the
issues raised by Lilly should properly be left to be determined by the Application
Judge, and Lilly seeking, if that were the case, that the Application Judge be
designated immediately for that purpose.
[13]
The parties’ arguments on that issue fail to
make a critical distinction between a motion to strike evidence filed pursuant
to Rules 306 and 307 and a motion such as that at bar. While both may share
the designation “motion to strike”, the former seeks to attack, on grounds of
admissibility, evidence filed by a party as of a right. In contrast, the
motion before me seeks to strike an affidavit purportedly filed pursuant to a
discretionary order of the Court, not on grounds of admissibility, as the term
is commonly understood, but on the grounds that it does not comply with the
conditions of the order pursuant to which it was filed. The former generally
seeks rulings as to the admissibility of the evidence itself, that is, in terms
of the laws of evidence and of its relevance to the pleadings; as such, the
rationale for deferring these rulings to the Application Judge can clearly be
seen.
[14]
Here, with the exception of Lilly’s argument to
the effect that the evidence is inadmissible as being outside the scope of the
NOA, Lilly’s objections have no basis in relevance or admissibility as such,
but call into issue whether or not Apotex’s sur-reply evidence meets the criteria
for filing additional evidence pursuant to Rule 312 and the terms of the order
of October 24, 2005. Flowing from and being dependant upon a
discretionary interlocutory order pursuant to Rule 312, the determination of
whether the sur-reply evidence conforms with the order of October 24, 2005
and should be allowed to stand on the record is a purely interlocutory and
procedural matter. The Application Judge would be in no better position than
any Judge or Prothonotary at an interlocutory stage to make that
determination. Furthermore, it is obvious that the minutiae involved in
reviewing the sequence of affidavits and determining whether specific
paragraphs constitute “proper reply” would constitute a needless, time
consuming and disruptive distraction to the determination of the merits of the
application. Deferring its determination to the Application Judge would make
as much sense as deferring the determination of a motion to file additional
evidence pursuant to Rule 312 to the merits.
[15]
I have therefore determined that unless an issue
requires a determination of admissibility at law or of relevance, there is no
justification for deferring the determination of Lilly’s motion to strike to
the Application Judge.
What is “proper sur-reply”?
[16]
The next issue to be addressed is that of the
criteria that I should apply to determine whether Apotex’s evidence complies
with the leave granted by the order of October 24, 2005.
[17]
Latching onto the terms of the order of October
24, 2005, to the effect that Apotex was limited to “proper sur-reply”, Lilly
urged the Court to apply the test for admissibility of reply evidence as set
out in Halford v. Seed Hawk Inc., (2003), 24 C.P.R. (4th) 220
at 226; 2003 FCT 141 at paragraph [15]:
[15] “Consequently, I believe
that the following principles govern the admissibilty of reply evidence:
1 - Evidence which is simply
confirmatory of evidence already before the court is not be allowed.
2 - Evidence which is directed to
a matter raised for the first time in cross examination and which ought to
have been part of the plaintiff's case in chief is not be
allowed. Any other new matter relevant to a matter in issue,
and not simply for the purpose of contradicting a defence witness, may be
allowed.
3 - Evidence which is simply a
rebuttal of evidence led as part of the defence case and which could have been
led in chief is not be be admitted.”
[18]
This argument was presented to and dismissed by
Justice Heneghan of this Court in Abbott Laboratories et al. v. Canada
(Minister of Health), (2003), 29 C.P.R. (4th) 450; 2003 FC 1512,
at paragraphs [19] to [21]:
[19] “In my opinion, the strict
test characterizing reply evidence in a trial does not necessarily apply
in respect of proceedings taken under the Regulations. Such proceedings are
dealt with by way of application; see Bayer AG v. Canada
(Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 377
(F.C.T.D.). They are governed by Part 5 of the Rules.”
[20] “Those Rules are silent
about filing reply evidence but Rule 312 provides for the filing of additional
affidavits. The issue was considered in the context of the former Rules of the
Federal Court in Eli Lilly Co. v. Apotex Inc. (1997), 76 C.P.R. (3d) 15
(F.C.T.D.), where the Court identified three factors that will be considered
when a party seeks to file additional affidavit evidence: will the further [page457] evidence serve the interests of
justice, will it assist the Court and will it cause substantial or serious
prejudice to the other parties.”
[21] “Abbott here is attempting
to impose a technical, legalistic meaning on the words “proper proceeding reply
evidence” which is unwarranted. This is an application for judicial review, it
is not a trial and the general rules concerning admissibility of evidence do
not apply. The Prothonotary was adjudicating a motion to introduce further
affidavits and in my opinion, she considered the appropriate factors as
established in the existing jurisprudence.”
(Emphasis mine)
[19]
This being said, I should add that I do not take
the decision in Abbott to mean that the principles set out in Halford
have no application whatsoever in a motion such as the present. Indeed, the Abbott
decision confirms that the criteria for filing additional evidence in an
application, including affidavits “in reply”, remain those set out for Rule 312
and that in determining whether an affidavit filed pursuant to conditional leave
is “proper”, regard must be had to these criteria. The application criteria of
Rule 312, as set out by the Federal Court of Appeal in Lapointe Rosenstein
v. Atlantic Engraving Ltd., (2002) 23 CPR (4th) 5, explicitly and
implicitly echo some of the same principles as are set out in Halford. For
instance, a condition of admissibility of additional evidence is that it must not
have been available prior to cross-examinations, and that a party may not be
allowed to split its case. Furthermore, the disallowance of evidence that is
simply confirmatory, expressed as a specific “rule” in Halford, would
equally be of relevance in considering the other criteria of Rule 312, to the
effect that the evidence must be of assistance to the Court and serve the
interest of justice.
[20]
In my opinion, Abbott merely cautions
against the strict application of the characterization of “proper reply” in Halford
to motions to strike evidence filed pursuant to an order under Rule 312.
In the end, such motions are to be determined in light of the same criteria as
a Rule 312 motion, which may well include consideration of whether the
evidence constitutes “proper reply”. Indeed, the responsive nature of the
evidence was a specific issue upon which Prothonotary Aronovitch’s underlying decision
in Abbott turned and was upheld.
[21]
As matters turned out, in the course of the
hearing before me, Mr. Radomski for Apotex specifically endorsed and agreed
with the principle that the very first criterion to be considered and
determined for every impugned paragraph is whether it is properly responsive to
the reply evidence filed by Lilly. If the impugned paragraph were found not to
be “proper reply”, that is, not properly responsive to Lilly’s reply evidence,
then it should be struck. If, on the other hand, the evidence is found to be
responsive, but its admissibility is still contested by Lilly on the grounds of
case-splitting or that it goes beyond the scope of the NOA, further
consideration of the criteria applicable to supplementary evidence and of the
spirit and intent of the order of October 24, 2005 would be required. Lilly
also agreed with that approach.
[22]
Addressing the responsive nature of the
sur-reply as a first step not only had the advantage of meeting with the
consensus of both parties, but is, in my view, the appropriate approach in the
circumstances.
[23]
Unlike the initial leave to file additional
evidence granted in Abbott, which was made in the context of case
management and specifically contemplated the possibility of a challenge as to
the “propriety and scope” of the reply evidence, the order of October
24, 2005 in this matter does not contemplate a specific mechanism for
controlling the propriety and scope of Apotex’s permitted sur-reply evidence;
it simply grants leave to Apotex to file “proper sur-reply to the Applicant’s
reply evidence”. In my view, the order of October 24 must be taken as having
determined that evidence filed by Apotex in direct sur-reply to the reply of
Lilly would prima facie meet the requirements of Rule 312 and should be
permitted to be filed without further motion. Thus, if the material filed by
Apotex in sur-reply is unresponsive to the reply affidavits filed by Lilly, it
is simply not in compliance with the terms of the leave granted and must be
struck. If, however, it is responsive, then Lilly would have to overcome the
presumption created by the order of October 24 to the effect that the evidence
should be allowed to be filed pursuant to Rule 312, subject to determination of
admissibility on the merits.
The criteria for responsiveness
[24]
As for the criteria by which the responsive
nature of the sur-reply evidence should be judged, I have adopted the
following, as suggested by counsel for Apotex:
·
Evidence should address directly what is in fact
said in the reply evidence.
·
For evidence to be responsive, it must
contradict, qualify or impeach what is stated in the reply evidence.
·
It is not enough that the sur-reply be on the
same subject-matter, related or relevant to the reply evidence.
·
It is not a proper sur-reply to attack the
conclusion reached by one expert in his reply affidavit on the basis of an
argument different from that which forms the basis of the reply affidavit. In
other words, the sur-reply must address, impeach or qualify the specific
analysis or argument made in the reply affidavit, not merely its conclusion.
[25]
In the course of applying these general principles
to the specifically impugned paragraphs, I have further followed the following
approach:
- Where an affidavit expressly purports to reply to a specific
argument, affidavit or paragraph of an affidavit, it must be responsive to
that specific evidence. Counsel may not sift through the component parts
of its and its opponent’s evidence and suggest how the individual
components of its sur-reply might otherwise validly be used to address,
impeach or qualify other aspects of the reply evidence. The evidence
herein consists of complex technical and scientific expert evidence.
Counsel may not invent or supply evidence linking its expert’s testimony
to other parts of the evidence where that link is, prima facie, not
intended by the express words of the affiant.
- While it is not fatal to an affidavit to fail to identify
specifically the statements to which it purports to reply, the Court will
not presume responsiveness merely because it uses the same terminology or
is on the same subject matter as the reply evidence. Affidavits in such a
case must be demonstrated to be in fact responsive, upon a fair reading of
both the impugned affidavit and that to which it appears to respond.
- The statements contained in an affidavit and to which an
affiant purports to reply must be given a fair reading, taking into
account their context and the purpose for which they are made. A sentence
cannot be taken out of context to provide an opportunity to expand on a
subject which is not germane to the argument being made.
[26]
Finally, I will admit to having taken a fairly
strict view of responsiveness. NOC proceedings are meant to be summary in
nature. Additional evidence beyond that contemplated in Rules 306 and 307 is
not filed as of a right, but upon leave; it should not be perceived as a
natural or inevitable part of NOC proceedings and when allowed, should be used
with restraint. Sur-reply evidence should, all the more, be considered an
exceptional step and be limited to essential and vital points. It is not an
exercise in having the last word on all issues. It is not the natural
conclusion of a “new round” of evidence.
[27]
In particular, where the sur-reply evidence introduced
new studies and publications that directly support and bolster the opinions
expressed in Apotex’s original affidavits, and frankly smacked of
case-splitting, I have been particularly vigilant in ensuring that Lilly’s
reply affidavits had indeed fairly invited and justified the introduction of
this new evidence in sur-reply, and that the link between the sur-reply and
reply was clearly made. To do otherwise would, I believe, have been
prejudicial to Lilly and not have been in the interest of justice. Although
Lilly, in crafting its reply evidence, had to expect criticism of its evidence
by way of sur-reply, it was still entitled to assume that Apotex had put
forward its case in full, and that it could critique it on that basis. Where,
on a fair reading of Lilly’s reply, it appears that the experts are critiquing
Apotex’s evidence or its sufficiency as presented, it would be prejudicial, and
would not be of assistance to the Court, to allow Apotex to supplement its case
under the guise of a reply.
[28]
On the other hand, I have let stand passages of
the sur-reply evidence that repeated or reiterated previously given evidence,
even when their responsiveness was tenuous, as I could see no prejudice to
Lilly in so doing.
APPLICATION TO THE FACTS
[29]
In the end, all decisions to strike paragraphs
or parts thereof were arrived at on the sole basis of lack of responsiveness. On
that basis, I struck all or parts of 140 paragraphs, together with some 60
exhibits referred to therein. The remaining paragraphs were found to be
responsive, and thus in compliance with the order of October 24, 2005; Lilly
either did not attempt or did not succeed in persuading me that these
paragraphs should be struck on a preliminary motion on any other ground.
[30]
There being but one ground upon which parts of
Apotex’s sur-reply evidence were struck, it would be excessively long, and of
limited use to review each paragraph individually in these reasons.
Determination was made on a paragraph-by-paragraph basis in the course of the
hearing, and parties advised verbally of the specific reasoning behind each
determination. It may, however be of use to explain by way of a few examples,
of how the principles outlined above applied to the facts and circumstances
herein.
[31]
The issue of an association or causal link
between the use of Olanzapine and diabetes provides several relevant examples
of how I applied the principles set out above to the particular circumstances
of this case.
[32]
Several of Apotex’s experts, in their initial
responding evidence, opined that Olanzapine use was associated with the
development of diabetes, and cited diabetes as a side-effect of Olanzapine.
Lilly’s reply to that issue is contained in the affidavits of Drs. Williams and
Nair.
[33]
Dr. Williams’ affidavit addresses this issue by
drawing a difference between showing an association and proving causation. Dr.
Williams’ affidavit argues that references showing an association do not
necessarily constitute evidence of causation, and explains the basis for his
opinion. To explain the basis for his argument, he refers to a selection of
studies, not referred to by Apotex’s witnesses, which consider the relationship
between the diseases being treated with Olanzapine and diabetes. He admits
these studies are not exhaustive on the subject, and states the basis upon
which he chose to rely on them. He concludes that the references relied upon
by Apotex’s witnesses do not demonstrate a causal link and at most, show a
possible association.
[34]
Dr. Nair essentially does the same exercise, although
his affidavit states specifically that it replies to the original affidavit of
Dr. Dordick, for Apotex, and is quite specific that it relies on the affidavit
and studies cited in Dr. Williams’ affidavit. Indeed it is clear on a fair
reading of Dr. Nair’s affidavit as a whole that the exercise he has
conducted was to analyse the studies relied upon by Dr. Dordick and those cited
by Dr. Williams and to give his opinion as to which set of studies is most
conclusive. His conclusions are, as for Dr. Williams, to the effect that the
studies so analysed do not prove causation.
[35]
It should also here be mentioned that Dr.
DiFonzo has also sworn a reply affidavit on behalf of Lilly in relation to the
diabetes issue. However, Dr. DiFonzo is not tendered as an expert witness:
his qualifications are not set out, and he presents himself as the Associate
V.P. of Regulatory Affairs and Quality Compliance for Lilly. His affidavit
does contain a brief statement of his understanding of whether scientific
studies to date suggest or prove an association between Olanzapine and
diabetes, but the affidavit as a whole is directed essentially to introducing
Lilly’s Canadian product monograph for Zyprexa, offering a risk-benefit
analysis of treatment with Olanzapine and discussing off-label sales of
Zyprexa.
[36]
None of the impugned sur-reply evidence led by
Apotex on the issue of diabetes address the basis and reasoning of Dr.
Williams’ argument as to how causation, as opposed to association, should be
proven and as to the limitations of various types of studies, such as
retrospective studies and studies with small populations, in proving
causation. None address the manner in which Dr. Nair analyses the studies
cited by Dordick and Williams, and how that analysis supports his conclusion.
[37]
Instead, Dr. Brock discusses the history of
diabetes, its correlation with weight gain and hyperglycaemia, and the
association between the use of Olanzapine, weight gain, hyperglycaemia and
diabetes, to conclude that there is indeed an association between Olanzapine
use and diabetes. This affidavit is not responsive to anything contained in
the Williams, Nair or even DiFonzo affidavits, except perhaps to the very broad
conclusions contained therein to the effect that a causal relationship between Olanzapine
use and diabetes has not been established by Apotex. Even so, it is obvious
that these broad conclusions are premised on these experts’ own definition of
“causation”, which Dr. Brock does not address.
[38]
Thus, the evidence is not responsive, on the
criteria agreed to by Apotex’s counsel at the hearing, as it merely disputes
the conclusions of Lilly’s reply affidavits, without addressing, impeaching or
qualifying their specific analysis or the arguments upon which they were made.
[39]
Similarly, Dr. Mayersohn, specifying that he was
replying to Dr. Williams’ affidavit, cites and introduces at paragraphs 11 to
20 eleven new studies and publications which support his conclusion that there
is a “direct connection”, “an association”, a “relationship” between Olanzapine
use and the incidence of diabetes. He does not discuss the distinction made by
Dr. Williams between association and “causation”. He does not address Dr. Williams’
criticism about the limitations of retrospective studies – indeed, on the face
of the affidavit, half of the new studies produced are retrospective studies.
These paragraphs, again, simply attack the conclusion found in a specific
paragraph of Dr. Williams’ affidavit without discussing or expressly taking
into consideration the basis for that conclusion. It is an instance where the
affiant merely introduces additional evidence to support or bolster a
conclusion previously given in chief, the foundation for which was criticized
in reply, without addressing the substance of the criticism. It is not
responsive.
[40]
These paragraphs, as well as several paragraphs
of Dr. Dordick’s sur-reply affidavit addressing new studies showing better or
stronger links or associations between Olanzapine and diabetes were struck as
being unresponsive. However, they also stand as examples of Apotex improperly splitting
its case, since new evidence going to the same conclusions and facts as given
previously is added after Lilly had responded to the evidence as initially
presented. If this sur-reply evidence is allowed to stand when it does not
closely track the reasoning of Lilly’s reply, it then becomes evidence which
Lilly does not have an opportunity to address directly, and is prejudicial. It
also has the potential of leaving the hearing Judge with only one side of a new
argument, which cannot be of assistance to the Court.
[41]
This result is to be contrasted with the
production, by Apotex in sur-reply, of the “Koro” and “Fuller” studies
(Exhibits “B” and “C” of Dr. Dordick’s sur-reply evidence). These studies
appear to have been relied upon, but neither identified nor produced, in Dr.
Dordick’s initial affidavit. Dr. Nair, in reply, criticizes Dr. Dordick for
this failure, but nonetheless makes an assumption as to the identity of the
studies, and then proceeds to make his own analysis of them – yet without
identifying or producing the studies. In sur-reply, Dr. Dordick finally
confirms that Dr. Nair has correctly identified the papers. He then cites,
produces and further comments on them. I agree with Lilly that this is a form
of case-splitting. However, that evidence clearly is responsive to Dr.
Nair’s. Furthermore, the “outing” of the shadow papers cannot prejudice Lilly,
as it had to expect that possibility when it chose to guess at and comment on
the unidentified studies. It is further clearly in the interest of justice
that the Judge on the merits have the actual text of the studies before him or
her, rather than simply each expert’s conflicting views thereon.
[42]
I will provide one final example. In Schedule
“A” of its written representations, Apotex relies on paragraphs 6(d) and 67 of
Dr. Williams’ affidavit as justification for the responsiveness of several
paragraphs of its sur-reply. Paragraphs 6(d) and 67 of the Williams affidavit
contain general statements to the effect that Olanzapine shows substantial
advantages over the other members of the genus described in the ’687 patent.
These statements are, I understand, a summary of conclusions and evidence
already contained in Lilly’s evidence in chief. They are made in the context
of the broader argument that the presence or absence of diabetes was not, in
any event, the basis for the selection of Olanzapine from the genus of the ’687
patent. The statements are, further, bare assertions, without a substantive
discussion. Yet Apotex has tendered evidence expanding on the validity of the
Olanzapine patent as a selection patent, in the guise of a sur-reply to these
statements. Such evidence is not “proper sur-reply”. It may relate to a
specific statement in an affidavit, but cannot be responsive, as a fair reading
of the affidavit in which it is found shows that the statement is not the point
being made, nor is one which forms the effective basis of the argument
developed in the reply. “Responding” to such a statement does not serve to
address, impeach or qualify the specific analysis or argument made.
COSTS
[43]
Lilly originally presented its motion seeking,
as its preliminary relief, the appointment of the hearing Judge for the purpose
of determining the remainder of its motion to strike. After an initial
scheduling telephone conference, Lilly maintained that order of proceeding and
it was decided that the hearing would proceed in two parts, allowing Apotex to
respond to the preliminary relief in a separate record. On the day scheduled
for the hearing of the preliminary part, Lilly resiled from its initial
position and submitted that the main body of the motion to strike should be
heard first, with the appointment of the hearing Judge relegated to a
subsidiary relief in the event the Court decided to defer determination of
admissibility to the hearing Judge. Apotex’s costs of travel and attendance at
a half-day hearing and the preparation of a separate motion record were
therefore thrown away and Apotex shall have its costs therefore. The scale,
however should be the middle of Column III of the Tariff; Lilly’s argument,
while novel, was not unduly complex and the material not voluminous.
[44]
As for the main part of the motion, Lilly was
ultimately successful for over 80% of the impugned paragraphs. It should have
its costs of the motion. I am not however prepared to award costs at a scale
higher than the middle of Column III of the Tariff. Awarding costs on that
scale does compensate Lilly for the length of the hearing since the Tariff takes
into account the number of hours spent. While the evidence was certainly
complex and voluminous due largely to the nature, scope and form of Apotex’s
impugned sur-reply, a conservative scale serves to take into account the
partial success of Lilly’s motion, and the fact that Lilly’s material and
argument missed the essential issue of responsiveness; Lilly’s motion material
was instead based on arguments of reiteration, case-splitting and the scope of
the NOA, which were not retained. Lilly’s choice of argument, and the way in
which its material was consequently structured, resulted in a hearing that was
more disorganized and therefore lengthier than it should have been.
“Mireille Tabib”
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