Date: 20070614
Docket: T-1836-06
Citation: 2007FC637
Ottawa, Ontario, Thursday, this 14th
day of June 2007
PRESENT: MADAM PROTHONOTARY MIREILLE TABIB
BETWEEN:
ALTANA PHARMA INC. and
ALTANA PHARMA AG
Applicants
- and -
NOVOPHARM LIMITED and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
In
this Application for a prohibition order pursuant to section 6(1) of the Patented
Medicines (Notice of Compliance) Regulations (the “Regulations”),
the Applicants have filed affidavit evidence from 13 expert witnesses. They did
not seek or obtain leave pursuant to section 7 of the Canada Evidence Act (the
“Act”), R.S.C. 1985, c. C-5 prior to filing these affidavits. The Respondent
Novopharm Limited moves for an order that the Applicants comply with the limits
set out in the section 7 of that Act. Although the Applicants deny being in
breach of section 7, they move, by cross-motion, for leave to file all the
expert evidence tendered if it is found that leave is required.
THE APPLICATION
[2]
This
Application was brought by the Applicants is in response to Novopharm’s Notice
of Allegation in respect of its proposed pantoprazole sodium tablets, wherein
Novopharm addresses Canadian Patents 2,089,748 (the “748 Patent”) and 2,092,694
(the “694 Patent”), and alleges that both patents are invalid, but that in any
event, neither would be infringed if an NOC were issued for Novopharm’s
proposed tablets.
[3]
Pantoprazole
is used in treating gastrointestinal disorders and ulcers, and its use as a
proton pump inhibitor to reduce gastric acid secretion is not protected by
current patents. Use of pantoprazole in the treatment of Helicobacter pylori
infections, which is known to cause the majority of such gastrointestinal
disorders, is however protected by the patents at issue. In very general terms,
the 748 Patent claims the use of pantoprazole in combination with
anti-microbial agents (also referred to as combination therapy) while the 694
patent claims a formulation of pantoprazole that is not resistant to gastric
juices, and the use of pantoprazole without other anti-microbials for the
treatment of H. pylori (also referred to as monotherapy). With respect
to non-infringement, Novopharm alleges that it will not suggest, represent,
induce or procure the use of its pantoprazole product for the treatment of H.
pylori, either in monotherapy or combination therapy, and that its tablets
will be enterically coated, that is, resistant to gastric juices.
SECTION 7 OF THE CANADA EVIDENCE ACT
[4]
Section
7 of the Act reads as follows:
|
7. Where, in any trial or other
proceeding, criminal or civil, it is intended by the prosecution or the
defence, or by any party, to examine as witnesses professional or other
experts entitled according to the law or practice to give opinion evidence,
not more than five of such witnesses may be called on either side without the
leave of the court or judge or person presiding.
|
7.
Lorsque,
dans un procès ou autre procédure pénale ou civile, le poursuivant ou la
défense, ou toute autre partie, se propose d’interroger comme témoins des
experts professionnels ou autres autorisés par la loi ou la pratique à rendre
des témoignages d’opinion, il ne peut être appelé plus de cinq de ces témoins
de chaque côté sans la permission du tribunal, du juge ou de la personne qui
préside.
|
[5]
The
Respondent urges that the correct construction of section 7 is to limit each
party to five expert witnesses, regardless of the number of issues requiring
expert evidence. Although I agree with the Respondent’s argument, this Court
has made it clear that previous decisions of this Court have indeed determined
that the limits imposed by section 7 are applicable to the issues in the case
rather than to the case as a whole, and that there is no basis upon which a Prothonotary
could distinguish these decisions (see: Merck & Co. v. Canada (Minister
of Health), 2003 FC 1511). I am therefore clearly bound to interpret
section 7 as applicable to issues in the case, and the Respondent will have to
take its argument on that matter to a Judge of this Court or to the Court of
Appeal.
[6]
As
a subsidiary argument, the Respondent submits that the Applicants have even
exceeded the limit of five experts per issue and that the Applicants must be
restricted to the affidavits of five of the 11 experts they have called on the
issue of infringement.
OUGHT THE MATTER TO BE
DEFERRED TO THE APPLICATION JUDGE?
[7]
The
Applicants submit that the matter of the admissibility of its expert affidavits
should be deferred to the application Judge. It is well recognized that motions
to strike or remove affidavit evidence in an application ought to be left to
the determination of the Judge hearing the application except in clear and
obvious cases or where deferring the determination would cause prejudice to the
other party. The Applicants cite the general principles applied by this Court
to motions to strike evidence in applications, and specifically rely on the
decision of Mr. Justice Pinard in GlaxoSmithKline Inc. v. Apotex Inc.,
T-876-02, September 4, 2003, where he so exercised his discretion on a similar
motion.
[8]
It
should be noted that the GlaxoSmithKline decision is unreported. In this
electronic age, every judgement or order accompanied by formal reasons becomes
a reported decision. Only “endorsed” or “speaking” orders, such as GlaxoSmithKline,
end up being unreported. As such orders are not ordinarily reported, they are
also not generally meant to have precedential value; they are addressed
primarily to the parties and the appropriate appellate Court, who will be fully
appraised of the procedural history and circumstances of the case and of the
arguments made and raised by the parties. Thus, the “reasons” of the Court are
usually stated in their bare essence, stripped of most context and of the
majority of the facts and arguments considered, even if relevant, leaving only
the most decisive elements of the case.
[9]
The
Court in GlaxoSmithKline applied the general principles cited above to
the circumstances of the case, and did indeed defer determination of the
Applicant’s motion to strike the Respondent’s evidence to the application
Judge:
“Here, such determinations are so difficult
to make that the Applicants themselves do not specify which affidavits or parts
of affidavits must be struck. In the circumstances, the determination
ought to be left to the judge hearing the main application (…)
[…]
In any event, it is not clear and
obvious to me that the evidence served and filed by the Respondent Apotex
Inc. comprises, with respect to any single issue, more than five expert
affidavits”
(Emphasis mine)
[10]
That
is all we know of the case. The number of issues involved, or even the number
of expert affidavits tendered by either side is not discussed. Whether any
party urged that prejudice might be suffered if the matter was deferred to the
merits is not mentioned.
[11]
Each
case must be determined on its own facts, and it is a matter of discretion
whether to determine the issue or defer it to the application Judge, having
regard to whether the matter is clear and whether prejudice will be caused to
the other party by deferring the matter to the main hearing. It also bears
repeating that proceedings under the Regulations are intended to be
dealt with in a summary manner and determined expeditiously; in exercising this
discretion, regard must be had as to whether an immediate determination would
tend to further or to frustrate this intention.
[12]
In
the present instance, I have of course considered whether the issue is clear
and obvious. However, I have also considered that the following factors require
that a determination be made at this time.
[13]
The
Respondent did not unduly delay in bringing this motion. It was announced
within a month of the service of the Applicants’ affidavits and served ten days
later.
[14]
If
Novopharm is correct in its alternative submissions that the Applicants are limited
to five experts on the issue of infringement, then the Applicants are not just
a little over the limits imposed by section 7, but more than twice over it:
instead of the affidavits of five expert witnesses, the Applicants have filed
the affidavits of 11 expert witnesses on the infringement issue. If the matter
is left for determination by the hearing Judge, the Respondent will be required
to prepare its case, and file evidence, to meet all of the evidence tendered.
Unless the Respondent’s evidence is prepared in a manner that strictly follows
and responds to each of the Applicants’ affiants independently (a procedural
straightjacket which is, in and of itself, of a prejudicial nature), it is
almost unavoidable that responses to various parts of the evidence the Applicants’
experts will be contained in the same affidavits, binding together potentially
inadmissible and admissible evidence. The intertwining process will most likely
be completed through the cross-examination process and the distillation of the
evidence in memoranda of fact and law. Thus, by the time the issue comes up for
determination by the application Judge, there may simply be no effective relief
available to the Respondent.
[15]
Furthermore,
should the Respondent prepare a response to every affidavit of every expert, it
too will end up with some 11 experts, some of which it may not be able to rely
upon. Alternatively, should the Respondent limit itself to five experts, it
would run the risk that results of the litigation be influenced by the “numerical
count of experts”. No party should be forced to make such gambles where the
issue can be determined on a preliminary motion.
[16]
There
is also the very ideals of a summary process and expeditious determination to
consider, ideals which are increasingly being trampled under the feet of stampedes
of experts.
[17]
Proceedings
under the Regulations are getting ever longer and more unwieldy. It is increasingly
rare for any of these proceedings to be determined within a year of filing; the
norm is 18 months and getting longer and that is a direct result of the growing
number of experts being called by the parties. Every additional expert
increases the amount of time required for the parties to file their respective
evidence. Every additional expert augments the logistical nightmare of
scheduling dates and places for cross-examinations, and lengthens the time
required for conducting cross-examinations. Every additional expert provides
more fodder for motions to strike, motion to file reply or even sur-reply
evidence. Every additional expert adds to the time required for the hearing of
the application, and every additional day of hearing makes the application harder
and longer to schedule. The toll taken by the proliferation of experts on the
Court, and ultimately, on the parties, was recently expressed by Justice
Johanne Gauthier of this Court in Eli Lilly Canada Inc. v. Apotex Inc.,
2007 FC 455:
[5]
However, it is worth mentioning that since the adoption of the Regulations,
it appears that NOC proceedings have become more and more complex. Today, they
can hardly be described as summary. In this instance, the applicant filed 10
affidavits in chief plus nine affidavits in reply, whereas Apotex filed 12
affidavits in chief and 11 more affidavits in sur-reply. The body of some of
these affidavits contain more than 80 pages. A list of the many experts who
supplied evidence along with their stated qualifications is attached as
Appendix A.
[6]
The hearing of the present applications lasted a full seven days
and did not go longer only because the parties agreed to limit their
representations to pointing the way to the most pertinent evidence that the
Court should consider and to outlining the legal and procedural issues to be
determined. There was little time to go through the voluminous books of
authorities submitted by the parties even though they agree that some of the
legal issues relating to “selection patents” are quite new and important.
Indeed, Apotex implies that such patents are to figure in many future NOC
proceedings and that, in the same manner that these patents are sometimes
described as “second generation patents”, one could describe the procedure for
addressing them as “second generation NOC”. Hopefully, we will find a more
efficient way of dealing with these so-called “summary proceedings” given that,
in this case, the need to limit the hearing to seven days meant that the Court
had to review more than 100 cases as well as a very substantial amount of
evidence after the hearing.
[7]
As will become apparent later, a good portion of this evidence
relates to issues which are simply not that relevant to the ultimate decision
to be made. Each side raised numerous objections to the evidence presented by
the other, including objections on the basis of hearsay and failure to put in
evidence facts underlying the experts’ opinions. The objections also include
attacks on the admissibility of certain evidence while both parties challenge
the weight to be attributed to various experts’ opinion.
[8]
This comment by the Supreme Court of Canada in R. v. D.D. (2000
SCC 43, [2000] S.C.J. No. 56 (QL)) is most appropriate and illustrates the need
for reform or, at least, better management of expert evidence in NOC
proceedings:
Finally, expert evidence is time-consuming and expensive. Modern
litigation has introduced a proliferation of expert opinions of questionable
value. The significance of the costs to the parties and the resulting strain
upon judicial resources cannot be overstated. When the door to the admission of
expert evidence is opened too widely, a trial has the tendency to degenerate
into “a contest of experts with the trier of fact acting as referee in deciding
which expert to accept.”
[18]
To
add to the burden of the Court, on the hearing of an application, the task of determining
such esoteric issues as how many issues exist, whether to grant leave after the
fact or to determine which portion of the evidence to strike, and which parts
of the responding affidavits and cross-examinations go with which part of the
evidence, does not bear contemplation.
[19]
For
these reasons, I find that in the circumstances, the issue of whether or not
the Applicants have exceeded the limits imposed by section 7 of the Act ought
to be determined, if reasonably possible, on this preliminary motion.
HOW MANY ISSUES ARE
THERE IN THIS APPLICATION?
[20]
In
order to apply section 7 of the Act as interpreted in Merck v. Canada,
it is essential to first determine how many issues there are and to identify
same. Only then can it be determined whether the number of experts called in
respect of each issue exceeds the permitted number.
[21]
It
is accordingly the first question I addressed to counsel for the parties at the
hearing. Counsel for the Respondent provided a concise and clear answer: there
are but two issues, invalidity of the patents and non-infringement.
[22]
As
for the Applicants, counsel identified 50 issues in this application:
As to the invalidity of the 748 patent: 11
issues;
On the non-infringement of the 748
patent: 12 issues;
On the invalidity of the 694 patent: 11
issues; and
On the non-infringement of the 694
patent: 16 issues.
[23]
I
leave aside invalidity issues: counsel for Novopharm concedes that invalidity
is at least one issue, and the Applicants have only filed evidence from two experts
in that regard (there is a disagreement between the parties as to whether the
affidavit of Dr. Senn-Bifinger is an affidavit of opinion or of fact, but that
is irrelevant: even if it were opinion, it would still add up to less than five
expert witnesses on that issue).
[24]
As
to the non-infringement issues, counsel for the Applicants identified them as
those listed in paragraphs 39 and 41 of their written submissions (see Appendix
I at the end of these reasons).
[25]
A
simple reading of this list of issues illustrates its artificial and contrived
nature. For example, items 39(a) to (d) are word-for-word the same as items
41(c) to (f), while items 39(e) and (f) are essentially the same, even if not
using the exact words, as items 41(h) and (i). All these items, further, are
essentially subsumed in item 39(f).
[26]
I
then asked counsel for the Applicants to identify to which of the 50 issues
identified each of the experts was deposing. The complete list is attached as
Appendix II at the end of these reasons.
[27]
For
the purpose of this discussion, suffice it to say that it turns out that no
expert is testifying at all to issues 39(a) or 41(a) to (c); that nine experts testify
to issues 39(c), (e), (f), 41(e) and (i), but “only” between six and eight as
to issues 39(g), (i), (j), 41 (g) and (h). The only issues to which less than five
experts testify are issues 39(b), 41 (d) and (f) (four experts each, but who had
already opined on most other “issues”), and items 41(k) to (p) (two experts, who
notably were the only two experts whose testimony is entirely independent from
the other so called “issues”).
[28]
Accordingly,
even on the Applicants’ own identification of the issues in this application,
it is plain that the Applicants have run afoul of section 7 of the Act in
respect of nine of their experts. That is itself enough to grant the Respondent’s
motion with respect to nine of the Applicants’ experts, namely, Drs. Corbin,
Elliott, Dresser, Hood, Julien, Wolman, Whittaker and Low, and Mr. MacDonald.
[29]
This
determination, however, does not end the matter, since it leaves for
determination whether the affidavits of Dr. McGinity and Professor Malfertheimer,
also going to non-infringement but focussing on the formulation aspects, are
also on the same “issue” and subject to leave being granted, or are on a
distinct issue.
[30]
As
mentioned above, Novopharm takes the position that all matters relating to
non-infringement are but different aspects of the single issue of infringement.
Although the Applicants’ attempt to identify some fifty infringement issues is obviously
contrived, it is fair to say that if infringement is not a single issue, then there
are at most two infringement issues: the first going to infringement of the use
claims of both patents, and the second going to infringement of the formulation
claims of the 694 Patent.
[31]
Contrary
to the Applicants’ argument that each patent raises distinct infringement
issues, all aspects of infringement of use claims clearly have in common and
center upon whether Novopharm’s product will be sold, promoted or effective for
the purpose of treating H. pylori infections and disorders. That neither
patent raises different or distinct factual issues in relation to use claims is
confirmed by the fact that none of the Applicants’ proposed experts on these
matters distinguish between the two patents in their comments as to how and for
what use Novopharm’s proposed product would be considered and prescribed. Thus,
all evidence relating to infringing use applies interchangeably to both patents
and these matters are, if a distinct “issue” from the infringement of the
formulation claims of the 694 Patent, no more than a single issue.
[32]
If
there is an argument to be made that there are, in this application, two
distinct infringement issues, one going to use, for which nine expert
affidavits have been tendered, and the other to formulation, for which two expert
affidavits have been tendered, the support for this argument rests exclusively
on the distinctiveness of the affidavits themselves: none of the “use” experts
opine on formulation, and none of the “formulation” experts opine on use.
However, the distinctiveness of the opinions is not, in my view, the appropriate
criterion for determining the number of issues in a proceeding or the number of
experts a party may file without leave.
[33]
It
is easy to conceive that the same delineation would occur in expert affidavits
addressing the many grounds of invalidity of a patent. Yet, the Federal Court
of Appeal in Pharmascience Inc. v. Canada (Minister of
Health) et al., 2007 FCA 140, at paragraph 41, has determined that
validity of a patent is a single issue:
“[41] What the NOC Regulations
require the second person to establish is, inter alia, that the patent
is invalid or that it would not be infringed. In other words, the “issue” to be
addressed is invalidity or non-infringement. The specific grounds on which the
second person wishes to demonstrate invalidity, whether that be by obviousness,
anticipation, overbreadth or lack of sound prediction, do not constitute
separate issues for the purpose of issue estoppel but are merely different
bases on which the second person may address the issue of invalidity. Consequently,
multiple NOAs from the same generic relating to a particular pharmaceutical and
alleging invalidity of a particular patent will generally not be permitted,
even if different grounds for establishing invalidity are put forward in each.
As a majority of this Court identified in P&G at paragraph 22, an
exception to the application of this rule might be made in cases where facts
material to the issue could not have been discovered with reasonable diligence
at the time of the first litigation. No such exception applies in the present
case, however. Pharmascience does not deny that it could have raised additional
grounds of invalidity in the first NOA, but merely contends that splitting its
claims is permissible within the scheme of the regulations.”
[34]
In
the very recent judgment of Eli Lilly Canada Inc. v. Novopharm Ltd. et al.,
2007 FC 596, Mr. Justice Hughes of this Court judged that this determination specifically
applied in the context of section 7 of the Act, if interpreted as limiting the
number of experts on a per issue basis:
“[5]
I pause to comment that the Canada Evidence Act,
R.S. 1985, c. C-5, section 7 provides that a party cannot submit the
evidence of more than five expert witnesses without leave of the Court. I
am sure that certain jurisprudence of this Court has lead some to believe that
this means five witnesses per issue. I leave that for another day.
[6]
The Federal Court of Appeal in Pharmascience Inc.
v. Canada (Minister of Health) et al. 2007 FCA
140 at paragraph 41 has told us that validity is a single issue. That is
the only issue before the court in this proceeding.
[7]
I remarked in open Court that the parties should
limit themselves to five experts. This went unheeded largely because it
was in the parties’ mutual interest to do so. It must be pointed out how
difficult it is for a court in NOC proceedings to assimilate masses of
purportedly expert opinions, predominantly on scientific matters, all in
written form, often comprising several volumes. Judges are human, not
computers.”
[35]
I
see no reason why this reasoning should not equally apply to the determination
of the number of issues involved in allegations of non-infringement, such that
the question of whether relevant claims of the patents would be infringed by
the making, constructing, using or selling of the proposed drug would also be a
single issue. After all, just as the determination that invalidity of a patent
is a single issue that can form the basis of issue estoppel, so are allegations
of non-infringement in respect of any specific formulation of a generic drug
(see: AB Hassle et al. v. Apotex Inc. et al. (2005), 38 C.P.R. (4th) 216
(F.C.), aff’d 2006 FCA 51, at paragraphs 73 to 80, and Pharmascience
(above), at paragraph 45).
[36]
In
addition to being consistent with the manner in which “issues” have been
identified in NOC proceedings, the determination that invalidity and
non-infringement are each a single issue for the purpose of section 7 of the
Act is also consistent with the purpose and intent of section 7 of the Act and addresses
the necessity for better and more efficient management of NOC proceedings as
the summary proceedings they are meant to be.
[37]
The
purpose of section 7 is to limit the number of experts that may be called by
the parties to what is considered a reasonable number, beyond which prior
leave of the Court must be obtained by demonstrating that a greater number of
experts is necessary for the determination of the issues, that there are no
unnecessary duplications in the evidence, and that the additional strain on the
time and resources of the Court and the parties is justified (see: Gorman v.
Powell, [2006] O.J. No. 4233 (S.C.J.), Burgess v. Wu, [2005] O.J.
No. 929 (S.C.J.) and Sopinka, John et al., The Law of Evidence in Canada, 2nd
ed., 1999, at pp. 664-666).
[38]
In
order for this purpose to be achieved, the circumstances in which a party’s
obligation to seek leave arises must be clear and easily ascertainable.
Otherwise, a party may, as was the case here and in too many NOC proceedings,
simply dump any number of expert affidavits into the record, leaving the onus
on the Respondent to first discern how many issues might be involved, how clear
the delineation is, and then determine whether it is worth it – both in terms
of delay and of its own interest in calling a large number of experts – to
mount a challenge. As the Court has found, to its dismay, in cases such as
Eli Lilly v. Novopharm (above) and Eli Lilly v. Apotex (above), the parties,
for a number of reasons, will not always do so. Uncertainty of application
cannot but be a significant barrier to the parties’ exercise of self- or mutual
restraint.
[39]
It
is also to be said that even if infringement and invalidity are considered to
be distinct issues, the parties will, in most NOCs, still have the absolute right
to introduce as many as 10 expert witnesses each: the same number that prompted
by the Court’s comments as to the excessive number of expert opinions of
questionable value in Eli Lilly v. Apotex (see list of experts in
Appendix “A” to that judgement).
[40]
I
therefore find that non-infringement is a single issue in this application,
which issue includes non-infringement of all claims of both patents (as
discussed above, Novopharm’s allegations of non-infringement of the 694 Patent
includes both formulation claims and claims for the use of the medicine, and the
latter involves the same arguments and evidence as for the 748 Patent).
[41]
The
Applicants have filed the affidavits of 11 experts in respect of the infringement
issue in this application, and six of them are therefore clearly inadmissible
without leave.
THE APPLICANTS’ MOTION
FOR LEAVE
[42]
The
parties have not brought to my attention any case from this Court in which the
factors to be considered in determining whether leave should be granted to
exceed the number of permitted experts have been discussed. A number of cases
from the Ontario Courts have been cited by the Respondent, more particularly, Burgess
v. Wu (above), where a list of eight factors was established. Most of these
factors, however, are either not ascertainable in the circumstances of this
case, influenced by the more restrictive interpretation given to section 12 of
the Ontario Evidence Act (five experts per side, for the case as a
whole), or of less relevance in proceedings under the Regulations than
in the context of a trial.
[43]
The
parties, however, seem to agree that the paramount consideration is whether the
proposed expert testimony is reasonably necessary to determine the issues in the
case. The amount of duplication in the proposed opinions, and the number of
distinct subjects involved, sometimes listed as separate factors, really are
elements from which that necessity can be ascertained. I would add, as an
important factor to be taken into consideration, the nature of the proceedings
for which the evidence is to be called. As mentioned, NOC proceedings are
intended to be summary in nature and expeditious. They do not finally determine
the issues of validity and infringement between the parties. The “necessity” of
presenting a full and complete evidentiary case on all aspects of all issues
must be viewed from this perspective. An Applicant will succeed on such an application
if it shows that any one of the Respondent’s allegation of non-infringement is
not justified; it is not required to address or to succeed on every allegation
of non-infringement.
[44]
The
Applicants’ motion seeks leave to rely upon the expert affidavits of all
thirteen experts they have filed in this application, including those of Drs
Fennerty and Marshall, opining on
validity, without mentioning which five affidavits they would call as of a
right for each issue and which affidavits are intended to be supplementary. The
Applicants provided no “middle ground” position in the event the Court
concluded that 11 infringement expert opinions was an excessive number; they
did not provide the Court with an indication of which affidavits would form the
core of their case if limited to five, how such limitation would affect their
case or how whatever gaps in their case could reasonably be remedied with the
addition of a more restricted number of experts than the full complement of 11 experts.
[45]
The
affidavits of Drs McGinity and Malfertheimer relate exclusively to the
formulation aspects of infringement, and the Respondent does not appear to take
issue with their necessity or usefulness. I am satisfied that they are
necessary and not duplicative of each other.
[46]
I
am also satisfied that in putting their case forward on infringement of use
claims, the Applicants probably need to rely on evidence from the point of view
of both the prescribing physicians and the pharmacists who will dispense the
medication. The Respondent’s submissions appear to accept this as well.
[47]
I
do not, however, accept the Applicants’ argument that the point of view of
prescribing physicians cannot be adequately presented without presenting the
evidence of physicians from a variety of provinces (namely, Ontario and British
Columbia) and from a variety of specialities (namely, gastroenterologists and
infectious disease specialists), in addition to survey evidence covering 410
physicians in Ontario and Quebec and representing both general practitioners
and specialists. To that effect, the Applicants have filed the affidavits of Dr.
Corbin (survey), Dr. Wolman (Ontario Gastroenterologist), Dr. Whittaker (B.C.
Gastroenterologist) and Dr. Low (Ontario Infectious Disease). The evidence of
these four experts is needlessly duplicative. Further, the evidence submitted
by the Applicants to support their position that their case would not be
complete without the opinions of all relevant specialists from all provinces is
unconvincing. If Dr. Wolman’s evidence to that effect is accepted, the
Applicants’ evidence as constituted is already inadequate as it fails to
include direct opinions from any physician in all provinces other than BC and
Ontario, of any infectious disease specialist in all jurisdictions other than Ontario or of any
general practitioner at all. Furthermore, the issue, as concerns infringement,
is simply whether the Respondent’s allegation of non-infringement is justified.
Inducement or procurement with respect to one class of physicians in one
province, if established, is all that is needed to overcome the Applicants’ burden
on that issue. The Applicants’ case can be sufficiently presented with the
evidence of one physician and one survey expert.
[48]
The
same comments are applicable to the Applicants’ affidavits from pharmacists.
The Applicants’ evidence in that respect comprises the Affidavit of Dr. Corbin
(survey), Dr. Elliott (Ontario community), Dr. Dresser
(Ontario hospital), Dr. Hood (BC community), Dr. Julian (Quebec community)
and Mr. MacDonald (formulary listings). I do not accept that the Applicants
reasonably need to present evidence from pharmacists in three provinces
(Ontario, Quebec and British Columbia) and in two types of environment
(community and hospital), as well as survey evidence of 701 community
pharmacists in Ontario and Quebec. Dr. Elliott’s affidavit in support of the
Applicants’ motion for leave is as unconvincing as Dr. Wolman’s.
[49]
Thus,
the Applicants’ case with respect to pharmacists’ point of view can be sufficiently
presented with the affidavit of one pharmacist and one survey expert.
[50]
This
leaves the formulary listings aspect. The Applicants have filed the affidavit
of Mr. MacDonald, who is not a pharmacist, to provide evidence as to
formulary listings across Canada. The Applicants’ representations and
evidence as to why a formulary expert is needed in addition to pharmacists’
evidence is to the effect that:
“While physicians and pharmacists are
familiar with formulary issues, from a “user” standpoint, neither a pharmacist nor
a physician would be able to provide expert opinion on formulary lists across
the country”.
(Emphasis mine)
[51]
As
I have determined with respect to pharmacists and physicians, evidence of the
potential for infringement in all provinces is unnecessary in this litigation.
The Applicants did not suggest that an understanding of how formularies are
elaborated is necessary to the presentation of their case, such as would
justify the introduction of Mr. MacDonald’s evidence as a distinct specialty.
The Applicants’ submissions as to the necessity for that evidence were based on
the need to bring evidence as to the formularies as they exist across the
country. Formulary listings for all provinces are not likely to be useful in
the absence of other evidence of physicians or pharmacists’ practices for all
provinces. I also note that two of the pharmacists’ affidavits filed by the
Applicants do discuss formulary listings, confirming that insofar as these are
relevant to the Applicants’ case, there is no need for a specific “formularies
expert” for the Applicants to make their case.
[52]
In
conclusion, the Applicants have not satisfied me that it is reasonably
necessary for them to call more than three expert witnesses to present their case
on infringement of use claims: one physician, one pharmacist and one to present
the results of surveys of physicians and pharmacists. Counting the Applicants’
two experts on formulation issues, the Applicants’ case does not necessarily
require more than five expert witnesses on the infringement issue. Furthermore,
granting leave for additional experts in the circumstances of this case would
not be consistent with the summary nature of these proceedings and the need for
the expeditious determination thereof.
ORDER
THIS COURT
ORDERS THAT:
1.
The
applicants may not rely on the evidence of more than five of the following
expert witnesses whose affidavits have been served to date in this proceeding:
Dr. Corbin, Dr. Dresser, Dr. Elliott, Dr. Hood, Dr. Julien, Dr. Low, Dr.
Malfertheimer, Mr. MacDonald, Dr. McGinity, Dr. Whittaker and Dr. Wolman.
2.
The
Applicants shall advise the Court and the other parties, within 5 days of the
date of this Order, as to which of the three experts’ evidence it shall be
relying upon in this proceeding. All affidavits from the other experts listed
in paragraph 1 of this Order shall be struck.
3.
The
Applicants’ motion is dismissed.
4.
Costs
of both motions to the Respondent Novopharm Limited.
“Mireille Tabib”
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