Date: 20090911
Docket: T-1636-08
Citation: 2009
FC 902
Toronto, Ontario, September 11, 2009
PRESENT: Kevin R. Aalto, Esquire, Prothonotary
BETWEEN:
ASTRAZENECA CANADA INC.,
ASTRAZENECA AB and
SHIONOGI SEIYAKU KABUSHIKI
KAISHA
Applicants
and
NOVOPHARM LIMITED and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
This
proceeding commenced by the Applicants (“AstraZeneca”) pursuant to the Patented
Medicines (Notice of Compliance) Regulations (the “Regulations”) seeks an
order, inter alia, prohibiting the Minister of Health from issuing a
Notice of Compliance to the Respondent (“Novopharm”) in respect of 5, 10, 20
and 40 mg rosuvastatin calcium tablets until the expiration of Canadian Patents
Nos. 2,072,945 (the ‘945 Patent) and 2,313,783 (the ‘783 Patent).
[2]
This
lengthy and intensely argued motion is the second chapter in an exchange of
motions regarding the conduct of this proceeding. It is a direct result
of a prior order granting a reversal of evidence regarding invalidity on the
motion brought by AstraZeneca. On that motion Novopharm strenuously resisted
reversing the evidence and argued that if such an order was made that Novopharm
be given a right of reply.
[3]
Although
this motion sought other relief including an order striking the Notice of
Application on the ground that it is vague and bereft of any particulars or
grounds in support of the bald assertions made, or alternatively an order
striking certain paragraphs of the affidavits of AstraZeneca’s witnesses, the
matter proceeded almost entirely on the basis of Novopharm’s right to file
reply evidence.
[4]
Before
dealing with the merits of the motion as it relates to the filing of reply
evidence it is helpful to put this motion in context. In its submissions on
the motion for reversal of evidence AstraZeneca made the following submissions:
2. Novopharm bears the evidential
burden on the allegation of invalidity. The proposed reversal of the order of
evidence on the allegation of invalidity will ensure that Novopharm adduces
evidence on an issue before AstraZeneca does. This will streamline the
proceeding by requiring Novopharm to define more specifically what it is
alleging as its grounds of invalidity first. This will avoid the Applicants
speculating and filing evidence in a vacuum and specifically, providing
evidence on every portion of prior art reference and possible point of alleged
invalidity before Novopharm has discharged its evidential burden on every such
issue.
39. Requiring Novopharm to serve
its evidence on alleged invalidity first will streamline the proceeding. It
will focus the dispute. It will reduce the likelihood of interlocutory
motions, including that the Applicants will have to seek to file reply evidence
should Novopharm rely, for example, on an unanticipated portion of one of the
cited references. It will also reduce the number of experts, the volume of
evidence, and minimize the proliferation of secondary issues. Accordingly
reversal of the order of evidence will result in the just, most expeditious and
least expensive determination of the merits without affecting Novopharm’s
substantive rights and maintaining the fairness of Novopharm’s procedural
rights. [emphasis added]
[5]
In
response, Novopharm made this argument:
49. Having regard to the
insufficiency of the Applicants’ Notice of Application and evidence on this
motion, and the likelihood that the Applicants’ will file factual evidence with
respect to the validity of the 945 Patent, the Court should not order a
reversal of evidence in this proceeding. Novopharm should not be put in a
position where it is forced to speculate regarding the evidence that the
Applicants will file on the issues of invalid selection and obviousness. If
required to do so, Novopharm will undoubtedly be forced to seek leave to file reply
evidence. Clearly, this will not result in the just, most expeditious and
least expensive determination of the issues. [emphasis added]
[6]
In
granting the motion to reverse the evidence on invalidity, the Court noted as
follows:
In my view, it is not axiomatic that the
right to file reply evidence be granted where there is a reversal of evidence
on invalidity. However, there will be cases where it is entirely likely that
reply evidence will be required once the innovator has responded to the evidence
of the generic where the filing of evidence is reversed. Based on my review
of the record and on the submissions of the parties, it is my view that this is
likely such a case. (T-1636-08, January 30, 2009) [emphasis added]
[7]
Notwithstanding
the vigorous argument of AstraZeneca that the reversal would result in avoiding
interlocutory motions dealing with reply evidence and lead to the just, most
expeditious and least expensive determination of this proceeding, such is
clearly not the case. Indeed, the reversal of evidence has resulted in
delaying this proceeding, adding another layer of expense (i.e. the
cross-examination of a witness on her affidavit conducted in the United States) in addition to the costs and
time expended on this motion.
[8]
Novopharm
is seeking to file the reply affidavits of three expert witnesses who each
filed affidavits in chief pursuant to the order reversing the evidence on
invalidity. The proposed reply affidavit of Dr. Romero is 24 pages in length
and comprises 66 paragraphs and many diagrams of chemical compounds. The
proposed reply affidavit of Dr. Scallen is 18 pages in length and comprises 36
paragraphs with several charts. Dr. Scallen’s affidavit also attaches as
exhibits five decisions of this Court and the Federal Court of Australia, which
deal with the drug atorvastatin calcium. The proposed reply affidavit of Dr.
Grieco is 15 pages in length and comprises 50 paragraphs.
[9]
Each of
these affidavits is required, so it is argued, because the Notice of
Application is bereft of any relevant facts to permit Novopharm to know the
case it has to meet. There is no information in the Notice of Application as
to why the ‘945 Patent is not a selection patent and no information regarding
rosuvastatin’s special advantage over other statins disclosed in an earlier
genus patent. Further, it is argued that the evidence of two of AstraZeneca’s
experts, Drs. Roush and Bartlett, provide lengthy discussions
as to why the ‘945 Patent is not obvious. That evidence was not known to
Novopharm when it served its evidence. Thus, as none of this evidence was
apparent from the Notice of Application and could not reasonably have been
anticipated, the issues on the application are not “fairly joined” and will not
be “fairly joined” unless Novopharm has a right of reply. Novopharm argues
that it was required to file its evidence, essentially in a vacuum, without
knowledge of AstraZeneca’s position as to:
(a)
why the
‘945 Patent is not a selection patent (or, if is one, why it is a valid
selection);
(b)
the nature
of any alleged special advantage;
(c)
why the
alleged patent is special;
(d)
why the
‘945 Patent is not anticipated by the Fey Application (the Australian patent);
and,
(e)
why the
‘945 Patent is not obvious.
[10]
As
Novopharm served its evidence without knowledge of AstraZeneca’s position on
any of these points, should it now have a right of reply?
[11]
AstraZeneca
argues that no reply is warranted. Essentially, it argues that Novopharm has
not demonstrated, based on the affidavit filed in support of this motion, of
any need to serve reply evidence; that such evidence in any event is an attempt
by Novopharm to split its case; that the evidence is repetitive and duplicative
of evidence already given; that “much” of it should have been known to
Novopharm and therefore should have been part of its evidence-in-chief; that
such reply evidence should be dealt with on cross-examination of AstraZeneca’s
experts; and, that it was available at an earlier date.
[12]
AstraZeneca
has filed a responding motion record which includes three charts attached to
the written representations. The charts total some 54 pages in length and
represent an analysis on a virtual paragraph by paragraph and line by line
basis why the reply evidence in each of the affidavits is improper and should
not be allowed.
[13]
Having
reviewed the affidavits in reply and the issues as formulated by Novopharm, it
is my view that the Court on the hearing of the Application will benefit from
reply evidence and the issues between the parties will be properly joined. In large
part this is because it is essential for the Court to have before it a record
from a party that responds to new evidence or facts or issues raised for the
first time by a party in its materials.
[14]
While
there is no automatic right of reply in proceedings under the Regulations,
where a party raises an issue or puts forward evidence that is new or
unanticipated to the other party, then that party ought to have the right of
reply. This is particularly so where a notice of application, as here, is
bereft of any substantive information or grounds in support and amounts to nothing
more than an empty collection of boilerplate denials. Reply evidence in such
cases becomes more than likely.
[15]
Here,
AstraZeneca has obtained a procedural advantage by obtaining an order reversing
the order of evidence on invalidity. It now seeks to enhance that advantage by
denying any right of reply to Novopharm in the face of evidence from
Novopharm’s witness that there are aspects of the responding evidence of
AstraZeneca that are new or were unanticipated. It is not for a generic/respondent
to speculate in its evidence as to every piece of evidence that an applicant
may choose to argue or put forward to support its application. This is
especially so, as noted, where the notice of application contains mere bald
denials. For example, in this Notice of Application, AstraZeneca simply states
in respect of invalidity:
20.
AstraZeneca
disputes that the ‘945 patent is invalid on any of the legal and/or factual
bases asserted by Novopharm, for at least the following reasons.
21.
If the
‘945 patent properly construed, is a selection patent, AstraZeneca disputes
that it is an invalid selection patent on any of the bases asserted by
Novopharm.
22.
AstraZeneca
also disputes that the claims of the ‘945 patent are anticipated, obvious, lack
utility, and claim more broadly than any invention made or disclosed, and that
the patent is insufficient on any of the bases asserted by Novopharm.
[16]
These are
simply bald denials and do not inform Novopharm of what evidence may be
ultimately lead by AstraZeneca to support them. There is no roadmap for
Novopharm to follow to understand the case which AstraZeneca will put forward.
Novopharm cannot know everything that AstraZeneca may lead by way of evidence and
is not required to speculate on every possible point. This was the exact
argument made by AstraZeneca in its motion seeking the reversal of evidence.
To speculate on every possible point that might be raised may lead to already
unnecessarily long affidavits that do not focus for the Court the issues to be
decided and likely lead to obfuscation of the real issues in dispute. It is
sufficient that if they can anticipate an area of evidence that will be lead
because it is raised or reasonably alluded to in the Notice of Application they
should endeavour to deal with it in their evidence-in-chief.
[17]
In my
view, AstraZeneca cannot have it both ways: obtain a procedural and strategic
advantage by having Novopharm lead its evidence first on invalidity and then argue
that Novopharm should anticipate everything that AstraZeneca might say in its
evidence and not be allowed to reply. As described in more detail below, much
of AstraZeneca’s argument is that Novopharm “could” or “should” have
anticipated the evidence and dealt with it in chief.
[18]
The
evidence before the Court, which AstraZeneca endeavoured to undermine in
cross-examination, is that the issues noted above were unexpected and thus
reply is necessary to join issue with AstraZeneca. It is argued by AstraZeneca
that it is a requirement for proper reply evidence that it was not available at
an earlier date. Thus, AstraZeneca argues that Novopharm and its experts could
and should have anticipated the evidence of AstraZeneca. In my view, that is a
bit like putting the cart before the horse. If the objective of reversing the
evidence on invalidity in proceedings under the Regulations is to let the
applicant know the case it must meet on this issue then that is all that is
required of the generic/respondent in leading its evidence-in-chief. It must
put all of its evidence forward to support the allegations it is relying upon
that are contained in its NOA. Novopharm did just that and endeavoured to
anticipate some of the evidence of AstraZeneca. However, it is AstraZeneca
that has now raised issues that Novopharm says it did not anticipate and now requires
leave of the Court to file reply.
[19]
The Court
has carefully considered all of the cases relied upon by AstraZeneca in support
of its arguments. In particular, Atlantic Engraving v. Lapointe Rosenstein
(2002), 23 C.P.R. (4th) 5 (F.C.A.) sets out the tests to be met by a
party seeking to file reply evidence. These tests are as follows:
(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 prejudice to the other side;
(d)
the
evidence was not available at an earlier date.
[20]
Subject to
the comments below, having reviewed the proposed affidavits and notwithstanding
their undue length, I am satisfied that they will assist the Court, serve the
interests of justice, and not cause substantial or serious prejudice to the
other side. With respect to the latter point, the affidavits are from the same
witnesses who gave affidavits in chief. Thus, there are no additional
cross-examinations to arrange.
[21]
The fourth
factor, whether the evidence was available at an earlier date, is more
problematic. AstraZeneca strenuously argues throughout its submissions and
charts that there is virtually nothing in the affidavits that was not “known”
at the time Novopharm delivered its original affidavits in chief. That may
very well be true but the fact that it was “known” or “available” is not the
end of the analysis. The knowledge of evidence or the availability of evidence
at an earlier date must mean evidence that was known to be relevant and
required. It must be remembered that it is Novopharm, as a result of
AstraZeneca’s motion, which is putting its best foot forward on the issues they
have delineated in their NOA to support their case and must meet their
evidential burden on the issue of patent invalidity. They have no roadmap from
AstraZeneca as to what evidence it will put forward to respond because the
Notice of Application comprises bald denials without any guidance as to
AstraZeneca’s position. It cannot be an answer that Novopharm could or should
know that AstraZeneca’s experts will take the positions they took. To do so is
to require parties in the position of Novopharm to guess and speculate at what
all of the evidence of AstraZeneca will be.
[22]
AstraZeneca
argues that there is no support for the proposition that Novopharm is entitled
to file reply evidence because it could not anticipate the evidence of
AstraZeneca. It is argued that to accept this argument would always lead to
the conclusion that reply evidence is proper as a party will never be able to
anticipate all of what another party will say. This generalization, while at
first blush appealing, fails detailed scrutiny. The fact that a party may
baldly state they did not anticipate evidence will not be sufficient to permit
reply evidence to be filed. The party will have to demonstrate, as here, that
they were caught by surprise and did not anticipate a position that is now
argued. In Solvay
Pharma Inc. et al v. Apotex Inc. et al. (T-427-06, June 15, 2007) Prothonotary
Tabib made the following observation regarding reply evidence:
I would add, as a general comment, that
the bald statement by any expert that he or she could not have anticipated a
certain approach or argument, or that a certain approach or argument is not in
the notice of allegation, should be accorded very little weight, if any. To
the extent the matter can be assessed on the plain reading of the notice of allegation
and affidavits by a lay person, then a bald statement by an expert to the
contrary will not carry weight. To the extent the assessment cannot be made
without an expert’s assistance, then a bald statement is of no assistance in
understanding or justifying the subtle distinctions that apparently need to be
made.(page 12)
[23]
It is to
be noted that Prothonotary Tabib’s comments were made in the context of a
notice of allegation which is a detailed statement of the position of the
generic. The affidavit of Dr. Romero in support of this motion states that the
reply is focused on matters which were not anticipated and then provides
specific details of that evidence and why it was not anticipated and her opinions
in response. That is sufficient to meet the required tests for reply evidence.
[24]
Having
found reply to be appropriate in this case, the affidavits may be served and
filed subject to the following observations. Reply evidence should be brief
and focused. Reply evidence should not engage in unnecessary and useless
editorializing. Reply evidence should not be repetitive of information that is
already contained in the evidence in chief except where necessary to establish
the point to be made in reply. In this case, AstraZeneca did not concede a
single sentence of any of the affidavits as being appropriate by way of
reply.
[25]
In the
cross-examination of Dr. Romero, AstraZeneca endeavoured to demonstrate that
Dr. Romero’s evidence should be discounted because she was unsure when she had
reviewed the Notice of Application and conceded she had never seen the NOA.
AstraZeneca criticizes Dr. Romero because if she had reviewed those documents
she would have understood better the case of AstraZeneca and “could and should”
have raised all of the matters in her reply affidavit in her original affidavit
in chief. This argument also fails scrutiny. Properly retained and instructed
experts are not advocates of a party. Experts should be independent and
provide their opinion on matters as requested or required by a party. It is
not for the expert to advocate a position or review documentation for the
purpose of advocating a position for a party. Such an approach could bring the
opinion of the expert into question and be given little weight. Here, Novopharm
sought and obtained an opinion based upon specific parameters set out in
counsel’s request. There is no necessity for the expert to go beyond the
parameters of the opinion requested unless it is obvious from the scope of the
opinion as requested. Failing to review the NOA or Notice of Application in
this case by Dr. Romero does not result in her evidence in support of this
motion being discounted nor the necessity of her reply evidence.
[26]
The major
attacks on the various paragraphs of the reply affidavits are that they are
argumentative; or they amount to case-splitting; or they are repetitive and
duplicate evidence already given; or, there are statements which simply
disagree with statements by AstraZeneca’s experts and should be the subject of
cross-examination. The Court is in agreement that to the extent reply
affidavits engage in case-splitting, argument or are repetitive, they are
improper. The difficulty is that the Court is being asked to parse the
proposed reply affidavits to determine what parts of the affidavits, if any,
offend these principles and should be struck. Experienced counsel ought to
know the proper approach to reply evidence and include only that which is
proper.
[27]
Having
determined that based on the evidence on this motion that some reply is
warranted on the issues described above, it is necessary to provide directions
to the parties as to the scope of the reply affidavits. It is an
extraordinarily wasteful exercise for the Court to review and parse purported
reply affidavits page by page, paragraph by paragraph, line by line or word by
word as argued by AstraZeneca. The volume of material and need to review and
understand the original affidavits as well as the proposed affidavits puts a
significant and unwarranted burden on the Court and has led, in this case, to
substantial delay, which is further discussed below.
[28]
Dealing
with the Romero affidavit, AstraZeneca made much of the fact that Dr. Romero
knew that her opinions should be “thorough and complete” as she acknowledged on
her cross-examination. Because Dr. Romero did not deal with certain issues in
her affidavit in chief AstraZeneca says that the reply affidavit, in large
part, amounts to case-splitting. For example, AstraZeneca makes this argument
on page five of its analysis of Dr. Romero’s affidavit:
In any event, at the time of her first
affidavit, Dr. Romero did have the Kathawal ‘895 “patent” and Beck papers (see
para. 105a) and f)), and could have been provided with the Kathawal review as
it is referenced in the NOA. She had the opportunity to express all her views
on these references at that time.
[29]
Much of
the case-splitting argument of AstraZeneca when one reviews their chart in
detail is that Dr. Romero “could” have given all of the evidence in chief.
However, Dr. Romero is not required to provide opinions she is not asked to
provide if AstraZeneca has not put the position in play. Thus, this argument
falls flat and the proposed reply affidavit should be accepted.
[30]
AstraZeneca
also points to a number of sentences which are repetitive of evidence given in
her first affidavit. One example of this is found in paragraph 24 of the
proposed reply affidavit (page 10 of the chart). A sentence fragment is
alleged to be repetitive of the first Romero affidavit. There is a lengthy
analysis by AstraZeneca of why this sentence fragment is repetitive. Frankly,
having carefully read the submissions it is virtually impossible, unless one
were a chemist, to understand how it is repetitive and, in the scheme of the
affidavit and the evidence as a whole, why it is improper reply. Even
responding to new unanticipated positions requires some modest amount of
repetition.
[31]
AstraZeneca
also argues that a number of paragraphs of the proposed reply affidavit are
improper because they are not expert opinions but are essentially
editorializing. Paragraphs 42 and 67 are examples. They are improper and
should be struck. The remainder of the affidavit is acceptable even though
some portions are repetitive of positions taken. They are not substantial in
the scheme of the affidavit and counsel should in future refrain from
permitting experts to engage in repetition of evidence previously given unless
absolutely required for context.
[32]
With
respect to the Grieco reply affidavit, AstraZeneca makes many of the same
points. It also argues that any references to the need for reply evidence
should be ignored as Dr. Grieco was not made available for cross-examination.
Having found on the basis of Dr. Romero’s affidavit that reply is appropriate,
I need not consider further the comments in either the Grieco or Scallen
proposed reply affidavits to the effect that reply is necessary. The most
inappropriate paragraph of the proposed Grieco reply affidavit is the final
paragraph which is nothing more than editorializing and is struck. It reads:
50. Drs. Roush and Bartlett ignore
these points and present a biased and misrepresentative view of the art that
does not reflect what a person of ordinary skill in the art, in the real world,
would have been taught.
[33]
AstraZeneca
is correct that this kind of argumentative editorializing oversteps the
boundary of proper reply. However, having carefully reviewed all of the
allegations made by AstraZeneca in its 19 page chart, the bulk of the
allegations fall into the same categories as those relating to Dr. Romero’s
proposed reply affidavit. Thus, having considered them all, even though some
are repetitive, they do not detract from the reply evidence and may remain.
[34]
Finally,
the attack on Dr. Scallen’s proposed reply affidavit is the same as that of Drs.
Romero and Grieco. Examples of the kind referred to above relating to Dr.
Romero’s affidavit abound. The attacks are fundamentally focused on what Dr.
Scallen could or should have said in his first affidavit. However, as he did
not, as with Dr. Romero’s and Dr. Grieco’s proposed reply affidavits, his reply
affidavit may stand subject to the removal of the argumentative editorializing
in paragraphs 35 and 36.
[35]
The other
issues on the motion were argued briefly but not to the extent of the need for
reply which was the real focus of the motion. Having considered the
submissions of the parties on these matters, those parts of the motion are
dismissed. It is my view that the Notice of Application should not be struck
as Novopharm now has the entirety of AstraZeneca’s positions and evidence on
the allegations in the Notice of Application. The fact that leave is granted
to Novopharm to file reply evidence permits a response to any of the concerns
regarding the bald allegations in the Notice of Application. Finally, although
Novopharm sought to strike the affidavit of Dr. Leiter and other portions of
AstraZeneca’s evidence on the basis that it did not deal with issues raised in
the Notice of Application, again by virtue of filing reply evidence the issues
with AstraZeneca are now fairly joined.
[36]
As
Novopharm has been substantially successful on this motion it is entitled to
its costs in any event of the cause.
[37]
The
hearings coordinator has established hearing dates for this matter in March,
2010. By virtue of the delay that has occurred by this motion, the parties are
now required to use their very best efforts to ensure that cross-examinations
are completely quickly to ensure the necessary filing dates are met for a March
hearing. The fact that this may put pressure on the parties is one of the
results of motions such as these which are vigorously contested in
circumstances where the need for reply has been met and should have been clear
to counsel.
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