Docket:
T-1555-12
Citation: 2013 FC 1036
Toronto, Ontario, October 11, 2013
PRESENT: Kevin
R. Aalto, Esq., Case Management Judge
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BETWEEN:
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PFIZER CANADA INC.
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AND G.D. SEARLE & CO.
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Applicants
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and
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APOTEX INC.
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AND THE MINISTER OF HEALTH
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Respondents
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REASONS FOR ORDER AND ORDER
[1]
This case is a poster child for why reversal
orders ought not to be granted except in the most exceptional of circumstances
in proceedings under the Patented Medicines (Notice of Compliance)
Regulations (Regulations). Exceptional circumstances might include a situation
in which counsel for the respective parties willingly consent to reversing
evidence. It is the parties’ case and if they wish to provide their evidence
on an issue before they are required to under the Federal Courts Rules,
they should have that option so long as it is justifiable and will not lead,
for example, to contested motions for reply or sur-reply.
[2]
In general, it appears that reversal orders do
not achieve the goal anticipated by the December 7, 2007 Practice Direction of
simplifying proceedings under the Regulations. The Practice Direction
was intended to outline approaches to proceedings under the Regulations for
discussion which might lead to the just, most efficient and least expensive
determination of the matter on its merits.
[3]
This is particularly so in the context of a
partial reversal of evidence which has led to the mischief in this case. The
Applicants (Pfizer) delivered its fact evidence in support of the patent in suit
first, followed by the Respondent’s (Apotex) evidence on validity, followed by
Pfizer’s evidence on validity. The mischief which has arisen is that the
Pfizer experts have now relied on an extensive number of clinical studies, monographs
and other documents which Apotex argues are facts and should have been
disclosed as part of the “fact” evidence.
[4]
Thus, the motion before the Court is brought by
Apotex to strike substantial portions, including exhibits, of the affidavits of
three of the experts filed on behalf of the Pfizer. The evidence sought to be
struck is evidence upon which the respective experts of Pfizer rely for their
opinions.
[5]
The portions of the affidavits sought to be
struck is extensive:
(a) Dr. Fennerty, sworn August 2, 2013, paragraphs 16, 17,
35, 36, 37 (second sentence), 39 (second to fourth sentences), 40, 41 (first
sentence), 43, 44, 45, 46, 47, 48, 55 (second last sentence), 56, 57, 58, 59,
60, 61, 62, 63, 64, 65, 66, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86,
87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 105 (last two sentences), 112, 121
(fifth sentence), 163 (last two sentences), and exhibits D, E, F, G, I, J, M,
N, O, P, R, T and V;
(b) Dr. Abramson, sworn August 6, 2013, paragraphs 14(e), 86,
101, 102, 103, 104, 105, 106, 120, 121, 122, 123, 136, 137, 138, 139, 140, 141,
142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 156 (first
sentence), 177, 179 (second last sentence), 210 (last two sentences), 223, 224,
225, 227 (to the extent the Lancet 2013 article is mentioned), 228, and
exhibits D, E, F, G, H, L, M, Q, R, S, T, U, V, W, Y and BB; and,
(c) Dr. Tugwell, sworn August 6, 2013, paragraph 17, 38
(second last sentence), 44, 45, 46, 47, 48, 51, 65, 66, 67, 68, 69, 70, 71, 72,
73, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103,
104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119,
120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135,
136, 173, 197, 198, 199, 200, 206, and exhibits G, H, I, J, O, P, U, V, W, X,
Y, Z, AA, BB and CC;
[6]
In large part, striking this much of these
affidavits amounts almost to a re-writing of the affidavits.
Background
[7]
This application involves the drug celecoxib and
Pfizer’s patent (the ‘576 Patent). Apotex delivered a Notice of Allegation
(NOA) on July 3, 2012. The NOA refers to utility and sound prediction as two
of the main grounds for attacking the validity of the ‘576 patent.
[8]
On August 16, 2013, Pfizer commenced this
proceeding under the Regulations. In this application Pfizer seeks as
part of its relief that there be a reversal of evidence.
[9]
As with all proceedings under the Regulations,
it is case managed. A case management conference was held in November 2012 to
“address” [the word used in the Practice Direction dated December 7, 2007] the
issue of reversal of evidence and the schedule for the proceeding. Apotex as
part of its schedule was seeking a hearing date in conjunction with another
application commenced prior to this one dealing with the same patent [the Mylan
Proceeding]. A reversal of evidence was consented to by the parties in the
Mylan Proceeding. However, in this case, Apotex was opposed to any reversal of
evidence and strongly expressed that view at the November case conference.
[10]
Pfizer indicated they would therefore bring a
motion for reversal of evidence. Such a motion would be for the purpose of
persuading the Court that reversal would result in the just, most expeditious
and least expensive determination of this application on the merits. Because
the Court could not accommodate a date for such a motion for a number of
months, Apotex acquiesced to a partial reversal of evidence. The parties
agreed to a schedule which included the partial reversal and contemplated a
hearing date in conjunction with the Mylan Proceeding.
[11]
The Court issued a Direction encompassing the
schedule as proposed by Pfizer as acquiesced in by Apotex. Thus, Apotex
expected that it would receive all of Pfizer’s fact evidence before putting
forward its evidence on invalidity with particular focus on inutility.
[12]
Pfizer delivered its “fact” evidence on January
15, 2013 which was comprised of the Affidavits of Drs. Manuela Berger (Berger
Affidavit) and Karen Seibert (Seibert Affidavit). The Berger Affidavit was
the main affidavit dealing with inutility. It contains fact evidence relating to
three specific studies: CONDOR, GI REASONS and SUCCESS.
[13]
Thereafter, on April 29, 2013, Apotex served its
evidence including four expert affidavits three of which addressed the issue of
inutility raised in the NOA. These affidavits dealt with the issues in the NOA
and responded to the factual evidence in the Berger Affidavit. Several of
Apotex’s experts opine on issues of utility and in the affidavit of one of their
experts, Dr. Flowers, the following statement is found:
I am informed by
counsel for Apotex that the Seibert Affidavit includes the factual information
related to the development of the subject matter of the ‘576 Patent, including celecoxib,
which the Applicants intend to rely upon in this proceeding. [para. 33]
[14]
On August 6, 2013, Pfizer served five expert
affidavits. Three of these affidavits addressed the issue of inutility: Drs.
Fennerty, Tugwell and Abramson. In these affidavits there are references to 25
pieces of literature (the Impugned Evidence) which are nowhere to be found referred
to in the Berger Affidavit or referred to in the notice of application. Only
one of the references appears to be a study which was published after Pfizer
delivered its first tranche of evidence: the Lancet 2013 meta-analysis.
[15]
It is recognized by Pfizer that because of the
way the Impugned Evidence has been raised that Apotex should have a right of
reply. In a rare gesture of magnanimity, not often seen in these types of
proceedings, Pfizer has served a “with prejudice” offer to resolve this motion
on the basis of the Court granting a right of reply to Apotex subject to some
restrictions. While this magnanimous gesture goes somewhat along the way to
cure the mischief created by the partial reversal, it does not provide a
complete answer.
[16]
While there was some suggestion in argument that
because it was only a Direction of the Court regarding the schedule and not a
formal order it has less impact. In my view, that is not the case. Breach of
an order may bring a wider range of remedies but Directions of the Court
nevertheless carry the weight of judicial decision making and are not mere
suggestions as to what should happen in the conduct of a case but are the expectation
of what shall happen.
[17]
On this motion, the parties have filed extensive
materials including the various lengthy affidavits in dispute and the affidavit
of a lawyer for Pfizer explaining his understanding of the meaning of “fact”
evidence within the context of a proceeding under the Regulations. He
was cross-examined at length. Because of the general rule that a lawyer should
not appear as counsel and witness on a matter, and because Apotex raised this
as an issue, outside counsel was retained by Pfizer to argue this motion.
Apotex’s
Position
[18]
Apotex argues that:
Complex, high-stakes
intellectual property proceedings are governed by procedural rules aimed at
fairness, full and timely disclosure, and efficiency. Purposeful, strategic
conduct involving non-disclosure, non-clarification or inaction, as the
Prothonotary and the Federal Court judge found here, disrespects these rules
and their aims. Those who disrespect the rules and their aims can hardly
expect courts to smile upon them when they look for a favourable exercise of
discretion under those rules.
[Bristol-Myers
Squibb Co. v. Apotex Inc., 2011 FCA 34 per Stratas J.A. at para. 37]
[19]
To that end, it is argued that Pfizer, having
made decisions regarding its “fact” evidence, it ought not now be able to
effectively split its case and pour in new “fact” evidence in the guise of
opinion evidence. There is obvious prejudice if a party splits its case. A
party is required to put its best foot forward at the first opportunity [see,
for example, Merck-Frosst-Schering Pharma GP v. Canada (Minister of Health),
2009 FC 914 at para. 25].
[20]
Apotex further argues that since the Impugned
Evidence falls outside the scope of the intention of the Court’s Direction
regarding reversal, no prejudice by Apotex need be shown. Indeed, the evidence
of Pfizer goes beyond replying to Apotex’s evidence and introduces the Impugned
Evidence. As there is obvious prejudice, I agree that Apotex need not
demonstrate prejudice by way of evidence on this motion.
[21]
Apotex argues that the Impugned Evidence is
filed in contravention of the Court’s Direction. However, there appears to be
a considerable difference of opinion between counsel on the meaning of “fact”
evidence. It cannot be definitively said, therefore, that the Impugned
Evidence contravenes the Court’s Direction.
[22]
Apotex seeks as well to have adverse inferences
drawn against Pfizer given matters which transpired at the cross-examination on
Pfizer’s affidavit in support of the motion. There was much sparring on the
cross-examination over what is or is not a “fact”. The general Pfizer position
being that it is the expert that relies on a particular study to support an
opinion so that it is not Pfizer that is relying on the fact but the expert.
In my view this is just sophistry. An example is as follows:
Q. In support of the assertion that Celecoxib is,
in fact, useful does your client intend to rely upon the study represented in
column 2 of schedule A to Apotex’s representations, namely the Emery study?
A. As support for the expert’s opinion that
Celecoxib is, in fact, useful.
Q. Good. Document 3, Goldstein. Is it Pfizer’s
intention to rely upon as a fact that the study conducted and described in
Goldstein was, in fact, conducted and the results obtained were, in fact,
obtained?
A. I think I would just characterize it in a
slightly different way, Mr. Brodkin. All the studies listed here support the
expert’s opinion as to the utility of Celecoxib.
Q. Do you accept that the studies themselves are
facts?
Mr. Mason: Well,
that’s an improper question.
Mr. Brodkin: Why?
Mr. Mason: What
he accepts or doesn’t accept is not relevant.
Mr. Brodkin: Good,
and what he says or doesn’t say is a fact or not is equally irrelevant.
Mr. Mason: No. What he accepts or doesn’t accept is
irrelevant. It’s not a proper question. If you want to rephrase your
question, I’m happy to let him answer.
Mr. Brodkin: I
think the question was fine, but the objection is noted.
Q.
Is that the study that run by
Goldstein in schedule A, row 3, a fact?
A. Are you asking me an abstract whether or not
Goldstein ran a study?
Q. Is that a fact?
A. Is that a fact? Um, well –
Q. Goldstein ran a study, is that a fact?
A. Whether Goldstein ran a study or didn’t run a
study?
Q. Yes?
A. Yes, it’s not the type of fact that we
understood would be necessary to put in amount with our factual evidence
because it’s the type of fact that support the expert’s opinion.
Q. Are the results obtained by Goldstein a fact?
A. Same answer.
[23]
The transcript is replete with cat and mouse
exchanges such as this. There are also seemingly endless colloquies between
counsel as to the scope and propriety of questions. The cross-examination is
also punctuated with pointed exchanges between counsel and between counsel and
the witness over the timing of evidence produced in the Mylan Proceeding. The
expert affidavits of Pfizer in that case were delivered in a time frame that
would have required Pfizer to be aware of much of the Impugned Evidence and
would have known about the experts’ intended use of the Impugned Evidence at
the time the expert affidavits of Pfizer were delivered to Apotex in this
proceeding.
[24]
At the hearing of the motion, counsel for Apotex
provided a summary of points from the cross-examination to demonstrate that
efforts to obtain relevant information on the cross-examination were thwarted
by the witness’ failure to make inquiries and abide by the Direction to Attend
and to properly inform himself. Twenty-two separate points are raised by
Apotex to demonstrate how Pfizer has obfuscated the process and failed to
properly respond to questions and the Direction to Attend.
[25]
It is disappointing that this case has spawned
this level of misbehaviour. It is largely based on two competing views among
counsel as to the extent of “fact” evidence. There is no doubt that there are
facts which form part of the Impugned Evidence which were known to Pfizer at
the time it delivered its “fact” evidence. The differences between counsel
deals with how one categorizes those facts.
[26]
In all, there is much merit to some of Apotex’s
complaints. The question is the appropriate remedy which is discussed in
greater detail below.
Pfizer’s
Position
[27]
Pfizer argues that their understanding of the
Court’s Direction and of the partial reversal of evidence was that it was
Pfizer’s internal factual evidence that was required and that it would be
impossible to provide all of the references which experts might reasonably
require to support their opinions.
[28]
In Pfizer’s Written Representations, Pfizer
“understood the term ‘fact evidence’ in the agreed schedule to refer to the
evidence of the fact witnesses that Pfizer was seeking to lead and ‘non-factual
evidence’ to refer to the evidence of expert witnesses that Pfizer was seeking
to lead” [para. 16]. It was argued that this is consistent with the approach
in partial reversal orders and provides a respondent with facts it could not
otherwise access.
[29]
Pfizer further argues that had it understood
that Apotex expected that all of the publicly available literature relating to Celecoxib
that might be referred to by its experts be provided, it would not have
proposed reversal of evidence. Pursuant to section 3 the Code of Conduct for
Expert Witnesses [Schedule to Rule 52.2] an expert’s report shall include (g)
the reasons for each opinion expressed; and, (h) any literature or other
materials specifically relied on in support of the opinions.
[30]
The affidavit in support of Pfizer’s position
explains the basis for not providing information relating to the Impugned
Evidence relied upon by their experts as follows:
. . . the applicant
is in no better position to identify and provide publicly available literature,
professional guidelines, reports or professional experience that supports an expert’s
opinion than a respondent. In my experience (and in this case, in respect of
the applicant’s expert evidence) this type of information is usually found be
the experts themselves, as support for their opinion. Indeed, it is precisely
this type of publicly available scientific information that expert witnesses
routinely rely on in support of their opinions, and, under the Code of
Conduct for Expert Witnesses, are required to attach. [para. 8]
[31]
In respect of this observation it can certainly be
said that it would be impossible for counsel to know all of the publicly
available literature that an expert might rely upon in support of their
opinions. However, in this case there was some significant amount of knowledge
which Pfizer’s counsel had concerning the literature to be relied upon by their
experts. Of particular note is the fact that there was a concession on the
cross-examination that preparation of the affidavits in the Mylan Proceeding
was well underway at the time the first tranche of Pfizer evidence was served
in this case.
[32]
Pfizer also argues that the Impugned Evidence under
attack is both admissible and relevant and that the Court on the hearing should
have the benefit of a full record not a truncated record which would result
from the striking of the Impugned Evidence. Pfizer argues to do so would cause
enormous prejudice to Pfizer. There is no doubt that the Impugned Evidence is
relevant and is admissible. But that is not the issue. The issue is whether
Pfizer has split its case and caused such prejudice to Apotex that it should be
struck.
[33]
In somewhat of an about face, Pfizer also argues
the approach of Apotex is impractical. They point to the Supreme Court’s
decision in Graat v. R., [1982] 2 S.C.R. 819 at p. 835 wherein it is noted
that “there is little, if any, virtue, in any distinction resting on the
tenuous, and frequently false, antithesis between fact and opinion. Since “the
line between ‘fact’ evidence and ‘opinion’ evidence is not clear”. They argue
that the paragraphs of the Impugned Evidence intertwine both “fact” and
“opinion”. One wonders how partial reversal of evidence could possibly lead to
a simplification of the proceeding and provide Apotex with a greater
understanding of the case it had to meet. Such an order is an invitation to
reply evidence or even sur-reply.
[34]
Pfizer also argues that the striking of
affidavits is an exceptional remedy. Again, this is true. It applies in cases
where the affidavits are scandalous, abusive or clearly irrelevant. The jurisprudence
of this Court dictates that only in those exceptional circumstances should
affidavits be struck. In Merck & Co. v. Canada (Minister of Health),
2003 FC 1511, Madam Justice Elizabeth Heneghan stated that “relying on the
jurisprudence of this Court which makes it clear that interlocutory motions to
strike affidavits should not be brought and the question of admissibility of
evidence should be left to the judge hearing the application” [at para. 6; see
also Mayne Pharma (Canada) Inc. v. Aventis Pharma Inc. 2005 FCA 50 at
para. 16; and Proctor & Gamble v. Canada (Minister of Health), 2009
FC 113].
[35]
Finally, there is the issue of prejudice to
Pfizer. It argues that to strike the Impugned Evidence will significantly
prejudice the right of Pfizer to support the utility of its patent. The record
before the hearings judge will be incomplete as the experts have relied on
publicly available literature to which Apotex also has access and could, but
chose not to, refer to it in their evidence attacking utility.
Disposition
[36]
In the end, this motion is about remedy in the
face of the mischief created by a partial reversal of evidence, acquiesced to by
Apotex. Misunderstandings about what is or is not “fact” evidence underlie the
positions of the parties. Thus, my conclusion that this is all about remedy
not admissibility.
[37]
Pfizer’s proposed remedy is that Apotex’s
complaint can be solved by way of filing reply evidence. To that end, as noted,
Pfizer has served a “with prejudice” offer to Apotex permitting Apotex to file
reply evidence.
[38]
The remedy which Apotex seeks is to strike the Impugned
Evidence in its entirety.
[39]
Apotex strenuously argues that this is a case
where the dictum of Justice Stratas ought to be applied and the Impugned
Evidence be struck. However, it is necessary to consider the context in which
Justice Stratas determined not to allow the amendment in the Bristol-Myers
case. That case was not a proceeding under the Regulations, but an
infringement/invalidity action which had been ongoing for over a decade. The
circumstances giving rise to this draconian result occurred because of the
factual background in that case. As Justice Stratas observed at para. 34:
For roughly an entire
decade, Apotex has conducted itself in a way that suggested that the issues of
lack of sound prediction and the broad inutility of nefazodone and its salts
were not real questions in controversy. If they were real questions in
controversy, they would have been addressed meaningfully at least at some time,
if not constantly, during this decade-long litigation. Instead, those questions
were no part of the discoveries or the pre-trial memoranda. Now, only at this
late date – years after the exchange of pre-trial memoranda – and without any
significantly new developments in the litigation, Apotex seeks a further and
better affidavit of documents from Bristol-Myers and embarks upon what the
Prothonotary called a “fishing expedition” concerning “the length and breadth
of the development of nefazodone.” Finally, as the Prothonotary also found,
even now on the eve of trial Apotex cannot articulate these supposedly “real
questions in controversy” with acceptable particularity. [para. 34]
[40]
And further at para. 38:
The result in this
case is even clearer if we apply the admonition in Merck, supra,
that the burden under the Canderel test is heavier when “the amendments
at issue…would result in a radical change in the nature of the questions in
controversy.” In light of the Prothonotary’s interpretation of Apotex’s 2004
amendments as being restricted to liver issues and in light of the foregoing
analysis, the proposed amendments would indeed result in a radical change to
the nature of the questions in controversy.
[41]
The Bristol Myers case turns on
exceptional circumstances and is distinguishable in large part from this
proceeding under the Regulations.
[42]
In all, this proceeding at this juncture given
that cross-examinations are planned for November 2013 and a hearing in March
2014, is in most unsatisfactory state of affairs.
[43]
Both remedies proposed are on the extreme ends
of the spectrum. In grappling with the two requested remedies it seems to me
that there is some middle ground which will remove the prejudice and allow
Apotex an opportunity to provide a fulsome reply to this Impugned Evidence which
is not struck. While this case comes close to the exceptional circumstances
requirement, a remedy can be fashioned to recognize the Court’s approbation of
the circumstances under which this state of affairs arose.
[44]
Some of the opinion offered in the Pfizer expert
affidavits is critical of Apotex’s experts. There are comments such as:
“Surprisingly, Apotex’s witnesses have not addressed this meta-analysis. They
have also not addressed the relevant Canadian and U.S. Guidelines on long-term
NSAID drug therapy and the need for gastroprotection which also support this
conclusion” [Fennerty, para. 17]; “and it is surprising to me that none of
Apotex’s witnesses have considered this publication” [Fennerty, para. 40].
Similarly, in paragraphs 113 through the first sentence of 116 of the Fennerty
Affidavit comments are critical of Apotex’s experts. All of these portions of
the Fennerty Affidavit will be struck.
[45]
The Abramson Affidavit is also critical of
Apotex’s failures to address the literature referred to for the first time in
Pfizer’s affidavits. For example, paragraph 89 and particularly in paragraph
138 which states: “A scientist considering this issue would certainly know
about and take into consideration the Cochrane meta-analysis, and I was
surprised that Apotex’s experts did not do so in considering whether Celecoxib
has significantly less harmful side effects than nonselective NSAIDs.”
Paragraphs 153, 154 and the latter half of paragraph 156 commencing with the word
“Thus” are of a similar ilk. All of these portions of the Abramson Affidavit
are struck.
[46]
In the Tugwell Affidavit there are similar
attacks on the Apotex experts. For example, in paragraph 73, Dr. Tugwell muses
as follows:
73. As an
aside, I find it curious that Apotex’s witnesses chose not to review these two
studies, but chose to criticize the CONDOR study primarily for elements of its
design that had been based on the results of these two studies (Dr. Chan is one
of the co-authors of CONDOR). In my view, Apotex’s witnesses do not look at
the CONDOR trial in its proper context and, in so doing, unjustly undermine the
importance of its findings.
[47]
It is indeed curious since Apotex had no
indication that any of the studies upon which Dr. Tugwell founds his opinions
would be referred to. In the circumstance of this case, it is not enough to
say “Oh well, Apotex should have known about all of theses studies and
commented on them”. Paragraphs 85, 86 and 173 are also critical of Apotex.
Thus, these paragraphs including paragraph 73 will be struck.
[48]
The remainder of the affidavits are not struck.
If I have missed any references in these lengthy affidavits which are critical
of Apotex’s experts and their failure to refer to or deal with any of the Impugned
Evidence as identified in the chart attached to Apotex’s Written Representations
they should be brought to the attention of the Court to determine whether they
should also be struck.
[49]
The remaining part of the remedy is the issue of
costs. It is my view that much of the mischief that has transpired has been
the result of Pfizer’s initial demand that there be a full reversal of evidence
which resulted in only a partial reversal. The “with prejudice” Offer to
Settle this motion is not a complete answer to the problem caused. Pfizer is
not entitled to costs. Indeed, it is my view that Apotex should have its substantial
indemnity costs of this motion. If the parties cannot agree on the quantum,
written submissions limited to three pages each may be made as to quantum
within 15 days of the date of this decision.
[50]
As well, Apotex should be compensated for the
extra reasonable costs which are to be incurred in preparing reply affidavits.
Apotex must contact these experts again and review all of this additional
material with them. It is not enough to say that Apotex would have had to do
it anyway had there been no reversal. Thus, the legal fees and expenses (e.g.
travel costs, if any, to meet experts etc.) relating to the reply affidavits
(though not the expert fees) should also be recovered by Apotex. Those costs
are in any event of the cause and subject to assessment if the parties are
unable to agree on the quantum.
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