Date:
20071115
Docket:
T-1048-07
Citation:
2007FC1195
Ottawa, Ontario, Thursday, this 15th
day of November 2007
PRESENT: MADAM PROTHONOTARY
MIREILLE TABIB
BETWEEN:
ELI
LILLY CANADA INC., ELI LILLY AND COMPANY,
ELI
LILLY COMPANY LIMITED and ELI LILLY SA
Plaintiffs
(Defendants
by Counterclaim)
-
and -
NOVOPHARM
LIMITED
Defendant
(Plaintiff
by Counterclaim)
REASON FOR
ORDER AND ORDER
[1] The Defendant, Novopharm Limited
(“Novopharm”) brought this motion seeking, amongst other relief, an Order
pursuant to Rule 227 of the Federal Courts Rules requiring the deponents
of the affidavits of documents of each of the Plaintiffs to submit to
cross-examination on their respective affidavits of documents and to serve a
further and better affidavit of documents.
[2] The motion is brought in the context of
the action by the Plaintiffs (hereinafter, collectively referred to as “Lilly”)
claiming infringement of its patent relating to olanzapine (which Lilly markets
under the brand name “Zyprexa”). By counterclaim, Novopharm seeks a
declaration of invalidity of the patent and damages pursuant to section 8 of
the Patented Medicines (Notice of Compliance) Regulations. Novopharm
brought this motion prior to any oral examination for discovery having been held.
1. Further and better
affidavits of documents
[3] On this motion, Novopharm has the burden
of establishing that documents in the possession, power or control of Lilly
exist, are relevant and have not been listed in Lilly’s affidavits of documents
or subsequently produced pursuant to the request for further production the
parties had been required to exchange by a previous scheduling order.
(a) Legal Relevance
[4] All of the documents Novopharm alleges
exist and have not been produced ultimately relate to the issue of the side
effects profile of olanzapine. All of Novopharm’s arguments as to the
relevance or usefulness of these documents were to the effect that these
documents would establish, one way or the other, or would lead to a train of
enquiry that would have the effect of establishing, one way or the other:
(a) whether olanzapine had, as of the priority date, the filing
date or the date of issuance of the patent, the advantages claimed in the
patent;
(b) whether, as an objective fact as of the present date, olanzapine
in fact has those advantages; or
(c) whether up to and until the issuance of the patent, Lilly knew
of facts going to those issues that it failed to disclose to the Patent Examiner.
[5] As a matter of legal relevance – that is,
whether the facts give rise to a legally arguable case at trial – Lilly does
not contest that the facts set out in (a) and (c) above raise reasonably
arguable issues, and it submits that it has indeed disclosed all documents
relevant to these issues – as per its understanding of relevance for the
purpose of Rule 222 of the Federal Courts Rules.
[6] As regards the facts set out in paragraph
(b) above, Lilly takes the position that, whether the argument is obviousness,
anticipation, lack of sound prediction, inutility, failure of promise or
material omission or addition, the existence of the advantages must be assessed
on the basis of the state of knowledge of persons skilled in the art, at the
very latest, at the laid open date. It submits that any knowledge gained after
that date can simply not be considered by the Court and is therefore not
relevant. Despite that position, Lilly submits that it has produced documents
relevant to the side effects profile of olanzapine up to and including 2001.
Lilly’s position is that, whether or not further documents dated after 2001
exist (and whether they do is a matter to be established by Novopharm), it is
not obliged to disclose them.
[7] Having carefully considered the pleadings,
I am satisfied that Novopharm’s pleadings do raise the non-existence of the
advantages disclosed or claimed in the patent as an objective fact to be
ascertained as of the date of the trial, and that Lilly has not made any
admission taking that plea out of issue. While Lilly’s arguments are
compelling, including its ultimate argument to the effect that a patent cannot
be valid at the date of the grant and become invalid over time, I cannot
conclude that it is plain and obvious that Novopharm’s arguments on the issue
are devoid of any chance of success at all. Accordingly, I find that documents
relevant to that issue had to be disclosed by Lilly; consequently, when I
proceed to consider whether Novopharm has established that relevant documents exist
in Lilly’s possession, power or control that have not been produced, I will
include in my consideration whether relevant documents exist relevant to whether
the advantages in fact exist in accordance with the state of the art after the
laid open date.
(b) Relevance pursuant to
Rule 222
[8] While Lilly has disclosed a significant
volume of documents, (over 345,000 pages) including documents up to 2001
containing clinical trial data and documents relating thereto, Novopharm notes
that these documents were selected from an even greater collection of documents
(approximately 918,000 pages) disclosed in US litigation involving the
equivalent patent. Novopharm submits that Lilly was not properly fulfilling
its obligation when it proceeded by selecting, from all the documents that may
relate to the facts in issue, those on which it intends to rely at trial and
those which might reasonably be supposed may directly or indirectly hurt its
case or assist Novopharm’s. Novopharm submits that Lilly’s assessment of what
would assist Novopharm is not good enough: Novopharm should be entitled to
review all of Lilly’s documents that might “relate” to an issue, because only
Novopharm is in a position to assess whether the documents may assist it or
hurt Lilly.
[9] Taking Novopharm’s argument to its logical
conclusion, relevance is no longer a function of the influence the information
in a document might have on the case, but is established simply on the basis of
whether a document relates, however indirectly, to a subject matter raised in
the action. I do not subscribe to Novopharm’s argument. If it is to be
accepted, a party might just as well hand over to its adversary the keys to its
premises so that the other might itself read all the documents that can be
found there and satisfy itself that these would not assist it or lead it to
further inquiries.
[10] Rule 222(2) reads as follows:
|
(2) “For the purposes of rules 223 to 232 and 295, a
document of a party is relevant if the party intends to rely on it or if the
document tends to adversely affect the party’s case or to support another
party’s case.”
|
(2) « Pour l’application des règles
223 à 232 et 295, un document d’une partie adverse est pertinent si la partie
entend l’invoquer ou si le document est susceptible d’être préjudiciable à sa
cause ou d’appuyer la cause d’une autre partie. »
|
[11] I note here that the application of this definition
of relevance is explicitly limited to affidavits or lists of documents. It
does not extend to oral examinations for discovery, nor to documents requested in
the context of examinations for discovery. I also note that documents that may
be adduced at trial are not limited to those listed in affidavits of
documents. Rule 232 provides that, in addition to documents disclosed in
affidavits of documents, documents produced on or subsequent to examinations
for discovery may be used at trial without leave of the Court. Thus, Rule
222(2) should not be read as circumscribing the entire discovery process, but
merely a party’s disclosure obligation in an affidavit of documents. The fact
that a document or a class of documents is not listed in an affidavit of
document does not preclude a party from asking, on discovery, questions that
may reveal the existence or relevance of such documents and, once appropriate
foundation has been laid, requesting production thereof.
[12] Paragraph 222(2) was added to the rules
relating to affidavits of document in 1998. Former Rule 448, which was
otherwise carried through unchanged in the 1998 revision to the Federal
Courts Rules, did not contain a definition of relevance, and the
jurisprudence of this Court was constant in applying the test developed over a
century ago in Compagnie Financière et Commerciale du Pacifique v. Peruvian
Guano Company (1882), 11 Q.B.D. 55 (C.A.), in which the words “a document
relating to any matter in question in the action” was interpreted as follows:
“It seems to me
that every document relates to the matters in question in the action, which not
only would be evidence upon any issue, but also which, it is reasonable to
suppose, contains information which may -- not which must -- either directly or
indirectly enable the party requiring the affidavit either to advance his own
case or to damage the case of his adversary. I have put in the words
"either directly or indirectly," because, as it seems to me, a
document can properly be said to contain information which may enable the party
requiring the affidavit either to advance his own case or to damage the case of
his adversary, if it is a document which may fairly lead him to a train of
inquiry, which may have either of these two consequences.”
[13] Peruvian Guano became part of the
standard test of relevance, not only for the purpose of documentary disclosure,
but for discovery at large. Indeed, it was cited as part of the well known and
oft-cited decision of Reading & Bates Construction Co. v. Baker Energy
Resources Corp. (1988) 24 C.P.R. (3d) 66 as to the scope of discovery.
[14] The Peruvian Guano test of relevance
has continued to be cited with approval by the Court of Appeal, even after
1998, in Apotex Inc. v. Canada, [2005] F.C.J. No. 1021, 2005 FCA 217
(C.A.) and SmithKlein Beecham Animal Health Inc. v. Canada, [2002]
F.C.J. No. 837, 2002 FCA 229. I note however, that neither case involved the
concept of relevance in the context of an affidavit of documents. Both cases
were concerned with questions and requests for production refused in oral
examinations for discovery and did not involve requests for further and better
affidavits of documents; SmithKlein Beecham, in particular, involved the
application of the Tax Court of Canada Rules, and not the Federal
Courts Rules (I also note that the Tax Court Rules’ requirements as to
documentary disclosure uses the expression “documents […] relating to any
matter in question between or among [the parties]”, an arguably wider
definition than that of our Rule 222(2), and one which, coincidentally, is much
closer to the definition construed in Peruvian Guano).
[15] It is clear that the Peruvian Guano
test of relevance still applies to oral discoveries in this Court, including
requests for documentary production at or following examinations for discovery.
The question is whether it continues to apply to a party’s disclosure
obligation through the affidavit of documents. Indeed, in the wake of the 1998
amendments, my colleague Prothonotary Hargrave considered, but did not then
need to determine, whether Rule 222(2) had the effect of restricting the scope
of relevance in that context. He wrote, in Galehead Inc. v. Trinity (the),
[1998] F.C.J. No. 1669:
“13. Rule 223(1) of the 1998
Federal Court Rules requires production of "all relevant documents".
Prima facie this is the same production as was required under former the rules,
however new Rule 222(2) goes on to define the concept of relevancy:
"... a document of a party
is relevant if a party intends to rely on it or if the document tends to
adversely affect the party's case or to support another party's case.".
On a strict reading of this
definition of relevancy, in Rule 222(2) a party, arguably, might not have to
produce a document which is relevant in the traditional sense and which
supports its own case, but upon which that party does not intend to rely. In
that sense the new rule for production of documents may be narrower than Rule
448.
14 In
addition, still dealing with the scope of production under the new rules, old
Rule 448, as interpreted by the Federal Court, required the production of
"... any document which
might reasonably be supposed to contain information which may directly or
indirectly enable the party requiring production to advance his own case or to
damage the case of his adversary.": C.M. Security Components Ltd. v.
Canada (1995), 79 F.T.R. 282 at 286 - 87.
In C.M. Security Mr. Justice
Teitelbaum to emphasis the point, underlined the words "might
reasonably", in the phrase "... which might reasonably be supposed to
contain information". Here we do have an element of conjecture or
assumption, however this did stop short of requiring production of documents on
a mere suspicion that the document might exist or might have some connection
with the proceeding. Rather the test, as set out in C.M. Security (supra) is
that the document ought to be one which might reasonably be supposed to contain
information which may directly or indirectly enable the party requiring
production to advance his or her own case or damage the case of his or her
adversary.
15 Certainly, under the
rules as they existed before April of this year, for a defendant to seek
production of the documents in question would have been held a fishing
expedition where the defendant was neither able to show that the material had
some semblance of relevancy nor, by persuasive evidence, to demonstrate that
such documents were available.”
[16] Some years later, in Seaspan
International Ltd. v. “Ewa” (The), [2004] F.C.J. No. 161, 2004 FC 124,
Prothonotary Hargrave revisited the issue and in light of the SmithKlein
Beecham decision, found that the definition of relevance in 222(2) had not
changed the test:
“8 The Smithkline case is based on the Tax Court of Canada Rules for
documentary discovery. However, in the course of considering the area, Madam
Justice of Appeal Sharlow referred to the usual cases, including Everest &
Jennings, for the formulation and application of the train of inquiry test. The
Court of Appeal concluded that the formulation of the test by Justice Bonner of
the Tax Court of Canada, in the trial decision of Smithkline, [2001] 2 C.T.C.
2086 at 2095 was proper:
On discovery the
examining party may seek information and admissions which will assist it not
only to defeat its opponent's case but also to advance the case which it seeks
to put forward.
This formulation is
essentially that set out in Federal Court Rule 222(2) which defines relevancy
so that one may know what to include in an affidavit of documents:
... a document of a
party is relevant if the party intends to rely on it or if the document tends
to adversely affect the party's case or to support another party's case.
The Court of
Appeal, in Smithkline, at 107, neatly concluded that the concept of defeating
an opponent's case or advancing one's own case was substantially the same as
the train of inquiry test. Thus, despite the intervening changes in the wording
of the rules for production of documents, the test set out in Everest &
Jennings, remains applicable.”
[17] I am not certain I would have come to the
same conclusion as my learned colleague as to whether or not Rule 222(2)
effectively narrows the definition of relevance set out in Peruvian Guano,
notably, by somewhat narrowing the “train of inquiry” test. I leave that for
another day.
[18] I do, however, agree with Prothonotary
Hargrave’s assessment in Seaspan, that the concept of advancing an
opponent’s case or defeating one’s own is central to relevance, both on the Peruvian
Guano test and on the strict wording of Rule 222(2). Unless the party
producing the affidavit intends to rely on a document at trial, it is not
obliged to disclose it unless “it is reasonable to suppose” that the document
would undermine its own case, advance its opponent’s, or would “fairly lead him
to a train of inquiry, which may have either of these two consequences”.
[19] In other words, it is not sufficient for a
document to merely relate to the facts at issue. If, for example, a document
can only reasonably be construed as supporting the disclosing party’s case, and
cannot be shown to lead to information that would reasonably be supposed to be
helpful to its opponent, then it need not be disclosed in an affidavit of
documents. A document which is neutral and can only reasonably be supposed to
lead to other similarly neutral documents is not relevant for the purpose of an
affidavit of documents. And on a motion for a further and better affidavit of
documents, the reasonable possibility that a document can have or lead to one
of the desired effects must be established by the moving party. To say that a
document might conceivably lead to other documents, which, although not in
themselves relevant, might then conceivably lead to useable information, is not
enough. It is precisely the type of fishing expedition which the jurisprudence
of this Court consistently refused to sanction. That is not to say that the
moving party must establish that the document sought will necessarily lead to
useable information: a reasonable likelihood will suffice; an outside chance
will not.
[20] I realize that it does leave the disclosing
party to be the arbiter of whether a document may be helpful to its opponent or
not. However, the deponent of an affidavit must apply his or her mind to the
exercise in good faith and doubt should be resolved in favour of disclosure.
This is all the more important because there is no automatic right of cross-examination
on such an affidavit. Nevertheless, an affidavit of documents remains a sworn
declaration that this has been done.
[21] Further, as mentioned above, and without
turning an examination on discovery into a cross-examination on affidavit, the
oral discovery process provides an opportunity – and perhaps the best
opportunity – for the examining party to clarify and provide foundation for its
understanding of what is relevant and to be disclosed, what are fair trains of
inquiry and where they might lead. In that sense, it is often simply premature
to bring motions for further and better affidavits of documents before
discoveries have started; this is especially so if the moving party is seeking disclosure
of large classes of documents that are not prima facie likely to contain
relevant information.
[22] Thus, I conclude that, whether on the wide
“train of inquiry” test, or a narrower reading of Rule 222(2), Novopharm is not
entitled to disclosure of every document in Lilly’s possession, power or control
that relate to the facts pleaded, whether or not they can directly or
indirectly assist its case. Novopharm is not entitled to disclosure of every
document in Lilly’s possession so that it might itself consider whether they
might be useful. Unless it can establish that Lilly’s vetting process was
inadequate, Novopharm must be satisfied by the sworn statements appearing in
Lilly’s affidavits of documents, to the effect that the affiant has diligently caused
the records to be searched and has made appropriate inquiries and disclosed, to
the full extent of his or her knowledge, information and belief, the documents
that would tend to adversely affect Lilly’s case or advance Novopharm’s.
[23] Thus, with respect to Novopharm’s general
complaint that Lilly’s affidavits of documents are prima facie deficient
because they fail to disclose all documents disclosed by Lilly in the context
of US proceedings, which documents clearly “relate” to the issues in this case,
I find the complaint not founded.
[24] The question which now arises is whether
Lilly’s approach in determining which of a wider class of documents should be
disclosed was reasonable and sufficient. Lilly has filed evidence on this
motion explaining the basis upon which it chose to include or exclude documents
from the vast initial documentary production in the US proceedings. It
explained that initial documentary production in the US proceeded on the basis
of “notice pleadings” and therefore resulted in documentary discoveries which
are much broader than the specific allegations of the final pleadings. From
that massive production, the US parties (including those adverse in interest to
Lilly) then selected and included in a “Unified Trial Exhibit List” all
documents on which they felt they might rely at trial (an even smaller
selection was eventually adduced at trial). Lilly’s evidence is that, having
considered the issues raised in the US and in the present proceeding, its
affiants were satisfied that all documents that might possibly relate to the issues
in this action had been part of the initial US disclosure, and that it was
reasonable to assume that any document which might undermine its case or assist
an opponent’s case on these same issues had been selected by Lilly’s opponents
and included in the Unified Trial Exhibit List.
[25] As mentioned above, Novopharm’s position
was that as a matter of legal principle, Lilly’s disclosure had to include all
documents relating to the issues pleaded, thus all documents of the
initial US production. Novopharm did not argue, other than through the
specific categories discussed below, that the basis upon which Lilly proceeded
was unreasonable or that applying that method resulted in relevant documents
being omitted. In any event, I am satisfied that in the circumstances of this
case, Lilly’s affiants did not proceed unreasonably. I do not accept that the
Rules require, as a matter of law, that an affiant in every case review
personally each document individually. All that the Rules require is that the
affiant cause to be conducted a diligent search and make appropriate inquiries
for the purposes of disclosure in the affidavit of documents. Lilly’s main affiant,
having notably also participated in the documentary discovery exercise in the
US, was satisfied that a diligent search had already been conducted for the
purpose of the US litigation and did make inquiries, which appear on their face
to be reasonable and appropriate, to determine which of those documents
corresponded to the Rule 222(2) definition. I can find no fault with this
approach generally.
[26] That being said, it may be that this
approach proved in practice unreliable or insufficient in that it failed to
“catch” relevant documents. A review of the documents which Novopharm contends
are missing would be indicative as to whether, despite an apparently reasonable
method of identifying documents, Lilly missed relevant documents and should
therefore be required to conduct a reassessment of its documents.
[27] I now proceed to consider the specific
categories of documents which Novopharm contends are missing.
i) Clinical trial
documents:
[28] At the hearing, Novopharm conceded that all
such documents had apparently been produced, up to and until 2001, and
accordingly restricted its argument to clinical trial data created after 2001. I
am satisfied that there is evidence establishing that clinical trials were
conducted in the period after 2001, that this data likely relates to side
effects profiles, and that it may therefore tend to advance Novopharm’s
position. It also appears from the transcripts of cross-examinations and from
Lilly’s argument at the hearing that Lilly has taken the view that such
documents are not relevant, regardless of whose case they would support, based
purely on the date the data came into existence. As mentioned above, all
documents containing clinical trial data that would tend to advance Novopharm’s
allegations as to the non-existence of the advantages claimed or disclosed in
the patent are legally relevant for the purpose of Lilly’s affidavits of
documents. Thus, Lilly has the continuing obligation, and will in any event be
specifically ordered, to review its records to determine whether clinical trial
documents created after 2001 exist and have not been disclosed, and if so, to
include them in a further and better affidavit of documents.
ii) Internal memos and documents relating to clinical trials:
[29] The evidence on record suggests that such
documents as had been created prior to 2001 would have been included in the
initial documentary productions in the US litigation and have therefore already
been considered for relevance and included as necessary in Lilly’s affidavits
of documents. I therefore limit my comments under this heading to such
documents as may have come in existence after 2001, since the record before me
shows that Lilly would not have considered such documents for potential
disclosure in any event.
[30] As mentioned above, the only fact in issue
to which post-2001 internal comments or communications might relate is the
objective existence or non-existence of the advantages disclosed or claimed in
the patent. This is clearly a matter of objective scientific fact, to be
established by expert evidence on the basis of the data which Lilly has or will
disclose. What Lilly or its employees think or believe as to the conclusions
to be drawn from the data is irrelevant and cannot advance Novopharm’s case
unless Lilly has made on the issues corporate statements amounting to
admissions. As the documents sought by Novopharm in this category are internal
communications between employees, they cannot reasonably be supposed to include
corporate statements.
[31] Could internal documents of Lilly
commenting on the clinical trial data be reasonably supposed to lead to a train
of inquiry that would advance Novopharm’s case or hurt Lilly’s? Novopharm’s
motion record does not suggest how that might be, and I cannot see how they
could lead to any train of inquiry that might advance Novopharm’s case other
than back to the original data to which they relate. As this data has or will
be provided, a document that has no use but to refer to it can have no
discernable benefit to Novopharm. Even if these internal memoranda could be
construed as technically included in the definition of Rule 222(2) because
they lead back to the clinical trial data, I would exercise my discretion to
relieve Lilly from their disclosure.
[32] Novopharm submits that these communications
might contain statements damaging to Lilly, as, for example, statements
admitting that certain information was known to Lilly at the time of the
prosecution of the patent, but not disclosed to the Patent Examiner.
Obviously, if any internal documents of Lilly contain such statements, the
particular documents are relevant and have to be disclosed. As mentioned
above, this still does not entitle Novopharm to have production of an entire
class of irrelevant documents just so that it can satisfy itself that Lilly did
not overlook those that were relevant. Still, it appears that Lilly would not
have included in its consideration for potential relevance documents created
after 2001. It should therefore, as part of its continuing obligation of
disclosure, make reasonable inquiries or take reasonable steps to ensure that
internal documents that might contain such damaging admissions are reviewed and
disclosed if they exist.
iii) Correspondence
between Lilly and Health Regulators:
[33] Again, for the same reasons, I confine my remarks
to the post-2001 period. Novopharm submits, and I agree, that it has been
established that correspondence was exchanged between Lilly and Health
Regulators relating to product monographs and labeling changes to include
warnings as to the side effects of olanzapine.
[34] Again, however, and based on the evidence
adduced by Novopharm itself, this correspondence would squarely be based on, and
would merely interpret or discuss the clinical data which Lilly has already or
will be disclosing. It cannot reasonably be supposed that Lilly has, in this
correspondence, admitted to any other negative side effects than those against
which publicly available labels and product monograph warn. Again, the only
information to which this correspondence might be supposed to lead is the same clinical
data and reports which have or will be produced. I am satisfied that this
class of documents would not advance Novopharm’s case, undermine Lilly’s or be
susceptible of leading to a train of inquiry having either result.
iv) Documents from products liability litigation:
[35] Exhibits “O” to “V” of Anna Hucman’s first
affidavit sworn October 5, 2007 are examples of documents which Novopharm
argues were not but should have been disclosed by Lilly.
[36] These documents were produced in the
context of product liability actions taken in the United States against Lilly
in relation to Zyprexa. Although covered by a confidentiality order in that
litigation, they were, in breach of that order, leaked to the New York Times
and were posted on the internet, so that Novopharm had access to them. Most of
those documents, but not all, are internal Lilly documents. Some pre-date the
date of issuance of the Canadian patent at issue, some were created
afterwards. Generally speaking, these documents can be said to relate to what
Lilly knew about the side effects of olanzapine and when, and how Lilly dealt
with this information in its public communications about or its promotion of
Zyprexa. In that, they clearly relate to the product liability action in which
they were disclosed, as I understand that at issue in that litigation is
whether Lilly misled the public or failed to adequately warn users as to the
side effects of the drug.
[37] Are these documents relevant to this
litigation? Novopharm has specifically pleaded, at paragraphs 20 to 22 of its
statement of defence and counterclaim, that Zyprexa has been the subject of
product liability lawsuits in the United States and Canada, that Lilly had
played down its own data as to side effects to promote Zyprexa, and that there
was an established pattern, from as early as 1986 through to as late as 2001,
to mislead “not only the Patent office, but also doctors and the general
public”, to boost sales of Zyprexa.
[38] Although these allegations formally make
relevant every document disclosed in said product liability actions, it is
trite law that a party may not enlarge the area of discovery indefinitely by
making irrelevant allegations which, even if substantiated, cannot affect the
result of the action. (Apotex Inc. v. Merck & Co., (2004), 33 CPR
(4th) 387 at par. 15, affirmed (2005), 38 CPR (4th) 289
(F.C.A.).
[39] Whether or not Lilly has been sued for
product liability in relation to Zyprexa, and whether or not it has misled any
person or body other than the Patent Examiner, cannot possibly make this patent
invalid. Accordingly, despite the allegations made in Novopharm’s statement of
defence and counterclaim as to these matters, I find that documents are not
relevant, and do not need to be disclosed, merely because they would tend to
establish Novopharm’s allegations that Lilly intended to or did mislead doctors
and the general public, or because they relate to allegations made in product
liability actions.
[40] That is not to say that documents disclosed
in product liability actions may not otherwise be relevant to the issues
properly raised in the present action. Documents tending to establish that
Lilly intentionally misled the Patent Examiner or omitted to communicate
relevant information of which it was aware are subject to disclosure. Reading
the allegations of the statement of defence and counterclaim generously, that
would include all documents tending to show what Lilly knew at the time of the
prosecution of the patent as to the side effects profile of olanzapine, but of
course, ending on the date of the issuance of the patent, that is, July 14,
1998.
[41] Documents “O”, “P” and “Q”, are dated 2001
and 2003. At best, they discuss what Lilly knew, as of their date, as to
certain side effects of Zyprexa. Lilly’s subjective knowledge after the
issuance of the patent is not relevant. To the extent the documents discuss
objective facts, they can only lead back to the data discussed therein, which
data has or will be provided. Mainly, as well, the documents concern the perceptions
of others on that matter. They contain no information as to what Lilly knew up
to and including the date of issuance of the patent or what Lilly might have
represented to the Patent Examiner. I find that these documents cannot,
directly or indirectly, advance Novopharm’s case or undermine Lilly’s, and as a
consequence, they did not have to be disclosed in Lilly’s affidavit of
documents.
[42] Document “R” contains information which
may, directly or indirectly, establish Lilly’s knowledge of certain issues as
of 1996, a relevant date for that issue. In particular, the document may
establish awareness on the part of Lilly as to whether certain forms of
statements could be considered misleading.
[43] Documents “S”, “T”, “U” and “V” all contain
information that may tend to advance Novopharm’s case, in that they may
directly or indirectly establish the state of Lilly’s knowledge or awareness as
to certain side effects of Zyprexa in the period prior to the issuance of the
patent. These documents are therefore relevant for the purpose of Lilly’s
affidavit of documents and should have been disclosed.
[44] Lilly has not filed evidence to the effect
that documents “R” to “V” were disclosed in its affidavit of documents,
contrary to the statements contained in Novopharm’s evidence to the effect that
they do not appear to be. I therefore find that the documents were not
disclosed by Lilly in its affidavit of documents when they should have been.
[45] The fact that five relevant documents
created before 2001 could be identified by Novopharm indicates that the process
used by Lilly to search for and identify relevant documents may not have been
adequate. Lilly will be required to review its documents with a view to
ensuring that all relevant documents be disclosed.
[46] I stress here that documents “R” to “V” are
relevant because of the specific information they contain. Having specific
regard to document “R”, other documents that can be described as being in the
same class of documents (for example, correspondence between X and Y, in year
Z, respecting Zyprexa) cannot reasonably be supposed to necessarily
contain that type of information, and may be irrelevant. Novopharm is only
entitled to disclosure of the documents from this class of documents that are
relevant; it is entitled to know that Lilly has reviewed its documents to
identify and disclose any document which may contain similarly relevant
information. As mentioned before, Novopharm is not entitled to have disclosure
of the entire class of documents to satisfy itself that relevant documents have
not been overlooked.
v) Expert
reports from other litigation:
[47] Any such report would have been created
after the date of issuance of the patent. They would speak only of what a
third party – the independent expert in question – thinks or believes of the
issues in question as of the date they were created, and are therefore
irrelevant. To the extent the reports discuss, and therefore could lead to,
relevant factual information, it is that information that may be relevant and
subject to disclosure. If that information is in Lilly’s power, possession or
control, it should already have been or should be disclosed.
[48] It is also noted that expert reports, if
they have not been filed publicly as exhibits in the proceedings for which they
were prepared, were either filed confidentially or were not filed at all. If
they were not filed, they are protected by litigation privilege. To the extent
they were filed and covered by a confidentiality order, Lilly could only waive confidentiality
insofar as its own information is concerned. Whatever part of Lilly’s expert
reports discuss information over which others are entitled to assert
confidentiality pursuant to a Court Order could not be disclosed by Lilly.
Counsel for Novopharm further conceded at the hearing that it is reasonable to
suppose that Lilly’s expert reports would not likely tend to advance
Novopharm’s case or undermine Lilly’s.
[49] For all these reasons, I am satisfied that
experts reports prepared for the purpose of other litigations are not relevant
and should not have been disclosed in Lilly’s affidavit of documents.
[50] I would mention, however, that to the
extent information of another party than Lilly protected by a confidentiality
order is available to Lilly and is relevant to this matter, it should have been
disclosed in Lilly’s affidavit of documents but in a manner that will not
breach the relevant confidentiality order. The evidence before me establishes
that even a description of such documents would contravene the confidentiality
order issued in the US litigation. As such, any disclosure that could be made would
amount to no more than a bare mention of “documents produced in litigation “X”
protected by a confidentiality order and for which confidentiality cannot be
waived by Lilly alone” and would be of little use to Novopharm. In the present
case, Novopharm is clearly already aware of the existence of such documents; it
therefore is unnecessary for Lilly to add that mention in a further and better
affidavit of documents.
vi) Prior art produced in
the US action:
[51] It is trite law that only that prior art
which is specifically alleged in pleadings is relevant. For the purpose of
Novopharm’s allegations of anticipation and obviousness, Lilly did not have to
disclose any document as to prior art in its possession, power or control
unless it intends to rely upon it at trial or it is specifically alleged in
Novopharm’s pleadings.
[52] However, because Novopharm’s pleadings
raise, as an issue, the objective non-existence of the advantages claimed or
disclosed in the patent and the invention’s objective failure of utility,
documents – whether internal to Lilly or publicly available – within the
possession of Lilly which would advance Novopharm’s case on that issue must be
disclosed.
[53] The evidence before me shows that Lilly
automatically excluded from its disclosure all published documents not created
by Lilly and not specifically alleged by Novopharm, on the basis that they were
un-alleged, and therefore irrelevant prior art. Lilly failed to consider
whether those documents could be used to support Novopharm’s assertion that
olanzapine does not in fact have the asserted advantages or effects. Lilly
must conduct a review of these documents and disclose those that may tend to
advance Novopharm’s case or hurt its own on these issues.
2. Extension of the
schedule for examinations on discovery
[54] As indicated at the hearing, whether or not
Novopharm has had communication of every relevant document from Lilly at this
time, does not, in the circumstances of this case, justify delaying Lilly’s
examination for discovery of a representative of Novopharm, in accordance with
the schedule set out in previous orders of the Court. Novopharm has not
establish what, if any, prejudice it would suffer from submitting to discovery
in advance of possibly receiving further documentary disclosure from Lilly. As
of issuing these reasons, I understand that this examination for discovery has
taken place as scheduled.
[55] Discoveries, by Novopharm, of the inventors
and of Lilly’s representatives are scheduled to take place during the first
week of December, 2007. It is a given, from the conclusions reached on this
motion, that some further documents will likely have to be produced by Lilly.
However quickly Lilly can review its documents and provide revised affidavits
along with whatever additional documents it might uncover, it is an exercise
that will likely take one or two weeks, with only a week or so left for
Novopharm to review the additional documents in preparation for discoveries.
Only if the volume of further disclosure is limited will it then be reasonable
to suppose that Novopharm will have had sufficient time to review them in order
to proceed with the discoveries. In the circumstances, I am satisfied that a
short extension of time for Novopharm to proceed with its discoveries of Lilly
and of the inventors is justified. As Novopharm has had the bulk of Lilly’s
documents for a considerable period of time, it seem to me that unless the
volume of documents to be received from Lilly is again as much as the volume
already produced, Novopharm should have more than enough of 45 days from
production of the revised affidavits of documents to prepare for and conduct examinations
for discoveries.
3. Other remedies
[56] Novopharm has, in the context of the
prosecution of this motion, had an opportunity to cross-examine the person who
swore the affidavit of documents on behalf of Eli Lilly and Company and Eli
Lilly and Company Limited, the entities most directly targeted by his motion.
Whatever benefit this exercise could have had has therefore already been
obtained; I can find no reason to subject any of Lilly’s affiants to a
cross-examination on affidavit at this time. I note as well that Novopharm did
not press that issue at the hearing. As for Novopharm’s request that the
solicitor who signed the certificate attached to the affidavit of document be
cross-examined, not only is there no precedent or legal basis for such a remedy
being granted, but no evidence was presented that would justify that request
being made, let alone being granted.
[57] The sole apparent purpose for Novopharm’s request
that it be advised of the identity of the representatives selected by Lilly for
discovery would appear to be to allow Novopharm to challenge the suitability of
that representative ahead of time. The notion that a party can challenge the
adequacy of a representative’s preparation before even beginning the examination
has no merit. Novopharm’s request for that remedy is denied.
[58] I am satisfied that the Plaintiff’s
proposal, that the examinations for discovery of three of its representatives
take place in Indianapolis, that one of the inventors be examined in England,
his place of residence, and that the representative of Eli Lilly Canada Inc. be
examined in Ottawa is the most fair and reasonable for both the parties and the
chosen representatives, as well as the most expeditious and least expensive in
the circumstances. That part of Novopharm’s motion requiring all examination to
take place in Toronto and Ottawa will likewise be dismissed.
[59] The other issues raised in Novopharm’s
notice of motion were either resolved or withdrawn at the hearing and require
no determination.
4.
Costs
[60] Although Novopharm is successful on part of
its motion, in that Lilly will be required to review its documents and provide a
revised affidavit of documents, which will serve to certify that the process
mandated by this order has been carried out and disclose such additional
relevant documents as the exercise will have revealed, success on this motion
can be said to be evenly divided. Novopharm’s allegations of wholesale and
“apparently deliberate” failure of Lilly to disclose documents was not made
out, a substantial number of documents alleged by Novopharm to be relevant have
been held not to be, and the majority of the other relief sought by Novopharm
were denied.
[61] The Court also notes that Novopharm
demanded that this motion be scheduled even before it had had the benefit of
Lilly’s response to its informal request for further and better documentary
disclosure, a step which had already been scheduled to occur. Indeed, the
record before me indicates that Novopharm finalized its motion record without
having properly reviewed, if it had reviewed at all, the substantial
documentary production made by Lilly. In all, Novopharm’s motion leaves the
distinct impression that its filing was motivated as much by the desire to delay
the conduct of these proceedings as by a legitimate need for further
disclosure.
[62] Costs will therefore be awarded in the
cause.
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