Date: 20101026
Docket: A-13-10
Citation: 2010 FCA 282
CORAM: NADON
J.A.
PELLETIER J.A.
STRATAS
J.A.
BETWEEN:
HOSPIRA HEALTHCARE CORPORATION
Appellant
and
ELI LILLY CANADA INC. and
ELI LILLY AND COMPANY
Respondents
REASONS FOR JUDGMENT
[1]
This is an
appeal from the decision of Mr. Justice Lemieux of the Federal Court dismissing
an appeal from a decision of Prothonotary Tabib who granted an order for the
further and better production of documents in an infringement action.
[2]
Eli Lilly
Canada Inc. and Eli Lilly and Company (Eli Lilly) hold the patent for an
intermediate process step used in the seven step process by which the drug
gemcitabine is produced. The patented process is known as the SN2
reaction. It is an improvement on an earlier process known as the SN1
reaction. Eli Lilly has no claim to the other steps in the fabrication process
nor to the drug gemcitabine itself. Hospira sells in Canada gemcitabine
manufactured in China by Jiangsu Hansen
Pharmaceutical Co. Ltd (Hansen). The allegation in Eli Lilly’s infringement
action is that Hansen uses the SN2 reaction in its manufacturing
process.
[3]
Hospira
filed an affidavit of documents in which it listed redacted copies of its
Abbreviated New Drug Submission, and of a batch report for the manufacture of
the drug.
[4]
Prothonotary
Tabib ordered the appellant Hospira to prepare and serve a further affidavit of
documents including “the open part and the closed part of its Drug Master File,
the relevant parts of its Abbreviated New Drug Submission as they relate to
Hospira’s process for manufacturing bulk gemcitabine, as well as amendments
thereto, and Batch Records and certificates of analysis for the bulk
gemcitabine imported and sold in Canada by Hospira.”
[5]
The
standard of review of the Prothonotary’s order concerning disclosure and
production in this case is that it must be “clearly wrong” before the Federal
Court or this Court can intervene. An example of “clearly wrong” is where the
Prothonotary’s discretion was founded upon a wrong principle or a
misapprehension of the facts. See Merck & Co. Inc. et al. v. Apotex Inc.,
2003 FCA 488; Novopharm Limited v. Eli Lilly Canada Inc., 2008
FCA 287, at paragraphs 52 and 57.
[6]
Before
this Court, Hospira raised two arguments. The first is that the Prothonotary
erred in principle in accepting the expert evidence of Dr. Kjell, a chemist
employed by Eli Lilly who had worked on the glycosylation process for a number
of years and who was listed as one of the inventors of the SN2
reaction. Hospira argued that Dr. Kjell’s evidence should be automatically
rejected because he was an employee of Eli Lilly and, therefore, lacked the
independence and the impartiality required of an expert witness
[7]
Counsel
for Hospira was unable to cite any authority for the proposition that an
employee cannot give opinion evidence on behalf of his or her employer merely
because of the employee’s lack of independence from the employer. I am unaware
of any basis for such a sweeping proposition which would have wide ranging
consequences.
[8]
While
there has been judicial commentary on the desirability of experts being
independent of the parties and impartial in their opinions (see, for example, National Justice Campania Naveria
SA v. Prudential Assurance Co. Ltd. (“The Ikarian Reefer”), [1993] 2 Lloyd’s Rep. 68, at pp. 81-82), one must
distinguish between independence and impartiality. There is
a corpus of law dealing with the question of independence as a bar to the
admissibility of an expert’s evidence, as opposed to a factor to be considered
in assessing the weight to be given to that evidence. Those cases are reviewed
in United City Properties v. Tong, 2010 BCSC 111. It is not necessary
for us to settle this debate in order to dispose of this case. I would say
though, that a review of many of those cases suggests that that which is being
attacked under the name of lack of independence is often, in fact, lack of
impartiality. Lack of impartiality is the mischief which has given rise to the
recent amendments to the Federal Courts Rules, SOR/98-106, to which
reference was made by counsel for Hospira.
[9]
None
of the cases relied upon by Hospira are authority for the proposition that the
testimony of a properly qualified expert may be rejected solely on the basis of
the latter’s lack of independence. Merck & Co v. Apotex Inc., 2004
FC 567, [2004] F.C.J. No. 684, deals with the issue of the appropriateness of a
protective order. No decision was made as to the admission or rejection of
expert evidence. In Biovail Pharmaceuticals Inc. v. Canada (Minister of
National Health and Welfare), 2005 FC 9, [2005] F.C.J. No. 7, the Court,
after repeating the often quoted passage from The Ikarian Reefer,
accepted as an expert witness the applicant’s Vice-President,
Pharmaceutical Technology, over the objections of the respondents who
questioned his financial interest in the outcome of the litigation. In Lundbeck
Canada Inc. v. Canada (Minister of Health), 2009 FC 146, [2009] F.C.J. No.
249, the Court rejected a challenge to the qualification of a certain witness
as an expert on the basis that the witness had testified for the same party 20
times in the past 30 years. The Court accepted his evidence after a reading of
his cross-examination disclosed his objectivity.
[10]
The
Prothonotary assessed Dr. Kjell’s evidence in the light of his
cross-examination and of the expert opinion tendered on behalf of Hospira. It
cannot be said that she was clearly wrong to have embarked on that exercise, or
that she misdirected herself in the course of it.
[11]
Hospira’s
second argument is that the Prothonotary erred in her application of the test
for relevance. The Prothonotary applied the broad relevance test which asks
whether a document is likely to undermine a party’s own case, to advance its
opponent’s or to lead its opponent to a train of inquiry which may do either of
the above. If the disclosure of a document is likely to lead to any of these
results, it is relevant and must be disclosed and produced.
[12]
Hospira
argued that the presumption of veracity which attaches to its regulatory
filings raised the bar in terms of whether it was likely that the documents
sought by Eli Lilly would advance its case, impair Hospira’s or suggest a train
of inquiry which might lead to either result. In effect, Hospira’s argument was
addressed to the requirement that a document be “likely to” produce one of
these effects in order to be considered relevant. In Hospira’s view, it was
unlikely that the documents requested would contradict its regulatory filings.
[13]
It is
true that regulatory filings provide a basis for administrative action, and to
that extent can be taken to be true unless and until some basis for
disbelieving them is made out. That said, this practical reality is without
consequences for the course of an infringement action. A party cannot resist
production of documents on the basis that, in a regulatory context, it has
filed documents which are inconsistent with the plaintiff’s allegations in an
infringement action. The likelihood that the requested documents are relevant
is not dependent upon a party’s good faith but upon the content of those
documents.
[14]
The best
example of this proposition is the batch records whose production Hospira
resisted. Once Hospira conceded that the batch records in issue “would
constitute direct evidence of the process actually used by Hansen in
manufacturing gemcitabine” (see the 2nd full paragraph on page 3
of the Prothonotary’s order), their relevance was obvious, notwithstanding any
of Hospira’s regulatory filings. As for the scope of the order for production,
the Prothonotary’s order is limited to lots of gemcitabine imported into Canada
and does not have the unlimited reach which counsel for Hospira attributed to
it, even though it may amount to a continuing obligation.
[15]
Hospira
also opposed production of its unredacted regulatory filings. Hospira argued
that since Eli Lilly’s only interest was in a single step of a multi-step
fabrication process, its demand for disclosure of Hospira’s entire unredacted
regulatory file amounted to a fishing expedition. As the Prothonotary pointed
out at page 10 of her order, “as Lilly has succeeded in establishing some
grounds for doubting the reliability of that part of the regulatory filings on
which Hospira intends to rely, it follows that the remaining portions of the
regulatory filings may point to other grounds upon which the disclosed portions
may be undermined; they are accordingly relevant.” I am unable to say that the
Prothonotary erred in applying the broad relevance principle to the facts in the
way she did. As a result, there is no basis on which we could intervene.
[16]
As a
result, I would dismiss the appeal with costs.
“J.D.
Denis Pelletier”
“I
agree.
M.
Nadon J.A.”
“I
agree.
David
Stratas J.A.”
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