Date: 20091231
Docket: T-1773-07
Citation: 2009 FC 1316
Ottawa, Ontario, December 31,
2009
PRESENT: The Honourable Mr. Justice Lemieux
BETWEEN:
ELI LILLY CANADA INC. and
ELI LILLY AND COMPANY
Plaintiffs
(Defendants by Counterclaim)
and
HOSPIRA HEALTHCARE CORPORATION
Defendant
(Plaintiff by Counterclaim)
REASONS FOR JUDGMENT AND JUDGMENT
Introduction and
background
[1]
Hospira
Healthcare Corporation (Hospira) appeals to this Court the June 19, 2009
Order of Prothonotary Tabib (the prothonotary) who is case managing this patent
infringement action launched by Eli Lilly Canada Inc. and Eli Lilly and Company
(Lilly) on October 4, 2007 and twice subsequently amended claiming
Hospira infringed its Canadian Patent 2,098,881 (the “ ‘881 patent”). The ‘881
patent is a process patent for the preparation, through a SN2 chemical
reaction known as glycosylation,
of
a beta anomer enriched nucleoside compound which is the essential component for
active pharmaceutical ingredient (API) in the manufacture of the drug gemcitabine hydrochloride
which has anti-tumor cancer properties. The prothonotary ordered Hospira to
serve upon Lilly a further and better affidavit of documents namely: (1) the
open part and the closed part of its Drug Master File (DMF); (2) the relevant
parts of its Abbreviated New Drug Submission (ANDS) and amendments to it, filed
with the Minister of Health (the Minister), which the Minister based the
issuance on August 23, 2007 of an NOC to Hospira authorizing it to sell the
drug in Canada; and, (3) the Batch Records relating to the process for
manufacturing gemcitabine (the drug or medicinal ingredient) along with the
certificates of analysis relating to the medicinal ingredient imported in bulk
form and sold in Canada by Hospira (the documents to be produced). She also
ordered Hospira to produce to Lilly unredacted and complete copies of the
documents.
[2]
The
documents Hospira had first listed in its initial affidavit of documents on
October 6, 2008 were: (1) heavily redacted excerpts of its ANDS; (2) a
confidential process description for the manufacture of the drug; and, (3) a
batch report for the manufacture of the drug. The last two mentioned documents
were obtained by Hospira from Hospira UK in the context of
litigation in the UK between the parties in respect of the drug.
[3]
Lilly’s
claim against Hospira has several unique features:
i.
Hospira
is not the manufacturer of the gemcitabine it uses to make appropriate dosages
of the drug sold in Canada. Its gemcitabine is manufactured in China by Jiangsu
Hansen Pharmaceutical Co., Ltd. (Hansen). Hospira imports its gemcitabine in
bulk from that supplier.
ii.
Both
Lilly and Hospira recognize that the ANDS Hospira filed with the Minister to
obtain its NOC was based on a glycosylation chemical reaction known as SN1 which
is not as efficient in producing beta anomers the central element of gemcitabine’s
API. Rather,
the SN1 reaction is more efficient in producing alpha anomers which
do not have anti-tumor properties.
iii.
Both
parties agree, if Hospira’s gemcitabine is produced on the basis of a SN1 reaction,
the ‘881 patent is not infringed because its process is based upon the SN2
reaction whose effect is to foster the production of the more desirable beta
anomers. The SN1 reaction was disclosed prior to the invention of
the SN2 process step in the manufacture of the API.
iv.
Both
parties also agree that either the SN1 or the SN2 reaction is
but an intermediary step in the manufacture of the API component of the drug.
The ‘881 patent does not claim a monopoly on the steps leading to the
preparation of the SN2 reaction (the upstream steps), nor does it
claim a monopoly on the separation and purification steps that follow the SN2
reaction (the downstream steps).
v.
In
its statement of claim, Lilly asserted “the processes claimed in the ‘881
patent are the only processes that can produce commercial quantities of gemcitabine
in an efficient and cost effective manner” and that, inter alia, between August
27, 2007 and December 3, 2007, Hospira imported in Canada commercial quantities
of gemcitabine manufactured in China by the SN2 reaction.
[4]
Hospira
submits Prothonotary Tabib erred in law and/or proceeded on a
wrong principle in making the order she did. It asserts her Order enables Lilly
to “embark on a fishing expedition by way of discovery, with respect to
irrelevant documents falling outside the scope of the process patent at issue,
premised only on Lilly’s unpleaded speculation of regulatory fraud on Health Canada.” Hospira
also asserts the foundation for Lilly’s speculation is that Hospira’s process
is not commercially viable because it was incompatible with Lilly’s business
model 20 years ago. Hospira also says the inventor of the ‘881 patent has
admitted Hospira’s process for the manufacture of the drug as described in its
ANDS filed with the Minister of Health is prior art to the patented process and
cannot infringe it.
[5]
The
parties did not fundamentally disagree on the standard of review on this appeal,
the legal test for relevance and the nature and the scope of the ‘881
patent.
(1) The standard of review
[6]
In
their written material, the parties had initially disagreed on the standard of
review. Notwithstanding the fact the prothonotary’s order was made upon a
motion by Lilly for a further and better affidavit of documents from Hospira,
Hospira’s counsel submitted the effect of the prothonotary’s order is to
prolong and maintain this action, since in the absence of that order, Lilly’s
action would be effectively over. Hospira’s counsel did not press this view in
oral argument recognizing, in my view, the recent jurisprudence on the issue
did not support her argument of this point.
[7]
In
my view, Prothonotary Tabib’s order is not vital to the resolution of this
action and therefore her decision is not to be reviewed by this Court de novo.
This standard of review on appeal was clearly established recently by the
Federal Court of Appeal (the FCA) in Eli Lilly Canada Inc. v. Novopharm Ltd.,
2008 FCA 287 (Novopharm) in which the FCA upheld a decision of this Court,
which in turn, upheld a decision of Prothonotary Tabib to compel a further and
better affidavit of documents in a patent infringement case launched by Lilly
(see Novopharm, paragraph 53). Consequently, Hospira has the burden of
demonstrating on this appeal in making the order Prothonotary Tabib made -
compelling a further and better affidavit of documents and the production of
those documents in unredacted form - she was clearly wrong, in the sense that
the exercise of her discretion to make such an order, was based upon a wrong
principle or upon a misapprehension of the facts. (See Merck & Co.,
Inc. et al v. Apotex Inc., 2003 FCA 488.)
(2) The legal test for relevance
[8]
The
legal test for relevance for determining what documents a party is entitled to
have listed in an affidavit of documents and produced for discovery was also
settled by the FCA in the Novopharm case. The test is based on the concept of “a
train of inquiry” namely, unless the party producing the affidavit of
document intends to rely on a document at trial, that person 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 [a
reasonable likelihood of leading] to a train of inquiry which may have either
of these two consequences. [My emphasis.]
(3) The nature and scope of the ‘881
patent
[9]
The
nature and scope of the ‘881 patent is also recognized by the parties. The ‘881
patent is entitled “Stereoselective
Glycosylation Process.” As noted, it relates to the manufacture of the drug gemcitabine which has anti-tumor cancer
properties. The ‘881 patent discloses and claims an intermediate process
step used in the overall seven step process to make the API of the drug. Specifically, the ‘881
patent claims a monopoly on step 5 of these intermediate steps, the SN2
reaction at the glycosylation stage in the API’s production
process for the drug.
[10]
The
focus of the ‘881
patent is on the SN2
reaction known as glycosylation. Hospira’s point is that glycosylation can occur
by one of two pathways: one through SN1 reaction and the other through
the SN2 reaction. As mentioned, Hospira recognized the SN2 reaction
yields better beta results but nevertheless the SN1 pathway is
acceptable even though it yields more undesirable alpha anomers in the nucleoside
compound the result of the glycosylation stage. Hospira also recognizes
the drug gemcitabine is a beta anomer and that the alpha anomer is not
gemcitabine and does not have the anti cancer properties of that drug.
[11]
The
crux of this litigation is what chemical reaction actually takes place at the glycosylation stage – the
SN1
reaction or the SN2 reaction. Either reaction takes place in Hansen’s
plant in China.
Prothonotary Tabib’s
decision
[12]
At
the beginning of her considerations for Order, she identified the central issue
in the patent action:
The central issue in this action is
whether the process used by Hospira’s supplier, Jiangsu Hansen Pharmaceutical
Co. Ltd. (“Hansen”) to manufacture in China the bulk gemcitabine subsequently
imported and sold by Hospira in Canada infringes the claims of the patent at
issue, the ‘881 Patent.
[13]
She
explained: “Hospira alleges that the process used by Hansen is a
previously known and disclosed process, known as the SN1 reaction.
Both parties agree that if Hospira’s gemcitabine was and is indeed manufactured
by Hansen using the SN1 reaction, then there is no infringement, as
the patented process is an entirely different process, known as the SN2
reaction.”
[14]
She
further noted : “Hospira has listed in its affidavit of documents and disclosed
to Lilly those portions of its regulatory filings with Health Canada showing the
relevant reaction. Again, Lilly concedes that the reaction disclosed in those
parts of the filings corresponds to the SN1 reaction, and that if it
is indeed the process followed by Hansen, there is no infringement.”
[15]
Prothonotary
Tabib next considered Lilly’s additional disclosure request category by
category. She indicated the main thrust of Lilly’s motion was on the issue
of the Batch production records and its related certificates of analysis
for the gemcitabine product actually imported by Hospira and offered for
sale. She devoted much of her analysis to that issue because: “Both parties
concede that those batch records would constitute direct evidence of the
process actually used by Hansen in manufacturing the bulk gemcitabine, and
assuming that they are accurate, would constitute direct evidence of whether
the process used by Hansen is the SN1 reaction or the SN2
reaction, and therefore, whether or not there is infringement.” [My
emphasis.]
(a) The Batch Records
[16]
She
identified the question on the motion before her, as it related to the batch
records, as “whether it is reasonable to suppose that these documents would
undermine Hospira’s case or advance Lilly’s; in other words, is it
reasonable to suppose that the batch records would show that Hansen uses the
SN2 reaction?” [My emphasis.]
[17]
She
analysed Hospira’s argument such likelihood was negated by the fact that its
regulatory filings unequivocally show that the SN1 process is
used; that Hospira had an obligation to be accurate and complete, and
“dire” consequences would result “if Hospira had represented to Health Canada
that it used the SN1 process while it was using in fact the SN2
process.” Hospira urged upon Prothonotary Tabib what was filed with Health Canada “is
tantamount to a declaration under oath and that it carries with it a
presumption of veracity which can only be rebutted by cogent evidence.”
[18]
For
a number of reasons, Prothonotary Tabib did not accept Hospira’s submission on
this point:
a. Hospira never
specified the nature of the “dire” consequences would strike it should its
supplier use the SN2 in its manufacturing process and it did not appear
from the record any provisions were made in the regulatory scheme for auditing
the accuracy of the process information provided.
b. Unless it
contained an admission against Hospira’s interest, she doubted very much a
certificate, addressed to Health Canada for the purpose of obtaining an NOC, as
to the process that will be carried out by a third party in the future,
could be relied upon by Hospira as evidence of the process actually used in
the context of an infringement action and “as such [she had] very serious
reservations as to Hospira’s proposition the certificate delivered to Health
Canada, in the circumstances of this action, is equivalent or tantamount to a
sworn statement by a representative of Hospira as to the process carried out by
Hansen.” She noted Hospira had tendered no evidence what system it had in place
to verify the continued accuracy of the statements made to Health Canada or that
anyone at Hospira has even reviewed the batch records for the imported
gemcitabine to verify that they ostensibly conform with the regulatory filings.
She further observed, while there was no evidence before her of any falsehood
on Hospira’s part, there was nothing on the record which would lead her to
believe Hospira’s faith in the continuing accuracy of its filings rests on
anything other than its own faith in its supplier and said she was not aware that
Hansen “had ever filed a similar certificate with Health Canada or made any
representation in this litigation as to the process it uses. She said no party has
indicated what penalty, if any consequences would be suffered by Hansen if it
chose to manufacture the bulk gemcitabine in a manner different than that contemplated
by Hospira.” She concluded: “I am therefore not satisfied that a presumption
even attaches as to the truthfulness or accuracy of Hospira’s certificate to
Health Canada, as it
relates to its supplier’s actual process.” [My emphasis.]
[19]
In
any event, she was satisfied Lilly had produced sufficient evidence to
demonstrate “the likelihood that the batch records would show that
Hansen uses the SN2
reaction instead of the SN1 reaction.” She analyzed two
affidavits and related cross examinations thereon. Lilly’s deponent was Dr.
Douglas Kjell, an expert in chemical process development in that organization. The
thrust of his evidence on using the SN1 process to manufacture bulk gemcitabine
was “so inefficient as to not be viable to produce commercial quantities of
that ingredient.” Its yield was very low and uses a highly reactive and
dangerous reagent and, as well, an inefficient and wasteful method of
purification.”
[20]
She also
considered the affidavit and cross examination of Hospira’s expert, Dr. Robert
Adlington. She described his evidence in the following terms: “However, rather
than contradicting or impugning the scientific basis on which Dr. Kjell reached
his conclusion that the SN1 process is not commercially viable, he
suggests, but without citing specific facts, that it is not impossible that
these obstacles could be overcome or offset by other efficiencies in other
parts of the process. He goes on to state that he has witnessed personally
the SN1 process being carried out by Hansen at its premises in China “on a commercial
scale”.
[21]
Prothonotary
Tabib indicated it was common
ground between the parties the batch Dr. Adlington witnessed being made by
Hansen in China had not been identified as one which was imported into Canada, and the batch in
question did not result in more than 10.7 kg of API. She said there was no
evidence on record as to what Hospira considers to be commercial quantities of
gemcitabine, and Dr. Adlington admitted he was not aware of either Hospira’s or
Hansen’s cost of production or other economic information. She found Dr.
Adlington, unlike Dr. Kjell, had no experience in the area of managing and
evaluating the costs of a process that is run on a large or commercial scale. She
gave little weight to Dr. Adlington’s view the process he witnessed at Hansen
was on a commercial scale. She did not accept Hospira’s submission Lilly had
not proven either it or Hansen’s intentions were to make or sell gemcitabine on
a commercial basis. She also discarded an attack on Dr. Kjell’s evidence as
being self-serving because he is an employee of Lilly who himself had
recommended Lilly not use the SN1 process. She ruled she could
accept evidence from an employee of a party if it was relevant and the expert
properly qualified “especially so where, as here, no evidence has been tendered
by the other party to directly contradict the scientific basis for the opinion
and where the testimony has not been shaken on cross-examination.” She
concluded:
I
therefore accept Dr. Kjell’s evidence to the effect that the SN1
process is extremely inefficient and wasteful and that it is more likely than
not that it would not be used in a commercial operation. That is sufficient to create a
reasonable basis to suppose that Hansen is not carrying out the SN1
process for the gemcitabine imported and sold by Hospira in Canada, notwithstanding Hospira’s perhaps genuinely held belief
and intent to the contrary, as evidenced by Hospira’s filings with Health Canada. Accordingly, I am satisfied that Lilly
has established a reasonable likelihood that the batch records of Hansen for
the gemcitabine imported and sold by Hospira in Canada could show the use of
the SN2 process and therefore directly advance Lilly’s case. These
documents are relevant and must be listed in the affidavit of documents, either
as documents within the power, possession or control of Hospira, if that is the
case, or if not, as documents in the power, possession or control of a third
party. [My emphasis.]
[22]
Finally,
she remarked that the batch records for the production of gemcitabine made in
the presence of Dr. Adlington were eventually produced to Lilly, but in a
heavily redacted form. The only rationale she could see for the redactions was
on the grounds of relevance i.e. they relate to parts of the process which is
not strictly covered by the claims of the patent, and that they are therefore
not relevant. She observed Hospira did make an argument relating to
confidentiality, but produced no evidence whatsoever showing that the portions
it has redacted are “particularly sensitive or confidential”, such that the
provisions of the confidentiality order already in place would not adequately
protect them.
[23]
She
concluded:
Hospira’s
sole basis for going through the trouble and expense of redacting portions of
such documents (therefore producing an obviously incomplete document) is lack
of relevance. In my view, the practice of parties redacting portions of
documents on no justification whatsoever other than lack of relevance, thus
putting the receiving party to the onus of establishing the relevance of the
redacted portions, is one to be avoided. Partial productions and redactions
should not be permitted unless on grounds of proportionality, onerousness, or
convenience or when genuine issues of confidentiality arise. Documents
produced pursuant to this order shall therefore not be redacted. [My emphasis.]
(b) The other documents sought
[24]
With
respect to the other categories of documents requested by Lilly for listing and
production, Prothonotary Tabib ruled “the same reasoning applies to Lilly’s
request that the entire, unredacted parts of the closed and opened portions of
Hospira’s DMF and of the ANDS, as they relate to the manufacture of bulk
gemcitabine, be disclosed and produced without redaction. To the extent they
are self-contained documents, rather than a collection of independent
documents, no reason for redaction has been made out.”
Analysis
(a) The Standard of Review
[25]
I
have already held that to succeed Hospira must show the Prothonotary erred by
exercising her discretion based upon a wrong principle or upon a
misapprehension of the facts.
(b) Hospira’s arguments
[26]
In
her written material, counsel for Hospira prefaced her points stating “the key
issue in this appeal is whether Lilly should be permitted to embark on a
wide-ranging discovery based on un-pleaded speculation Hospira has
misrepresented its manufacturing process to Health Canada.” She added
that the foundation for Lilly’s speculation is that Hospira’s process is
not commercially viable because it is incompatible with Lilly’s business model
nearly 20 years ago.”
[27]
First,
Hospira asserted the prothonotary had misconstrued Lilly’s cause of action when
she ordered Lilly should have access to Hospira’s entire process for the
manufacture of gemcitabine and not merely the intermediate stage (the glycosylation stage that
is relevant to the ‘881 patent). Counsel submits prothonotary Tabib erred when
she “concluded that “commercial viability” of a defendant’s action is relevant
to a determination of possible infringement” and further erred when “finding
the entire synthesis is the relevant process for the purposes of an
infringement analysis [and] in doing so she effectively redefined the scope of
the ‘881
patent providing protection for the production of gemcitabine per se as opposed
to the intermediate.”
[28]
Second,
she argues the
prothonotary’s finding “that an SN1 reaction is not “commercially
viable” because it requires the use of a dangerous chemical known as TMS-triflate”
constitutes a collateral attack on the Minister’s decision to issue an NOC to
Hospira, because in so doing, he had to consider whether Hospira’s drug based
on gemcitabine was safe and effective.
[29]
Third,
counsel for Hospira urged upon the Court, the prothonotary erred when she
failed to recognize Lilly’s allegation of infringement rests solely on its
speculation as to the intentions and/or motive of Hospira/Hansen, i.e. a
finding that Hospira was motivated to make and sell gemcitabine on “a
commercial basis” under Lilly’s undefined parameters. In other words, the
prothonotary erred when she took into account a totally irrelevant factor in
assessing infringement – the factor of “commercial viability”.
[30]
Fourth,
she argues the prothonotary fell into error when she found there was no
presumption that the content of Hospira’s ANDS should be presumed true. Counsel
for Hospira submits the prothonotary’s conclusion on this point reflects a
misinterpretation of the regulatory scheme of the Food and Drug Regulations.
She refers to a UK decision holding an untrue certification would
constitute a fraudulent misrepresentation to a regulatory authority and such a
course of action being “commercial suicide”. She couples this argument with a
further point the prothonotary erred in finding that no serious consequences
could ensue from a misrepresentation to Health Canada. She also
asserts prothonotary Tabib further erred Hospira had the burden of proving
regulatory fraud which had not been pleaded by Lilly.
[31]
Finally,
Hospira argued the prothonotary misrepresented the facts when she concluded
there was a reasonable likelihood the batch records sought by Lilly would show
use by Hansen of the SN2
process and therefore infringement.
[32]
In
oral argument, counsel for Hospira on the following findings said to have been
made in error: (1) ordering the disclosure of the entire seven steps to produce
the API
when the ‘881
patent only claimed a monopoly on the SN2 glycosylation stage; (2) a finding of no
presumption that what had been filed with the Minister was true; (3) a finding
of an un-pleaded regulatory fraud; and, (4) misapprehension of the facts
by giving weight to an old business model of “commercial viability” proffered
through the affidavit of Dr. Kjell, a current and longtime employee of Lilly
who was neither independent or objective. In reply argument, counsel for
Hospira argued the prothonotary made her critical findings when she had
insufficient evidence before her to do so. She pointed for example: (1) the
yield for the SN1 reaction had not been updated; (2) the
prothonotary overplayed the risks of producing gemcitabine using TMS-triflate; and, (3) Lilly’s
commercial viability model did not appropriately take into account the changes
in labour costs in developed countries versus China.
Analysis and conclusions
[33]
I
will quickly dispose of some of the arguments put forward by counsel for
Hospira because, with respect, in my view, what is asserted by Hospira as findings
made by the prothonotary were in fact not findings at all.
[34]
A
reading of her decision as a whole clearly tells this Court Prothonotary Tabib
was focussed on one issue which is all she decided: whether the evidence
presented by the parties assessed in their totality was sufficient to satisfy
her the relevancy test and, in particular, the “train of inquiry” test had been
met i.e. the evidence was such that it was reasonable to suppose the documents
sought in the further and better affidavit of documents would undermine its
Hospira’s case, advance by Lilly’s case or would fairly lead to a train of
inquiry which may have either of these consequences.
[35]
In
coming to the conclusion she did that additional disclosure was warranted, the
prothonotary carefully weighed the evidence submitted by both sides and the
cross-examination on those affidavits.
[36]
In
this context, in my opinion, the prothonotary made no finding:
i.
That
Hospira had made any misrepresentation in its ANDS to the Minister. However, she
also found there was no evidence Hansen (as opposed to Hospira in its ANDS) had
made any representation whatsoever to the Minister and, in particular,
asserting the use of the SN1
reaction at the glycosylation stage.
ii.That
Hospira’s ANDS did not have the benefit of truthfulness, but held, in the
particular facts of the case before her, where the supplier of the bulk gemcitabine
was an offshore supplier who had made no representations to the Minister, where
Hospira had not led evidence of any verification system in place to review and
verify what glycosylation
process was used in the bulk gemcitabine it imported and Lilly’s
evidence on the commercial viability of the SN1 reaction,
Hospira could not rely on the presumption.
iii.The
prothonotary did not make a finding “commercial viability” was a factor in
considering whether there was infringement or not. What she decided was there
was sufficient evidence before her leading her to be satisfied what she was
ordering was relevant to Lilly’s action.
iv.The
prothonotary did not find that by ordering the production of the entire process
followed to make the API for the gemcitabine, Lilly was expanding the limited
claims protected under the ‘881 patent. All she decided was that disclosure of
the entire process was relevant to a specific plea in Lilly’s statement of
claim, namely, of patent infringement by using the SN2 reaction.
Sufficient evidence had been led to convince her the sought after documents by
Lilly met the relevancy test in the context of a further affidavit of documents
motion.
v.The
prothonotary’s decision was not a collateral attack on the Minister’s finding
in terms of the Minister’s statutory duty as to the safety and efficiency of
the drug Hospira sold to consumers in Canada in dosage form. Lilly has not attacked
the Minister’s
NOC to
Hospira and has not alleged the drug Hospira markets in Canada is unsafe or
ineffective. What Lilly has alleged is that, in so doing, Hospira has infringed
its ‘881
patent by its supplier’s use of the SN2 reaction.
[37]
I
have had an opportunity to review the affidavits and the cross-examinations of
Drs. Kjell
and Adlington. I agree with counsel for Lilly there was in the record before
her sufficient evidence to support each of her findings made by the prothonotary
which were based, in my view, on the application of the correct test for
relevance in the context of a motion for a further and better affidavit of
documents.
[38]
In
particular, for example, Dr. Adlington acknowledged that:
a. All yields of
each step in the process to the making of the gemcitabine is important as they
all contribute to the overall yield (Adlington’s cross-examination, page 29, question
77).
b. Knowing the
starting material for the process related to an SN2 reaction is important. Such starting
material had to be based on an alpha anomer (Adlington’s cross-examination,
page 153, question 547).
c. To determine
whether gemcitabine was prepared in a cost effective manner a person with the
particular expertise would have to have information on the upstream steps
necessary to prepare for the
SN2 reaction (Adlington’s cross-examination, pages 86 to 89).
d. Costs were
factors which needed to be considered for a company to be commercially viable
i.e. make a profit to support its overall business venture (Adlington’s
cross-examination, pages 30 and 87).
[39]
Clearly,
on the basis of this evidence, the prothonotary had ample evidence to find the
upstream and downstream steps from step 5 were relevant and should be produced.
[40]
It
should be noted the question whether the prothonotary had sufficient evidence
or misconstrued the evidence is a finding of fact in respect of which the
prothonotary is owed a large measure of deference. See by analogy the Supreme
Court of Canada’s recent decisions in Dunsmuir v. New
Brunswick, 2008
SCC 9 and Canada (Citizenship and Immigration) v. Khosa, 2009 SCC 12.
[41]
In
terms of Dr. Kjell’s
affidavit evidence and cross-examination, a review of the record reveals the
prothonotary had sufficient un-contradicted evidence to support her finding the
use of the SN1 process was inefficient in terms of yields, residual
waste and dangers related to its production with TMS-triflate.
[42]
She
was not persuaded by the argument advanced by Hospira a change of material
circumstance had occurred since the early 1990’s when Dr. Kjell worked on the SN1 reaction
to determine if commercial quantities of gemcitabine could be made in a
viable way. Moreover, I find no error in her appreciation of Dr. Kjell’s
evidence the weight she gave to that evidence and the preference she gave to
that evidence over the evidence of Dr. Adlington which in any event she found
largely corroborative of Dr. Kjell’s.
[43]
In
the result, Hospira’s appeal must be dismissed as it has not satisfied its
heavy onus of demonstrating to the Court the prothonotary clearly erred in
making the order under review. On the contrary, I am of the view the order she
made was correct and proper.
JUDGMENT
THIS COURT
ORDERS AND ADJUDGES that this appeal is
dismissed with costs, fixed at the upper range of the units in Column IV of the
Tarriff.
“François
Lemieux”
_____________________________
Judge
Email this Content