Date: 20090323
Docket: T-575-08
Citation: 2009 FC 251
Ottawa, Ontario, March 23,
2009
PRESENT: The Honourable Mr. Justice Barnes
BETWEEN:
PFIZER CANADA INC., PFIZER
LIMITED and
PFIZER RESEARCH AND DEVELOPMENT COMPANY,
NV/SA
Applicants
and
PHARMASCIENCE INC.
and THE MINISTER OF HEALTH
Respondents
AMENDED REASONS FOR ORDER AND
ORDER
[1]
This
is an appeal by Pfizer Canada Inc., Pfizer Limited and Pfizer Research and
Development Company, NV/SA (collectively referred to as Pfizer) from a
Prothonotary’s decision which denied a motion for production of documents that
Pfizer says are necessary and relevant to the prosecution of its Notice of
Compliance (NOC) application. This proceeding arises from the second of two
motions by Pfizer seeking production of essentially the same material. The
initial motion was dismissed by Prothonotary Kevin Aalto whose decision was
upheld on appeal by Justice Russel Zinn.
I.
Background
[2]
Pharmascience
Inc. served its Notice of Allegation (NOA) on Pfizer on February 22, 2008 in
respect of Pfizer’s 1,321,393 and 2,170,278 Patents, which concern the drug
product Norvasc (amlodipine besylate). Pfizer responded with an application
under the NOC Regulations seeking an order prohibiting the Minister of Health
(Minister) from issuing a NOC to Pharmascience until the expiry of those
patents. Pharmascience responded with a motion of dismissal under ss. 6(5)(a)
and (b) of the NOC Regulations on the basis of allegations of non-infringement
and ineligible listing.
[3]
Pfizer
initially sought production of a range of documents that were ostensibly
relevant to an argument that the Minister may have erred in his treatment of Pharmascience’s
new drug submission. Pfizer brought a motion for production of several
documents which it asserted were necessary “to make its case regarding the
adequacy of Pharmascience’s drug submission”. It is clear from the record that
this motion was more narrowly framed than Pfizer’s initial letter of
May 5, 2008 to Pharmascience which had demanded these documents also on
the basis of their claimed relevance to Pharmascience’s allegation of
non-infringement. I have no evidence before me to indicate why Pfizer later framed
its initial motion as narrowly as it did and without any obvious reference to
the substantive issue of non-infringement.
[4]
In
Pfizer’s initial motion to produce, Prothonotary Aalto examined the issue of
relevance in the context of allegations concerning the actions of the Minister.
He also considered the issue of their relevance to the substantive issue of non-infringement.
This is evident from the following passage from his decision:
It is the Notice of Allegation that
defines the issues to be determined in the proceedings under the Regulations.
The Notice of Allegation in this case deals with validity and infringement and
not with matters of safety and efficacy [see s.5 of the Regulations; and, see
also, Fournier Pharma Inc. v. Canada (Minister of Health) 2004 FC 1718
at pars. 6 and 8; and, Bayer, supra.]. Pharmascience has
provided Pfizer with relevant portions of the Pharmascience NDS for the
Pharmascience product in issue. Those documents disclose, among other things,
the drug substance, manufacturer name, the specifications for the drug
substance, the manufacturing process and stability protocols for that product.
Pharmascience has also provided a copy of its product monograph. Those are
obviously necessary, relevant and important documents.
In the circumstances of this case I am
not persuaded that the additional extensive of array of documents sought by
Pfizer are either necessary, relevant or important for Pfizer to be able to
assert its position in this proceeding. There is a pending motion by
Pharmascience under section 6(5) of the Regulations. The issues raised on that
motion relate to whether or not the drug product of Pharmascience is the same
as the drug product of Pfizer and estoppel. The documents sought by Pfizer are
also not relevant to the issues raised on that motion. In the end result the
motion is dismissed. […]
[5]
Prothonotary
Aalto’s decision was appealed and the appeal was heard by Justice Zinn: see Pfizer
Canada Inc. et al. v. Pharmascience Inc. et al., 2008 FC 950. Justice Zinn
recognized that Prothonotary Aalto’s decision was not limited to the relevance
of the requested documents to the actions of the Minister but also included the
question of their relevance to the substantive issues raised in Pharmascience’s
NOA. According to Justice Zinn’s decision, Pfizer argued before him that Prothonotary
Aalto had erred by characterizing the requested documents as being directed to
issues of product safety and efficacy (see para. 16). Justice Zinn dismissed
the appeal on the basis that the documents were not relevant to any
issue arising in the proceeding (see para. 18).
[6]
Pfizer
then brought a second motion for production of substantially the same documents
requested in its first motion. This second production motion was based on
evidence and argument that the documents were relevant to the substantive issue
of non-infringement and that an order ought to issue accordingly. Prothonotary
Martha Milczynski heard Pfizer’s second motion and dismissed it. Her reasons
for doing so are contained in the following passage from her Order:
Pharmascience resists, as it did in the
first motion, to provide any information regarding the process for making the
raw material, a description of the manufacturing process, process development
or composition of the dosage form and its components. Pharmascience argues
that the Applicants sought and were denied this information in the first
production motion, and even if there were new documents sought, Pharmascience
argues that such requests could have and ought to have been pursued in the
first motion. I must agree. The present motion is in effect, the Applicants’
“second bite at the cherry” and must be denied.
Particularly in the case of applications
under the PMNOC Regulations, motions for production, even if they seek
different things (which I am not satisfied is the case here), cannot be brought
on a serial or piecemeal basis. Applications under the PMNOC Regulations are
summary proceedings and must be heard and determined within the two year period
set out. There is no time for multiple production motions and the added
complexity and inevitable delay such practice would entail. As set out by the
Supreme Court of Canada in Danyluk v. Ainsworth Technologies Inc., 2001
SCC 44, paras. 18-20:
The law rightly seeks a finality to
litigation. To advance that objective, it requires litgants [sic] to put their
best foot forward to establish the truth of their allegations when first called
upon to do so. A litigant, to use the vernacular, is only entitled to one bite
at the cherry.
A person should only be vexed once in the
same cause.
It is from this decision that the
Applicants appeal.
II. Issues
[7]
Did
the Prothonotary err in her decision to refuse Pfizer’s motion for production
of documents?
III. Analysis
[8]
It
is not entirely clear to me that Pfizer fully articulated its relevancy
argument in its initial production motion before Prothonotary Aalto.
Nevertheless, Pfizer cannot now assert that it overlooked the issue of
substantive relevancy on that motion because it initially requested production
from Pharmascience on that broader basis in its letter of May 5, 2008. It has
also produced no evidence to explain why it so narrowly framed its initial
motion when it was apparently of the view that the same documents were relevant
to the non-infringement issue.
[9]
I
can identify no error in Prothonotary Milczynski’s decision in the application
of her discretion to refuse relief on the basis of issue estoppel or on the
alternative ground of abuse of process by re-litigation. In matters such as
this an applicant is expected to put its best and strongest case forward at
first instance and it should not be permitted to split its argument if it loses
on the first attempt. While I accept that these rules may not always be
rigidly enforced in the context of interlocutory motions, there should be some
explanation offered where the initial motion was not exhaustive. In these
circumstances I would not be disposed to exercise my discretion any differently
for exactly the same reasons given by Prothonotary Milczynski.
[10]
I
also agree with Pharmascience that Pfizer’s second motion for production amounts
to a collateral attack on the Order of Justice Zinn. Justice Zinn ruled that
the requested documents were not relevant to any of the issues arising in the
underlying application. Whether or not that finding exceeded the scope of the
motion before him, it nevertheless represented a finding that should be
addressed on appeal and not effectively challenged with a second motion
claiming the same relief.
[11]
I
would add that I do not find the evidence of Dr. Stephen Byrn to provide a
compelling case for the relevancy of these documents. The evidence of Dr. Alexander
Klibanov seems to be sufficient to establish that Pfizer’s claim amounts to no
more than unlikely speculation or, in the vernacular, “a fishing expedition”:
also see the decision of Prothonotary Aalto in Pfizer v. Apotex
(T-876-08 and T-886-08) dated February 10, 2009.
[12]
In
the result, this motion is dismissed.
ORDER
THIS COURT ORDERS that this motion is dismissed.
“ R. L. Barnes ”
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