Date: 20060728
Docket: T-560-05
Citation: 2006 FC 937
Vancouver, British
Columbia,
July 28, 2006
PRESENT: Roger R. Lafrenière, Esquire
Prothonotary
BETWEEN:
PFIZER CANADA INC. and
WARNER-LAMBERT COMPANY, LLC
Applicants
and
THE MINISTER OF HEALTH and NOVOPHARM
LIMITED
Respondents
REASONS FOR ORDER AND ORDER
[1]
By motion dated July 18,
2006, the Applicants,
Pfizer Canada Inc. and Warner-Lambert Company LLC (collectively, Pfizer), seek
leave to allow each of the parties to file a memorandum of fact and law up to
45 pages in length.
[2]
Pfizer’s motion is opposed by the Respondent, Novopharm Limited
(Novopharm), on the grounds that Pfizer has not presented any evidence that it
is unable to adequately present its case within the 30 page limit prescribed by
Rule 70(4) of the Federal Courts Rules (Rules).
[3]
Rule 70(4) provides that the Court may grant leave to a party to
file a memorandum of fact and law that exceeds 30 pages in length. The only
issue on this motion is whether Pfizer has established the requisite
evidentiary basis for this Court to grant the relief requested.
Facts
[4]
This proceeding is an application by Pfizer under the Patented
Medicines (Notice of Compliance) Regulations (Regulations).
Novopharm is seeking approval from Health Canada for its atorvastatin calcium
10, 20, 40 and 80 mg tablets (Novopharm Tablets) and has compared the Novopharm
Tablets to Pfizer's atorvastatin calcium tablets which are sold as Lipitor.
Pfizer has listed Canadian Letters Patent No. 2,021,546 ('546 Patent) on the
Patent Register in respect of Lipitor.
[5]
Pfizer commenced this application on March 24, 2005 in response
to a Notice of Allegation and Detailed Statement delivered by Novopharm (NOA)
which alleges, among other things, that the relevant claims of the '546 Patent
are invalid. In particular, Novopharm has alleged that certain claims of the '546
Patent are invalid on the basis that:
(a)
the claims are anticipated by U.S. Patent 4,681,893;
(b)
the claims are obvious in light of the prior art; and
(c)
the claims are double patented over the claims of Canadian Patent
No. 1,330,441.
[6]
Pfizer served its affidavits-in-chief on August 19, 2005,
consisting of the following eleven affidavits:
(a)
The 35-page confidential
Affidavit of Dr. Bruce D. Roth sworn August 17, 2005. Dr. Roth is the inventor of the '546 Patent.
(b)
The 28-page confidential Affidavit of Roger S.
Newton sworn August 17, 2005. Dr. Newton is a biochemist who was involved in
the initial development of atorvastatin calcium.
(c)
The 57-page confidential Affidavit of Dr. William
R. Roush sworn August 17, 2005. Dr. Roush is a medicinal chemist.
(d)
The 32-page confidential Affidavit of John M.
Dietschy sworn August 16, 2005. Dr. Dietschy is a medical doctor.
(e)
The 25-page confidential
Affidavit of Michael P. Doyle sworn August 17, 2005. Dr. Doyle is an
organic chemist.
(f)
The 14-page confidential Affidavit of Dr. Peter
Lionel Spargo sworn August 5, 2005. Dr. Spargo is a development chemist.
(g)
The 25-page confidential Affidavit of
Christopher Bokhart sworn August 15, 2005. Mr. Bokhart is an economics
consultant in the pharmaceutical industry.
(h)
The 19-page confidential Affidavit of Sam
Gourdji sworn August 15, 2005.
Mr. Gourdji worked at Pfizer as Director of Marketing at the time of Lipitor’s
launch in Canada.
(i)
The four-page confidential Affidavit of Tom
Brogan sworn August 17, 2005.
Mr. Brogan is a consultant in the pharmaceutical industry.
(j)
The 25-page affidavit of
Peter Howard Jones sworn August 17, 2005. Dr.
Jones is a medical doctor.
(k)
The two-page affidavit
of Maria Klapka sworn August 18, 2005. Ms.
Klapka is Director of Regulatory Policy and Intelligence, Medical Division at
Pfizer.
[7]
On November 4, 2005, Pfizer served and filed a Fresh as Amended
Notice of Application clarifying that only one claim is at issue in this
proceeding.
[8]
Novopharm served its responding affidavits on December 15, 2005, consisting of the following ten affidavits:
(a)
The 49-page confidential Affidavit of Dr. Clayton H. Heathcock
sworn November 28, 2005. Dr. Heathcock is a professor in the Graduate School at
the University of California at Berkeley.
(b)
The 28-page confidential Affidavit of Gilbert
W. Adelstein sworn December 14, 2005. Dr. Adelstein is a medicinal chemist.
(c)
The 32-page confidential Affidavit of Alfred
Alberts sworn December 14, 2005. Dr. Alberts is an independent pharmaceutical
and scientific consultant.
(d)
The 34-page Confidential Affidavit of Joseph
Weinstock sworn December 14, 2005. Dr. Weinstock is an independent
consultant in the pharmaceutical industry.
(e)
The 25-page Confidential Affidavit of Gene C.
Ness sworn December 15, 2005. Dr. Ness is a Professor of Biochemistry
and Molecular Biology in the College of Medicine at the University of South
Florida.
(f)
The 30-page confidential Affidavit of Dr. Lea Prevel
Katsanis sworn December 14, 2005. Ms. Katsanis is an associate professor in the
Department of Marketing at the John Molson School of Business at Concordia University.
(g)
The 16-page affidavit of Dr. Peter Loewen sworn December 14, 2005.
Dr. Loewen is a clinical pharmacist.
(h)
The seven-page affidavit of Bruce M. Gagala
sworn December 14, 2005.
Mr. Gagala is a lawyer in the United States.
(i)
The 10-page Affidavit of Anna Hucman sworn December 15, 2005. Ms. Hucman
is a law clerk at Heenan Blaikie.
(j)
The two-page supplementary Affidavit of Anna Hucman sworn
December 15, 2005.
[9]
On March 3, 2006, Prothonotary Martha Milczynski, who is case
managing the proceeding, granted Pfizer's motion for leave to file reply
evidence and, at the same time, granted leave to Novopharm to file sur-reply
evidence.
[10]
Pursuant to the Order dated March 3, 2006, Pfizer filed seven
reply affidavits and Novopharm filed six sur-reply affidavits in response to
Pfizer's reply affidavits.
[11]
Cross-examinations of the parties’ affiants began on March 31,
2006 and were completed on July 5, 2006.
[12]
Pfizer sought Novopharm’s consent to an order granting leave to
the parties to each serve and file a memorandum of fact and law of 45 pages in
length. Consent was refused by Novopharm on the grounds that this application
is a straightforward matter and that no justification has been provided to
exceed the 30-page limit.
Analysis
[13]
Rule 70(4) provides that, unless otherwise ordered by the Court,
a memorandum of fact and law, exclusive of the list of authorities and
appendices, shall not exceed 30 pages in length.
[14]
The 30-page limit exists to ensure that the issues are presented
to the Court in a concise manner, as commented upon by the Court of Appeal in Sawridge
Band v. Canada (2006), 145 A.C.W.S. (3d) 971, 2006 FCA 52 at
paragraph 20:
Conciseness is
a virtue which is always in demand but, in my experience, often conspicuous by
its absence from memoranda of fact and law filed in this Court. I do not
recall an occasion when I thought that the expansion of a memorandum by another
10 pages would have improved things. Quite the contrary, in fact.
[15]
Such limitation on the length of written argument is not unique
to the Federal Court. In a Practice Direction governing the procedure on civil
appeals in the Ontario Court of Appeal dated October 7, 2003, the Chief Justice
of that Court directed that in the majority of appeals, the length of the
factum should be 30 pages or less. In the Ontario Court of Appeal, where
counsel is of the opinion that a factum of more than 30 pages is needed, a
motion for leave is required. On such a motion, the moving party is expected to
include a copy of the proposed factum in the motion record.
[16]
This Court has the discretion under Rule 70(4) to lift the
restriction on the length of memoranda of fact and law. However, it will only do
so where the party seeking such relief has provided a reasonable explanation
and established the existence of special circumstances.
[17]
I agree with Novopharm that Pfizer’s affidavit evidence in
support of the motion is somewhat wanting. In particular, there is no evidence
specifically demonstrating that the issues in this proceeding are more complex
or numerous than the issues in any other proceeding under the Regulations.
[18]
Moreover, the Court cannot assess whether or not Pfizer’s
proposed memorandum of fact and law will be of assistance to the Court since a
draft document has not been produced. Had the Court, and the other parties,
been given an opportunity to review the proposed memorandum, the need may have
been apparent and this motion may not have been contested.
[19]
In a routine application, a party moving
for relief pursuant to Rule 70(4) would be expected to demonstrate the
complexity of the issues and clearly establish the need to file additional
written submissions. As well, as a matter of good practice, a draft memorandum should
be produced for the Court’s consideration. It remains, however, that this is
not a routine proceeding.
[20]
It can be gleaned from the record that Novopharm has raised
numerous legal issues in relation to Canadian Patent No. 2,021,546 ('546
Patent) which is owned by Pfizer. To address these issues, the parties have
served and filed thirty-five affidavits from twenty-one expert and fact
witnesses, and nineteen of the deponents have been cross-examined. The factual
record, in and of itself, is therefore exceptionally voluminous.
[21]
Moreover, five
days have been set aside for the hearing of the application, which does not
entail viva voce evidence, and will be limited to oral submissions of counsel. The
duration of the hearing, as agreed to by the parties, suggests substantial time
will be required to canvass the facts and the issues.
[22]
The overriding factor to consider on such
motions is whether by granting leave to file a lengthier memorandum the
hearing judge will be better able to make a proper determination of this
application on its merits. Based on my review of the NOA, the Amended Notice of
Application, and the affidavits on the record, I conclude that 30 pages will
not suffice to enable counsel to present the facts and argument in a manner
that is cohesive and accessible to the Court. In fact, it would be a disservice
to the judge hearing the application to insist that Pfizer slash its written
submissions simply to comply with a page limit geared towards routine
applications.
ORDER
THIS COURT ORDERS that
1.
The parties may each serve and file, with their respective records, a
memorandum of fact and law of 45 pages in length.
2.
This Order is made without prejudice to Novopharm’s right to raise
any argument with respect to costs directed towards the length of the parties'
memoranda of fact and law.
3.
The costs of this motion shall be in the cause.
“Roger
R. Lafrenière”
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