Date: 20100414
Docket: T-1868-09
Citation:
2010 FC 409
Toronto, Ontario, April 14, 2010
PRESENT: Madam Prothonotary Milczynski
BETWEEN:
PFIZER CANADA INC.,
WARNER-LAMBERT COMPANY AND
WARNER-LAMBERT COMPANY LLC
Applicants
and
NOVOPHARM LIMITED,
THE MINISTER OF HEALTH,
NORTHWESTERN UNIVERSITY AND
THE BOARD OF REGENTS FOR
THE UNIVERSITY OF OKLAHOMA
Respondents
REASONS FOR ORDER AND ORDER
[1]
By letter dated October 1, 2009, Novopharm served the Applicant,
Pfizer Canada Limited (“Pfizer”) with a Notice of Allegation and Detailed
Statement (the “NOA”) pursuant to section 5 of the Patented Medicines
(Notice of Compliance) Regulations (“PMNOC Regulations”) in relation to the
drug pregabalin.
[2]
In response to the NOA, on November 13, 2009, Pfizer commenced
the within application for judicial review pursuant to section 6 of the PMNOC
Regulations for an order prohibiting the Minister of Health from issuing a
Notice of Compliance (“NOC”) to Novopharm until after the expiry of five
patents: Canadian Patent Nos. 2,134,674, 2,297,163, 2,255,652, 2,325,045 and
2,327,285.
[3]
The parties have agreed to the form of a confidentiality order,
with the exception of the matter of the NOA which Novopharm seeks to have
designated as confidential and sealed in the court record. It is not so much
from the eyes of the public at large that Novopharm seeks to keep the NOA
confidential, but the eyes of other generic drug manufacturers who are already
in a the process of seeking an NOC for their pregabalin product and are parties
to an application under the PMNOC Regulations (as in the case of ratiopharm
Inc.), or more importantly, from those generic drug manufacturers who have yet
to deliver their NOA’s.
[4]
There is no provision in the PMNOC Regulations relating to
whether or not NOA’s are confidential unlike other pieces of information or
documents that are treated as confidential, such as Abbreviated New Drug
Submissions. There is also no precedent in this Court for
designating an NOA as confidential in the manner and for the purpose Novopharm
seeks.
[5]
To protect the confidentiality of the NOA prior to the hearing of
this motion, Novopharm unilaterally marked the NOA as confidential and
indicated to Pfizer when the NOA was delivered on or about October 1st
, that it was being delivered by Novopharm to Pfizer on a confidential basis.
[6]
Novopharm submits that it has “made a substantial investment in
the production of the Novopharm NOA [and] has treated and
maintained the Novopharm NOA as confidential. Novopharm argues that “there is
no public benefit to disclosing the Novopharm NOA. If Novopharm is successful
in this litigation and the Novopharm NOA is made available to Novopharm’s
competitors, those competitors could use the Novopharm NOA to ‘springboard’
onto the pregabalin market at considerably less expense than that incurred by
Novopharm.” Indeed, the evidence indicates that Novopharm incurred some
$200,000.00 in costs to prepare its NOA.
[7]
With respect to the nature of the information
contained in the NOA, Novopharm concedes that the contents of the NOA do not
contain trade secrets, commercially sensitive information or other types of
confidential information. Novopharm confirmed at the hearing of the motion
that there is nothing in the NOA that could or should be redacted to protect
the confidentiality of the information. In this case, Novopharm essentially
submits that the sum is greater than the parts – it is the entire work product
that Novopharm seeks to protect (including the information that is publicly
available), to prevent other generics from copying or relying in any way on
Novopharm’s NOA to further their own endeavours to obtain an NOC.
[8]
What Novopharm seeks is truly exceptional to the
principle of open and accessible court
proceedings. For the reasons below, the
order sought by Novopharm is denied.
NOA and Novopharm’s Interest in
Confidentiality
[9]
The NOA is not a pleading or court document.
The PMNOC Regulations require that an NOA containing a detailed statement of
the legal and factual basis for the allegations of non-infringement and/or
invalidity of a patent be delivered by a generic drug manufacturer. The NOA
cannot be amended once it has been delivered, thus it is important that it be
as detailed and thorough as possible.
[10]
In the case of the Novopharm NOA, I accept that
its preparation required substantial time (approximately 10 months), effort,
resources and money. This included consulting with and obtaining opinions from
internal scientific experts at Novopharm and its related company Teva, and from
Bennett Jones who developed the legal arguments and assembled the prior art.
The construction of the five patents, the reliance on specific pieces of prior
art and the arguments advanced in the NOA were all developed as a result of the
skill, knowledge and effort of Novopharm and its advisors, experts and
counsel. The NOA may well be unique, novel and original as Novopharm contends
in the structure and support of its arguments and be a first-class piece of
work.
[11]
As Novopharm noted, the purpose of this
“investment” is to be a very close second if not the first generic to obtain an
NOC for its pregabalin product. As detailed in the affidavit of Ildiko Mehes,
general counsel at Novopharm, Novopharm is seeking the advantage to capture the
greatest possible portion of the market share for its pregabalin product and
the reinforcement of Novopharm’s reputation as a market leader with the
purchasers of its products.
[12]
Novopharm is the second applicant in Canada to deliver an NOA for generic
pregabalin, ratiopharm Inc. being the first – and whose NOA is publicly
available in the Court record. But as indicated, Novopharm is most concerned
with other generic drug manufacturers who may be in the queue and who may gain
insight and assistance from reviewing the Novopharm NOA. As stated by
Novopharm:
If Novopharm’s
generic competitors are allowed to free-ride on Novopharm’s investment and are
able to again market access at the same time or shortly after Novopharm, then
Novopharm would forever lose the opportunity to benefit from being the first or
one of the first generics in the generic pregabalin market in terms of market
share, after having incurred substantial cost to do so. Novopharm’s
competitors would profit from having access to the Novopharm NOA by gaining
earlier and less expensive market entry, to Novopharm’s direct detriment. This
constitutes the impairment of a significant commercial interest of Novopharm.
Confidentiality
and Rule 151 of the Federal Courts Rules
[13]
Confidentiality orders are an exception to the
rule that court proceedings should be open and subject to public scrutiny. The
public’s interest in open and accessible court proceedings should not be
compromised absent exceptional circumstances. As held by the Supreme Court of
Canada in Sierra Club of Canada v. Canada (Minister of Finance), [2002]
2 SCR 522, confidentiality orders under Rule 151 of the Federal Courts Rules
should only be granted when:
(i)
such an order is necessary to prevent a serious
risk to an important interest, including a commercial interest, in the context
of litigation because reasonable alternative measures will not prevent the
risk; and
(ii)
the salutary effects of the confidentiality
order, including the effects on the right of civil litigants to a fair trial,
outweigh its deleterious effects, including the effects on the right to free
expression, which in this context includes the public interest in open and
accessible court proceedings.
There are three
elements to the first part of the Sierra Club test:
(i)
the risk in question must be real and
substantial, in that the risk is well grounded in the evidence, and poses a
serious threat to the commercial interest in question;
(ii)
in order to qualify as an “important commercial
interest”, the interest in question cannot merely be specific to the party
requesting the confidentiality order, the interest must be one which can be
expressed in terms of a public interest in maintaining confidentiality; and
(iii)
the Court must consider not only whether
reasonable alternatives to a confidentiality order are available, but must also
restrict the order as much as is reasonably possible while preserving the
commercial interest in question.
[14]
In addition, a party seeking a confidentiality
order must establish that at all relevant times the information was treated as
confidential. The information must be of a “confidential nature” such that a
reasonable expectation of it being kept confidential has arisen, as opposed to
information which a litigant would simply prefer to keep confidential.
[15]
Novopharm has acknowledged that the content of
the information in its NOA is not confidential, and agreed that no part or
parts should be redacted to preserve confidentiality. From Novopharm’s
perspective, the entire NOA must be kept confidential from a particular segment
of the public (other generics) to prevent those generics from relying on the
way Novopharm researched, compiled, organized and argued its allegations and
detailed statement of fact and law relating to the validity of the patents in
issue and non-infringement. Novopharm’s commercial interest in so doing, is to
ensure these generics do not gain market entry any faster or for less expense
than they would otherwise as a result of their relying on Novopharm’s NOA and
not doing their own work.
[16]
There are some significant problems with
Novopharm’s argument. First, there is no evidence of a serious risk to
Novopharm’s commercial advantage with respect to its market position and what
it hopes to be the timing of its market entry. Novopharm assumes it will
succeed on all five patents in issue in this case and makes assumptions about
how its and ratiopharm’s hearings will be scheduled by the Court. Novopharm
may or may not be first or a close second on the market. There is also no
evidence other than its own confidence in the quality of its work product to
suggest that other generics will be lining up to copy any part of the Novopharm
NOA, particularly when there is no evidence that ratiopharm’s NOA has attracted
such keen attention (or evidence that ratiopharm’s NOA should not warrant it).
[17]
Secondly, and in any event, Novopharm’s market
position cannot be characterized as an important commercial interest within the
meaning of Sierra Club. The commercial interest identified by Novopharm
is narrow and personal to Novopharm, namely, its first-to-market status and its
investment of time and money in the preparation of its NOA. There is no
principle or element of public interest in the confidentiality at stake of the
NOA, unlike the public interest identified in Sierra Club in maintaining
confidentiality of the information at issue in that case. In Sierra Club,
disclosure would cause a breach of a confidentiality agreement – there is a
public interest in preserving such agreements. There is no public interest in
ensuring Novopharm the time and/or exclusivity of its market entry over any
other generic drug manufacturer.
[18]
With respect to the second element of the Sierra
Club test, I am satisfied that the deleterious effects of the confidentiality
order proposed by Novopharm outweigh any alleged salutary effects. Open and
accessible court proceedings are one of the hallmarks of a democratic society
and promote public confidence in the integrity of the courts and administration
of justice.
[19]
To compromise the principle of an open judicial
process in the manner sought by Novopharm is only to protect Novopharm’s
interest in maintaining a possible commercial advantage over other generics. It
would also likely lead to even greater secrecy surrounding the proceeding and
other parts of this application. If the NOA is designated as confidential, any
documents referring to the purported novel and original arguments in the NOA
may need to be designated in whole or have portions redacted, and any hearing
regarding an interlocutory matter and/or the hearing on its merits may need to
be conducted in camera. The order sought by Novopharm will therefore
restrict public access to information, which information Novopharm has
acknowledged is not in and of itself confidential and restrict access to the
proceedings to the degree where much would be conducted in secret. While
Novopharm submits that the NOA is of no value to the public and would be of
little interest to anyone but the immediate parties and other generics, what
Novopharm seeks would gravely diminish the importance and value of open and
accessible court proceedings and the need to preserve the public’s confidence
in the integrity of the administration of justice.
[20]
Accordingly, the motion must be dismissed.
ORDER
THIS COURT ORDERS that:
1.
The motion
be and is hereby dismissed.
2.
In the
event the parties cannot agree on the costs of this motion, the parties may,
within fifteen days, file written submissions no longer than three pages in length.
“Martha Milczynski”
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