Date: 20100210
Docket: T-2009-09
Citation: 2010
FC 120
TORONTO, ONTARIO, February 4, 2010
PRESENT: Madam Prothonotary Milczynski
BETWEEN:
EPICEPT
CORPORATION
Applicant
and
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER AND ORDER
[1]
This is
the second motion brought by the Applicant, EpiCept Corporation for an order
under Rule 151 of the Federal Courts Rules. For the purposes of this
application for judicial review, the Applicant seeks to maintain the
confidentiality of:
(i)
the
identity of the Applicant company;
(ii)
the
identity of any employee of the Applicant company;
(iii)
the brand
name of the drug product;
(iv)
the
medicinal ingredient and variations of the medicinal ingredient;
(v)
other drug
products containing the medicinal ingredient or its variations;
(vi)
the disease
at issue in the new drug submission (“NDS”) filed by the Applicant; and
(vii)
otherwise,
the entire contents of the NDS.
[2]
The only
difference between this motion and the first which was dismissed in its
entirety without prejudice to the Applicant bringing a further motion for a
confidentiality order, is that the Applicant is no longer pursuing the further
relief that the very existence of a judicial review of a decision of the
Minister of Health ought also be kept from the public record. The Minister
takes no position on this motion, having opposed in part the first.
Background
[3]
In the
ordinary course, an innovator drug manufacturer seeking approval may file a
confidential NDS and apply to have any patent applicable to the drug product on
the Patent Register pursuant to sections 3 and 4 of the Patented Medicines
(Notice of Compliance) Regulations (“PMNOC Regulations”). The
innovator would also seek protection of its data under s.C.08.004.1 of the Food
and Drug Regulations. In these cases, even the fact that an NDS has been
filed is confidential and would not become known unless and until a Notice of
Compliance (“NOC”) has been issued. At that time, if the drug is an eligible
innovative drug, it is listed on the Register of Innovative Drugs, and if the
patent is eligible, it is listed on the Patent Register (s.3(7) of the PMNOC
Regulations).
[4]
Thus, only
when a NOC is issued, would the public know that a drug manufacturer has sought
approval to market a particular drug, that approval has been granted, that the
data supporting the approval is protected by virtue of section C.08.004.1(3) of
the Food and Drug Regulations, and that the drug is protected by a
patent for the purposes of the PMNOC Regulations.
[5]
By virtue
of C.08.004(3) of the Food and Drug Regulations, if the innovator’s drug
is eligible for data protection, a generic manufacturer may not file its
submission for approval of a copy of the drug until at least six years after
the NOC was issued to the innovator for the drug, and may not receive an NOC until
at least eight years after the NOC has issued – even if the innovator’s drug is
not protected by a patent. Finally, if the innovator’s drug has a patent
listed against on the Patent Register, the generic manufacturer must, pursuant
to the PMNOC Regulations, address that patent by way of Notice of
Allegation, submitting that the patent is invalid and/or would not be infringed
by the generic drug product. In the event a proceeding is commenced by the
innovator to prohibit the Minister of Health from issuing an NOC to the
generic, unless the Court is satisfied that the patent would not be infringed,
the generic manufacturer must also await the expiry of the patent before
obtaining its NOC.
[6]
In the
present case, EpiCept Corporation filed a NDS with Health Canada on August 5, 2009 for the
approval of CEPLENE (histamine dihydrochloride) for remission maintenance in
acute myeloid leukemia. As part of its NDS, EpiCept requested that CEPLENE be
designated as an innovative drug pursuant to the data protection provisions of
the Food and Drug Regulations. As noted above, the data protection
provisions provide an eight year term of market exclusivity for eligible
“innovative drugs” listed on the Register of Innovative Drugs.
[7]
EpiCept
also submitted one patent for listing on the Patent Register with respect to
CEPLENE. This patent will expire in 2010, and as acknowledged at paragraph 8
of its written submissions, EpiCept is relying on the market exclusivity
provided by data protection to protect its product in Canada for eight years following the issuance
of a NOC.
[8]
On August
27, 2009, the Office of Patented Medicines and Liason, on behalf of the
Minister, expressed its “preliminary view” that CEPLENE is not an “innovative
drug” and would not be added to the Register of Innovative Drugs. EpiCept
sought reconsideration of this decision by submitting responding submissions
and affidavit evidence to the Minister.
[9]
On
November 2, 2009, the Minister rejected EpiCept’s arguments and maintained its
decision that CEPLENE was not eligible for listing on the Register of
Innovative Drugs, and on December 1, 2009, EpiCept commenced the within
application for judicial review.
Confidentiality
[10]
EpiCept
seeks a confidentiality order to prevent the disclosure of its NDS for CEPLENE,
and argues that to protect the confidentiality of the NDS, it is necessary to
use neutral designations on any public documents: “Company X”, “Employee X”,
“Drug Product A”, “Medicinal Ingredient A”, and “Human Disease A”. The
Applicant also seeks leave to file an amended notice of application
incorporating these neutral designations, and further submits that this relief
is necessary to protect the confidentiality of the NDS and would cause only
minimal impairment to the public court system.
[11]
EpiCept
submits that it does not have approval to sell any products in Canada, and that CEPLENE is its only
marketed product around the world. EpiCept further submits that its
competitors have no way of knowing if CEPLENE is eligible for data protection,
as this information would only be made available to the public by Health Canada
after a NOC is issued.
[12]
While the
fact of EpiCept’s filing of an NDS would have been confidential in the ordinary
course unless and until a NOC was issued, EpiCept issued a press release on
November 9, 2009 announcing:
EpiCept Corporation (Nasdaq and OMX
Nordic Exchange: EPCT) today announced that Health Canada has accepted for
review the Company’s New Drug Submission (NDS) for Ceplene (histamine
dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML)
patients in first complete remission. Health Canada’s performance target for the completion
of review and a decision is within 300 days.
****
This news release and any oral statements
made with respect to the information contained in this news release, contains
forward-looking statements within the meaning of the Private Securities
Litigation Regorm Act of 1995. Such forward- looking statements include
statements which express plans, anticipation, intent, contingency, goals,
targets, future development and are otherwise not statements of historical
fact. These statements are based on our current expectations and are subject
to risks and uncertainties that could cause actual results or developments to
be materially different from historical results or from any future results
expressed or implied by such forward-looking statements. Factors that may
cause actual results or developments to differ materially include: the risk
that Ceplene will not receive regulatory approval or marketing authorization in
the United States or Canada…
****
You are cautioned not to place undue
reliance on any forward-looking statements, any of which could turn out to be
wrong due to inaccurate assumptions, unknown risks or uncertainties or other
risk factors.
[13]
Thus the
fact that EpiCept sought marketing approval for CEPLENE is information that is
public, as is the medicinal ingredient and human disease. I would also note,
however, that for whatever reasons it has, this information contained in the
press release was made public by EpiCept after it had already been
informed of the Minister’s decision that CEPLENE was not eligible for data
protection. The Court can only surmise that it is the decision denying data
protection and its judicial review application that EpiCept is most concerned
be kept confidential.
Confidentiality and the Public Interest
[14]
The test
to be met for the issuance of a confidentiality order pursuant to Rule 151 of
the Federal Courts Rules is a high one. In accordance with the Supreme
Court of Canada’s decision in Sierra Club of Canada v. Canada (Minister of
Finance) [2002]
2 SCR 522, the party requesting such
order must satisfy the Court that the information sought to be sealed “should
be treated as confidential, notwithstanding the public interest in open and
accessible court proceedings”. The public interest is in the open and
transparent administration of justice – not some narrow view of the public’s
perception or interest in the particular subject matter of a particular
proceeding. Only in exceptional cases, and where circumstances warrant can the
public interest in open courts be outweighed by the need to prevent a serious
risk of harm or prejudice to an important interest, which may include a
commercial interest. In that regard, some degree or element of public interest
will also be identified in protecting the confidentiality of information and
restricting access to the court process and file. For example, in Apotex
Inc. v. Canada [1993]
FCJ No. 427, Justice McGillis noted that it was in the public interest to
protect the confidentiality of information contained in new drug submissions,
arguably to encourage full and complete information disclosure to regulatory
agencies and continued research and development:
The
perceived confidentiality of information flowing from a drug manufacturer to
the Department of National Health and Welfare is a cornerstone of the system
pertaining to the processing of new drug submissions and the issuance of
notices of compliance. For this system to function effectively, the
confidential nature of the relationship ought to be honoured and maintained to
the extent possible.
[15]
By issuing
the press release, it can be said that EpiCept put its competitors on notice:
(i)
that any
competitor interested in producing a generic copy of the CEPLENE will have had
the opportunity to consider whether it will be eligible for data protection;
(ii)
that in
accordance with the legislative requirement for eligibility for innovative
drugs, the drug must not contain either a medicinal ingredient contained in a
previously approved drug, or a variation of such medicinal drug;
(iii)
that the
medicinal ingredient in CEPLENE is histamine hydrochloride; and
(iv)
that
informed competitors could come to some determination as to whether histamine
hydrochloride is likely to qualify CEPLENE for data protection.
[16]
Nonetheless,
EpiCept submits that if the current application for judicial review of the
decision to deny data protection is made public, it would be harmed by the
“head start” its competitors would enjoy to prepare regulatory submissions to
enter the market themselves. It seeks to keep secret the negative decision
regarding data protection, its application for judicial review, and the entire
content of the application, which coincidentally would also allow EpiCept to
maintain the impression left by its press release, notwithstanding the
disclaimer contained therein.
[17]
I cannot
see the concerns and risks identified by EpiCept as any reasonable basis to
order the breadth of confidentiality sought, which would essentially result in
a secret proceeding being conducted in this Court. EpiCept has failed to
identify any interest, other than the most narrow and private of commercial
interests in support of its proposed order that in no way outweighs or should
sweep aside the public interest in open and accessible court proceedings.
[18]
In any
event, if it is successful in the within application EpiCept will not lose its
competitive advantage – its competitors will be prohibited from filing any
regulatory submissions for six years. If EpiCept is unsuccessful, competitors
may or may not enter the market sooner, but not because of having received any
“confidential” information through this proceeding.
[19]
Accordingly,
this motion is dismissed with the exception of the granting of the protection
sought for the NDS filed with the Minister, which may be filed confidentially.
The parties may submit a draft confidentiality order consistent in that respect
with these reasons.
ORDER
THIS COURT ORDERS that:
1.
Leave is
granted to the parties to file the New Drug Submission filed by EpiCept
Corporation on August 5, 2009 on a confidential basis pursuant to Rule 151 of
the Federal Courts Rules.
2.
The
balance of the motion is dismissed.
“Martha Milczynski”
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