Docket: T-485-17
Citation:
2017 FC 548
Ottawa, Ontario, June 5, 2017
PRESENT: Madam Prothonotary Mireille Tabib
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BETWEEN:
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INNOVATOR
COMPANY
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Applicant
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and
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THE ATTORNEY
GENERAL OF CANADA AND THE MINISTER OF HEALTH
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Respondents
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ORDER AND REASONS
[1]
The Applicant identified itself in instituting
this judicial review application as “Innovator Company”. That is not its real
name, but a pseudonym used to keeps its identity confidential.
[2]
The Applicant is an innovative pharmaceutical
company who filed a New Drug Submission (“NDS”) with Health Canada with the
view of obtaining approval to market in Canada a certain drug, the identity of
which it also wishes to keep confidential. The Minister of Health determined
that the Applicant’s submission makes a direct or indirect comparison to a
product for which another innovator (the “Other Innovator”) whose identity is
also undisclosed, has one or more patents listed on the Patent Register
maintained pursuant to the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133, as amended, (the “Regulations”). As such, the Minister determined
that the Applicant is a Second Person as defined in the Regulations,
that s 5 of the Regulations is triggered and that the Applicant is
required to address the patents listed against the Other Innovator’s product.
[3]
The Applicant seeks judicial review of the
Minister’s decision. In particular, it alleges that its submission references
certain clinical studies in respect of which both the Applicant and the Other
Innovator have propriety rights to use the resulting data, as well as publicly
available journal articles relating to the product at issue. The Applicant
submits that the Minister erred in mechanically applying the Regulations
and failing to consider that the Applicant is not merely a generic seeking to
use an innovator’s confidential data or to early-work a listed patent, but an
innovator in its own right, who has a proprietary interest in the data
generated by the studies and the right to use it.
[4]
The Notice of Application seeks an order
declaring that the Applicant’s NDS does not trigger the application of s 5 of
the Regulations, an order quashing the Minister’s decision finding that
the NDS triggers the application of s 5 of the Regulations and an order
directing the Minister to process the NDS without requiring the filing of Form
Vs.
[5]
The Applicant now brings this motion seeking a confidentiality
order in respect of its own identity, the identity of its drug product, the
entire content of its NDS and any information it provided to the Minister in
support of its NDS. Although not specifically stated in the proposed order, the
confidentiality order would extend to the identity of the Other Innovator.
[6]
The Other Innovator is not named as a respondent
to the judicial review, even under a pseudonym, and was not served with or
notified of either the Notice of Application or the motion for a confidentiality
order. The Applicant’s submissions and evidence on this motion are to the
effect that the Applicant would stand to suffer irreparable harm if the Other
Innovator were to become aware that it has filed an NDS in relation to the drug
product at issue.
[7]
In response to the motion, the Attorney General
takes the position that the Other Innovator is a necessary respondent to this
application and that the confidentiality order sought cannot be granted so as
to deprive the Other Innovator of the right to be notified of the Application
and to decide whether or not to participate in it. The Attorney General further
submits that it is premature to fix the other terms of the confidentiality order
until the Other Innovator has been notified, has had an opportunity to decide
whether to participate, and if so, to speak to the parameters of the confidentiality
order that would strike the appropriate balance between the protection of the
Applicant’s rights, the Other Innovator’s rights to meaningfully participate in
the application and the public interest in open and accessible court
proceedings.
[8]
For the reasons that follow, I agree with the Attorney
General’s position.
[9]
The circumstances of this matter are
indistinguishable from the circumstances in Apotex Inc. v Canada (Minister
of Health), 2006 FC 846 (Apotex 2006). In that case, Apotex had
instituted an application for judicial review seeking an order to compel the
Minister to process its Abbreviated New Drug Submission for a drug product
without regard to the Regulations. There, as is the case here, the issue
to be determined in the underlying application was whether the Regulations
apply to the submission. There, as here, the applicant had not notified the innovator
who had an interest in the drug product to which the Minister had determined the
ANDS had directly or indirectly made reference. In determining that this
innovator was as necessary party, the Court considered relevant case law and
held as follows:
12 The respondent points to two decisions
of this Court, in respect of the NOC Regulations, in which the applicant
generic had not disclosed the innovator's identity and was required to do so.
In Apotex Inc. v. Attorney-General of Canada et al., (1994), 79 F.T.R. 235, 56
C.P.R. (3d) 261 (T.D.) Justice Simpson concluded that a patent holder has an
interest which on its application may lead to the granting of party status in
proceedings between the generic and the Minister and that it was necessary to
so identify the patent holder so it could decide whether to take steps to
participate.
13 In Apotex Inc. v. Canada (Minister of
Health(2000), 186 F.T.R. 84, 4 C.P.R. (4th) 421 (T.D.) the generic sought to
use a foreign product not sold in Canada as the Canadian Reference Product and
disclosed the innovator's identity only in the face of motions to intervene
brought by several other companies and an industry association. Apotex then
sought to have the participation of the innovator with the proprietary interest
limited. Justice McGillis held that the innovator was entitled to unrestricted
party status.
14 I see no substantial difference
between what Apotex seeks to achieve in the present matter and what it
attempted to do in the case before Justice McGillis in 2000. It seeks to
litigate its dispute with the Minister over the application of the NOC
Regulations without the inconvenient intervention of an innovator company which
may have proprietary rights over the Canadian Reference Product upon which it
seeks to rely in its ANDS.
15 The overarching principle at issue in
this matter is that of the public interest in open and accessible court
proceedings. The authority to grant a protective order is a discretionary
exception to that principle. The commercial interests of the applicant are of
secondary importance but can be accommodated where, as set out in Sierra Club,
the salutary effects of a protective order outweigh its deleterious effects. When
faced with a motion to grant such an order, a prothonotary has the
responsibility to ensure, in my view, that the party seeking the exercise of
the Court's discretion has served notice on all persons who may be directly
affected by the underlying application.
16 The motion for a protective order
in this context cannot be isolated from the question of whether all of the
necessary parties have been properly served notice of the underlying
application as one effect of granting the order will be to prevent anyone
who may have an interest from learning of the proceedings. I agree with the
respondent that it was apparent that the proprietary interests of a third party
innovator may be directly affected by the application and the motion. Given
the nature of the regulatory scheme, evidence to establish this was not
required.
[Emphasis
added]
[10]
The Applicant relies on the subsequent decision
of a Prothonotary in Novopharm Limited v The Minister of Health and Attorney
General of Canada, 2010 FC 566. My colleague in that case seems to have
found grounds to distinguish Apotex 2006 and the preceding line of
jurisprudence on the basis of the question at issue in the underlying
application. The question in the Novopharm case was whether the
Applicant was required to address a patent put on the Register after it had
filed its ANDS, which the Prothonotary considered to be a different issue from
those raised in Apotex 2006 and the other two cases relied upon by the
Court in Apotex 2006.
[11]
I am not persuaded that this distinction is warranted.
At its root, whatever the Applicant’s basis might be to argue that s 5 of the Regulations
does not apply, the relevant issue before the Court is the validity of the
Minister’s decision that the Applicant’s submission triggers the application of
the Regulations; the order sought in all cases is one that would set
aside the Minister’s decision. The Courts have consistently held that a
proceeding seeking to set aside a decision by the Minister to the effect that a
patent listed on the Register must be addressed directly affects the innovator
who listed the patent against the referenced product.
[12]
The analysis conducted in the recent case of Hospira
Healthcare Corp. v Canada (Minister of Health), 2014 FC 179, upheld at 2014
FC 235 and 2014 FCA 19, although it considered a different regulatory regime,
confirms that the rationale behind that conclusion is that the Minister’s
decision that the Regulations are engaged confers a direct benefit to
the innovator whose patent is referenced, and that a proceeding to set aside
that decision directly affects that innovator. This is so whether or not the
innovator participated in the Minister’s decision or is even aware of it:
19 Sanofi's Eloxatin and oxaliplatin have
been listed on the Register of Innovative Drugs. Sanofi is therefore entitled
to benefit from the market exclusivity promised by section C.08.004.1 and to
the protection of its data against direct or indirect comparison by others. The
Minister has determined, in the decision under review, that Hospira has made
such a comparison and impinged upon the protection extended to Sanofi. He has
determined that market exclusivity has been triggered against Hospira's product
and in favour of Sanofi. Hospira's application seeks to reverse that decision
and withdraw the protection and benefits to which the Minister has determined
Sanofi was entitled. It is beyond question that the order sought will directly
prejudice Sanofi, as it will remove the protection and its right to the
exclusion of Hospira's product from the market, both of which were intended for
Sanofi's direct benefit.
20 The fact that the Food and Drugs
Regulations do not contemplate the participation of Sanofi in the Minister's
initial determination or a specific legal recourse in the event the data protection
regime is triggered or breached does not negate Sanofi's standing. As
formulated in Forest Ethics Advocacy, above, the test for standing does not
require that legal rights or obligations flow to a person from the order
sought; it is sufficient that it be prejudicially affected in a direct way.
[13]
The Applicant submits that its right to maintain
the confidentiality of its NDS is paramount, and should be preserved as long as
possible. It argues that it is not necessary or in the interest of justice to
involve the Other Innovator at the stage of this judicial review, as the
Innovator’s legal rights, if any, will still be protected: if the application
is unsuccessful and the Applicant is obliged to address and does address the
Other Innovator’s patents, all its rights under the Regulations will be
available. If the application is successful and the Minister eventually issues
a NOC to the Applicant, the Other Innovator will then have standing to seek
judicial review of the Minister’s issuance of the NOC, as confirmed by the
Federal Court of Appeal in Ferring Canada Inc. v Canada (Minister of Health),
2007 FCA 276.
[14]
This was one of the arguments my colleague
retained in Novopharm. I note however that the decision in Novopharm
seems to proceed from the understanding that the only interest sufficient to
require that a party be named as a respondent to a judicial review application is
where a legal right is affected. The Court considered that an innovator’s legal
rights, in the context of the Regulations, are only those triggered once
a Second Person chooses to address a listed patent by serving a Notice of
Allegation, or those recognized to arise when the Minister decides to issue an
NOC. The Prothonotary in Novopharm did not consider that the Minister’s
decision that the Regulations were engaged conferred any enforceable
legal rights on the innovator. He viewed the loss of the market exclusivity
inherent to the scheme of the Regulations to be a commercial interest only,
and insufficient to mandate the inclusion of the innovator as a respondent in
the case before him.
[15]
The decision of the Court of Appeal in Forest
Ethics Advocacy Association v Canada (National Energy Board), 2013 FCA 236 has
since clarified that a party has a direct interest and standing to bring or be named
a respondent in a judicial review proceeding, not only when its legal rights
are affected or legal obligations are imposed on it, but also when “it is prejudicially affected in some direct way” (at
para 20). As later referred to and applied in Hospira, above, it has now
become clear that even though an innovator has no direct legal right to
participate in the Minister’s decision as to whether the Regulations are
engaged or to compel the Minister to enforce the Regulations, once a
decision has been made by the Minister that the Regulations are engaged
in favour of a particular innovator, a direct commercial benefit is conferred
on that innovator, sufficient to give it standing as a respondent in a judicial
review of that decision.
[16]
I am satisfied that the Other Innovator is a person
directly affected by the order sought in the underlying application, and that
it ought to have been named as a respondent. I am further satisfied that the
motion for a confidentiality order cannot be considered without giving an
opportunity to the Other Innovator to be heard.
[17]
The Applicant tendered a confidential affidavit
at the hearing, in support of the merits of its motion for a confidentiality
order. The Applicant asked that, if I determined that the motion should be
adjourned and that the Other Innovator should be notified, the confidential
affidavit be returned to the Applicant to preserve its confidentiality as
against the Other Innovator.
[18]
As I have decided to adjourn the motion without
considering its merits or the confidential affidavit, there is no need to
retain the confidential affidavit in the Court’s record and the Applicant’s
request will be granted.
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