Docket:
T-1963-13
Citation: 2014 FC 179
Ottawa, Ontario, February 26, 2014
PRESENT: Madam
Prothonotary Tabib
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BETWEEN:
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HOSPIRA HEALTHCARE CORPORATION
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Applicant
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And
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THE MINISTER OF HEALTH AND ATTORNEY GENERAL OF CANADA
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Respondents
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REASONS FOR ORDER AND ORDER
[1]
The present motion raises the issue of an
innovator’s standing and right to be made a party to a judicial review of the
Minister of Health’s administration of that part of the Food and Drugs
Regulations, CRC, c. 870 implementing a data protection regime pursuant to
Canada’s obligations under the North American Free-Trade Agreement (“NAFTA”)
and the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”).
Background
[2]
Sanofi-Aventis Canada Inc. (“Sanofi”)
manufactures and sells in Canada the drug Eloxatin, which contains oxaliplatin
as an active pharmaceutical ingredient. On June 15, 2007, the Minister of
Health determined that Eloxatin and oxaliplatin were innovative drugs and
placed them on the Register of Innovative Drugs (the “Register”), maintained
pursuant to subsection C.08.004.1(9) of the Food and Drugs Regulations.
[3]
The data protection regime set out in section
C.08.004.1 aims to protect the data submitted in support of an application for
approval to market innovative drugs containing a new chemical entity, by
preventing others from using the innovator’s data in support of their own
applications for drug approval. When a drug is placed on the Register of
Innovative Drugs, the Minister is precluded from receiving from another
manufacturer an application for a Notice of Compliance entitling it to market
that drug in Canada for a period of six years, where that application is based
on or refers to the data provided by the innovator. The Minister may not,
either, issue an NOC for such an application for a further period of two years.
[4]
On October 27, 2006, before oxaliplatin was
listed on the Register, Hospira filed a New Drug Submission (NDS) seeking an
NOC for a drug containing “Chemical Entity A” as its active ingredient. Sanofi
has good reason to believe that “Chemical Entity A” is, in fact, oxaliplatin.
On this motion, Hospira does not admit that “Chemical Entity A” is oxaliplatin,
but does not deny that Sanofi has reasonable grounds to believe that it is.
Hospira has undertaken, if the Court finds that the innovator whose drug is
listed as “Chemical Entity A” has a right to be added as a respondent to this
application, to notify and name that innovator. For the purposes of the hearing
and of these reasons, and for ease of understanding, the assumption has been
made that “Chemical Entity A” is oxaliplatin, although it is not necessary, and
the Court does not, determine that this is in fact the case.
[5]
The Minister initially rejected Hospira’s NDS,
for reasons that have nothing to do with data protection. Following Hospira’s
successful judicial review of the Minister’s initial refusal, the Minister
resumed his examination of Hospira’s NDS. By then, Eloxatin and oxaliplatin had
been listed on the Register. As is often the case, the Minister sought
additional information from Hospira to assist in his assessment of the drug’s
safety and efficacy. In one of its answers, Hospira made reference to the
product monograph for Eloxatin. The Minister considered that Hospira had thereby
made “direct or indirect comparison” between its drug and Eloxatin, and advised
Hospira that, pursuant to section C.08.004.1, it would not issue Hospira’s NOC
for the drug until the expiration of the data protection period, even though
Hospira’s ANDS was otherwise approvable.
[6]
Hospira brings this application to judicially
review the Minister’s decision, challenging the Minister’s interpretation and
application of section C.08.004.1 of the Food and Drugs Regulations.
It says that the data protection provisions do not apply to its NDS because it
was filed before Eloxatin was entered on the Register. In any event, it argues
that it did not directly or indirectly compare its product to Eloxatin, that if
it did, the reference did not appear in its initial NDS and that post-filing
amendments are excluded from the scope of the relevant section, and that the
reference was mandated by the Minister without due notice that it would be
deemed to trigger the application of data protection. Hospira’s notice of
application for judicial review does not name, and was not served on Sanofi or
any party other than the Minister.
[7]
To the extent “Chemical Entity A” is in fact oxaliplatin,
Sanofi argues that it is a person directly affected by the order sought by
Hospira in this judicial review application, and that as such, Hospira ought to
have, and should be ordered to, name it as a party respondent.
Analysis
[8]
Rule 303 of the Federal Courts Rules
requires an applicant to a judicial review to name as a respondent “every
person directly affected by the order sought in the application”. Hospira in
this application seeks “an Order quashing and setting aside the Minister’s
decision (…) which refused to issue the applicant a notice of compliance for
Drug A (…) and an Order of mandamus requiring the Minister to forthwith issuance
[sic] a notice of compliance to Hospira for Drug A”. The question before the
Court is therefore simply whether Sanofi would be directly affected by such an
order.
[9]
The parties are ad idem that the
appropriate test for determining whether a party has a direct interest is the
same whether the party is a proposed applicant or a proposed respondent, and that
it was most recently articulated by the Federal Court of Appeal in Forest
Ethics Advocacy Assn. v Canada (National Energy Board), 2013 FCA 236 as
follows:
“20.
A party has a “direct interest” under subsection 18.1 (1) of the Federal
Courts Act when its legal rights are affected, legal obligations are
imposed on it, or it is prejudicially affected in some direct way : League
for Human Rights of B'Nai Brith Canada v. Odynsky, 2010 FCA 307 at
paragraphs 57-58; Rothmans of Pall Mall Canada Ltd. v.
Canada (M.N.R.), [1976] 2 F.C. 500
(C.A.); Irving Shipbuilding Inc. v. Canada (A.G.), 2009 FCA 116.”
[10]
There is no case directly on point, that is, a
case where an innovator’s standing has been determined in the context of a
review of the Minister’s decision that the data protection regime applied or
did not apply to a specific submission in respect of a listed Innovative Drug.
[11]
The only decision involving the data protection
regime in which standing was discussed is Lundbeck Canada Inc. v. Canada
(Minister of Health) 2008 FC 1379, aff’d 2009 FCA 134. In that case,
Lundbeck, whose drug was not listed as an Innovative Drug on the Register, was
seeking a declaration that it should be so listed, and orders preventing the
Minister from accepting, reviewing and acting upon drug submissions filed by
two generics, on the basis that there was no existing “Canadian Reference Product”
as well as on the basis that its product should be listed on the Register. The
Court found that Lundbeck’s application was bereft of any merit. On the issue
of the data protection regime, it found that Lundbeck’s drug was not, and
clearly could not be, listed on the Register, and that the new data protection
regime therefore could not apply to it. The trial Judge also made a general
finding that Lundbeck lacked standing to interfere with the Minister’s
consideration of an ANDS under the Food and Drugs Regulations. Hospira
notes that the Judge included in his conclusion on standing reference to
Lundbeck’s challenges under the data protection provisions (at paragraph 25).
There is, however, no discussion of the principles of standing as they might
apply to the new data protection regime. Further, if the trial Judge’s decision
were to be interpreted as a determination of law that innovators have no
standing whatsoever when it comes to the data protection regime, it would deny
to a manufacturer the standing to even challenge the Minister’s determination
as to whether or not to list its own drug on the Innovative Drug Register. This
would clearly be wrong, given that Sanofi’s standing was accepted on that very
issue in Teva Canada Ltd. v Canada (Minister of Health), 2011 FC 507,
2012 FCA 106. In any event, the Federal Court of Appeal in Lundbeck expressly
upheld the conclusions of the trial judge that the applications had no merit,
and declined to consider the issue of standing. I therefore conclude that the Lundbeck
case is not determinative of this matter.
[12]
All parties have noted two clear and constant
lines of jurisprudence on the issue of standing in respect of the regulations
made under the Food and Drugs Act.
[13]
On the one hand, it has been held that an innovator
drug manufacturer does not have standing to bring or respond to an application
to judicially review a decision of the Minister of Health under the Food and
Drugs Act or the Food and Drugs Regulations in respect of the
issuance or proposed issuance of an NOC to another drug manufacturer (Merck
Frosst Canada Inc v Canada (Minister of Health), [1997] FCJ No 1847,
Glaxo Canada Inc v Canada (Minister of Health & Welfare), [1988] 1 FC
422, aff’d (1990) 31 CPR (3d) 29, Pfizer Canada Inc v Canada (Minister of
National Health and Welfare), (1986), 12 CPR (3d) 438). The rationale for
these cases has consistently been that the Minister alone is charged with the
protection of the public’s health and safety, that issues of the safety and
efficacy of drugs are of no concern to third-party manufacturers and that the
economic and competitive impact on them is not sufficient to hold that they are
“directly affected” by the issuance of an NOC to a competitor.
[14]
On the other end of the spectrum, there is
equally constant jurisprudence that an innovator whose patents are listed
against a drug on the register maintained under the Patented Medicine
(Notice of Compliance) Regulations, SOR/93-133 (“PM(NOC)Regulations”)
does have standing where the issue in a judicial review is whether or not the
rights and protections afforded to it under the PM(NOC)Regulations are
engaged by another manufacturer’s application for an NOC (Ferring Inc v
Canada (Minister of Health), [2007] FCJ No 1138, Apotex Inc v Canada (Attorney
General), [1994] FCJ No 879, Apotex Inc v Canada (Minister of Health),
2006 FC 846, Nu-Pharm Inc v Canada (Attorney General), 2001 FCT 973, Apotex
Inc v Canada (Minister of Health), [2000] FCJ No 248). The Courts have
generally distinguished these cases from cases related to the Minister’s
administration of the Food and Drugs Regulations on the basis that the
PM(NOC)Regulations do recognize and afford protection for innovators’
patent rights: generic drug manufacturers who, for the purpose of establishing
safety and efficacy, compare their products to an innovator’s product against
which a patent is registered are required to either await the patent’s expiry
before obtaining an NOC, or to address why the patents are invalid or would not
be infringed. This triggers specific legal rights for the innovator.
[15]
Contrary to Hospira’s submissions, one cannot
draw from these two lines of cases simple and absolute propositions that are
determinative of the matter at issue here, such as that innovators have
standing where the PM(NOC)Regulations are engaged but none when only the
Food and Drugs Regulations are involved, that an economic or competitive
prejudice is always too remote to “directly affect” a person, or that the only
kinds of interests that can give rise to standing in administrative proceedings
under the Food and Drugs Act are those for which the regulations
contemplate a legally enforceable right or legal recourse. In the end, it
always comes down to whether the order sought affects the legal rights of the
innovator, imposes legal obligations on it, or prejudicially affects it in some
direct way. In the circumstances of the cases cited above where the
administration of the Food and Drugs Regulations was at issue, no legal
rights were affected and no legal obligations imposed, and the Courts found
that the competition resulting from the issuance of an NOC did not, of itself,
affect the innovator in a direct way. In cases involving the PM(NOC)
Regulations, legal rights were affected. These were the factors considered
by the Court, not some arbitrary distinction between the Food and Drugs
Regulations and the PM(NOC) Regulations.
[16]
In the case before me, assuming that “Chemical
Entity A” is oxaliplatin, it is clear that an order reversing the Minister’s
determination that the data protection regime was engaged and ordering the
issuance of an NOC to Hospira would prejudicially affect Sanofi in a direct
way, and not merely because it would suffer economic or competitive prejudice.
[17]
The data protection regime established by
section C.08.004.1 specifically recognizes and intends to protect the interests
of innovative drug makers by guaranteeing them exclusivity in the market place
for the designated period of data protection against those who may refer to or
use the data they have generated to establish the safety or efficacy of their
drug. The purpose and intent of the data protection regime as a direct benefit
to innovators whose products are listed on the Register is explicitly set out
in the Regulatory Impact Analysis Statement that introduced the new regime:
“The
amendments to section C.08.004.1 of the Food and Drug Regulations
(“Regulations”) are intended to provide new drugs with an internationally
competitive, guaranteed minimum period of market exclusivity of eight years.”
(…)
“The
obligations in TRIPS require that signatories provide protection against the
unfair commercial use of the data, whereas NAFTA requires that signatories
provide a reasonable period of time during which a subsequent manufacturer is
prohibited from relying on the originator’s data for product approval.
(…)
In
keeping with the provisions, the government has decided to provide this
protection by allowing the innovator, or the originator of the data submitted
for regulatory approval, to protect investments made in the development of the
product by providing a period of market exclusivity.”
[18]
The Federal Court of Appeal has further
recognized that the data protection regime, as implemented by section
C.08.004.1, did intend to confer on an innovator market exclusivity as the
chosen means to give effect to Canada’s obligations to protect the innovator’s
data under NAFTA and TRIPS. Canadian Generic Pharmaceutical Assn. v Canada (Minister of Health), 2010 FCA 334, at para 76:
“76 In my view, the DPR is in clear accord
with the enabling provision. It is a regulation, the purpose of which is to
implement, in relation to drugs, article 1711 of NAFTA and paragraph 3 of
article 39 of TRIPS. Market exclusivity, conferred by the DPR on an innovator,
is the means chosen by the Governor in Council to give effect to the relevant
provisions of NAFTA and TRIPS. More particularly, the DPR is, in my view, a
step taken by the Governor in Council "... to ensure that the data is
protected against unfair commercial use".
[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.
[21]
For these reasons, I am satisfied that the
innovator whose product is listed on the Register of Innovative Drugs as
corresponding to “Chemical Entity A” is a person directly affected by the order
sought and that it is to be added by Hospira as a respondent to the
Application.
[22]
Much of Hospira’s arguments were directed to the
merits of the Minister’s decision, presumably in an attempt to demonstrate that
the decision was so clearly ill-founded that the benefit of the data protection
regime could not, on the facts, have accrued to Sanofi and that Sanofi
therefore cannot be a party affected by the order sought. The merits of the
Minister’s decision are not relevant to the determination of whether Sanofi
would be directly affected by the order sought. The Minister’s decision is
valid, effective and provides benefits to Sanofi, until reversed,
notwithstanding Hospira’s argument that it should not have been made. The order
sought by Hospira would remove those benefits. In any event, I have not been
satisfied that the Minister’s interpretation of the Regulations is
clearly without merit.
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