Date: 20081216
Docket: T-296-08
Citation: 2008 FC 1379
Ottawa, Ontario, December 16, 2008
PRESENT: The Honourable Mr. Justice Lemieux
BETWEEN:
LUNDBECK CANADA INC.
Applicant
and
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL OF CANADA
AND RATIOPHARM INC.
Respondents
Docket: T-1143-08
AND
BETWEEN:
LUNDBECK CANADA INC.
Applicant
and
THE MINISTER OF HEALTH AND
COBALT PHARMACEUTICALS INC.
Respondents
and
H. LUNDBECK A/S
Respondent/Patentee
REASONS FOR JUDGMENT AND JUDGMENT
Introduction
[1]
In
this proceeding, two generic drug manufacturers, ratiopharm Inc. (ratiopharm)
and Cobalt Pharmaceuticals Inc. (Cobalt), seek to strike judicial review
applications initiated by Lundbeck Canada Inc. (Lundbeck) pursuant to section
18.1 of the Federal Courts Act against each of them in which Lundbeck
seeks to review “the decision or act of the Minister of Health (the Minister)
to accept the submission of and to review the abbreviated new drug submission
(ANDS) of [ratiopharm and of Cobalt] identifying as an alleged Canadian
Reference Product (CRP) EBIXA, the applicant’s brand of Memantine”. Amongst the
relief sought by Lundbeck is an order quashing the Minister’s decision to
accept each submission and to each ANDS identifying EBIXA as an alleged CRP as
well as directing the Minister not to review both ANDS and prohibiting the Minister
from issuing an NOC or NOC/c until EBIXA is issued an NOC. Lundbeck also seeks
a declaration that EBIXA is an “innovative drug” under the relevant provision
of the Food and Drug Regulations (FDR) entitling it to a six year
prohibition from examining both ANDS after the issuance of an NOC to EBIXA.
Background
[2]
In
2002, Health Canada adopted a Policy
known as “Notice of Compliance with conditions (NOC/c)”. The application of the
Policy is restricted to drug products indicated for serious, life-threatening
and severely debilitating illnesses or conditions for which no drug is
presently marketed in Canada. The purpose of the Policy is to
facilitate early access by physicians and patients to drugs which Health Canada
believes have promising evidence of clinical effectiveness. For such drugs, the
Policy allows for the filing of a New Drug Submission (NDS) or a Supplementary
New Drug Submission (SNDS) which, if approved, leads to the issuance of a
Notice of Compliance with conditions labelled (NOC/c) rather than the normal
Notice of Compliance (NOC).
[3]
On
December 8, 2004, Lundbeck Canada Inc. (Lundbeck) received from the
Minister of Health (the Minister) a Notice of Compliance with conditions
(NOC/c) for its product EBIXA pursuant to section C.08.004 of the Food and
Drug Regulations (the Regulations). The conditions attached to the
NOC/c were those outlined in the Policy. EBIXA is indicated for the treatment
of moderate to severe dementia of the Alzheimer’s type. Its medicinal
ingredient is Memantine.
[4]
On
December 24, 2007, ratiopharm filed with the Minister an ANDS for the
purpose of obtaining an NOC enabling it to market its ratio-Memantine product.
In its ANDS, ratiopharm compared its product to EBIXA (the Canadian Reference
Product or CRP).
[5]
On
June 2, 2008, Cobalt filed an ANDS with the Minister for an NOC enabling
it to market its co-Memantine product. Cobalt’s CRP was also EBIXA.
[6]
Lundbeck
commenced judicial review proceedings against the Minister and against ratiopharm
in Court file T-296-08 and against the Minister and Cobalt in Court file
T-1143-08. In both cases, as noted, Lundbeck seeks to review “the decision or
act of the Minister of Health (the Minister) to accept the submission of and to
review the abbreviated new drug submission” of ratiopharm and Cobalt “identifying
as an alleged CRP EBIXA, the applicant’s brand of Memantine”.
[7]
In
both judicial review applications, Lundbeck seeks the following relief:
1. (a) A declaration
that EBIXA is not a CRP pursuant to the Food and Drug Regulations,
C.R.C.,
c. 870, (“FDR”) and will not acquire such status until the issuance
of a Notice of Compliance (“NOC”) in respect of such product.
(b) A declaration
that the decision or act of the Minister to accept the submission of and to
review [the] ANDS …
identifying EBIXA as an alleged CRP, is unlawful and invalid.
(c) An order
quashing and setting aside the decision or act of the Minister to accept the
submission
of and to review the ANDS … identifying EBIXA as an alleged CRP, and directing
the Minister to not review and to reject the ANDS.
(d) An order
prohibiting the Minister from issuing a NOC or NOC/c to … with respect
to [the] ANDS … identifying EBIXA as an alleged CRP, until such time as the
Minister issues a NOC (as distinct from a NOC/c) for EBIXA.
2. (a) A
declaration that EBIXA is an “innovative drug” pursuant to Section C.04.004.1
of
the FDR, as amended by the Regulations Amending the Food and Drug
Regulations
(Data Protection), SOR/2006-241, Oct. 5, 2006.
(b) An order
prohibiting the Minister from, and/or a declaration that the Minister is
prohibited from, accepting and reviewing the ANDS … identifying EBIXA as
an alleged CRP, and directing the Minister to reject the submission of said
ANDS …, until six (6) years after the issuance of a NOC in respect of EBIXA.
3. In
the alternative to the relief requested in paragraph 2 above, an order
prohibiting the Minister from, and/or a declaration that the Minister is
prohibited from, issuing a NOC in respect the ANDS … identifying EBIXA as an
alleged CRP, until five (5) years after the issuance of a NOC in respect of EBIXA.
[8]
In
the interest of completeness, I describe the conditions which were
attached to Lundbeck’s NOC/c. These conditions were incorporated in a letter of
undertaking provided by Lundbeck to the Minister prior to the issuance of the
NOC/c and included obligations by Lundbeck (1) to conduct a controlled study
for a period between six months to a year on patients with moderate to severe
Alzheimer’s disease whose purpose is to confirm efficacy results in two
previous studies; (2) to provide Periodic Safety Update on a quarterly
basis for the first two years and at lesser intervals in subsequent years; (3)
to report to the Minister all serious adverse drug reactions; (4) to provide
for acceptance by the Minister a draft of a Dear Healthcare Professional
Letter; (5) to provide a draft Fact Sheet outlining in lay language the
potential risks, benefits and side effects for EBIXA for the indication of the
symptomatic treatment of moderate to severe dementia of the Alzheimer’s type;
and (6) to provide for acceptance by the Minister a draft of the Product
Monograph consistent with the requirements of the Policy.
[9]
Having
obtained its NOC/c, Lundbeck proceeded to apply to the Minister to list two
patents on the Patent Register, maintained by the Minister, pursuant to the Patented
Medicines (Notice of Compliance) Regulations (the NOC Regulations).
Canadian Patent No. 2,426,492 (‘492) and Canadian Patent No. 2,014,453 (‘453)
are maintained on the Register for Lundbeck’s EBIXA brand of 10 mg Memantine
tablets.
[10]
When
both ratiopharm and Cobalt submitted their respected ANDS to Health Canada, they each
served, as required by the NOC Regulations, a Notice of Allegation (NOA)
pursuant to the NOC Regulations which if controverted by Lundbeck
entitles the innovator to commence a prohibition proceeding in the Federal
Court against the two generic drug manufacturers. The NOC Regulations
provide Lundbeck with an automatic statutory stay of 24 months during which the
Minister cannot issue an NOC to either ratiopharm or Cobalt. Lundbeck’s
proceedings against ratiopharm were commenced on March 13, 2008 in Court file
T-414-08 and against Cobalt on August 8, 2008 in Court file T-1226-08.
Position of the parties
[11]
By
way of preliminary separate motions heard together, ratiopharm and Cobalt, as
respondents, seek to strike Lundbeck’s judicial review applications for the
following reasons:
1. Lack of standing to bring the
applications for judicial review because Lundbeck not a person directly
affected by the Minister’s action or decision;
2. The judicial
review applications are premature in that the Minister has yet to make a
decision on their individual ANDS;
3. The judicial
review applications are bereft of any chance of success on the merits;
4. The judicial
review applications are an abuse of process because Ludbeck is marketing
Memantine, has listed patents on the Patent Register and has commenced a
proceeding under the Patented Medicines (Notice of Compliance) Regulations
in respect of those patents.
[12]
Counsel
for the Minister appeared at the motions but did not file a memorandum of fact
and law. He submitted a letter dated October 20, 2008 to the Court to the
effect that the Minister “supports and consents to the motions brought by the
respondents ratiopharm Inc. and Cobalt Pharmaceuticals Inc.”
[13]
ratiopharm
adds a further ground to strike. Its counsel argues that the Minister made no “decision”
within the meaning of that term as legislated in section 18.1 of the Federal
Courts Act.
[14]
Lundbeck,
in its written representations, expressed the view that on December 8, 2004,
the Minister granted Lundbeck conditional marketing authorization referred to
as a Notice of Compliance with conditions for its EBIXA brand. It indicates
Lundbeck’s marketing is subject to the conduct of further studies to verify the
safety and the efficacy of its drug and indicates that these studies are not
yet completed and “Lundbeck still has only an NOC/c rather than an NOC.”
[15]
Lundbeck
submits that it filed its judicial review application “to resolve whether a
generic pharmaceutical company is entitled, in order to obtain an NOC, to
compare its product to an innovative product which has only received an NOC/c”
adding that it is asking the Court “to determine whether EBIXA, which is the
object of an NOC/c can be a Canadian Reference Product (CRP) in accordance with
section C.08.001.1 of the FDR”. [Emphasis mine.]
[16]
Lundbeck
also states that another purpose of its judicial review application is to
resolve whether data protection is available to innovative drug companies
required pursuant to their NOC/c to provide additional data on the safety and
efficiency of its drug and, if so, from what date and for how long.
[17]
Lundbeck
asserts, based on information received from the Minister on a consent order,
the ANDS of both ratiopharm and Cobalt have been accepted at screening. It also
says NOC/c’s have never been the subject of legal proceedings in Canada and, as
such, the judicial proceedings “are indeed raising novel and controversial
issues”.
[18]
In
terms of its legal submissions, Lundbeck submits:
· Based on the
jurisprudence of this Court to strike a judicial review application at a
preliminary stage requires exceptional circumstances and should succeed only if
the judicial review application is “bereft of any chance of success”. Lundbeck
asserts neither ratiopharm nor Cobalt meet the test for striking out the
judicial review application in which they are respondents.
· As to
standing, Lundbeck submits the generic manufacturers have the onus of
demonstrating such is the case and that it has standing because it is directly affected
by the Minister’s decision or act and there is no other remedy available to it.
It says its legal rights are affected, the decision imposes legal obligations and
prejudicially affects it. It points to section 5(1) of the NOC Regulations
and the requirement that a second person such as ratiopharm and Cobalt are
obligated to send an NOA if it files an ANDS for an NOC and compares its drug
with another drug marketed in Canada under an NOC. This has happened in each
case and the result is that the validity and non-infringement of Lundbeck
patent on the Register for EBIXA is in issue with the result that the
Minister’s acceptance for review of the ANDS has affected its legal rights and
has imposed legal obligations on it. It also points to the data protection
provision of the FDR and argues the mere fact of accepting the filing of
the ANDS is a breach of the legal protection granted to it. It argues the fact
that Lundbeck, an innovative drug company, will be less inclined to develop
innovative drugs if it knows the Minister will carry out a comparison study and
deny it data protection strongly militates in favour of a finding that it has
standing. It submits, even if the Court finds that Lundbeck only has a
commercial interest, such interest is sufficient to challenge the Minister is
acting without jurisprudence.
· Lundbeck
argues it has no other remedy than to seek judicial review of the Minister’s
decision or act to accept the ANDSs for filing and that the current NOC
proceedings do not afford it any remedy because their basis is fundamentally
different. Moreover, Lundbeck has no available judicial means to enforce a data
protection breach.
· Lundbeck
submits the judicial review application is not premature and says that the
argument there was no decision and if there was a decision it is interlocutory
and has no merit. Lundbeck argues this Court’s jurisdiction in judicial review
extends beyond decisions.
· It argues the
decision is not an interlocutory one because by accepting the ANDS from
ratiopharm and Cobalt, the Minister has made a final determination that EBIXA
is a CRP and that Lundbeck cannot benefit from the specific form of data
protection granted by the FDR which, in its view, prohibits the mere
filing of the ANDS until the expiry of six years from the issuance of an NOC.
It adds that if an NOC is not issued to ratiopharm or Cobalt, it will not be
because EBIXA is not a CRP or because it [Lundbeck] is not entitled to data
protection but because the generics have not demonstrated bioequivalence. In
any event, it submits interlocutory decisions can be reviewed in special
circumstances namely jurisdiction. The point Lundbeck makes here is that if
EBIXA is not a CRP, the Minister has no jurisdiction to review the ANDSs.
Moreover, if EBIXA is entitled to data protection, the Minister is prohibited
from accepting for filing the ANDS. Lundbeck submits its data can only be
protected if the Minister does not process both ANDS filed and forcing
Lundbeck to wait until an NOC is issued is tantamount to completely negating
this form of protection. It concludes its argument on the point by stating the
interlocutory decision case law is limited to tribunals which the Minister is
not a tribunal arguing “he is exercising discretionary authority granted to
him by the Food and Drugs Act and its regulations”. [My emphasis.]
· Lundbeck
submits its judicial review application is not on its face bereft of any chance
of success taking issue with the contention that as a matter of law the market
authorization granted by the Minister must be an NOC because it is the only
form of marketing known to the FDR. Lundbeck argues its judicial review
application seeks to resolve a novel question of law that has never been
decided by the Courts; it is an important question with far reaching
implications since 40 products have been approved by way of NOC/c in Canada. Lundbeck
points to section C.08.004(1) of the FDR and states that section
provides “that the Minister may either issue an NOC or notify the manufacturer
that the submission is not in compliance”. It then writes “the Minister has
gone beyond this and imposed conditions to the marketing authorization. This is
not contested by …, yet it would want the Court to overlook the way in which
the Minister choose to exercise his powers for the purposes of other sections
of the FDR”. It states these conditions have a profound impact on the
marketing authorization by (1) preventing patent holders from securing
reimbursement of the cost of the drug from public health plans; (2) forcing
Lundbeck to incur considerable time, effort and expense to carry out
confirmatory studies “while the generic manufacturer may simultaneously be
flooding the market with generic products.” It points to section C.08.002.1(d)
of the FDR which require that the conditions of use of the generic drug
fall within the conditions of use for the CRP which is impossible to attain in
respect of a NOC/c drug since use in Lundbeck’s case is tied to the performance
of additional clinical trials and the submission of results to the Minister
which neither ratiopharm nor Cobalt is not in a position to perform. On data protection,
Lundbeck submits its EBIXA brand should qualify under the new version of
C.08.04.1 because clearly on October 6, 2006 when it came into force, Lundbeck
had not submitted all of the data required by the Minister and considerable
investment is required to complete the data. It submits the Minister requires
additional data which should lead this Court to rule in these circumstances
that the section prevents ratiopharm and Cobalt from even filing its ANDS.
· Finally,
Lundbeck refutes the allegation its proceeding is an abuse of process by
claiming that an NOC/c is not an NOC in this judicial review application and
contemporaneously filing a prohibition application under the NOC Regulations
which presumes the existence of an NOC to list patents on the Register which
triggers the application of the whole scheme under those Regulations.
Lundbeck argues the nature of its judicial review application and its
prohibition application, under the NOC Regulations are fundamentally
different. It submits the within proceedings question the validity of the ANDS
pursuant to the FDR whereas those under the NOC Regulations seek
to contest patent-related claims made in the NOA served on Lundbeck by
each of the drug manufacturers. Moreover, it adds this is not a case of re-litigation
which was at the basis of the cases cited by ratiopharm and Cobalt.
Analysis and Conclusions
[19]
For
the reasons that follow, the motions to strike Lundbeck’s applications for
judicial review launched by ratiopharm and Cobalt must succeed on three grounds
(1) lack of standing on the part of Lundbeck; (2) inability of Lundbeck to pursue
an interlocutory decision; and (3) on the merits, Lundbeck’s application for
judicial review is futile and bereft of any chance of success.
(1) Standing
[20]
The
jurisprudence teaches:
1)
It
is permissible to deal with standing on a motion to strike but in order to do
an assessment must be made whether there is sufficient material before the
Court in terms of facts, law and arguments for a proper understanding as to the
nature of the Lundbeck’s interests. This criteria is met: the material facts
are not in dispute and the law is settled.
2)
Lack
of a standing on a motion to strike should only be made in the clearest
cases: the Court should not have any doubt Lundbeck has no standing to pursue
its judicial review application (Sanofi-Aventis Canada Inc. v. the Minister
of Health et al, 2008 FC 129, at paragraph 19). That test is also met here.
[21]
Since
1986, the Federal Court of Appeal and this Court have held an innovative drug
manufacturer has no standing to launch a judicial review application under
section 18 of the Federal Courts Act, i.e. is not directly affected, by
a decision of the Minister of Health in the administration of the Food and
Drugs Act and Regulations when examining a submission of a generic drug
company for an authorization to market its product – an NOC. (See Pfizer
Canada Inc. v. Canada (Minister of Health and
Welfare),
12 C.P.R. (3d) 438 (C.A.) and Glaxo Canada Inc. v. the Minister of National
Health and Welfare et al, 31 C.P.R. (3d) 29 (C.A.)).
[22]
Building
on that jurisprudence, Justice Hugessen put it admirably as follows in Merck
Frosst Canada Inc. v. Canada (Minister of Health), [1997] F.C.J. No. 1847
(F.C.); 146 F.T.R. 249:
11 Some of the cases have used concepts
such as absence of standing and non-justiciability as a convenient shorthand to
describe this limitation on the patentee's rights. Seizing on this the
applicants argue, based on such cases as Canada v. Finlay, [1986] 2
S.C.R. 607, Canada v. Borowski, [1981] 2 S.C.R. 575 and Operation Dismantle
v. Canada, [1985] 1 S.C.R. 441, that they do indeed have standing and that
the issues that they raise are, in fact, justiciable. The argument mistakes
the form for the substance. It is not lack of standing or justiciability in the
strict sense of those words which prevents the applicants from raising
non-compliance with the health and safety concerns of the Food and Drug Act,
and Regulations; it is simply that those matters are of no concern to them and
cannot be raised by them in an attack on a decision of the Minister to issue an
NOC. It is the Minister himself who is charged with the protection of the
public health and safety and no private interest of the applicants arises from
his alleged failure to perform his duties with respect to other persons.
[My emphasis.]
12 As an exception to the foregoing,
however, the Patented Medicine (Notice of Compliance) Regulations - the
"linkage" Regulations - do give the Merck applicants a right, at the
very least by implication, to enforce compliance by both Apotex and the
Minister with those Regulations and to object to the issuance of an NOC on the
grounds of non-compliance therewith. The linkage Regulations, however, do not
have the effect of incorporating into themselves the whole of the Food and
Drug Act and Regulations so as to create any right for the applicants to
enforce the latter. Their clear and evident purpose is to provide an additional
patent protection to the patentee in respect of his intellectual property
rights and they have absolutely nothing whatever to do with public health and
safety.
[23]
His
decision was sustained by the Federal Court of Appeal at [1999] F.C.J. No.
1536.
[24]
The
enactment of the NOC Regulations has not created an opportunity for
innovative drug companies to challenge the Minister of Health’s administration
of the Food and Drugs Act and Regulations. This was made clear by the
Federal Court of Appeal in Ferring Inc. v. Canada (Minister of Health),
2007 FCA 276 which held in that case an innovative drug company had standing to
challenge the Minister’s decision because it was made in the course of administering
the NOC Regulations.
[25]
When
Lundbeck’s notice of application is examined, it is evident, in my view, that
all of the relief sought by it relates to the Minister’s administration of the Food
and Drugs Act in relation to the ANDSs submitted by ratiopharm and Cobalt.
There is no other purpose behind Lundbeck’s judicial review application but to
block the Minister’s consideration of those submissions and if cleared by the
Minister on health and safety grounds, the issuance of an NOC to them. This,
Lundbeck has no standing to do and that includes its challenges under the data
protection provisions (both new and old) which are contained in section
C.08.004.1(1) of the FDR.
[26]
For
two recent applications of an innovative drug company’s lack of standing to
challenge the Minister’s decision in matters involving a generic company’s
submissions for an NOC and the Food and Drugs Act and Regulations (see Sanofi-Aventis
Canada Inc. v. the Minister of Health, 2008 F.C. 1062 and GlaxoSmithKline
Inc. v. Attorney General of Canada, Docket T-000-07, December 21, 2007).
(2) Judicial Review of Interlocutory
Decisions
[27]
It
is settled law, save in exceptional circumstances, decisions of an
interlocutory nature are not to be pursued on judicial review (Prince
Rupert
Grain Ltd. v. Grain Workers’ Union, Local 333, 2005 FCA 402,
at paragraph 2) and as put by Justice O’Reilly in Fairmont Hotels
Inc. v. Director Corporations Canada, 2007 F.C. 95, at paragraph 9:
9 Generally
speaking, interlocutory rulings by decision-makers are not subject to appeal or
judicial review. Courts are concerned not to permit parties to unduly delay or
segment proceedings, or drive up the costs of litigation unnecessarily.
Further, they are naturally reluctant to rule on procedural or administrative
matters that may turn out to be superfluous or insignificant when the dispute
is decided on the merits, or where an adequate alternative remedy is available
at that point: Szczecka v. Canada (Minister of Employment and Immigration),
[1993] F.C.J. No. 934 (C.A.) (QL); Zundel v. Citron, [2000] F.C.J. No.
678 (F.C.A.) (QL); Prince Rupert Grain Ltd. v. Grain Workers' Union, Local
333, 2005 FCA 401, [2005] F.C.J. No. 2055 (C.A.) (QL), Sherman v. Canada
(Customs and Revenue Agency), 2006 FC 715, [2006] F.C.J. No. 912, (F.C.)
(QL).
[28]
The
Federal Court of Appeal recently reaffirmed this jurisprudence in CHC Global Operations, a
division of CHC Helicopters International Inc. v. Global Helicopter Pilots
Association,
2008 FCA 344.
[29]
The
Court was informed that in, both present cases, the Minister is processing the
ANDS submissions of ratiopharm and Cobalt. He is in the review stage of the
process which involves the application of section C.08.002.1 and provides that
a generic drug manufacturer of a new drug may file an ANDS for the new drug
where “in comparison with a Canadian reference produce (a) the new drug is the
pharmaceutical equivalent of the Canadian reference product” that term having
been defined in section C.08.001.1 as “Canadian reference product means a
drug in respect of which a Notice of Compliance is issued pursuant to section
C.08.004 and which is marketed in Canada by the innovator of the drug.”
[30]
Under
the FDR, it is the mandate of the Minister, whether it be on the submission of
NDS by an innovator or an ANDS by a generic, not to issue an NOC – an
authorization to market a drug in Canada unless satisfied as to the safety and
efficiency of that drug (see section C.08.004).
[31]
Clearly
on the facts of this case, the Minister’s decision, after screening the ANDS of
ratiopharm and Cobalt, is an interlocutory decision and not a final one
because the final outcome involves the Minister’s determination whether to
issue an NOC under the FDR subject to the applicability of the NOC
Regulations.
[32]
I
am not convinced by Lundbeck’s arguments there are any exceptional
circumstances in this case to override the general rule. Lundbeck’s counsel
attempted to frame the issue of the EBIXA as a CRP under an NOC/c as a
jurisdictional question. In my view, no jurisdictional question arises here –
whether EBIXA is a CRP is a determination made by the Minister in the ordinary
course of the administration of the Food and Drugs Act and Regulations.
As Justice Pelletier put it in Prince Rupert Grain Inc., the Court
should be cautious in easily characterizing a legal question as one of
jurisdiction.
(3) Lundbeck’s applications bereft of
merit
[33]
The
nub of Lundbeck’s argument on the merits is that the market authorization it
received in December 2004 is a conditional market authorization. It is not a
full NOC because Lundbeck must conduct confirmatory studies on EBIXA, educate physicians,
submit safety reports and its labels and product monograph contain cautionary
language all matters which ratiopharm and Cobalt will not be constrained if
they obtain their NOC and which, in any event, makes their product not
comparable to EBIXA i.e. not a CRP. On this last point as to what conditions
the Minister may attach to ratiopharm or Cobalt product, Lundbeck’s argument is
purely speculative as is evident from the Minister’s decision dated March 31,
2008, confirmed on April 2, 2008, as well as a proposed Notice to the Policy to
be issued dated April 2, 2008 on the kinds of conditions which the Minister may
attach to generics such as ratiopharm and Cobalt’s NOC if one is to be
issued, a matter which has yet to be determined.
[34]
The
law is clear that a judicial review application should only be struck on the
merits only if the application is bereft of all possibility of success (see LJP
Sales Agency Inc. v. Canada (Minister of National Revenue), 2007 FCA 114, Apotex
Inc. v. Canada (Governor in Council), 2007 FCA 374 and Sanofi-Aventis Canada
Inc. v. Novopharm Ltd., 2007 FCA 163). In my opinion, Lundbeck’s application for
judicial review in these two cases cannot possibly succeed. They are futile.
[35]
The
argument that an NOC with conditions labelled an NOC/c is not an NOC for all
purposes of the Food and Drugs Act including its linkage to the NOC
Regulations is one which, if given credence, would have form trump substance.
[36]
The
plain fact is that Lundbeck, on December 8, 2004, was issued an NOC (and
nothing else) for EBIXA in these terms:
This is to notify you that, pursuant to
section C.08.004 of the Food and Drug Regulations, the above new drug
submission complies with the requirements of sections C.08.002 and C.08.005.1
of the Regulations. As a manufacturer, you are further reminded of your
obligations under C.08.002(1)(d), C.08.007 and C.08.008. These obligations are
detailed on the reverse of this notice.
You have undertaken to conduct timely,
well designed studies to verify the clinical benefit of this drug. You have
also undertaken to provide appropriate educational material and comply with any
post-market surveillance commitments and advertising, labelling and
distribution requirements placed on the drug. Failure to comply with any one or
all of these undertakings may be interpreted as suggesting, inter alia, the
possibility of insufficient evidence, at that time, to establish the
effectiveness of the drug for the purposes recommended. Accordingly,
consideration will be given to regulatory action, removing the product from the
market under the authority of the Food and Drug Regulations.
[37]
On
the face of the statute, Lundbeck could not be issued something other than an
NOC if it was to be authorized to market EBIXA because that is what the statute
and the regulations require.
[38]
Section
C.08.002 of the FDR provides that “no person shall sell or advertise a
new drug unless the Minister has pursuant to section C.08.004, issued a Notice
of Compliance to the manufacturer and that Notice of Compliance has not
been suspended.”
[39]
Section
C.08.004 provides if the Minister is satisfied about an NDS or an ANDS or a
supplementary submission to either complies with the stated provisions of the FDR,
he shall issue a Notice of Compliance.
[40]
As
previously noted, a CRP is keyed to the issuance of a Notice of Compliance.
[41]
When
the Minister’s Policy labelled “Notice of Compliance with conditions (NOC/c) Policy
and Guidance” is examined, it is plain to appreciate that this Policy is
designed to be integrated within the regulatory framework of the FDR and not to
be an exception to it. In this perspective, NOC/c is simply a coined term for
administrative convenience. This term has no legal effect and could not have
unless the FDR was modified. In contrast, when the Minister wishes to authorize
the sale of a drug other than through an NOC, the Minister would have recourse
to section C.08.010 and issue a letter of authorization for Special Access
Programmes which is not the case here.
[42]
The
validity of the Notice of Compliance with conditions (NOC/c) Policy was not
challenged by any of the parties before me. As I have stated, examining the FDR
as a whole, lead me to conclude that this Policy fits comfortably with the
exercise of the Minister’s discretionary authority as mandated in the FDR to be
satisfied about the safety and efficacy of drugs sold on the Canadian market
and to attach appropriate conditions in the circumstances such as is the case
here. I note that under the provisions related to NDS and ANDS, the Minister
may require any additional information or material respecting the safety and
efficacy of the new drug. See also section C.08.008.
[43]
Similar
reasoning applies to the relief sought by Lundbeck with respect to the data
protection provisions of the FDR which were amended effective October 5, 2006
(the new regime). These amendments considerably enhanced the protection for
innovative drugs that contain a medicinal ingredient, not previously approved by
the Minister and is not a variation thereof as defined.
[44]
The
old regime contained in C.08.004.1 had been the subject of judicial
interpretation (see the judgment of Justice Evans, then a member of the Trial
Division, in Bayer Inc. v. Canada (Attorney General), 84 C.P.R. (3d) 129
sustained on appeal in Bayer Inc. v. Canada (Attorney
General),
87 C.P.R. (3d) 293).
[45]
Under
the old data protection regime, the protection was not triggered unless the Minister
examined any information or material filed with the Minister in a new drug
submission by the innovator that contains a chemical or biological substance
not previously approved for sale in Canada as a drug and relies on that data
for the purpose of establishing the safety and efficacy of the generic
manufacturer’s ANDS. As pointed out by the Federal Court of Appeal, the
administration of this provision was subject to a Policy of the Minister
whereby he would notify the generic drug manufacturer of his intent to rely on
the innovator’s information in order to provide the generic with an opportunity
to supply his own information so as not to trigger the data protection
provision which prohibited the Minister from issuing an NOC to the generic for
a period of five years from the date of the innovator’s NOC. The new regime
abolishes the examination and reliance requirements of the old regime and establishes
a Register of drugs to which the new provision applies.
[46]
I
have no doubt the new regime does not apply to Lundbeck and this for two
reasons. Lundbeck did not show EBIXA was on the register maintained by
the Minister. More important, section 2 of the amended regulations provide a
transitional clause to the effect that the old regime continues to apply to a
drug in respect of which a Notice of Compliance was issued before June 17, 2006
which is the case for EBIXA.
[47]
In
view of these findings, I need not deal with the other grounds raised by
ratiopharm or Cobalt, particularly, the abuse of process argument.
JUDGMENT
THIS COURT
ORDERS AND ADJUDGES that the judicial
review applications initiated by Lundbeck Canada Inc. in Court files T-296-08
and T-1143-08 are dismissed with separate costs to each respondent generic
company in each file. If the matter of costs cannot be settled between the
parties, anyone of them may approach the Court to schedule cost submissions. A
copy of these reasons for judgment and judgment shall be placed on each file.
“François Lemieux”
___________________________
Judge
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