Date: 20070305
Docket: T-2047-06
Citation: 2007 FC 232
Ottawa, Ontario, March 5, 2007
PRESENT: The Honourable Mr. Justice Shore
BETWEEN:
APOTEX
INC.
Applicant
and
THE GOVERNOR IN COUNCIL,
THE MINISTER OF HEALTH and
THE ATTORNEY GENERAL OF CANADA
Respondents
REASONS FOR ORDER AND ORDER
OVERVIEW
[1]
This
is a motion brought by the Respondents primarily for an order striking out the
Notice of Application and dismissing the proceeding, on the basis that the
Applicant has no standing to make this judicial review application.
[2]
In
a second motion heard before the Court, Eli Lilly Canada Inc. sought to be
added as a Party Respondent to this Application, or in the alternative, an
intervenor. The decision in response to the first motion, in effect, takes into
account the second motion, in that Eli Lilly acknowledged that its motion would
be moot or premature if the Court decided that the Applicant had no standing to
make the Judicial Review Application
at this time.
[3]
Apotex
is a company that manufactures and distributes generic drugs. It challenges
legislation that was enacted very recently, the Regulations Amending the
Food and Drug Regulations (Data Protection), SOR/2006-241 (Data Protection
Regulations) (published October 18, 2006). Apotex claims that the Data Protection
Regulations are ultra vires the enabling legislation (subsection 30(3)
of the Food and Drugs Act, R.S. 1985, c. F-27). It also claims that to
the extent the enabling legislation may confer the authority to make the Data
Protection Regulations, it too is ultra vires.
[4]
The
Data Protection Regulations impose particular limitations on certain
manufacturers that seek, pursuant to Part C, Division 8 of the Food and Drug
Regulations, C.R.C. c. 870, a notice of compliance for a new drug; however,
at this time, Apotex has no genuine interest in any issue raised, and is
not a party directly affected within the meaning of section 18.1 of the Federal
Courts Act, R.S.C. 1985, c. F-7, as amended.
[5]
Accordingly,
without further evidence before the Court at this time, this Application is
bereft of success. The Notice of Application is struck out and the Application
is dismissed.
[6]
An
Application for Judicial Review can be made only by a person directly affected,
and that person must name as a Respondent every other person directly affected.
To the extent that the Order sought in this Application will affect Apotex, it
will affect a large number of other parties; however, those parties have not
been named as Respondents, and the identity of certain parties is confidential.
BACKGROUND
The Data
Protection Regulations
[7]
On
October 18, 2006, the new Data Protection Regulations were published in the
Canada Gazette Part II, having been registered October 5, 2006 (As noted in the
Regulatory Impact Analysis Statement, the proposed amendment was
pre-published June 17, 2006, after which the government consulted extensively
with stakeholders, including generic and innovator drug manufacturers and their
trade associations). (Data Protection Regulations, Moving Parties’ Motion Record,
pp. 26-35).
[8]
The
operative portion of the Data Protection Regulations is subsection
C.08.004.1(3), which provides as follows:
|
(3) If a
manufacturer seeks a notice of compliance for a new drug on the basis of a
direct or indirect comparison between the new drug and an innovative drug,
(a) the manufacturer may not file a new drug
submission, a supplement to a new drug submission, an abbreviated new drug
submission or a supplement to an abbreviated new drug submission in respect
of the new drug before the end of a period of six years after the day on
which the first notice of compliance was issued to the innovator in respect
of the innovative drug; and
(b)
the Minister shall not approve that submission or supplement and shall not
issue a notice of compliance in respect of the new drug before the end of a
period of eight years after the day on which the first notice of compliance
was issued to the innovator in respect of the innovative drug.
|
(3) Lorsque le
fabricant demande la délivrance d’un avis de conformité pour une drogue
nouvelle sur la base d’une comparaison directe ou indirecte entre celle-ci et
la drogue innovante :
a) le
fabricant ne peut déposer pour cette drogue nouvelle de présentation de
drogue nouvelle, de présentation abrégée de drogue nouvelle ou de supplément
à l’une de ces présentations avant l’expiration d’un délai de six ans suivant
la date à laquelle le premier avis de conformité a été délivré à l’innovateur
pour la drogue innovante;
b) le ministre ne peut approuver une
telle présentation ou un tel supplément et ne peut délivrer d’avis de
conformité pour cette nouvelle drogue avant l’expiration d’un délai de huit
ans suivant la date à laquelle le premier avis de conformité a été délivré à
l’innovateur pour la drogue innovante.
|
[9]
Apotex
is a manufacturer and distributor of pharmaceutical products. Most of the
products are “generic”. As the largest Canadian generic drug manufacturer, it
describes, in general terms, the process by which the Minister of Health
ordinarily reviews and approves submissions made by generic manufacturers for
“notices of compliance”, which signify the Minister’s permission for these
manufacturers to market their drugs.
[10]
Nowhere
in its Notice of Application does Apotex state that it has made any submission
for a notice of compliance that the Minister, pursuant to the Data Protection
Regulations, has refused to consider, has refused to approve, or in respect of
which has refused to issue a notice of compliance. Indeed, Apotex does not
refer to any action of any kind taken pursuant to the Regulations. It
describes no situation in which the Regulations have actually been applied or
put into operation.
[11]
Notwithstanding
these omissions, Apotex, cites as grounds for its Application:
(a) that
the operation and application of the Data Protection Regulations show no
rational connection to the enabling provision;
(b) that
the implementation of the measures represented by the enabling provision and
the Regulations is beyond federal competence;
(c) that
the enabling provision permits the exercise of sweeping, indeterminate, and
uncertain powers; and
(d) that
it does not know precisely how restrictively, or expansively, the Regulations
will actually be applied.
(Notice of Application, Moving Parties’
Motion Record, pp. 18-22).
Procedural History
[12]
About
a month after the publication of the Data Protection Regulations, on November
22, 2006, Apotex filed the Notice of Application in this proceeding.
[13]
On
December 19, 2006, counsel for the Respondents wrote to the Court and to
counsel for the Applicant in response to a request under Rule 317, indicating
that Rule 317 does not apply in this case, because there is no “decision” being
challenged.
[14]
On
January 8, 2007, the Applicant filed its affidavits in support of its Application.
On consent of the parties, the Respondents’ affidavits were served and filed
February 22, 2007.
[15]
On
January 18, 2007, Apotex filed a Notice of Motion for an Order requiring the
Respondents to comply with Rule 317.
[16]
On
February 5, 2007, Eli Lilly Canada Inc. filed a Notice of Motion for an Order
adding it as a party Respondent to this proceeding or, alternatively, granting
it leave to intervene. As the primary ground for its motion, Eli Lilly refers
to two new drug submissions it has recently made that contain data intended to
be protected by the Data Protection Regulations. (Notice of Motion by Eli Lilly
Canada Inc., Feb. 5, 2007, Moving Parties’ Motion Record, pp. 36-48). Eli
Lilly’s motion was also heard February 27, 2007 by the undersigned.
A Related Proceeding
[17]
On
November 14, 2006, the Canadian Generic Pharmaceutical Association initiated an
application very similar to this one (Court File No. T-1976-06) and amended its
Notice of Application January 19, 2007. On January 30, 2007, a motion to strike
the Application on the ground that the Applicant had no standing was heard. It
was dismissed in a decision issued February 9, 2007. (Reasons for Orders in
T-1976-06, Moving Parties’ Motion Record, pp. 49-61). A Notice of Appeal
respecting that decision was issued February 19, 2007. (Moving Parties’ Motion
Record, pp. 62-66).
ISSUES
[18]
(1) Does
Apotex have the standing required to bring this Application?
(2) Should
the Application be struck out?
ANALYSIS
Does Apotex
have the standing required to bring this Application?
[19]
No
person may seek judicial review in this Court unless that person is “directly
affected by the matter in respect of which relief is sought”. (s.18.(1), Federal
Courts Act, above. The only exception occurs where an Applicant has public
interest standing, discussed below). Plainly, the rationale for this
requirement has at least two elements: to ensure that appropriate parties are
brought before the Court, and to ensure that no matter is brought before the
Court until it actually has an effect to be examined.
[20]
For
an Applicant to be considered “directly affected”, the matter at issue must be
one which adversely affects its legal rights, impose legal obligations on it,
or prejudicially affect it directly. (Reference is made to: Rothmans of Pall
Mall Canada Ltd. v. Canada (Ministry of National Revenue – M.N.R.), [1976]
2 F.C. 500 (C.A.); Kwicksutaineuk/Ah-kwa-mish Tribes v. Canada (Minister of
Fisheries and Oceans), 2003 FCT 30 (T.D.), [2003] F.C.J. No. 98 (QL), at
para. 8, aff’d on other grounds 2003 FCA 484, [2003] F.C.J. No. 1893 (C.A.)
(QL), leave to appeal to S.C.C. refused [2004] S.C.C.A. No. 55).
[21]
The
Data Protection Regulations specify particular limitations on certain
manufacturers that seek a notice of compliance for a new drug. Until the situation
arises in which a manufacturer has sought a notice of compliance and the
Minister has acted on it, or refused to act on it, pursuant to the Data
Protection Regulations, the “matter” will have no direct effect, and no party
will be directly affected. Until then, neither the issue nor the Applicant is
properly before the Court.
[22]
Such
were findings in two previous applications dismissed by this Court, both also
brought by Apotex (and another drug manufacturer) in respect of other
regulations. (Apotex Inc. v. Canada (Minister of
National Health and Welfare), [1998] F.C.J. No. 1092; Apotex Inc. v.
Canada (Minister of
National Health and Welfare), [1998] F.C.J. No. 1096; aff’d on other
grounds, [1999] F.C.J. No. 1978 (F.C.A.). There, as here, the regulations at
issue affected the rights of drug manufacturers that made particular new drug
submissions. There, as here, the Applicants had not made such new drug
submissions.
[23]
The
Court ruled that the Applicants had no standing to bring the application. In
one case, the Court stated:
[5] …I am not
satisfied that the applicants have standing to bring this application for
judicial review. Neither has filed for a notice of compliance by comparison or
reference to a drug to which the Patent relates and neither has sent to the
holder of the Patent a notice of allegation of non-infringement...
[6] If and when
a notice of compliance submission is made, if then Glaxo Biochem Inc. brings an
application for judicial review to determine whether the allegation of
non-infringement is justified, the issue of whether the Patent is properly on
the Register will be before this Court and the applicant or applicants in
connection with the new drug submission will also be properly before this
Court.
(Apotex Inc. v. Canada (Minister of
National Health and Welfare), [1998] F.C.J. No. 1092).
[24]
In
the other case, the Court sated:
[14] The applicants are generic drug manufacturers and, as such,
are each regularly engaged in the process of making new drug submissions in
accordance with the Regulations. Each is also regularly engaged in the
litigation contemplated by those Regulations, litigation brought against them
by "brand name manufacturers" or "first persons". However,
there is no specific patent or patents on the Register that is or are identified
in this proceeding and in relation to which either of the applicants has filed
a new drug submission.
…
[16] On the evidence before me, I find no basis to conclude that
the applicants are "anyone directly affected" by the Minister's
course of conduct in maintaining the Register, within the meaning of subsection
18.1(1) of the Federal Court Act. The applicants are not "second
persons" with identifiable direct interests at stake under the Regulations
under which the Minister maintains the Register. I conclude that while they
are, or may some day become so, in respect of a specific entry or entries on
the Register, that is insufficient to constitute a direct interest to support
this application.
…
[18] I conclude that, even if the subject matter of this
application is a proper subject of judicial review, the applicants nonetheless
lack standing to bring this application. (Emphasis of the Court.)
(Apotex Inc. v. Canada (Minister of
National Health and Welfare), [1998] F.C.J. No. 1096).
[25]
In
this proceeding, Apotex has the same lack of standing. There is no evidence
that the Data Protection Regulations have been applied to impose any actual
limitation on Apotex – or on any other drug manufacturer seeking a notice of
compliance. As in the cases described above, the possibility that Apotex may
at some time in the future be affected by the Regulations does not give it
standing now.
[26]
This
consideration demonstrates that Apotex has no standing and should not be
permitted to proceed; however, the same analysis may be taken further, in case
it be feared that the matter might otherwise be beyond challenge.
[27]
At
some future time, particularly given the known litigiousness of this industry,
the appropriate case will arise in one of two situations. A generic
drug manufacturer will make a submission for a notice of compliance for its
version of a particular drug made by an innovator manufacturer, and the
Minister will make a decision that implements the Data Protection Regulations.
In one situation, the Minister may refuse to accept the submission, or to
approve it, or to issue a notice of compliance. The generic drug manufacturer
can then initiate a Judicial Review Application on appropriate grounds
(including, if so advised, those raised here). In that Application, the Applicant
would name as a Respondent the innovator manufacturer of the drug to which the
generic drug is compared. In the second situation, the Minister may accept the
submission, approve it, and issue a notice of compliance. The innovative drug’s
manufacturer can then, on appropriate grounds, initiate a Judicial Review Application.
In that Application, the Applicant would name as a Respondent the generic
manufacturer of the drug to which the notice of compliance is issued.
[28]
In
either of those ways, both a situation in which a direct effect has arisen, and
its directly affected parties, will be properly before the Court. To attempt to
determine the current application, in which no such situation exists, is
contrary to a well-recognized judicial principle – a Court should not be asked
to intervene in an abstract debate without the benefit of a live dispute on a
particular set of facts. (Reference is made to: The Professional Institute
of the Public Service of Canada v. Canada (Customs and Revenue Agency),
2004 FC 507, [2004] F.C.J. No. 649 (QL), in which the application was dismissed
as premature and speculative, esp. at paras. 77-78; Corp. of Canadian civil
Liberties Assn. v. Canada (Attorney General), [1998] O.J. No. 2856 (C.A.),
esp. at paras. 91-92). Justice John C. Major noted (though in a Charter case
involving public interest standing), the principle “…mirrors the Court's
vigilance in ensuring that it hears the arguments of the parties most directly
affected by a matter. In the absence of facts specific to the appellants, both
the Court's ability to ensure that it hears from those most directly affected
and that Charter issues are decided in a proper factual context are
compromised.” (Hy
and Zel’s Inc. v. Ontario (Attorney General), [1993]
S.C.R. 675, at para. 20).
[29]
Further,
it cannot be suggested that Apotex may have public interest standing. A party
seeking public interest standing must satisfy the Court that, among other
things, there is no other reasonable and effective way to bring the issue
before the Court. This criterion has been described by the Supreme Court of
Canada as being “at the heart of the discretion to grant public interest
standing”
(Hy and Zel’s, above, at para. 16), because “a court should have
the benefit of the contending views of the persons most directly affected by
the issue”.
(Finlay v. Canada (Minister of Finance), [1986] 2
S.C.R. 607 infra, at para. 35). There is clearly a more reasonable and
effective means to bring this issue before the Court – either of the means
described above.
[30]
Thus,
Apotex is not a person directly affected by the matter in respect of which
relief is sought, and may not make this Application for Judicial Review at this
time.
Should the
application be struck out?
[31]
While
it is said that a motion to strike an Application for Judicial Review should be
used in very exceptional cases, the Court will and should dismiss an
Application for Judicial Review in this manner if it is so clearly improper at
to be bereft of any chance of success at this time. (Pharmacia Inc. v.
Canada (Minister of National Health and Welfare) (F.C.A.), [1995} 1 F.C.
588 (C.A.); [1994] F.C.J. No. 1629 (QL)).
[32]
On
that basis, Notices of Applications have been struck out in a number of cases.
Examples include the following:
(a) where
the Court had no jurisdiction because the Applicant:
i. could
have utilized a statutory grievance (Bouchard) or appeal procedure (Ontario
Hydro and Fast);
ii. brought
the Application in the wrong division of the Court (Rocky Mountain);
iii. challenged
a decision not made by a federal board, commission, or tribunal (Mennes,
Spatling, Scheuneman and Brazeau);
iv. challenged
a letter or a decision that did not create a legal effect that was subject to
judicial review (Kourtchenko and Moses);
v. failed
to seek any substantive relief that was within the jurisdiction of the Court (Nourhaghighi,
Lavoie and Al-Mhamad).
(b) where
it was clear that the Applicant could not satisfy the pre-conditions for the
issuance of the remedy in a mandamus application (Rocky Mountain);
(c) where
other legislation provided a remedy in a complete code (Syntex);
(d) where
the Applicant sought a declaration requiring the Respondent to comply with the
law in the future (Syntex);
(e) where
the relief sought is moot or can otherwise have no practical effect (Canada (Attorney
General) v. Canada (Information Commissioner));
(f) where
allowing the Application to proceed would amount to an abuse of process because
precisely the same issue had been litigated in previous applications (even
though with different Respondents) (Hoffman-LaRoche and Syntex).
(Bouchard
v. Canada (1999) 255 N.R. 183 (F.C.A.), [1999]
F.C.J. No. 1807 (QL);
Ontario
Hydro v. UMG Telecommunications Inc., [1998] F.C.J. 746 (C.A.) (QL);
Fast
v. Canada (Minister of Citizenship and
Immigration),
[2001] 1 F.C. 257, [2000] F.C.J. 1116 (T.D.) (QL);
Rocky
Mountain Ecosystem Coalition v. Canada (National Energy Board), (1999)
174 F.T.R. 17, [1999] F.C.J. No. 1223 (QL);
Mennes
v. Canada (Attorney General), (1998)
149 F.T.R. 317 (T.D.); [1998] F.C.J. No. 800; aff’d (1999), 247 N.R. 295 (C.A.);
Spatling
v. Canada (Solicitor General), 2003 FCT 621, [2003] F.C.J.
No. 621 (QL), at para. 5;
Scheuneman
v. Canada (Attorney General), 2003 FCA 194, [2003] F.C.J. No. 686 (C.A.) (QL);
Brazeau
v. Canada (Attorney General), 2003 FCT 621, [2003] F.C.J.
No. 687 (C.A.) (QL);
Kourtchenko
v. Canada (Minister of Citizenship and
Immigration),
(1998) 146 F.T.R. 23 (T.D.), [1998] F.C.J. No. 159 (QL);
Moses
v. Canada, 2002 FCT 1088, [2002] F.C.J.
No. 1444 (QL);
Nourhaghighi
v. Canada (Human Rights Commission), [2001] F.C.J. No. 75 (T.D.)
(QL), at para. 6;
Lavoie
v. Canada,
[2000] F.C.J. 360 (T.D.) (QL);
Al-Mhamad
v. Canada (Canadian Radio-Television and Telecommunications Commission), 2003 FCA 45, [2003] F.C.J.
No. 145 (C.A.) (QL);
Rocky
Mountain,
above;
Syntex (U.S.A.) L.L.C. v. Canada (Minister of Health), 2002 FCA 289, [2002] F.C.J. No. 2020
(QL);
Syntex
(U.S.A.) L.L.C. v. Canada (Minister of Health, 2001 FCT 1185, [2001] F.C.J. No. 1647
(QL);
Canada (Attorney General) v. Canada (Information Commissioner), [1998] 1 F.C. 337 (T.D.), [1997] F.C.J.
No. 1160, aff’d [2000] F.C.J. No. 17 (C.A.);
Hoffmann-LaRoche
Ltd. v. Canada (Minister of National Health and
Welfare), (1998) 158
F.T.R. 135 (T.D.), [1998] F.C.J. No. 1706;
Syntex
(U.S.A.) L.L.C. v. Canada (Minister of Health), 2001 FCT 1185, above, at paras. 18-22).
[33]
Similarly,
a Judicial Review Application should be struck out where the applicant has no
standing to initiate it. The Court may determine the issue of standing as a preliminary
matter on a motion to strike an Application for Judicial Review, and may strike
the application in a very clear case.
(Reference
is made to: Sierra Club of Canada v. Canada (Minister of Finance), [1999] 2 F.C. 211 (T.D.), [1998] F.C.J.
No. 1761 (QL), at paras. 24-26; Alberta v. Canada (Wheat Board), [1998] 2 F.C. 156 (T.D.), [1997] F.C.J.
1484 (QL), aff’d on other grounds [1998] F.C.J. No. 1747 (C.A.) (QL)).
[34]
As
noted by the Supreme Court of Canada, in Finlay above, the matter is one
for judicial discretion:
[16] … it is a matter of
judicial discretion, having regard to the particular circumstances of a case,
whether to determine the question of standing with final effect as a
preliminary matter or to reserve it for consideration on the merits… It
depends on the nature of the issues raised and whether the court has sufficient
material before it, in the way of allegations of fact, considerations of law,
and argument, for a proper understanding at a preliminary stage of the nature
of the interest asserted… (Emphasis of the Court.)
[35]
Apotex
is not a party directly affected within the meaning of section 18.1 of the Federal
Courts Act; nor can it be said to have public interest standing at this
time. As Justice John Evans has noted in Sierra Club, above:
[26] Of course, when the
Court has sufficient material to enable it to make a determination, then it may
properly deny standing on a preliminary motion…
CONCLUSION
[36]
Accordingly,
it can and should be concluded at this time that the Application is bereft of
any possibility of success. As an Application for Judicial Review may only be
made by a person directly affected by the matter in respect of which relief is
sought, and Apotex is not such a person, it is plain and obvious that the Application
for Judicial Review cannot succeed. The Notice of Application is struck out and
the application is dismissed without costs.
ORDER
THIS COURT ORDERS that the Notice of
Application be struck and that the Application be dismissed without costs.
“Michel M.J. Shore”
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