T-449-87
Glaxo Canada Inc. (Plaintiff)
v.
Minister of National Health and Welfare, Attor
ney General of Canada and Apotex Inc. (Defen-
dants)
and
Novopharm Limited (Intervenor)
INDEXED AS: GLAXO CANADA INC. V. CANADA (MINISTER OF
NATIONAL HEALTH AND WELFARE)
Trial Division, Rouleau J.—Toronto, May 27, 28,
29, June 3 and 4; Ottawa, September 22, 1987.
Food and drugs — Defendant filing new drug submission —
Notice of compliance issued — Plaintiff competitor, seeking
interlocutory injunction — Alleging its confidential data
improperly used, breach of fiduciary relationship, inconsistent
and unequal application of Regulations, failure to verify
safety of defendant's drug — Application denied — Plaintiff
without standing — Only purpose of application to prevent
competition — No right to interfere with official action affect
ing competitor — Validity of legislation, Regulations not
challenged — Allegations unsupported by evidence.
Practice — Parties — Standing — Plaintiff seeking inter
locutory injunction restraining sale of competitor's drug —
Attorney General proper plaintiff where harm to public gener
ally — Plaintiffs legal rights not prejudicially affected by
Minister's granting competitor notice of compliance — Stand
ing for public interest recognized if justiciable issues raised
and plaintiff demonstrating special interest, prejudice — No
justiciable issue — Application dismissed.
Judicial review — Equitable remedies — Injunctions —
Drug manufacturer seeking to restrain Minister from granting
competitors notices of compliance — Alleging breach of
fiduciary relationship in improperly using confidential data,
inconsistent and unequal application of Regulations and fail
ure to verify safety of competitor's drug — No standing to
seek injunction in public law area where private right not
affected and no special damages — Considering nature of
Minister's statutory responsibilities, no judicial review of dis
cretion unless acting arbitrarily or illegally — Plaintiff
demonstrating neither strong prima facie case nor irreparable
harm — Interlocutory injunction denied.
The plaintiff, Glaxo, sells a drug, developed from Ranitidine,
under the trade name "Zantac". Several manufacturers had
secured compulsory licences for Ranitidine. The defendant,
Apotex, filed a new drug submission for Ranitidine and a notice
of compliance was issued. Glaxo seeks an interlocutory injunc
tion restraining the Minister of National Health and Welfare
from: (1) granting a notice of compliance to Ranitidine manu
facturers; (2) utilizing plaintiffs confidential information; (3)
permitting Apotex to sell Apo-Ranitidine and restraining
Apotex from selling this drug.
The plaintiffs case is that a substantial portion of the data in
the defendant's new drug submission was plaintiffs confidential
information not available to Apotex. The Minister is said to
have breached a fiduciary relationship with Glaxo, applied the
Regulations inconsistently and unequally and breached his duty
to verify the safety profile of Apo-Ranitidine. As a result, the
plaintiff would lose its proprietary rights over its data and
competitiveness in the market place.
Held, the application should be dismissed.
The plaintiff does not have standing to bring this action. A
person has standing to protect his own interest; the Attorney
General is the appropriate plaintiff where harm is suffered by
the public generally. A private individual may seek an injunc
tion in the area of public law only if a private right is also
interfered with or if he has suffered special damages resulting
from interference with a public right.
Glaxo's only purpose in bringing this application was to
prevent competition. The plaintiffs legal rights had not been
prejudically affected by the Minister's decision to grant Apotex
a notice of compliance. Glaxo had no right to interfere with
official action affecting a competitor merely to prevent that
competitor from obtaining some advantage.
Although the Court has a discretion to recognize standing on
the basis of the public interest, the action must raise justiciable
issues in which the plaintiff has a genuine interest. In seeking
public interest standing to challenge administrative action, a
party must demonstrate a special interest and prejudice. The
plaintiffs concern for public health and safety is one shared
with the general public. Its only interest is economic. There was
no justiciable issue. The validity of the legislation or Regula
tions was not challenged. Rather, the plaintiff desires judicial
review of a regulatory decision with which it disagrees. Consid
ering the nature of the responsibilities under the legislation, it
was clear that the Court might not interfere with the exercise
of the Minister's discretion so long as it was not exercised
arbitrarily or illegally.
Glaxo's allegations, that the Minister had wrongfully utilized
its data and failed to satisfy himself as to the safety of the
defendant's drug, were based on speculation. There was no
evidence of unauthorized use of information or of discrimina
tion by requiring more information from plaintiff than from the
defendant.
There were additional reasons for denying an interlocutory
injunction. The plaintiff had not made out a strong prima facie
case nor had it shown irreparable harm in that any damages
would be calculable by reference to sales of the defendant's
drug.
STATUTES AND REGULATIONS JUDICIALLY
CONSIDERED
Federal Court Act, R.S.C. 1970 (2nd Supp.), c. 10.
Food and Drugs Act, R.S.C. 1970, c. F-27.
Patent Act, R.S.C. 1970, c. P-4, s. 41 (as am. by R.S.C.
1970 (2nd Supp.), c. 10, s. 64).
CASES JUDICIALLY CONSIDERED
APPLIED:
Rothmans of Pall Mall Canada Limited v. Minister of
National Revenue (No. 1), [1976] 2 F.C. 500 (C.A.);
Finlay v. Canada (Minister of Finance), [1986] 2 S.C.R.
607; (1986), 71 N.R. 338; Boulis v. Minister of Man
power and Immigration, [1974] S.C.R. 875.
CONSIDERED:
Rosenberg et al. v. Grand River Conservation Authority
et al. (1976), 12 O.R. (2d) 496 (C.A.); Re Pim and
Minister of the Environment et al. (1978), 23 O.R. (2d)
45 (H.C.J.); Attorney-General for Ontario v. Grabar-
chuk et al. (1976), 67 D.L.R. (3d) 31 (Ont. H.C.J.);
Thorson v. Attorney General of Canada et al., [1975] 1
S.C.R. 138; Nova Scotia Board of Censors v. McNeil,
[1976] 2 S.C.R. 265; Minister of Justice of Canada et al.
v. Borowski, [1981] 2 S.C.R. 575; American Cyanamid
Co. v. Ethicon Ltd., [1975] A.C. 396; [1975] 1 All ER
504 (H.L.); Pfizer Canada Inc. v. Minister of Health &
Welfare et al. (1986), 12 C.P.R. (3d) 438 (F.C.A);
Apotex Inc. v. Canada (Attorney General), [1986] 2 F.C.
233; 9 C.P.R. (3d) 193 (T.D.).
REFERRED TO:
Astra Pharmaceuticals Canada Ltd. et al. v. Apotex Inc.
(1984), 1 C.P.R. (3d) 513 (F.C.T.D.); Pfizer Canada
Inc. v. Attorney-General of Canada et al. (1986), 8
C.P.R (3d) 532 (F.C.T.D.); Apple Computer Inc. et al. v.
Macintosh Computers Ltd. et al. (1985), 3 C.P.R. (3d)
34 (F.C.T.D.); Syntex Inc. v. Apotex Inc., [1984] 2 F.C.
1012; 1 C.P.R. (3d) 145 (C.A.); Wyeth Ltd. v. Novo-
pharm Ltd. (1985), 7 C.P.R. (3d) 399 (F.C.T.D.).
COUNSEL:
John P. G. Bell and J. Martin Peters for
plaintiff.
Marlene I. Thomas for defendants Minister
of National Health and Welfare and Attorney
General of Canada.
Harry B. Radomski for defendant Apotex
Inc.
W. A. Kelly, Q.C., for intervenor Novopharm
Ltd.
SOLICITORS:
Shibley, Righton & McCutcheon, Toronto,
for plaintiff.
Deputy Attorney General of Canada for
defendants Minister of National Health and
Welfare and Attorney General of Canada.
Goodman & Goodman, Toronto, for defen
dant Apotex Inc.
Fasken & Calvin, Toronto, for intervenor
Novopharm Ltd.
The following are the reasons for order ren
dered in English by
ROULEAU J.: This is a motion for interlocutory
injunctive relief brought pursuant to the provisions
of the Federal Court Act, R.S.C. 1970 (2nd
Supp.), c. 10, as amended, and of the Food and
Drugs Act, R.S.C. 1970, c. F-27 and Regulations
thereto as amended wherein the plaintiff seeks an
interlocutory injunction:
a) restraining the defendant Minister from
i) granting a Notice of Compliance to manufacturers of
the drug Ranitidine,
ii) utilizing in any manner confidential information and
data of the plaintiff;
b) restraining the defendant Minister from continuing to
permit the defendant Apotex Inc. to sell, advertise for sale or
market in any manner its drug Apo-Ranitidine pursuant to
its Notice of Compliance;
c) restraining the defendant Apotex Inc. from selling, adver
tising for sale or marketing in any manner its drug Apo-
Ranitidine pursuant to its Notice of Compliance.
This case centres around the process by which
new drugs are approved for manufacture and sale
in Canada. The Health Protection Branch is a
branch of the Department of National Health and
Welfare. One of the duties and obligations of the
branch is to process new drug submissions made
by pharmaceutical manufacturers for a notice of
compliance pursuant to the Food and Drugs Act
and its Regulations. The Minister of National
Health and Welfare is responsible for the adminis
tration of the Act and the Regulations and is
vested with the duty to oversee the operation of the
Health Protection Branch and the application of
the Regulations governing new drug submissions.
Before selling a new drug in Canada, a phar
maceutical company is required to obtain a notice
of compliance from the Health Protection Branch.
In order to obtain a notice of compliance a com
pany is required to submit to the branch a new
drug submission containing extensive material,
including a product monograph, as set out in the
Regulations. The central purpose of the Regula
tions is to ensure that any new drug meets rigorous
safety profile standards in order to protect the
Canadian public. If, upon review, the Minister
finds the new drug submission to be satisfactory,
he is compelled to issue a notice of compliance
pursuant to the Regulations.
The plaintiff Glaxo Canada Inc. is a subsidiary
company of the multinational pharmaceutical
company called Glaxo situated in the United King
dom. Glaxo manufactures, sells and advertises for
sale pharmaceutical products throughout Canada.
One of the plaintiff's major pharmaceutical prod
ucts is a drug developed from Ranitidine and
which it has marketed and sold in Canada since
1982 by the trade name "Zantac". The drug is
primarily used for the inhibition of secretion of
gastric acid and pepsin in the human stomach and
is prescribed by doctors to provide relief from pain,
to promote ulcer healing and to control certain
conditions such as duodenal ulcers, benign gastric
ulcers and to reduce ulcer recurrence.
In order to sell Zantac and advertise it for sale
in Canada, the plaintiff submitted a new drug
submission to the Health Protection Branch and a
notice of compliance was issued by the Minister on
November 26, 1981. On June 19, 1986 the Minis
ter issued a second notice of compliance to the
plaintiff for a supplement to its new drug submis
sion for Zantac. The plaintiff's supplemental new
drug submission involved a change to the plain
tiffs product monograph for Zantac.
Section 41 of the Patent Act, R.S.C. 1970, c.
P-4, as amended [by R.S.C. 1970 (2nd Supp.), c.
10, s. 64], sets out a procedure whereby a phar
maceutical company can obtain a compulsory
licence to produce and market a generically
equivalent drug subject to the payment of a royal
ty to the originator of the drug. Subsection 41(4)
of the Act provides that the Commissioner of
Patents shall, on application by any person for a
licence, grant a licence in the case of a patent
relating to medicine, or for the preparation or
production of medicine except where he sees good
reason not to grant such a licence.
Pursuant to these provisions of the Patent Act,
Novopharm Ltd., Genpharm Inc., Medichem Inc.,
Frank W. Horner Inc. and Apotex Inc. have all
obtained or applied for compulsory licences for
Ranitidine. The defendant Apotex Inc. filed with
the Minister a new drug submission for the sale
and advertising of Ranitidine and a notice of com
pliance was issued to Apotex on February 23,
1987.
It its statement of claim the plaintiff maintains
that the data provided by the plaintiff in its new
drug submissions submitted to the Minister was
provided on the basis that it would only be used for
the purpose of evaluating the plaintiff's new drug
submission and that it would not be used for any
other purpose without the plaintiffs permission.
Accordingly, the plaintiff maintains that a special
trust and fiduciary relationship exists between the
plaintiff and the Minister with regard to the data
and the knowledge derived from it.
The plaintiff maintains that the new drug sub
mission filed by Apotex should have included the
same type of data which the plaintiff's new drug
submission contained. However, the plaintiff
alleges that a substantial portion of the data which
Apotex was required to submit pursuant to the
Regulations was the plaintiffs confidential data
and not available to Apotex. Therefore, by issuing
a notice of compliance to Apotex, when its new
drug submission was incomplete, the Minister
applied the Regulations in a manner which was
unequal and inconsistent with the manner and
standard utilized in evaluating the plaintiffs new
drug submission. The plaintiff alleges that the
Minister has breached his duty to apply the Regu
lations in a fair, equal and consistent manner.
Furthermore, the plaintiff maintains that the Min
ister breached his duty to verify the safety profile
of Apotex' new drug and to ensure that Apotex
met the requirements of the Regulations.
The plaintiff also alleges that, by using the
plaintiffs data to process and evaluate Apotex'
new drug submission, the Minister has breached
his fiduciary relationship with the plaintiff.
As a result of the issuance of a notice of compli
ance to Apotex, the plaintiff maintains that it will
lose its proprietary rights over its data and conse
quently the plaintiff will suffer a loss of competi
tiveness in the market place.
In summary, the plaintiff alleges in its statement
of claim that in processing Apotex' new drug
submission the Minister has:
(a) failed to ensure that the Regulations were applied in a
fair and consistent manner;
(b) failed to ensure the confidential nature of the plaintiff's
data; and
(c) failed to ensure that the requirements of the Regulations
were satisfied in the Apotex New Drug Submission.
The plaintiff seeks in its statement of claim the
following relief against the defendants:
(a) a declaration that the Minister has breached his fiduciary
duties to Glaxo, and that he failed in his statutory duties by
issuing a N.O.C. [Notice of Compliance] to Apotex, and by
applying the Regulations to Glaxo unfairly, inconsistently
and in a discriminatory manner;
(b) prohibition to prohibit the Minister from using any Glaxo
data or knowledge derived from it in the processing of any
new drug submissions;
(c) mandamus to require the Minister to fulfill his statutory
duties to protect the Canadian public's health and safety by
revoking the Apotex N.O.C. for the Ranitidine drug and to
fulfill his duties to Glaxo by maintaining the confidentiality
of its information;
(d) an injunction to prevent the Minister from:
(i) issuing notices of compliance for Ranitidine until the
Regulations have been complied with;
(ii) continuing to permit Apotex from selling or advertising
its Ranitidine drug or taking any other action pursuant to
its N.O.C.;
(iii) using the Glaxo data and knowledge derived from it in
the processing of new drug submissions of other
companies;
(iv) releasing the Glaxo data to other companies;
(e) an injunction to prevent the respondent Apotex from
selling or advertising for sale the Apotex drug including all
taking of orders, filling of orders and manufacturing, ship
ping or handling of the Apotex Drug;
(f) damages arising out of:
(i) the Minister's breach of confidentiality out of the use of
Glaxo data;
(ii) the Minister's breach of statutory duties and unfair
and discriminatory application of the Regulations.
Before embarking upon an examination of the
plaintiff's arguments in support of its application
for an interlocutory injunction and the defendants'
counter arguments, I intend to deal first with the
issue of the plaintiffs status or locus standi to
bring these proceedings. It is the position of the
defendants that the plaintiff has no standing to
attack the Minister's decision to grant the defen
dant Apotex Inc. a notice of compliance as that
decision does not directly affect the plaintiff. This
submission is based on the premise that a party
will not have sufficient standing to challenge an
administrative decision of the government where
the decision does not affect the legal rights of the
party nor can it be said to affect their interests
prejudicially in any direct sense. Therefore, in
order for a party to establish status to maintain an
action, it must have a direct legal interest in the
matter as compared to an economic interest. The
defendants argue that the plaintiff in this case does
not have a direct legal interest in the decision of
the Minister regarding the defendant Apotex Inc.
or to seek to review or be involved in the Minister's
decision regarding the other companies; the plain
tiffs concerns are purely economic in seeking to
maintain its monopoly, a concern which does not
translate into a legal interest.
The plaintiff submits that after a notice of
compliance has been issued, a competitor of the
recipient of the notice of compliance has, prima
facie, the full right to commence an action in order
to have the decision and the act of the Minister
reviewed. Accordingly, if the plaintiff is of the
view that the notice of compliance has been illegal
ly issued to the defendant Apotex, then there is
legal recourse available to the plaintiff in this
Court. In support of this proposition, the plaintiff
relies upon the Federal Court of Appeal decision in
Rothmans of Pall Mall Canada Limited v. Minis
ter of National Revenue (No. 1), [1976] 2 F.C.
500 wherein Le Dain J. stated, at pages 509-510:
It may be conceded that in certain contexts a competitive
interest may be regarded as conferring status to challenge
administrative action, as for example, on certiorari to quash the
grant of a licence allegedly in excess of jurisdiction ....
The present case is not one that raises any question of the limits
of statutory authority. The most that is raised is a question of
administrative interpretation that the authorities are obliged to
make in their application of the governing statute. Indeed, the
action in this case is not of the kind that is subject to chal
lenge .... There is no decision here determining rights or
obligations in an individual case .... There is no duty to act
judicially or fairly in a procedural sense .... there is no public
duty of any kind that the appellants have a right to enforce.
The plaintiff maintains that it is clear law that a
participant in a regulated industry has the prima
facie right to object to and restrain official acts
which are illegal or in excess of jurisdiction, and to
restrain unlicensed or illegal competition arising as
a result.
Generally in administrative law cases there is
seldom a dispute as to the standing or locus standi
of the applicant to seek relief. Locus standi is
understood to mean legal capacity to challenge an
act or decision. The majority of proceedings for
judicial review are brought by the party who is the
direct object of the decision maker's attention, for
example, where a licence is refused, property is
expropriated or money is not paid. Locus standi
does become an issue, however, when one moves
outside of that class, for example, the interests of a
property owner anticipating a serious loss of
amenity as a result of an administrative decision to
permit the building of a high rise or, as in this
case, the interests of competitors.
The traditional rule has been that a person has
standing to protect his own interest but has no
standing to represent the interest of the public or
to bring an action to restrain the violation of a
public right. Where matters involving the public
interest are concerned, the Attorney General, and
not private individuals, has always been regarded
as the appropriate person to seek relief. In Rosen-
berg et al. v. Grand River Conservation Authority
et al. (1976), 12 O.R. (2d) 496 (C.A.) and in Re
Pim and Minister of the Environment et al.
(1978), 23 O.R. (2d) 45 (H.C.J.) it was held that
the Attorney General is the proper party to repre
sent the public interest either in his own right or in
relation to someone else. Accordingly, in matters
of public nuisance, private individuals can only sue
if they have suffered damage themselves or have
suffered damages over and above that suffered by
the public at large. The Attorney General has been
generally recognized as always having standing to
challenge any unlawful administrative action or
unconstitutional legislation. In Attorney-General
for Ontario v. Grabarchuk et al. (1976), 67
D.L.R. (3d) 31 (Ont. H.C.J.) Reid J. stated, at
page 36:
There are numerous precedents in England and Australia for
the proposition that the Attorney-General, as the protector of
public rights and the public interest, may obtain an injunction
where the law as contained in a public statute is being flouted.
This is so notwithstanding that, (a) the statute itself may
contain penalties of a different kind, and (b) all possible
alternative remedies have not been exhausted. The position of
the Attorney-General as custodian of the public interest is the
same whether one speaks of England, Australia or Canada.
This is clear from such decisions as the Public Accountants
Council v. Premier Trust Co., [1964] 1 O.R. 386, 42 D.L.R.
(2d) 411, and Cowan v. Canadian Broadcasting Corp., [1966]
2 O.R. 309, 56 D.L.R. (3d) 578. In the latter case, Mr. Justice
Schroeder said for the Court of Appeal [at p. 314 O.R., p. 583
D.L.R.]:
Under our law, the Attorney-General is by law the repre
sentative of the public interests which are vested in the
Crown and are enforceable by the Attorney-General as the
Crown's officer.
In bringing an action for an injunction in the
area of public law a party will have standing where
the interference with a public right also interferes
with a private right of his own and where he has
no private right but has suffered special damage as
a result of interference with a public right. Where
the harm done by the unlawful action is suffered
by the public generally, then a private individual
has no capacity to sue for an injunction to restrain
the wrongful action. Again, this is the function of
the Attorney General who represents the general
public and has in mind the public's interest in
ensuring that excesses of statutory authority or
breaches of statutory duties are restrained.
Therefore, in order to have standing to challenge
the decision of the Minister, the plaintiff must
show that its legal rights or some other of its
interests have been prejudicially affected in a
direct sense. I am not satisfied that the plaintiff
has satisfied either of these criteria. The sole
motive on the plaintiff's part in bringing this
application appears to me to be to prevent compe
tition in a market where it has, up to the date of
the Minister issuing a notice of compliance to the
defendant Apotex Inc., enjoyed a virtual monopo
ly. I agree with the defendants that such a concern
on the part of the plaintiff does not translate into a
legal right or interest sufficient to bestow on the
plaintiff standing to bring the present action. In
Rothmans of Pall Mall Canada Limited v. Minis
ter of National Revenue (No. 1), supra, Le Dain J.
stated, at pages 509-510:
A person should not, however, in my view, have the right tc
interfere with or meddle in official action affecting an existin€
competitor for the sole purpose of preventing that competitor
from obtaining some advantage, particularly where the actior
complained of is something that the person complaining is free
to take advantage of himself. That kind of interest appears tc
have been clearly rejected in the case of Regina v. Commis
sioners of Customs and Excise [1970] 1 W.L.R. 450 (albeit
one of mandamus), where Lord Parker C.J. said [at page 456]
"Secondly, as it seems to me, in any event the interest, or the
motive, which is moving this application is what I would ter>r
an ulterior motive, a motive of putting people out of business
and nothing more." The public interest in competition must be
borne in mind in exercising the judicial discretion as to whether
to recognize standing in a competitive relationship.
As a competitor of the defendant Apotex Inc. it
is not surprising that the plaintiff is concerned
with the decision of the Minister to grant Apotex a
notice of compliance. Nevertheless, that concern
does not, in my opinion, constitute a legal interest.
The Minister's decision to grant Apotex a notice of
compliance has not altered the plaintiff's legal
rights or imposed legal obligations upon it in any
way. As previously stated, a competitor such as the
plaintiff does not have a right to interfere with
official action affecting another competitor for the
sole purpose of preventing the latter competitor
from obtaining some advantage. I am of the view
that the effect on the plaintiff of the Minister's
decision to issue a notice of compliance to the
defendant Apotex Inc. is too indirect, remote or
speculative to provide the plaintiff with standing
under the general rule. Accordingly, the plaintiff
must rely on what is essentially a public interest
standing.
The plaintiff submits that, quite apart from its
standing based upon violations of private rights, it
has standing to pursue its action because:
(a) it has a sufficient personal interest in the legality of the
actions of the Minister and the Department in using a Notice
of Compliance to Apotex to bring it within the general
requirement for standing to challenge an exercise of statu
tory authority by an action for declaration and injunction;
(b) this Court has an additional discretion to recognize
public interest standing in the circumstances of this case; and
(c) in light of the facts of this case, such discretion should be
exercised in favour of the plaintiff.
It has now been established by the Supreme
Court of Canada that there is a judicial discretion
within the Court to recognize standing on the basis
of public interest standing in certain limited cir
cumstances. In Finlay v. Canada (Minister of
Finance), [1986] 2 S.C.R. 607; (1986), 71 N.R.
338 the issue before the Court was whether a
private individual has standing to sue for a decla
ration that certain payments out of the Consolidat
ed Revenue Fund were illegal on the ground that
they were not made in accordance with the appli
cable statutory authority. Specifically, the ques
tion to be determined was whether a recipient of
provincial assistance, who claimed to be prejudiced
by certain provisions of the provincial legislation
respecting such assistance, should be recognized as
having standing to seek a declaration that pay
ments by the federal government to the provincial
government of contributions to the cost of such
assistance, pursuant to the Canada Assistance
Plan, R.S.C. 1970, c. C-1, were illegal as being
contrary to the authority conferred by the Plan.
Le Dain J. writing for the Court held that the
answer to these questions involved a consideration
of the discretionary control over standing to assert
a purely public right or interest by an action;
something which has traditionally been vested in
the Attorney General. What had to be considered
was whether the approach to public interest stand
ing reflected in the decisions of Thorson v. Attor
ney General of Canada et al., [1975] 1 S.C.R.
138; Nova Scotia Board of Censors v. McNeil,
[1976] 2 S.C.R. 265; and Minister of Justice of
Canada et al. v. Borowski, [1981] 2 S.C.R. 575, in
which there was a challenge to the constitutional
ity of legislation, applied to a non-constitutional
challenge to the statutory authority for adminis
trative action.
The Supreme Court held that the respondent
did not have a sufficiently direct, personal interest
in the legality of the federal cost-sharing payments
to bring him within the general requirement for
standing to sue, without the consent of the Attor-
ney General, for a declaration or an injunction to
challenge an exercise of statutory authority. The
Court was of the opinion, however, that the
respondent should be recognized, as a matter of
judicial discretion, as having public interest stand
ing to bring his action. The approach to public
interest standing reflected in the judgments of the
Court in Thorson, McNeil and Borowski, in which
there was a challenge to the constitutionality or
operative effect of the legislation, was extended to
a non-constitutional challenge by an action for a
declaration as to the statutory authority for public
expenditure or other administrative action. The
respondent met the criteria set out for the discre
tionary recognition of public interest standing in
Thorson, McNeil and Borowski in that his action
raised justiciable issues, the issues were serious
ones and the respondent had a genuine interest in
them. Accordingly, the respondent was recognized
as having standing to sue for injunctive as well as
declaratory relief.
In my opinion, the plaintiff in the case at bar
fails to meet the requirements set out in the Finlay
decision (supra) which would bestow upon it
public interest standing to challenge the Minister's
decision to issue a notice of compliance to the
defendant Apotex Inc. In order to acquire public
interest standing to challenge the validity of
administrative procedures, a party must demon
strate that it has a special interest in the legislation
and that it will suffer special prejudice as a result
of the illegal actions. A party whose legal rights
are not affected and who is merely seeking to
enforce public rights will not be granted standing
to seek a declaration or injunction. This principle
of law was expressed by Le Dain J. in the Finlay
decision (supra) at pages 620-621 S.C.R.; 353-354
N.R. where he stated:
In Australian Conservation Foundation, supra, in which the
High Court of Australia applied the rule in Boyce to deny
public interest standing to challenge the validity of administra
tive procedures respecting a requirement for an environmental
impact statement, Gibbs J., at p. 268, made the following
observations concerning the meaning to be given to the words
"special damage peculiar to himself' in Boyce:
Although the general rule is clear, the formulation of the
exceptions to it which Buckley J. made in Boyce y Padding-
ton Borough Council is not altogether satisfactory. Indeed
the words which he used are apt to be misleading. His
reference to "special damage" cannot be limited to actual
pecuniary loss, and the words "peculiar to himself" do not
mean that the plaintiff, and no one else, must have suffered
damage. However, the expression "special damage peculiar
to himself', in my opinion should be regarded as equivalent
in meaning to "have a special interest in the subject matter
of the action".
In Borowski, supra, Laskin C.J., dissenting, referred to the
general rule as follows at p. 578: "Unless the legislation itself
provides for a challenge to its meaning or application or validity
by any citizen or taxpayer, the prevailing policy is that a
challenger must show some special interest in the operation of
the legislation beyond the general interest that is common to all
members of the relevant society.
In my view the plaintiff has not demonstrated
that it will suffer any extraordinary prejudice as a
result of the actions of the Minister. The concern
that public health and safety may be jeopardized
by the issuance of a notice of compliance to the
defendant Apotex Inc. is a concern which the
plaintiff shares with the general public, but it is
not a particular or unique interest to the plaintiff
which satisfies the test for public interest standing.
Furthermore, the issues raised in the within
proceedings are not justiciable. No questions of
law, in my opinion, have been raised for resolution
by the plaintiff, but rather the plaintiff is seeking
to have this Court review the merits of the regula
tory decision taken by the Minister and to chal
lenge the sufficiency of the evidence before the
Minister prior to his decision to issue the notice of
compliance to the defendant Apotex Inc.
The plaintiff is in fact asking this Court to
review the findings of the Minister's officials who
were responsible for examining the Apotex new
drug submission and making recommendations
which led to the issuance of the Apotex notice of
compliance. Not only is the plaintiff asking me to
review these findings, it is also seeking to have the
Court substitute the Minister's opinion with its
own. I think it is trite to say that this Court is not
in a position nor does it befit the Court's function
to second-guess the opinion of the technical
experts employed by the Minister.
As previously stated, the plaintiff has no gen
uine interest in any issue raised in this case other
than a purely competitive or economic interest.
Therefore, it is my conclusion that the plaintiff
has no standing to bring the present action. While
that finding would dispose of the matter, I intend
to deal briefly with the other issues raised, in the
event that my finding on this question should not
be sustained.
The plaintiff submits that in accordance with
the House of Lord's decision in American Cyana-
mid Co. v. Ethicon Ltd., [1975] A.C. 396; [1975]
1 All ER 504, the test for an interlocutory injunc
tion will be satisfied if the plaintiff shows the
following: 1) there is a serious issue to be tried; 2)
pending trial the plaintiff is at risk of suffering
some injury which cannot be compensated for or
adequately remedied other than through the oper
ation of an interlocutory injunction, that is, the
plaintiff is at risk of irreparable harm; 3) the
balance of convenience favours the plaintiff; and
4) the injunction will preserve the status quo.
It is argued by the plaintiff that the facts of this
case clearly establish a number of serious issues to
be tried. To begin with there is the issue of the
serious risk to the health and safety of the Canadi-
an public as a result of the Minister's unlawful
failure to require the defendant Apotex Inc. to
comply with the Regulations with the result that
the safety and efficacy of the Apotex drug has not
been verified. The next issue is the discriminatory
manner in which the plaintiff has been treated as a
result of the Minister's unlawful failure to apply
the Regulations in an equal, fair and consistent
manner in his evaluation of the new drug submis
sion of the defendant Apotex. The third issue,
argues the plaintiff, is the Minister's failure to
maintain the confidentiality of the plaintiff's data
by unlawfully utilizing that data during its evalua
tion of the new drug submission of the defendant
Apotex Inc. and in formulating the decision to
issue a notice of compliance to Apotex. Finally, the
plaintiff submits there are the issues of the Minis
ter's lack of authority to grant a notice of compli
ance to the defendant Apotex and the issue of
Apotex selling its drug at a time when its safety
and efficacy have not been verified pursuant to the
Regulations and that the selling of such drugs
directly affects the reputation of the plaintiff and
its drug Zantac.
The plaintiff further argues that if this Court
does not grant an interlocutory injunction, then
irreparable harm not compensable in damages will
be suffered by it. It is the plaintiffs position in this
regard that the Court must have foremost concern
for the safety of the intended users of the drug and
that the Canadian public is at serious risk as long
as the defendant Apotex' drug is being manufac
tured and sold when its safety and efficacy have
not been established and verified by the Minister
pursuant to the Regulations. In turn, any harm
suffered by the public will, the plaintiff argues, be
inextricably linked to the long-standing reputation
of the plaintiff and its drug Zantac. The marketing
of the drug of the defendant Apotex when its
safety has not been established and verified pursu
ant to the Regulations will cause the public,
according to the plaintiff, to lose confidence in the
plaintiff's drug and will, as a result, detrimentally
affect the reputation of Glaxo.
It is the plaintiffs contention in support of its
action for an interlocutory injunction that as be
tween itself and the defendant Apotex Inc. the
balance of convenience favours the plaintiff
because the reputation of the plaintiffs drug as a
safe and effective one is of long standing in the
market. The defendant's drug, on the other hand,
is a new drug in Canada which has only been
marketed for a short time. In the event that the
Minister's failure to verify the safety and efficacy
of the defendant's drug results in adverse reaction
to members of the Canadian public to whom it is
prescribed, then the plaintiffs drug will be directly
and immediately affected. The plaintiff argues
that the protection of the Canadian public by
ensuring that only safe drugs are sold and adver-
tised for sale in Canada must outweigh any short-
term harm to the defendant Apotex as a result of
the interruption in the sale of its drug until its
safety has been fully established pursuant to the
Regulations.
Finally the plaintiff submits that the purpose of
an interlocutory injunction is to preserve the status
quo and since the defendant Apotex has just com
menced marketing its drug, it is only just that the
status quo in this case be preserved pending trial
because not to do so would be to permit the public
to suffer a serious and unacceptable risk to health
and safety.
As to the plaintiff's first argument in support of
granting an interlocutory injunction, that there are
serious issues to be tried, I have previously
expressed my opinion that the facts of this case do
not reveal any justiciable issues.
The legislative scheme set out in the Food and
Drugs Act and the Regulations provides a mech
anism whereby the safety and efficacy of a new
drug on the Canadian market is assessed and
monitored. The Regulations contemplate a process
in which the manufacturer of a new drug acquires
the right to sell or advertise that drug for sale only
when the Minister is satisfied that the claims made
by the manufacturer for the drug are substantiat
ed. The Minister signifies his satisfaction by issu
ing a notice of compliance. The Minister's decision
to issue such a notice is discretionary. In exercising
his discretion, the Minister weighs the benefit of
the drug against the foreseeable risk of adverse
reaction to it. In Pfizer Canada Inc. v. Minister of
Health & Welfare et al. [(1986), 12 C.P.R. (3d)
438 (F.C.A.)], the Court held that the Minister's
decision to issue a notice of compliance for a
particular drug is a decision made on the basis of
public health considerations. The Minister in exer
cising his discretion weighs the predicted benefit of
the drug in relation to the foreseeable risk of
adverse reaction to it. The Minister's determina
tion is one made in contemplation of public health
and represents the implementation of social and
economic policy.
The function of the Minister and his responsibil
ity in administering the Act and Regulations was
described by Walsh J. in Apotex Inc. v. Canada
(Attorney General), [1986] 2 F.C. 233; 9 C.P.R.
(3d) 193 (T.D.), at pages 241 F.C.; 198 C.P.R. in
the following terms:
It is the responsibility of the Minister and his staff of technical
experts to apply the Act and Regulations and protect the
public, not to protect commercial and economic interests of
competitors or even originators of the product in question.
In my opinion, the nature of the power bestowed
on the Minister by the legislation, the subjective
determination as to what additional information is
required prior to a notice of compliance being
issued, the subjective requirement that the Minis
ter be satisfied that the new drug submission com
plies with the Regulations, the absence of any
requirement in the legislation that competitors or
other manufacturers participate in the process, and
the scientific nature of the inquiry into the safety
or efficacy of the drug, make clear that the Minis
ter's decision is not open to review at the suit of a
competitive manufacturer.
If the discretion bestowed upon the Minister by
the legislation has been exercised bona fide and
has not been influenced by irrelevant consider
ations nor exercised arbitrarily or illegally, then
this Court is not entitled to interfere, even if it
would have exercised the discretion in a different
manner. That this is the criteria by which the
exercise of a statutory discretion must be judged is
made clear by the decision of the Supreme Court
of Canada in Boulis v. Minister of Manpower and
Immigration, [ 1974] S.C.R. 875.
In this case, the plaintiff seeks to have the Court
review the merits of the regulatory decision made
by the Minister with respect to the new drug of the
defendant Apotex Inc. and challenges the suffi
ciency of the evidence which was before the Minis
ter in relation to this new drug. The plaintiff, as
far as I can ascertain, simply disagrees with the
exercise of the Minister's discretion. The present
action does not involve any challenge to the validi
ty of the legislation or the Regulations thereunder
or the statutory or regulatory authority that is
being exercised; the action does not amount to
anything more than an attempt by the plaintiff to
have this Court review a regulatory decision
which, in my opinion, has no bearing on the
plaintiff.
The evidence presented by the plaintiff relates to
the merits of the Minister's decision and to the
sufficiency of the evidence before the Minister
prior to making his decision to issue a notice of
compliance to the defendant Apotex. In my view,
there exists a serious doubt as to whether the
weight and sufficiency of the evidence before the
Minister is even open to attack by the plaintiff. In
any event, there is no evidence to support the
plaintiff's assertion that the Minister could not
have satisfied himself as to the safety and efficacy
of the defendant's drug. In this regard, the plain
tiff is relying on pure speculation. The uncon-
tradicted and direct evidence of the Minister's
officials is that all the necessary data and informa
tion was submitted by the defendant Apotex in
compliance with the Regulations and that the
Regulations were satisfied leading to the issuance
of a notice of compliance signifying the safety and
efficacy of the defendant's drug. The plaintiff has
failed to put forward anything which would lead
me to disregard this evidence of the Minister's
officials and has been unable to produce evidence
which contradicts or otherwise negates it.
With respect to the plaintiff's assertion that the
Minister must have wrongfully utilized the plain
tiffs data in processing the defendant Apotex' new
drug submission, the plaintiffs evidence again
amounts, in my opinion, to nothing but sheer
speculation without any direct and probative evi-
dentiary value. The plaintiff maintains that since
the defendant Apotex could not have had the
resources, technical expertise or the time to pro
duce a new drug submission sufficient to meet the
requirements of the Regulations and allow the
Minister to satisfy himself as to the safety and
efficacy of the Apotex drug, then the Minister
must have utilized the plaintiffs data in order to
satisfy himself that the defendant's drug was safe.
The evidence simply does not support the plain
tiff's allegations; the defendant Apotex firmly
denies that any confidential data of the plaintiff
was disclosed to it by the Minister and his offi
cials; the statement of the Crown witnesses in their
affidavits and cross-examination are to the effect
that no confidential data of the plaintiff was dis
closed to the defendant Apotex except in one
limited instance on February 16, 1987 when cer
tain of the plaintiff's data was compared to confi
dential data of the defendant Apotex. However,
the sworn evidence of the Minister's officials was
that the comparison in question was not used in
assessing the Apotex new drug submission. The
evidence further established that the departmental
personnel were fully aware that they were not to
use the confidential data of a drug manufacturer
when assessing the data of another. Again the
plaintiff was unable to provide any contradictory
evidence which would lead to a finding that its
confidential data had been used by the Minister in
assessing Apotex' new drug submission. Indeed,
the contents of the Apotex new drug submission
have never been seen by the plaintiff and no
information was made available to the plaintiff
either directly or indirectly as to the contents of
the Apotex new drug submission. Accordingly, I
am of the view that there has not been any unau
thorized use of the plaintiffs confidential informa
tion.
The final allegation of the plaintiff is that the
Minister discriminated against it by requiring
more information and data in its new drug submis
sion than was required of the defendant Apotex.
The plaintiff bases this assertion upon the allega
tion that generic drug manufacturers are not
required to submit the extensive information and
data which is required of originator manufactur
ers.
Once again I find no evidence to support this
argument. In fact, the evidence of the Minister's
officials is that the very same standards are
applied to all manufacturers without regard to
whether they are an originator or a generic manu
facturer. Further it is clear that the body of knowl
edge available to the defendant regarding the drug
Ranitidine was greater than that which was avail
able to the plaintiff at the time of its new drug
submission. Accordingly, some matters not known
or not proven at the time of the plaintiff's new
drug submission had become matters of public
knowledge by the time the defendant Apotex made
its new drug submission. I am satisfied that if
there did exist any differences in treatment of the
plaintiff, such differences arose out of circum
stances which differed from those in existence at
the time when the defendant's new drug submis
sion was being considered and not because the
treatment afforded to the plaintiff differed from
that afforded to any other manufacturer.
In my opinion, the plaintiff has failed to satisfy
the requirements for the issuance of an interlocu
tory injunction. It is trite law that an interlocutory
injunction is an extraordinary legal remedy which
is to be granted only in special cases. The thresh
old test requires the plaintiff to establish a strong
prima facie case. It is true that a lower test has, in
the past, been applied and has been described as
requiring the plaintiff to establish a serious ques
tion or arguable case. Nevertheless, the Court has
indicated on a number of occasions that the former
test is to be preferred. See for example Astra
Pharmaceuticals Canada Ltd. et al. v. Apotex Inc.
(1984), 1 C.P.R. (3d) 513 (F.C.T.D.), at page
517; Pfizer Canada Inc. v. Attorney-General of
Canada et al. (1986), 8 C.P.R. (3d) 532
(F.C.T.D.), at page 535; Apple Computer Inc. et
al. v. Macintosh Computers Ltd. et al. (1985),
3 C.P.R. (3d) 34 (F.C.T.D.), at page 39; Syntex
Inc. v. Apotex Inc., [1984] 2 F.C. 1012; 1 C.P.R.
(3d) 145 (C.A.), at pages 1023-1024 F.C.; 153-
154 C.P.R.; and Wyeth Ltd. v. Novopharm Ltd.
(1985), 7 C.P.R. (3d) 399 (F.C.T.D.), at pages
404-405.
In order to meet the prima facie test, the right
asserted by the plaintiff must be very clear so as to
leave little doubt as to what the result at trial
would be. In considering whether this threshold
test has been met, the Court must consider the
nature of the plaintiff's evidence and its probative
value. In the case at bar, for the reasons which I
have hereinbefore discussed, the plaintiff has not
demonstrated a strong prima facie case. The plain
tiff cannot even meet the lower standard for the
granting of an interlocutory injunction because, in
my view, it cannot show that there is a serious or
arguable issue to be tried. As stated, I have grave
doubts as to whether the plaintiff has any standing
whatsoever to bring this application. In any event,
the plaintiff has failed to provide the Court with
any probative evidence to support its allegations
and which would warrant the issuance of an inter
locutory injunction.
As to the question of irreparable harm, it is
incumbent on the plaintiff to demonstrate that
such harm is not compensable by an award of
damages and the evidence must be clear and not
speculative. It is not sufficient for the purpose of
granting an interlocutory injunction that mere dif
ficulty in calculating the quantum of damages be
shown. In the present case the plaintiffs claim of
irreparable harm is speculative but in any event
any damages which the plaintiff may suffer are
calculable as they will simply result from the sale
of the defendant Apotex' drug; that is, the plaintiff
will suffer a loss in sales readily calculable by
reference to the sales made by the defendant
Apotex Inc. Any of the other claims made by the
plaintiff that it will suffer irreparable harm
because of some adverse effect on its reputation as
a result of the sale of the defendant Apotex' drug
are, as I have previously stated, purely speculative.
Accordingly, the plaintiff having failed, in my
opinion, to make out a prima facie case and having
failed to show irreparable injury not compensable
by damages, the balance of convenience favours
maintaining the status quo until trial.
For the above reasons, the plaintiff's application
for an interlocutory injunction is dismissed.
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