Date: 20080318
Docket: T-2102-07
Citation: 2008 FC 359
Ottawa, Ontario, March 18, 2008
PRESENT: The Honourable Mr. Justice Beaudry
BETWEEN:
SCHERING-PLOUGH CANADA INC.
and SCHERING CORPORATION
Applicants
and
PHARMASCIENCE INC., SEPRACOR
INC.,
and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
This is an
application brought by respondent, Pharmascience Inc. (Pharmascience) to
strike, set aside or reject the notice of appearance filed by respondent
Sepracor Inc. (Sepracor) pursuant to Rule 305 of the Federal Courts Rules,
SOR/98-106 (the Rules).
BACKGROUND
[2]
Pharmascience
brings a motion to strike, set aside or reject the notice of appearance,
because it was not made in accordance with Form 305; Sepracor replaced with the
word “oppose”, which is prescribed by the Form, with “participate”.
[3]
Sepracor
is the owner of Canadian Patent No. 2,276,136, one of two patents whose
validity is at issue. As such, Sepracor wishes to support the position of the
applicant, Schering-Plough Canada Inc. (Schering-Plough), who is the “first
person” as defined by the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133 (PM(NOC) Regulations).
|
2. “first person” means the
person referred to in subsection 4(1);
4. (1) A first person who
files or who has filed a new drug submission or a supplement to a new drug
submission may submit to the Minister a patent list in relation to the
submission or supplement for addition to the register.
|
2.
«première
personne» La personne visée au paragraphe 4(1).
4. (1) La première personne
qui dépose ou a déposé la présentation de drogue nouvelle ou le supplément à
une présentation de drogue nouvelle peut présenter au ministre, pour
adjonction au registre, une liste de brevets qui se rattache à la
présentation ou au supplément.
|
[4]
The first
person may apply to the Court for an order prohibiting the Minister from
issuing an NOC, pursuant to subsection 6(1) of the PM(NOC) Regulations. The
first person therefore has the ability to commence an application. The owner of
a patent, if different from the first person, is required by subsection 6(4) of
the PM(NOC) Regulations to be made a party to the application. However, paragraph
303(1)(b) of the Rules provides that every person required to be named
as a party under an Act of Parliament pursuant to which the application is
brought, must be named as a respondent. As such, Sepracor is named as a
respondent. Subsections 6(1) and 6(4) of the PM(NOC) Regulations and paragraph
303(1)(b) of the Rules provide the following:
|
6. (1) A first person may,
within 45 days after being served with a notice of allegation under paragraph
5(3)(a), apply to a court for an order prohibiting the Minister from issuing
a notice of compliance until after the expiration of a patent that is the
subject of the notice of allegation.
(4)
Where the first person is not the owner of each patent that is the subject of
an application referred to in subsection (1), the owner of each such patent
shall be made a party to the application.
303. (1) Subject to subsection
(2), an applicant shall name as a respondent every person
(a)
directly affected by the order sought in the application, other than a
tribunal in respect of which the application is brought; or
(b)
required to be named as a party under an Act of Parliament pursuant to which
the application is brought.
|
6. (1) La première personne
peut, au plus tard quarante-cinq jours après avoir reçu signification d’un
avis d’allégation aux termes de l’alinéa 5(3)a), demander au tribunal de
rendre une ordonnance interdisant au ministre de délivrer l’avis de
conformité avant l’expiration du brevet en cause.
(4)
Lorsque la première personne n’est pas le propriétaire de chaque brevet visé
dans la demande mentionnée au paragraphe (1), le propriétaire de chaque
brevet est une partie à la demande.
303. (1) Sous réserve du
paragraphe (2), le demandeur désigne à titre de défendeur :
a)
toute personne directement touchée par l’ordonnance recherchée, autre que
l’office fédéral visé par la demande;
b)
toute autre personne qui doit être désignée à titre de partie aux termes de
la loi fédérale ou de ses textes d’application qui prévoient ou autorisent la
présentation de la demande.
|
ISSUES
[5]
The issues
on this motion are as follows:
a) Is there a conflict
between subsection 6(4) of the PM(NOC) Regulations and the Rules, such that the
PM(NOC) Regulations should prevail, or was Sepracor properly named as a
respondent?
b) Can a respondent party
file a notice of appearance if it does not intend to oppose the application?
PHARMASCIENCE ARGUMENTS
[6]
Pharmascience
submits that, pursuant to Rule 305, a notice of appearance may only be filed by
a respondent who intends to oppose an application. Pharmascience submits that
the notice of appearance filed by Sepracor is not in compliance with Rule 305
and Form 305, as it has been interpreted by the Federal Court of Appeal in Canadian
Tire Corp. v. Canadian Bicycle Manufacturers Assn., [2005] F.C.J. No. 2023,
2005 FCA 408.
[7]
In Canadian
Tire, above, the Federal Court of Appeal found that a notice of appearance
that stated an intent to “support the Application” was
not acceptable, as it did not comply with either the language or intent of Rule
305:
[8] The domestic producers say
that rule 305 means that only a respondent who intends to oppose the
application may serve and file a notice of appearance. Since the notice of
appearance served and filed by the importers states that they "support the
Application", it does not comply with rule 305 and the Court should reject
it.
[9] In support of this
interpretation of rule 305, the domestic producers rely on a decision of Stone
J.A. in Society of Composers, Authors and Music Publishers of Canada v.
Canadian Assn. of Internet Providers, [2001] F.C.J. No. 166, 2001 FCA 4
("SOCAN"), in which he struck the records of two parties who were not
opposing an application, but advancing supportive arguments. He said (at para.
11)
As I see it, Rule 305 was
intended to play a pivotal role in the overall scheme and operation of the Part
5 rules. That Rule requires a named respondent to signify by way of a notice of
appearance an intention "to oppose an application". This step
allows the parties and the Court to know at an early stage which of the named
respondents will truly oppose the section 28 application. The service and
filing of the notice of appearance ensure that any respondent truly opposed
to the application will be served with all further documents in the
proceeding and so enable effective participation. As I have already stated, if
no notice of appearance is filed, Rule 145(a) disentitles a named respondent
from being served with any further documents in the section 28 proceeding.
[Emphasis in original]
[10] The importers make two
responses. First, they say that SOCAN is distinguishable. They argue that the
respondents in SOCAN were interveners before the Copyright Board, the
administrative tribunal under review. Further, the respondents in that case had
filed notices of appearance which indicated that they intended to oppose the
application for judicial review, but then filed an application record in
support of the application for judicial review.
[11] I do not agree. These
differences are not material to the rationale provided by Stone J.A. for
interpreting rule 305 to permit respondents to file a notice of appearance only
if they intend to oppose an application for judicial review. The purpose of
rule 305 is to enable the parties and the Court to know at an early stage of
the proceeding which respondents intend to oppose an application, and thus to
limit the serving and filing of application records accordingly.
[13] The second argument advanced on
behalf of the importers is that, if not permitted to file a notice of
appearance, they will be denied their right to procedural fairness, since they
will have no opportunity to defend their interests, which would be adversely
affected if the application were dismissed. This is because, unless they have
entered a notice of appearance, they will have no right to notice of any
further steps or documents in the proceeding: rule 145. They say that their
perspective is different from that of the applicant, Canadian Tire, and that
they may have different arguments to make in support of the application.
[14] I do not accept this argument.
If the importers are concerned about ensuring that their interests are fully
canvassed, they may seek intervener status in Canadian Tire's application
pursuant to rule 109. Alternatively, they could have applied to be joined as
applicants.
SEPRACOR ARGUMENTS
[8]
Sepracor raises
several issues in response, and submits that Canadian Tire, above, is
not applicable to a case brought pursuant to the PM(NOC) Regulations.
[9]
Sepracor argues
that subsection 6(4) of the PM(NOC) Regulations requires that the patentee be
added as a party to the underlying application. However, it contends that the
Regulations contain no requirement that the patentee be added as either an
applicant or a respondent, and as such it is open to the applicant to name the
patentee as a respondent.
[10]
Sepracor cites
two recent cases decided by Justice Hughes that support this principle: Pfizer
Canada Inc. v. Canada (Minister of Health), [2007] F.C.J. No. 237, 2007 FC
167, and Pfizer Canada Inc. v. Canada (Minister of Health), [2007] F.C.J. No. 239, 2007
FC 169, for which a single decision was rendered (hereinafter jointly referred
to as Pfizer Canada). At paragraph 15, Justice Hughes stated:
[15] It is not fatal to an
application that the owner of the patent who is not a "first person"
was not a party initially provided that the owner is joined as a party at an
appropriate subsequent time. The purpose in joining the owner is clear, the
owner should be before the Court when its patent is under consideration. If the
owner will not join as an Applicant it can be joined as a Respondent.
[11]
Sepracor advances
that it is clear that a respondent/patentee in a proceeding under the PM(NOC) Regulations
will not be opposing an application which seeks to defend the validity of its
patent, and that the notice of appearance must therefore be modified to accommodate
this unique situation. It also argues that if a patentee was not able to be
named as a respondent unless it intended to oppose an application, then subsection
6(4) of the PM(NOC) Regulations, would be meaningless.
[12]
Sepracor
submits that there is clearly a conflict between subsection 6(4) of the PM(NOC)
Regulations, which does not specify how the patentee must be named when added
as a party, and paragraph 303(1)(b) of the Rules, which requires that
every person required to be named as a party by an act of Parliament under
which the application is brought, must be named as a respondent.
[13]
Sepracor
relies on paragraph 14 of Pfizer Canada, above, in support of the
position that the PM(NOC) Regulations prevail in case of a conflict with the Rules:
[14] I do not view the matter in the
same way as the generics Pharmascience and Cobalt do. Section 6(1) is the
mandatory provision, a "first party" must commence an application
directed to the Minister within 45 days of receipt of a notice of allegation.
That is mandatory. Once the application is commenced the matter falls to be
determined, as to procedure, under the Federal Courts Rules unless there
is a conflict with the NOC Regulations, in which case the Regulations
prevail. […]
[14]
Finally, Sepracor
is of the view that a modified notice of application meets the concerns of the
Court in Canadian Tire, and SOCAN, cited above, and therefore, the
notice of appearance in this case allows the parties to know at an early stage
which parties will truly oppose the application.
PHARMASCIENCE REPLY
[15]
In its
reply, Pharmascience pleads that there is no conflict between the PM(NOC)
Regulations and the Rules, as alleged by Sepracor, and as such the assertion
that Canadian Tire does not find application in the case at bar is
without merit. Pharmascience cites Professor Ruth Sullivan in Sullivan and
Driedger on the Construction of Statutes (4th ed., Butterworths,
2002), at pp. 264:
Overlapping provisions are presumed to
apply. When two provisions are applicable without conflict to the same facts,
it is presumed that each is meant to operate fully according to its terms. So
long as overlapping provisions can apply, it is presumed that they are
meant to apply…
[16]
Pharmascience
contends that subsection 6(4) of the PM(NOC) Regulations and Rule 303 can
coexist; the Rules complement the PM(NOC) Regulations rather than conflict with
them.
ANALYSIS
Sepracor is a properly named respondent
[17]
Before
determining the fundamental issue of this motion, I must determine whether a
conflict exists between the PM(NOC) Regulations and the Rules.
[18]
At the
hearing, it was brought to my attention that Pfizer Canada, above, was
appealed to the Federal Court of Appeal (Pfizer Canada Inc. v. Canada (Minister of Health), [2008] F.C.J. No. 54, 2008
FCA 15 (F.C.A.)). The appeal was dismissed. The judgment of the Court was
delivered orally. Paragraphs 7 and 8 state:
[7] Subsection 6(4) of the NOC
Regulations while mandatory does not give any time limit for the patentee
to be added as a party. The motions judge was correct in supplementing the
provision with the assistance of the Federal Courts Rules.
[8] In Pfizer Canada Inc. v. Canada (Minister of Health), [2007] F.C.J. No. 267, 2007
FC 205; aff'd [2007] F.C.J. No. 923, 2007 FCA 244, the Federal Court (Phelan
J.) explained at paras. 17, 18 and 19 that the Federal Courts Rules
apply to proceedings initiated under the Regulations to the extent that
the Rules do not conflict with the Regulations themselves. He wrote:
[17] The Regulations
are not a complete code. There are numerous aspects of NOC proceedings which
are governed either by the Federal Courts Act or its Rules. The Regulations
enjoy supremacy only in respect of matters which conflict with the more general
provisions found in the Act or the Rules.
[18] The fundamental
requirement under the Regulations is that an application to the Court must be
commenced within 45 days of the notice of allegation. The Court has no
jurisdiction to extend the 45 days because the general rule on extensions would
be in direct conflict with Regulation s. 6(1). (Merck Frosst Canada Inc. v.
Canada (Minister of National Health and Welfare) (1997), 72 C.P.R. (3d) 453
(F.C.T.D.))
[19] However, once the
matter is commenced within the statutory time limits, the Federal Courts
Rules, SOR/98-106, apply except where there is a conflict. The Act and
Rules apply to a number of matters not specifically addressed in the
Regulations including the right to appeal. (Bayer AG v. Canada (Minister of
National Health and Welfare) (1993), 51 C.P.R. (3d) 329 (F.C.A.) at 336).
[19]
It is my
opinion that no conflict exists between subsection 6(4) of the PM(NOC)
Regulations and paragraph 303(1)(b) of the Rules. I agree with
Pharmascience’s submission that the provisions must be construed to be
overlapping provisions. When read as an overlapping paragraph, 303(1)(b)
of the Rules merely brings an additional requirements to subsection 6(4) of the
PM(NOC) Regulations, that is that the patentee must be named as a respondent.
[20]
Having
determined that Sepracor was properly named as a respondent, the fundamental
question raised by this motion must now be addressed.
A
named respondent cannot file a modified notice of appearance in order to
present arguments supporting the applicants’ position
[21]
The real
issue before the Court is not whether the notice of appearance should be struck,
set aside or rejected because of a technical defect to Form 305, but rather whether
Sepracor may make representations in support of the applicant, Schering-Plough,
by virtue of the fact that it modified the notice of appearance to reflect its
real interest. It is my opinion that Sepracor may not.
[22]
I agree
with Pharmascience’s contention that Canadian Tire, above, finds
application in the case at bar; following the decision of the Federal Court of
Appeal, Sepracor may not file and serve a modified notice of appearance in
order to make submissions that further the position of the applicant,
Schering-Plough. Only a respondent who intends to oppose the application may
file and serve a notice of appearance.
[23]
At the
hearing, Secpracor cited Aventis Pharma Inc. v. Apotex Inc., [2004]
F.C.J. No. 688, 2004 FC 570, in support of its submission that a respondent may
present arguments in support of the applicant’s position. Justice Gauthier
wrote at paragraph 19:
[19] It is clear from the decisions
of McGillis J. in Apotex Inc. v. Canada (Minister of Health), (2000) 4
C.P.R. (4th) 421 and Blanchard J. in Nu-Pharm Inc. v. Canada (Attorney
General), (2001) 14 C.P.R. (4th) 280 (affirmed at (2002) 17 C.P.R. (4th)
288) that under the Federal Court Rules, 1998, there is no provision
permitting the Court to limit the rights of a person who is a proper and
necessary party to a proceeding. Thus, the respondent/patentee should be
entitled to participate fully in the proceeding ans [sic] this includes
the fundamental right to present its evidence.
[24]
I am not
persuaded that Aventis Pharma, above, is determinative of the present
issue. The aforementioned order was rendered in the context of a motion to
strike evidence. The motion before the Court in the present case is a motion to
strike, set aside or reject a notice of appearance under Rule 305, a situation
which was squarely dealt with in Canadian Tire, above. Canadian Tire
applies precisely to the facts of the present application, and post-dates the
decision cited by Sepracor.
[25]
Sepracor
argued at the hearing that Pharmascience’s concerns could be dealt with by
adopting a schedule following which evidence would be submitted. Had
Phamascience consented to the implementation of a schedule, this argument might
be persuasive. However, the use of a schedule is not provided for by the Rules
and as such cannot be imposed on a party who does not consent to its use.
[26]
For the
foregoing reasons, it is my opinion that the notice of appearance must be
rejected. If Sepracor wishes to make representations that support the
application, it may seek intervener status pursuant to Rule 109, or apply to be
joined as an applicant pursuant to Rule 104.
ORDER
THIS COURT ORDERS that the notice of appearance
filed on behalf of Sepracor be struck from the Court’s Record. Costs in the
cause.
“Michel Beaudry”
Email this Content