Date: 20070710
Docket: T-2300-05
Citation: 2007
FC 696
Ottawa, Ontario, July 10, 2007
PRESENT: The Honourable Mr. Justice Shore
BETWEEN:
APOTEX
INC.
Plaintiff
and
ASTRAZENECA
CANADA INC.
Defendant
REASONS FOR ORDER AND ORDER
OVERVIEW
[1]
When does
the clock start ticking? When do calendar days begin to be counted to determine
profits? After an inventor’s patent protection is no longer in effect, when can
a generic entity begin to aspire to work towards and collect financial fruits
of an orchard left for a newly-claimed harvest and its harvester? That is
subject-matter for a trial to decide.
All that is examined and
confirmed, in this proceeding, is, simply, who can make a claim as an
interested party, initiating an action. The basis of the claim, and how much is
to be acquired, if anything, is also for a trial to determine in respect of
entitlement.
INTRODUCTION
[2]
This is a
motion brought by the Defendant, AstraZeneca Canada Inc. (AstraZeneca), to set
aside the Order of Prothonotary Roza Aronovitch, dated June 6, 2007, that
dismissed AstraZeneca’s motion to strike Apotex Inc.’s (Apotex) Statement of
Claim.
[3]
The
fundamental issue is whether AstraZeneca demonstrates that it is plain and
obvious that Apotex’s Statement of Claim discloses insufficient material facts
to support a cause of action under section 8 of the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133 (Regulations).
[4]
The interpretation
of the law in regard to section 8 of the Regulations is in an “embryonic
state”. As such, the Court is hesitant to strike out section 8 claims at the
pleadings stage. (Apotex Inc. v. Eli Lilly an Co. et al. (2004), 36
C.P.R. (4th) 111 (F.C.A.) at paras. 14, 16; Apotex Inc. v. Laboratoires
Fournier S.A., [2006] O.J. No. 4555 at paras. 10-11; Apotex Inc. v.
Syntex Pharmaceuticals International Ltd. (2001), 16 C.P.R. (4th) 473 (F.C.T.D.) at para.
15, aff’d (2002, 20 C.P.R. (4th) 190 (F.C.A.); Apotex Inc. v.
Merck & Co. (2004) 248 F.T.R. 82, [2004] F.C.J. No. 1495 (QL).)
[5]
This Court has held
that matters of the interpretation of section 8 should be deferred to trial:
[15] …There is not yet a clear understanding of what s. 8 of the
Patent Regulations really means…
[18] …the contentious issues are of a complex nature better suited
for determination at trial…
(Apotex
Inc. v. Syntex Pharmaceuticals International Ltd., above.)
[17] The Court has also had
a number of other occasions to look at s. 8 without reaching a determination of
its meaning. In total, on no less than 11 occasions, this Court and the Federal
Court of Appeal have concluded that issues of interpretation of s. 8 should
proceed to trial…
(Apotex Inc. v. Merck & Co.,
above.)
FACTS
The Action
[6]
This
action was commenced by Statement of Claim issued December 29, 2005, which
seeks various forms of relief in respect of Apotex’s delayed entry into the
market for its Omeprazole 20 mg capsules, Apo-Omeprazole. (Statement of Claim,
Motion Record of AstraZeneca at Tab 3 (Statement of Claim), para. 1.)
[7]
Apotex’s
essential complaint in this action is that, by virtue of the improper
institution and prosecution by AstraZeneca of proceedings under the Regulations
in Court File No. T-2311-01, as alleged by Apotex. Apotex was delayed in
obtaining approval for its Apo-Omeprazole capsules and, thus, requests to be
compensated for alleged harm suffered as a consequence. (Statement of Claim,
paras. 15-20.)
Regulatory Context
[8]
As with
all new drugs, before Apotex could market Apo-Omeprazole 20 mg capsules, it had
to obtain marketing approval from the Minister of Health (Minister). Such
marketing approval is received in the form of a Notice of Compliance (NOC).
(Statement of Claim, paras. 6-7.)
[9]
Prior to
1993, the Minister’s process for the approval of new drug submissions was
focussed solely on issues of the health and safety of the proposed product. (Bristal-Myers
Squibb Co. v. Canada (Attorney General) (2005), 253 D.L.R. (4th)
1 at 13 (S.C.C.) (Biolyse).)
[10]
In 1993,
as part of a broad overhaul of the Patent Act, R.S.C. 1985, c. P-6, the
Minister’s health and safety approval process was linked with the enforcement
of patent rights. This was accomplished, in part, via the enactment of the
Regulations. (Biolyse, above.)
[11]
The
Regulations provide for, among other things, early notice, being given to a
patentee (or its authorized Canadian representative) by a prospective
competitor, that the competitor has filed or intends to file a new drug
submission with the Minister seeking a NOC for a generic version of the drug
already marketed by the patentee. (Regulations, section 5.)
[12]
In response
to such notice, the patentee has the opportunity to commence judicial review
proceedings which, regardless of their substance or merit, have the effect of delaying
the prospective competitor’s NOC from the Minister. (Biolyse, above at
pp. 16-17.)
[13]
The
operation of the Regulations has been described as follows:
Enacted by the Governor in Council under provisions of the Patent
Act Amendment Act, 1992, S.C. 1993, c. 2, which abolished the system of
compulsory licensing for patented medicines, and grafted onto the regulatory
controlling system established by the Food and Drug Regulations, C.R.C.
1978, c. 870, the new set of regulations were aimed at contributing to the
protection of private commercial patent rights.
The main features of the new protective scheme may be described in a
nutshell as follows: The Ministerof National Health and Welfare ("the
Minister") is responsible, under the Food and Drug Regulations, for the
issuance of "notices of compliance" (hereinafter "NOC")
attesting to the health, safety and efficacy of drugs. An NOC is a prerequisite
for marketing drugs. The drug manufacturer who holds or is licensed under
subsisting patents is invited to file a patent list with the Minister
indicating each of the drugs for which it already holds an NOC. From that point
on, any other manufacturer who applies for an NOC in respect of the same drug,
must support its new drug submission (hereinafter "NDS") by an
allegation asserting that the listed drug patent would not be infringed if its
application was granted, and explaining the basis for the assertion. A notice
of such allegation must be served on the holder of the patent. Within 45 days
of service of the allegation, the holder of the patent who wishes to dispute
the justification of the allegation must seek an order from the Federal Court
prohibiting the Minister from issuing the NOC applied for, and the Court will
issue the order unless it finds that the allegation is justified. An NDS for a
listed medicine must be left in abeyance until the expiration of the time given
to the patent-holder to respond and, if proceedings in prohibition are
commenced, until they are dismissed or another 30 months expires. However, in
the absence of proceedings, the Minister is directed to process the application
and, unless there is any concern for public health and safety, will issue the
NOC requested.
(Apotex
Inc. v. Canada (Minister of National Health and
Welfare) 1997, 76 C.P.R.
(3d) 1 at 3 (F.C.A., leave to appeal to S.C.C. refused, [1997] S.C.C.A. No.
528.)
[5] When a patent holder
commences a prohibition application under the Regulations, the Minister's
authority to issue the notice of compliance for the new drug is automatically
stayed pending the determination of the prohibition proceedings. This automatic
stay is in place for a maximum of 24 months, unless extended pursuant to s.
7(5). The automatic stay prescribed by the Regulations has
been described as draconian because it permits a patent holder
to delay the entry of competitors into the market without having to establish
even a prima facie case of patent infringement: Merck Frosst Canada Inc. v.
Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193, 80
C.P.R. (3d) 368.
(Bristol-Myers Squibb Canada
Inc. v. Canada (Attorney General) (2001), 11 C.P.R. (4th)
539 (F.C.A.).)
[14]
Given the
draconian nature of the presumptive statutory stay and the lack of any
corresponding undertaking as to damages, the Regulations provide for a right of
action in favour of an aggrieved general company who has suffered delay in
obtaining its NOC because of proceedings under the Regulations which ultimately
turn out to be unsuccessful. (Regulations, section 8.)
[15]
It is
pursuant to its right of action that Apotex initiated its claim against AstraZeneca.
AstraZeneca initiated and lost a proceeding against Apotex under the
Regulations and, therefore, delayed Apotex’s market entry.
AstraZeneca’s Motion to Strike
[16]
Rather
than plead to Apotex’s Statement of Claim by way of Statement of Defence, AstraZeneca
has instead moved to strike Apotex’s claim. The purported basis for AstraZeneca’s
motion was that Apotex had not pleaded the requisite elements of a section 8
claim. (Order of Prothonotary Aronovitch, dated June 6, 2007; Motion Record of AstraZeneca
at Tab 4 (Strike Dismissal Order), p. 2.)
[17]
By Order
dated June 6, 20007, Prothonotary Aronovitch dismissed AstraZeneca’s motion to
strike Apotex’s claim, granting two of AstraZeneca’s alternate request for
particulars.
[18]
In her Reasons
for Order, Prothonotary Aronovitch outlined the submissions of AstraZeneca,
first raised at the return of its motion:
At the hearing the defendant fleshed-out its
argument, and urged on the Court that Apotex be required to plead the elements
now recognized in the jurisprudence as identifying “a second person” for the purposes
of triggering section 5(1) of the Regulations, (Ferring Inc. v.
Canada (Minister of Health) [2007] F.C.J. No. 420, at para. 59). The point
being that, having regard to those elements, Apotex may not be a “second
person” with standing to bring this section 8 proceeding.
One of the cumulative elements cited in Ferring,
supra, as triggering section 5(1) of the Regulations, and thereby
bringing a generic within the definition of a “second person”, is that the
“other drug has been marketed in Canada”.
Astrazeneca says that Losec was not marketed in Canada after 1996, and that Apotex may
therefore not have standing to sue for damages.
As further support for its argument, the
defendant relies on Sanofi-Aventis Canada Inc. v. Canada (Minister of Health) (2006) 54 C.P.R. (4th)
387 (F.C.), where the Court was persuaded that Apotex was not a “second
person”, notwithstanding that a prohibition proceeding was pending.
(Strike Dismissal Order, p. 2.)
[19]
The
Prothonotary then rejected AstraZeneca’s arguments for four distinct reasons.
[20]
First, she
held that AstraZeneca’s arguments would be more properly raised by a defence.
Apotex is not obliged to rebut the argument that it is not a “second person”
before such an argument is raised by AstraZeneca.
[21]
Second,
she held, consistent with a long line of cases that an interpretation of
section 8 is best left for trial; AstraZeneca is seeking an interpretation of
section 8 which is thus left for trial.
[22]
Third, the
Prothonotary found that Apotex had pleaded sufficient facts to support a
section 8 cause of action and that AstraZeneca had “not nearly” met its burden
on a motion to strike. (Strike Dismissal Order, p. 3.)
[23]
Fourth,
and finally, the Prothonotary added that it was possible that, despite
accepting AstraZeneca’s arguments in respect of subsection 5(1), an
interpretation of section 8 would nonetheless support Apotex’s standing to
bring a section 8 claim. This further issue of interpretation “presents an
arguable issue of mixed fact and law that the jurisprudence holds must be
reserved for trial.” (Strike Dismissal Order, p. 3.)
[24]
Further to
the Order of Prothonotary Aronovitch, dated June 6, 2007, Apotex served and
filed further particulars, as ordered. (Particulars of Statement of Claim,
dated June 13 2007; Responding Motion Record of Apotex at Tab 1.)
AstraZeneca Appeals the
Dismissal of its Motion
[25]
AstraZeneca
seeks to set aside the Order of Prothonotary Aronovitch and to have its
underlying motion to strike granted.
ISSUES
[26]
While AstraZeneca
has urged this Court to engage in a de novo review, it has chosen to
specify two alleged errors committed by the Prothonotary. In order to more
fully respond to the two alleged errors of law, the Court addresses the
following issues by which to answer AstraZeneca’s request that the Statement of
Claim be struck:
(a) The Test on a
motion to Strike;
(b) The section 8
Claim;
(c) Did the
Prothonotary reverse the burden?
(d) Did the
Prothonotary misinterpret the Regulations?
ANALYSIS
(a) The Test on a
Motion to Strike
[27]
The
threshold on a motion to strike paragraphs in a pleading is well-settled and
difficult to meet: the Court must be convinced beyond doubt that it is “plain
and obvious that the impugned paragraphs fail to disclose a reasonable cause of
action or defence.” (Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959 at
980.)
[28]
The Court
must accept the facts as proven, and then ask whether the allegation contained
in the impugned paragraphs is so clearly futile that the responding party would
have no possible chance of success at trial. The pleading must be read
generously with due allowance for drafting deficiencies. The Court should not
resolve disputed questions of law. The Court should only strike paragraphs in
the clearest of circumstances where there is no arguable basis for including
the matters to which objection has been taken. (Federal Courts Rules,
SOR/98-106; Hunt, above; Operation Dismantle Inc. et al. v. The Queen
(1985), 18 D.L.R. (4th) 481 at 488 (S.C.C.).)
[29]
Furthermore,
the Court has stated repeatedly that the allegations in a Statement of Claim
must stand unless the impugned portions fail to disclose a “scintilla of a
cause of action”. (Charette v. Delta Controls, 2003 FCA 425, [2003]
F.C.J. No. 1696 (F.C.A.) (QL) at para. 3; Apotex Inc. v. Wellcome Foundations
Ltd. (1996), 68 C.P.R. (3d) 23 (F.C.T.D.) at 41.)
[30]
A motion
to strike a Statement of Claim should not simply be granted even where
“elements may be missing and others incomplete”. The central question on the
motion is whether the pleading contains enough information for the opposing
party to know “with some certainty” the case to be met in respect of the
Statement of Claim. (Pharmaceutical Partners of Canada Inc. v. Faulding (Canada) Inc. (2002), 21 C.P.R. (4th)
(F.C.T.D.) 166 at para. 13; Shubenacadie Indian Band v. Canada (Minister of
Fisheries and Oceans), 2002 FCA 249, [2002] F.C.J. No. 880 (QL); Sweet
v. Canada (1999), 249 N.R. 17 (F.C.A.) at para. 19; Novartis AG v.
Apotex Inc., 2006 FC 1277, [2006] F.C.J. No. 1595 (F.C.) (QL) at para. 15.)
(b) Section 8 Claim
[31]
In order
for AstraZeneca to sustain its appeal of the Prothonotary’s decision, it must
establish that it is plain and obvious that the Statement of Claim does not
plead a reasonable cause of action.
[32]
An issue
raised in respect of the Statement of Claim is the purported failure of Apotex
to plead that it is a “second person” under the Regulations.
[33]
As a
counterbalance for the “draconian” automatic statutory stay conferred upon a
“first person” under the Regulations in the absence of an undertaking for
damages, section 8 enables a generic manufacturer to bring an action in order
to obtain compensation for having been improperly subjected to a proceeding
under the Regulations.
|
8. (1) If an application
made under subsection 6(1) is withdrawn or discontinued by the first person
or is dismissed by the court hearing the application or if an order
preventing the Minister from issuing a notice of compliance, made pursuant to
that subsection, is reversed on appeal, the first person is liable to the
second person for any loss suffered during the period
(a) beginning on the
date, as certified by the Minister, on which a notice of compliance would
have been issued in the absence of these Regulations, unless the court
concludes that
…
(b) ending on the date
of the withdrawal, the discontinuance, the dismissal or the reversal.
|
8. (1) Si la demande présentée aux termes du paragraphe 6(1) est retirée
ou fait l’objet d’un désistement par la première personne ou est rejetée par
le tribunal qui en est saisi, ou si l’ordonnance interdisant au ministre de
délivrer un avis de conformité, rendue aux termes de ce paragraphe, est
annulée lors d’un appel, la première personne est responsable envers la
seconde personne de toute perte subie au cours de la période :
a) débutant à la date, attestée par le ministre, à laquelle un avis
de conformité aurait été délivré en l’absence du présent règlement, sauf si
le tribunal conclut :
[...]
b) se terminant à la date du retrait, du désistement ou du rejet de
la demande ou de l’annulation de l’ordonnance.
|
(Apotex Inc. v. Laboratoires Fournier S.A., above, at
paras. 10-11.)
[34]
From both
the language of the subsection and from the purpose of the right of action, it
appears that a significant element of a section 8 claim is that an application
made under subsection 6(1) of the Regulations is withdrawn or discontinued by
the first person or dismissed by the Court.
[35]
The latter
part of subsection 8(1) is of relevance for the purpose of treating the
determination of the loss of the second person, as set out, in section 8.
(Regulations, subsection 8(2).)
[36]
As found
by the Prothonotary, “Apotex has pleaded sufficient facts to support a cause of
action pursuant to section 8.” For the purpose of this proceeding, AstraZeneca
has not established an error, legal or otherwise, that undermines this
decision. (Strike Dismissal Order, p. 3.) (The future cannot be foresee at this
juncture; it must be witnessed when encountered; reference is made to
paragraphs [53] and [54] below.)
[37]
First,
paragraph 16 of the Statement of Claim pleads that there was a prohibition proceeding
that was commenced by AstraZeneca which was dismissed by the Court.
… By Order dated December 30, 2003, Mr.
Justice O’Keefe dismissed a prohibition proceeding bearing Court File no.
T-2311-01 that had been commenced by the Defendant in respect of the ‘762
Patent.
[38]
Second,
the Statement of Claim pleads, at paragraphs 15, 16 and 17, the time at which
Apotex would have received a NOC, if it was not for the prohibition proceedings
which had a bearing as to the date of dismissal and the date upon which Apotex
received its NOC.
[39]
Third,
Apotex pleads the losses suffered at paragraph 18 of the Statement of Claim:
By reason of the Patent Regulations,
the issuance of Apotex’s NOC for Apo-Omeprazole 20 mg capsules was delayed from
January 3, 2002 to January 27, 2004.
[40]
Fourth,
Apotex claims for losses suffered and makes an alternative claim for an
accounting of profits and an additional claim for disgorgement of AstraZeneca’s
revenues. In addition, Apotex has further pleaded particulars in respect of its
claims for damages and disgorgement. (Statement of Claim, paras. 19-20;
Particulars of Statement of Claim dated June 13, 2007, Responding Motion Record
of Apotex at Tab 1.)
[41]
Furthermore,
AstraZeneca was a party to the prohibition proceedings and, therefore, the
facts to those proceedings are relevant. (AstraZeneca Canada Inc. v. Apotex
Inc., 2005 FC 43, [2005] F.C.J. No. 74; 2005 (F.C.) (QL) at paras. 17-18.)
[42]
AstraZeneca
has not established a deficiency in Apotex’s pleading that would prevent AstraZeneca
from pleading its case in regard to the Statement of Claim.
[43]
The
definition of a “second person” under the Regulations is a “person referred to
in subsection 5(1) or (2) who files a submission or supplement referred to in
those subsections.” (Regulations, section 2.)
[44]
By
pleading, first, that Canadian Letters Patent No. 2,133,762 (‘762 Patent) was
listed on the Patent Register and prevented Apotex from receiving a NOC and,
second, that AstraZeneca commenced a prohibition proceeding against Apotex in
respect of the ‘762 Patent, Apotex has pleaded material facts in support of its
conclusion that it was a “second person”. As pleaded, it was obliged to address
the ‘762 Patent pursuant to subsection 5(1) of the Regulations and did so by
way of notice of allegation that led to a prohibition proceeding. In addition, it
was AstraZeneca that initiated the prohibition proceedings.
[45]
In her
reasons, Prothonotary Aronovitch identifies the “second person” argument of AstraZeneca:
At the hearing the defendant fleshed-out
its argument, and urged on the Court that Apotex be required to plead the
elements now recognized in the jurisprudence as identifying “a second person”
for the purposes of triggering section 5(1) of the Regulations, (Ferring
Inc. v. Canada (Minister of Health) [2007] F.C.J. No. 420, at para. 59).
[46]
In Ferring
Inc. v. Canada (Minister of Health), 2007 FC 300, [2007] F.C.J.
No. 420 (QL):
[59] It is
important to note that the Supreme Court was quite specific in paragraph 40 as
to the reason for the reference, it was for demonstrating bioequivalence.
Section 5(1) of the NOC Regulations are specific in stating that a
person is only required to take steps to issue a notice of allegation to the
innovator who has listed patents (thus become a "second person") if:
- that
person has filed for an NOC;
- that
person has compared reference or made reference to another drug;
- for the
purposes of demonstrating bioequivalence;
- and
that other drug has been marketed in Canada pursuant to an NOC; and
- there is a
patent list pertinent to that NOC.
[47]
Significantly,
given the putative state of section 8 jurisprudence to which reference is made,
regardless of whether AstraZeneca is or is not ultimately correct, such a
determination should be made on the basis of a full record at the close of
trial.
[48]
The interpretation
of the law in regard to section 8 is in an “embryonic state”. As such, the
Court is hesitant to strike out section 8 claims at the pleadings stage. (Apotex
Inc. v. Eli Lilly and Co. et al., above; Apotex Inc. v. Laboratoires
Fournier S.A., above; Apotex Inc. v. Syntex Pharmaceuticals
International Ltd., above;
Apotex Inc. v. Merck & Co., above.)
[49]
This Court has held
that matters of the interpretation of section 8 should be deferred to trial:
[15] …There is not yet a clear understanding of what s. 8 of the Patent
Regulations really means…
[18] …the contentious issues are of a complex nature better suited
for determination at trial…
(Apotex Inc. v. Syntex Pharmaceuticals
International Ltd., above.)
[17] The Court has also had
a number of other occasions to look at s. 8 without reaching a determination of
its meaning. In total, on no less than 11 occasions, this Court and the Federal
Court of Appeal have concluded that issues of interpretation of s. 8 should
proceed to trial…
(Apotex Inc. v. Merck &
Co., above.)
[50]
Applied to the
present case, the arguments of AstraZeneca relate to the interpretation of
section 8. The Prothonotary rejected AstraZeneca’s assertion that it was not
seeking or advocating an interpretation of section 8 by the Court. (Strike
Dismissal Order, p. 3.)
[51]
The inclusion of the
words “second person” in section 8 by which to import the case law in respect
of subsection 5(1) would have to be analyzed in respect of the Ferring
factors to determine relevance in regard to section 8; such a requirement can
only arise from an actual interpretation of section 8.
[52]
Moreover, it is, as
yet, to be determined whether the interpretation proposed to the Court by AstraZeneca
is appropriate under the specific circumstances of the case at bar.
[53]
It is possible that a
purposive interpretation of section 8 of the Regulations would result in a
different nuance to the understanding of “second person” within the context of
section 8.
[54]
Regulations in
respect of second persons are, yet, to be determined as to what second persons
have a right to avail themselves, subsequent to a determination as to which
party is, in fact, a second party.
[55]
For resolution in
regard to the above, an in-depth analysis is required, thus, a need exists to
proceed to trial.
(c) Did the Prothonotary reverse
the burden?
[56]
The first error that AstraZeneca
alleges is that the Prothonotary improperly reversed the burden of the parties
by not obliging Apotex to plead the elements of a section 8 cause of action.
[57]
AstraZeneca has
characterized the Prothonotary’s decision as requiring AstraZeneca to plead as
an improper reversal of the onus upon the motion:
The
Prothonotary’s holding also fails to recognize that the burden is on Apotex to
plead that it has standing as a “second person” to seek relief under s. 8 of
the Regulations. By requiring Astra to allege that Apotex has not
pleaded that it is a “second person” within s. 8, the finding improperly shifts
the burden to Astra.
(AstraZeneca
Written Representations at para. 37.)
[58]
The Prothonotary did
not decide that AstraZeneca could plead by way of defence that “Apotex has not
pleaded that it is a ‘second person’”. Rather, the Prothonotary’s Order, simply
determined that the Statement of Claim was sufficient and that AstraZeneca
could plead its own set of material facts in that regard.
[59]
As set out above,
Apotex has pleaded the material facts for consideration as to its section 8
claim, including material facts to establish the legal conclusion for
consideration that Apotex is a second person under the Regulations. AstraZeneca,
therefore, has notice of Apotex’s position and is able to plead in respect of this
version of the facts in its response. The Prothonotary, therefore characterized
the arguments of AstraZeneca as requiring Apotex to anticipatorily plead an
answer to a possible defence.
In
my view, these are not arguments to impugn the sufficiency of the pleadings.
Rather, they raise defences to the action that must be pleaded. It is not for
Apotex to answer to the defence before it is made, nor to rebut the argument
that it may not be a “second person” in its statement of claim.
(Srike
Dismissal Order, p. 2.)
(d) Did the
Prothonotary misinterpret the Regulations?
[60]
The Prothonotary’s Reasons
for Order determined that the question of whether AstraZeneca’s construction of
section 8 is correct, and, therefore, also the question of whether any
competing interpretations are correct, “calls for the interpretation of s. 8
and presents an arguable issue of mixed fact and law that the jurisprudence
holds must be reserved for trial.” (Strike Dismissal Order, p. 3.)
[61]
As is set out above,
the Prothonotary’s decision that it was inappropriate to come to a final
conclusion as to the interpretation of section 8 of the Regulations at the
pleadings stage is well supported by the jurisprudence.
[62]
Once the Prothonotary
determined that the interpretation advocated by AstraZeneca could not be
accepted as conclusive at this stage, she was well supported in her
determination that Apotex has pleaded sufficient material facts to support a
section 8 claim. In addition, as set out above, Apotex had further pleaded
material facts to support consideration of the legal conclusion that it was a
second person.
[63]
For all of the above
reasons, at this stage of the proceedings, the Prothonotary did make an
appropriate determination, recognizing that all else is left to the trial.
CONCLUSION
[64]
For all of these
reasons, AstraZeneca’s motion is dismissed with costs in the cause and AstraZeneca
is ordered to deliver its Statement of Defence within forty five days (rather
than 15 days), based on a consideration of particulars recently delivered by
Apotex to AstraZeneca, for the purpose of greater clarity in respect of
preparation of the matter for trial.
ORDER
THIS COURT ORDERS:
1. AstraZeneca
Canada Inc.’s motion to set aside the Order of Prothonotary Aronovitch, dated
June 6, 2007, be dismissed with costs in the cause; and
2. AstraZeneca
Canada Inc. is to deliver its Statement of Defence within forty five days
(rather than 15 days), based on a consideration of particulars recently
delivered by Apotex to AstraZeneca, for the purpose of greater clarity in
respect of preparation of the matter for trial.
“Michel M.J. Shore”
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