Docket: T-1885-14
Citation:
2016 FC 1055
Ottawa, Ontario, September 19, 2016
PRESENT: Madam Prothonotary Mireille Tabib
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BETWEEN:
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ALCON CANADA
INC.,
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ALCON
LABORATORIES, INC.,
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ALCON
PHARMACEUTICALS LTD., AND
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ALCON RESEARCH,
LTD.
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Plaintiffs
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and
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APOTEX INC.
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Defendants
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AND BETWEEN:
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APOTEX INC.
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Plaintiff By Counterclaim
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and
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ALCON RESEARCH,
LTD.
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Defendant By Counterclaim
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ORDER AND REASONS
[1]
The liability phase of this infringement action
is scheduled to proceed to trial on November 27, 2017. Quantification issues
have been bifurcated and will proceed in a second phase if the Court
determines, after the first phase trial, that Alcon’s ‘370 Patent is valid and
infringed by Apotex’s Apo-Travoprost Z ophthalmic pharmaceutical solution.
[2]
Apotex now moves for leave to amend its
statement of defence and counterclaim to add a new ground of invalidity by
anticipation, a defence of ex turpi causa based on anti-competitive
conduct, and two new defences based on the concepts of issue estoppel, abuse of
process and the doctrine of election, arising from the prior prohibition proceedings
commenced by Alcon in relation to the same patent and product.
[3]
At the hearing, because the parties agreed that
the ex turpi causa defence relates solely to the quantification of
damages, the parties consented to an order dismissing Apotex’s motion in
respect of the amendments raising that defence, without prejudice to Apotex’s
right to seek leave to make the same amendments at the beginning of the second
phase of the action, if any, and on the understanding that Alcon would not be
able to use the delay between now and then as a further defence to the motion.
[4]
The motion therefore proceeded only in respect
of proposed new paragraphs 98 to 104 (the anticipation defence), paragraphs 53
to 55 (the issue estoppel, abuse of process defence) and paragraphs 30 to 41
(the election defence).
I.
Context and Chronology
[5]
In 2014, Apotex wished to come to market with a
generic version of Alcon’s Travatan Z ophthalmic solution. It served on Alcon a
notice of allegation in accordance with the Patented Medecine (Notice of
Compliance) Regulations SOR/93-133, as amended (the “PM (NOC) Regulations”), alleging that the ‘370
Patent, covering the formulation for Travatan Z, was invalid. The prohibition
application commenced by Alcon in response was dismissed in the summer of 2014;
Apotex obtained its NOC and started offering Apo-Travoprost Z for sale in
August 2014. Almost immediately thereafter, Alcon launched this infringement
action against Apotex and Apotex sued Alcon in a separate action (T-1844-14)
for damages for having been kept off the market, pursuant to section 8 of
the PM (NOC) Regulations.
[6]
Although the two actions have proceeded at
different paces, Apotex has repeatedly but unsuccessfully asked for the two
actions to be consolidated and heard together. Alcon construes the present
motion to amend as yet another salvo in this continuing battle, aimed at
delaying the trial of this action so that Apotex’s section 8 action can “catch-up” and be heard at the same time (see, for
further context, Apotex v Alcon Canada Inc., 2016 FC 720, a decision
issued in that related section 8 action on Apotex’s motion to bifurcate). Apotex
denies the motives ascribed to it by Alcon.
[7]
Although the motion to amend was only filed at
the end of July 2016, after the trial date was fixed, Apotex had announced its
intention to move to amend as early as mid-May 2016.
[8]
Discoveries were conducted in early March 2016.
Alcon first requested that a trial date be fixed in this matter at the end of
March 2016. During the course of a case conference in April 2016, the Court
asked the parties and counsel to refrain from taking new commitments in
September and December 2017 to allow for the potential trial of this matter. It
is after that, in mid-May 2016, that Apotex first submitted to Alcon a draft of
its proposed amendments. Alcon withheld its consent to the amendments.
[9]
Motions to compel were heard and the trial date
was formally fixed in June 2016. Given Alcon’s refusal to consent to Apotex’s
proposed amendments, the Court also fixed a schedule for briefing and hearing
this motion to amend.
II.
Applicable Law
[10]
Amendments should be permitted where the
interests of justice would be served and where they would not cause an
injustice to the other party that cannot be compensated in costs. There is no
fundamental disagreement between the parties as to the factors that the Court
must consider in determining whether the interests of justice would be served
by allowing amendments. These factors include: The timeliness of the motion to
amend, the extent to which the proposed amendments would delay the expeditious
trial of the matter, the extent to which a position taken originally by a party
has led the other to follow a course of action which it would be difficult or
impossible to alter and whether the amendments will facilitate the Court’s
consideration of the true substance of the dispute on its merits (Teva
Canada Ltd v Gilead Sciences Inc, 2016 FCA 176, Sanofi-Aventis v Teva
Canada Ltd, 2014 FCA 65, Merck and Co Inc v Apotex Inc, 2003 FCA
488).
[11]
It is also beyond dispute that amendments that
fail to disclose a reasonable cause of action or defence or could be struck
pursuant to Rule 221 should not be permitted.
[12]
Where the parties diverge is the extent to
which, in considering the merits of proposed amendments, the Court should apply
the same stringent criteria applicable to motions to strike, whereby proposed
allegations of fact must be accepted as proven and novel arguments of law must
be allowed to proceed to determination by a trial judge unless they are certain
to fail, or whether the Court may take a “realistic
view” of the law and the litigation process, to determine whether
proposed amendments have a “reasonable chance of
success”. Alcon suggests that there is a difference between the two
standards, the latter being less stringent than the former.
[13]
I am satisfied that this motion may be
determined without having to resolve this issue. For the reasons below, I am
satisfied that, even using the “realistic view”
standard advanced by Alcon, the new anticipation defence presents a reasonable
prospect of success, and that parts of the proposed defence of issue estoppel
and abuse of process and the entirety of the defence of election fail to
disclose a reasonable defence, even using the stringent standards applicable to
Rule 221 motions to strike.
III.
The Anticipation Defence
[14]
Apotex’s proposed amendments plead that details
of the Travatan Z formulation, including a list of 15 specific details that
match the claims of the patent, were disclosed to the public by employees and
representatives of Alcon Research and others during, or in association with,
the annual meeting of the Association for Research in Vision and Ophthalmology
(“ARVO”) in May 2006, and in an abstract presented and published at the ARVO
meeting; the amendments also allege that these disclosures were reported in
certain specifically identified scientific press articles.
[15]
Alcon argues that these allegations have no
reasonable prospect of success because, as a matter of fact, one of the
essential elements of the claims, being a limitation on the concentration of
anionic species, was not even known or discovered by the inventors until after
the ARVO meeting of 2006, and because none of the documents pleaded, on their
face, even mention anionic species, let alone their concentration in the
composition.
[16]
Assuming, without determining, that the Court
may look at evidence for the purpose of evaluating whether the proposed
amendments have a reasonable prospect of success, that evidence should have at
least a modicum of robustness and reliability. Motions to amend should not be
defeated on the basis of incomplete or inconclusive evidence, as it would
require the amending party to respond by attacking the credibility of its
opponent’s evidence or adducing evidence of its own to establish its claim,
turning motions to amend into motions for summary judgment.
[17]
The only evidence adduced by Alcon on this
motion consists of one answer it has given to an undertaking on discovery,
giving a date on which the inventors “determined”
the limits on the concentration of anionic species. This evidence is unsworn
and untested. Even if believed, evidence of when the inventors “determined” the relevant limits would not by itself
negate the possibility that other employees or representatives of Alcon, or
others having had access to Alcon’s information might, as alleged in the
proposed amendments, have independently made statements as to the appropriate
concentrations. Alcon’s bare reliance on the absence of the specific words “anionic species” in the documents mentioned in the
amendments is equally insufficient, given that these are complex scientific
documents.
[18]
I do not accept Alcon’s objection that reference
in the proposed amendments to “others who directly or
indirectly obtained information from Alcon research” is too vague, a
fishing expedition or irrelevant. The expression is not used to investigate what
information was obtained by others prior to the alleged public disclosure, but
to describe and identify those who allegedly made the disclosure at the ARVO
meeting.
[19]
I am accordingly satisfied that the proposed
amendments are sufficiently particularized and have a reasonable prospect of
success. I note that while Apotex has not shown why it could not have included
these allegations in its defence and counterclaim at the outset of this action,
it has raised the issue as part of its examination for discovery of Alcon and
asked a series of questions on the ARVO meeting. These questions were ruled
irrelevant in the absence of specific pleadings, but, if the amendments are now
permitted, discovery can proceed expeditiously, the bulk of the questions
having already been formulated. I am satisfied that the delay in raising this
defence is not prejudicial and will not disrupt or delay the trial. I am also
satisfied that the proposed amendments go directly to an issue in controversy
between the parties. Leave to make these amendments should accordingly be
granted.
IV.
The Defence of Estoppel and Abuse of Process
[20]
The impugned paragraphs read as follows:
53. In Federal Court File No.
T-1667-12, Justice Kane found that:
(a) Systane Free was “very relevant
prior art” to the 370 patent;
(b) “the components of the
preservation system in Systane Free are the same as the preservation system in
Claim 13” of the 370 patent;
(c) “Systane Free cannot be
characterised as a different system” than that of the 370 patent;
(d) “Systane Free taught the combined
use of zinc chloride, boric acid and propylene glycol and sorbitol”; and
(e) Any differences between the
preservative system in Systane Free and that described in the 370 patent would
have been “more or less self-evident” to a skilled person.
54. Given that the prohibition
application in Federal Court File No. T-1667-12 involve the same parties (or
their privies) as this action, determined that the purported invention of the
370 patent is obvious in view of Systane Free and resulted in a final decision
(2014 FC 791), by reason of issue estoppel and abuse of process, the Plaintiffs
are precluded from contesting or making any allegations inconsistent with the
findings of fact that were fully litigated and finally decided in Federal Court
File No. T-1667-12, including those set out at paragraph 53 of this Statement
of Defence, as they are binding in respect of the present action.
55. By reason of cause of action
estoppel, the Plaintiffs are also precluded from contesting or making any
allegations inconsistent with Justice Kane’s finding in Federal Court File No.
T-1667-12 that the 370 patent is invalid on the basis of obviousness.
[21]
These allegations could have been included in
Apotex’s original defence. However, because they rest on the record constituted
in the prohibition proceeding and do not require discovery, the delay in
raising them cannot be prejudicial. To the extent they raise an arguable
defence, they should be permitted.
[22]
The Federal Court of Appeal, after conducting a
thorough review of the jurisprudence, ruled in Apotex v Pfizer Ireland
Pharmaceuticals, 2011 FCA 77 (Sildenafil 2011) that issue estoppel
or abuse of process could apply to prevent a party from re-litigating or
re-arguing, in an action, the conclusions of fact reached in a prior NOC
proceedings “on the same evidence, with the same
arguments” as were adduced in the prohibition proceedings. The Federal
Court of Appeal, however, explicitly reaffirmed the existing and consistently
upheld principles that res judicata, “in the
sense of cause of action estoppel, the doctrine that a party cannot relitigate
a cause of action that has already been dealt with”, does not apply
between an NOC proceeding and a subsequent action (at paragraph 18), and that
the defences of issue estoppel, abuse of process and others “cannot apply in respect of the question of a patent’s
validity” (at paragraph 19). To the extent issue estoppel or abuse of
process can apply, it is only in respect of certain factual and legal issues,
and then only in the absence of a different evidentiary record or significant
new argumentation.
[23]
The reasoning of the Court of Appeal in Sildenafil
2011 expressly recognizes and affirms the ability of a party to introduce new
evidence or to raise new argument in a subsequent action to argue for a
different conclusion than was reached in the earlier NOC proceeding, and in
fact mandates the trial judge in such circumstances to reconsider the issue in
light of the full record before him or her (paragraph 25).
[24]
What paragraph 55 of the proposed amendments
pleads is that “by reason of cause of action estoppel” Alcon is precluded from “contesting or making any allegation inconsistent with”
Justice Kane’s findings “that the patent is invalid on
the basis of obviousness”. This paragraph offends the Federal Court of
Appeal’s express ruling that cause of action estoppel in respect of the
validity of a patent does not disclose a reasonable defence and as a result, I
am satisfied that it should not be allowed.
[25]
The proposed paragraph 54, for its part, pleads
that Alcon is “precluded from contesting or making any
allegations inconsistent with” Justice Kane’s findings of fact “as they are binding in the present action”. As
drafted, this paragraph could be read as suggesting that Alcon is precluded
from introducing new evidence or new argument in support of a different result,
rather than simply precluded from re-litigating the factual findings enumerated
in paragraph 53 “on the same evidence and with the same
arguments”. Such an allegation would go directly against the principles reaffirmed
by the Court of Appeal in Sildenafil 2011, to the effect that findings
in prior NOC proceedings are not binding in subsequent actions, but that as a
matter of discretion, and based on the evidence adduced before him or her, the
judge hearing the subsequent action could apply the doctrines of issue estoppel
and abuse of process to bar re-litigation (see for examples of application: Janssen
Ortho Inc v Novopharm Ltd. 2006 FC 1234, Astrazeneca Canada Inc
v Apotex Inc 2014 FC 638, aff’d 2015 FCA 158 and Apotex Inc v Pfizer
Ireland, 2014 FCA 13 at paragraph 25).
[26]
Apotex has however put before the Court as
evidence on this motion the specific pleadings that were under consideration
and were allowed to stand by the Federal Court of Appeal in Sildenafil
2011. These pleadings are drafted in the following form:
“In [the prior NOC proceeding] it was found
that [a certain issue of fact or law]. This finding is binding in this action.
Apotex is precluded from re-litigating [this issue] due to issue estoppel,
collateral estoppel, comity and abuse of process”.
[27]
To the extent the form of the proposed
amendments here is not materially different from the amendments permitted in Sildenafil
2011, I am bound to read and interpret them in a manner consistent with the
ruling in Sildenafil, and conclude that they disclose a reasonable
defence. The plea that a party is precluded from “contesting”
prior factual findings “as they are binding in this
action” is not materially different from the plea that a prior finding
is binding and the party is precluded from “re-litigating”
the issue. However, the plea that a party is precluded from “making any allegation inconsistent with” a prior
finding cannot be given any meaning other than to preclude a party from leading
evidence different from that led in the prior proceeding and cannot disclose an
arguable defence. These words will accordingly be struck from proposed
paragraph 54.
[28]
I should add that Apotex’s reliance on the case
of Apotex Inc. v Pfizer Ireland, 2012 FC 1339, affirmed at 2014 FCA 13, is
misplaced. The Federal Court in that case dismissed an infringement action on
summary judgment because it found it was bound by the Supreme Court of Canada’s
determination, in a prior prohibition proceeding, that the same patent was void
for insufficiency of disclosure. However, the Federal Court’s dismissal was
based on its conclusion that the issues on which the Supreme Court ruled were
issues of law, not issues of fact. Here, the proposed amendments clearly relate
to the factual findings of Justice Kane and not to any determination of law. In
any event, on appeal from the Federal Court’s decision, the Federal Court of
Appeal in Apotex v Pfizer Ireland, 2014 FCA 13 pointed out at paragraph
25 that to avoid summary judgement, “Pfizer should have
adduced or referred to evidence that addresses how the skilled reader would
construe the specification, and why that construction casts doubt on the
correctness of the construction adopted in Teva 2012”. This
reinforces the conclusion that, even on issues of law informed by evidence, it
remains open to a party in an infringement action to adduce new or different
evidence to reach different results.
V.
The Defence of Election
[29]
The proposed amendments set out a two-pronged
argument. First, Apotex alleges and argues that by commencing a prohibition
application in response to Apotex’s Notice of Allegation, Alcon elected to take
the benefit of the 24 month stay under the PM (NOC) Regulations, and
thereby accepted the consequences and waived the right to assert the ‘370
Patent in a subsequent infringement action. Based on the doctrines of election,
waiver, approbation and reprobation and abuse of process, Alcon is therefore
precluded from pursuing the infringement action and disentitled from any
relief. Second, Apotex alleges and argues that in the prohibition proceedings,
Alcon “elected” to instruct its only expert
witness not to consider Systane Free as forming part of the prior art in forming
its opinion on obviousness. Given that election and Justice Kane’s findings
that Systane Free did form part of the prior art, the proposed amendments
allege that Alcon is either “barred from”
commencing this patent infringement action, from asserting that the ‘370 Patent
is not invalid and from seeking any relief against Apotex, or “barred from” asserting that Systane Free did not form
part of the prior art, from instructing its expert in a different manner and from
leading the expert evidence it ought to have led in the prohibition
application. Apotex further alleges that, in launching Apo-Travoprost Z, it
relied on Alcon’s prohibition proceedings strategy and on its outcome; as a
result, it argues that Alcon is estopped from bringing an infringement action
or seeking damages against Apotex.
[30]
The essence of the defence framed by these
amendments is that Apotex is precluded from instituting or succeeding an
infringement action either solely by reason of the prior prohibition
proceeding, or in conjunction with the “special
circumstances” arising from the evidence it led in the course of the
prohibition proceeding and Apotex’s reliance on it, or, alternatively, that
these circumstances preclude Alcon from leading different evidence in the
action than it led in the application.
[31]
As mentioned above, the Federal Court of Appeal
in Sildenafil 2011 conducted a thorough review of the jurisprudence to
conclude unequivocally that the following principles, set out in Pharmacia
Inc v Canada (Minister of National Health & Welfare) (1994), 58 C.P.R.
(3d) 209 (Fed. C.A.) and reiterated in Apotex Inc v Syntex Pharmaceuticals
International Ltd [1999] F.C.J. No. 548, 166 F.T.R. 161, 1 C.P.R. (4th) 22 remained applicable:
...If the Governor in Council had
intended by these regulations to provide for a final determination of the
issues of validity or infringement, a determination which would be binding on
all private parties and preclude future litigation of the same issues, it
surely would have said so. This court is not prepared to accept that patentees
and generic companies alike have been forced to make the sole assertion of
their private rights through the summary procedure of a judicial review
application. As the regulations direct that such issues as may be
adjudicated at this time must be addressed through such a process, this is a
fairly clear indication that these issues must be of a limited or preliminary
nature. If a full trial of validity or infringement issues is required this
can be obtained in the usual way by commencing an action.
[emphasis added]
[32]
The Federal Court of Appeal concluded its
analysis by reiterating that: “For the same reasons,
issue estoppel, abuse of process and the other defences pleaded by Merck also
cannot apply to the question of a patent’s validity”. As further
discussed above, the Court of Appeal’s analysis in Sildenafil 2011
expressly contemplates the right for a party to a prohibition proceeding to
bring, in a subsequent infringement action, significant and important new
evidence and argument.
[33]
The proposed amendments plainly and obviously
cannot succeed, as they seek a result which is contrary to the specific and
established law developed and applied the context of materially similar facts.
These principles have been reiterated and applied to permit new evidence to be
raised and to reach different conclusions in infringement actions brought
subsequent to prohibition proceedings (Janssen Ortho Inc v Novopharm Ltd.
above and Astrazeneca Canada Inc v Apotex Inc, above).
[34]
Apotex relies on the cases of Hunt v Carey
Canada Inc [1990] 2 S.C.R. 959, Fullowka v Whitford (1996) 147 DLR (4th)
531 and R v Imperial Tobacco Canada Ltd 2011 SCC 42, to argue that it is
raising a novel defence, that a motion to strike is not the appropriate time to
decide important or serious questions of law, and that even authority binding
on a motions judge is not sufficient ground to strike a pleading if an appeal
to a higher court might produce a different view of the law.
[35]
A defence that has previously been considered
and rejected does not become a “novel” defence or an argument, worthy of
proceeding to a trial, simply because it is clothed in the vocabulary of other
common law or equitable doctrines. Where the legal effects of certain factual
circumstances have been extensively and repeatedly analyzed in a variety of
different situations, that coherent principles have been developed to address
them and that these principles have been applied consistently, it can be said
that the law is settled. A party who wishes to challenge settled or established
law must do more than invoke common law or equitable doctrines as if they were
incantations whose mysteries can only be fathomed after a full trial.
[36]
The Federal Court in Merck and Co Inc v
Apotex Inc 2012 FC 454 examined a number of factors in determining whether
a defence that had previously been held unavailable at law should nevertheless
be allowed to stand. These factors include: that the plea had found persuasive
support in US jurisprudence, that the original English decision was 125 years
old and had only been applied twice in Canada, in both cases after a full trial
rather than on motions to strike, that a subsequent decision of the Supreme
Court of Canada signaled a change in the law of damages, and that the argument
in support of the plea was cogent and compelling (see paragraph 24). In Galand
Estate v Stewart 1992 ABCA 334 at paragraph 35, the Alberta Court of Appeal
recognized that a claim should not be struck out if the trend of recent
decisions suggests that the law is moving toward supporting such a claim, but
cautioned that did not mean a plea challenging existing law should be permitted
“simply because in the 25th Century Buck Rogers will be
able to do anything he wants” but in case of “foreseeable
sorts of trends in the law.”
[37]
Apotex has not brought to my attention any
Canadian or foreign jurisprudence providing persuasive support for its
argument. The case law on which the countervailing established law is based is
recent, authoritative, abundant and consistent. There is no trend of recent
decisions that would support its plea. More importantly, Apotex has not
presented an argument in support of the plea that is cogent or compelling, on
the contrary.
[38]
The doctrine of election, or of approbation or
reprobation, whether at common law or in equity, is fundamentally premised on a
person exercising or accepting inconsistent or irreconcilable rights or
recourses. As explained in Charter Building Co v 1540957 Ontario Inc, 2011
ONCA 487 at paragraph 22, the only difference between the doctrine at common
law and the doctrine in equity is the element of choice. The commonality
between the two remains the existence of an inconsistency between two
irreconcilable decisions or situations:
22 As can be seen, there is a
fundamental difference between the two doctrines. The equitable doctrine of
election does not involve choice between alternatives. To establish an election
in equity, it is unnecessary to show that the electing party made a conscious
choice between inconsistent rights at the time when the original decision was
made. In fact, an equitable election does not involve making a choice at all — it
involves accepting the consequences of a decision already made. On the other
hand, the common law doctrine is all about choice. It applies to prevent a
person who has made a decision from resorting to an inconsistent course of
action that he has specifically rejected.
[39]
The jurisprudential conclusion that res
judicata, issue estoppel and abuse of process do not prevent a party to a
prohibition proceeding from subsequently bringing an infringement action or
from introducing new or different evidence or arguments in a subsequent action
precludes any argument that there can be inconsistency in exercising the two
recourses or in a party’s choice of evidence. Indeed, appeals from prohibition
proceedings are commonly dismissed as moot when NOCs have already been issued,
on the basis that an unsuccessful innovator has an appropriate recourse in an
infringement action (Janssen v Teva 2015 FCA 36, citing Abbott
Laboratories v Apotex 2007 FCA 368, Pfizer v Apotex 2001 11 CPR
(4th) 245 and Eli Lilly v Novopharm 2007 FCA 359).
[40]
Similarly, the doctrine of waiver cannot
conceivably apply to a party’s decision to bring one form of proceeding, given
the jurisprudential determination that both forms of proceeding can be pursued.
[41]
Apotex argues that the pleaded factual situation,
where Alcon instructed its only expert witness not to consider what the Court
found to be very relevant prior art in providing his opinion on obviousness, is
a “unique factual context” that justifies its
novel but reasonable defence being allowed to proceed to trial. Apotex however
fails to provide a cogent rationale for its argument that the factual context
pleaded would support the application of the doctrines of election, waiver,
estoppel or abuse of process or a different application of established concepts.
The factual context pleaded in the amendments, even if taken as proven, is no
more than a decision by Alcon as to the evidence it chose to lead in the
prohibition proceeding. There is nothing unique in it, and certainly nothing
that could conceivably be construed as inconsistent with Alcon’s recognized
right to bring forth a better evidentiary record in a subsequent action.
[42]
Apotex has cited Apotex Inc v Pfizer Canada
Inc 2014 FCA 250 in support of its argument that the Court has recognized
that there may be instances where a concession made or position taken in one
proceeding may be construed as binding upon the conceding party in another
proceeding. The facts pleaded here concern solely the evidentiary decisions
made by Alcon in the prohibition proceedings. Such decisions, even as pleaded,
do not begin to rise to the level of an inconsistent or irreconcilable
concession or position. They are on the contrary, entirely consistent with the
Courts’ jurisprudence to the effect that it is permissible to introduce in an
action a better evidentiary record than on a prior prohibition proceeding
between the same parties.
[43]
The additional allegation that Apotex relied on
the strategy adopted by Alcon in the prohibition proceeding when deciding to
launch its product adds nothing to the analysis. Even if proven, a person’s
unilateral reliance on another person’s exercise of a right that is not
inconsistent with another cannot form the basis of a defence in election,
waiver or estoppel.
[44]
Apotex’s proposed paragraphs 30 to 41 fail to disclose
an arguable defence and leave to add them must be denied.
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