Date: 20071017
Docket: T-2300-06
Citation: 2007 FC 1057
BETWEEN:
SANOFI-AVENTIS
CANADA INC.
Applicant
and
PHARMASCIENCE INC. and
THE MINISTER
OF HEALTH
Respondents
and
SCHERING CORPORATION
Respondent / Patentee
REASONS FOR JUDGMENT
MACTAVISH
J.:
[1]
In
a pair of recent decisions, the Federal Court of Appeal has clearly attempted
to limit the proliferation of pharmaceutical litigation under the Patented
Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”), and
to encourage the efficient use of scarce judicial resources.
[2]
In
Pharmascience Inc. v. Canada (Minister of Health) et al., 2007 FCA 140
(“Abbott”), the Federal Court of Appeal determined that a generic drug
manufacturer who wishes to challenge the validity of a patent owned by an
innovator company by means of the PM(NOC) Regulations must do so by
“putting its best foot forward”. If the generic’s allegations of invalidity
are found not to be justified, issue estoppel will operate to preclude the same
generic from raising allegations of invalidity, based on different grounds, in
a second Notice of Allegation.
[3]
In
Sanofi-Aventis Canada Inc. v. Novopharm Ltd., 2007 FCA 163 (“Novopharm”),
the Federal Court of Appeal held that it was an abuse of process for an
innovator company to assert the validity of a patent in a Notice of Application
under the PM(NOC) Regulations involving one generic, if the same
allegation of invalidity had already been found to be justified in an earlier PM(NOC)
proceeding involving a different generic.
[4]
Both
factual situations arise in this case.
[5]
Relying
on Abbott, Sanofi-Aventis Canada Inc. and Schering Corporation say that
Pharmascience Inc. should be estopped from alleging the invalidity of patent in
dispute in a second Notice of Allegation, as this Court has found previous
allegations of invalidity made by Pharmascience in relation to the same patent
not to be justified.
[6]
In
contrast, Pharmascience says that the combined effect of a decision of this
Court involving a different generic, which found that allegations of invalidity
with respect to the patent in issue were justified, and the Federal Court of
Appeal’s decision in Novopharm, is that Sanofi-Aventis and Schering are
estopped from asserting the validity of the patent.
[7]
For
the reasons that follow, I am of the view that the reasoning of the Federal
Court of Appeal in Abbott applies here. Pharmascience’s initial
allegation of invalidity has been finally determined, and issue estoppel should
operate to preclude it from making further allegations of invalidity, albeit on
different grounds. I further decline to exercise my discretion to allow
Pharmascience to proceed with its allegations of invalidity.
[8]
Accordingly,
an order will go declaring that Pharmascience cannot rely on the allegations of
invalidity asserted in its second Notice of Allegation relating to Canadian
patent No. 1,341,206 (the “’206 patent”).
The Parties
[9]
Schering
Corporation is the owner of the ’206 patent. Under the terms of licences from
Schering, Aventis Pharma Inc. and its successor Sanofi-Aventis Canada Inc.
manufacture a drug containing a medicine called ramipril, which is an ACE
inhibitor. Ramipril is one of the compounds covered by the ’206 patent.
[10]
Pharmascience
is a manufacturer of generic drug products. Pharmascience wants to enter the
market with its own ramipril product.
Background
[11]
In
order to understand the parties’ arguments in this case, it is necessary to
have an appreciation of the sequence of events leading up to this hearing.
[12]
In
previous PM(NOC) proceedings involving these same parties or their
predecessors, Pharmascience alleged that the ’206 patent was invalid due to
double patenting.
[13]
In
March of 2005, Justice Snider found that Pharmascience’s allegation of
invalidity was not justified. As a result, she issued a prohibition order
preventing the Minister of Health from issuing a Notice of Compliance to
Pharmascience in relation to ramipril until after the expiry of the ’206
patent: see Aventis Pharma Inc. v. Pharmascience Inc., 2005 FC 340 (“Aventis
Pharma”).
[14]
Justice
Snider’s decision was subsequently affirmed by the Federal Court of Appeal
(2006 FCA 229), and leave to appeal to the Supreme Court of Canada was denied
([2006] S.C.C.A. No. 362).
[15]
Several
months after Justice Snider rendered her decision in Aventis Pharma, in
prohibition proceedings involving a different generic, I concluded that
Schering did not have a sound basis for predicting the utility of the invention
claimed in the ’206 patent at the time that it applied for the patent. As a
consequence, I dismissed Aventis’ application for prohibition in that case,
allowing for a Notice of Compliance to issue to Apotex with respect to
ramipril: see Aventis Pharma Inc. v. Apotex Inc., 2005 FC 1283 (“Apotex”).
[16]
My
decision was subsequently upheld by the Federal Court of Appeal: see Aventis
Pharma Inc. v. Apotex Inc., 2006 FCA 64. Leave to appeal to the Supreme
Court of Canada was sought by Sanofi-Aventis (Aventis’ successor), and was
denied by the Supreme Court in April of 2006 ([2006] S.C.C.A. 136).
[17]
After
I rendered my decision in Apotex, and before the appeal of Justice
Snider’s decision in Aventis Pharma was heard, Pharmascience moved for
an order from the Federal Court of Appeal barring Sanofi-Aventis from asserting
that the ’206 patent was valid, in light of my decision in Apotex.
[18]
The
Federal Court of Appeal dismissed Pharmascience’s motion. In so doing, the
Federal Court of Appeal observed that my decision in Apotex did not
amount to a final determination of the validity of the ’206 patent. Rather, I
simply determined whether the Apotex’s Notice of Allegation was justified, and
thus whether an order of prohibition should issue: see Pharmascience Inc. v.
Sanofi-Aventis Canada Inc., 2006 FCA 210.
[19]
Allegations
as to the invalidity of the ’206 patent made in PM(NOC) proceedings
involving a third generic manufacturer then entered the picture. In September
of 2006, in Sanofi-Aventis Canada Inc. v. Novopharm Ltd., 2006 FC 1135,
Justice Tremblay-Lamer summarily dismissed Sanofi-Aventis’ application for an
order of prohibition against Novopharm in relation to the ’206 patent for the
drug ramipril.
[20]
Justice
Tremblay-Lamer found that Sanofi-Aventis’ application for prohibition amounted
to an abuse of process, given that Novopharm’s allegations regarding lack of
sound prediction were very similar to those that had successfully been advanced
by Apotex in the prior proceeding before me.
[21]
On
November 15, 2006 Pharmascience served its second Notice of Allegation in
relation to the ’206 patent. In this NOA, Pharmascience asserted that the
patent was invalid on several different grounds, including lack of sound
prediction, lack of utility, the claims being broader than the invention, and
by operation of section 53(1) of the Patent Act, R.S., 1985, c. P-4.
[22]
Sanofi-Aventis
then commenced this application, seeking to prohibit the Minister of Health
from issuing a Notice of Compliance to Pharmascience in relation to ramipril
until after the expiry of the ’206 patent. In its Notice of Application,
Sanofi-Aventis also sought a declaration that Pharmascience’s November 15, 2006
Notice of Allegation was “invalid”.
[23]
In
this regard, Sanofi-Aventis asserted that in light of Justice Snider’s decision
in Aventis Pharma rejecting Pharmascience’s earlier allegations of invalidity,
Pharmascience was barred from making further allegations of invalidity in
relation to the ‘206 patent by the doctrines of abuse of process, res
judicata and / or issue estoppel.
[24]
In
April of this year, the Federal Court of Appeal released its decisions in Abbott
and Novopharm. The Court’s findings in these two cases have been
summarized in the introduction to this decision, and the implications of those
findings for this litigation will be discussed further on in these reasons.
[25]
In
response to Sanofi-Aventis’ Notice of Application, Pharmascience asserts that
it is an abuse of process for Sanofi-Aventis to dispute Pharmascience’s
allegation that the ’206 patent was invalid for lack of sound prediction, in
light of my decision in Apotex. In support of this contention,
Pharmascience relies on subsection 6(5) of the PM(NOC) Regulations and
the Federal Court of Appeal’s decision in Novopharm. Accordingly,
Pharmascience asked that the portion of Sanofi-Aventis’ application seeking
such a determination be struck.
[26]
In
an Order dated July 25, 2007, Prothonotary Tabib found that the two arguments
were interdependent, and that they had to be determined in advance of any
determination as to whether the allegations in Pharmascience’s NOA were
justified. As a consequence, she ordered that Sanofi-Aventis’ request for a
declaration that Pharmascience’s November 15, 2006 Notice of Allegation was not
a valid NOA, and Pharmascience’s argument that Sanofi-Aventis was estopped from
arguing the validity of the ’206 patent in this proceeding, be determined
first. These are the issues before me.
Issues
[27]
The
parties’ competing positions raise the following issues:
1. Which
issue has to be determined first? Sanofi-Aventis’ allegation that
Pharmascience is precluded from making further allegations of invalidity in
relation to the ’206 patent by the doctrines of abuse of process, res
judicata and / or issue estoppel? Or Pharmascience’s contention that it is
an abuse of process for Sanofi-Aventis and Schering to argue the validity of
the ‘206 patent?
2. Is
Pharmascience precluded from making further allegations of invalidity in
relation to the ’206 patent by the doctrines of abuse of process, res
judicata and / or issue estoppel?
3. Is
it an abuse of process for Sanofi-Aventis and Schering to argue the validity of
the ’206 patent?
Which Issue Has To Be
Determined First?
[28]
The
parties made only brief submissions on this point. Given that Sanofi-Aventis’
application for prohibition was triggered by Pharmascience’s Notice of
Allegation, the scope of Pharmascience’s NOA has to be determined first.
Sanofi-Aventis’ need to assert the validity of the ’206 patent only arises if
Pharmascience is in a position to raise the invalidity of the patent. If
Pharmascience is precluded from raising the issue of invalidity in its NOA, the
scope of Sanofi-Aventis and Schering’s ability to defend the validity of the ’206
patent becomes irrelevant.
Is Pharmascience
Precluded From Making Further Allegations of Invalidity?
[29]
In
determining Pharmascience is precluded from making further allegations of
invalidity in relation to the ’206 patent, the first question that I will
address is whether the doctrine of issue estoppel is engaged in this
proceeding, in light of Justice Snider’s decision in Aventis Pharma Inc. v.
Pharmascience Inc..
[30]
Issue
estoppel is a public policy doctrine designed to advance the interests of
justice: Danyluk v. Ainsworth Technologies Inc., [2001] S.C.R. 460, 2001
SCC 44. Its object is to prevent parties from re-litigating issues that have
already been decided in other proceedings.
[31]
The
policy considerations underlying the doctrine of issue estoppel include the
need to have an end to litigation, as well as the desire to protect individuals
from having to defend multiple legal proceedings arising out of the same set of
circumstances: Angle v. Canada (Minister of National Revenue), [1975] 2
S.C.R. 248, at p.267, per Laskin J. (dissenting).
[32]
Concerns
have also been expressed about the cost of duplicative proceedings, as well as
the risk of inconsistent results if the same issue is pursued in multiple fora:
Rasanen v. Rosemount Instruments Ltd. (1994), 17 O.R. (3d) 267 (Ont. C.A.).
[33]
As
the Supreme Court of Canada noted in Angle, there are three elements that
must be established to engage the doctrine of issue estoppel:
i) The same issue
is being decided in each proceeding;
ii) The decision
which raises the issue estoppel is a final decision; and
iii) The parties to
the two proceedings are the same parties, or are their privies.
[34]
It
is clear from the Supreme Court of Canada’s decision in Maynard v. Maynard,
[1951] S.C.R. 346, that even if the precise issue before the Court has not
previously been litigated, issue estoppel will operate to preclude a party from
litigating a new issue, where that issue could have been raised in the earlier
proceeding by the exercise of reasonable diligence, but was not: see also Apotex
Inc. v. Merck & Co., 19 C.P.R. (4th) 163, at ¶26, Fidelitas Shipping
Co. v. V/O Exportchleb, [1966] 1 Q.B. 630 (C.A.) and Apotex Inc. v.
Merck & Co. et al. (1999), 5 C.P.R. (4th) 363.
[35]
Even
if all three elements necessary to engage the doctrine of issue estoppel are
present, the Court still has the residual discretion to refuse to apply issue
estoppel in “special circumstances”: see, for example, Arnold v. National
Westminster Bank, PLC, [1991] 2 A.C. 93 at 110-11 and Doering v.
Grandview (Town) [1976] ] 2 S.C.R. 621.
[36]
Pharmascience
acknowledges that this proceeding involves the same parties as were before Justice
Snider in Aventis Pharma, or their privies, and further accepts that as
a result of the Supreme Court of Canada denying leave in that case, Justice
Snider’s decision is now final. Pharmascience also acknowledges that its NOA
in this case raises the same issue – that is, the validity of the ’206 patent –
as was in dispute before Justice Snider.
[37]
As
a consequence, Pharmascience concedes that all three of the requirements for
the establishment of issue estoppel are present in this case.
[38]
Pharmascience
also acknowledges that in Abbott, the Federal Court of Appeal has held
that in circumstances such as this, issue estoppel will ordinarily operate to
preclude a generic from raising allegations of invalidity based on different
grounds in a second Notice of Allegation.
[39]
However,
Pharmascience submits that “special circumstances” exist in this case, with the
result that it should not be precluded from challenging the validity of the ’206
patent. According to Pharmascience, there has been a change in the law since
Justice Snider rendered her decision, such that it would be unfair to preclude
Pharmascience from raising new grounds of invalidity in relation to the ’206
patent.
[40]
Pharmascience
identifies this change in the law as being the combined effect of my finding in
Apotex that Schering did not have a sound basis for predicting the
utility of the invention claimed in the ’206 patent at the time it applied for
the patent, and the Federal Court of Appeal’s decision in Novopharm
allowing generics to “piggy-back” onto invalidity findings made in the context
of PM(NOC) proceedings involving other generics.
[41]
Thus
the question for determination is whether there are “special circumstances” in
this case such that I should exercise my discretion and allow Pharmascience to
challenge the validity of the ’206 patent on new grounds.
Analysis
[42]
The
starting point for my analysis must be a consideration of the scope of the
Court’s discretion not to apply the doctrine of issue estoppel in proceedings
that involve the same issue being litigated by the same parties, where another
judge has already finally determined the issue.
[43]
Citing
the Supreme Court in Danyluk, the Federal Court of Appeal observed in Abbott
that while there is no doubt that such a discretion exists, this discretion
must be very limited in its application: see Abbott at ¶51.
[44]
The
Federal Court of Appeal also noted that the Court’s discretion is intended to
ensure that issue estoppel is not applied unfairly in the circumstances of a
given case: Abbott, at ¶53.
[45]
That
is, the Federal Court of Appeal observed that the purpose of this overriding
discretion was to “ensure that the operation of issue estoppel promotes the
orderly administration of justice but not at the cost of real injustice in the
particular case”: Abbott at ¶53, quoting Danyluk.
[46]
It
is also clear from the jurisprudence that the factors which may be relevant in
deciding whether to exercise this discretion will differ from case to case: Danyluk,
at ¶67.
[47]
There
is, however, some dispute in the jurisprudence as to whether a change in the
law is a factor that would warrant the exercise of the Court’s discretion not
to apply the doctrine of issue estoppel.
[48]
Some
Canadian jurisdictions have recognized a change in the law as a relevant factor
(see, for example, Hockin v. Bank of British Columbia (1995), 123 D.L.R.
(4th) 538 (B.C.C.A.)). However, in Apotex Inc. v. Merck & Co., 19
C.P.R. (4th) 163, Justice Malone observed that neither the Federal Court of
Appeal or the Supreme Court of Canada has ever found that a change in the law
would justify relaxing the application of issue estoppel: Merck, at ¶35.
[49]
If
I assume, as Justice Malone did, that a change in the law can indeed constitute
a special circumstance in the appropriate case, the next question is whether
there has indeed been a change in the law relating to PM(NOC)
proceedings.
[50]
Pharmascience
asserts that my decision in Apotex and the Federal Court of Appeal’s
decision in Novopharm, when taken together, amount to just such a change
in the law.
[51]
I
do not agree.
[52]
According
to Pharmascience, my decision in Apotex represents “a new and definitive
decision as to the validity of the ’206 patent, namely that for the purposes of
the [PM] (NOC) Regulations an allegation is justified that the ‘206
patent lacks a sound basis for predicting the alleged utility of the invention
claimed therein”.
[53]
This
is clearly not the case.
[54]
The
Federal Court of Appeal has already commented on the significance of my
decision in Apotex in the context of the appeal of Justice Snider’s
decision in Pharmascience. As the Court noted, my decision in that case
involved the factual determination, based upon the evidentiary record before me
in that case, that Apotex was justified in asserting that Schering did not have
a sound basis for predicting the utility of the invention claimed in the ’206
patent at the time that it filed its application for the patent: see Pharmascience
Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA 210.
[55]
In
Apotex, I decided that Aventis had not demonstrated that Apotex’
allegation as to invalidity was not justified. Decisions made under the PM(NOC)
Regulations are not in rem decisions, do not decide the question of
validity, and are not binding on other judges in subsequent NOC proceedings:
see Novopharm, at ¶30.
[56]
My
decision in Apotex does not, therefore, amount to a change in the law.
[57]
Insofar
as the Novopharm decision is concerned, Pharmascience points to the
following statement by Justice Harrington in Sanofi-Aventis Inc. v.
Laboratoire Riva Inc., 2007 FC 532, at ¶68:
Mr. Justice Sexton's decision in Novopharm
[…] drives home the point that mere litigation, with another party, of a point
already decided, can constitute, without more, an abuse of process, even if it
is not clear and obvious that the application would have failed on the merits. This
decision marks a clear development in the law as applicable in NOC proceedings.
[emphasis added]
[58]
Does
this mean that there has therefore been a change in the law of the type that
has been found in the jurisprudence to amount to “special circumstances”
justifying the exercise of the Court’s discretion? I think not.
[59]
First
of all, in Novopharm, Justice Sexton simply applied the existing law
relating to abuse of process to the facts before the Court in that case. As
Justice Sexton himself noted in Abbott¸ the fact that no decision may
have previously considered the specific question at issue in a given case does
not mean that the decision changes the applicable law: see Abbott at ¶60-61.
[60]
Moreover,
my review of the cases relied upon by Pharmascience in this regard demonstrates
that the type of ‘change in the law’ that has been found to justify relief from
the application of the doctrine of issue estoppel occurs when the result in a
later decision dictates that the findings in an earlier decision were clearly
wrong.
[61]
In
such cases, courts have held that it would be unfair not to allow a party to
derive the benefit of the later decision, notwithstanding the fact that the
party may have previously litigated the point and lost: see, for example, Hockin,
previously cited, and Arnold v. National Westminster Bank, PLC, [1991] 2
A.C. 93, as well as Minott v. O'Shanter Development Co. (1999), 42 O.R.
(3d) 321 (Ont. C.A.)).
[62]
This
is not the situation that we have here. There is no suggestion that Justice
Snider’s decision in Aventis Pharma Inc. v. Pharmascience Inc. was made
in error, such that it would be unfair to deny Pharmascience the right to
re-litigate the issue of the validity of the ’206 patent. Indeed,
Pharmascience concedes that Justice Snider’s decision was not clearly wrong.
[63]
Moreover,
even if the Federal Court of Appeal’s decision in Novopharm had been
released prior to the hearing before Justice Snider, it would not have assisted
Pharmascience. Having been the first generic to challenge the ’206
patent, there was no earlier decision involving a successful invalidity
challenge by another generic that Pharmascience could have relied on. That is,
Novopharm could not have affected the outcome of the case before Justice
Snider.
[64]
As
a consequence, I am not persuaded that there has been a change in the law that
would warrant the exercise of my discretion in Pharmascience’s favour.
[65]
The
question still remains as to whether there are other bases on which I should
exercise my discretion in Pharmascience’s favour in this case.
[66]
In
this regard, I note that issue estoppel is an equitable doctrine, and, as the
Supreme Court of Canada has stated, the rules governing issue estoppel should
not be mechanically applied. Rather, the task for the Court is to balance the
public interest in the finality of litigation with the public interest in
ensuring that justice is done on the facts of a particular case: Danyluk,
at ¶33.
[67]
Moreover,
Danyluk teaches that the exercise of the Court’s discretion is
necessarily case-specific, and will depend on all of the circumstances in a
particular case. That is, the Court must ask whether, in the context of the
case in issue, the application of the doctrine of issue estoppel would work an
injustice: Danyluk, at ¶63.
[68]
Pharmascience
says that it would be unfair if it were the only generic that was unable to
benefit from the combined effect of my decision in Apotex and the
Federal Court of Appeal decision in Novopharm.
[69]
I
am not persuaded that this is an unfair result, in the circumstances.
[70]
Pharmascience
made the strategic decision to move quickly, in order to be the first generic
to take a run at the ’206 patent by means of the PM(NOC) Regulations.
The company made a further tactical decision not to ‘put its best foot
forward’, but to allege invalidity only on the ground of double patenting in
its first NOA.
[71]
Pharmascience
concedes that there was nothing preventing it from alleging that the ’206
patent was invalid for lack of sound prediction at the time that it served its
first NOA.
[72]
As
a consequence, I do not accept Pharmascience’s contention that my decision in Apotex
amounts to “relevant new material” not otherwise discoverable by the exercise
of due diligence.
[73]
Moreover,
as the Federal Court of Appeal made clear in the Abbott decision (at ¶60),
the law has always been that generics are precluded from bringing multiple NOAs
asserting invalidity on different grounds. As a result, at the time that it
served its first NOA, Pharmascience knew, or should have known, that if it was
unsuccessful in its attack on the ’206 patent based on double patenting, it
would be precluded from advancing other grounds of invalidity in the future.
For whatever reason, it chose to put all of its eggs in one basket.
[74]
Pharmascience
gambled. It lost. It has to live with the consequences.
[75]
In
addition, Pharmascience is not without a remedy. If Pharmascience wants to be
in a position to market ramipril, it remains open to it to bring an impeachment
action in relation to the ‘206 patent.
[76]
There
is a further reason for declining to exercise my discretion in Pharmascience’s
favour. The situation in which Pharmascience finds itself in this case is
precisely the situation that Pharmascience faced in the Abbott case.
Nevertheless, the Federal Court of Appeal felt it appropriate to apply issue
estoppel against Pharmascience in that case.
[77]
That
is, in Abbott, Pharmascience had alleged in an NOA that a patent owned
by an innovator company was invalid on the basis that the claims were broader
than the invention disclosed. Following PM(NOC) proceedings in this
Court, Pharmascience’s allegations were not found to be justified, and a writ
of prohibition was issued against the company.
[78]
However,
in subsequent NOC proceedings involving the same patent but other generics,
this Court found other companies’ allegations of invalidity to be justified.
[79]
Pharmascience
then served a second NOA, asserting different allegations of invalidity. The
Federal Court of Appeal found that the doctrine of issue estoppel operated in
those circumstances to preclude Pharmascience from making further allegations
of invalidity. Clearly the Federal Court of Appeal did not consider this to be
an unjust result.
[80]
It
is true that the Federal Court of Appeal had not yet rendered its decision in Novopharm
at the time that the Abbott decision was issued. However, Novopharm
was under reserve, and the decision in Novopharm was released just a few
days after that in Abbott. Justice Sexton wrote both decisions. The
cases are clearly intended to establish policy regarding proceedings under the PM
(NOC) Regulations, and have to be read together.
[81]
It
is, therefore, reasonable to conclude that Justice Sexton was aware of the fact
that his decision in Abbott would preclude Pharmascience from being able
to “piggy-back” onto the findings in other NOC proceedings in the same way that
other generics could. He did not find this to be an unjust result in that
case, and I do not do so here.
[82]
In
this regard it does bear noting that there is one very material difference
between the position of the generic in Novopharm as compared to that of
Pharmascience in this case. That is, at the time that Novopharm sought to rely
on invalidity findings made in prohibition proceedings involving another
generic, Novopharm had not previously challenged the validity of the patent in
question by means of a Notice of Allegation.
[83]
In
other words, Novopharm was not endeavouring to re-litigate a battle that it had
already fought and lost.
[84]
For
all of these reasons, I therefore decline to exercise my discretion in
Pharmascience’s favour. In accordance with the decision of the Federal Court
of Appeal in Abbott, I find that the doctrine of issue estoppel should
apply to preclude Pharmascience from raising further allegations of invalidity
based on new grounds in its second Notice of Allegation.
[85]
As
a consequence, an order will issue declaring that Pharmascience cannot rely on
allegations of invalidity in its second Notice of Allegation relating to the ’206
patent.
Other Issues
[86]
In
light of my conclusion in relation to the question of issue estoppel, it is
unnecessary to address the parties’ arguments in relation to Pharmascience’s
second NOA based upon cause of action estoppel or abuse of process.
[87]
Moreover,
given that I have found that Pharmascience is precluded from relying on
allegations of invalidity in its second Notice of Allegation relating to the ’206
patent, the question of the scope of Sanofi-Aventis’s ability to assert the
validity of the ’206 patent in its Notice of Application does not arise.
Costs
[88]
Each
party shall have two weeks to serve and file submissions in writing regarding
costs, which are not to exceed five pages in length. The parties will each
then have one further week in which to serve and file any reply submissions,
not to exceed two pages in length.
“Anne
Mactavish”
Ottawa, Ontario
October
17, 2007