Date: 20091019
Docket: T-794-09
Citation: 2009 FC
1053
Ottawa, Ontario,
October 19, 2009
PRESENT: The Honourable Mr. Justice Martineau
BETWEEN:
ELI
LILLY CANADA INC.
Applicant
and
APOTEX INC.
and THE MINISTER OF HEALTH
Respondents
and
ELI LILLY AND COMPANY LIMITED
Respondent/Patentee
REASONS FOR JUDGMENT AND
JUDGMENT
[1]
The
Court is asked to decide whether Apotex Ltd. (Apotex) or Eli Lilly Canada Inc.
and Eli Lilly and Company Ltd. (together Eli Lilly) should be precluded from pursuing
their Notice of Allegation (NOA) or prohibition application under the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended (the NOC
Regulations).
[2]
For
the reasons that follow, I have determined that Apotex is precluded by the
doctrine of issue estoppel from pursuing their current NOA which is null, void
and of no effect.
I. BACKGROUND
[3]
Olanzapine
is used in the treatment of disorders of the central nervous system. Eli Lilly
markets three forms of olanzapine pharmaceutical products: olanzapine tablets
in 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg doses (marketed as ZYPREXA); orally
disintegrating olanzapine tablets in 5mg, 10mg, 15mg and 20 mg doses (marketed
as ZYPREXA ZYDIS); and an olanzapine injection formula in a 10mg/mL dose
(marketed as ZYPREXA INTRAMUSCULAR).
[4]
The
products above have all been issued Notice of Compliances (NOC) in connection
with Canadian Patent No. 2, 041, 113 (the ‘113 Patent) which is included on the
Patent Register maintained by the Minister of Health (the Minister).
[5]
The ‘113
Patent is a selection patent from the class of compounds covered by the 1, 075,
687 (the ‘687 Patent) and is said to have “atypical anti-psychotic
properties and an improved side effect profile over the genus of compounds as
claimed [by the ‘687 Patent]”.
Previous NOA
[6]
This
is not the first time Eli Lilly is before this Court defending the validity of the
‘113 Patent with respect to an NOA served by Apotex.
[7]
On
December 16, 2004, Apotex served Eli Lilly with an NOA claiming that in
relation to the conventional olanzapine tablet, “all of [Eli Lilly’s] claims
[pursuant to the ‘113 Patent were] void and of no effect” due to anticipation,
obviousness, double patenting and fraud pursuant section 53 of the Patent
Act, R.S.C. 1985, c. P-4 (Patent Act).
[8]
A
further NOA was served by Apotex on March 21, 2005 to specifically incorporate
the 10 mg strength tablet marketed by Eli Lilly into their original NOA. This second
NOA incorporated by reference all the factual and legal arguments that were set
out in the original NOA, and the two NOAs were consolidated to form one single
NOA (the previous NOA).
Prohibition Order
[9]
In
accordance with subsection 6(1) of the NOC Regulations, Eli Lilly applied to
this Court for an order “prohibiting the Minister from issuing a notice of
compliance until after the expiration of the [‘113 Patent].”
[10]
On
April 27, 2007, the Court granted Eli Lilly’s prohibition application (Eli
Lilly Canada Inc. v. Apotex Inc, 2007 FC 455, aff’d 2008 FCA 44 (Eli
Lilly)).
[11]
In
granting the prohibition order, Justice Gauthier found that Apotex failed to
substantiate their allegations. With regard to the argument on the basis of
sufficiency put forth by Apotex at the hearing, the Court found that unlike new
use compounds, where the patent hinges on the use of the invention, “in
selection patents where the selected compound is only generally described or
encompassed within a known genus or class of compounds, it is the selected
compound itself that is new” (Eli Lilly, at paragraph 95).
[12]
Furthermore,
the Court noted that it would be allowing Apotex to challenge the validity of
the patent on the basis of sufficiency if it accepted the argument that the ‘113
Patent was not a valid selection patent because it did not provide the benefits
promised in the disclosure (Eli Lilly, at paragraph 106). Since
sufficiency was not pleaded in its NOA, Apotex was prohibited from relying on
it during the hearing (Eli Lilly at paragraph 119).
[13]
Apotex
appealed to the Federal Court of Appeal on the grounds that Justice Gauthier
ought to have considered the sufficiency of the ‘113 Patent in making a
determination on its validity. In dismissing the appeal, the Federal Court of
Appeal held that “the applications judge correctly held that the sufficiency of the
disclosure is a stand alone ground which ought to have been raised in the NOA”
(Eli Lilly Canada Inc. v. Apotex Inc., 2008 FCA 44 at paragraph 3 (Eli
Lilly 2008)).
Other proceedings
[14]
On
November 13, 2007, Apotex began impeachment proceedings against Eli Lilly
seeking a declaration that the ‘113 Patent is invalid. As of the hearing date
in these proceedings, nothing beyond the pleadings had been submitted to the
Court (see file T-1971-07).
[15]
In
a different proceeding before this Court, Eli Lilly also sought an order of
prohibition against another generic pharmaceutical company, Novopharm Ltd. (Novopharm),
who had served Eli Lilly with an NOA alleging that the ‘113 Patent was invalid
on the grounds of anticipation, obviousness, double-patenting, utility,
sufficiency and fraud, as understood in section 53 of the Patent Act.
[16]
On
June 5, 2007, 2 months after the Eli Lilly, supra, decision, the
Court found that Novopharm’s allegations with respect to everything except
sufficiency were not justified. With regards to sufficiency, Justice Hughes
stated that:
[T]he ‘113 patent fails to provide
sufficient disclosure in its specification as to the invention, if any, in
selecting olanzapine from a previously disclosed group of compounds… [n]o data
was given. We are left only with rhetoric such as “high level of efficicency”
and “mild and transient” and “lower” side effects.
[…]
The Court finds that Lilly has not
demonstrated that Novopharm’s allegations as to sufficiency are not justified
and for that reason the application is dismissed…
(Eli
Lilly Canada Inc. v. Novopharm Ltd., 2007 FC 596 at paragraphs 162 and 191
(Novopharm decision))
[17]
As
a result of the Federal Court’s decision above, Novopharm was issued an NOC by
the Minister, and as a result of this, on November 6, 2007, the Federal Court
of Appeal dismissed Eli Lilly’s appeal on grounds of mootness (Eli Lilly
Canada Inc. v. Novopharm Ltd., 2007 FCA 359).
[18]
Consequently,
Eli Lilly brought an action against Novopharm for infringement with respect to
the ‘113 Patent. At the time of this hearing, the decision was still under
reserve (see file number T‑1048-07).
The current proceedings
[19]
This
brings us to the current proceedings.
[20]
In
compliance with the NOC Regulations, Apotex, after having filed on November 28,
2008 a Supplemental Abbreviated New Drug Submission (supplemental ANDS) for an
NOC in relation to orally disintegrating olanzapine tablets, served Eli Lilly
with an NOA by way of a letter dated March 27, 2009 (the current NOA).
[21]
Apotex
now alleges that in relation to the orally disintegrating olanzapine tablet,
“each and every one of the claims of the ‘113 Patent are invalid, void, of no
force and effect and unenforceable…for insufficiency as not complying with the
requirements of subsection 27(3) of the Patents Act.”
[22]
In
support of their allegation of invalidity of the ‘113 Patent, Apotex now exclusively
relies on Justice Hughes’ Novopharm decision and the subsequent
dismissal of Eli Lilly’s appeal to the Federal Court of Appeal.
[23]
Eli
Lilly filed a Notice of Application on May 15, 2009 (the current application) seeking:
(1) a declaration that the current NOA is an abuse of process and/or not a
proper NOA and detailed statement; and/or (2) an order to prohibit
Apotex from being granted an NOC by the Minister.
[24]
On
June 23, 2009, Apotex filed a Notice of Motion seeking an order pursuant to
subsection 6(5)(b) of the NOC Regulations dismissing Eli Lilly’s current
application on the ground that it is “redundant, scandalous,
frivolous or vexatious or is otherwise an abuse of process in respect of one or
more patents” since Eli Lilly has already defended these allegations in the Novopharm
decision, and lost.
Bifurcation of Issues
[25]
Upon motions by Eli Lilly seeking orders to set a schedule for the
completion of pre-hearing steps and for the separate determination of issues,
Prothonotary Tabib ordered a bifurcation of issues, such that a hearing would
be set down for the determination of:
1.
whether Apotex’s current NOA is an abuse of process, not a proper
notice of allegation and detailed statement as contemplated by the NOC
Regulations; and
2.
whether Eli Lilly’s current application is an abuse of process.
[26]
Since
the final determination of whether Apotex’s current NOA is an abuse of process
or not would be determinative of all proceedings currently brought under the
NOC regulations, and given that Eli Lilly’s application was triggered by the
Apotex’s current NOA, it follows that this issue should be dealt with first (see
Sanofi-Aventis Canada Inc. v. Pharmascience Inc., 2007 FC 1057 at paragraph
28, aff’d 2008 FCA 213 (Pharmascience)).
II. PRELIMINARY
OBJECTION
[27]
Apotex
has taken the position that neither the bifurcation order nor the current NOA
make explicit reference to the issue estoppel doctrine. Thus, this Court cannot
examine the argument made by Eli Lilly that Apotex is precluded from pursuing
the current NOA on the basis of the application of the doctrine of issue
estoppel.
[28]
The
preliminary objection made by Apotex is dismissed.
[29]
The
present instance is readily distinguishable from the situation contemplated in AstraZeneca
AB v. Apotex Inc., 2006 FC 7 at paragraphs 10-11 and 17-18 and upon which
Apotex relies.
[30]
Prothonotary
Tabib, the case manager in this proceeding, bifurcated the issues in order to
have the Court finally determine at the outset of the present proceedings
whether, inter alia, Apotex’s letter dated March 27, 2009 is an abuse of
process, not a proper notice of allegation and detailed statement as
contemplated by the NOC Regulations, as amended and it therefore a nullity. (emphasis
added)
[31]
Upon
reading Eli Lilly’s NOA, it is apparent that the factual basis for pleading
issue estoppel and abuse of process is the same, and that in both cases, as
mentioned in paragraph 15 of the NOA, Eli Lilly’s complaint is that “[b]y its
actions, Apotex is seeking to relitigate its case on the ‘113 Patent, contrary
to principles of law and equity”. As such, Eli Lilly does not need to amend
their NOA to plead the doctrine of issue estoppel before the Court.
[32]
The
application of the doctrine of issue estoppel is fully addressed by Eli Lilly
and Apotex in their respective memorandum of fact and law. That said, rule 75
of the Federal Court Rules, SOR/98-106, provides that the Court may, on
motion at any time, allow a party to amend a document, on such terms as will
protect the rights of all parties.
[33]
To
deny Eli Lilly the opportunity to invoke the doctrine of issue estoppel would
be to prefer form over substance. In practice, this would serve only to further
delay the proceedings, as Eli Lilly has no intention whatsoever to abandon
their argument and, if necessary, would be formally seeking from the Court the
authorization to amend their notice of application accordingly.
[34]
Indeed,
upon receiving Eli Lilly’s memorandum of fact and law, Apotex became aware that
issue estoppel was raised especially in light of Eli Lilly’s assertion that
Apotex’s current NOA is a nullity under the doctrine or res judicata,
issue estoppel and abuse of process. No adjournment has been sought by Apotex
to deal with the issue estoppel argument and I am therefore entitled to
consider the matter today (Abbott Laboratories v. Canada (Minister of
Health),
2007 FCA 140 at paragraph 23 (Abbott)).
III. ISSUE
ESTOPPEL
[35]
When
a generic pharmaceutical company seeks immediate permission to market a drug
that is either directly or indirectly comparable to a drug already patented by
another innovator company, they must serve the company with an NOA asserting
either that the proposed product does not infringe the patent and/or that the
patent itself is invalid (NOC Regulations, s. 5(1)).
[36]
This
in turn triggers the right of the innovator company to seek an order from the
Court prohibiting the Minister from issuing a NOC to the generic which would
permit them to market said drug (NOC Regulations, s. 6(1)).
[37]
Within
the realm of such NOC proceedings, it is essential that both the generic and
the innovator company “put forward their entire case, complete with all relevant
evidence, at first instance” or risk having their subsequent proceedings on
the same issues dismissed for abuse of process (Sanofi-Aventis Inc. v.
Novopharm Ltd., 2007 FCA 163 at paragraph 50 (Sanofi-Aventis)).
[38]
The
relationship between the doctrines of abuse of process and issue estoppel was
canvassed by Justice Arbour in Toronto (City) v. Canadian Union of Public
Employees (C.U.P.E.), Local 79, 2003 SCC 63 at paragraphs 37 and 38 (CUPE):
37 […] the doctrine of abuse of process engages "the inherent
power of the court to prevent the misuse of its procedure, in a way that would
... bring the administration of justice into disrepute" (Canam Enterprises Inc. v. Coles (2000), 51 O.R. (3d) 481 (C.A.), at para. 55, per Goudge J.A., dissenting (approved [2002] 3 S.C.R. 307,
2002 SCC 63)). Goudge J.A. expanded on that concept in the following terms at
paras. 55-56:
The doctrine of abuse of process engages the inherent power of the
court to prevent the misuse of its procedure, in a way that would be manifestly
unfair to a party to the litigation before it or would in some other way bring
the administration of justice into disrepute. It is a
flexible doctrine unencumbered by the specific requirements of concepts such as
issue estoppel. See House of Spring Gardens Ltd. v.
Waite, [1990] 3 W.L.R. 347 at p. 358, [1990] 2 All E.R. 990 (C.A.).
One circumstance in which
abuse of process has been applied is where the litigation before the court is
found to be in essence an attempt to relitigate a claim which the court has
already determined. [Emphasis added.]
As Goudge J.A.'s comments indicate, Canadian courts have applied
the doctrine of abuse of process to preclude relitigation in circumstances
where the strict requirements of issue estoppel (typically the
privity/mutuality requirements) are not met, but where allowing the litigation
to proceed would nonetheless violate such principles as judicial economy,
consistency, finality and the integrity of the administration of justice. (See,
for example, Franco v. White (2001), 53 O.R. (3d)
391 (C.A.); Bomac Construction Ltd. v. Stevenson,
[1986] 5 W.W.R. 21 (Sask. C.A.); and Bjarnarson v.
Government of Manitoba (1987), 38 D.L.R. (4th) 32 (Man. Q.B.), aff'd
(1987), 21 C.P.C. (2d) 302 (Man. C.A.).) This has resulted in some criticism,
on the ground that the doctrine of abuse of process by relitigation is in
effect non-mutual issue estoppel by another name without the important
qualifications recognized by the American courts as part and parcel of the
general doctrine of non-mutual issue estoppel (Watson, supra,
at pp. 624-25).
38 It
is true that the doctrine of abuse of process has been extended beyond the
strict parameters of res judicata while borrowing
much of its rationales and some of its constraints. It is said to be more of an
adjunct doctrine, defined in reaction to the settled rules of issue estoppel
and cause of action estoppel, than an independent one (Lange, supra, at p. 344). The policy grounds supporting abuse of
process by relitigation are the same as the essential policy grounds supporting
issue estoppel (Lange, supra, at pp. 347-48):
The two policy grounds, namely, that there be an end to litigation
and that no one should be twice vexed by the same cause, have been cited as
policies in the application of abuse of process by relitigation. Other policy
grounds have also been cited, namely, to preserve the courts' and the
litigants' resources, to uphold the integrity of the legal system in order to
avoid inconsistent results, and to protect the principle of finality so crucial
to the proper administration of justice.
[39]
Therefore,
the policy underlying the two doctrines is very similar. It may even be said
that the doctrine of issue estoppel is more restrictive since it only operates
when specific criteria have been met. Abuse of process, on the other hand, is a
residual power granted to the Court to prevent abuse of the Court’s process (CUPE
at paragraph 35). For the purposes of the present case, it is important that,
as noted above, the doctrine of abuse of process operates in circumstances “where
allowing the litigation to proceed would nonetheless violate such principles as
judicial economy, consistency, finality and the integrity of the administration
of justice,”
but the criteria required for issue estoppel have not been met (CUPE at
paragraph 37).
[40]
Issue
estoppel applies where: (1) the same question has been decided; (2) the
decision which is said to create the estoppel was final; and (3) the parties to
the judicial decision or their privies were the same persons as the parties to
the proceedings in which the estoppel is raised or their privies (see Angle
v. Canada (Minister of National Revenue – M.N.R.), [1975] 2 S.C.R. 248).
[41]
As
indicated by the Supreme Court’s decision in Danyluk v. Ainsworth
Technologies Inc., 2001 SCC 44 at paragraph 33 (Danyluk), the first
step is to determine whether the moving party has established the
preconditions to the operation of issue estoppel set out by Dickson J. in Angle,
supra. If successful, the Court must still determine whether, as a matter
of discretion, issue estoppel ought to be applied: British Columbia
(Minister of Forests) v. Bugbusters Pest Management Inc. (1998), 50
B.C.L.R. (3d) 1 (C.A.), at paragraph 32; Schweneke v. Ontario (2000), 47 O.R.
(3d) 97 (C.A.), at paragraphs 38-39; Braithwaite v. Nova Scotia Public
Service Long Term Disability Plan Trust Fund (1999), 176 N.S.R. (2d) 173 (C.A.), at
paragraph 56.
[42]
In
Abbott, supra, at paragraph 2, Justice Sexton found that:
… generics should in most circumstances
be precluded by the doctrine of issue estoppel from alleging for a second time
that a patent is invalid, unless the basis relied upon for the subsequent
allegation could not be determined with reasonable diligence at first instance,
or some special overriding circumstance exists to warrant a judge exercising
her discretion not to apply issue estoppel on the facts of the particular case.
[43]
In Pharmascience,
supra, the Court followed the Abbott decision. In that case, Pharmascience had previously served Sanofi-Aventis with an NOA
alleging that the patent in question was invalid. Upon an application for a
prohibition order by Sanofi-Aventis, this Court found that Pharmascience’s
allegations were not justified. After this determination, another generic
successfully served Sanofi-Aventis with an NOA challenging the same patent on
the basis of invalidity. In light of that decision, Pharmascience issued a
second NOA, again alleging invalidity, and Sanofi-Aventis applied to this Court
to have them estopped.
[44]
In
granting Sanofi-Aventis’ application, the Court found at paragraph 7:
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.
[45]
Apotex
argues that issue estoppel is not applicable in the present circumstances
because the current application will not decide the same question as was
determined in Eli Lilly, supra. Specifically, Apotex contends
that because the product at issue in each proceeding is different (the
conventional tablet was litigated before Justice Gauthier; whereas, it is the
orally disintegrating tablet at issue in the present application) the cause is
fundamentally different and therefore issue estoppel does not apply.
[46]
According
to Apotex, it is significant that in the Abbott decision, Justice
Sexton, at paragraph 41 provides that “multiple NOAs
from the same generic relating to a particular pharmaceutical and
alleging invalidity of a particular patent will generally not be permitted,
even if different grounds for establishing invalidity are put forward in each”
(emphasis added).
[47]
With
respect to the current NOC proceedings, Apotex argues that what is being determined
is not the validity of the patent, as Eli Lilly submits, but rather, whether or
not the Minister may grant a given party an NOC for a given product. In support
of this submission Apotex refers to David Bull Laboratories (Canada) Inc. v.
Pharmacia Inc., [1995] 1 F.C. 588 at paragraph 13 (C.A.).
[48]
The
arguments made by Apotex are not convincing.
[49]
In
the current proceedings, as in Eli Lilly, the allegations made in the
current NOA by Apotex are with regards to the invalidity of the ‘113 Patent.
Therefore it is an oversimplification to categorize the issue on an NOC as
whether or not the Minister should grant an NOC to the product in question.
[50]
In Procter
& Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), 2003
FCA 467 at paragraph 25 (P&G), Rothstein J.A. (as he then was),
speaking for the Federal Court of Appeal, approved the following passage from
page 9 of Lord Denning’s decision in Fidelitas Shipping Co., Ltd. v. V/O
Exportchleb, [1965] 2 All E.R. 4 (C.A.):
But
within one cause of action, there may be several issues raised which are
necessary for the determination of the whole case. The rule then is that, once
an issue has been raised and distinctly determined between the parties, then,
as a general rule, neither party can be allowed to fight that issue all over
again. The same issue cannot be raised by either of them again in the same or
subsequent proceedings except in special circumstances….And within one
issue, there may be several points available which go to aid one party or the
other in his efforts to secure a determination of the issue in his favour. The
rule then is that each party must use reasonable diligence to bring forward
every point which he thinks would help him. If he omits to raise any particular
point, from negligence, inadvertence, or even accident (which would or might
have decided the issue in his favour), he may find himself shut out from
raising that point again, at any rate in any case where the self-same issue
arises in the same or subsequent proceedings.[Emphasis added.]
[51]
More
recently, the Federal Court of Appeal in Abbott, supra, referred
to the above passage, at paragraph 39, before moving on to look at the
“question” that is addressed in NOC proceedings. Again at paragraph 41, Justice
Sexton speaking for the Court of Appeal notes:
In other words, the "issue" to be addressed is
invalidity or non-infringement. The specific grounds on which the second person
wishes to demonstrate invalidity, whether that be by obviousness, anticipation,
overbreadth or lack of sound prediction, do not constitute separate issues for
the purpose of issue estoppel but are merely different bases on which the
second person may address the issue of invalidity.
[52]
Other
key remarks were made by Justice Sexton, at paragraph 46, where reference is
made to the prior decision of the Federal Court of Appeal in AstraZeneca AB v.
Apotex Inc., 2005 FCA 183 (AstraZeneca). In AstraZeneca, the
Court found that a second NOA submitted by the generic was not an abuse of
process. In distinguishing Abbott from that case, Justice Sexton notes:
The
second difference between AstraZeneca and the present case is of vital
importance. In AstraZeneca, the NOAs at issue both alleged
non-infringement, rather than invalidity. As Layden-Stevenson J. explained in AB
Hassle, where different formulations of the generic drug are at issue,
multiple NOAs alleging non-infringement may be permissible. It is intuitive
that if a generic makes material changes to its formulation in an attempt to
avoid infringing the listed patent, it may submit a new NOA alleging
non-infringement by the new product. Similarly, if it was the process for
making the generic drug that infringed the patent, a new process adopted by the
generic may give rise to a subsequent NOA alleging non-infringement of the patent.
That is not to say that minor variations to the formulation or process will be
sufficient to permit a new NOA. Only where the change is of significance might
a new NOA be permitted. Multiple NOAs alleging invalidity, in contrast, are
not permissible because the factual basis does not change depending on the
circumstances of the generic. Unless a material fact could not be uncovered by
reasonable diligence at the time of the first NOA, subsequent NOAs alleging
invalidity will generally not be permitted. In AstraZeneca, Evans
J.A. appreciated this distinction. From his reasons, it appears that Apotex
made a significant change to the formulation of its drug product between the
first and second NOAs. The second NOA was therefore permitted because the factual
basis for the allegations in it was separate and distinct from that in the
first NOA. (Emphasis added.)
[53]
It
is clear that all three criteria required for issue estoppel have been met in
this case. The issue to be determined in the current application is the same as
that which was determined in Eli Lilly, supra, namely whether or
not the ‘113 Patent is invalid as alleged in the previous NOA. Justice
Gauthier’s decision is final, as it was affirmed by the Federal Court of
Appeal, and the parties in the Eli Lilly case are the same as the ones
in the present application.
[54]
Since
Apotex served the previous NOA on the basis of invalidity, I find that the same
issue is being addressed in the current application.
[55]
In
view of the
Federal Court of Appeal’s pronouncement in Abbott, it is of no
importance that Apotex is currently alleging invalidity on the basis of
sufficiency, a particular ground of invalidity which was not raised the first
time in the previous NOA. In Pharmascience, the Court also found that the issue
in common was the validity of the Sanofi-Aventis patent (Pharmascience, supra
at paragraph 36).
[56]
Apotex
has consistently attacked each and every claim in the ‘113 patent as being
invalid; they do no limit themselves to particular claims. This is evidenced in
the wording of the previous NOA which, as set out above, provides that “we
[Apotex] allege that all of its [the ‘113 Patent] claims (claim 1-22)
are invalid, void and of no effect” (emphasis added). Furthermore, in their
further NOA submitted by way of a letter dated March 21, 2005, Apotex
reiterated that “…those allegations [in the previous NOA] are allegations of
invalidity of the ‘113 Patent, and thus, necessarily address the ‘113 Patent in
respect of each and every listing on the Patent Register” (emphasis
added).
[57]
I do
not accept that the cause is fundamentally different today simply because the
formulation or form of the pharmaceutical product to which a NOC is sought by
the generic is slightly different. For the purpose of the doctrines of issue or
abuse of process, what really matters are the claims of the ‘113 Patent with
respect to drugs containing olanzapine.
[58]
Apotex
has submitted that regardless of whether the criteria for issue estoppel are
met, since both abuse of process and issue estoppel are discretionary
doctrines, the Court may still choose not to apply it in the circumstances
because no court has ever specifically considered whether Apotex should receive
market approval for the orally disintegrating olanzapine tablets.
[59]
Again,
I believe the emphasis on the product made by Apotex is misplaced.
[60]
While
no court has considered this specific issue, this Court has considered the
validity of the ‘113 Patent in light of allegations brought by Apotex. As
Justice Mactavish noted in Pharmascience, supra at paragraph 2, “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".” The fact
that Apotex has failed to do so does not entitle them to a second chance.
[61]
There
has been no evidence put forth to suggest that Apotex could not have raised the
issue of sufficiency in the previous NOA and that Justice Gauthier in Eli
Lilly, supra, refused to accept Apotex’s sufficiency argument
pleaded at the hearing. This is not a case where there is some special
overriding circumstances that would warrant the judge exercising his discretion
not to apply issue estoppel on the facts of the particular case.
[62]
In
refusing to exercise her discretion in Pharmascience, supra,
Justice Mactavish noted that Pharmascience would not be without remedy
since it remained open to them to begin an impeachment action in relation to
the patent in question.
[63]
Given
that Apotex has already commenced an impeachment action, I do not feel that the
circumstances of the present case warrant an exercise of my discretion not to
apply the doctrine of issue estoppel.
IV. CURRENT NOA
NULL, VOID AND OF NO EFFECT
[64]
I
find that Apotex is precluded from pursuing with their current NOA.
[65]
Eli
Lilly has taken the position that there was no need for the Court to make a new
prohibition order if Apotex was precluded from pursuing with their current NOA
and/or same was declared to be null, void and of no effect.
[66]
I
agree with Eli Lilly.
[67]
In
accordance with section C.08.004 of the Food and Drug Regulations,
C.R.C., c. 870 the Minister shall, after completing an examination of, inter
alia, a supplemental ANDS, issue a NOC with respect to the supplemental ANDS,
but only if that submission complies with section C.08.003. Section C.08.003
requires Apotex to file a supplemental ANDS where any of a number of listed
changes have been made to its drug product.
[68]
This
provision can only be relied upon where a notice of compliance has previously
been issued. Thus, where there is no issued NOC based on the previous
submission, Apotex cannot rely upon, and the Minister cannot issue a NOC,
unless and until the parent NOC expires. As the Minister is prohibited until
expiry of the ‘113 Patent from granting such an NOC, there is no ability for
the Minister to issue an NOC on the supplemental ANDS.
[69]
For
all these reasons, Apotex’s current NOA seeking a NOC for a supplemental
abbreviated new drug submission for olanzapine is null, void and of no effect.
V. CONCLUSION
[70]
In
conclusion, Eli Lilly is entitled to a declaration to the effect that Apotex is
precluded by the doctrine of issue estoppel from pursuing their current NOA
dated March 27, 2009 which is null, void and of no effect. As a result, the
current prohibition application made by Eli Lilly and related motion to dismiss
made by Apotex are terminated. Costs shall be awarded in favour of Eli Lilly.
JUDGMENT
THIS COURT DECLARES, ADJUDGES AND ORDERS
that Apotex
is precluded by the doctrine of issue estoppel from pursuing their current NOA
dated March 27, 2007 which is null, void and of no effect. As a result, the
current prohibition application made by Eli Lilly and related motion to dismiss
made by Apotex are terminated. Costs are awarded in favour of Eli Lilly.
“Luc
Martineau”
Email this Content