Docket: T-1736-10
Citation:
2014 FC 876
Toronto, Ontario, September 15, 2014
PRESENT: Case Management Judge Kevin R. Aalto
BETWEEN:
APOTEX INC.
Plaintiff
and
PFIZER CANADA INC., WARNER LAMBERT COMPANY LLC
AND PFIZER INC.
Defendants
AND BETWEEN:
WARNER LAMBERT COMPANY, LLC
AND PFIZER INC.
Plaintiffs
by Counterclaim
and
APOTEX INC.
Defendant
by Counterclaim
ORDER
AND REASONS
The best laid schemes o' mice an' men /
Gang aft a-gley.*
[1]
“And so it goes” for case
management decisions as well. This is a further chapter in the ongoing saga of
Apotex Inc.’s (Apotex) claim for Section 8 damages relating to the
Defendants/Plaintiffs by Counterclaim’s (Pfizer) branded drug product Lipitor,
the active pharmaceutical ingredient (API) being atorvastatin.
[2]
The motion before the Court is brought by Pfizer
to further amend its Further Fresh as Amended Statement of Defence and
Counterclaim (Defence). Given that no discoveries have yet taken place even
though the action was commenced in 2010, it would be almost axiomatic that these
amendments if meritorious would be granted. However, this motion is
vigourously opposed as it arises five months after a Bifurcation Order was made
relating to an issue which, on the unique facts of this case, is novel [see Apotex
Inc. v. Pfizer Canada Inc. et al, 2014 FC 159].
The simplified statement of the bifurcated issue is: “What is the start date
for the Section 8 damages claimed by Apotex?” (Start Date Issue).
Background
[3]
By way of brief background, the Start Date Issue
arises because the Minister of Health (Minister) has issued two patent hold
letters for different dates relating to Apotex’ two different atorvastatin formulations.
The following facts are summarized from the reasons for the Bifurcation Order.
[4]
Pfizer has certain patents listed on the Patent
Register against the drug Lipitor including patents relating to various
polymorphic forms of Atorvastatin. Pfizer sells generic pharmaceutical
products in Canada through its GenMed Division and received an NOC in respect
of GD-Atorvastatin on November 15, 2006.
[5]
On September 27, 2006 Apotex served two Notices
of Allegation (NOA) in respect of Pfizer’s polymorphic patents. Apotex’s
submission for its amorphous atorvastatin product (First Apotex Product) was placed
on “patent hold” by the Minister of Health on May 15, 2007. Notices of
Application were issued by Pfizer pursuant to the Patented Medicines (Notice
of Compliance) Regulations (Regulations) seeking prohibition
orders. Those applications were eventually discontinued.
[6]
On February 19, 2009 Apotex delivered NOA’s in
relation to its submission to Health Canada for an Apotex product containing atorvastatin
propylene glycol solvate (Second Apotex Product) in respect of Pfizer’s
polymorphic patents. Notices of Application under the (Regulations) were
commenced by Pfizer in response to the February 19, 2009 Apotex NOA’s.
Apotex’s submission for the Second Apotex Product was placed on patent hold by
the Minister of Health on February 22, 2010.
[7]
Apparently, the Second Apotex Product indicates
one of the problems the inventors sought to overcome was reduced stability
associated with forms of atorvastatin such as the amorphous atorvastatin
formulation being the First Apotex Product.
[8]
Apotex obtained NOC’s for both its First Apotex
Product and its Second Apotex Product on May 19, 2010. Subsequently, Apotex
marketed in Canada only the Second Apotex Product. At the time of Apotex’s
launch of its Second Apotex Product, it issued a press release dated May 19,
2010 which explained that by virtue of its own crystal form of atorvastatin it
had essentially solved the stability issues associated with other forms of atorvastatin.
Apotex stated in its press release that it had “spent many years and many
millions of dollars on the development and litigation processes for this
product”. The prohibition applications commenced by Pfizer in response to
Apotex’s NOA’s were discontinued on consent on May 26, 2010.
[9]
There are, apparently, a number of generic
pharmaceutical manufacturers who have delivered NOA’s in respect of one or more
of the patents listed on the Patent Register against Lipitor. On May 19 and
20, 2010, the Minister, in addition to the NOC’s issued to Apotex, issued seven
other generic pharmaceutical manufacturers NOC’s in respect of generic atorvastatin
products. Subsequently, an additional six pharmaceutical manufacturers
received NOC’s for their respective atorvastatin products.
[10]
In this action, Apotex seeks Section 8 damages
for a three-year period commencing May 15, 2007 and ending May 19, 2010.
Pfizer argues that Apotex’s Section 8 damages are limited to the three-month
period commencing February 10, 2010 and ending on May 19, 2010. Pfizer’s
position is that there can be no Section 8 damages relating to the longer term
because the three-year period relates to the First Apotex Product that Apotex
never brought to market.
[11]
Pfizer sought to have the Start Date Issue
bifurcated. The Bifurcation Order was issued February 20, 2014 substantially
on the terms sought by Pfizer. Apotex did not appeal.
[12]
It is against this background that Pfizer comes
again to the Court but this time to amend virtually all of the paragraphs of its
Fresh As Amended Statement of Defence and Counterclaim (Proposed Amendments)
which are referenced in the Bifurcation Order. To put the issue in context,
the Bifurcation Order provides as follows:
In this Order:
(a)
“Start Date Issue” means the issue of the relevant date that the period of liability
(if any) commenced pursuant to section 8(1)(a) of the Patented Medicines
(Notice of Compliance) Regulations, SOR/93-133 as amended. For greater
certainty, the Start Date Issue shall include the determination of the issues
raised in paragraphs 17-23 of the Amended Statement of Claim dated May 30,
2011; in paragraphs 10-17, 19-21 and 23-25 of the Further Fresh as Amended
Statement of Defence and Counterclaim dated April 25, 2012; and in paragraphs
5-9 of the Fresh as Amended Reply and Defence to Counterclaim dated July 28,
2011.
(b)
“Start Date Phase” means discovery and all other steps up to and including a trial or
other determination of the Start Date Issue, including any appeals.
(c)
“Other Issues”
means all issues in the action other than the Start Date Issue.
1.
The Start Date Issue shall be determined
separately from, and prior to, the Other Issues.
2.
Insofar as it raises the Other Issues, this
action shall be stayed pending the completion of the Start Date Phase. During
the Start Date Phase there shall be no documentary or other discovery on matters
relating solely to the Other Issues.
3.
The Parties shall confer on the schedule to be
followed for the determination of the Start Date Phase. In the event that the
parties are unable to agree on a schedule, either party may bring a motion to
the Court for directions.
4.
The Other Issues shall de determined separately
from, and only after the completion of, the Start Date Phase.
[13]
At this stage of the proceedings the parties
have exchanged affidavits of documents related to some issues but examinations
for discovery have not yet been commenced. Both Apotex and Pfizer complain
that the other side has not produced relevant documentation. Discoveries on
the Start Date Issue are imminent.
[14]
The trial of the Start Date Issue is set for
four days commencing June 22, 2015.
[15]
Since the Bifurcation Order was issued, Pfizer
changed its counsel. This has resulted in some delay as new counsel have been
required to get up to speed on the issues in this case. It has also resulted
in the current motion seeking the Proposed Amendments.
[16]
Of the paragraphs enumerated in the definition
of the Start Date Issue, Pfizer now seeks to amend virtually all of those
paragraphs. By implication, any amendment to these paragraphs in the Defence
will result in a variation of the Bifurcation Order. This motion was filed and
argued by Pfizer as a pleading amendment motion and not as a variation of an
order motion. However, one cannot ignore the inexorable result of allowing the
Proposed Amendments and the impact they will have on the Start Date Issue. The
Proposed Amendments are attached to these Reasons as Schedule “A”.
[17]
The dilemma which these Proposed Amendments
create is that, notwithstanding the arguments of Pfizer, the issues on the Start
Date Issue case are expanded by virtue of these Proposed Amendments; they were
not part of the original case at the time of the bifurcation motion and
therefore were not addressed in the context of the bifurcation motion; and, if
allowed, the Start Date Issue is lengthened and more complicated. It is no
answer, as suggested by Apotex, that the Proposed Amendments, if allowed, not
be part of the Start Date Issue. Thus, as with many proceedings, a balance
must be struck to accommodate the interests of all the parties in putting their
case forward.
Position of Pfizer
[18]
Pfizer argues that the Proposed Amendments “do
not radically alter the pleaded case nor do they require that the Bifurcation
Order be varied” [para. 34, emphasis added, Pfizer’s Written Representations].
On the latter point they are correct as the Bifurcation Order simply refers to
paragraph numbers and no modification of those paragraphs is required. What
this submission misses is that the Proposed Amendments are contained in the
current paragraph numbers and to change the Defence is to change the Bifurcation
Order by expanding its scope to include the new allegations. With respect to
the former point, notwithstanding the very able arguments of counsel for
Pfizer, the description of the Proposed Amendments as not “radically” altering
the case implicitly acknowledges that they do, in fact, alter the case as
pleaded.
[19]
Pfizer argues that the Proposed Amendments fall
into three broad categories: 1) the NOA Amendments; 2) the Election Amendments;
and 3) the Updating Amendments.
[20]
With respect to the NOA Amendments, Pfizer seeks
to amend various paragraphs of the Defence to plead that Apotex’s 2006 NOA’s
have no legal effect because those NOA’s did not include the information
required by the Regulations. This was an allegation made by Pfizer in
the prohibition proceedings but was never determined as those proceedings were
discontinued. Pfizer argues that Apotex was aware of this allegation and it is
nothing new and there is no injustice or prejudice to Apotex by allowing these
amendments. They argue that it is essential for the judge hearing the Start
Date Issue to have the full picture on all issues and this amendment is part of
the picture. However, the legal effect of the NOA’s was not part of the
bifurcation motion nor was it addressed in that context.
[21]
The Election Amendments raise an esoteric issue
of law regarding Apotex’s decision to market only the Second Apotex Product.
The election to do so, as Pfizer argues disentitles Apotex to damages for the
three-year period. These amendments also deal with Apotex’s decisions to
change the drug formulation and drug substance of its products and then enter
the market with only the Second Apotex Product. In support of its argument
that these Election Amendments do not alter the Bifurcation Order, Pfizer notes
that these amendments are simply a legal argument and that the amendments clarify
and particularize these arguments. One wonders that if the issue is already
part of the current pleadings, why these amendments are required?
[22]
With respect to the Updating Amendments, they
reflect the importance, as Pfizer argues, of accurate pleadings. The Updating
Amendments simply correct references in Pfizer’s Defence and do not broaden the
scope of the Start Date Issue. For example, in paragraph 13 Apotex’s 2009 NOA’s
state that Apotex made an “abbreviated drug submission” relating to the Second
Apotex Product while the documentation from the Minster states that it was a
“supplemental abbreviated new drug submission”. Of all of the Proposed Amendments,
this group is closest to being housekeeping or clarification amendments.
[23]
In summary, Pfizer argues that there is no
prejudice to Apotex and the interests of justice require that these “routine” Proposed
Amendments be granted.
Apotex’s Position
[24]
For its part, Apotex strenuously disagrees with
Pfizer’s position that the Proposed Amendments will not lengthen or broaden the
Start Date Issue. Apotex argues that the Proposed Amendments “are real, are
substantial and demonstrate prejudice”. Apotex argues that the Proposed Amendments
are neither clarifications, particularizations nor housekeeping but substantive
new elements which fundamentally alter the scope of the Start Date Issue to the
detriment of Apotex. The thrust of Apotex’s argument opposing the Proposed
Amendments is with respect to the prejudice which Apotex will suffer respecting
the trial of the Start Date Issue.
[25]
Apotex argues that the Proposed Amendments are
objectionable as they (i) seek to amend and expand the Start Date Issue; (ii)
constitute a “radical change” in the position of Pfizer; (iii) are not relevant
or fail to disclose a reasonable cause of action; and, (iv) ought to have been
raised earlier.
[26]
Given the outcome of this motion, it is not
necessary to review Apotex’s position on each of the Proposed Amendments in
detail. A brief review will suffice. For example, Apotex argues that the
Proposed Amendment to Paragraph 14 is not a defence to a Section 8 claim as it
invites a reconsideration of whether or not Apotex’s 2006 NOA’s were proper and
whether they had any effect under the Regulations. This, so Apotex
argues, reopens the proceedings under the Regulations and, if allowed,
would require expert evidence on regulatory matters and further evidence as to
the scope of those discontinued proceedings.
[27]
Similarly, the Proposed Amendment to Paragraph
13 puts in issue the Minister’s regulatory decision to issue NOC’s to Apotex
and whether Apotex’s products are different not only because they are different
formulations (amorphous v. propylene glycol solvate) but are also a change in
drug substance. This allegation will require more scientific evidence
involving the Apotex products and the Apotex API.
[28]
Apotex’s arguments respecting other parts of the
Proposed Amendments point to the fact that the issues now raised were not
argued as part of the bifurcation motion. The issue of election, the propriety
of the NOA’s and the involvement of the Minster and the Minister’s discretion
will require additional discovery and evidence. Apotex argues that the additional
time to be ready in 9 months and the extra issues cannot be dealt with in the four
days of trial time set aside for the Start Date Issue.
Analysis
[29]
Although the Proposed Amendments amend the
Bifurcation Order, given the disposition of this motion, the analysis applied
is that of amending pleadings. Whether amendments should be granted is in the
discretion of the Court.
[30]
There is considerable jurisprudence dealing with
the provisions of Rule 75 and the factors to be considered on motions to
amend. Rule 75 provides that the Court may at any time allow a party to amend
“on such terms as will protect the rights of all parties.” The jurisprudence,
[see, for example, Canderel Ltd. v. Canada, [1994] 1 F.C. 3 at para. 3
(FCA); Merck & Co. v. Apotex Inc. (3302), 30 C.P.R. (4th)
40; and, Bristol Myers Squibb Co. v. Apotex Inc., 2011 FCA 34], sets out
the basic approaches to amendments. The classic statement on amendments is found
in Canderel as follows at p. 10:
A pleadings amendment should be allowed for the
purpose of determining the real questions in controversy, provided that
allowing the amendments would not result in an injustice to the other party that
is not capable of being compensated by an award of costs and the amendment
would serve the interests of justice.
[31]
Subsequent cases have noted that the discretion
to allow amendments is to be guided by two factors: (1) prejudice; and (2)
interests of justice. Both criteria should be met by the moving party. All
relevant factors must be considered by the Court in assessing any amendments.
Among the factors to be considered, if applicable, include:
Do the amendments withdraw admissions of
result in “radical” change of the matters in controversy;
Will the amendments facilitate the Court’s
consideration of the real issues in dispute;
Have the amendments been considered at a
pre-trial conference;
Has a position of a party led the opposite
party to pursue a course of action that may be difficult to alter;
The conduct of the parties and specifically
the conduct of the party proposing the amendments;
Will the amendments delay the expeditious
trial of the matter;
The timeliness of the motion to amend; and,
Prejudice which is
non-compensable by costs or otherwise.
[see, generally, Merck
& Co. v. Apotex Inc. 2003 FCA 488 at para. 30 and Bristol Myers Squibb
Co. v. Apotex Inc., 2011 FCA 34, at paras. 4, 5, 28 and 33]
[32]
All of these factors do not apply here as there
has been no pre-trial and the action, for all the steps taken to date, is still
in its relative infancy notwithstanding four years have elapsed since its
inception as no discoveries have yet taken place.
[33]
A further factor that must be considered is
whether the Proposed Amendments disclose a reasonable cause of action or
defence. Dealing with this point, although Apotex argues that the Proposed
Amendments, in large part, do not amount to a recognized defence to a Section 8
damage claim, the novelty of a defence or a claim, if it has some semblance of
possibility, should not be determined at the pleadings stage. Section 8 damage
cases are an evolving area of law and one should not arbitrarily close the door
to possible defences without the benefit of a full record before a trial
judge. Unless a claim or a defence is “bereft of any chance of success” [see Hunt
v. Carey Canada Inc., [1990] 2 S.C.R. 959], subject to the
overriding considerations of justice and prejudice, it should be allowed. At
this juncture, I am not prepared to find that any of the Proposed Amendments
are bereft of any chance of success.
[34]
Turning to a consideration of the applicable factors
set out above, it is my view that, on balance, the Proposed Amendments should
be granted. While the amendments change some of the matters in controversy
they are not so radical as to amount to a new and different case. Further,
these issues have been on the periphery given the prior proceedings under the Regulations
between these parties.
[35]
The Proposed Amendments have not caused Apotex
to pursue a course of action that cannot be altered save and except for a
consideration of the Start Date Issue considered in greater detail below.
Apotex criticizes Pfizer for the timeliness of this motion and for bringing it after
the hearing of the bifurcation motion. Pfizer knew about all of the issues
that form the Proposed Amendments well prior to the argument of the bifurcation
motion. However, Pfizer has changed counsel and these concerns of Apotex can
be addressed by way of remedy. This is particularly so since these Proposed
Amendments affect the expeditious determination of the Start Date Issue.
[36]
In my view, the interests of justice and any
prejudice can be compensated by way of remedy.
Conclusion
[37]
I am in substantial agreement with the position
of Apotex regarding the impact of the Proposed Amendments on the Bifurcation
Order. Without directly seeking a variation of the Bifurcation Order, Pfizer
is indirectly amending the Bifurcation Order. All of these Proposed Amendments
expand significantly the scope of the Start Date Issue and make it virtually
impossible for the Start Date Issue to be determined as originally contemplated
when Pfizer sought and obtained the Bifurcation Order.
[38]
Notably, Pfizer in its submissions on the
bifurcation motion argued, inter alia, that “an early determination of
the Start Date Issue has the potential to lead to significant savings of time
and expense for both parties and for the Court” [para. 90] and that the
determination of the Start Date Issue “is likely to lead to fewer interlocutory
disputes between the parties, thereby decreasing the time to trial” [para.
108].
[39]
The latter point already rings hollow. The
number of interlocutory motions is increasing. A production motion was brought
by Pfizer in conjunction with this motion. That motion was brought
notwithstanding that on the bifurcation motion it was asserted in Pfizer’s
written representations that the parties had exchanged affidavits of documents
and productions. The production now requested of Apotex relates primarily to
the Proposed Amendments. That motion was not dealt with on the merits pending
the outcome of this motion.
[40]
Next, Apotex advised at the hearing of this
motion that it seeks to bring its own production motion because Pfizer did not
meet a date in a scheduling order for the production of financial data.
Correspondence sent to the Court subsequent to the hearing of this motion underscores
vividly that these parties are still not in agreement on production and that
the Court’s intervention will be required. All of these interlocutory steps
not only have eliminated the Start Date Issue trial dates but further
interlocutory proceedings may very well jeopardize the actual trial dates.
[41]
Given the timeframes and the ongoing sparring of
the parties over production, I have no confidence that the Start Date Issue can
be ready for mid-2015 given the Proposed Amendments and, more importantly, the
penchant for these parties to litigate every single issue to the Nth degree. As
noted, the Court has recently received recent correspondence from each side
relating to the other sides failure to produce relevant documents.
[42]
Further, as Case Management Judge, I am reminded,
virtually on every case conference and motion, that this is the “biggest”
section 8 case or that there is the prospect of a billion dollar plus damage award.
Cost-saving, as contemplated by Rule 3, is simply not a realistic objective in
this case. There is nothing in this case that raises an earth-shattering issue
which would fundamentally affect society or even big pharma litigation
generally. It is simply about money and the number of zeros on the damage award
to either one of two very sophisticated entities. This case will be decided on
its own unique facts when the trial commences on April 4, 2016.
[43]
Thus, the Proposed Amendments are granted and the
Bifurcation Order relating to the Start Date Issue is vacated. The parties
shall be ready for trial commencing April 4, 2016 on ALL issues. It is always
in the discretion of the trial judge in the conduct of the trial to determine
which issue(s) and in which order they will proceed. To that end, and given
the propensity for these parties to spar over everything, I also have no
confidence that a reasonable schedule can be established between the parties in
a timely way to have this matter ready for trial. Thus, it is necessary to
unilaterally and arbitrarily impose timelines and restrictions on the conduct
of this litigation to ensure the trial commences on time.
[44]
In all, the Court’s expectation with respect to
the Start Date Issue was, as stated in the Reasons for the Bifurcation Order:
. . . However, in my view, the bifurcation of
an issue need not inexorably lead to the resolution of the litigation in its
entirety, it is sufficient that if, on a balance of probabilities, the
determination of an issue will lead to a shorter trial, a more focused
discovery, contained production and less expert evidence. Such is the
expectation in this case if the Start Date Issue is first determined.
[2014 FC 159 at para. 47]
[45]
And so it goes, these best laid plans have gone
completely awry.
SCHEDULE A
Proposed Amendments to Pfizer’s Further
Fresh as Amended Statement of Defence and
Counterclaim dated April 25, 2012 (paras. 10-17, 19-21 and 23-25)
Prior
Proceedings between the Parties Under the Regulations
10. Apotex
first served a Notice of Allegation dated November 18, 2005 relating to
amorphous atorvastatin on November 21, 2005. In response to this Notice of
Allegation, Pfizer Canada Inc. commenced an application bearing court file no.
T-16-06.
11. On
January 2, 2008, the application in court file no. T-16-06 was dismissed.
12. In
September 2006, Apotex served Notices of Allegation alleging
non-infringement of additional patents other than Canadian Patent
2,021,546 (the "Additional Patents") in September, 2006pertaining
to crystal forms of atorvastatin, inter alia (the "September
2006 NOAs"). TheWhile the September 2006 NOAs stated that
Apotex had filed an abbreviated drug submission (the "First ApotexAmorphous
ANDS") to the Minister of Health for its products containing anhydrous
amorphous atorvastatin hemicalcium (the "First Apotex Product"), Apotex
had not in fact filed an ANDS and did not include the requisite certification
with its material. The factual basis for the allegations of
non-infringement was that the First Apotex Product was amorphous and did not
contain any of the crystal forms claimed in the Additional Patents.
13. In
February 2009, Apotex served additionalfurther Notices of Allegation
alleging non-infringement of the Additional Patents (the "February 2009
NOAs"). TheWhile the February 2009 NOAs stated that Apotex
had madefiled an abbreviated new drug submission to the
Minister of Health on July 9, 2008 (the "Second Apotex
ANDS"). The Second Apotex ANDS was for a new, the submission was in
fact a supplemental abbreviated new drug submission (the “PGS SANDS”) for a
change in drug substance and formulation of atorvastatindrug
product, namely, atorvastatin calcium in the form of propylene glycol
solvate (the “Second Apotex Product"). The factual basis for the
allegations of non-infringement was that the Second Apotex Product did not
contain any of the crystal forms claimed in the Additional Patents. Apotex
elected to pursue the Second Apotex Product by means of a supplemental
abbreviated new drug submission (and not a fresh abbreviated new drug
submission) and, as a result, elected to change its formulation and drug
substance from the Amorphous ANDS to the PGS SANDS.
14. The
proceedings arising fromIn relation to the September 2006 NOAs, Pfizer
Canada Inc. and Warner Lambert Company commenced two applications: Court File
Nos. T-1995-06 and T-2145-06 (which was later consolidated with T-1995-06)
(these proceedings, together with Court File No. T-16-06, are hereinafter
referred to as the “2006 Proceedings”). In the 2006 Proceedings, Pfizer alleged
that the September 2006 NOAs were not properly notices of allegation and had no
legal effect under the Regulations. The 2006 Proceedings in relation to the
September 2006 NOAs were discontinued between May 19, 2010 and June 10, 2010 and
never decided on their merits.
15. The
proceedings arising fromIn relation to the February 2009 NOAs, Pfizer
Canada Inc. and Warner Lambert Company commenced two applications: Court File
Nos. T-579-09 and T-580-09 (the “2009 Proceedings”). The 2009 Proceedings were
discontinued on May 20, 2010. Apotex elected not to pursue a section 8 claim
in respect of the 2009 Proceedings.
16. On
May 19, 2010, Apotex received Notices of Compliance in respect of both
the First and Second Apotex Products on May 19, 2010. The Notices of
Compliance approve products containing two different medicinal ingredients,
corresponding with the two Apotex Products.provide authorization for
drug identification numbers solely related to the Second Apotex Product. Apotex
submitted a single product monograph for both the Amorphous ANDS and the PGS
SANDS which made reference only to the Second Apotex Product. Apotex does not
have a product monograph nor a set of drug identification numbers which would
permit Apotex to sell the First Apotex Product. Apotex has never been in a
position to sell the First Apotex Product.
17. Apotex
began manufacturing, using, offering for sale and/or selling Apo-Atorvastatin
on or about May 19, 2010. Apotex does not sell and has never sold the
First Apotex Product.
Apotex’s Claim
19. In
its amended statement of claim ("Claim"), Apotex claims entitlement
to section 8 damages from May 15, 2007 until May 19, 2010. Apotex has
not provided any facts in its Claim to substantiate thisits proposed
start date. In particular, Apotex has failed to:
(a) provide a date
certified by the Minister on which a notice of compliance for either the First
or Second Apotex Products would have been issued ("the relevant
date");
(b) identify which
of either the First or Second Apotex Products it alleges was allegedly
approvable on the relevantits proposed start date;
(c) confirm that
the product it alleges was approvable on the relevantits proposed
start date is the product it is currently marketing in Canada as Apo-Atorvastatin.
20. The
Defendants deny that either the First or Second Apotex Products was approvable
on May 15, 2007 and puts Apotex to the strict proof thereof.
21. Further,
the Defendants state that the only product marketed as Apo-Atorvastatin is the
Second Apotex Product, for which Apotex did not file an ANDSSANDS
until July 2008, and in respect of which it did not serve an NOANOAs
until February 19, 2009.
Delay in the The Filing of an ANDSSANDS and Service of NOAs
23. The
Defendants deny that May 15, 2007 represents a relevant, or any other
date, is an
appropriate
“start date” for Apotex's Claim, becauseas the product currently
marketed as Apo-Atorvastatin is the Second Apotex Product, andwhich was
not approvable on May 15, 2007. and was not the subject of the 2006
Proceedings. Apotex cannot claim damages it did not suffer arising from May 15,
2007 since Apotex never served proper notices of allegation and never properly
engaged the Regulations in respect of the 2006 Proceedings.
24. Apotex
chose to delay the filing of the Second Apotex ANDS until July 2008, and chose
to further delay the service of NOAs in respect of the SecondFurther, it
is clear from its dealings with Health Canada that Apotex elected to switch its
Amorphous ANDS and the First Apotex Product relating to the 2006 Proceedings to
the PGS SANDS, to pursue a single set of drug identification numbers and to
commercialize the Second Apotex Product relating to the 2009 Proceedings. As a
result of the doctrine of election, at law or in equity, Apotex is precluded
from pursuing any claims in relation to or in respect of the Amorphous ANDS,
the First Apotex Product untilor the following year2006
Proceedings. The Defendants state that these choices disentitle Apotex to
any claim for damages.
25. In
the alternative, if the Second Apotex Product was approvable on May 15, 2007,
the Defendants assert that Apotex chose to continue to pursue the 2006
Proceedings and to delay the service of NOAs in respect of the Second
Apotex Product until nearly two years later, namely February 19, 2009. The
Defendants further assert that Apotex's choice to delay filing of its ANDS and or
SANDS and/or the service of NOAs in respect of its productthe
Second Apotex Product disentitles it to any claim for damages during this
period.
Email this Content