Date: 20081230
Dockets: T-371-08
T-372-08
T-373-08
Citation: 2008
FC 537
Toronto, Ontario, December 30, 2008
PRESENT: Kevin R. Aalto, Esquire, Prothonotary
BETWEEN:
File
No. T-371-08
ASTRAZENECA CANADA INC. and
ASTRAZENECA AKTIEBOLAG
Applicants
and
APOTEX INC. and THE MINISTER
OF HEALTH
Respondents
File No. T-372-08
ASTRAZENECA CANADA INC. and
ASTRAZENECA AB
Applicants
and
APOTEX INC. and THE MINISTER
OF HEALTH
Respondents
File No. T-373-08
ASTRAZENECA CANADA INC. and
ASTRAZENECA AB
Applicants
and
APOTEX INC. and THE MINISTER
OF HEALTH
Respondents
AMENDED REASONS FOR ORDER AND ORDER
[1]
These
cases are all Applications commenced under the Patented Medicine (Notice of
Compliance) Regulations. They deal with various patents and have
essentially the same parties except for file T-377-08 in which Takeda
Pharmaceutical Company Limited (“Takeda”) as patentee, is named as a Respondent
in addition to the other Respondents, Apotex and the Minister. All seven
Applications are being case managed together and will ultimately be heard
together. They all involve drugs known as omeprazole and esomeprazole and
there are different patents for these drugs referred to in each of the
Applications.
[2]
The
Notices of Motion seek virtually identical relief. First, an order is sought
that the Applications proceed as specially managed proceedings. There was no
issue concerning this head of relief, nor could there be, as pursuant to the
Practice Direction issued by the Chief Justice on December 7, 2007 all
new NOC proceedings are to be continued as specially managed proceedings.
Thus, the same case management judge was appointed for all of the Applications
by order of the Chief Justice made April 7, 2008. Second, attached to each
motion was a proposed timetable for completing the steps in the Applications.
This, too, was not the subject of much debate and the proposed timetables set
out in Appendix A to each of the Notices of Motion are approved subject to any
changes necessary resulting from this ruling.
[3]
The relief
requested which was hotly debated was whether the Respondent, Apotex Inc.
(“Apotex”), should be required to file its evidence on invalidity before the
service of the Applicants’ evidence. This requested reversal of filing
evidence applies to only three of the seven Applications in which the validity
of the patent is raised as an issue by Apotex. Counsel for the Applicants
relies in large part on the Practice Direction to support the requested
reversal of the evidence.
[4]
The
Practice Direction provides, in part, as follows:
A judge or prothonotary will be assigned
as case management judge to each newly instituted NOC proceeding. The case
management judge or Prothonotary will convene a conference with counsel for the
parties shortly after all parties have appeared in the proceeding or the time
for appearance has expired. At that conference, counsel for the parties will
be expected to address:
1. whether it is
appropriate to reverse the order in which some or all of evidence is submitted, that
is, the respondent (generic) would file some or all of its evidence first and
the applicant (brand) file some or all its evidence in response;
[5]
It is to
be noted that one fundamental aspect of the Practice Direction is to
incorporate the general principle of both Rules 3 and 385 of the Federal
Courts Rules into the case management of NOC proceedings. That principle
is that NOC proceedings are to be case managed “to ensure the just, most
expeditious and least expensive disposition of the proceeding”.
[6]
Thus, in
the specific circumstances of these seven applications, the issue is whether it
is “appropriate” that Apotex file its evidence first on the issue of validity
in three of the seven Applications. It should be noted that Counsel for the
Applicants argues that two of the three patents in issue in the three
applications have not been litigated before while there has been litigation
involving the remaining one and as well as, apparently, the four other
Applications where the reversal of filing evidence is not sought.
[7]
While the
Practice Direction launches a new era of case management for NOC proceedings to
ensure they move to a hearing in a just and timely manner, it is my view that
reversing the filing of evidence in this series of Applications will not
achieve that result. Thus, the ordinary approach should be followed and the
Applicants will file their evidence first in accordance with the schedule the
parties have agreed to.
[8]
In
reaching this conclusion, I have carefully considered the submissions of
counsel for the Applicants and the objectives of the Practice Direction.
Counsel for the Applicants argues that reversing the evidence will meet the
policy objectives of the Practice Direction by not only refining the issues but
also reducing the volume of evidence thus ensuring the “just, most expeditious
and least expensive” determination of these Applications. In particular,
counsel points to the fact that there are 60 items of prior art cited by Apotex
in Schedule E to the Notices of Allegation (“NOA”). Counsel argues that the
Applicants are compelled to deal with all of them as there is no indication
whether all or any of these will be the subject of Apotex’ evidence. Thus, it
is argued, it makes good sense to reverse the evidence as this will result in
cost saving and be more expeditious. However, if it were only three cases and
not seven this argument would be more persuasive. Here, the NOA’S are very
detailed and outline with great specificity exactly what the issues are and
what evidence supports Apotex’ invalidity argument. It can hardly be said that
given the history of litigation and the detailed information contained in the
NOA’s that the Applicants do not know nor have reasonably detailed insight into
the position of Apotex on invalidity. Further, in reviewing Schedule E it is
apparent that many of the references to monographs and texts is limited to but
a few pages of each reference. Thus, while the 60 items, at first blush, may
seem like a large number of items to respond to, the actual pages referred to
do not appear to be that significant especially where there has been a prior
litigation history involving these drugs although perhaps not specifically to
two of the patents.
[9]
The NOC
proceeding is a flawed procedure in that a party with the onus on a particular
issue does not have to file their evidence first. This approach to some extent
encourages parties to engage in a “cat and mouse” game of what precise grounds
and evidence they rely upon in support of their respective positions until the
hearing. The process does little to narrow the issues.
[10]
One
approach to clarifying the positions at an early stage is to provide for the
reversing of the filing of evidence on validity issues. This approach meets
the objective of moving the matter forward in a more cost effective and
expeditious way. It is being ordered more frequently notwithstanding that it
removes a “tactical advantage” from the generic that is advancing the position
of invalidity of the patent. However, to do so there must be a reasonable prospect
that there will be a savings in time and expense [see, for example, Purdue
Pharma v. Pharmascience Inc., 2007 FC 1196]. In my view of this
specific series of cases, no such savings in time and expense will be achieved
by requiring Apotex to lead its evidence first on validity. Indeed, as these
cases will be heard by the same Judge, there is a real possibility of confusion
developing during the course of the hearing over who has the onus on certain
issues. This group of NOC proceedings is complex enough without adding further
complications and possible confusion over the reversal of evidence in three of
them.
[11]
If the
Applicants are prejudiced by virtue of having to lead their evidence first and
do not, for example, lead evidence on an unexpected point that is raised by
Apotex, there is ample flexibility within the case management regime as
contemplated by the Practice Direction, to counteract such prejudice by, for
example, allowing the filing of reply evidence. Thus, the objectives of “just,
least expensive, most expeditious” can be easily met within the case management
regime. In the circumstances, the motion will be dismissed insofar as it
relates to the reversal of the filing of evidence.
[12]
There are
three further matters that arose during argument that require comment.
First, the parties advised that they are refining the form
of a draft protective order and will forward a draft order to the Court for the
Court’s approval.
[13]
Second, as
these seven Applications are being case managed together, except for filings
which relate specifically to each case individually, there is no need to
duplicate materials seven times. For issues that are common to all of the
Applications it is sufficient that a style of cause incorporating all of the
styles of cause be used.
[14]
Third,
prior to the hearing of these motions, an issue arose concerning the form of
Notice
of Appearance filed by Takeda. In its Notice of Appearance,
Takeda altered the form prescribed by the Rules by substituting the word
“participate” for the word “oppose”. This Court has recently held that such a
change to the Notice of Appearance is improper and has stuck it out [see Schering
Plough Canada Inc. et al v. Pharmascience Inc et al, 2008 FC 359]. The
Schering-Plough decision was issued after Takeda had filed its Notice of
Appearance in file T-377-08. In light of this decision, Apotex brought a
motion to strike the Notice of Appearance of Takeda. As the Schering-Plough
decision is now under appeal, I issued a direction that until the appeal is
heard and disposed of, Apotex’ motion is adjourned sine die as is the
counter motion brought by Takeda seeking to apply, inter alia,
the curative provisions of Rules 55, 56 and 59 (b).
[15]
In the
circumstances, to ensure these applications all move forward in a timely way,
the parties in T-377-08 will follow the timeline in Schedule A to the Notice of
Motion in file T-377-08 in which Takeda is named as Respondent/Patentee. One
of the purposes of the Practice Direction is to provide the flexibility to ensure
that NOC proceedings move fairly and efficiently to a hearing within the strict
timeline of two years contained in the PM(NOC) Regulations. Case
management provides the opportunity for the Court to react quickly to issues as
they arise and to provide the necessary directions to carry out the purposes of
the Practice Direction. As I noted in a prior Direction issued in these files:
Within the case management regime there
is much flexibility in responding to the specific needs of a case or group of
cases that may be outside the traditional jurisprudence or practice of the
Court. Thus, counsel should not necessarily feel constrained by the
jurisprudence or past practices in dealing with procedural issues. Counsel are
encouraged to look for innovative and common sense approaches to solving issues
without unduly dwelling on procedural precedent.
[16]
Thus,
until the issue of the form of the Notice of Appearance is dealt with by the
Federal Court of Appeal, these matters will continue together in accordance with
the timelines proposed. The Court will provide the appropriate directions
concerning the status of Takeda in response to the decision of the Federal
Court of Appeal and any directions the Federal Court of Appeal may give
concerning the status of a patentee named as a respondent in an application
where it will not be opposing the applicant.
ORDER
THIS COURT ORDERS that
1.
The
timetables attached as Schedule “A” to the Notices of Motion in files T-373-08,
T-376-08, and T-378-08
are hereby approved.
2.
The
timetables attached as Schedule “A” to the Notices of Motion in files T-371-08,
T-372-08 and T-374-08 are
hereby approved subject to an amendment to remove the reference to Apotex
filing first on the issue of invalidity so that these timetables track the same
timetables as the Applications referred to in paragraph 1 of this Order.
3.
The
timetable attached as Schedule “A” to the Notice of Motion in file T-377-08 is
hereby
approved subject to further
review of the status of Takeda Pharmaceutical Company Limited as a
Respondent/Patentee following the Federal Court of Appeal’s disposition of the
appeal in Schering-Plough et al v. Pharmascience Inc. et
al.
4.
In the
event that any of the times stipulated in the timetables require amendment,
such
amendment shall be sought by
the party by arranging a case conference with the Court which will issue the
appropriate directions without a party being required to bring a motion.
5.
The motion
brought by Apotex Inc. to strike the Notice of Appearance of Takeda
Pharmaceutical Company Limited and the motion brought by Takeda Pharmaceutical
Company Limited granting leave to vary the form of their Notice of Appearance
as filed are both adjourned sine die pending the decision of the Federal
Court of Appeal in Schering-Plough et al. v. Pharmascience Inc. et al.
6.
Counsel
for the Applicant(s) shall arrange a case conference with the Court following
the filing of the Respondent’s evidence in order to review the status of the
Applications.
7.
No party
shall serve any motion in any of these Applications unless and until a case
conference has been convened
to review the issue(s) which will be the subject of the proposed motion.
8.
Any party
may, at any time, request a case conference with the Court to review any issue
that arises in the conduct of these
Applications.
“Kevin R. Aalto”
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