JAZZ PHARMACEUTICALS, INC. v. ROXANE LABORATORIES, INC.
Filing
282
OPINION. Signed by Magistrate Judge Joseph A. Dickson on 12/30/2013. (nr, )
THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
DRAFT NOT FOR PUBLICATION
Civil Action No.:
2:10-CV-06108-ES-JAD
JAZZ PHARMACEUTICALS, INC.,
Plaintiff,
OPINION ON
DEFENDANT' S MOTION
TO AMEND ITS ANSWER
v.
ROXANE LABORATORIES, INC.,
[ECF No. 218]
Defendant.
I.
INTRODUCTION
The
instant action is a
patent-infringement case
Plaintiff Jazz Pharmaceuticals,
Roxane
patents
Laboratories,
after
Application
("FDA")
( "ANDA'')
("Jazz")
for
( "Roxane")
Inc.
Roxane's
Inc.
filing
of
with the U.S.
an
in which
is suing Defendant
infringing
Abbreviated
various
New
Drug
Food and Drug Administration
seeking the FDA's approval to market and sell a generic
version of Jazz's Xyrem® drug.
Pending before this Court is Defendant Roxane Laboratories,
Inc.'s
("Roxane")
Motion to Amend its Answer to include two
additional affirmative defenses:
hands;
Jazz
considered
has
the
opposed
parties'
the
(2)
prosecution laches and unclean
instant
submissions
motion.
and
for
The
the
Court
has
reasons
set
forth below defendant's motion to amend is hereby Granted.
1
II.
RELEVANT FACTUAL AND PROCEDURAL HISTORY
On or about July 8, 2010, Roxane filed an ANDA with the FDA
seeking
approval
to
market
and
distribute
a
generic
sodium
oxybate product stated to be the bioequivalent to Jazz's XYRE~
product.
(ECF No.
Amend,
at p.
at
11).
p.
initiated
6;
Roxane's Brief In Support of Motion to
see also ECF No.
In
five
219,
response
222,
Roxane's
separate
( 5)
to
actions
Jazz's Opposition Brief,
ANDA
application,
which
consolidated into the above captioned matter.
were
Jazz
ultimately
(See ECF No.
222,
at p. 11; see also ECF No. 214, April 12, 2013 Opinion and Order
Granting Jazz's Motion to Consolidate).
filed
on
November
( "Cmpl t. ") ) .
The
consolidated under
12, 2013.
22,
2010
(see
aforementioned
the
The instant action was
ECF No.
five
1,
(5)
above-captioned docket
Jazz's
Complaint
actions
number
were
on April
(See ECF No. 214 1 ) .
On February 7,
2011,
an initial scheduling conference was
held in the instant matter.
Entry from February 7, 2011).
(ECF No. 12, Letter Order) ;
(Minute
During that conference, the Court
reserved on setting a pretrial scheduling order to permit Jazz
1
The Court's Order and Opinion dated April 12, 2013 [ECF No.
214], consolidated the suits docketed under Civil Action Nos.
10-6108; 12-6761 and 12-7459 under the earliest filed action,
Civil Action No. 10-6108. It also should be noted that prior to
the Court's April 12, 2013 Opinion and Order, two prior actions
(Civil Action Nos.
11-660
and 11-2523 had already been
consolidated with the 10-6108 action, thereby accounting for the
five (5) actions that are substantively contained in the 10-6108
action. (See ECF No. 222 at. p. 6, FN 3).
2
to obtain information from a third party it needed in order to
submit
the
its
Due
Infringement Contentions.
parties,
a
formal
scheduling
(ECF
No.
order was
60,
not
Pretrial
between
entered until
Scheduling
Order
September
1,
("PSO")).
This initial PSO set a deadline of December 5, 2011,
as
2011.
to disputes
the deadline
for
the parties to amend the pleadings and/or
On July 28,
add parties.
( Id.) .
to
Cathy L.
the
were
Hon.
filed
on
Waldor,
December
5,
2011, this case was reassigned
U.S.M.J.
2011,
Opening Markman
expert
Markman issues closed on January 5,
discovery
2012,
briefs
regarding
and Markman briefing
closed on February 3, 2012 with the filing of responsive Markman
(PSO at
papers.
After
various
~~
7, 9, and 10).
engaging
discovery
irt
extensive
related
motion
issues
on
December
instant action was
transferred to the
U.S.M.J.
15,
On
consolidate,
April
2013,
after
for
(ECF No. 215, Scheduling Order, at
2013
Scheduling
motion on April 26,
Amend).
Roxane
Jazz
Hon.
10,
regarding
2012,
Steven C.
granting
Jazz's
the
Mannion,
motion
to
the Court entered an Amended Scheduling Order that
included a briefing schedule
15,
practice
Order,
2013.
filed a
the
~
Roxane
instant motion to amend.
timely
(See ECF No.
timely Opposition
filed a timely Reply.
Pursuant to the April
7).
218,
the
instant
Roxane' s Motion to
[See
(See ECF No.
3
filed
ECF No.
224,
222]
Roxane' s
and
Reply
Brief). On September 9,
2013,
the instant matter was reassigned
to the undersigned Magistrate Judge.
III. DISCUSSION
B.
Rule lS{a)
Rule 15 (a)
of the Federal Rules of Civil Procedure,
which
governs amendments to pleadings, provides, in relevant part:
A party
(1) Amending as a Matter of Course.
may amend its pleading once as a matter of
course within:
(A) 21 days after serving it, or
(B)
if
the
responsive
pleading
pleading
is
is
one
to
required,
which
21
a
days
after service of a responsive pleading or 21
days
after
12(b),
service
of
a
motion
under
Rule
(e), or (f), whichever is earlier.
(2) Other Amendments.
In all other cases, a
party may amend its pleading only with the
opposing
party's
court's leave.
written
consent
or
the
The court should freely give
leave when justice so requires.
Fed.
R.
Civ.
amendments
in
P.
15 (a).
light
of
The federal
the
rules liberally allow for
"principle
4
that
the
purpose
of
pleading is to facilitate a proper decision on the merits," and
provide
that
if
the
underlying
facts
might be a proper subject of relief,
relied
by
a
party
that party should have the
opportunity to test its claims on the merits.
371 U.S. 178, 182 (1962)
upon
Foman v.
Davis,
(internal quotations marks omitted).
Under Rule 15, the decision to permit an amendment rests in
the
See id.;
sound discretion of the Court.
Heyl
Paterson
&
Int'l Inc. v. F.D. Rich Housing of V.I., Inc., 663 F.2d 419,
The United States Supreme Court has stated that
(3d Cir. 1981).
leave
to
undue
delay;
amend under
(2)
prejudice; or (4)
Rule
bad
15 may be
faith
or
denied
dilatory
futility of amendment.
in
cases
motive;
of:
(3)
( 1)
undue
See Foman, 371 U.S. at
182; see also Arthur v. Maersk, Inc., 434 F.3d 196, 204
2006)
425
(3d Cir.
(stating that "[1] eave to amend must generally be granted
unless
equitable
considerations
Stated differently,
absent
render
it
otherwise
substantial prejudice,
unjust").
an amendment
should be allowed under Rule 15 unless denial can be grounded in
bad faith or dilatory motive,
repeated failure
allowed,
or
truly undue or unexplained delay,
to cure deficiencies by amendments previously
futility
of
the
proposed
amendment ( s) .
Long
v.
on
the
Wilson, 393 F.3d 390, 400 (3d Cir. 2004).
Jazz
opposes
Roxane's
motion
to
amend
primarily
basis of the futility of the two defenses that Roxane seeks to
add stating that "the legal theories it asserts have no basis in
5
law and directly contradict the rights accorded to an inventor
under United States patent law"
(ECF No.
222,
Jazz's Opposition
Brief, at p. 6). Jazz also argues, less vigorously, that because
Roxane
could
have
asserted
the
two
defenses
years
ago,
the
instant motion to amend is untimely. (Id.).
a. Undue Delay & Prejudice
Regarding undue delay,
the Court of Appeals for the Third
Circuit has stated:
The passage of time, without more, does not
require that a motion to amend a complaint
be denied; however, at some point, the delay
will become "undue," placing an unwarranted
burden
on
the
court,
or
will
become
"prejudicial," placing an unfair burden on
the opposing party. The question of undue
delay, as well as the question of bad faith,
requires that we focus on the plaintiffs'
motives for not amending their complaint to
assert this claim earlier; the issue of
prejudice requires that we focus on the
effect on the defendants.
Adams v. Gould,
Inc.,
citations omitted).
(3d
Cir.
2001)
739 F.2d 858,
868
(3d Cir.1984)
(internal
See also Cureton v. NCAA, 252 F.3d 267, 273
(stating
that
"the
question
of
undue
delay
requires that we focus on the movant's reasons for not amending
sooner").
Furthermore,
under
Rule
15,
leave
to
amend
is
generally granted where, during the course of discovery, a party
discovers
"new
CIV.A.90-1417,
evidence."
1990 WL
See,
153960,
at
6
~'
*4
Slade
(D.N.J.
v.
Fauver,
Sept.
24,
No.
1990)
(granting leave to amend where new claims were discovered and
"proposed amendments had no dilatory purpose and no significant
discovery
or
Kronfeld v.
(D.N.J.
1986)
pretrial
First
preparation
had
Jersey Nat' 1 Bank,
taken
638
F.
place
Supp.
.");
1454,
1460
(granting motion to amend upon discovery of new
evidence where it did "not appear that the incidental prejudice
is an insufficient ground on which to deny leave to amend, undue
delay or undue prejudice support denial.
To
determine
if
a
party would be
unduly prejudiced,
the
Court considers whether the amendment will result in additional
discovery or costs,
theories,
or the need to defend against new facts or
Cureton,
252
F. 3d at 273,
or an inability to obtain
and present evidence that the non-movant would have offered had
the amendment been timely.
652
(3d Cir.
undue
proposed
the
pleading
Robinson,
886 F.2d 644,
As the Long court observed,
1989).
prejudice,
Bechtel v.
non-moving
would
"(i)
party
require
the
show
opponent
significant
additional
resources
prepare
trial;
significantly delay the
for
the dispute;
or
( ii)
(iii)
prevent the
to
must
conduct
[non-movant]
timely action in another jurisdiction."
to establish
Long,
that
to
expend
discovery
and
resolution of
from bringing a
393 F.3d at 400
(adopting the standard of Block v. First Blood Assocs.,
34 4 ( 2d Cir. 1993) ) (internal quotation marks omitted) .
7
the
988 F.2d
As an initial point,
this Court rejects Jazz's contention
that Roxane's filing of the instant motion to amend is untimely.
The operative Scheduling Order in this case set the deadline for
Roxane
2013.
to
file
(See
motion
on
its motion
ECF No.
April
215,
26,
to
at
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