SHIRE LLC v. COREPHARMA, LLC
Filing
81
MEMORANDUM OPINION AND ORDER re. 62 ; the parties' Discovery Confidentiality Order does not bar Shire from reviewing Amerigen's confidential information, including its ANDA, to determine if the '768 Patent was infringed. Signed by Magistrate Judge Joel Schneider on 7/24/2015. (drw)
[Doc. No. 62]
THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
CAMDEN VICINAGE
SHIRE LLC,
:
:
Plaintiff,
:
:
v.
:
:
COREPHARMA, LLC,
:
:
Defendant.
:
______________________________:
SHIRE LLC,
:
:
Plaintiff,
:
:
v.
:
:
AMERIGEN PHARMACEUTICALS LTD, :
:
Defendant.
:
______________________________:
SHIRE LLC,
:
:
Plaintiff,
:
:
v.
:
:
PAR PHARMACEUTICAL, INC.,
:
et al.,
:
:
Defendants.
:
______________________________:
Consolidated
Civil No. 14-5694 (RMB/JS)
Civil No. 14-6095 (RMB/JS)
Civil No. 15-1454 (RMB/JS)
MEMORANDUM OPINION AND ORDER
Background
This Memorandum Opinion and Order is a direct follow up to
the Court’s May 27, 2015 Memorandum and Order [Doc. No. 59]
1
addressing a dispute between Shire and Amerigen involving their
Discovery
Confidentiality
Order
(“DCO”)
in
this
patent
infringement case. (Hereinafter referred to as the “Order”). Prior
to entering the Order, Shire and Amerigen sought the Court’s
interpretation of paragraph 5.3 of New Jersey’s standard DCO. The
parties disputed whether under paragraph 5.3 Shire could use
Amerigen’s
confidential
information
produced
in
discovery,
specifically its Abbreviated New Drug Application (“ANDA”), to
determine if Amerigen infringed U.S. Patent No. 6,913,768 (“the
‘768 Patent”), a Shire patent not named in the complaint. Amerigen
sought to amend the DCO to clarify that confidential information
exchanged during discovery may only be used with respect to the
patents named in the complaint, U.S. Patent Nos. RE42,096 (the
‘096 Patent) and RE41,148 (the ‘148 Patent). 1
In other words,
Amerigen wanted to bar Shire from reviewing its ANDA to determine
if the ‘768 patent was infringed.
On May 27, 2015, the Court entered its Order denying without
prejudice Amerigen’s motion to amend the DCO. The Court determined
that:
[A] party may use confidential information to add
a new patent to a case, provided that the new patent
is sufficiently related to the pleaded claims and
defenses that an amendment would be permitted under
1
At the present time, this action addresses whether
Amerigen’s proposed generic version of Adderall XR® infringes
certain claims within Shire’s ‘096 and ‘148 Patents. For additional
background, see the Court’s May 27, 2015 Order.
2
the applicable Rules of Civil Procedure. As a
result, Shire may only use Amerigen’s confidential
information to determine whether the ‘768 Patent
should be added to the complaint if the ‘768 Patent
is sufficiently related to the patents-in-suit so
that an amendment would be permitted under Rule 15.
Order
at
17.
The
Court’s
ruling
derived
from
the
fact
that
paragraph 3 of the DCO provides that confidential information may
only be used for the prosecution or defense of “this action.” The
Court reasoned that “[t]he term limiting the use of confidential
information ‘to this action’ is broader than Amerigen’s proposal
seeking to limit the use to only the ‘claims and defenses’ already
asserted in the complaint.” Id. at 7. The Court’s ruling made it
clear,
however,
that
Shire’s
use
of
Amerigen’s
confidential
information is not unlimited. Id. at 15. As noted, Shire may use
Amerigen’s confidential information to determine if a new patent
may be added to the case only if the new patent is sufficiently
related to the patents named in the complaint that joinder of the
new patent would be permitted under Fed. R. Civ. P. 15.
The
difficulty the Court faces is that “there appears to be no clearcut standard for determining whether patents are ‘related’.” Id.
at 17.
Further, as the Court previously noted, “[t]he precise
standard the Court must use to determine if Shire’s new patent
[‘768] is sufficiently related to the patents-in-suit is not
consistently set forth in the case law.” Id. at 15.
3
Through no fault of the parties, the Court noted in its Order
that sufficient information was not provided for the Court to
determine whether the ‘768 Patent was “sufficiently related” to
the
patents-in-suit.
In
response,
the
parties
submitted
supplemental letter briefs which are now before the Court. Not
unexpectedly, Shire argues the ‘768 Patent is related to the
patents in suit and Amerigen claims it is not related. For the
reasons to be discussed, the Court finds the ‘768 Patent is
sufficiently related to the patents-in-suit so that an amendment
would
be
Amerigen’s
permitted
under
confidential
Rule
15. 2
information,
Thus,
Shire
including
its
may
review
ANDA,
to
determine if the ‘768 Patent was infringed.
In its letter brief Shire argues that the ‘768 Patent is
sufficiently related to the ‘096 and ‘148 Patents-in-suit for three
(3) reasons: (1) the claims and specification of the ‘768 Patent
refer extensively to Adderall XR®; (2) all three patents relate to
components
of
pharmaceutical
formulations
suitable
for
oral
administration and delivery of amphetamine salts; and (3) the three
listed inventors of the ‘768 Patent are also listed inventors for
2
As the Court stated in its May 27, 2015 Order, the Court’s
analysis focuses on whether the ‘768 Patent is sufficiently related
to the patents-in-suit to permit joinder under Rule 15. In this
context the Court does not need to address undue delay, futility,
etc., which is typically examined in a Rule 15 analysis. See May
27, 2015 Order at 8 n.5.
4
the ‘096 and ‘148 Patents. Due to the relatedness of the three
patents, Shire argues “the validity or infringement analysis ...
would require looking at similar data, references, and testimony
related to drug formulation, release and absorption, and treatment
of ADHD.” July 9, 2015 Letter Brief (“LB”) at 4. Shire also argues
that the relatedness of the three patents is evidenced by its
assertion of the ‘768 Patent in other patent cases involving
generic versions of Adderall XR® and by Amerigen’s discovery
requests for information related to the ‘768 patent in this case.
In contrast to Shire, Amerigen argues that the ‘768 Patent is
unrelated because it is not within the ‘096 or ‘148 family trees
and because it does not share any common patent application with
the patents-in-suit. Amerigen also asserts that the patents are
not related because the ‘768 Patent is not listed in the FDA’s
Orange Book in connection with Adderall XR®. In contrast, Amerigen
points out that the ‘046 and ‘148 Patents-in-suit originated from
the same parent application and both patents are listed in the
Orange
Book
in
connection
with
Adderall
XR®.
Additionally,
Amerigen argues that while the three noted inventors of the ‘768
Patent are also listed inventors on the ‘046 and ‘148 Patents, the
patents
list
five
additional
inventors.
Amerigen
also
distinguishes several of Shire’s specific assertions that the
claims and specification of the three patents are the same or
similar. Amerigen argues that because of the “marked” differences
5
between
the
patents-in-suit
and
the
‘768
Patent,
different
discovery will be needed which will be “highly disruptive” to the
case. June 26, 2015 LB at 4. Amerigen contests that Shire’s
assertion of the ‘768 Patent in previous Adderall XR® cases is
material to the relatedness issue and points out that it only
propounded discovery related to the ‘768 Patent in response to
Shire’s threat of asserting the ‘768 Patent.
Discussion
Based on the record before the Court, the Court finds that
the ‘768 Patent is sufficiently related to the patents-in-suit so
that the ‘768 Patent could be added to the case under Rule 15.
Thus, the effect of the Court’s ruling is that Shire may review
Amerigen’s ANDA to determine if the ‘768 Patent is infringed even
though the ‘768 Patent is not currently named in the complaint.
The
Court
starts
its
analysis
by
emphasizing
that
its
“relatedness” analysis focuses on how the term is used in the
context of Rule 15, not in a strict “patentese” sense. Thus,
Amerigen’s primary argument is not dispositive. See June 26, 2015
LB at 1.
(“In other words, the ‘768 Patent is not a parent,
continuation or divisional of either of the patents-in-suit, nor
does it have any other relationship to those patents from the
perspective of the U.S. Patent and Trademark Office.”)
As discussed, even though the ‘798 Patent is not strictly
related to the ‘046 and ‘148 Patents as that term is technically
6
used, it is still sufficiently related so as to permit joinder
under Rule 15.
The Court recognizes that the Orange Book does not
list the ‘768 Patent for Adderall XR® and that the ‘768 Patent
does not have any patent applications in common with the patentsin-suit. The Court also recognizes that the ‘768 patent has no
familial
relationship
with
the
patents-in-suit.
These
facts,
however, are not dispositive on the issue before the Court. In
order to add a patent to an existing complaint courts do not
require that patents be within the same family tree or part of the
same patent application. Put another way, relatedness in the
current context is not the equivalent of what it means to be
literally related within a patent family tree. This is evidenced
by the fact that some courts only require that a new patent be
“potentially related” or relate “in some way” to the patents-insuit in order to be joined to a case. See Masimo Corp. v. Philips
Electronics N. Am. Corp., C.A. No. 09-80, 2010 WL 1609899, at *1
(D. Del. Apr. 20, 2010); Aten Intern. Co., Ltd v. Emine Technology
Co., Ltd., C.A. No. 09-0843, 2010 WL 1462110, *3–*5 (C.D. Cal.
2010).
The Court finds that the ‘046, ‘148 and ‘768 Patents are
sufficiently related because, inter alia, the ‘768 Patent refers
extensively
components
to
of
Adderall
XR®
pharmaceutical
and
all
three
formulations
7
patents
suitable
relate
for
to
oral
administration and delivery of amphetamine salts. 3 LG Electronics
U.S.A., Inc. v. Whirlpool Corp., C.A. No. 10-311, 2011 WL 4043394,
at *2 (D. Del. 2011)(permitting amendment where all the patents
concerned refrigerator technology). Additionally, the ‘768 Patent
shares the same inventors involved in the patents-in-suit. See
Aten, 2010 WL 1462110, at *4 (finding new patents were sufficiently
related
when
all
the
patents
at
issue
related
to
the
same
technology and had the same inventor). While Amerigen’s specific
distinctions between the patents-in-suit and the ‘768 Patent are
noted (see Amerigen LB 2-3), these arguments do not suggest that
the patents are comprehensively unrelated. See Masimo, 2010 WL
1609899, at *1. In fact, Amerigen does not argue and the Court
does not find that the technology at issue is “totally different.”
Matsushita Elec. Indus. Co., 2007 WL 127997, at *3. Rather, the
Court
finds
that
all
three
patents
concern
the
same
general
technology and claim pharmaceutical formulations suitable for oral
administration and delivery of amphetamine salts.
3
Shire writes, “[h]ere, all three patents claim Pharmaceutical
formulations suitable for oral administration and delivery of
Amphetamine Salts…. [A]ll three patents also recite limitations
directed to release of amphetamine salts and the target amphetamine
blood levels produced by the claimed formulations[.]” July 9, 2015
LB at 4. Shire also writes, “[v]arious claims of the ‘148 and ‘768
Patents are also directed towards the treatment of ADHD with
amphetamine salts, dose proportionally, and the use of certain
excipients.” Id.
8
Even if the Court accepted Amerigen’s argument that “simply
referencing ADHD, a very common disorder, cannot be sufficient to
demonstrate
relatedness,”
Shire
has
demonstrated
much
more.
Amerigen LB at 4. Shire has demonstrated that the ‘768 Patent makes
similar, though not identical claims to the ‘046 and ‘148 Patents.
For
example,
the
Abstract
of
the
’768
Patent
notices
“[a]
pharmaceutical composition compris[ing] a once-a-day sustained
release formulation of at least one amphetamine salt which provides
mean plasma concentration profile aspects in human ADHD patients
which are substantially the same as that provided by Adderall XR®
type pulsatile formulations.” Amerigen argues this overlap is “the
equivalent of arguing that a tire patent and a headlight patent
must be related merely because both can be associated with a car.”
Amerigen LB at 2. The Court disagrees. Although there is variation
among the precise elements recited in the patents’ claims, the
analogy to tires and headlights is not appropriate. Rather, the
Court agrees with Shire that a more appropriate analogy is three
patents directed to methods of producing a particular kind of
headlight. Shire Reply at 2.
The parties agree, and the Court has not found, a case on
point and that the issue before the Court appears to be one of
first impression.
However, the line of cases the Court looks to
for guidance, those addressing when new patent claims may be added
9
to
existing
litigation
under
Rule
15,
support
Shire. 4
In
LG
Electronics U.S.A., 2011 WL 4043394, at *2, Whirlpool opposed LG’s
motion to add new patents to the case because the new claims would
“unnecessarily complicate the litigation.” The court permitted the
amendment finding that all of the patents at issue concerned
refrigerator technology. Id. In particular, the court noted that
one new patent “while not directly comparable to the other patentsin-suit,
was
sufficiently
related
to
the
overall
theme
of
refrigerator technology so as not to warrant a separate lawsuit.”
Id.
Similarly, in Masimo Corp., 2010 WL 1609899, at *1, Masimo
opposed Philips’ motion to assert a new counterclaim because the
new patent was “unrelated to the patents already asserted in th[e]
case.” Masimo also argued that courts reject motions to add new
claims which are not “closely related to the subject matter of the
4
Cases in this district provide limited guidance. In
Osteotech, Inc. v. Regeneration Technologies, Inc., C.A. No. 064249 (FLW), 2008 WL 2036795 (D.N.J. May 9, 2008), the defendant
argued that the addition of the plaintiff’s proposed new patent
claim would improperly expand the scope of the case. The plaintiff,
conversely, contended the two patents concerned "exactly the same
process.” Id. at *1. Without much discussion the court permitted
the amendment and noted the plaintiff’s representation that the
two patents concerned “exactly the same process.” Id. at *2. In
Astrazeneca AB v. Ranbaxy Pharm., Inc., C.A. No. 05-5553 (JAP),
2008 WL 5272018 (D.N.J. Dec. 16, 2008), the defendant argued it
would be prejudiced by the addition of the plaintiff’s proposed
new patent claim. Id. at *3. The court found that no undue
prejudice would result and noted that the proposed new patent claim
involved the “same product at issue” and would not “overly
complicate [the] matter.” Id.
10
original claims.” Id. (citing Dluhos v. Strasberg, C.A. 00–3163
(JCL), 2005 WL 1683696, at *2 n.3 (D.N.J. 2005)). 5 Philips, in
opposition, argued that the new patent was “closely related to
Philips'
already-asserted
products
already
at
patents
issue.”
Id.
and
at
involves
*2.
technology
Masimo
attempted
and
to
distinguish the claims of the new patent and the patents-in-suit.
Id. at *2. The court rejected Masimo’s arguments and permitted
Philip’s new counterclaim finding that it was appropriate to add
the new patent which was “potentially related” to the technology
at issue.
In Aten Intern. Co., supra, Aten sought to add three patents
to a case which all related generally to KVM switches and shared
a common inventor. Emine opposed Aten’s motion, arguing that the
new patents would introduce separate and distinct causes of action.
2010 WL 1462110, at *3. The court permitted the amendment, noting
that although only one of three proposed patents was within the
same patent family, all three patents related “in some way” to KVM
switches. Id. at *4.
The decision in Matsushita Elec. Indus. Co. v. CMC Magnetics
Corp., C.A. No. 06-04538, 2007 WL 127997, at *3 (N.D. Cal. Jan.
12, 2007), contrasts with the foregoing authorities.
5
In that case
The Masimo court distinguished the Dluhos case because in
Dluhos the court found that undue delay would result if the pro se
plaintiff was permitted to add claims which were “factually and
analytically distinct” from the claims in the original complaint.
11
Matsushita opposed CMC’s proposed counterclaim because it “dealt
with totally different technology.” Matsushita's complaint accused
CMC's optical discs of infringing its patents, while CMC's proposed
counterclaim accused Matsushita's DVD players of infringing its
patents. Id. The court agreed with Matsushita and found that,
“[t]he
product
proposed
than
counterclaim
Matsushita's
involves
infringement
an
entirely
claims.”
Id.
different
Stated
a
different way, the court found that the two technologies related
“only in a very broad sense” and noted that the addition of the
counterclaim would add undue complexity into the case, requiring
jurors to learn the technology related to both optical storage
media and DVD players. Id. at *4. The situation in Matsushita is
markedly different than what exists here.
As to Amerigen’s argument that adding the ‘768 Patent will be
“highly disruptive” to the case (Amerigen LB at 4), the argument
is premature. Shire has not yet moved to add the ‘768 Patent. The
issue will be addressed when and if Shire moves to amend its
complaint to add the ‘768 Patent.
While the Court understands Amerigen’s concern about its
confidential information, the Court reiterates that to the extent
Amerigen argues it is materially prejudiced by the Court’s ruling
or that its confidential information is being misused, the argument
is overblown. The DCO makes it clear that Shire can only use
Amerigen’s confidential information in connection with this case.
12
The DCO also makes it clear that Shire cannot use Amerigen’s
confidential information for anti-competitive purposes. The Court
and parties recognize that the DCO “is intended to prohibit parties
from using confidential information to litigate separate actions
and unrelated claims.” Order at 12. Further, one must keep in mind
that Shire already has a copy of Amerigen’s ANDA. If Shire intended
to misuse Amerigen’s confidential information this already could
have been done. The parties undoubtedly recognize that unless they
mutually protect each other’s confidential information and follow
the strictures of the DCO, their patent claims and defenses cannot
be effectively heard and decided. The parties have a joint interest
in this occurring.
The Court again emphasizes that it is not deciding whether it
will grant a motion to amend to add the ‘768 Patent to the case if
the motion is filed. That issue is not before the Court. As
repeatedly emphasized, the Court analyzes different factors in the
present context than it will analyze to decide if Shire’s motion
to amend will be granted.
Conclusion
For the foregoing reasons, the Court finds that Shire has
demonstrated that the ‘768 Patent is sufficiently related to the
patents-in-suit so that an amendment would be permitted under Rule
13
15. Accordingly, Shire may review Amerigen’s ANDA to determine if
the ‘768 Patent was infringed. 6
ORDER
Accordingly, for all the foregoing reasons,
IT IS on this 24th day of July, 2015 hereby
ORDERED that the parties’ Discovery Confidentiality Order
does
not
bar
Shire
from
reviewing
Amerigen’s
confidential
information, including its ANDA, to determine if the ‘768 Patent
was infringed.
s/ Joel Schneider
JOEL SCHNEIDER
United States Magistrate Judge
The fact that Amerigen may have requested discovery
regarding the ‘768 Patent or that Shire filed different lawsuits
where the ‘768 Patent was combined with other patents, is not
material to the Court’s decision.
6
14
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