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Glenmark Generics et. al. v. Sanofi-Aventis et. al.

Glenmark Generics et. al. v. Sanofi-Aventis et. al.

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Published by PriorSmart
Official Complaint for Declaratory Judgement in Civil Action No. 2:14-cv-02374-SRC-CLW: Glenmark Generics Ltd. et. al. v. Sanofi-Aventis U.S. LLC et. al. Filed in U.S. District Court for the District of New Jersey, the Hon. Stanley R. Chesler presiding. See http://news.priorsmart.com/-lafy for more info.
Official Complaint for Declaratory Judgement in Civil Action No. 2:14-cv-02374-SRC-CLW: Glenmark Generics Ltd. et. al. v. Sanofi-Aventis U.S. LLC et. al. Filed in U.S. District Court for the District of New Jersey, the Hon. Stanley R. Chesler presiding. See http://news.priorsmart.com/-lafy for more info.

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Published by: PriorSmart on Apr 16, 2014
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IN
THEUNITED
STATES
DISTRICT
COURT
FORTHEDISTRICT
OFNEW
JERSEYGLENMARKGENERICS
LTD.
and
 
GLENMARKGENERICS
INC.,
USA
 
Plaint
iJfs
SANOFI-AVENTIS
U.S.
LLC
and
 
Civil
Action
No.
 
FERRING
8.V.
 
Defendants.
 
PLAINTIFFS
GLENMARKGENERICS
LTD.
AND
GLENMARKGENERICS
INC.,
USAS
COMPLAINTFOR
DECLARATORY
JUDGMENTS
OF
PATENT
NONINFRINGEMENT
 N 
IN
VALIDITY
PlaintiffsGl enmarkGenerics
Ltd.
 individually,“GlenmarkLtd.”
and
GlenmarkGenerics
Inc.
US
individually,GlenmarkUSA collectively,
Glenmark
bring
this
action
against
DefendantsSanofi-Aventis
U.S.LLC
 individually,
“Sanofi-Aventis
U.S.”
and
Ferring
B.V.
 together,Defendants
for
a
declarationthatGlenmark
has
notinfringed,
doesnot
infringe,
and
will
not
infringe
any
valid
and
enforceableclaim
of
U.S.
Patent
No.
7,022340
 “the
340
patent” .
THE
NATUREOF
THEACTION
1 
This
action
is
based
on
the
patent
laws
of
the
United
States
Title
35
of
the
UnitedStates
Code.
Defendants
have
asserted
ri ts
under
the
‘340
patentbased
on
GlenmarkUSA’stiling
of
an
AbbreviatedNe w
Drug
Application Ai”DA 
No.
201-831
with
the
United
StatesFood
and
 rug
Administration
for
approval
to
marketgen ericversions
of
Defendants’
DDA
V
Tablets
 desmopressinace tate 
drug
product.
In
conjunction
with
the
ANDA
filing 
Glenmark
USAfiled
Paragraph
IV
Certification
with
respect
to
the
‘340
patent.
which
wasand
 
currently
is
listed
in
the
“OrangeBook”withrespect
to
Defendants’DDAVP®
Tablets
FDAhas
tentativelyapproved
Glenmark’s
ANDAproduct
but
Glenmark
caimot
obtain
final
approval
until
it
obtains
a
courtdecisionthat
its
product
doesnot
infringethe
‘340
patent
orthatthe‘340
patent
is
invalidor
unenforceable.Glenmark
is
entitled
by
law
to
bring
and
maintain
thisaction
for
declaratoryjudgment
of
patentnon infringement unenforceabilityand/orinvalidityunder
the
DeclaratoryJudgment
Act
and
the
MMA’where,
as
here,
Defendants
did
not
sue
Glenmarkwithin
45
days
of
receipt
of
Glenmark’snotice
of
Paragraph
IV
Certification
asto
the340
patent
and
GlenmarkprovidedDefendants
an
Offer
of
ConfidentialAccess
to
Glenmark’sANDA
for
its
generic
desmopressin
acetatetablets.
THEPARTIES
2.
Glenmark
Ltd.
is
an
Indiancompanyhaving
its
principalplace
of
business
at
GlenmarkHouse HDO CorporateBuilding Wing
-A,
B
D
Sawant
Marg
Chakala
Off
WesternExpressHighway Mumbai400099 Maharashtra
India.
Glenmark
Ltd.
develops
and
manufacturesprescriptionpharmaceutical
drugs
includingaffordable high quality
generic
medicines.
3.
Glenmark
USA
isa
Delawarecorporationwith
its
principal
place
of
business
at
750
Corporate
Drive
Mahwah
New
Jersey
07430.
GlenmarkUSAdevelops
and
manufacturesprescriptionpharmaceuticaldrugs includingaffordable high qualitygenericmedicines.Glenmark
USA
is
the
North
Americandivision
ofGlenmark
Ltd.
“MMA ”
or
the
Mcdicare
Modernization
Act,”refers
to
parts
of
the
Hatch-Waxman
Act
amendments
to
theFederalFood,Drug,and
Cosmetic
Act
 “FFDCA” ,
as
amended
by
Title
Xl
of
the
Medicare
Prescription
Drug.
Improvement,
and
ModernizationAct
of
2003.
Pub.
L.
No.
108-173,
117
Stat.
2006 2003 :
see
also
Caraco
Pharm.
Labs.,
Ltd.
 
Forest
Labs.,
Inc..
527
F.3d
1278
 Fed.
Cir.
2008 .
 
4.
Based
on
publicly
availableinformation,
Sanofi-Aventis
U.S.LLC
is
a
Delaware
corporation
with
its
principal
place
of
business
at
55
Corporate
Drive,
Bridgewater.
New
Jersey
08807.
On
information
and
belief.
Sanofi-Aventis
U.S.LLC
manufactures
and
sells
pharmaceutical
products
throughout
the
United
States,
includingwithin
the
State
of
New
Jersey.
5.
Based
on
publicly
availableinformation,Ferring
B.V.
is
a
corporationorganized
and
existing
under
the
laws
of
the
Netherlands
with
its
corporate
headquarters
at
PolarisAvenue
144,
2132
JX
iloofddorp,
The
Netherlands.
On
information
and
belief
Ferring
BY.
is
engaged
in
the
research,
development,manufacture,
and
sale
of
pharmaceutical
products.
JURISDICTION
AND
VENUE
6.
This
actionarises
under
the
patent
laws
of
theUnited
States
35
U.S.C.
 
et
seq.
and
the
DeclaratoryJudgment
Act,
28
U.S.C.
§s
2201
and
2202.
7.
This
Court
has
subjectmatter
jurisdiction
overthis
action
pursuant
to
28
U.S.C.
 
1331
and
1338 a
because
this
actioninvolvessubstantialclaimsarisingunder
the
United
States
Patent
Act
 35
U.S.C..
 
etseq. ,
the
DeclaratoryJudgment
Act
 28
U.S.C.
 
2201
and
2202 ,andthe
MMA
 21
U.S.C.
§
355 j 5 C
and
35
U.S.C.
§
271 e 5 .
8.
This
Court
hasgeneral
personal
jurisdiction
over
Sanofi-Aventis
U.S.
because
it
has
its
principal
place
of
business
in
Bridgewater,
New
Jersey.
The
Courtalso
has
personal
jurisdiction
over
Sanofi-Aventis
U.S.
because
it
regularlyconductsbusiness
in,
has
availed
itselfof
the
rights
and
benefits
of
the
laws
of.
andhas
regular
and
systematiccontact
with,
theState
of
New
Jersey.
Sanoti-Aventis
U.S.
alsohas
previouslysubmitted
to
and
availed
itselfof
the
jurisdiction
of
this
Court
by
filing
lawsuits
in
the
UnitedStates
District
Court
for
the
District
of
NewJersey.
See,
e.g.,
 
:07-cv-03
143,
3:07 cv 03
163,
1:1
3-cv-06827,
and
1:1
2-cv-04709.
9.
This
Court
has
personal
jurisdiction
over
Ferring
B.V.
On
information
and
belief
ferring
 
has
previouslysubmitted
to
the
jurisdiction
ot
this
Court
and
availeditself
of
the

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