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Bayer Pharma Et. Al. v. Par Pharmaceutical Et. Al.

Bayer Pharma Et. Al. v. Par Pharmaceutical Et. Al.

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Published by PatentBlast
Bayer Pharma et. al. v. Par Pharmaceutical et. al.
Bayer Pharma et. al. v. Par Pharmaceutical et. al.

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Published by: PatentBlast on May 16, 2013
Copyright:Attribution Non-commercial

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05/16/2013

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INT
HE
UNITED
ST
ATES DISTRICT
COURT
F
OR
THE
DISTR
ICT OF
D
ELA
WAREB
AYER
PHA
RM
A AG,
BA
Y
ER
INTELLECTUAL
PR
OPE
RT
YGMBH and
BAY
ER
HEALTHCARE
PHARM
AC
EUTICALS
IN
C.,
)
))
)))
laintiffs,
)
C.A.
No.___
__
____ _ v.
)
)
PAR
PHARMACEUTI
CA
L,INC. and
PAR
P
HARM
ACEUTICAL
COMPANIES,I
NC.
))
))
Defendants.
)
COMPLAINT
Plaintiffs Bayer
Phanna
AG, Bayer Intellectual Property GmbH, and BayerHealthCarePharmaceuticalsInc. (collectively"Plaintiffs"), by their attorneys,hereby allege as follow
s:
NATURE OF THE ACTION
1.
This is
an
actionforpatent infringement
W1der
the
pa
tent laws
of
theUnitedStates,Title 35,
Un
ited States Code,that arises out
of
the filing by
Pa
r Pharmaceuti
ca
l,Inc.
of
Abbreviated
New
Drug Application ("ANDA") No. 204786 with the U.S. Food and Drug Admini
stra
tion
("FDA
'') seeking appr
ova
l to manufactureand sellgeneric versions
of
STAXYN®
prior
to
theexpiration
of
U.S.
Pa
te
nt
Nos. 6,362,178 and 7,696,206.
TH
EPARTIES
2. Plaint
if
f Bayer
Ph
anna
AG, formerlyknown as Bayer Schering
Ph
ruma
AG,
is a corporation
or
ganized and existing un
der
the
Ja
ws
of
the Federal
Rep
ublic
of
Germany,
wit
ha place
of
business
at
Mtillerstrasse 178,13353 Berlin,Germany.
 
3. Plaintiff Bayer Intellectual Property
Gm
bH is a corporation organizedand existingunder thelaws
of
the
Fed
eralRepublic
of
Germany, withaplace
of
business at AlfredNobel-Strassc 10, 40789Manheim,Germany.4.PlaintiffBayer HealthCare Pharmaceuticals Inc. isacorporation organized and existing underthe laws
of
the State
of
Delaware, with a place
of
business at6West Belt,Wayne,
New
Jersey.5.
On
information and belief,defendantPar Pharmaceutical, Inc.
is
acorporationorganized and existing under the laws
of
the State
of
Delaware,having a place
of
businessatOneRam RidgeRoad,Spring Valley,NY10977anda place
of
businessat30 DunniganDrive,
Suff
ern,
NY
10901.
6.
Oninformation and
be
lief,defendant
Par
PharmaceuticalCompanies, Inc.("ParCompanies")isa corporation organizedandexisting underthelaws
of
theState
of
Delaware,havinga place
of
businessat300Tice Boulevard,WoodcliffLake,
NJ
07677.7. Oninformationand be
li
ef:
Par
Pharmaceutical, Inc.is a wholly-ownedsubsidiary
of
Par Companies and iscontrolledanddominatedby ParCompanies. Upon informationandbelief,
Par
Pharmaceutical,Inc. develops andmanufacturesnumerous generic drugsfor sale andusethroughouttheUnited States at the directi
on
of,underthe control of, andfor thedirectbenefit
of
Par Companies.8.
On
informationandbelief, ParPharmaceutical,
In
c.'s
preparationandsubmission
of
ANDA No. 204786 for ParPharmaceutical,
In
c.'s
VardenafilHydrochlorideOrallyDisintegratingTablets,
10
mg(Par's
"ANDA
Product'') was doneat thedirectionof, underthecontrol of,andforthedirect benefit
of
Par Companies.2
 
9.
Oninformationandbelief,andconsistent withtheirpractice withrespect toothergenericproducts,following any
FDA
appr
ova
l
of
ANDA
No.204786,Par Pharmaceutical,Inc.and P
ar
Companieswillact inconcertto distribute andse
ll
Par's ANDAProductthroughoutthe United Statesandwithin Delaware.These twoentitiesare hereafter collectivelyreferred
to
as
"Par."Upon informat
io
n and
b
elie
f~
followi
ng
anyFDA approval
of
ANDANo. 204786,
Par
knowsandintendsthatitsANDA Product will bedistributed andsold
in
the Unit
ed
Statesandwithin
De
laware.
JURISDICTIONAND VENUE
10.ThisCourt hassubject matterjurisdi
ct
ion pursuant to28 U.S.C.
§§
1331,
1338(a),2201,and 2202.
11
.
Par
P
hann
aceutical,Inc. and
Par
Companiesare subjecttopersonal jurisdictionin Delaware because,
am
ongotherthings,
th
eyareincorporatedinDelaware,they regularlytransact and/or solicitbusiness
in
Delaware,haveconsented to jurisdictionin Delaware
in
cases
ar
ising out
of
theirfiling
of
ANDAs,andhave
pu
rposefullyavailed themselves
of
thisforum such that they should reasonably anticipate being haledintocourthere.
12.
On
informationand belie
f,
Par
Pharmaceutical,Inc. and
Par
Com
pa
niessharecommonemployees,officersand/ordirectors. 13.
On
information andbelief,
Par
Ph
armaceutical,Inc.and
Par
Companiesareagents
of
eachothe
r,
and
/or
operateinconcertasintegratedparts
of
Par
's
business.14.
On
informationandbelief,variousproducts forwhich
Par
Pharmaceutical, Inc. isthenamedapplicantonapprovedANDAs are availab
le
at retailpharmaciesin Delaware, andareavailable fordirectpmchase
by
pharmaciesinDelaware and elsewhere.
3

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