throbber
Case 1:14-cv-01171-GMS Document 1 Filed 09/10/14 Page 1 of 15 PageID #: 1
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`I N TH E UN I TED STA TES D I STRI C T C O URT
`F O RTH E D I STRI C T O F D EL A W A RE
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`C .A . N o.
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`)))))))))
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`))))))
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`TEVA PH A RM A C EUTI C A LS USA , I N C .,
`TEVA PH A RM A C EUTI C A L
`I N D USTRI ES LTD ., TEVA
`N EURO SC I EN C E, I N C ., andYED A
`RESEA RC H A N D D EVELO PM EN T C O .,
`LTD .,
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`Plaintiffs,
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`v .
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`SA N D O Z, I N C . A N D M O M EN TA
`PH A RM A C EUTI C A LS, I N C .
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`D efendants.
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`C O M PL A I N T
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`PlaintiffsTev a Ph arm aceuticalsUSA , I nc., Tev a Ph arm aceuticalI ndustriesLtd., Tev a
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`N euroscience, I nc. andYeda Research andD ev elopm entC o., Ltd. (collectiv ely“Plaintiffs”or
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`“Tev a”) bring th isaction forpatentinfring em entanddeclaratoryjudg m entag ainstD efendants
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`Sandoz, I nc. andM om enta Ph arm aceuticals, I nc. (collectiv elyreferredto as“D efendants”or
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`“Sandoz”).
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`N A TURE O F TH E A C TI O N
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`1.
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`Th isisan action byTev a forinfring em entof UnitedStatesPatentN o. 8 ,232,250
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`(“th e’250patent”) andUnitedStatesPatentN o. 8 ,39 9 ,413(“th e’413patent”). Th isaction
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`arisesoutof th efiling of an A bbrev iatedN ew D rug A pplication (“A N D A ”) bySandozseeking
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`approv albyth eUnitedStatesF oodandD rug A dm inistration (“F D A ”) to sellg eneric v ersionsof
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`C O PA XO N E® 40m g /m L injection, Tev a’sinnov ativ etreatm entforpatientsw ith relapsing -
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`form sof m ultiplesclerosis, priorto th eexpiration of th e’250and’413patents.
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`

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`Case 1:14-cv-01171-GMS Document 1 Filed 09/10/14 Page 2 of 15 PageID #: 2
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`Tev a
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`TH E PA RTI ES
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`2.
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`Tev a Ph arm aceuticalsUSA , I nc. (“Tev a USA ”) isa D elaw arecorporation w ith its
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`principalplaceof businessat109 0H orsh am Road, N orth W ales, Pennsylv ania 19 454-109 0.
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`3.
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`Tev a Ph arm aceuticalI ndustriesLtd. (“Tev a Ltd.”) isan I sraelicom panyw ith its
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`principalplaceof businessat5B aselStreet, P.O . B ox319 0, Petah Tikv a, 49 131, I srael.
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`4.
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`Tev a N euroscience, I nc. (“Tev a N euroscience”), isa D elaw arecorporation w ith
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`itsprincipalplaceof businessat9 01E. 104th Street, Suite9 00, K ansasC ity, M issouri6 4131.
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`5.
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`Yeda Research andD ev elopm entC o. Ltd. (“Yeda”) isan I sraelicom panyw ith its
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`principalplaceof businessisatP.O . B ox9 5, Reh ov ot, 7 6 100, I srael.
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`Sa ndoz
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`6 .
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`Upon inform ation andbelief, Sandoz, I nc. isa corporation org anizedandexisting
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`underth elaw sof C olorado w ith itsprincipalplaceof businessat506 C arneg ieC enter, Suite
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`400, Princeton, N J08 540.
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`7 .
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`Upon inform ation andbelief, M om enta Ph arm aceuticals, I nc. isa corporation
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`org anizedandexisting underth elaw sof D elaw arew ith itsprincipalplaceof businessat6 7 5
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`W estK endallStreet, C am bridg e, M A 02142.
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`JURI SD I C TI O N A N D VEN UE
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`8 .
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`9 .
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`Th isaction forpatentinfring em entarisesunder35U.S.C . § 27 1.
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`Th isC ourth asjurisdiction ov erth esubjectm atterof th isaction pursuantto 28
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`U.S.C . §§ 1331and1338 (a), andth eD eclaratoryJudg m entA ct, 28 U.S.C . §§ 2201and2202.
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`10.
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`Venueisproperin th isJudicialD istrictunder28 U.S.C . § 1400(b) and§ 139 1.
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`2
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`

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`11. Upon inform ation andbelief, th isC ourth aspersonaljurisdiction ov erD efendant
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`Sandoz.
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`12. Upon inform ation andbelief, D efendantSandozm arkets, distributesand/orsells
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`g eneric drug sth roug h outth eUnitedStatesandw ith in th eStateof D elaw are. Upon inform ation
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`andbelief, Sandoz, h aseng ag edin andm aintainedsystem atic andcontinuousbusinesscontacts
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`w ith in th eStateof D elaw are, andh aspurposefullyav aileditself of th ebenefitsandprotections
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`of th elaw sof D elaw are. D efendantSandozh asalso com m itted, oraided, abetted, contributedto
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`and/orparticipatedin th ecom m ission of, th etortiousaction of patentinfring em entth ath asledto
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`foreseeableh arm andinjuryto Tev a, w h ich m anufacturesC O PA XO N E® , forsaleanduse
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`th roug h outth eUnitedStates, including th eStateof D elaw are. Sandozh asappliedforF D A
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`approv alto m arketandsella g eneric v ersion of C O PA XO N E® 40m g /m L th roug h outth e
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`UnitedStates, including in D elaw are. F urth er, upon inform ation andbelief, Sandoz, affiliatesof
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`Sandozand/orsubsidiariesof Sandozarereg isteredw ith th eD elaw areB oardof Ph arm acyasa
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`“D istributor/M anufacturer”and“Ph arm acy-W h olesale”of drug products.
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`13. Upon inform ation andbelief, th isC ourtalso h aspersonaljurisdiction ov erSandoz
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`becauseitprev iouslyh asbeen suedin th isdistrict, didnotch alleng eth isC ourt’sassertion of
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`personaljurisdiction ov erit, andav aileditself of th isforum byasserting counterclaim sforth e
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`purposeof litig ating a patentinfring em entdispute. See e.g. Genzyme Corporation et al. v.
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`Sandoz, Inc., C .A . N o. 13-01507 (D . D el.);UCB Inc., et al. v. Sandoz, Inc., C .A . N o. 13-01216
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`(D . D el.));Merck Sharp & Dohme Corp. v. Sandoz., 14-009 16 (D .D el.).
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`14. Upon inform ation andbelief, th isC ourth aspersonaljurisdiction ov erD efendant
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`M om enta.
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`3
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`

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`15. Upon inform ation andbelief, D efendantM om enta isa com panyincorporatedin
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`th eStateof D elaw are.
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`16 . Upon inform ation andbelief, D efendantM om enta m arkets, distributesand/or
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`sellsg eneric drug sth roug h outth eUnitedStatesandw ith in th eStateof D elaw are. Upon
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`inform ation andbelief, M om enta h aseng ag edin andm aintainedsystem atic andcontinuous
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`businesscontactsw ith in th eStateof D elaw are, andh aspurposefullyav aileditself of th ebenefits
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`andprotectionsof th elaw sof D elaw are. D efendantM om enta h asalso com m itted, oraided,
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`abetted, contributedto and/orparticipatedin th ecom m ission of, th etortiousaction of patent
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`infring em entth ath asledto foreseeableh arm andinjuryto Tev a, w h ich m anufactures
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`C O PA XO N E® , forsaleanduseth roug h outth eUnitedStates, including th eStateof D elaw are.
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`M om enta h asappliedforF D A approv alto m arketandsella g eneric v ersion of C O PA XO N E®
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`40m g /m L th roug h outth eUnitedStates, including in D elaw are.
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`B A C K G RO UN D
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`Th e’250Pa tent
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`17 .
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`Th e’250patent, entitled“Low F requencyG latiram erA cetateTh erapy”w asduly
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`andleg allyissuedon July31, 2012.
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`18 .
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`EtyK ling eristh enam edinv entorof th e’250patent.
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`19 . Yeda isth esoleow nerbyassig nm entof allrig h ts, titleandinterestin th e’250
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`patent.
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`20.
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`21.
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`Tev a Ltd. isth eexclusiv elicenseeof th e’250patent.
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`Th e’250patentislistedin th eF D A publication “A pprov edD rug Productsw ith
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`Th erapeutic Equiv alenceEv aluations,”com m onlyreferredto as“th eO rang eB ook”(“O rang e
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`B ook”), w ith respectto C O PA XO N E® .
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`4
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`

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`22.
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`A trueandcorrectcopyof th e’250patentisattach edasExh ibitA .
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`Th e’413Pa tent
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`23.
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`Th e’413patent, entitled“Low F requencyG latiram erA cetateTh erapy”w asduly
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`andleg allyissuedon M arch 19 , 2013.
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`24.
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`EtyK ling eristh enam edinv entorof th e’413patent.
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`25. Yeda isth esoleow nerbyassig nm entof allrig h ts, titleandinterestin th e’413
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`patent.
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`26 .
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`27 .
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`28 .
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`Tev a Ltd. isth eexclusiv elicenseeof th e’413patent.
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`Th e’413patentislistedin th eO rang eB ookw ith respectto C O PA XO N E® .
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`A trueandcorrectcopyof th e’413patentisattach edasExh ibitB .
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`Tev a ’sC O PA XO N E® Product
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`29 .
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`Plaintiffsresearch ed, dev eloped, appliedforandobtainedF D A approv alto
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`m anufacture, sell, prom oteand/orm arketa g latiram eracetateproductknow n asC O PA XO N E® .
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`30.
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`Tev a USA isth eh olderof N ew D rug A pplication (“N D A ”) num ber02-06 22,
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`approv edbyth eUnitedStatesF oodandD rug A dm inistration (“F D A ”) forth euseof g latiram er
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`acetate, m arketedasC O PA XO N E® , forth etreatm entof patientsw ith relapsing form sof
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`m ultiplesclerosissuch asrelapsing -rem itting m ultiplesclerosis.
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`31.
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`Tev a’sinnov ativ eC O PA XO N E® productissuppliedassing le-doseprefilled
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`syring esth atcontain 40m g /m lg latiram eracetateforinjection, m anufacturedbyTev a
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`Ph arm aceuticalI ndustriesLtd., andm arketedandsoldin th eUnitedStatesbyTev a
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`N euroscience, I nc.
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`Th eSa ndozA N D A
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`32.
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`Sandozfiledan A N D A under21U.S.C . § 355(j) seeking F D A approv alto
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`m anufacture, use, offerforsale, sellin andim portinto th eUnitedStatesg latiram eracetate
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`5
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`

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`injection, 40m g /m L, purportedto beg eneric to Tev a’sC O PA XO N E® (“Sandoz’sG latiram er
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`A cetateProduct”), priorto th eexpiration of th e’250and’413patents.
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`33.
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`F D A assig nedth eA N D A forSandoz’sG latiram erA cetateProductth enum ber
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`206 9 21.
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`34.
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`Sandozalso filedw ith th eF D A a certification pursuantto 21U.S.C .
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`§ 355(j)(2)(A )(v ii)(I V) alleg ing th atth eclaim sof th e’250and’413patentsareinv alid,
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`unenforceable, and/orw ouldnotbeinfring edbyth em anufacture, use, im portation, saleoroffer
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`forsaleof Sandoz’sG latiram erA cetateProduct(“Sandoz’sParag raph I V C ertification”).
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`35.
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`B yletterdatedA ug ust27 , 2014, SandoznotifiedTev a th atith adfiledA N D A
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`N o. 206 9 21seeking approv alto m arketSandoz’sG latiram erA cetateProductpriorto th e
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`expiration of th e’250and’413patents(“SandozN oticeLetter”).
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`36 .
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`37 .
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`Tev a receiv edth eSandozN oticeLetterno earlierth an A ug ust28 , 2014.
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`Th isA ction isbeing com m encedbeforeth eexpiration of forty-fiv edaysfrom th e
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`dateof receiptof th eSandozN oticeLetter.
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`38 . Upon inform ation andbelief, both Sandoz, I nc. andM om enta Ph arm aceuticals,
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`I nc. subm itted, collaboratedand/oractedin concertin th epreparation orsubm ission of A N D A
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`N o. 206 9 21.
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`C O UN T I F O RI N F RI N G EM EN T O F U.S. PA TEN T N O . 8,232,250B YSA N D O Z
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`39 .
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`Th ealleg ationsof th eproceeding parag raph s1–38 arerealleg edandincorporated
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`h erein byreference.
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`40.
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`Th euseof Sandoz’sG latiram erA cetateProductiscov eredbyoneorm oreclaim s
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`of th e’250patent.
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`6
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`

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`41.
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`Th ecom m ercialm anufacture, use, offerforsale, sale, m arketing , distribution
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`and/orim portation of Sandoz’sG latiram erA cetateProductw ouldinfring eoneorm oreclaim sof
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`th e’250patent.
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`42. Under35U.S.C . § 27 1(e)(2)(A ), Sandoz’ssubm ission to F D A of Sandoz’s
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`A N D A to obtain approv alforSandoz’sG latiram erA cetateProductw ith a Parag raph I V
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`C ertification relatedth ereto beforeth eexpiration of th e’250patentconstitutesan actof
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`infring em ent, andif approv ed, th ecom m ercialm anufacture, use, offerto sell, sale, or
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`im portation of Sandoz’sG latiram erA cetateProductcontaining g latiram eracetate, w ould
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`infring eoneorm oreclaim sof th e’250patent.
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`43.
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`Sandozw asaw areof th e’250patentw h en eng ag ing in th eseknow ing and
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`purposefulactiv itiesandw asaw areth atfiling Sandoz’sA N D A w ith Sandoz’sParag raph I V
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`C ertificationsw ith respectto th e’250patentconstitutedan actof infring em entof th e’250
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`patent.
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`44. Upon inform ation andbelief, Sandozseeksapprov alfrom th eF D A to
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`m anufacture, use, offerforsale, sellin andim portinto th eUnitedStatesSandoz’sG latiram er
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`A cetateProductindicatedforth etreatm entof patientsw ith relapsing form sof m ultiplesclerosis.
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`F urth er, upon inform ation andbelief, Sandozseeksapprov alfrom th eF D A to m anufacture, use,
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`offerforsale, sellin andim portinto th eUnitedStatesSandoz’sG latiram erA cetateProduct,
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`w h ich w illbeindicatedforadm inistration th reetim esperw eekw ith atleast48 h oursbetw een
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`ev eryinjection.
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`45. Upon inform ation andbelief, Sandozplansandintendsto, andw ill, infring eth e
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`’250patentim m ediatelyandim m inentlyupon approv alof Sandoz’sA N D A .
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`7
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`

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`46 . Upon inform ation andbelief, im m ediatelyandim m inentlyupon approv alof
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`Sandoz’sA N D A , th erew illbedirectinfring em entof th eclaim sof th e’250patentunder35
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`U.S.C . § 27 1(a).
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`47 . Upon inform ation andbelief, Sandoz, under35U.S.C . § 27 1(b), actedin concert,
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`activ elysupported, participatedin, encourag ed, and/orinducedth einfring em entof oneorm ore
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`claim sof th e’250patent.
`
`48 . Upon inform ation andbelief, Sandozplansandintendsto, andw ill, activ ely
`
`induceinfring em entof th e’250patentw h en Sandoz’sA N D A areapprov ed, andplansand
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`intendsto, andw ill, do so im m ediatelyandim m inentlyupon approv al.
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`49 . Upon inform ation andbelief, Sandozknow sth atSandoz’sG latiram erA cetate
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`Productareespeciallym adeoradaptedforusein infring ing th e’250patentandth atSandoz’s
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`G latiram erA cetateProductisnotsuitableforsubstantialnon-infring ing uses. Upon inform ation
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`andbelief, Sandoz, under35U.S.C . § 27 1(c), plansandintendsto, andw ill, contributeto th e
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`infring em entof th e’250patentim m ediatelyandim m inentlyupon approv alof th eSandoz’s
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`A N D A .
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`50.
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`Th eforeg oing actionsbySandozconstituteand/orw ouldconstituteinfring em ent
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`of th e’250patent, activ einducem entof infring em entof th e’250patentand/orcontribution to
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`th einfring em entbyoth ersof th e’250patent.
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`51. Upon inform ation andbelief, Sandozactedw ith outa reasonablebasisfor
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`believ ing th atitw ouldnotbeliableforinfring ing th e’250patent, activ elyinducing infring em ent
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`of th e’250patentand/orcontributing to th einfring em entbyoth ersof th e’250patent.
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`52.
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`Tev a w illbesubstantiallyandirreparablyh arm edbySandoz’sinfring ing
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`activ itiesunlessth eC ourtenjoinsth oseactiv ities. Tev a w illh av eno adequaterem edyatlaw if
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`8
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`

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`Sandozisnotenjoinedfrom th ecom m ercialm anufacture, use, offerto sell, salein and
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`im portation into th eUnitedStatesof Sandoz’sG latiram erA cetateProduct.
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`53.
`
`Sandoz’sactiv itiesrenderth iscasean exceptionalone, andTev a isentitledto an
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`aw ardof th eirreasonableattorneyfeesunder35U.S.C . § 28 5.
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`C O UN T I I F O RD EC L A RA TO RYJUD G M EN T O F
`I N F RI N G M EN T O F U.S. PA TEN T N O . 8,232,250B YSA N D O Z
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`54.
`
`Th ealleg ationsof th eproceeding parag raph s1–53arerealleg edandincorporated
`
`h erein byreference.
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`55. Upon inform ation andbelief, Sandozplansto beg in m anufacturing , m arketing ,
`
`selling , offering to selland/orim porting Sandoz’sG latiram erA cetateProductsoon afterF D A
`
`approv alof Sandoz’sA N D A .
`
`56 .
`
`Such conductw illconstitutedirectinfring em entof oneorm oreclaim son th e
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`’250patentunder35U.S.C . § 27 1(a), inducem entof infring em entof th e’250patentunder35
`
`U.S.C . § 27 1(b), andcontributoryinfring em entof th e’250patentunder35U.S.C . § 27 1(c).
`
`57 .
`
`Sandoz’sinfring ing patentactiv itycom plainedof h erein isim m inentandw ill
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`beg in follow ing F D A approv alof Sandoz’sA N D A .
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`58 .
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`A sa resultof th eforeg oing facts, th ereisa real, substantial, andcontinuing
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`justiciablecontrov ersybetw een Tev a andSandozasto liabilityforth einfring em entof th e’250
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`patent. Sandoz’sactionsh av ecreatedin Tev a a reasonableappreh ension of irreparableh arm and
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`lossresulting from Sandoz’sth reatenedim m inentactions.
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`59 . Upon inform ation andbelief, Sandozw illknow ing lyandw illfullyinfring eth e
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`’250patent.
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`6 0.
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`Tev a w illbeirreparablyh arm edif Sandozisnotenjoinedfrom infring ing th e
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`’250patent.
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`9
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`

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`C O UN T I I I F O RI N F RI N G EM EN T O F U.S. PA TEN T N O . 8,399,413B YSA N D O Z
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`6 1.
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`Th ealleg ationsof th eproceeding parag raph s1–6 0arerealleg edandincorporated
`
`h erein byreference.
`
`6 2.
`
`Th euseof Sandoz’sG latiram erA cetateProductiscov eredbyoneorm oreclaim s
`
`of th e’413patent.
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`6 3.
`
`Th ecom m ercialm anufacture, use, offerforsale, sale, m arketing , distribution
`
`and/orim portation of Sandoz’sG latiram erA cetateProductw ouldinfring eoneorm oreclaim sof
`
`th e’413patent.
`
`6 4. Under35U.S.C . § 27 1(e)(2)(A ), Sandoz’ssubm ission to F D A of Sandoz’s
`
`A N D A to obtain approv alforSandoz’sG latiram erA cetateProductw ith a Parag raph I V
`
`C ertification relatedth ereto beforeth eexpiration of th e’413patentconstitutesan actof
`
`infring em ent, andif approv ed, th ecom m ercialm anufacture, use, offerto sell, sale, or
`
`im portation of Sandoz’sG latiram erA cetateProductcontaining g latiram eracetate, w ould
`
`infring eoneorm oreclaim sof th e’413patent.
`
`6 5.
`
`Sandozw asaw areof th e’413patentw h en eng ag ing in th eseknow ing and
`
`purposefulactiv itiesandw asaw areth atfiling Sandoz’sA N D A w ith Sandoz’sParag raph I V
`
`C ertificationsw ith respectto th e’413patentconstitutedan actof infring em entof th e’413
`
`patent.
`
`6 6 . Upon inform ation andbelief, Sandozseeksapprov alfrom th eF D A to
`
`m anufacture, use, offerforsale, sellin andim portinto th eUnitedStatesSandoz’sG latiram er
`
`A cetateProductindicatedforth etreatm entof patientsw ith relapsing form sof m ultiplesclerosis.
`
`F urth er, upon inform ation andbelief, Sandozseeksapprov alfrom th eF D A to m anufacture, use,
`
`offerforsale, sellin andim portinto th eUnitedStatesSandoz’sG latiram erA cetateProduct,
`
`10
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`

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`w h ich w illbeindicatedforadm inistration th reetim esperw eekw ith atleast48 h oursbetw een
`
`ev eryinjection.
`
`6 7 . Upon inform ation andbelief, Sandozplansandintendsto, andw ill, infring eth e
`
`’413patentim m ediatelyandim m inentlyupon approv alof Sandoz’sA N D A .
`
`6 8 . Upon inform ation andbelief, im m ediatelyandim m inentlyupon approv alof
`
`Sandoz’sA N D A , th erew illbedirectinfring em entof th eclaim sof th e’413patentunder35
`
`U.S.C . § 27 1(a).
`
`6 9 . Upon inform ation andbelief, Sandoz, under35U.S.C . § 27 1(b), actedin concert,
`
`activ elysupported, participatedin, encourag ed, and/orinducedth einfring em entof oneorm ore
`
`claim sof th e’413patent.
`
`7 0. Upon inform ation andbelief, Sandozplansandintendsto, andw ill, activ ely
`
`induceinfring em entof th e’413patentw h en Sandoz’sA N D A isapprov ed, andplansandintends
`
`to, andw ill, do so im m ediatelyandim m inentlyupon approv al.
`
`7 1. Upon inform ation andbelief, Sandozknow sth atSandoz’sG latiram erA cetate
`
`Productisespeciallym adeoradaptedforusein infring ing th e’413patentandth atSandoz’s
`
`G latiram erA cetateProductisnotsuitableforsubstantialnon-infring ing uses. Upon inform ation
`
`andbelief, Sandoz, under35U.S.C . § 27 1(c), plansandintendsto, andw ill, contributeto th e
`
`infring em entof th e’413patentim m ediatelyandim m inentlyupon approv alof th eSandoz’s
`
`A N D A .
`
`7 2.
`
`Th eforeg oing actionsbySandozconstituteand/orw ouldconstituteinfring em ent
`
`of th e’413patent, activ einducem entof infring em entof th e’413patentand/orcontribution to
`
`th einfring em entbyoth ersof th e’413patent.
`
`11
`
`

`
`Case 1:14-cv-01171-GMS Document 1 Filed 09/10/14 Page 12 of 15 PageID #: 12
`
`7 3. Upon inform ation andbelief, Sandozactedw ith outa reasonablebasisfor
`
`believ ing th atitw ouldnotbeliableforinfring ing th e’413patent, activ elyinducing infring em ent
`
`of th e’413patentand/orcontributing to th einfring em entbyoth ersof th e’413patent.
`
`7 4.
`
`Tev a w illbesubstantiallyandirreparablyh arm edbySandoz’sinfring ing
`
`activ itiesunlessth eC ourtenjoinsth oseactiv ities. Tev a w illh av eno adequaterem edyatlaw if
`
`Sandozisnotenjoinedfrom th ecom m ercialm anufacture, use, offerto sell, salein and
`
`im portation into th eUnitedStatesof Sandoz’sG latiram erA cetateProduct.
`
`7 5.
`
`Sandoz’sactiv itiesrenderth iscasean exceptionalone, andTev a isentitledto an
`
`aw ardof th eirreasonableattorneyfeesunder35U.S.C . § 28 5.
`
`C O UN T I V F O RD EC L A RA TO RYJUD G M EN T O F
`I N F RI N G M EN T O F U.S. PA TEN T N O . 8,399,413B YSA N D O Z
`
`7 6 .
`
`Th ealleg ationsof th eproceeding parag raph s1–7 5arerealleg edandincorporated
`
`h erein byreference.
`
`7 7 . Upon inform ation andbelief, Sandozplansto beg in m anufacturing , m arketing ,
`
`selling , offering to selland/orim porting Sandoz’sG latiram erA cetateProductsoon afterF D A
`
`approv alof Sandoz’sA N D A .
`
`7 8 .
`
`Such conductw illconstitutedirectinfring em entof oneorm oreclaim son th e
`
`’413patentunder35U.S.C . § 27 1(a), inducem entof infring em entof th e’413patentunder35
`
`U.S.C . § 27 1(b), andcontributoryinfring em entof th e’413patentunder35U.S.C . § 27 1(c).
`
`7 9 .
`
`Sandoz’sinfring ing patentactiv itycom plainedof h erein isim m inentandw ill
`
`beg in follow ing F D A approv alof Sandoz’sA N D A .
`
`8 0.
`
`A sa resultof th eforeg oing facts, th ereisa real, substantial, andcontinuing
`
`justiciablecontrov ersybetw een Tev a andSandozasto liabilityforth einfring em entof th e’413
`
`12
`
`

`
`Case 1:14-cv-01171-GMS Document 1 Filed 09/10/14 Page 13 of 15 PageID #: 13
`
`patent. Sandoz’sactionsh av ecreatedin Tev a a reasonableappreh ension of irreparableh arm and
`
`lossresulting from Sandoz’sth reatenedim m inentactions.
`
`8 1. Upon inform ation andbelief, Sandozw illknow ing lyandw illfullyinfring eth e
`
`’413patent.
`
`8 2.
`
`Tev a w illbeirreparablyh arm edif Sandozisnotenjoinedfrom infring ing th e
`
`’413patent.
`
`PRA YERF O RREL I EF
`
`W H EREF O RE, Tev a respectfullyrequestth efollow ing relief:
`
`(a)
`
`(b)
`
`a judg m entth atth e’250and’413patentsarev alidandenforceable;
`
`a judg m entth atSandoz’ssubm ission of th eA N D A N o. 206 9 21, w asan actof
`
`infring em entof oneorm oreclaim sof th e’250and’413patentsandth atth em aking , using ,
`
`offering to sell, selling , m arketing , distributing , orim porting of Sandoz’sG latiram erA cetate
`
`Productpriorto th eexpiration of th e’250and’413patentsw illinfring e, activ elyinduce
`
`infring em entand/orcontributeto th einfring em entof oneorm oreclaim sof th e’250and’413
`
`patents;
`
`(c)
`
`an O rderpursuantto 35U.S.C . § 27 1(e)(4)(A ) prov iding th atth eeffectiv edateof
`
`anyF D A approv alof th eSandozA N D A N o. 206 9 21oranyproductth euseof w h ich infring es
`
`th e’250or’413patents, sh allbea dateth atisnotearlierth an th eexpiration of th e’250and’413
`
`patents;
`
`(d)
`
`an O rderpursuantto 35U.S.C . § 27 1(e)(4)(B ) perm anentlyenjoining Sandozand
`
`allpersonsacting in concertw ith Sandozfrom com m erciallym anufacturing , using , offering for
`
`sale, selling , m arketing , distributing , orim porting Sandoz’sG latiram erA cetateProduct, orany
`
`13
`
`

`
`Case 1:14-cv-01171-GMS Document 1 Filed 09/10/14 Page 14 of 15 PageID #: 14
`
`productth euseof w h ich infring esth e’250or’413patents, orinducing orcontributing to th e
`
`infring em entof th e’250or’413patentsuntilafterth eexpiration of th e’250and’413patents;
`
`(e)
`
`an O rderpursuantto 35U.S.C . § 28 3perm anentlyenjoining Sandozandall
`
`personsacting in concertw ith Sandozfrom com m erciallym anufacturing , using , offering for
`
`sale, selling , m arketing , distributing , orim porting Sandoz’sG latiram erA cetateProduct, orany
`
`productorcom poundth euseof w h ich infring esth e’250or’413patents, orinducing or
`
`contributing to th einfring em entof th e’250or’413patents, untilafterth eexpiration of th e’250
`
`and’413patents;
`
`(f)
`
`an O rderenjoining Sandozandallpersonsacting in concertw ith Sandozfrom
`
`seeking , obtaining , orm aintaining approv alof th eSandozA N D A N o. 206 9 21beforeth e
`
`expiration of th e’250and’413patents;
`
`(g )
`
`an aw ardof Tev a’sdam ag esoroth erm onetaryrelief to com pensateTev a if
`
`Sandozeng ag esin th ecom m ercialm anufacture, use, offerto sell, saleorm arketing or
`
`distribution in, orim portation into th eUnitedStatesof Sandoz’sG latiram erA cetateProduct, or
`
`anyproductorcom poundth euseof w h ich infring esth e’250or’413patents, orth einducem ent
`
`orcontribution of th eforeg oing , priorto th eexpiration of th e’250and’413patentsin
`
`accordancew ith 35U.S.C . § 27 1(e)(4)(C );
`
`(h )
`
`a judg m entth atth isisan exceptionalcaseandaw arding Tev a itsattorneys’fees
`
`under35U.S.C . § 28 5;
`
`an aw ardof Tev a’sreasonablecostsandexpensesin th isaction;and
`
`an aw ardof anyfurth erandadditionalrelief to Tev a asth isC ourtdeem sjustand
`
`(i)
`
`(j)
`
`proper.
`
`14
`
`

`
`Case 1:14-cv-01171-GMS Document 1 Filed 09/10/14 Page 15 of 15 PageID #: 15
`
`O F C O UN SEL:
`
`D av idM . H ash m all
`Elizabeth J. H olland
`G O O D W I N PRO C TERLLP
`Th eN ew YorkTim esB uilding
`6 20Eig h th A v enue
`N ew York, N Y 10018 -1405
`(212) 8 13-8 8 00
`dh ash m all@ g oodw inprocter.com
`eh olland@ g oodw inprocter.com
`
`D arylL. W iesen
`Joh n T. B ennett
`N ich olasK . M itrokostas
`G O O D W I N PRO C TERLLP
`Exch ang ePlace
`B oston, M A 02109
`(6 17 ) 57 0-1000
`dw iesen@ g oodw inprocter.com
`jbennett@ g oodw inprocter.com
`nm itrokostas@ g oodw inprocter.com
`
`W illiam G . Jam es
`G O O D W I N PRO C TERLLP
`9 01N ew YorkA v e. N W
`W ash ing ton, D C 20001
`(202) 346 -4000
`w jam es@ g oodw inprocter.com
`
`D ated: Septem ber10, 2014
`
`B A YA RD ,P.A .
`
`/s/ Stephen B. Brauerman
`Rich ardD . K irk(rk09 22)
`Steph en B . B rauerm an (sb49 52)
`Vanessa R. Tiradentes(v t539 8 )
`Sara E. B ussiere(sb57 25)
`222D elaw areA v enue, Suite9 00
`W ilm ing ton, D E 19 8 01
`(302) 6 55-5000
`sbrauerm an@ bayardlaw .com
`v tiradentes@ bayardlaw .com
`sbussiere@ bayardlaw .com
`
`Attorneys for Plaintiffs Teva Pharmaceuticals
`USA, Inc., Teva Pharmaceutical Industries
`Ltd., Teva Neuroscience, Inc. and Yeda
`Research and Development Co., Ltd.
`
`15

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