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DM_US 55841402-5.058823.0336 A Facsimile: (713) 739-7592 Telephone: (713) 653-1781 Houston, TX77002 1000 Louisiana, Suite3900 [email protected] ( JOHN C.LOW MCDERMOTT WILL&EMERYLLP Facsimile: (310) 277-4730 Telephone: (310) 277-4110 Los Angeles,CA90067 2049 CenturyParkEast,Suite3800 [email protected] JASON D.STRABO(246426) [email protected] DEREK J.MEYER(278346) MCDERMOTT WILL&EMERYLLP (650)815-7401 Facsimile: (650)815-7400 Telephone: Menlo Park,CA94025 275 Middlefield Road,Suite100 [email protected] SHANE G.SMITH(272630) [email protected] WILLIAM G.GAEDE,III(136184) MCDERMOTT WILL&EMERYLLP Danish Corporation, PHARMAA/S,a SANTARIS a Delawarecorporation,and PHARMAA/SCORP., SANTARIS v. Corporation, a Delaware ISIS PHARMACEUTICALS,INC.,
ttorne y s IN AND FOR THESOUTHERN IN ANDFOR f or IsisPharmaceuticals,Inc Defendants. Plaintiff, pro hacvice IN THEUNITEDSTATESDISTRICTCOURT
) SAN DIEGODIVISION .
FOR SECOND DEMAND Case No.11-CV-02214GPC
DISTRICT OFCALIFORNIA
PATENT
AMENDED
FOR C ASE 2
ND INFRINGEMENT N
JURY O A .
11-CV-02214 MENDED P ATENT
COMPLAINT TRIAL TRIAL C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT
GPC ( KSC
(KSC) )
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successors-in-interest, co-conspirators,prin Defendants wereat all times reality exist.Isis is informed andbe Santaris PharmaA/SCorp, where aunityofinterest andownership United States.SantarisPharma A/SCorp.is targeted therapiesthroughthird parties in Pharma A/SCorp.,isinthebusiness Pharma A/S,itselfandthroughitswholly Denmark. Oninformation having aprincipalplaceofbusinessatKogle biopharmaceutical company organizeda DM_US 55841402-5.058823.0336 PlaintiffIsisPharmaceuticals, Inc Pharma A/SCorp.andSantar under thelawsofDelaware, California andthroughouttheUnitedStates. RNA-targeted therapiesth commercializing owned subsidiaryofSantarisPharmaA/ explained below,SantarisPharma A/SCo Court, Carlsbad,California92010. business in the State of California. On business intheStateofCalifornia. 92130. Oninformation andbelief,Santaris place ofbusinessat12626High BluffDriv incorporatedin privately heldcompany, 1. 3. 2.
Plaintiff IsisPharmaceuticals,Inc. On information andbelief,Santaris On informationandbelie
such thatseparatepersonalitiesofthetwo donotin and belief,asfurther having itsprincipalplaceof is PharmaA/S(collectivel relevantthepartners, officers,agents,assignees, THE PARTIES PARTIES THE f, DefendantSantarisPharmaA/SCorp.isa of discovering and commercializingRNA- -1- ., complains againstDefendantsSantaris nd existingunderthe lawsofDenmark, the StateofDelaware,havingaprincipal the StateofCalifornia andthroughoutthe exists between Santaris PharmaA/Sand S, isinthebusinessofdiscoveringand lieves, andonthat basisalleges,that information andbelief,asfurther cipals, alteregos,or employees ofeach rp., itself and as the agent and wholly rp., itselfandastheagentwholly ownedsubsidiary andagent,Santaris PharmaA/SCorp.isregistered todo the alter ego of Santaris Pharma A/S, egoofSantarisPharma A/S, thealter rough thirdpartiesintheStateof e, Suite440,SanDiego,California (“Isis”), isacorporationorganized Pharma A/S is a privately held PharmaA/Sisaprivatelyheld
Allé 6,DK-2970Hørsholm, C y “Santaris”)asfollows: ASE explained below,Santaris business at 2855 Gazelle businessat2855Gazelle 2 ND N O A .
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attached asExhibit1.) attached Pharmaceuticals, Inc.,asassi Patent”) entitled“Gapped2' Modified Santaris PharmaA/SisproperunderFede the rightsandbenefitsunderCaliforniala that SantarisconductsbusinessintheStat Patent”) entitled“Antisense 1400. contends that itisnotdoingbusiness continuous contactsintheStateofCalifornia. attached asExhibit 2.) attached Pharmaceuticals, Inc., asassi 1331, 1338(a)andSection2201. The Courthassubjectmatter jurisdictionove prior tothe expirationofU.S.Patent sale, offertosell,useorimportation ofIs of theUnitedStates(Title35 DM_US 55841402-5.058823.0336 and omissions allegedherein,andth other, orwereotherwiseres 9. 8. 7. 6. 5. 4.
On May23,2000, UnitedStatesPa On December4,2001,UnitedStates Venue isproperinthis district pursuantto28U.S.C.§§1391(b)and To theextentthatSantarisPh This Court haspersonaljurisdiction ov This isanactionforpatentinfringe
JURISDICTION ANDVENUE JURISDICTION THE PATENTS-IN-SUIT ponsible for,contributed to, Modulation ofBetaCateninE gnee oftheinventors.(Acopy‘199 Patent is gnee oftheinventors. (Acopyofthe‘500Patent is ereby incurredliabilitytherefore. Nos. 6,326,199, 6,066, -2- is’s patentedmethodsand/orcompositions in California,personaljurisdictionover ral RuleofCivilProcedure4(k)(2). e of California, andhasavaileditselfof e ofCalifornia, States Code)andarising from Santaris’s w, andhasengagedin Oligonucleotides”issuedtoIsis r this action pursuant to 28 U.S.C. §§ r thisactionpursuantto28U.S.C.§§ arma A/S(Denmark)successfully ment arisingunderthepatentlaws PatentNo.6,326,199(the “‘199 tent No.6,066,500(the “‘500 er Santarisbyvirtueofthefact C ASE or participatedintheacts 2 xpression” issuedtoIsis ND N O A .
11-CV-02214 MENDED 500, and6,440,739. P ATENT substantialand C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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DM_US 55841402-5.058823.0336 Expression” issuedtoIsisPharmaceuticals, Patent”) entitled“AntisenseModulati copy ofthe‘739PatentisattachedasExhibit3.) have beenownedbyIsisatalltimes, enforceable. in vivo establishes safety.Researchintheseareas medication. Thisprocessdetermines approp been identifiedasapotentialdrugthat activity, itwillentertheprocessofdrugdevelopment. identified throughtheforegoingprocess numbers ofcompounds fortheirbiologi a targethasbeenvalidatedinrelevantdi potentially relevantfortreatingdisease. example, thereductionofa target validationphase,pharmaceutical discovery involves targetva process bywhichdrugsaredesignedand/ regulatory approvalto market form thebasis forafilingwiththe clinicaldatagenerateddurin clinical and ultimately inpatientstoassess therapeutic 10. 11. 12. 13. studiesandclinicaltrialsinh
On August27,2002,UnitedStates The ‘199,‘500and‘739Patents (collectivelythe“patents-in-suit”) In thefieldsofmedicine andbi Drug development referstoactivitie DRUG DISCOVERYANDDEVELOPMENT
lidation anddrugcandidate id given protein target will yield a biochemical change given proteintargetwillyielda biochemical change the drug intheUnitedStates. the Food andDrugAdministration (FDA)for -3- arefullymaintained, andarevalid g thedrugdiscoveryphasemayultimately Candidate identification commences after Candidateidentificationcommencesafter sease models andofteninvolvesscreening cal activity.Onceacompound hasbeen on ofGlioma-AssociatedOncogene-2 ealthy volunteerstoassesssafety,and generallyincludesanumber ofrequired and shown tohavethespecificdesired researchers testahypothesisthat,for riate formulation anddosing, aswell Inc.,asassigneeof value as a medication. Certainpre- valueasamedication. seek toestablishitssuitabilityasa or identified. Theprocessofdrug otechnology, drugdiscoveryisthe s undertakenafteracompound has Patent No.6,440,739(the“‘739 C ASE 2 entification. Duringthe ND N O A .
11-CV-02214 MENDED P ATENT the inventors.(A C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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DM_US 55841402-5.058823.0336 many typesofmolecules necessaryfo cells orfrom patients protein ofunknownfunction example, aresearchercanuseantisense used inbasicresearchtobetter understa modulate proteins that arenot amenableto has severaladditionaladvant presents anotherwaytotreatandpotentia rather thaninterferingwithproteinfuncti Thus, antisense works bypreventingor Antisense compounds targetspecificmRNAsth proteins. Antisensetechnologydiffersfr information embodied inthemRNAintoproteins. messenger RNA(mRNA).Duringtransla step, thegeneticinformation foragiven into proteinsintwostepscalledtranscrip hold theinformation necessarytomake pr many diseases.Genesar overproduction orabnormal productionofprotei polymer, oftencalledan“oligonucleotide,” Enbrel) aredesignedtobind andinterfe industries, suchassmallmolecules ( 14. 16. 15.
Proteins are fundamentalcomponents An antisensecompound istypically ashort,single-stranded DNA Most drugsproducedbythepharmaceuticalandbiotechnology
ANTISENSE TECHNOLOGY ANTISENSE TECHNOLOGY of aparticulardisease. e DNAchemical entitieswithin and observetheconsequences.Onemay usenormal ages overtraditionaldrugs,includingtheabilityto e.g. -4- , Lipitor)ormonoclonal antibodies( reducingproteinproductionaltogether, on after it is produced. This mechanism on afteritisproduced.Thismechanism tion andtranslation.Atthetranscription nd thefunctionoftargetproteins. For r carryingoutcellularfunctions.The in cellstoreduce theproductionofa lly curedisease.Antisensetechnology protein iscopiedto re withthefunction ofdisease-causing om thosepharmaceuticalapproaches. oteins. Thisinformationisconverted tion, cellular machineryconvertsthe small molecule drugs.Itcanalsobe that iscomprised ofindividual units at encodedisease-causingproteins. ns isimplicated orassociatedwith of alllivingcells,andinclude C ASE 2 ND N thenucleiofcellsthat O A .
11-CV-02214 MENDED P a molecule called amoleculecalled ATENT C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC e.g. )
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therapeutic benef production ofproteinsinvolvedindis preventingsynthesisof the mRNA, thereby cellular enzyme, calledRNas transcript (the“sense”strand)thatencode oligonucleotides aredesignedtobind properties –aconceptthatliesatthe as cancer,diabetes,cardiovasculardiseas expanded thereachofantisense to manyproteinsassoci research targeted Crooke, M.D.,Ph.D.,andhiscoll diseases ofgeneticorigin. Isis wasfo properties. components canbechemically modified (iii)aph pentofuranosyl sugar moiety, and components: (i)anitrogen-containing 10-50 nucleotides.Nucleotideunits DM_US 55841402-5.058823.0336 1 called nucleotides. with abroadpipelineof24drugsin deve 350 people. optimize them. IsisisaCarlsbad,Calif understand more fundamenta Chief ExecutiveOfficerandactivelyl antisense worksandtranslatingthisne designs andmethodsofdrugdiscovery. Du Anoligonucleotideischemically synthe 17. 18. ISIS AND ITS BUSINESS OF ANTISENSE DRUGDISCOVERY OFANTISENSE ISIS ANDITSBUSINESS
Isis isthegloballeaderinantise Since Isis’sinception,thecomp its forpatients.
1 Theseoligonucleotidescanbe e H,recognizes thatduplexandcausesdegradationof lly howantisensedrugsworkandtofurther drugsbyaddressingawiderangeofdiseasessuch eagues. Tothisday,Dr unded in1989byantisen -5- byhybridization toaspecificmRNA w knowledgetooptimi ornia-based company thatemploysnearly ring structure known asa“base”,(ii) eads agroupofresearchers looking to sized andhasalengththattypicallyspans lopment andseveralot ease, antisense drugscanthuscreate ease, antisense osphate-containing linker. Any oftheseosphate-containing linker. Any s atargetproteintoform aduplex.A e, neurodegenerativediseaseandother ated with different diseases. Isis has differentdiseases.Isishas ated with are themselves comprised of three comprised are themselves to alteranoligonucleotide’s natural nse drug discovery and development, nse drugdiscoveryanddevelopment, heart ofIsis’sinventions. These the targetprotein.Byinhibiting ring its twenty-two yearhistory,Isis any hasfocusedonstudyinghow modified toaltertheirnatural C ASE 2 . CrookeservesasIsis’s ND N O A .
11-CV-02214 MENDED P se pioneerStanley hers inearlystage ATENT ze antisensedrug C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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development funding. million inpaymentsfrom fees,milestones, performed byIsis. Since2007,Isis’spa partners furtherdeveloptheantisensedr enables Isistoearnupfrontfees,mile compounds, “gapmers”comprise linked nuc cell asembodied inthemethodclaimsof the invention of“gapmer”or“gapped” and commercialization. Isis and commercialization. antisense compounds andtechnology,rather therapeutic importance. modified antisensecompounds thatcanin scientists toidentifyproteintargetsof commercialize thepurchasedantisensedrug commercialize development andclinicaltrials,seek technology. Isis’spharmaceutical co drugs thatIsisidentifiesinthedrugdiscove with andreliesonotherpharm because some basic research doesnotneed research because somebasic and cost-efficiently produce aseriesof encoding it. Platform technology enables theownerof platform tomore rapidly independent ofthe specificproteintarg compound designthatcan beincorpor DM_US 55841402-5.058823.0336 2 antisense technology. has madeenormous investments oftime, “Platform antisense tec 20. TECHNOLOGY ISIS’S PATENTED ANTISENS 19.
One ofIsis’s earliest and most tran Isis maintains itsfocusonfurthe
2 Thisantisensedrugdesignplatform technologyallowsIsis hnology” generallyreferstofeatures ofantisense hasdevelopedabusinessm aceutical companiestodeve -6- interest, and tocreatepotentchemically-interest, and mpany partnerstypically perform drug eted orthebasesequence ofthemRNA ugs basedonthedrugdiscoveryresearch oligonucleotide compoundsforusesin a stone payments,and productsincorporating thetechnology final marketapproval,andultimately to beperformedfor E DRUGDESIGNPLATFORM money andeffort to developplatform ry phaseusingIsis’splatformantisense ated into anyantisense compound, hibit virtually anyspecificproteinof rtnerships generatedmore than$840 the‘199Patent.Likeallantisense equityinvestment, andresearch leotides (oligonucleotides)andhavea thanonlate-stage candidates.This sformative platform technologiesis r research and developmentof r researchand C ASE odel inwhichitpartners 2 ND lop furthertheantisense N O A .
11-CV-02214 MENDED each newproduct. P drugdevelopment royalties asIsis’s businessstrategy ATENT C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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reproduced below: methods isfoundin Santaris’s 2010Annual lacking suchmodifications. Theoligonucl of theoligonucleotide inthepresenceof resistance. Specifically,itemploys phosphor binding affinity ofthe oligonucleotideto bonded tothe4' positionoftheribosering. 2' position oftheriboseringwithanoxy- ribose sugarrings,calledlockednucleic aci middle apl oftheoligonucleotidecomprises DM_US 55841402-5.058823.0336 and foridentifyingpotentialdrugcandidates. protein in a celland,therefor antisense compounds areparticularlysu pentofuranosyl sugarmoie oligonucleotide toitstarget;andapl degradation bycellularnucleases and comprise modifications arrangedalong target mRNAtodisrupttheproductionof hybridizes base sequencethatspecifically 22. 21.
The aboveoligonucleotideisf An exampleofagapmeroligonucle
ties whichelicitdegradationofthemRNA.Such ties e, areusefulforidentifying -7- nucleases, whichdegradeoligonucleotides theoligonucleotide toprotect itfrom urality ofunmodified 2'-deoxy-erythro- ited forreducingthe amount oftarget to thecomplementary sensestrandofa its complementary strand. Finally,the eotide alsocomprises the resultingprotein. to increasebindingaffinity ofthe d (“LNA”),whichissubstituted atthe TheLNAmodification increasesthe Report,arelevantsectionofwhichis urality ofnucleotides thatcomprise 2'- othioate linkages,toincreasestability methylene bridgethatiscovalently unctionalized toincreasenuclease otide used in Isis’s patented otide usedinIsis’spatented C ASE targets oftherapeuticvalue 2 ND N O A .
11-CV-02214 MENDED P Gapmersfurther ATENT modified bicyclic C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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DM_US 55841402-5.058823.0336 deoxy-erythro-pentofuranosyl s compounds directedtoglioma-associat 23. contacted withacelltoinhibit theproduction ofaprotein. prevents the productionofthetargetpr attract RNaseH,whichinturncauses to beta-cateninandgarneredpatentprotec therapeutic benefittopatients.Isisde the productionofbeta-cateninproteinin mRNA,andtherebyca catenin affecting thecolonandskin.Antisense shown topromote developmentofsevera compounds attheoverproduction ofaprotei Drs. C. Frank BennettandLexM.Cowsert. specific diseaseindications.Onesuch compounds incorporatingits platform technol antisense compounds claimedinthe‘500Pa with antisensecompoundsthatreducebe contacti inhibition processthatcomprises Patent. The‘500Patentalsoclaims a production ofglioma-associated oncogene mRNA, andtherebycausethedestruction of Antisense oligonucleotidesthathybridiz 2 isassociatedwithanumber ofhuman developmentalsyndromes andcancers. of glioma-associated oncogene-2.Overe modulate theproductionofaproteinisIsis’s ultimately provide atherapeuticbenefittopa
Isis hasalsodesigned,evaluated, 24.
Another patentdirectedtoantise
use thedestructionofthis ugar moieties. Thisportion veloped severalantisensecompounds directed -8- cancer cells, and may ultimately cancercells,andmay provide a xpression ofglioma-associated oncogene- method forpracticingIs tion fortheseinventionsthroughthe‘500 degradation ofthe mRNA,andthereby e totheglioma-associated oncogene-2 oligonucleotides thathybridize tobeta- ng cellsortissuesin ed oncogene-2and otein. Theaboveoligonucleotideis anddevelopedcandidateantisense tent arenotrequired tobegapmers. n called“beta-catenin,”whichhasbeen -2 protein in cancer cells, and may -2 proteinincancer cells,andmay invention wasconceivedatIsisby tients. Isisdevelo ‘739Patent,directedtotheexpression ta-catenin proteinproduction.The l typesofcancers,includingthose ogy asappliedtocertaintargetsfor this genetic message, decrease the thisgeneticmessage,decreasethe nse compositions andmethodsthat Thisinvention directs antisense C ASE geneticmessa 2 ND N of thegapmer servesto O A .
ped severalantisense 11-CV-02214 MENDED P alaboratorydish ATENT garnered patent is’s beta-catenin C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT ge, decrease GPC ( KSC )
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activities anduses: production ofaspecificprotein.TheSa toscreentargets and/or theabilityofs functional modifications, asdescribe also discussedabove,are methylene bridgethatiscovalentlybound hydroxyl groupatthe2'position ofaribos As discussedabove,alockednucleicacid thatcomp discover andcommercializegapmers These activitiesareindirectcompetition services andproductstopharmaceutical antisense compounds incellassaystoassist DM_US 55841402-5.058823.0336 antisense compounds claimedinthe‘739Pa compounds thatreduceglioma-associated cellsorti contacting process thatcomprises claims amethodforpracticingIsis’s protection fortheseinventionsthroughth 26. 25.
On information andbelief,Santaris Santaris engagesinthebusiness
INFRINGING ACTS BY SANTARIS ACTSBYSANTARIS INFRINGING antisense compoundshavingaspecificarrangement of d andclaimedinthe‘199Patent. -9- ynthesized oligonucleotidestoinhibitthe ntaris 2010AnnualReport confirms these glioma-associated oncogene-2inhibition company customers intheUnitedStates. customers company e ringhasbeensubstituted withanoxy- to the 4' position of the ring. Gapmers, to the4'positionofring.Gapmers, ssues inalaboratorydishwithantisense withthe identificationofpotential gene e ‘739Patent.ThePatentalso tent arenotrequired tobegapmers. isamodified nucleotideinwhicha oncogene-2 protein production.The with Isis.Santariswasfoundedto of sellingantisensedrugdiscovery rise lockednucleicacidnucleotides. usestheLNA-containinggapmer C ASE 2 ND N O A .
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DM_US 55841402-5.058823.0336 ‘199 Patent.Santaris’s further sells andoffersforsaleinthe LNAantisense screen gapmer with agapmer,isusedbySantarisasre Thus, theIsismethod patentedinthe‘1 sale to pharmaceutical companies. sale topharmaceuticalcompanies. antisense technologypioneeredandpatent services foracertainprice.Oninformat customers, pursuanttowhichSantarisagr agreemen incommercial memorialized involve Santarisperforming somecomb services IsissellsoroffersforsaleintheUnited States. commercial salesoroffers compounds tothecustomerforfurther reducing target protein,and(4)transfer compounds (typicallyhundredsorthousands (3)synthesisand therapeutically relevant, experiments designedto the discoveryand/or identification ofpossible proteintargets, (2)validation exchange forcashconsideration:(1)as Patent andthe‘739Patent, respectively. catenin andglioma-associated oncogene-2 and soldto EnzonPharmaceuticals,Inc forantisense. viable therapeutictarget target forwhichIsishasal with IsisbyadvancingandsellingL 27. 28.
On informationandbelief,atleas On informationandbelief,Santaris
businesshasbeenbuiltar ready invested research time ready investedresearch for salecompetewiththe determine whetherinhibiti molecules foractivityinhi NA gapmercompounds foraspecificmRNA -10- says usinggapmerantisensecompounds for United Statesthepatentedmethods ofthe 99 Patent,whichinvolvescontacting acell of gapmer-based antisense technology and of gapmer-basedantisensetechnology Specifically, Santarishasofferedforsale ., antisense compounds thatinhibitbeta-., ion andbelief,these ed byIsis,andsellingofferingitfor testing ofanumber ofgapmerantisense ts with its pharmaceutical company ts withitspharmaceuticalcompany eed to transfer property and/or perform eed totransferpropertyand/orperform ination ofthefollowingactivitiesin search tooltoidentify targetsand/orto productioninviolation ofthe‘500 validation anddevelopment.These ) to screenforeffectiveness in has attempted tocompete directly t someofSantaris’ssalesare ound exploitingtheplatform C ‘199 Patentdrugdiscovery and money tovalidateasa ASE on oftarget proteinis 2 biting atarget.Santaris ND N O A .
11-CV-02214 agreements typically agreements MENDED P ATENT C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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DM_US 55841402-5.058823.0336 criteria specifiedin the2006EnzonAgre shown bythedefinitions ofkeycontract country, met eachandeverylimitation ofthe offers andsales,aswellthebeta- oligonucleotide contemplated bySantaris a subject matter oftheasserted claims ofth Compounds, andpressreleasesbyEnzon a presentations made byEnzonscientists describing theSantaris-generated LNA patent applicationsbetweenSantaris pursuant totheEnzon-Santaris agreem and importing antisense oligonucleotide exempt under35U.S.C.§271(e)(1). infringing sales,offers,andimportations by claims aspartofits performance oligonucleotides thatmeet eachandev money paidbyEnzon,withSantar oligonucleotide productsand/orresearch to sell,andimportations amounted tosale limitations oftheassertedclaims ofthe‘ milestones constituteand/orevidenceactivitie payments toSantarisupontargetiden target identificationforpaymentbyEnz of beta-cateninpursuanttothe2006Enzon to thebeta-cateningenetargetmeeting Santaris’s importation intotheUnitedStates, evidenced bySantaris’sofferingtoselland 30. 29.
Exemplary evidenceofthemaking, Exemplary On information andbelief,Santaris
under the2006EnzonAgreement.These -11- catenin oligonucleotideimported intothis ent maybefoundin commonly-assigned specific criteria,(2) ery limitation oftheasserted‘500Patent and Enzon,publicly-available scientific 500 Patent.Theseinfringingsales,offers e ‘500Patent.Moreover,thebeta-catenin terms andtargeta tification and/orachievementofother on, and(4)Enzon’smakingmilestone nd/or Enzon atthetime oftheinfringing s, offers,andimportations ofantisense Agreement, (3)Santaris’sinvoicingthat sale withintheUnitedStates,aswell services bySantarisinexchangefor compounds directed tobeta-catenin nd Santaris,eachofwhichdescribes asserted ‘500Patentclaims, atleastas is delivering beta-catenin-specific is deliveringbeta-catenin-specific (1) ofproductsand/ ement itself,Santaris and/orEnzon Santarisand/or Enzonareactsnot s bySantaristhatdirectlyinfringeall ’s infringement isaresultofand using, selling, offering forsale, C ASE 2 ND N nd compound selection O Enzon’s identification A .
11-CV-02214 MENDED P ATENT or servicesrelated C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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asserted claims ofthe‘739Patent. press releasesbyEnzon andSantaris, each Enzon scientistsdescribing the useof between SantarisandEnzon, Enzon-Santaris agreementmay befoundin and importing antisenseoligonucleotidecom exempt under35U.S.C.§271(e)(1). infringing sales,offers,andimportations by Patent claims aspartofits performan specific oligonucleotidesthatmeeteach Santaris in exchangeformoney paidby importations ofantisense oligonucleotide infringing sales,offerstosell,andimpor DM_US 55841402-5.058823.0336 that directlyinfringealllimitations ofth achievement ofother milestones constitute Enzon’s makingmilestonepaym Santaris’s invoicingthattargetidentif (2) Enzon’sidentification ofgli2pursuanttothe2006EnzonAgreement,(3) to theglioma-associated oncogene-2(“gli2”) Santaris’s importation intotheUnitedStates, evidenced bySantaris’sofferingtoselland 6hereto itself attachedasExhibit gene sequence.Thisevidenceisinaddi Agreement, andpublicknowle documents relatedtothenegotiation thedeliveredo documents characterizing 32. 31.
Exemplary evidenceofthemaking, Exemplary On information andbelief,Santaris
publicly-availablescientific dge andinformation concerningthe beta-catenin ents toSantarisupontargetidentificationand/or and discussedinparagraphs50-60, ce underthe2006EnzonAgreement.These -12- Santaris-generated LNA Compounds, and e assertedclaims of ication forpaymentbyEnzon,and(4) and everylimitation oftheasserted‘739 tion tothe2006Enzon-Santaris contract and performanceofthe2006Enzon Moreover,thegli2 oligonucleotide ligonucleotides, Santarisand/orEnzon commonly-assigned patentapplications of whichdescribessubject matterofthe tations amounted tosales,offers,and and/orevidenceactivitiesbySantaris sale withintheUnitedStates,aswell Enzon, withSantarisdeliveringgli2- products and/orresearch servicesby pounds directedtogli2pursuantthe genetargetmeetingspecificcriteria, (1) ofproductsand/ Santarisand/or Enzonareactsnot ’s infringement isaresultofand using, selling, offering forsale, C ASE 2 ND presentationsmade by N the ‘739 Patent. These the ‘739Patent. These O A .
11-CV-02214 MENDED P ATENT or servicesrelated infra C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC . ( KSC )
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that showsuchinducing activity the ‘199Patent.Examples ofnonpublic its pharmaceutical partnersand/orcollabor know-how forscreeningortargetvalidation partners and/ortheircollaborators.At States eachstepofthemethodsclaimed an LNAcompound withthecellinsuch company partnersintendingthattheyuse partners, Santarissupplie gene target.Undertheterms oftheagre screen fortheactivityofsuppliedL DM_US 55841402-5.058823.0336 related tothenegotiati characterizing thedeliveredoligonucleo its specified inthe2006EnzonAgreement definitions ofkeycontractterms an oftheasse every limitation sales, aswellthegli2 contemplated bySantarisand/orEnzonatthetimeofinfringingoffersand Exhibit 6heretoanddiscu evidence isinaddition tothe 2006Enzon public knowledgeandinform know how associatedwiththecontacti Further, Santarishaslicensedandprovide inventors ofthe‘199Patentandisdirect that stemmedfrom theoriginal patent app prior to2006.Indeed,Santarisunsuccessf infringement ofthe‘199Patent.Santaris 33.
On informationandbelief,Sant
on andperformanceofthe oligonucleotide imported into ssed inparagraphs50-60, d thatknow-howandmateri rted ‘739Patentclaims,atleastasshownbythe ation concerningthe gli2genesequence.This ng ofanLNAmolecule withacell -13- d targetandcompound selectioncriteria may befoundat NA molecules and/ortofurther validatea the time ofproviding suchmaterialsand ements withcertainofthepharmaceutical tides, Santarisand/or Enzondocuments in the‘199Patentbypharmaceutical documents recentlyproduced bySantaris d to its pharmaceutical company partners company d toitspharmaceutical such materialsandknowhowtocontact lication filedintheUnitedStatesby has hadknowledgeofthepatentatleast ators wouldconstitute infringementof a mannerthatperforms intheUnited ed tosimilar patentedsubject matter. ully challengedIsis’sEuropeanPatent purposes, Santarisknewthattheactsof elf, Santarisand/or Enzondocuments -Santaris contractitselfattachedas aris hasfurtherinducedthe infra 2006 Enzon Agreement, and 2006 EnzonAgreement, C ASE this country,meteachand . als tothepharmaceutical 2 ND SANAS00007725-29; SANAS00007725-29; N O A .
11-CV-02214 MENDED P ATENT C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC in vitro ( KSC to )
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sale hasoccurredandtherevenueisbooked, SANAS00012607; SANAS00023623;SANAS00117937. show suchactivitymay befoundat rewards ofownership ofth 2010 AnnualReport.UnderSantaris’s accordance withSantaris’srevenuerecogni As evidenceofsuchsales,Santarisreco Patents, Santarisreceivedsubstantial in the‘199Patentandcompositions ‘199 Patent.Examples ofnonpublicdocum DM_US 55841402-5.058823.0336 SANAS00012607; SANAS00021473;SANAS00023623;SANAS00117937. SANAS00012407-410; SANAS00010598; SANAS00007921; SANAS0000239; pharmaceutical partnersand/or toassi the UnitedStatesusingmethodsofth techniques for Revenue comprises 35. transaction canbemeasured reliably. company, andthe costincurred orto economic benefitassociatedwith amount ofrevenuecanbemeasured 34. with ownershipnoreffectivecont continuing managerialinvolvement been transferredtothebuyer, significant riskandrewardsofownership ofthegoods/services has general incomecriteriafor considered realizedorrealizableandearned. thete inaccordancewith agreements development contracts. Incomeisrecognizedovertheperiodof payments
On information andbelief,inreturn On informationandbelie in vitro , andother incomeassociatedfromresearchand
screeningofLNAmolecules product salesand e goods/services havebeen SANAS00010598; SANAS00011827at39-42; f, Santarishasperform -14- payments from pharmaceutical companies. companies. payments frompharmaceutical rol overthegoods/servicessold and methods claimedinthe‘500and‘793 Santaris Pharmaretainsneither SANAS0000185; SANAS00012056-84; gnizes therevenuefrom thepayments in st existingpharmaceutical partnersin e ‘199Patenttodemonstratepotential the transactionwillflowto recognitionhastobemet,all policy, whenthesignificant riskand to thedegreeusuallyassociated rms oftheagreementswhenitis
ents recentlyprodu reliably, itisprobablethatthe viz tion policy,assetforthinSantaris’s be incurred in respect of the beincurredinrespect ofthe up-front payments SANAS00011827 atpp.39-42; : for the sale of the methods recited for thesaleofmethods recited employing themethods ofthe C This means thatthe This means ASE transferred tothe buyer,a 2 ND N O A .
ed infringingactsin ed 11-CV-02214 MENDED ced bySantaristhat P , ATENT milestone C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT , the GPC ( KSC )
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Competition andPatentTerm against patentinfringement: 271(e)(1)). Moreover, theFederalCircuithas Lifesciences I,Ltd. 1585 (1984)(the“1984 Thus, thenatureofinterferenceis can doistestthedrugforpurposesof Patent, and/orthe‘793 drug discovery servicesanddrugcandidate enterprise ofofferingfor 857, reprinted in1984U.S.C.C characterized itslimits, noting thatthe“nat submission ofinformationun submission totheFDA,thatuseis‘reas wouldbeappropriatetoincludeina ifsuccessful, the compound inresearch that, particular biologicalprocess,toproduce reasonable basisforbelievingthata the patentholder”wouldnot exemption, holding thattheexemption research underthe1984Actwassubject DM_US 55841402-5.058823.0336 within theUnitedStatesorimport 38. manufacture, use,orsaleofdrugs submission ofinformationundera invention…solely forusesreasonabl It shallnotbeanactofinfringement 37. 39. 36.
This provisionentered title35in 35 U.S.C.§271(e)(1)(“Section271 In 2005,the SupremeCourtreaffirm In sum, oninformation andbelief,
, 545U.S.193,207 (2005)(quotingthetextofSection Act”). TheHouseCommittee sale andsellingtoitspharm besubstantial,” but“ RestorationActof1984,P .A.N. at2692,2714(stating der .federallaw.’” induce infringementofthe‘199Patent. de minimus -15- patented compound maywork,througha or veterinarybiological products. submitting datatotheFDAforapproval. a particularphysiological effect,and uses onably-related’ tothe‘developmentand may existwhere“adrug-maker hasa into theUnitedStatesapatented y relatedtothedevelopmentand Federal lawwhichregulatesthe ure oftheinterferencewithrights to make,use,offer s thatinfringethe‘199Patent,‘500 to theSection271(e)(1)clinicaltrial held thatresearchtools used indrug [sic].”). [sic].”). ed thatnotalldrugdiscoveryand 1984 aspartoftheDrugPrice de minimus Santarishasengagedinan (e)(1)”) defines aceutical company customers aceutical company C that initiatedthisprovision ASE ub. L.No.98-417,98Stat. Merck KGaAv.Integra 2 ND N that “allthatthegeneric O [sic].” H.R.Rep.No. A .
11-CV-02214 MENDED to sell,orsell P ATENT a safeharbor C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC
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v. Innovasystems,Inc. DM_US 55841402-5.058823.0336 3 quoted above,Santarisbookedmillions ofdo approval, falloutside theprot discovery anddevelopment,arenot of developmentwhere theSection271( develop someoftheresulti products. Regardlessofwhetherthe Glaxo andEnzon(seebelo revenues aregeneratedinpartfrom Santar A/S recognizedDKK217.9minrevenues customers areresponsiblefordevelo In Santaris’s2010AnnualReport,Santarisnotes: revenueth constitute commercial payments contemplated bytheSantaris belief, thesubstantialsumsreceived the safeharborprovisionof35U.S.C. FDA forregulatoryapproval,andtherefor not reasonablyrelatedtoth patented gapmer antisensetechnology.On Santaris2010Annual Report,p.31. 40. 42. 41. platform development oftheCompany’spi development milestone paymentsfrompartners, based onprudentcost management Since thecompletionofSeries
On informationandbelie On informationandbelief,Santaris’s pharmaceuticalindustry According toSantaris’s 2010Annual , withoutanynewadditionalfinancing
, 536F.3d1256,1265(Fed.Cir.2008). w) andothercommercialac ng compounds andeventually e developmentandsubmissi ection ofSection271(e)(1). at Santarisusestofund f, andasdescribedinthe 2010AnnualReport -16- pment andregulator pharmaceutical company customers later customerslater company pharmaceutical C roundin2007theCompanyhas, § 271(e)(1).Rather,oninformation and by Santaris,andthesignificantfuture e arenotexempted from infringement by andgeneration compared toDKK72.6min2009.”The -pharmaceutical companyagreements, peline, organizationandLNA informationandbelie beenabletocontinue the e)(1) exemption attaches, Santaris’s e)(1) exemptionattaches, Santaris’s themselves thesubjectofregulatory themselves is’s collaborationswithPfizer,Shire, llars ofrevenuefro report, “In2010SantarisPharma 3
tivity as alleged herein. tivity asallegedherein. C ASE advance adrugtophase on ofinformation tothe and developitsbusiness. 2 Proveris ScientificCorp. ND N of up-frontsand O A . y approvalofdrug
11-CV-02214 MENDED P ATENT f, these sales are f, thesesalesare m salesofIsis’s C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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Santaris 2010Annual Report,Santaris DM_US 55841402-5.058823.0336 transactionsarenotthemselves commercial submission to the FDA. And Santaris’sact submission totheFDA.And 271(e)(1). United Statesinviolation ofthe‘199Patentareactsnotexempt under35U.S.C.§ pharmaceutical partnerstoscreenLNA ‘199 PatentintheUnitedStatesand/or January 4,2011,press release targeted drugs”(the “2011Pfizer-Santaris LockedNucleicAc Santaris PharmaA/S As describedinthepressrelease,Pfizer and belief,Santariscontinue Isis, Santaris’s actsofinfringement, asfurt on thesale,offerforuseandimpor Santaris hasbuiltacommercia States thatdepressandharm thevalueofIs platform antisensetechnologythatthepatentprotects. undermined theva price. Theseactivities would transferand/orperform and belief,Santarisactivelypursuedtrans claimed inthe‘199Patentuptodateof Further, Santaris’scommercialagreements sales bySantarisoftechnologythat in inter alia 43. 45. 44. T
HE In addition to completed In additiontocompleted On January4,2011,Sant The followingexamples ofknownagreementsrepresentprofitable , intheform oflostorvalue-diminished licensingopportunities. J ANUARY ANUARY
4,
2011, d toofferforsaleinth the methods claimed inthe methodsclaimed the l enterprise that competes l enterprisethatcompetes is attachedheretoas Exhi
A NNOUNCED NNOUNCED aris announcedanagreem sales andpast offers -17- her detailedherein,ar id (LNA)DrugPlatform todevelopRNA- fringes the‘199,‘500and‘739Patents. compounds and/orvalidatetargetsinthe actions with potential customers where it potentialcustomers whereit actions with paid Santaris“$14million foraccessto inducingtheiractualandprospective thatpatent’sexpiration.Oninformation received $14million fromPfizerin Agreement”). (Acopy oftheSantaris amount tooffersforsaleintheUnited s ofusingthepatent relatedtothegene is’s patents, ofherein. ascomplained tation ofIsis’spa lue ofthe‘199PatentandIsis A GREEMENT e UnitedStatesthemethods C ASE with Isisandthatdepends 2 bit 4.)Asstatedin the ND N for sale,oninformation ‘199 Patent for a stated ‘199 Patentforastated W O A .
ITH ITH e inflicting harm on e inflictingharm on 11-CV-02214 MENDED ent withPfizer,Inc. P tented technology. ed methodsofthe ATENT ration ofdatafor P FIZER C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC
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constitute patentinfringeme of the‘199Patentat Pfizer touse,intheUnitedStates,Isis’s DM_US 55841402-5.058823.0336 entities arereferredtoas“Pfizer.” additional milestone payments which $7million waspaidtoSantaris belief, thisagreementrepres and thediscovery ofleadantisenseLNAmo agreed topaymilestones toSantarisuponth future milestones paymentsinadditionto exchange foraccesstoSantaris’sLNA Santaris’s commercialpurposes. Santaris hasrecognizedasrevenuepaymen for saleandsellingoftheSantariste occurred intheUnitedStates.Oninforma incorporated underthelawsofDelaware, infringed Isis’smethods claimed in use ofaresearchtool thatisnotitself an offerforsale,a useand/orinduci 271(e)(1) because: (a) itcons 48. 46. 47. 49.
gapmer compounds toidentifydrug Offering forsaleandsellingthe pro On informationandbelief,Santar On information andbelief,conf On informationandbelief,Pfizeris target RNAforvalidationpurposes;and/or Offering forsaleandsellingthepr On informationandbelief,suchac
time ofinducingtheacts,andknewthat such actswould nt ofthe‘199Patent ented anexpansionofa2009agreementwithWyethin . PfizeracquiredWyethin2009andcollectively,the titutes anofferforsale, a the‘199Patent,includingby, the subjectofFDAappr technology, andmayreceive$600million in -18- methodsclaimed inthe‘199Patent,knew chnology intheUnitedStatestoPfizer ng useofthemethods up frontplusapotential $83million in royaltiesonsales.Specifically,Pfizer ts from Pfizerandusedsuchrevenuefor tion and belief,theactivityofoffering tion and e identificationofuptotengenetargets and Santaris’soffer lecule candidates. tivity isnot exempt underSection in theUnitedStates. candidates fordrugdevelopment. is furtherinducedWyethand/or ocess ofusinggapmerstoreduce a United States based company, aUnitedStatesbasedcompany, cess ofscreeningandidentifying irming thatasalehasoccurred, C ASE sale, useand/orinducing 2 ND N O A oval; (b)itconstitutes .
11-CV-02214 MENDED On informationand claimed inthe‘199 P ATENT inter alia for saleand C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC , ( KSC )
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of theEnzonagreementisattachedhereto pay additionalmilest Further, Enzon reimbursedSa million indevelopmentandregulatorymilestone payments. addition totheupfrontpayments,Santaris oncogene-2 (“gli2”) targets information andbelief,Enzonnominated in the‘199Patentandcompositions cove gapmer compounds thatinhibit thenominate nominated sixAdditional Targetsfor wh oftheEnzonagreement,a the execution DM_US 55841402-5.058823.0336 evidenced bySantaris’srec by Santaristhatitselfisnot reasonabl target cell;and/or(c)isacommercialoffe process toproducetheparticularphysiological effectofinhibiting the selected for believingthat aspecificcompound may Patent indiscoveryactivitybeforethetr 27, 2006,pressreleaseisatt Pharmaceuticals, Inc.(the“2006Enzon-Sant Santaris soldtwoantisensegapmermolecu selection ofanLNAgapmercompound that Additional Targetsandforthe design, id compositions andmethodsclaimed inthe‘ to beta-cateninorgli2 using Isis’s then designed,synthesized 51. 50.
T HE On informationandbelief,asde On July27,2006, Santarisa J ULY
ones toSantarisuponsuccessful 27,
2006, , and screened LNAgapmer , andscreened ognition ofrevenuefromPfizer. ached heretoasExhibit5, under the2006Enzon-Santaris ntaris $2million fordevel
A NNOUNCED NNOUNCED methods patentedin the‘199Patentand -19- ained researcher formed a reasonable basis ained researcherformedareasonablebasis y relatedtoFDAapproval,asfurther as Exhibit 6.)Onin nd in accordance with its terms, Enzon Enzon nd inaccordancewithitsterms, 500 Patent(directed to beta-catenin)and r forsale, sale,use, red inthe‘500and‘739Patents.On les andtargetstoEn the beta-cateninandglioma-associated ich SantarisagreedtoidentifyLNA entification, synthesis, screening and entification, synthesis,screeningand d targetsusingIsis’s methodspatented nnounced anagreementwithEnzon aris Agreement”).(Acopyofthe July A is eligibletocollectmore than$200 work througha particularbiological GREEMENT GREEMENT met certainacceptan tailed furtherbelo and aredactedpublicversion C identificationofuptosix opment work,andagreedto candidatescomplementary ASE 2 W ND N Agreement.Santaris O ITH A .
formation andbelief, 11-CV-02214 and/orinducing use MENDED P zon for$6million. E ATENT NZON w, subsequentto ce criteria.In C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT
GPC ( KSC )
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nomination ofbeta-cateninasatarget, days. ( Enzon’s requestsforofferin Enzon’s target nominationon such revenueforits and (ii)makeanassociatedpayment.In Targets, whichdidnothaveto Enzon wascontractuallyrequiredto(i) orpriorto On NewJersey. Bridgewater, claims ofthe‘500Patent.Thisofferwas patented inventions,including methodsa targetsforaperiod nominated Santaris wasprovided, bythe terms ofth Enzon Contract,§5.1(a).)UponEnzon’s discovery servicesperformed bySantaris nominate potentialtargets thatwouldbe oligonucleotide products specificforth sell itsdrugdiscovery services andth six Additional Targets,whichmanifested an Targets. Confirming thata 2008, EnzonpaidSantarisfordelivering Santaris toEnzonmeteach in theEnzoncontract.Thebeta-cat and deliverLNACompounds directed toeach DM_US 55841402-5.058823.0336 the ‘739Patent(directedtogli2).On 52. 53. 54. See id
More specifically,aspartofits On information andbelief,Santar On information andbelief,Enzondesi ., §5.2(a).)
commercial purposes. sale occurred,Santarisrec and everylimitation of theas itiated a “ReservationPeriod” includeanyoftheoriginal of3daysandformally co the basisofa“Conflict.” enin-specific LNACompound deliveredby -20- information andbelief, which constitutedalega response, Santariswas anddeliveryofresulting products.( e contract,anopportunity to reviewthe to Enzon,whichhasalegalresidencein thelastdayof ReservationPeriod, designate atotalofsix(6)Additional e beta-cateningene target.Enzon’s e resulting LNA-containingantisense candidate molecules forsixAdditional nd products,setforthinthe asserted request foranofferviaitsnomination, acceptance ofSantar acceptance the subjectofcontingentdrug oftheAdditionalTa contract withEnzon,Enzonwasto is confirmedandacceptedEnzon’s gnated beta-cateninasoneofthe ognized thisrevenueandused C ASE serted ‘500Patentclaims. nfirm and accept, or reject nfirm andaccept,orreject setofNominated Targets, 2 of aspecifiednumber of ND N Id O A . . Theacceptanceof
11-CV-02214 MENDED and forexample, in required togenerate P ATENT l offertosellthe is’s priorofferto rgets asdetailed C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC See )
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Additional Targets as detailedintheEn required togenerate anddeliverL Nominated Targets,and(ii)ma six (6)Additional Targets,which didnot last dayoftheReservation Enzon, whichhasalegalresi products, setforthin the asserted claims constituted alegaloffertosellthepate conflict astogli2,and agreedtoEnzon’ DM_US 55841402-5.058823.0336 consequence ofthisinfringingsa a portionofthepaymentsoweditunder2006EnzonAgreementas a into theUnitedStates.Oninformationa 7.2 ofthe Enzon-SantarisContract.On pay money toSantarisaspartofthe“A United States.Enzon’sacceptanceofSantar of Isis’spatentedinventionsin theasse designation ofbeta-cateninpursuanttothe oligonucleotide productsresulting from the contract. Santarissubsequently import uponacceptanceanddesigna was complete ‘500 Patent.TheunauthorizedsaleofIsis Isis’s patentedmethodinvent using Isis’s patentedmethods,completed Isis’s patentedmethodsandproducts.Sa discovery servicesrelatedto was obligated Santaris Enzon’s payment, 55.
On information andbelief,Santaris
Period, Enzonwascontractually thebeta-cateningenetarg dence inBridgewater,NewJe ions setforthin theassertedmethod claims ofthe ke anassociatedpayment. le andsubsequentimportation. NA Compounds directedNA Compounds toeachofthe -21- dditional TargetFees”describedinSection rted claimsofthe‘500Patentwithin nd belief,Santarisrecognized,asrevenue, nted inventions,including methods and ofthe ‘739Patent.Thisofferwasto s nomination ofgli2 asatarget,which information andbelief, performance oftheunauthorized saleof ’s patentedproducts ed thebeta-catenin zon contract.The gli2-specific LNA ntaris’s performance ofthoseservices, to perform,anddiditsdrug performance ofIsis’spatentedmethods terms of the contract constituted a sale thecontractconstitutedasale of terms have toinclude anyofthe original tion ofbeta-cateninpursuanttothe is’s offertriggeredtheobligationto alsoconfirmedthattherewasno C et inDenmark,whichused ASE Inresponse,Santariswas 2 requiredto(i)designate ND N rsey. Onorpriortothe O A .
11-CV-02214 MENDED in theUnitedStates P -specific antisense ATENT in exchange for inexchangefor C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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DM_US 55841402-5.058823.0336 of Isis’spatentedinventionsin theasse gli2 pursuanttotheterms ofthecontract oligonucleotide productsspecificfortheg asserted ‘739Patentclaims. Compound deliveredbySantaris toEnz its drugdiscoveryservicesandth Additional Targets,whichmanifested anac gli2 genetargetinDenmark,whichused was obligatedtoperform, anddidperform, its Contract. Oninformationandbelief,in part ofthe “AdditionalTargetFees”descri acceptance ofSantaris’soffertriggeredth Isis’s patentedmethods intotheUnitedStat gli2-specific antisenseoligonucleotide designation ofgli2pursuanttothecontr patented productsintheUnitedSt claims in theassertedmethod performance oftheunauthorizedsaleIsis Santaris’s performance ofthoseservices, Agreement asaconsequenceofthisinfr recognized, asrevenue,aportion ofth Enzon has“soleownership, co and ‘739Patents,to sublicense, todevel in “SelectedLNACompounds,” including specifically, underthe 2006 Enzon-Santaris Ag commercialize such compounds 56. 57.
On informationandbelief,Enzon Further confirming thatasaleo
ofthe‘739Patent.The ntrol andresponsibility for” in theUnitedStates. On ates wascomplete uponacceptanceand -22- products resultingfrom theperformance of e paymentsoweditunderthe2006Enzon inging saleandsubsequentimportation. op, import, offerforsa constituted asalewith rted claimsofthe e resulting LNA-containingantisense on meteachandeverylimitation ofthe act. Santarissubsequentlyimported the using Isis’spatentedmethods, completed exchange forEnzon’spayment,Santaris e obligationtopaymoney toSantarisas bed inSection7.2oftheEnzon-Santaris li2 genetarget.En Isis’spatentedme ceptance ofSantaris’sprioroffertosell es. Oninformation those compounds coveredbythe‘500 ’s patentedmethod inventions setforth drugdiscoveryservicesrelatedtothe ccurred, oninformationandbelief, reement, Santarisrelinquished rights designated gli2asoneofthe C ASE unauthorized saleofIsis’s 2 ND information and belief, N regulatory filings in the O ‘739 Patent.Enzon’s A .
11-CV-02214 MENDED zon’s designationof thods andproducts. le, sellorotherwise in theUnitedStates P and belief,Santaris ATENT C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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recognition ofreve not reasonablyrelated toFDAapproval, offe and/or(c) isacommercial target cell; process toproducetheparticularphysiological effectofinhibiting the selected believing thataspecificcompoundmay wo discovery activitybeforethetrainedre Patent, andcompounds andmethodsclaime offer forsale,aimpor of aresearchtoolthatisnotitselfthe 271(e)(1) because:(a)itconstitutesanoffer DM_US 55841402-5.058823.0336 Enzon-Santaris Agreement. United Statesforthe candidatemolecu sale, andimportation toEnzon inter alia methods andthe‘500‘739patentedcompositions andmethods,includingby, importing SantarisTechnologytotheUnited of theSantaristechnologyin UnitedStat incorporated underthelawsofState 60. 59. 58. ,
On informationandbelief,suchac into theUnitedStates. specific forbeta-cateninand/or gl Selling, offeringtosell,and/ and/or gapmer candidatesto identify drug Offering forsaleorsellingthepr On informationandbelie On informationandbelief,Enz and reducetargetRNAforfurtherdrugdiscovery; Offering forsaleorsellingthepro
nue from Enzon. tation, and/oruseofthe occurred in theUnitedStates. occurred in subject ofFDAapproval;(b)itconstitutesan f, theactivityofoffe -23- les acquiredfrom Santarisunderthe2006 searcher formedareasonablebasisfor searcher r forsale,and/or Delaware,andSantar for sale, a sale, importation, and/oruse importation, for sale,a es toEnzon,aswelltheactivityof or importing antisensecompounds as further evidenced by Santaris’s furtherevidencedby as States, infringedIsis’s‘199patented d inthe‘500and‘739Patents, rk through aparticularbiological ocess ofscreeningandidentifying ioma-associated oncogene-2inor candidatesfordrugdevelopment; tivity isnot exempt underSection cess ofusing gapmers toidentify on isaU.S.-basedcompany, methods claimedinthe‘199 C ASE 2 ND ring forsaleandselling N O A .
11-CV-02214 MENDED P importation thatis ATENT is’s offerforsale, C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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would constitutepatentinfringement of knew ofthe‘199Patentattime ofi collaborators to use,intheUnited States, believing thataspecific compoundmay wo in discoveryactivity beforethetrained offer forsale,a use, a researchtoolthat (a)itconstitutesanofferfo 271(e)(1) because: DM_US 55841402-5.058823.0336 methods recitedinthe‘199Patent,includingby, selling oftheSantaristechnologyin the UnitedStates.Oninformation andbelie Cambridge, MassachusettsandSantaris’s offe from Shireandusedsuchrevenue and confirming asalehaso Santaris press release is attached hereto isattached Santaris pressrelease payments inconnectionwiththese fivepr future. Santarispotentiallycouldcolle for threetargetsandanadditionaltwota and royalties forprovidingaccessto[San significan whereby Santariswould“receive 64. 63. 62. 61. T HE
A gapmer candidatestoidentifydrug Offering forsaleandsellingthe pro On informationandbelief,suchac On informationandbelief,Santarisfurther inducedShireand/orits and reducetargetRNAforfu Offering forsaleandsellingthe pro On informationandbelief, Shir On August24,2009,Santarisannoun UGUST
is notitselfthesubject ofF 24,
2009, or inducinguse ofthemethods claimedinthe‘199Patent ccurred, Santarishasrecogni
A NNOUNCED NNOUNCED for Santariscommercialpurposes. -24- the ‘199PatentinUnitedStates. nducing the acts,andknew thatsuchacts as Exhibit7.)Oninformation andbelief, researcher formed a reasonable basis for formed areasonablebasisfor researcher ct more than$360million inmilestone Isis’s methods claimedinthe‘199Patent, rther drugdiscovery;and/or taris’s] LNA technology”andexclusivity ograms. (Acopyofth t upfront payments, milestone payments payments t upfrontpayments,milestone rgets tobenominated byShireinthe United StatestoShireinfringed Isis’s A f, theactivityofofferingforsaleand r forsaleandtoShireoccurredin GREEMENT GREEMENT r sale, a sale, use, or inducing use of orinducinguseof use, r sale,a rk through aparticular biological candidates fordrugdevelopment. tivity isnot exempt underSection e PLCmaintainsoperationsin inter alia DA approval;(b)itconstitutesan cess ofusing gapmerstoidentify cess ofscreeningandidentifying ced anagreementwithShirePLC C ASE W zed asrevenuepayments , 2 ND N ITH ITH O A .
11-CV-02214 MENDED P e August24,2009, S ATENT HIRE HIRE C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT PLC GPC ( KSC )
MCDERMOTT WILL & EMERY LLP ATTORNEYS AT LAW SILICON VALLEY 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 Case 3:11-cv-02214-GPC-KSCDocument283Filed10/17/14Page26of30
North CarolinaandSantaris’sofferforsale States. On information andbelief, theactiv States. Oninformation 271(e)(1) because: (a) itconstitu 271(e)(1) because:(a) DM_US 55841402-5.058823.0336 evidenced bySantaris’srecogni by Santaristhatitselfisnot reasonabl target cell;and/or(c)isacommercialoffe process toproducetheparticularphysiological effectofinhibiting the selected Santaris pressreleaseisatta payments underthe agreementwithGSK. could potentiallycollectinexcessof access toSantaris’sLNAtechnology andexcl million asanupfrontpayment,milestone Santaris’s commercialpurposes. (“GSK”)wherebySant GlaxoSmithKline the ‘199Patent,includingby, Santaris technologyintheUnitedStatesto Santaris hasrecognizedasrevenuepaymen tool that isnotitselfthe subjectofFDA a saleand/oruseof the methods claimed before the trained researcher formed are before thetrainedresearcher T HE D 68. 67. 66. 65. ECEMBER ECEMBER
gapmer candidatestoidentifydrug Offering forsaleandsellingthe pro On informationandbelief,suchac On informationandbelief,GSKma On information andbelief,conf 19,2007,Santaris On December and reducetargetRNAforfu Offering forsaleandsellingthe pro 19,
2007,
ched heretoasExhibit8.) A NNOUNCED NNOUNCED inter alia tion ofrevenuefromShire. tes anofferforsale,asale , -25- approval; (b)itconstitute $700million inupfrontandmilestone asonable basisforbelieving thataspecific A rther drugdiscovery;and/or y relatedtoFDAapproval,asfurther GSKinfringedIsis’smethodsrecitedin r forsale, sale,use, GREEMENT GREEMENT payments, androyaltiesforproviding payments, in the ‘199Patent andsaletoGSKoccurredintheUnited ts from GSKandused ity ofofferingforsa aris would receive approximately$8 aris wouldreceive (AcopyoftheDecember 19,2007, candidates fordrugdevelopment. tivity isnot exempt underSection usivity forfourtargets.Santaris announcedanagreementwith cess ofusing gapmerstoidentify cess ofscreeningandidentifying irming thatasalehasoccurred, intains operations in Durham, intains operationsinDurham, W C ASE ITH ITH 2 and/or use of a research and/oruseofaresearch ND N O G A .
in discoveryactivity 11-CV-02214 and/orinducing use MENDED LAXO le andsellingofthe P ATENT s anofferforsale, suchrevenuefor S C MITH I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC K ( KSC LINE )
MCDERMOTT WILL & EMERY LLP ATTORNEYS AT LAW SILICON VALLEY 28 27 26 25 24 23 22 21 20 19 18 17 16 15 14 13 12 11 10 9 8 7 6 5 4 3 2 1 Case 3:11-cv-02214-GPC-KSCDocument283Filed10/17/14Page27of30
contained inparagraphs1–68. attorneys’ feesunder35U.S.C.§285. enjoined from infringingthe‘199Patent. pursuant to 35U.S.C.§271(a),byengagi DM_US 55841402-5.058823.0336 approval, asfurtherevidencedbySantar commercial offerforsalea particular physiologicaleffect compound mayworkthroughaparticul contained inparagraphs1–68. of the‘199Patent. offer tosell,sale,orimportation oftheIs pursuant to 35U.S.C.§271(a),byengagi ‘199 PatentintheUnitedStates. Patent, pursuantto 35U.S.C.§271(b),by 76. 77. 75. 74. 73. 70. 69. 71. 72.
Plaintiff realleges andincorporat Plaintiff realleges On informationand belief,Santar andPlai This caseisexceptional, Plaintiff hasbeeninjuredbySantaris’sinfringement. Santaris’s infringementiswillful. On informationandbelief,Santar andincorporat Plaintiff realleges On informationandbelief,Santaris Plaintiff willbesubstantiallyandirre
(Infringement ofthe‘500Patent) (Infringement ofthe‘199Patent) SECOND CAUSE OF ACTION SECOND CAUSEOFACTION FIRST CAUSEOFACTION nd/or salethatisnot ofinhibitingtheselected -26- is’s recognition ofrevenuefromGSK. is patentedmethodspriortotheexpiration ng in the commercial manufacture,use, ng inthecommercial ng in the commercial manufacture,use, ng inthecommercial ar biological processtoproducethe actively inducinginfringementofthe is hasinfringedthe ‘500Patent, is hasinfringedthe‘199Patent, es byreferencetheallegations es byreferencetheallegations ntiff isentitledtoanawardof hasfurtherinfringedthe‘199 parably harmedifSantarisisnot reasonably relatedtoFDA C ASE target cell;and/or(c)isa 2 ND N O A .
11-CV-02214 MENDED P ATENT C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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by Santaris; A/S Corp.andSantarisPharmaA/S, attorneys’ feesunder35U.S.C.§285. enjoined from infringingthe‘739Patent. the expirationof‘739Patent. contained inparagraphs1–68. offer tosell,sale,orimportation ofthe pursuant to 35U.S.C.§271(a),byengagi attorneys’ feesunder35U.S.C.§285. enjoined from infringingthe‘500Patent. the expirationof‘500Patent. DM_US 55841402-5.058823.0336 offer tosell,sale,orimportation ofthe 1. WHEREFORE, Isispraysforjudgment ag 87. 86. 85. 84. 82. 83. 81. 80. 79. 78.
A judgment thatthe‘199,‘500and This case is exceptional, andPlai This caseisexceptional, Plaintiff hasbeeninjuredbySantaris’sinfringement. Santaris’s infringementiswillful. Plaintiff willbesubstantiallyandirre Plaintiff realleges andincorporat Plaintiff realleges On informationandbelief,Santar This case is exceptional, andPlai This caseisexceptional, Plaintiff hasbeeninjuredbySantaris’sinfringement. Santaris’s infringementiswillful. Plaintiff willbesubstantiallyandirre
(Infringement ofthe‘739Patent) THIRD CAUSEOFACTION PRAYER FORRELIEF -27- claimed compositions a claimed compositions a respectfully requeststhefollowingrelief: ng in the commercial manufacture,use, ng inthecommercial is hasinfringedthe‘739Patent, es byreferencetheallegations ainst Defendants,SantarisPharma ntiff isentitledtoanawardof ntiff isentitledtoanawardof ‘739 Patentshavebeen infringed parably harmedifSantarisisnot parably harmedifSantarisisnot C ASE 2 ND N O A .
11-CV-02214 MENDED nd methods priorto nd methods priorto P ATENT C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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DM_US 55841402-5.058823.0336 participation withalloranyofthem fro agents, servants, employees, andthose agents, servants,employees, expiration ofthe‘199,‘500an selling, orimporting intotheUnitedStates within thescopeof35U.S.C.§271(e)(1); ae: October17,2014 Dated: awarded itsattorneys’feesincurredin damages soadjudged betrebledpursuantto35U.S.C.§§283and284; 2. 6. 5. 4. 3.
A judgment forapermanentinjunctionenjoining Santaris, itsofficers, Such otherandfurtherreliefasthe Costs andexpensesinthisaction; A judgmentthatthisisanexceptionalcaseandPlaintiffbe An awardofdamagestogetherwith
Respectfully submitted, d/or ‘739Patents,exceptas By: MCDERMOTT WILL&EMERYLLP Attorneys forIsisPharmaceuticals,Inc. this actionpursuantto35U.S.C.§285; -28- m manufacturing,using, persons actinginactiveconcertor Isis’s methodsorproductspriorto the /s/ WilliamG.Gaede,III Court deems justandappropriate. interest,andajudgment thatthe William III G.Gaede, C ASE 2 to suchactivities,ifany, ND N O A .
11-CV-02214 MENDED P ATENT offering tosell,
C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )
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DM_US 55841402-5.058823.0336 ae: October17,2014 Plaintiffrespectfully requestsajury Dated:
DEMAND FORJURYTRIAL DEMAND MCDERMOTT WI By:
Attorneys forIsisPharmaceuticals,Inc. -29- trial onallissuestriablethereby. /s/ WilliamG.Gaede,III William III G.Gaede, C ASE LL &EMERYLLP
2 ND N O A .
11-CV-02214 MENDED P ATENT
C I OMPLAINT FOR OMPLAINT FOR NFRINGEMENT GPC ( KSC )