仿制藥品中專利糾紛解決方案

Welldevelopedpatentprotectionsystem

成熟的專利保護(hù)制度

Welldevelopedawarenessofpatentprotection

成熟的專利保護(hù)意識

Marketrules

公平的市場規(guī)則RuleofGame游戲規(guī)則PatentProtectionofPharmaceuticals

藥品專利保護(hù)的形式Compounds,mAbs

化合物，單抗Pharmaceuticalcomposition

藥物組合物Medicaluse

制藥用途：適應(yīng)癥Formulation

制劑Methodofmanufacture

制造方法Secondaryinventionssuchassalts,crystalformsetc.

衍生發(fā)明，例如鹽、晶型等Freedom-to-operate

排除專利侵權(quán)風(fēng)險(xiǎn)

Expiryofcompoundpatentdoesnotnecessarilymeanfreedom-to-operate

化合物專利過期并不當(dāng)然意味著不再有侵權(quán)風(fēng)險(xiǎn)PharmaceuticalFTOrequiressystematicpatentsearchandanalysisoneachfactorssuchasAPI,formulation,manufactureprocessetc.

排除侵權(quán)風(fēng)險(xiǎn)需要就藥品的活性成分、配方、制造方法等各個(gè)環(huán)節(jié)進(jìn)行系統(tǒng)的專利檢索、分析

FTOsearchandanalysisrequireprofessionalskill

專利侵權(quán)風(fēng)險(xiǎn)的檢索和分析需要專業(yè)的知識和技能PatentInfringementAnalysis

專利侵權(quán)分析

Claimconstructionanddoctrineofestoppel;

權(quán)利要求的解釋和禁止反悔原則

Fullcoverageofclaimfeatures;

侵權(quán)判定的全面覆蓋原則

Literalinfringement

文字侵權(quán)Infringementunderdoctrineofequivalents

等同侵權(quán)PatentInfringementAnalysis

專利侵權(quán)分析RulesoninfringementunderDOC

等同侵權(quán)的判斷標(biāo)準(zhǔn)substantiallythesamemeans基本相同的手段;substantiallythesamefunction基本相同的功能；

substantiallythesameeffect基本相同的效果；

obvioustooneskilledintheart兩特征的替換顯而易見。InterpretationofFunctionalFeatures

功能性特征的解釋InCourts,afunctionallimitationisconstruedascoveringspecificembodimentsasdescribedinthespecificationandequivalents

thereof

法院對功能性限定的解釋限于說明書中的具體實(shí)施方式和其等同方式ICUMedicalvs.HainanBaiheMedical(2010):non-infringementbecause14examplesallrelatetoafunctionallydefinedsealwithpassagethereininthepatentwhilethesealindefendant’sproductissolid.

北京二中院2010年案例DesignAround規(guī)避設(shè)計(jì)Keepfromthepatentprotectionscope

跳出專利保護(hù)范圍Lackofaclaimfeature

缺少權(quán)利要求的技術(shù)特征Changeaclaimfeature

改變權(quán)利要求的技術(shù)特征ValidityChallenges挑戰(zhàn)專利的有效性Patentinvalidationprocedureandsubsequentadministrativeaction專利無效程序以及隨后的行政訴訟PriorArtDefense現(xiàn)有技術(shù)抗辯

Art.14ofJudicialInterpretation

最高人民法院關(guān)于專利糾紛司法解釋第14條Wherealltechnicalfeaturesaccusedoffallingintothescopeofapatentrightareidenticaltoorhavenosubstantivedifferencerelativetocorrespondingtechnicalfeaturesinasingletechnicalsolutionofthepriorart.與現(xiàn)有技術(shù)中單一技術(shù)方案相同或無實(shí)質(zhì)性差別，則直接認(rèn)定不侵權(quán)PatentDisputeDuringDrugApproval

藥品注冊過程中的專利糾紛PatentdisclosurerequirementunderDrugRegistrationRegulation

藥品注冊管理辦法要求披露專利信息

Anon-infringementstatementbasedonprofessionalopinion專利不侵權(quán)的保證應(yīng)該基于專業(yè)的檢索分析意見Otherwise,thereissignificantlegalrisk

否則存在顯著的法律風(fēng)險(xiǎn)Governmentagencyisadvisedtomorerelyonprofessionallegalopinions建議政府機(jī)構(gòu)更多依賴專業(yè)的法律意見

DisputeResolution

爭議解決Negotiation

友好協(xié)商Litigation

訴訟途徑Declaratoryjudgmentsuitbygenericcompany;

仿制藥公司提起確認(rèn)不侵權(quán)之訴ActionunderDrugAdminstrativeLawbythepatentee;

專利權(quán)人提起藥品行政管理法下的訴訟Non-infringementDeclaration

不侵權(quán)確認(rèn)之訴

ShanghaiPharmavs.Sunstone

(2010)

Couldadeclaratoryactionbeaccepted