181500CNENPatentDisputeResolutionReGenericsNov18仿制药品中专利纠纷解决方案.ppt

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1、Well developed patent protection system 成熟的专利保护制度 Well developed awareness of patent protection 成熟的专利保护意识 Market rules 公平的市场规则,Rule of Game 游戏规则,Patent Protection of Pharmaceuticals药品专利保护的形式,Compounds,mAbs 化合物，单抗 Pharmaceutical composition 药物组合物 Medical use 制药用途：适应症 Formulation 制剂 Method of manufact

2、ure 制造方法 Secondary inventions such as salts,crystal forms etc.衍生发明，例如盐、晶型等,Freedom-to-operate排除专利侵权风险,Expiry of compound patent does not necessarily mean freedom-to-operate 化合物专利过期并不当然意味着不再有侵权风险 Pharmaceutical FTO requires systematic patent search and analysis on each factors such as API,formulation

3、,manufacture process etc.排除侵权风险需要就药品的活性成分、配方、制造方法等各个环节进行系统的专利检索、分析 FTO search and analysis require professional skill 专利侵权风险的检索和分析需要专业的知识和技能,Patent Infringement Analysis专利侵权分析,Claim construction and doctrine of estoppel;权利要求的解释和禁止反悔原则 Full coverage of claim features;侵权判定的全面覆盖原则 Literal infringement

4、文字侵权 Infringement under doctrine of equivalents 等同侵权,Patent Infringement Analysis专利侵权分析,Rules on infringement under DOC 等同侵权的判断标准 substantially the same means 基本相同的手段;substantially the same function 基本相同的功能；substantially the same effect 基本相同的效果；obvious to one skilled in the art 两特征的替换显而易见。,Interpret

5、ation of Functional Features功能性特征的解释,In Courts,a functional limitation is construed as covering specific embodiments as described in the specification and equivalents thereof 法院对功能性限定的解释限于说明书中的具体实施方式和其等同方式ICU Medical vs.Hainan Baihe Medical(2010):non-infringement because 14 examples all relate to a

6、functionally defined seal with passage therein in the patent while the seal in defendants product is solid.北京二中院2010年案例,Design Around 规避设计,Keep from the patent protection scope 跳出专利保护范围Lack of a claim feature 缺少权利要求的技术特征Change a claim feature 改变权利要求的技术特征,Validity Challenges 挑战专利的有效性,Patent invalidat

7、ion procedure and subsequent administrative action专利无效程序以及随后的行政诉讼,Prior Art Defense 现有技术抗辩,Art.14 of Judicial Interpretation 最高人民法院关于专利纠纷司法解释第14条Where all technical features accused of falling into the scope of a patent right are identical to or have no substantive difference relative to correspondi

8、ng technical features in a single technical solution of the prior art.与现有技术中单一技术方案相同或无实质性差别，则直接认定不侵权,Patent Dispute During Drug Approval药品注册过程中的专利纠纷,Patent disclosure requirement under Drug Registration Regulation 药品注册管理办法要求披露专利信息 A non-infringement statement based on professional opinion 专利不侵权的保证应该

9、基于专业的检索分析意见 Otherwise,there is significant legal risk 否则存在显著的法律风险 Government agency is advised to more rely on professional legal opinions 建议政府机构更多依赖专业的法律意见,Dispute Resolution争议解决,Negotiation 友好协商 Litigation 诉讼途径Declaratory judgment suit by generic company;仿制药公司提起确认不侵权之诉Action under Drug Adminstrati

10、ve Law by the patentee;专利权人提起药品行政管理法下的诉讼,Non-infringement Declaration不侵权确认之诉,Shanghai Pharma vs.Sunstone(2010)Could a declaratory action be accepted in the approval stage considering the Bolar exception in Patent Law?YES2010年石家庄中院案例：新专利法下在药品审批阶段仍然可以提起专利不 侵权确认之诉,THANK YOU.,Wenping Chenchenwenpingkingandwood,