仿制药品中专利纠纷解决方案.pptVIP

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 manufacture 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, 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 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。 Interpretation 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 functionally defined seal with passage therein in the patent while the seal in defendant’s 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