Patent Dispute Resolution Relating to Generics
仿制药中的专利纠纷解决方案
Wenping Chen 陈文平
November 18, 2011
Rule of Game 游戏规则
Well developed patent protection system
成熟的专利保护制度
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 Adminstrative Law by the patentee; 专利权人提起药品行政管理法下的诉讼
Freedom-to-operate
排除专利侵权风险
Expiry of compound patent does not necessarily mean freedom-tooperate 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
Well developed awareness of patent protection
成熟的专利保护意识
Market rules
公平的市场规则
药品专利保护的形式
Patent Protection of Pharmaceuticals
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
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
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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? YES 2010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
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
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与现有技术中单一技术方案相同或无实质性差别，则直认定 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
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THANK YOU.
Wenping Chen
chenwenping@
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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
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
Patent invalidation 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
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Where all technical features accused of falling into the scope of a patent right are identical to or have no substantive difference relative to corresponding technical features in a single technical solution of the prior art.
专利侵权分析
Patent Infringement Analysis
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。