医疗方法可专利性研究

【作者】 庹明生；

【导师】 张玉敏；

【作者基本信息】 西南政法大学 ， 法律， 2007， 硕士

【摘要】 医疗方法在我国被排除在专利法客体之外。其理由：一是出于人道主义的考虑和社会伦理的原因，医生在诊断和治疗过程中应当有选择各种方法和条件的自由；二是，这类方法直接以有生命的人体或动物体为实施对象，无法在产业上利用。美国通过对医疗方法专利权效力的限制基本上解决了第一个问题；欧洲专利公约将原来认为医疗方法属不具产业利用性之规定，修正为不属于专利法保护的对象，也就是说现行的欧洲专利公约认为医疗方法还是可能具有产业利用性的；日本，2002年4月11日东京高等法院判决给医疗方法可专利性留下了生存的空间；Trips理事会也在对医疗方法专利是否开禁进行审议。等等都表明：医疗方法可予以专利保护是一种趋势。而在我国，我们仍然沿用欧洲专利公约以往的理念，只是在形式上跟进欧洲专利公约，很少有人对医疗方法可专利进行理论和实务方面的探讨。本文从对世界主要国家、地区及专利组织对于医疗方法可专利性的介绍中得到启示：对于医疗方法可专利性的制度构建、完善必须来源于医疗方法可专利性的实践，即对于医疗方法可专利性的制度的运用；从理论上分析医疗可专利性问题得出的结论：医疗方法可专利性具有正当性，其可专利性和社会公共利益是一致的；构建我国医疗方法可专利性制度应当建立一个相对开放的体系，以开放医疗方法可专利性的实践。完善复审委员会以确保在我国形成自己的对医疗方法可专利性的理念和价值判断体系。本文分三个部分。第一部分是世界主要国家、地区、专利关于医疗方法可专利性的介绍。根据世界主要国家、地区、专利组织对于医疗方法开放的程度不同，将世界上的主要国家、地区、专利组织对于医疗方法可专利的立法例分为完全开放型、部分开放型和未开放型三种。该部分重点对美国、欧洲专利公约组织、日本关于医疗方法可专利性的规定和实践介绍。美国专利法从来没有排除医疗方法的可专利性。在专利审查的实践中，美国通过判决或决定形成了不予专利保护；给予专利法保护；给予专利法保护但权利的效力应当受到限制三个阶段。其理由也从医疗方法不属于发明的范畴，医疗方法的结果具有不确定性，医疗方法专利授予不符合公众的利益和医师的职业道德。到后来认为：医学或外科方法是不可以进行专利保护的主题仅仅是因为包含了治疗人体，该决定明显应当被否决。最终1980年美国最高法院确立了“在阳光下任何由人类所制造的物品都可以受到专利制度保护”的著名论断。美国现行专利法对医疗方法专利权利效力的限制是各方利益平衡的结果，其各方提出的理由及最终的规定对于我们构建医疗方法专利制度具有一定的参考价值。欧洲专利公约明确将医疗方法排除在该公约的保护范围之外，但是公约及其后的专利审查基准均未对医疗方法内涵划定一个清楚界限。欧洲专利局对于医疗方法相关专利申请的审查是以维持公共利益为前提下，将医疗方法在一定范围内作限缩解释为原则。欧洲专利局技术上诉委员会决定T385／86对诊断方法的判断原则归纳为：检查和资讯、判断症状阶段、推定医学判断阶段，且三步缺一不可；认为诊断方法的可专利性，是依据诊断的方法本身性质来判断；必须由具有医学知识的人员来操作。该原则先后被T775／92决定、T964／99决定所打破。治疗方法判断规则，欧洲专利局上诉委员会通过一系列决定进行界定，认为：“治疗”不应仅限定于使疾病治愈、恢复健康的处置方法，还包括用于维持健康的预防疾病方法。由自然环境引起的“暂时性”的生理状况，由于其可藉简单的休息而消除，此种症状的解除不属于“治疗”的范畴；所请方法中只要是其中之一种物质处理步骤的目的牵涉到治疗即为治疗方法；是否需要医学人员进行操作只是一个辅助条件。介入生物体并不会使生物体死亡的方法都归为手术方法，且在处理方法之多个步骤中，只要出现一个手术步骤就被归结为手术方法，不具有可专利性。日本关于医疗方法可专利性，是在其审查基准中规定的。其理由是认为医疗方法无法在产业中利用，且仅限于对人体的医疗方法。该认识被2002年东京高等法院判决打破。2003年日本特许厅针对医疗方法公布有关“产业上利用性部分”修正版本也限制了医疗方法的范围。第二部分是医疗方法可专利性的分析针对医疗方法可专利性论争的焦点。从医疗方法归属于知识产品这一出发点，分析了医疗方法具有财产法保护对象的特征；用法律经济学的观点论述了医疗方法可作为专利法的客体，认为医疗方法可专利性具有正当性。从专利法目的的社会属性分析医疗方法的可专利性和公共利益的一致性；从专利权的赋予和保护的社会属性来看，准予医疗方法专利的弊端是可以克服的。在公共政策中关于知识产权的保护政策讨论中，我们认为在“国际化”潮流下的今天，给与医疗方法以弱保护是不合适的。第三部分是我国医疗方法可专利性的介绍和制度完善介绍我国医疗方法可专利性的制度和欧洲专利公约组织对医疗方法可专利性的制度比较，发现：我国医疗方法可专利性制度，实际上是欧洲专利组织专利法及一系列决定所形成的规则的“翻版”。只不过是有其形式而没有其实质。借鉴美国、日本的经验，结合我国的实际情况建议：删除专利法第二十五条第一款第三项之规定，在法律的层面上，解除医疗方法这一禁区，在专利法在相关条文中可以采用美国的模式对可授予医疗方法专利的权利效力进行限制；在指南层面上，采用日本的模式对医疗方法专利划定一个“相对禁区”，给医疗方法可专利性制度运用留下一定的空间，形成制度制定和运用的良性互动；完善专利复审委员会的人员选任制度；规定专利复审委员会解释指南职权；规定专利复审委员会应当在决定中将各方意见公之于众；专利复审委员会定期将决定进行整理以指导审查实务。更多还原

【Abstract】 The reasons that medical methods have been kept out of Patent Law in our country are: humanitarianism and ethics, namely, a doctor should have a right electing different medical methods, and these can’t be utilized in Industry because its’ objects are living human or animal bodies. In American, the first problem has been solved through restricting patent fight. In Europe, patent-ability of medical methods has gone through from inapplicable to applicable in Industry. In Japan, a space for patent eligibility of medical methods is left over by Tokyo Superior Court’s judgment, April 11, 2002. Trips’ council is discussing whether to lift a ban for it. These indicate: that medical methods are given Patent Law protection is a trend.In our country, we still stick to past idea of EPC. Little probe into patent-ability of medical methods from theory and practice. We give some ideas from this dissertation: that patent constitution of medical methods are established and consummated should derive from the practice of its; patent-ability of medical methods has its rightness because its and public profits are consistent. We should set up an open Patent Law system; perfecting Patent Reviewing Committee may ensure that we establish our-self idea and value system in medical methods patent.The dissertation is divided into three parts.The first part is "introducing medical methods patent system of major countries, districts and patent constitutions in the world."According to opening extent, legislations of major countries, districts and patent constitutions in the world are divided into three types: complete opening, part opening and un-opening. We focus to introduce the legislation and practice of American, EPC and Japan in medical methods patent.There is not exempted from Patent Law in America for medical methods patent. In practice, it has undergone three stages: un-giving Patent Law protection; giving Patent Law protection and giving Patent Law protection, but its effectiveness restricted. Its’ reasons has evolved from granting medical methods patent and public profits, professional morality of physician being not unanimous, to granting it patent because it is made by man. These days, America Patent Law is a balance of all profits. Its reasons and descriptions for constituting our patent system of medical methods have value.Medical methods are excluded from European Patent Treaty, but medical methods aren’t defined by it and guideline. In practice, they are defined in a narrow scope according to public profits. Diagnose methods are concluded: check and consultation, symptom judged, medicine supposed, and three stages being must, and these must be done by medicine staff because of themselves. Therapy methods don’t only include heal diseases, but include prevent diseases also. That symptom is caused by surroundings, can be eliminated by having a rest isn’t belong to therapy methods. It isn’t must to complete these by physician.Surgery method is defined as entering into creature body and not causing him death. A method that includes several steps shouldn’t be granted patent if a step is considered as surgery method.Japan, medical patent is prescribed in guideline. Medical methods are not granted patent (only human body), because they can’t be utilized in industry. This idea has been gone through by Tokyo Superior Court’s judgment.The second part is "the analysis regarding the patent-ability of medical methods".From property law, medical methods should be its object; from legal economics, medical methods should be the object of patent law; from the motive of patent law, it is identical to grant patent to medical methods with public profits; from social nature of patent, disadvantage of granting medical methods patent may be conquered. In public policy of intellectual property, we think it un-right to give medical methods patent less protection.The third part is "introducing and consummating patent system of medical methods in our country".Though comparing patent-ability of medical methods of our country and with EPC, we find that we is a copy of European Patent Treaty, but formal not substantial.Using for reference of America and Japan, and our actuality, we suggest: first, we should delete 25s1(3) of Patent Law and adopt the mode of America, granting patent to medical methods and restricting its effectiveness; second, we should adopt the mode of Japan, giving a "relative forbidden zone" to medical methods patent in guideline; third, complete Patent Reviewing Committee, including: selecting personnel, granting it to explain guideline, prescribing it must promulgate different ideas in decisions to public and summarize decisions for guiding practice in a role period.更多还原