“孤儿药”智力成果特殊激励和规制机制研究

发布时间：2018-05-09 14:51

本文选题：孤儿药 + 市场独占销售权　；参考：《华东政法大学》2015年硕士论文

【摘要】：对于许多研习知识产权法的人而言,“孤儿药”可能属于一个极其陌生的概念。随着人类医疗卫生水平提升、社会伦理道德进步以及知识产权法、竞争法、药事法等相关法律的演进,对于创设“孤儿药”特殊激励、保护、规制机制的研究,理应得到更多法律人的关切。“孤儿药”,亦称罕见病专用药,专门指称用于预防、诊断、治疗或者控制罕见疾病或者罕见状态的药物,广义的孤儿药还包括疫苗、诊断试剂、医用器械等。较之普通药物,“孤儿药”针对的目标市场狭窄、研发难度极大、研发投入惊人,同时还面临药物专利审查期间冗长、专利有效保护期间被占用、临床实验样本有限无法满足行政审批要求、相关专门性立法空白等法律困境。故,极易成为被药企“遗弃的孤儿”。但是,罕见病患者对于“孤儿药”的依赖却往往是攸关性命且终其一生的,这一对困扰法律、医学乃至社会的矛盾亟待解决,且应当寻求妥善之策。“孤儿药”,亦称罕见病专用药,专门指称用于预防、诊断、治疗或者控制罕见疾病或者罕见状态的药物,广义的孤儿药还包括疫苗、诊断试剂、医用器械等。较之普通药物,“孤儿药”针对的目标市场狭窄、研发难度极大、研发投入惊人,同时还面临药物专利审查期间冗长、专利有效保护期间被占用、临床实验样本有限无法满足行政审批要求、相关专门性立法空白等法律困境。故,极易成为被药企“遗弃的孤儿”。但是,罕见病患者对于“孤儿药”的依赖却往往是攸关性命且终其一生的,这一对困扰法律、医学乃至社会的矛盾亟待解决,且应当寻求妥善之策。本文以“孤儿药”之中可专利化、不适宜专利化的智力成果为焦点,集中考查美、欧、日、韩等发达国家在孤儿药立法、司法方面的先行经验,尝试探索解决我国“孤儿药”困局的法律出路。从宏观法律体系层面来看,笔者认为解决孤儿药专利特殊保护机制的路径大致存在两种模式:第一,在现有专利制度框架内,创设针对孤儿药的例外规则;第二,借鉴发达国家广泛采用的模式,在广义的知识产权法框架内创设孤儿药法案——形成一套与专利制度并行不悖的特殊保护机制,并允许和鼓励药企根据研发潜在药物的不同属性选择合适的保护路径。同时,本文充分结合我国特殊国情和相关立法倾向性,总结和归纳一些有益的启示和经验,撰此拙文,权作抛砖引玉之用。本文共分五个章节。第一章对“孤儿药”及罕见病的相关背景知识进行概述,厘清本文将会涉及的医药概念,为后文展开论述做必要铺垫。同时,在此基础上对世界范围内主要国家、尤其是发达国家关于“孤儿药”立法情况进行了整理和汇编,大致阐明了“孤儿药”立法的总体发展脉络。第二章将视角返回中国,本人通过大数据整理、法律法规梳理、文献比较研究等方式,深入剖析了中国“孤儿药”的发展现状,揭示了中国“孤儿药”研发迟滞、求药无门、药价畸高的尴尬。另外,针对上述“孤儿药”的现实窘境,本人从专利法、不正当竞争法等相关领域的既定规则出发,分析了现行规则对于此类特殊客体激励和保护机制失灵的法律根源,以及“孤儿药”寻求现行法律保护掣肘的其他深层根源。第三种重在阐述和分析以美国孤儿药法案(Orphan Drugs Act)、孤儿药实施条例(Orphan Drugs Regulations)、《药价竞争和专利期限补偿法》(“哈奇·维克斯曼修正案”,Hatch-Waxman Amendments)为代表的各国立法经验,总结和梳理了一些列值得借鉴的规则,既包括激励机制,也包括对不正当竞争的规制机制。同时,本人收集、考查、分析、比较了丰富详实的案例资料,如Baker Norton Pharmaceuticals,Inc.v.United States Food and Drug Administration,Genentech,Inc.v.Bowen,Sigma-Tau Pharmaceuticals,Incorporated,v.Bernard A.Schwetz,Intermedics.Inc.v.Ventritex.Inc.,Amgen.Inc.v.International Trade Commission等。通过上述经典判例,动态阐述了司法判例推动立法日臻完善的进程,探讨和反思各国“孤儿药”法案创设的激励和规制机制的成效和缺陷。第四章尝试探讨我国“孤儿药”智力成果特殊保护机制的解决之道。在前文的基础上,本人提出了两种宏观的构想:(一)在现行广义的知识产权法、药事法框架内创设针对性的“孤儿药”的例外规则;(二)仿效发达国家经验,创设专门的孤儿药法案。本文进一步考虑到我国尚处于发展中国家的特殊国情,不适合仿效倾向经济利益的美国规则,也不适合复制欧盟、日本等寻求平衡的立法初衷,应当以适当照顾公共健康为创设规则的根本要义和精神。故,本文在提出一些激励机制构想的同时,侧重于对相关限制和规制不正当竞争的研究,主要指:(一)在现行广义的知识产权法、药事法框架内创设针对性的“孤儿药”的例外规则,同时相应地完善和细化Bolar例外(Bolar Exemption)规则,包括桔皮书制度(Orange Book)、专利链接(Patent Linkage)制度,涉诉中止审查制度、仿制药市场独占销售期制度等,鼓励仿制药企积极挑战现有医药专利;(二)如果通过创设孤儿药法案的途径,那么同时应当考虑孤儿药上市后限制药价畸高、消除市场垄断、撤销市场独占销售权、控制药物伦理风险等问题,注重兼顾病患福祉、社会公共利益与制药行业经济利益之间利益平衡。第五章总结全文核心观点,阐述对我国改革和探索“孤儿药”特殊保护机制的启示,重申对“孤儿药”特殊激励和规制机制的研究正是“为天才之火浇上利益之油”的延伸。无论今后的立法实践会选择何种方式,在平衡患者福祉和药企利益的过程中,知识产权法律都应该发挥它应有的积极作用。
[Abstract]:For many people studying intellectual property law, "orphan medicine" may belong to an extremely strange concept. With the improvement of the level of human health and health, the progress of social ethics and morality, the law of intellectual property, the law of competition and the law of medicine, the study of the special incentive, protection and regulation mechanism for the creation of "orphan drugs", "Orphan drugs", also known as special drugs for rare diseases, specifically refer to drugs used in the prevention, diagnosis, treatment or control of rare diseases or rare states. The generalized orphan drugs include vaccines, diagnostic reagents, medical instruments, and so on. It is narrower than the target market for universal drugs and orphan drugs. It is very difficult, the R & D investment is amazing, and it also faces the lengthy period of drug patent examination, the occupation of the patent effective protection, the limited clinical experimental samples can not meet the administrative examination and approval requirements, the relevant special legislative blanks and other legal difficulties. Therefore, it is very easy to be abandoned by the pharmaceutical enterprises. "The dependence of" is often a life and a lifetime. This is an urgent solution to the contradictions of law, medicine and society. "Orphan medicine", also known as a special medicine for rare diseases, specifically refers to drugs used in the prevention, diagnosis, treatment or control of rare diseases or rare States, and a broad sense of orphan drugs. It includes vaccines, diagnostic reagents, medical instruments and so on. The target market is narrower than the common drug, "orphan medicine", the research and development is very difficult, the R & D investment is astonishing, the period of drug patent examination is long, the patent effective protection is occupied, the clinical laboratory sample is limited to meet the requirements of administrative examination and approval, related special legislation. Therefore, it is very easy to be abandoned by the pharmaceutical enterprises. However, the dependence of the rare patients on the "orphan medicine" is often a vital and final life. This is an urgent solution to the contradictions of law, medicine and even the society, and should be sought. This article is patented in the "orphan medicine". It is not suitable for the intellectual achievements of patentability to focus on examining the legislative and judicial experience of orphan drugs in the developed countries of the United States, Europe, Japan, Korea and other developed countries, trying to explore the legal way out to solve the dilemma of "orphan medicine" in our country. From the macro legal system level, the author thinks that the path to solve the special protection mechanism of orphan drug patent exists roughly. Two models: first, in the framework of the existing patent system, create exceptional rules for orphan drugs; second, draw on the widely adopted model in the developed countries, create an orphan drug bill within the framework of the broad sense of intellectual property law - to form a set of special protection mechanisms that do not run counter to the patent system, and to allow and encourage pharmaceutical enterprises to submerse according to research and development. At the same time, this article fully combines our country's special national conditions and the relative legislative tendency to sum up and sum up some useful revelations and experiences in this article. This article is divided into five chapters. The first chapter is about the related background knowledge of "orphan medicine" and rare diseases. The article clarifies the concept of medicine that will be involved in this article, and makes the necessary paving for the later article. At the same time, on this basis, the main countries in the world, especially the developed countries, have been collated and compiled about the legislation of "orphan medicine", and the general development of the "orphan medicine" legislation is roughly clarified. The second chapter returns the angle of view. In my country, I have thoroughly analyzed the development status of "orphan medicine" in China through large data sorting, law and regulation, literature comparison and so on. It reveals the awkward situation of Chinese "orphan medicine" research and development, no door and high price. In addition, in view of the realistic predicament of the "orphan medicine", I from the patent law, the unfair competition law and so on. According to the established rules of the related fields, the legal origin of the failure of the incentive and protection mechanism of such special objects, and the other deep roots of the "orphan medicine" for the protection of the existing legal protection are analyzed. The third emphasis is on the American Orphan Drug Act (Orphan Drugs Act), the orphan drug implementation Ordinance (Orphan Dr) UGS Regulations), < price competition and patent term compensation law > ("Hacci Waxman amendment", Hatch-Waxman Amendments) as the representative of the legislative experience of various countries, summed up and combed some of the rules worthy of reference, including the incentive mechanism, including the regulation mechanism of unfair competition. At the same time, I collect, examine, analyze, and compare More detailed and detailed case data, such as Baker Norton Pharmaceuticals, Inc.v.United States Food and Drug Administration, Genentech, Inc.v.Bowen, Sigma-Tau, etc. In the fourth chapter, we try to explore the solution to the special protection mechanism of the intellectual achievement of "orphan medicine" in our country. On the basis of the previous article, I put forward two kinds of macro ideas. (1) to create an exceptional rule of "orphan medicine" in the framework of the current broad sense of intellectual property law and medicine law; (two) to create a special orphan drug bill in the imitation of the experience of the developed countries. This article further considers that the special national conditions of China are still in the developing countries and are not suitable for the imitation of the American rules of economic interest. To copy the European Union, Japan and so on to seek the balance of legislation, we should take proper care of public health as the fundamental meaning and spirit for the creation of rules. Therefore, this article puts forward some ideas of incentive mechanism and focuses on the study of the related restrictions and regulation of unfair competition, mainly: (1) in the current broad sense of intellectual property law and the framework of the pharmaceutical law To create an exceptional rule of "orphan medicine", and to improve and refine the Bolar exception (Bolar Exemption) rules, including the orange book system (Orange Book), the patent link (Patent Linkage) system, the prosecution suspension review system, the pharmaceutical market monopolizing the sale period system and so on, encourage the generic pharmaceutical enterprises to challenge the existing medical specialty. (two) if the orphan drug bill is created, it should be considered at the same time to consider the limit of the drug price after the orphan drug listing, eliminate the market monopoly, revoke the market monopoly and control the risk of drug ethics, pay attention to the welfare of the patients and balance the interests of the social public interests and the economic interests of the pharmaceutical industry. The full text points out the inspiration of the special protection mechanism for the reform and exploration of "orphan medicine" in our country, reaffirms the extension of the study on the special incentive and regulation mechanism of "orphan medicine", which is the extension of "the oil of interest for the fire of genius". In the process, intellectual property law should give full play to its positive role.

【学位授予单位】：华东政法大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R95;D923.42

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