基于专利分析的抗抑郁药物发展研究

发布时间：2018-04-22 18:02

本文选题：专利分析 + 抗抑郁药　；参考：《河南大学》2014年硕士论文

【摘要】：随着生活节奏的加快、社会压力的增加,人们心理承受力降低,患抑郁症的比例有增无减,抑郁症已成为世界第二大疾病(仅次于心脑血管病)。抑郁症患者之多且治疗周期之长,已成为近年来抗抑郁药物畅销的原因,因而抗抑郁药物也成为各大制药公司研究的热点。但随着化学创新药物的研发越来越难,仿制药产业日渐兴盛。我国作为仿制药生产大国,必然会对抗抑郁药物的仿制引起重视。尤其是随着我国《药品注册管理办法》的修改,必然会加速我国仿制药上市,而我国药品专利法对药品的专利保护也越来越严格,到时我国仿制药企业可能会面临更多的专利诉讼。鉴于此,本文采用文献归纳、比较研究对抗抑郁药物国内外发展现状进行了系统全面的研究,以国家知识产权局专利检索与服务系统、欧洲专利局、美国食品药品监督管理局橙皮书所提供的数据为基础,运用专利统计分析和内容分析方法,对抗抑郁药物中国专利申请现状有了大体的了解,并通过对全球畅销及新上市抗抑郁药物专利文献信息及专利保护策略进行深入的探讨。本文首先对专利分析相关概念与方法进行了简单概述,然后对抗抑郁药物专利进行了统计分析,并对全球畅销及新上市抗抑郁药物专利文献信息进行了内容分析,在此基础上,对抗抑郁药物专利保护策略进行分析,最后试图从专利信息中寻求技术信息、法律信息,为我国仿制药企业的抗抑郁药物研发和经营提供参考。专利统计结果显示,抗抑郁药物在我国近20年专利申请较多,高达1917件,国内申请人专利在数量上稍占优势,表明我国已经开始重视抗抑郁药物的研发,但研发仍处于公司、高校研究所、个人三分天下的局面,若提高专利的成果转化率,公司需加强与高校研究所和有潜力的个人合作。内容分析结果表明,全球畅销及新上市抗抑郁药物的原研公司通过对化合物专利的产品构型申请盐、晶型、溶剂化物、代谢物等专利及剂型改造如复方制剂、缓控释制剂等新剂型的基本专利和方法专利,用途专利等外围专利来延长产品专利保护时间,获取市场独占权。但同时,通过关注专利的同族中国专利及法律状态,发现有些专利未在我国申请保护,或者已有专利因各种原因权利已终止。因而我国仿制药企业可以免费使用终止专利的技术信息,加快仿制药上市。专利策略研究结果显示,成功开发的药物在专利保护上往往通过构筑药品专利保护网,围绕化合物分子构型申请基本专利,并通过申请外围专利阻止仿制药上市。仿制药企业在了解药品专利保护网的构成后,应及早对药物专利文献进行研究,寻找专利网的漏洞并编织属于自己的专利网络以分得市场。
[Abstract]:With the quickening of life rhythm and the increase of social pressure, people's psychological endurance decreases, and the proportion of depression increases. Depression has become the second largest disease in the world (second only to cardiovascular and cerebrovascular diseases). The large number of depression patients and the long treatment cycle have become the reason for the popularity of antidepressants in recent years, so antidepressants have also become a hot research topic in many pharmaceutical companies. But with the development of chemical innovative drugs becoming more and more difficult, the generic drug industry is flourishing. As a big country in the production of generic drugs, China is bound to pay attention to the imitation of antidepressant drugs. In particular, with the revision of the Administration of Drug Registration in China, it will inevitably accelerate the marketing of generic drugs in China, and the patent protection of drugs in China's drug patent law is becoming more and more stringent. At that time, China's generic drug companies may face more patent litigation. In view of this, this paper makes a systematic and comprehensive study on the status quo of antidepressant drugs at home and abroad by means of literature summarization, with the patent retrieval and service system of the State intellectual property Office, the European Patent Office, Based on the data provided by the US Food and Drug Administration's orange peel book and using the methods of patent statistics and content analysis, the current status of patent applications for antidepressant drugs in China has been generally understood. The patent information and patent protection strategy of global best-selling and new anti-depressant drugs were discussed. In this paper, the concepts and methods of patent analysis are briefly summarized, then the patent of antidepressant drugs is statistically analyzed, and the literature information of global best-selling and newly listed antidepressant drugs patent is analyzed. This paper analyzes the patent protection strategy of antidepressant drugs, and finally attempts to seek technical information and legal information from patent information to provide reference for the development and management of antidepressant drugs in Chinese generic drug enterprises. The results of patent statistics show that the number of patent applications for antidepressants in China in the past 20 years is as high as 1917. The number of patents for domestic applicants is slightly dominant, indicating that our country has begun to attach importance to the research and development of antidepressants, but the research and development is still in the company. College research institute, the situation of individual three world, if raise the result conversion rate of patent, the company needs to strengthen with university research institute and potential individual cooperation. The results of content analysis show that the worldwide best-selling and newly marketed antidepressant companies apply for the patent of salt, crystal form, solvation, metabolites, and other patent and dosage forms for the patented compounds, such as compound preparation, etc. The basic patent and method patent of the new dosage form, the external patent such as the use patent, etc., to prolong the patent protection time and obtain the market exclusive right. But at the same time, it is found that some patents have not been applied for protection in our country, or the rights of patent have been terminated for various reasons by paying attention to the patent of the same family in China and its legal status. As a result, Chinese generic drug enterprises can use the technical information of terminating patents free of charge, and speed up the marketing of generic drugs. The results of patent strategy research show that the successful drug development often applies for basic patent around the molecular configuration of compounds by constructing a drug patent protection network and prevents generic drugs from going on the market by applying for a peripheral patent. After understanding the composition of drug patent protection network, generic drug enterprises should study the patent documents as soon as possible, find the loopholes of patent network and weave their own patent network to get the market.
【学位授予单位】：河南大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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