本文選題：藥品 + 注冊審批��； 參考：《重慶醫(yī)科大學(xué)》2014年碩士論文

【摘要】：藥品作為一種與人體健康和生命直接相關(guān)的特殊商品，其技術(shù)創(chuàng)新和研發(fā)投資回報可以通過專利制度來獲得保障，而其安全性、有效性和質(zhì)量可控性則由嚴(yán)格的行政審批管理來規(guī)制。隨著我國醫(yī)藥產(chǎn)業(yè)國際化進(jìn)程的加快以及藥品注冊管理法規(guī)體系的不斷完善和規(guī)范，藥品注冊過程中的專利侵權(quán)糾紛案日益增多，藥品專利保護(hù)問題越發(fā)成為藥品注冊審批中的焦點問題。藥品專利鏈接制度的建立則是將藥品注冊與專利保護(hù)有效鏈接，注冊過程中應(yīng)充分考慮藥品的專利問題，同時鼓勵仿制藥的發(fā)展以增加公眾用藥的可及性，旨在平衡促進(jìn)創(chuàng)新與保護(hù)公眾健康之間的關(guān)系。我國《藥品注冊管理辦法》2002年以來以藥品專利鏈接制度為主題進(jìn)行了兩次修改，但制度尚處于嘗試和完善階段，其科學(xué)性、合理性和可操作性存在諸多問題，藥品“注冊中的專利問題”依然十分突出。因此新時代下如何建立完善我國藥品專利鏈接制度，進(jìn)一步完善政府的監(jiān)管職能將是未來我國藥品注冊管理部門所要關(guān)注的重要課題。 本文通過解析藥品注冊管理法規(guī)體系的形成與發(fā)展以及我國醫(yī)藥產(chǎn)業(yè)當(dāng)前的發(fā)展現(xiàn)狀深入剖析我國藥品專利鏈接制度形成的制度背景和現(xiàn)實背景。并通過恒瑞-賽諾菲專利糾紛一案分析我國藥品專利鏈接制度存在的不足，，目前我國藥品專利鏈接制度存在專利權(quán)屬狀態(tài)說明不清晰，專利申明可信度低、專利糾紛缺乏有效的救濟(jì)途徑、“專利期屆滿前2年”規(guī)定無實際意義、未建立藥品專利期延長制度、數(shù)據(jù)保護(hù)獨占期缺乏針對性等問題，因此借鑒美國專利鏈接制度的成功經(jīng)驗，本文分別從實體和操作兩個層面提出了完善建議。
[Abstract]:As a special commodity directly related to human health and life, the return on investment in technology innovation and R & D can be guaranteed through the patent system, and its safety. Effectiveness and quality controllability are regulated by strict administrative examination and approval management. With the acceleration of the internationalization of the pharmaceutical industry in China and the continuous improvement and standardization of the regulatory system of drug registration, the number of patent infringement disputes in the process of drug registration is increasing day by day. Drug patent protection has become the focus of drug registration and approval. The establishment of drug patent link system is to link drug registration with patent protection. In the process of registration, the patent problem of drugs should be fully considered, and the development of generic drugs should be encouraged in order to increase the accessibility of drug use to the public. The aim is to balance the relationship between promoting innovation and protecting public health. The measures for Drug Registration Administration in China have been revised twice since 2002 on the subject of drug patent link system, but the system is still in the stage of trial and perfection, and there are many problems in its scientific, rational and operational aspects. The patent problem in drug registration is still very prominent. Therefore, how to establish and perfect the drug patent link system under the new era, and how to further perfect the government's supervisory function will be an important subject that our drug registration administration departments should pay close attention to in the future. By analyzing the formation and development of the regulatory system of drug registration and the current development situation of the pharmaceutical industry in China, this paper deeply analyzes the institutional background and the realistic background of the formation of the pharmaceutical patent link system in China. And through the case of Hengru-Sanofei patent dispute, this paper analyzes the shortcomings of the drug patent link system in China. At present, the patent ownership status of the drug patent link system in our country is not clear, and the patent declaration credibility is low. Patent disputes lack effective remedies, the "2 years before the expiration of patent period" has no practical significance, the system of prolonging the patent period of drugs has not been established, and the exclusive period of data protection is short of pertinence, etc. Therefore, using the successful experience of the patent link system in the United States for reference, this paper puts forward some suggestions from two aspects: entity and operation.
【學(xué)位授予單位】：重慶醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R951

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