|
|
Optimization research on Perfecting Proprietary Right Protection System of New Test Data in China |
Xu Zhihua1,Huang Li'na1,2 |
1.School of Law, Zhongnan University of Economics and Law, Wuhan 430073,China;2.School of Law, Guangxi University of Finance and Economics, Nanning 530003,China |
|
|
Abstract The proprietary right protection system of new drug test data aims to grant the additional period of protecting the proprietary right of the public new drug test data, to extend the period of rights of the new drug researchers so as to eliminate the adverse effects caused by the huge cost of new drug research. Using the method of legal analysis and comparison, the article analyzes the situation of China's new drug test data protection system and points out that there are four problems to be solved in the system: the legislative status, the protection target, the protection of the object, exception applicable scope. This article also describes the construction of the necessity and the theoretical basis of the proprietary protection system of new drug test data, and puts forward legislative proposals from five aspects and the improvement of the patent protection system of new drug test data, by learning from the advanced experience of foreign countries.
|
Received: 06 December 2016
|
|
Corresponding Authors:
Xu Zhihua
|
|
|
|
[1]叶云卿.药品试验资料专属权近期国际发展之趋势——我国资料专属权制度及因应国际趋势应有之调整[J].政大智慧财产评论,2013(11):41.
[2]FORD N.Patents,access to medicines and the role of non-gov-ernmental organizations[J].J Gene Med,2004,1(2):137.
[3]CHRISTINE D.Gallraith,dying to know:a demand for genuine public access to clinical trial results data[J].Mis.L.Rev,2009(9):705-710.
[4]全球制药企业研发数据比较[EB/OL]www.askci.com/news/data/2014/10/14/154316tx28.shtm,2014.
[5]AARON X F.Secrecy,monopoly and access to pharmaceuticals in international trade law[R].Protection of Marketing Approval Data Under the TRIPS Agreement 45 HARV INTLLJ,2004(6):443-465.
[6]梁志文.药品数据保护的比较分析与立法选择[J].政法论丛,2014(4): 82.
|
[1] |
. [J]. SCIENCE & TECHNOLOGY PROGRESS AND POLICY, 2013, 30(5): 106-110. |
|
|
|
|