我国新药试验数据专有权保护制度优化研究

新药试验数据专有权保护制度旨在通过对公开的新药试验数据授予额外期限专有权保护,延长新药研发人的权利期限,达到消除因新药研发成本巨大而带来的不利影响。运用法理分析和比较借鉴方法,通过对我国新药试验数据保护制度现状进行分析,指出该制度存在立法定位、保护对象、保护客体、例外适用范围4个亟待解决的问题。阐述了构建我国新药试验数据专有权保护制度的必要性及理论基础,在借鉴国外先进经验的基础上,提出应从5个方面构建和完善我国新药试验数据专有权保护制度的立法建议。

Optimization research on Perfecting Proprietary Right Protection System of New Test Data in China

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.