药品试验数据保护与专利保护之平行并存性研究

Parallel and coexisting research of drug trial data protection and patent protection

依据《与贸易有关的知识产权协议》第39条第3款的规定,世界上很多国家都实施了药品试验数据保护,并使之成为了与专利保护平行并存的重要的药品知识产权保护手段之一。然而二者平行并存的合理性以及产生的负面效应也是备受质疑。本文在对药品专利保护和试验数据保护进行深入理论分析的基础上,对二者平行并存的合理性进行探讨,并提出降低药品专利保护和试验数据保护并存的负面效应的应对措施,对正确解读药品试验数据保护的内涵和意义以及完善相关立法具有一定的借鉴意义。

Based on the provisions of the article 39.3 of TRIPS, many countries have implemented drug trials data protection, and making it an important means of pharmaceutical intellectual property protection parallel to and coexisting with the patent protection. However, the rationality and the negative effects of the parallelism and coexistence of the two protections are also being questioned. In this paper we theoretically analyzed drug trial data protection and patent protection, explored the rationality and put forward the countermeasures to reduce the negative effects of the parallelism and coexistence of the two protections. This paper provided references for the correct inter- pretation of meaning and significance of drug trial data protection and the improvement of relevant legislation.