The Study On Exclusive Protection Of Drug Test Data

As a special commodity with public interest and commercial value,medicine is closely related to human health and commercial development and even national political stability.Since the Hatch-Waxman Act of 1984 in the United States began to protect drug test data,the "Trade-Related Intellectual Property Rights Agreement"(Regarding Trade-Related Intellectual Property Rights Agreement,hereinafter referred to as "TRIPS Agreement"),which came into effect in 1995,Article 39.3 In the article,for the first time,it provides unified protection for drag test data at the international level.All parties provide protection of drug test data information not less than the minimum protection standard of the TRIPS agreement.Later,a higher standard TRIPS of the TRIPS standard has been developed.In 2015,the Comprehensive Progressive Trans-Pacific Partnership Agreement(Comprehensive Progressive Trans-Pacific Partnership,hereinafter referred to as the "CPTPP Agreement")was the representative of the TRIPS-Plus standard for exclusive drug test data protection,including many countries within the country.Launch the legal protection of drug test data.This article first summarized the general theory of data protection for drug trials in the first part.The second part is an inductive analysis of the current status and existing problems of the protection of drug test data:by comparing the different protection systems and corresponding problems of the TRIPS agreement and the CPTPP agreement at the international level,this showed the trend of international protection.Then,analyzed the current status and existing problems of data protection for drug trials in China under this trend.The third part was discussed the conflicts of interest and coordination under the exclusive protection system of drug test data.Focused on measures to balance relevant interests in the US domestic legal system.In addition,the coordination between the protection of pharmaceutical patents and the protection of drug trial data in China was discussed.The fourth part were suggestions to China for perfecting the trend of exclusive protection of international drug test data.Finally,it was concluded that China should strive to establish and improve China's exclusive protection system for drug test data under the trend of exclusive protection of international drug test data,taking relevant U.S.regulations as reference and combining with the applicable conditions of CPTPP agreement standards.