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药品试验数据专有权是有别于专利权的新型知识产权。对其施加保护具有积极和消极影响,需要在利益平衡基础上寻求合理适度的制度架构。实践中,《TRIPS协定》为药品试验数据保护确立了最低标准,但以《TPP协议》为代表的区域贸易机制却进行了超出《TRIPS协定》标准的扩张。对此,我国应保持高度警惕,坚持在《TRIPS协定》多边规则基础上进行国内立法调整,并通过适时加入《TPP协议》谈判,来提高规则制定的国际话语权,防止药品试验数据保护扩张的蔓延。
The exclusive right of the drug test data is a new type of intellectual property that is different from the patent right. It has positive and negative impacts on the protection it imposes, and needs to find a reasonable and appropriate institutional framework based on the balance of interests. In practice, the TRIPS Agreement sets the minimum standards for the protection of pharmaceutical test data. However, the regional trading mechanism represented by the TPP has been expanded beyond the standards of the TRIPS Agreement. In response, China should maintain its vigilance and insist on making adjustments to its domestic legislation on the basis of the multilateral rules of the TRIPS Agreement and improve the international discourse right of rules-making through the timely joining of the “TPP Agreement” negotiations so as to prevent the expansion of the protection and expansion of pharmaceutical test data spread.