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《跨太平洋伙伴关系协定》对农用化学产品和药品规定了高水平的数据保护制度,这是美国在国际上积极推行其管制性排他权制度的结果。国家对药品、农药等产品的上市进行管制,以确保产品的安全性;这既给创新者增加了额外的成本负担,也为保护其创新成果提供了新的制度工具。相比专利权,它不仅保护对象更广,而且更为便捷、有效。它补偿创新者因产品上市管制所承担的成本,保护为产品上市而获取的研发成果,降低创新产品的保护成本,具有激励创新的正当性。但是任何专有权保护的创设都伴随着社会成本的产生,故管制性排他权的具体制度应该在创新者、竞争者、监管当局与社会公众的不同利益之间进行平衡。
The Trans-Pacific Partnership Agreement sets a high standard of data protection for agrochemicals and pharmaceutical products as a result of the United States’ active international implementation of its system of exclusive exclusion. The state regulates the listing of pharmaceuticals, pesticides and other products to ensure product safety. This not only adds additional cost burden to innovators, but also provides new institutional tools for protecting innovations. Compared to patent rights, it not only protects the broader object, but also more convenient and effective. It compensates innovators for the cost of product listing control, protects the research and development results obtained for the product launch, reduces the protection cost of innovative products and has the legitimacy to encourage innovation. However, the creation of any exclusive protection is accompanied by the generation of social costs. Therefore, the specific system of regulatory exclusion should strike a balance between the different interests of innovators, competitors, regulators and the general public.