试验数据知识产权保护的国际规则演进

The Evolution of International Intellectual Property Rules for Test Data Protection

对于试验数据和其他数据的知识产权保护是原研药产业发达的欧美国家延长对其产品垄断权的"长青战略"的重要组成部分。各国对于数据的知识产权保护主要有两种模式:第一种是商业秘密保护,即将试验数据作为未披露信息,对第三方施加保密义务;第二种则是专门保护,即赋予数据独占权。自20世纪80年代开始,美国和欧共体通过国内立法或指令的形式确定了数据独占权。此后,欧美开始不遗余力地通过双边和多边途径将数据独占权制度扩散或移植到其他国家。《TRIPS协议》采取了第一种模式,规定了试验数据的商业秘密保护。但是,《TRIPS协议》的数据保护条款没有满足美国的需求,发达国家仍然力图继续通过自贸协定推动数据独占权在全球范围内的扩张。然而,发展中国家出于公共健康的考虑,普遍对于后TRIPS时代的数据保护扩张采取了抵制态度。一些发展中国家甚至废除了已经建立的数据独占权,而适用TRIPS标准。美国虽然在特朗普总统上任之后退出了TPP,但TPP清晰体现了美国在知识产权国际保护中所采取的"论坛转移"战略,完整勾勒出美国从国内法到双边条约再到多边条约,不断提高知识产权保护标准的路线图。

Intellectual property protection for test data and other data is an important part of the evergreening strategy by the EU and the US to maintain the monopoly by pharmaceutical companies.There are two models for data protection:one is trade secret protection where a third party is obliged to keep confidential of undisclosed information;the other is sui generis protection which is also referred to as data exclusivity.From the 1980s,the US and the EC established data exclusivity domestically.The US and the EC started legal transplants of its domestic rules on data exclusivity to other countries via multilateral and bilateral arrangements.The trade secret protection of test data as undisclosed information in TRIPS did not satisfy the US ambition on data protection.In post-TRIPS era,there is North-South discrepancy on the protection of test data.On the one hand,the US and the EU continuously expanded the regime of data exclusivity globally;on the other hand,some developing countries abolished the domestic data exclusivity regime established before TRIPS due to concerns on public health and access to medicines.The data exclusivity in TPP has exceeded TRIPS and most other previous FTAs.Though the US withdrew from the TPP during the Trump administration,data exclusivity is a typical example of how the US used the strategy of forum shifting in intellectual property from domestic law to bilateral FTAs and multilateral treaties.