TPP生物药品数据保护条款研究被引量：5

A Research on TPP Biologics Data Protection Clause

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摘要《跨太平洋伙伴关系协定》(TPP)知识产权章节提出了与《TRIPS协定》第39条第3款"药品数据保护"不同的生物药品数据保护条款。相较于化学药品,生物药品的专利授予范围更窄,不确定性更大,因此生物药品更加依赖数据保护。美国希望通过TPP对生物药品给予更长的数据保护期,保证生物医药企业的垄断利润。由于与其它大多数国家的法律规制存在较大差异,并有可能危及公共健康,该条款在谈判中遭到了强烈抵制。然而,生物药品的数据保护议题仍将成为药品数据保护制度的发展趋势。 TPP intellectual property chapter proposes a ＂biologics data protection＂ article, which is different with TRIPS 39.3. Compare to chemical products, biological products are more dependent on data protection than patent, since biologics are diffi cult to secure broad patent protection. The U.S. expect to safeguard its biopharmaceutical industry by provide a longer data protection period. Because of its difference with the legal system of other countries, and it may harm the public health, the negotiation of this article faces strong opposition. However, biologics issue will still be the development trend of data protection system.

作者张磊夏玮

机构地区上海对外经贸大学WTO研究与教育学院上海高校智库国际经贸治理与中国改革开放联合研究中心

出处《知识产权》 CSSCI 北大核心 2016年第5期116-120,共5页 Intellectual Property

基金国家社会科学基金项目<WTO争端解决机制下中国参与国际经贸规则制定的实证研究及对策>(13BGJ034) 上海高校智库项目的阶段性研究成果

关键词 TPP 生物药品数据保护专利 TPP biologics data protection patent

分类号 D997.1 [政治法律—国际法学] D922.16 [政治法律—宪法学与行政法学]

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参考文献11

1https://medium.com/@jamie-love/tpp-designed-to-make-medicine-more-expensive-reforms-more-difficuh-e6a94a5d4a18,最后访问日期:2015年9月12日.
2冯洁菡:《TRIPS协议下对药品试验数据的保护及限制--以国际法和比较法为视角》,载《武大国际法评论(第十一卷)》,第125页.
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