How to Rise Up to Challenges under Accelerated Enforcement of Patent Linkage

作者/编者:Shi Bisheng and Guan Xiangyu
作者单位:金杜律师事务所
创作年代:2017
出处/来源:金杜律师事务所
学科分类:知识产权法学
所属机构:金杜律师事务所
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摘要

In October 2017, the China Food and Drug Administration (“CFDA”) released a series of documents regarding reform of China’s drug administration system. This new patent linkage system (“PLS”) is discussed in two important documents: Opinions on deepening the reform of the examination and approval system and encouraging the innovation of pharmaceutical and medical devices (“the Opinions”) issued by the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council on 8 October 2017; and A revised draft of Provisions for Drug Registration (“the Provisions”) issued by CFDA on 23 October 2017. The PLS links the registration procedure of a generic drug for marketing and patent rights. The Opinions and the Provisions signal an acceleration of the enforcement of the PLS in China, although complete enforcement might still take one or two years.

关键词: Patent Linkage; Experimental Data Protection; Patent Challenge

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