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The patent linkage rules in CPTPP belong to the TRIPS-plus clause, which are divided into two types, including soft ones and strong ones. The member states of CPTPP can choose either of the two. Different from the soft ones, strong patent linkage rules pay more attention to the expansion of the patent rights of the brand name manufacturer, rather than the resolution of disputes. Though not as the member state of CPTPP, China would further establish the patent linkage system. Learning from the experience of U.S., Canada, Australia and Singapore, the system of patent linkage should be based on the HWA. It is wise to regulate the patent linkage system under the Chinese patent law and under the law of pharmaceutical administration. The coordination and cooperation between CFDA and SIPO should also be strengthened. In addition, it’s essential for China to establish the disclosure of patent information system like Orange Book and provide some provisions related to the disciplinary mechanisms on the notification obligations. Furthermore, referring to foreign legal system, a set of controls is also needed for the reduction or prevention of the lawsuit abuse. Keywords—CPTPP; patent linkage system; generic drug; brand name drug

proceedings of the 3rd international conference on judicial, administrative and humanitarian problems of state structures and economic subjects (jahp 2018)

From American Acts to CPTPP Rules: the Enlightenment to Patent Linkage Reforms in China