China has been implementing a plethora of new laws and measures that are particularly favorable to drug companies, such as patent term extension and patent linkage. Details of the new implementation measures for patent linkage (technically “early dispute resolution mechanisms for drug patents”) came into effect on July 4, 2021. At around the same time, China’s public registration system for innovator companies to list patent associated with marketed drugs (China’s version of the US FDA’s “Orange Book”) began accepting registrations. It has been close to one year since these mechanisms were put in place. Now, the first legal decisions from these patent challenges are coming out. China’s Patent Linkage System…
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China Releases Draft Implementation Guidelines for the Drug Administration Law
The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval will be stayed pending Paragraph IV litigation results. Technical review for things like safety and efficacy will proceed regardless. Although previously published Patent Linkage Measures indicate that the maximum stay period is 9 months, these Guidelines only say “a certain period.” The regulatory approval process for generic biologics and traditional Chinese medicines will not be…
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CHINA: New Patent Examination Guidelines Now Available for Public Comment
Two months after the new Chinese Patent law came into effect, the CNIPA has released a new set of Patent Examination Guidelines (proposed version) for public comments on Aug 3, 2021. Here are the explanation of the amendments (Chinese only). Here is the full set of proposed amendments (Chinese only). Briefly, the new amendment focuses on the following points: Updated Design Application System, involving requirements for partial designs and GUI applications, obviousness standard for designs, domestic priority, and other procedural requirements; Newly added provisions about the Patent Cooperation Treaty, including incorporation, priority restoration, addition, correction, etc.; Newly added provisions about Patent Term Extension and Patent Term Adjustment’; Newly added provisions…
