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China Releases Draft Examination Guidelines for the new Patent Law

2020年12月4日
The Chinese Patent Office (CNIPA) is moving forward at breakneck speeds aiming to get all the necessary pieces in place for the June 1, 2021 date when the new 4th Amendment of the Patent Law will come into effect. Most recently, this means a flurry of drafts coming out from CNIPA, including, but not limited […]

NMPA's Releases Draft Measures for Data Protection (Data Exclusivity)

2025年9月4日
In March 2025, China's National Medical Products Administration (NMPA) released yet another set of draft implementation measures on data protection.1 Key highlights of these new measures include the following: A Bit of History China's journey toward a comprehensive pharmaceutical data protection framework has been ongoing for over two decades, a roller coaster ride from its […]

China Releases Draft Implementation Guidelines for the Drug Administration Law

2022年6月2日
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 […]

Miss the 12-month Filing Deadline? China Finally Allows Patent Applicants to Restore, Add, or Correct a Priority Claim

2024年4月15日
Three major 'remedial’ systems taken from the PCT Regulations have been introduced in the third revision of the Implementation Regulations of the Chinese Patent Law in 2023 (hereinafter referred to as the "Implementation Regulations"). We previously discussed one of these remedial systems, Incorporation by Reference based on Rule 45 of the Implementation Regulations, which allows […]
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