It’s been a year and a half since the new Chinese Patent Law came into effect (1 June 2021). Although various versions of draft Examination Guidelines have been released, thus far no official finalized versions have been confirmed. On October 31, 2022, yet another new list of proposed amendments was published[1], this time consolidating the previous sets of proposed changes from 2020 to 2021 to the Examination Guidelines. As this version looks closer to a finalized version, we are cautiously optimistic that an official set of guidelines may soon be released. As such, we think it’s worth looking a bit more closely into this current draft version. Below are a…
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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 Patent Office (CNIPA) Releases More Details About Patent Term Adjustment (PTA) in the Draft Examination Guidelines
The new 4th Amendment of the Chinese Patent Law came into effect on June 1, 2021. Right before that date, the Chinese Patent Office (“CNIPA”) released some “Interim Measures” to give us a taste of what was to come, though they have yet to released the actual Implementation Rules. Two months later, CNIPA finally released Draft Patent Examination Guidelines in conjunction with the new Patent Law. We have provided a summary of the key points at this link, and for the next several posts, we will explore some of those topics in greater detail. “PTA” in the Patent Law Patent term compensation for patent office delay, which we will refer…
