On July 4, 2021, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) released details on the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage”), effective July 4, 2021. Below is a summary highlighting key provisions and changes from the draft measures. Creation of an “Orange Book” List A new public registration platform has been created that lists “Patent Information” for all drugs marketed in China (similar to the US “Orange Book”). Drugs must be approved in China in order to be listed, and unlisted drugs cannot use these new “Patent Linkage” mechanisms. What “Patent Information” needs to be provided?…
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China Top 10 Patent Re-Examination and Invalidation Cases of 2020 CNIPA Upholds Bayer’s Rivaroxaban Patent
The development of China’s approach to patents, especially those in the pharmaceutical and biotech space, has been fascinating to watch. Those of us who have practiced in the area for a long time have been frustrated by the Chinese patent office’s overly strict rules regarding patentability (e.g., high data support standard and refusal to consider post-filing data), while at the same time being more lax on enforcement. Things have changed a lot in the past five years as China has revamped its patent system in numerous ways. The creation of an entirely new IP court system, the introduction of a new patent law (only the 4th revision in its 40+…
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China Top 10 Cases of 2020 – CNIPA Upholds Second Medical Use Patent from University of Bordeaux
The development of China’s approach to patents, especially those in the pharmaceutical and biotech space, has been fascinating to watch. Those of us who have practiced in the area for a long time have been frustrated by the Chinese patent office’s overly strict rules regarding patentability (e.g., high data support standard and refusal to consider post-filing data), while at the same time being more lax on enforcement. Things have changed a lot in the past five years as China has revamped its patent system in numerous ways. The creation of an entirely new IP court system, the introduction of a new patent law (only the 4th revision in its 40+…
