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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Breaking: China Released New Implementation Measures for the New Patent Linkage System
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?…
