As China is growing from a pharmaceutical giant into a pharmaceutical power, since 2016, the CPC Central Committee and the State Council have issued a series of documents to clarify the intention of exploring the establishment of the drug patent linkage system. As an important institutional innovation in China's medical intellectual property protection, the drug patent linkage system provides balanced protection for both brand name drugs and generic drugs, thus creating a sound social ecology that protects innovation, encourages challenges, stimulates competition, sustains progress, and protects the health and well-being of the public.
Recently, the Supreme People's Court has included the issue of application of law concerning drug patent linkage disputes in the 2020 judicial interpretation project plan. The specific implementation of the drug patent linkage system has evoked extensive discussions from all walks of life. In particular, at the core of the implementation of such a system lies how to design a patent dispute resolution method in line with China's national conditions under such system.
The Blue Paper, with a total of nearly 70,000 Chinese characters, was completed in six months by a team of lawyers led by Tina Tai, partner of King & Wood Mallesons with rich patent experience in pharmaceutical chemistry, focusing on how to resolve patent disputes when establishing a patent linkage system in China. From the perspectives of historical development, implementation methods, policy orientation, market system and administrative and judicial systems, this Blue Paper proposes feasible patent dispute resolution methods in China based on China's national conditions and administrative and judicial practice by providing a detailed analysis and summary of generic drug approval and patent dispute resolution methods in various countries. It is hoped that this Blue Paper will contribute to the development of China's drug patent linkage system.
This Blue Paper is jointly released by King & Wood Mallesons and the KWM Institute.
Chinese version only