After the fourth amendment of the Patent Law,Article 76 of the Patent Law stipulates that in the process of review and approval of the listing of a drug,the applicant for a marketing license and the patentee or interested party may resolve the relevant patent disputes through judicial or administrative channels,which formally establishes a Chinese style drug patent linkage system in coordination with the development of China’s pharmaceutical industry from the legislative level.After years of legal practice and industrial development,a series of problems have arisen in the application of the drug patent linkage system,and the U.S.has continuously adjusted some of the rules,and countries have made adjustments in transplanting the drug patent linkage system.The patent linkage system has also been adapted to the development of the pharmaceutical industry in their own countries,and the rules have been improved locally.The introduction of drug patent link system in China is reasonable: first,the drug patent link system is in line with the legal principle of interest balance and the value pursuit of legal justice in China.Second,to reconcile the conflict between drug listing application for administrative license and innovative drug patent protection will help to improve the research enthusiasm of generic drug enterprises,take into account the prior legitimate rights and interests of innovative drug patentees,and reduce the risk of patent infringement.Third,it is in line with the goal of building a powerful intellectual property country in the new era and the coordinated innovation and development of the pharmaceutical industry.The first chapter of this paper introduces the patent linkage system holistically and summarily,with specific logic of introduction of the system,its origin and development in extraterritoriality,controversial introduction in China,analysis of the rationality of introduction,and historical evolution and formal establishment in China.Chapters 2,3and 4 are parallel and focus on the three sub-systems under the drug patent linkage system,examining the linkage of the drug patent information registration system,the patent challenge system and the waiting period system with the current system in China.Chapter 2 focuses on the interface between China’s listed drug patent information registration platform and the existing database of China’s Listed Drug Inventory,which has been organized to establish China’s listed drug patent information registration platform.The author suggests clarifying the scope of registration of drug patent information,setting up a pre-examination procedure,establishing an opposition application procedure and a correction registration mechanism.Chapter 3 discusses the interface between patent challenge litigation and the Bolar exception.Before the amendment of the Patent Law,China had already initially conceived of building a drug patent linkage system,but China has not yet provided for one of the linkage bases of the drug patent linkage system,i.e.,proposed infringement,and if a new type of patent infringement is established based on administrative legislation alone,this is contrary to the provisions of the Legislative Law.In addition,at the practical level,the courts usually apply the Bolar exception principle to exclude the act of applying for marketing approval of drugs as infringement of patent rights.After the amendment of the Patent Law,the legal basis of the patent linkage system for pharmaceuticals in China was established through the establishment of the "lawsuit to confirm the scope of protection of patent claims",without the establishment of the "proposed infringement" which leads to the inappropriate expansion of the type of patent infringement,and The Bolar exception can be effectively connected with the Bolar exception.Chapter 4 discusses the interface between the waiting period system and patent dispute resolution procedures.Since in practice patentees are prone to abuse the waiting period in order to obtain evergreen patents for originator drugs,in order to avoid improperly setting the waiting period and contradicting the original intention of early dispute resolution,the author suggests weighing the length of the waiting period,taking into account the trial cycle of litigation cases,the rate of reversal,the probability of administrative decisions to litigation and other influencing factors,and improving the interface between the waiting period and the pre-litigation injunction system.China has initially built the basic framework of the drug patent linkage system,and is constantly improving the specific measures and related systems therein.On the basis of fully understanding and studying the background and specific contents of the establishment of overseas drug patent linkage system,China takes the essence of it and draws on and transplants the drug patent linkage system from both the legislative intent and practical development.Based on the author’s understanding,this paper hopes to study the existing drug patent linkage system in China,combine the actual industrial status in China,and provide some references for further improving the legal framework of drug patent linkage in China and exploring the practical application path in accordance with the relevant processes and characteristics of patent examination and drug registration in China. |