Research On The Drug Patent Term Compensation System From The Perspective Of Innovation-imitation Balanc

Drug patents are closely related to public health.In order to ensure the safety and effectiveness of the circulation of new drugs in the public domain after their official launch,most countries around the world currently adopt the form of legislation to strictly regulate the clinical trials and administrative approval procedures of new drugs before their launch.This setting often leads to a reduction in the effective patent period of new drugs after their launch.Due to the high risk,high cost,and long cycle characteristics of new drug research and development,it is generally difficult for pharmaceutical companies to obtain reasonable returns and benefits,which is not conducive to encouraging pharmaceutical companies to conduct new drug research and development.Based on this background,the pharmaceutical patent term compensation system emerged as the times require.It is a system that provides reasonable compensation to compensate for the impairment of the patent term caused by clinical trials and administrative approval procedures for new drugs before they are officially launched.This system initially originated in the United States,and later was used for reference by Japan,the European Union,and other countries and regions.It has produced good results in the process of applying the system.Considering that China’s pharmaceutical companies are gradually enhancing their research and development capabilities for new drugs,and national drug use has gradually transitioned from relying solely on generic drugs in the past to preferring original research drugs,the time is ripe to establish a drug patent term compensation system in China.On October 17,2020,in the newly adopted Fourth Amendment to the Patent Law,the pharmaceutical patent term compensation system was officially established at the legislative level,clearly stipulating the purpose and principles for the application of the system.In order to cooperate with the system to take root,the China National Intellectual Property Administration issued the new Article 85 of the Suggestions on the Revision of the Detailed Rules for the Implementation of the Patent Law(Draft for Comments),which further specified the applicable objects,compensation time,application procedures and conditions of the system.This document is a subordinate law applicable to the newly revised Patent Law,and there are still some areas that do not meet practical needs.It is not in line with the actual situation of China,which is still a large country of generic drugs.The scope of application of the system,special incentive provisions for children’s drug research and development,pre-trial transition provisions,and public objection procedures need to be improved.This article focuses on the problems existing in the draft for comment and the practical needs of society in practice,and proposes countermeasures and suggestions for improving the shortcomings of the document,with a view to improving the accessibility of drugs and the enthusiasm of original drug research and development in practice.The first chapter of this article mainly elaborates the basic theory of the system,introduces the definition of the concept of pharmaceutical patent term compensation in the academic community,summarizes the characteristics of the system itself,and combs the overall context of its development as well as the positive impact on Western countries since the implementation of the system.The second chapter mainly demonstrates the positive effects that the implementation of the system in China at the current stage may have on our country from the perspective of innovation and imitation balance,based on a comprehensive consideration of the basic national conditions of China as a large country of generic drugs,in order to demonstrate the necessity of implementing the system in China.The third chapter starts from the perspective of introducing the pharmaceutical patent term compensation system in China,comprehensively introducing the main content of the legislative motivation,development and evolution,applicable standards,and existing problems of implementing the system in China.Due to the early implementation of the system in foreign countries and the accumulation of rich experience in practice,the fourth chapter mainly examines relevant extraterritorial legislation in order to provide reference ideas for China to improve legislation.The fifth chapter mainly starts from the shortcomings of the system,draws on the relevant legislative experience of foreign countries and the actual national conditions of China,and proposes countermeasures and suggestions for improving the system,hoping that the system can maximize the incentive for new drug research and development,and ensure the healthy and sustainable development of China’s pharmaceutical industry.