Research On Drug Patent Term Extension System

Drug patent term extension system refers to the granting of an additional monopoly period to the patentee after the expiration of the patent term in order to compensate for the time spent on clinical trials,review and approval as a result of going public,to promote drug innovation and stimulate the enthusiasm of patent holders.In 1984,the United States passed the "The Drug Price Competition and Patent Term Restoration Act",also known as Hatch-Waxman Act.This initiative has been followed by many countries in the world.The European Union,Japan,South Korea and other countries have established drug patent term extension system.There is no denying that the system can solve the problem of shortening the actual protection period of drug patent,and it can promote the research and development of new drugs.Based on China’s actual needs,the patent law was amended for the fourth time on October 17,2020,and establish the drug patent term extension system.It’s stipulated in paragraph 3 of article 42.Then,the State Intellectual Property Office issued the Implementation Rules of the Patent Law（Draft）on November 27,2020,in which articles 84 fourths to 84 eighths were added to provide detailed provisions on the application of the system.This paper will analyze drug patent term extension system,including the realistic basis and legal basis of the system,the legislative background of China’s provisions of the system,and comments on the value and dilemma of the relevant legislative provisions.On the basis of reviewing the legislation of foreign countries and basing on the situation of our country,this paper puts forward some specific suggestions to maximize the benefits of the system.This article consists of the following four parts:The first part is the basis of drug patent term extension system.The practical basis of the system is demonstrated by expounding the particularity of pharmaceutical industry and drug patent.At the same time,the legal basis behind the system is demonstrated.Analysis from three perspectives of interest balance,public domain and law and economic theory.The second part is the legislative background and evaluation of China’s drug patent term extension system.The reasons for China’s establishment of the system are as follows:first,solve the current development dilemma of China’s pharmaceutical industry,forcing China to move from generics drugs to innovative drugs;second,respond to the call for a "Healthy China" and promote the rapid development of health care;third,implement the obligations under the China-US Economic and Trade Agreement.The analysis of legislation is carried out from two aspects:legislative value and legislative dilemma.Among them,the legislative dilemma mainly include:the relevant legislative provisions need to be improved,including the core elements and the system interface;how to improve the public access to drugs while implementing the system?The third part is the extraterritorial review of the drug patent term extension system.This paper compares and analyzes the system in the United States,the European Union and Japan from the three aspects of legislative provisions,legislative intent and legislative effect,in order to provide reference for improving the drug patent term extension system in China.The fourth part is the improving of the drug patent term extension system in China.Firstly,the core elements of drug patent term extension were optimized from two aspects of clarifying the definition of "new drug" and perfecting the basic procedure and objection mechanism.Secondly,it is clear that the drug patent term extension can be retroactive.Finally,the measures to improve the accessibility of drugs,including the improvement of drug patent link system and drug price negotiation mechanism,are described.