A Study On The System For Patent Term Extensions Of Drug Products

The System for Patent Term Extensions of drug products means that in order to make up for the loss of patent time caused by the examination and listing approval,the drug patent owner may apply for an additional period of patent extension for a certain period if certain conditions are met.At present,there is no System for Patent Term Extensions of drug products in China.The United States established the system in 1984,and then Japan,the EU,Australia,South Korea,Taiwan and other countries and regions also established the system.At the same time,both the TPP and the Free Trade Agreements signed between the United States,the European Union and other developing countries have the articles of ProtectionTerm Extension.The changes in the international situation undoubtedly exert some pressure on our country.In the meantime,the pharmaceutical industry in our country has been developing rapidly in recent years,and there is a vast consumer market.However,some factors including the pharmaceutical industry lacking of independent innovation,generic drugs occupying main proportion in the current pharmaceutical market,foreign countries mostly monopolizing our high-end pharmaceutical market,hindered the rapid development of China's pharmaceutical industry.In October 2017,The General Office of the CPC Central Committee and the General Office of the State Council issued the?Opinions on Deepening the review and approval system reform and encouraging the Innovation of Medical Devices for Medicines?,In this document,the government puts forward a pilot program of compensation for the term of drug patents for the first time,proposing to compensate for delays due to clinical trials and review as well as listing approval.based on that,it is necessary to explore the practical conditions about the System for Patent Term Extensions of drug products in our country.On the basis of drawing on the experience of extraterritoriality,we should study how to construct the System for Patent Term Extensions of drug products in our country.This article comprehensively uses many research methods,such as historical research,comparative research and empirical research,and makes a detailed study on the System for Patent Term Extensions of drug products in five parts:The first part is the introduction of the System for Patent Term Extensions of drug products.This part starts with the concept and characteristics of the System for Patent Term Extensions of drug products,combs the development of the system,and analyzes the current impact of the system,finally reveals the role of System for Patent Term Extensions of drug products in promoting innovation and the pursuit in the process of implementation Balance of interests.The second part analyzes the necessity and rationality of the System for Patent Term Extensions of drug products.On one hand,the necessity of this system is demonstrated through the specialties of the pharmaceutical industry,pharmaceutical patents and drug approvals;on the other hand,this part arguments this system' existence of rationality through the perspective of the game of interest between patent and generic drugs,the relationship between patent protection and drug prices,and the relationship between drug prices and consumer demand.The third part is the comparison and analysis of the extraterritorial regulations on Protection Term Extension of drug patents.Enumerating the provisions in the international conventions reflects that the establishment of the system is an international trend,and at the same time they provide support and guarantee for the establishment of the system in our country.This part also analysis and discusses the legislative provisions on the United States,the European Union and Japan from the appropriate patent types,the conditions,the licensing requirements,the term determination and other aspects to provide reference for our country to build the system.The forth part is the research on the conditions of establishing the System for Patent Term Extensions of drug products.This part From three aspects to explore whether there is a need for our country to establish the system.First one is current conditions of industries:our pharmaceutical industry develops rapidly,but the generic drugs dominated the market.Second one is the legislative conditions:drugs patent tends to be limited and bound as well as legislative system of the patent linkage system and Bolar exception need to perfect.Third one is the conditions of policies such as developing of pharmaceutical industry in our country,keeping drug price in a rational range and so on.The fifth part is the specific recommendations of establishment of the System for Patent Term Extensions of drug products in our country.By comparing the regulations of different countries and combining the current situation in our country,this paper constructs the basic framework of the System for Patent Term Extensions of drug products and puts forward the specific provisions from five aspects:proper persons,proper patent types,the conditions of applying for a patent extension,the term determination and the rights during the term.In terms of conflicts between patent protection and public health,this paper proposed to perfect the Bolar exception,the patent linkage system,compulsory license and parallel import as well as perfect tne policies such as the drug price negotiation policy,canceling the government pricing of drugs.