The System For Patent Term Compensation Of Drug Products

The system for Patent Term Compensation of drug products,also known as the system for Patent Term Extension 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 patentee may apply for an additional period of patent compensation for a certain period if specific conditions are met.This system was created by the United States in 1984 when Congress passed the Drug Price Competition and Patent Restoration Act,also known as the Hatch-Waxman Act,which aims to remedy the lack of innovation of original drug research enterprises caused by the drug patent period reduction.Subsequently,Japan,Korea,the European Union,Canada and other countries and regions have established the system.Based on this reason,this thesis intends to conduct in-depth study with a view for improving the system for Patent Term Extension of drug products.This thesis consists of five parts:The first part mainly talks about the historical evolution of the system for Patent Term Compensation of drug products.The system for Patent Term Compensation of drug products is originated in the United States.By analysis of the origin and development of this system,and the history of the development of this system in other major countries in the world,thus providing a systematic understanding of this system.The second part primarily introduces the legal basis of the system for Patent Term Compensation of drug products.The three perspectives of the balance of interests theory,the public domain theory and the economics of law will be selected as the legal basis of the system for Patent Term Compensation of drug products.First of all,the system for Patent Term Compensation of drug products balances the interests of the drug patentee and generic drug companies,and meets the requirements of balance of interests.Secondly,it can stimulate drug research and development and provide innovative materials for the public domain.Thus,this system reflects its rationality under the public domain theory.Finally,the system for Patent Term Compensation of drug products is beneficial to improve social efficiency and reasonable in the economics of law.The third part mainly talks about the practical dilemma of the system for Patent Term Compensation of drug products in our country.This system in China is still in the stage of establishing rules and regulations,and the primary dilemma is the lack of core elements of the system.Moreover,the system for Patent Term Compensation of drug products will provide strong patent protection to the drug patentee,which will cause conflicts to the rights of the public’s health.The conflict between the right to health and the system for Patent Term Compensation of drug products is mainly manifested in the drug accessibility that affects the public.The fourth part is the comparison and analysis of the extraterritorial regulations on the system for Patent Term Compensation of drug products.Through comparative analysis of the representative system in the United States and the European Union,the core elements of the system are extracted.The similarities and differences between the US and the EU in terms of the system can motivate China to improve the system for Patent Term Compensation of drug products.It is worthy of reference and absorption.The fifth part is to put forward suggestions on the improvement of the system for Patent Term Compensation of drug products in China.Firstly,the government should improve the core elements of the system for Patent Term Compensation of drug products.Secondly,the Catalogue of Chinese Listed Drugs should be improved and used as the basis for the system for Patent Term Compensation of drug products.Finally,a patent challenge system needs to be established to improve drug accessibility.