Research On The Reduced Application Of Full Compensation Principle

In October 8,2017,the trial of the term compensation system for drug patents was first explicitly proposed in the two "comments on the reform of the deepening review and approval system to encourage the innovation of medical instruments and instruments"(hereinafter referred to as "opinion").The purpose is to protect the effective protection of patent medicines for clinical test and review and approval.To compensate for the drug innovation,to encourage the development of new drugs,to encourage innovative drugs to enter the market,and to improve the situation and current situation of drug supply and demand imbalance in our market.Prior to the release of this opinion,according to China's patent law,the term of patent rights for all invention patents is 20 years,and there is no special compensation system for patent protection period in the field of medicine.It is an important innovation in the field of China's drug system to give appropriate compensation for the delayed effective patent period due to drug clinical trials and listed review and approval.However,there are no specific provisions for the implementation of the term compensation system in the opinion.After the implementation of the drug patent protection period compensation system in the countries such as the United States,Japan and the EU,it has achieved good results.It is necessary for us to learn from the international experience actively in the process of implementation in the future,and combine with the specific national conditions of our country to speed up the establishment of a suitable compensation for the protection period of drug patent for the development of our country.Because drug innovation is different from general invention and innovation,it needs special investment.At the same time,the direct relationship of drugs affects the safety and health of the public.From the previous research and development to the market and to the later period,the supervision must be strictly checked to ensure the safety and rigour of each link.The supervision and management of drugs is usually more stringent and complex than other goods.It takes a long process to develop a drug from the original authorization to the final approval of the market.This leads to a shortened period of effective protection for drug patents,which is shorter than the effective protection period of the general patent products.There is a sharp contrast between a large amount of investment in the early stage and the short period of return.The shortening of the effective protection period of drug patent leads to the innovation subject often unable to obtain profits or even to recover the cost.In the past,the long term will fight against the enthusiasm of the innovation subject and the enthusiasm of research and development,which is not conducive to the healthy circulation and healthy development of the pharmaceutical industry in China..Therefore,it is the focus of this study to explore the feasible way of the drug patent protection period compensation system in our country and establish the medical patent protection period compensation system suitable for the actual conditions of our country.This article is divided into four parts:The first part is a general analysis of the basic concepts of compensation system in the period of drug patent protection.This part first introduces the basic definition of the drug patent protection period compensation system,then combs the generation and development history of the drug patent protection period compensation system.The system of patent protection period compensation is first produced in the United States,which originated from the Hatch-Waxman act of the United States in 1984.Then it analyzes the specific content of the compensation system for the period of patent protection,including the scope of drugs that can be applied for patent compensation,the conditions to grant the patent compensation,the calculation method of the patent compensation period,the procedure of the application and the procedure of the objection.By reviewing the basic concepts of compensation system in the period of drug patent protection,we will lay a foundation for the following research on the compensation system of the patent protection period.The second part:this part tries to discuss the legitimacy basis of establishing the compensation system of drug patent protection period.From the two parts of theory and practice,we discuss the legitimacy of the system.The third part:To compare and evaluate the compensation system of drug patent protection period at home and abroad.By enumerating the development and specific regulations of the compensation system for the protection period of drug patent in the United States,Japan,Europe and other developed countries,it is compared with the current legislation of our country.Where to learn.The fourth part:To explore the proposal of the compensation system for drug patent protection in China under the new situation.This part introduces the realistic background of developing the system in our country under the new situation,and puts forward some suggestions on the construction of the system and mechanism for the trial of the compensation system for drug patent protection period in China.