Research On The Patent Term Extensionsystem Of Drug

Drugs are related to human life,health and safety,and their approval and supervision on the market are usually very strict,and the procedures are very tedious.From the research and development of new drugs to the market,they need to invest huge capital and research and development energies.Based on the particularity of drugs,in order to encourage drug innovation and ensure drug accessibility,systems such as extension of drug patents have been established.The purpose of the drug patent extension system is to make up for the consumption of drug patent duration in the process of clinical trials and examination and approval of new drugs,and to encourage innovative drug research and development.In recent years,the research and development of innovative drugs in China has made great progress.under the background of building a powerful country with intellectual property rights,the improvement of drug patent protection system is an important way to further promote China from a big pharmaceutical country to an innovative pharmaceutical power.The opinions on deepening the Reform of the examination and approval system and encouraging the Innovation of Pharmaceuticals and Medical Devices issued on October 8,2017 proposed for the first time to carry out a pilot system for extending the term of drug patents to encourage continuous innovation in the field of drug manufacturing.appropriately extend the return period of drug manufacturing enterprises protected by patent monopoly,so as to encourage the research and development of new drugs and encourage innovative drugs to enter China's market.To improve the imbalance between supply and demand of drugs in China's market.The 2019 draft of the Amendment to the Patent Law(draft)also clearly stipulates the drug patent term extension system,which indicates that China's pharmaceutical patent protection system is about to enter a new stage.however,the specific application rules of the drug patent extension system have not yet formed a final conclusion.Therefore,it is necessary to comprehensively study the drug patent term extension system,make a detailed comparison of the legislative background and implementation effect of the drug patent term extension system in other countries,combined with the development status and needs of China's pharmaceutical industry,it provides a reference for the establishment of drug patent extension system in our country.The Drug Price Competition and Patent Term Restoration Act passed by the United States in 1984 proposed this system for the first time to balance the interests of pharmaceutical companies and consumers.After the introduction of this system,manypharmaceutical powers have not only stimulated the research and development enthusiasm of their innovative drug enterprises,but also alleviated the pressure of medical payment system.At present,the practical needs of China's pharmaceutical industry,the reform requirements of drug patent protection,and the need to improve the overall health level of the people all show the necessity of establishing this system in our country.And with the enhancement of the creativity of pharmaceutical enterprises,the improvement of the level of public health management,and the strengthening of coordination among government departments,our country has the ability to introduce this system.On this basis,by comparing the scope of drug protection,application conditions,application approval procedures and specific time calculation basis and standards of this system in foreign countries,the following suggestions are put forward for our country to construct this system: first,make clear the scope of the extension of drug patent application,and take the drug scope and the type of patent as the two standards.Second,the conditions for the extension of the patent application period should be unified,including: the applicant must be the patentee,the drug has already passed the listing examination and approval before the application is extended,and the drug patent must be extended within three months of the issuance of the listing license decision.and can only apply for an extension of the time limit.Third,standardize the approval procedures for the extension of drug patents,strengthen inter-departmental cooperation,and maintain the flow of drug-related information through the linkage of various departments.Fourth,determine the specific duration of the extension of drug patents.Through a comprehensive consideration of the development experience of the mature market,the applicable rules of the drug patent term extension system are clarified in order to provide reference for the construction of the drug patent term extension system in our country.