Research On The Legal System Of Compensation For Patent Period Of Drugs

In 1984,the United States Congress passed the famous Hatch-Waxman Act,which for the first time clearly stipulated the legal system for drug patent term compensation.Since then,Japan,the European Union and other countries and China's Taiwan region have established their own legal systems for patent compensation for drugs and have continued to modify and improve them in practice to better play their role in stimulating innovative drugs.From a global perspective,the establishment of a legal system for drug patent term compensation is a trend,and it is also an inherent requirement for China to promote pharmaceutical innovation.On January 6,2020,China and the United States signed the first phase of the economic and trade agreement,in which Article 1.12 of the patent clearly stipulates the compensation of the effective patent term,which indicates that the establishment of a legal system for drug patent term compensation has been officially put on the agenda in China.The purpose of this article is to deeply explore the basic theory of drug patent term compensation,combining the specific content of drug patent term compensation legal systems in foreign countries and regions,and make a correct evaluation of the system based on this,and fully discuss the introduction of China's legal system for drug patent term compensation.Necessity and feasibility,and finally combined with China's actual national conditions,to build a legal system for drug patent period compensation with Chinese characteristics.This article is divided into four parts:The first part is the basic theory of drug patent term compensation.Compensation for drug patent term refers to the granting of a certain additional period of patent compensation protection after the expiry of the statutory patent drug patent term in order to compensate for the valid patent period occupied by the clinical trials and administrative review and approval procedures previously required for the drug to be marketed.Drug patent term compensation has the characteristics of drug-specific rights,compensation for patent term losses,legal timeliness of compensation,and economic value.The theory of drug economics,the theory of labor and property rights,and the theory of balance of interests are the theoretical foundations of drug patent period compensation.The second part is the legal system and evaluation of patent compensation for extraterritorial medicines.The legal system for the compensation of patent periods inforeign countries specifically includes the provisions on compensation for drug patent periods in international conventions,and the legal system for compensation for drug patent periods in the United States,the European Union,Japan,and Taiwan.The clear scope of compensation,reasonable compensation methods,strict compensation procedures,and a sound opposition mechanism are evaluations of the legal system for compensation of patents for foreign medicines.The third part is the necessity and feasibility of introducing a legal system for drug patent compensation in China.The necessity of introducing a legal system for drug patent term compensation in China includes four aspects,which are conducive to the production of innovative drugs in China,encourage the import of innovative drugs,urge the review and approval of new drugs,and improve China's patent law system.Existing supporting system support,national drug innovation policy support and experimental results are feasible for China to introduce a legal system for drug patent period compensation.The fourth part is the construction of the legal system for the compensation of the patent period of Chinese medicines.First,clarify the applicable requirements of drug patent term compensation,including specifically the applicable objects and conditions;second,standardize the method of drug patent term compensation,including the calculation of the compensation period and the limitation of rights during the compensation period;again,improve the drug patent period compensation Procedures,including application procedures and approval procedures;Finally,improve the objection mechanism for drug patent period compensation,including the submission of due diligence,the holding of objection hearings and the results of objection processing.