Research On The Improvement Of Drug Patent Term Compensation System

China has a large population and a huge demand for drugs,but the domestic innovative drug market has been monopolized by foreign pharmaceutical companies for a long time and a large number of innovative drugs have been delayed due to the lack of sufficient patent protection,which seriously affects the accessibility of drugs and impairs public interests.In order to coordinate the contradiction between the specificity of drugs and the duration of patent protection,the United States and the European Union have set up a system of compensation for the duration of drug patents,i.e.,drugs that meet the legal requirements can obtain additional patent protection after the expiration of the patent term to compensate for the time occupied by clinical trials and administrative approval of drugs.Theoretically,the establishment of the drug patent term compensation system can not only achieve a balance between innovative drug manufacturers,generic drug manufacturers and public interests,but also economically enhance the interests of innovative drug manufacturers and reduce the R&D costs of innovative drugs.The newly revised Patent Law of China in 2020,Article 42,paragraph 3,for the first time legislatively clarifies the drug patent term compensation system.Through the comparison of the Patent Law,the Opinions on Amendments to the Implementing Rules of the Patent Law(Draft for Comments)and the Opinions on Amendments to the Implementing Guidelines of the Patent Law(Draft for Comments),China’s drug patent term compensation system has problems such as the legislative model is not yet clear,there are conflicts in the compensation objects,the compensation conditions lack operability,the calculation method of the compensation term is too general and the lack of objection procedure.Based on the examination and analysis of typical cases in the United States and the European Union,suggestions for the improvement of China’s drug patent term compensation system include: firstly,the three-part legislative model of "patent law + special law + patent implementation guidelines" should be clarified;secondly,the applicable objects should be unified,and the active ingredient should be used to interpret the new drug.Third,based on the current situation of domestic drug development,the compensation conditions should be set up strictly,and the operability of the compensation conditions should be improved;Fourth,the calculation of the compensation period should be refined,and the time of inaction of the applicant should be deducted on the basis of the projection model;Fifth,the opposition procedure should be improved,the subject,period and requirements of the opposition should be clarified,and the incentive mechanism should be set up to improve the operational effectiveness of the objection.