Research On Extending The Term Of Pharmaceutical Patents

Drugs involve people's life and health.Drug regulatory agencies in various countries generally hold a prudent and strict attitude towards drug listing applications,which results in the increase of time cost and waste of patent period for patent holders in the process of drug listing approval.In order to make up for the impairment caused by administrative approval procedures to the patent protection period of drugs,Many big drug countries have stipulated that the period of patent can be extended in exceptional cases if they meet the legal conditions.With the revision of the patent law,the extension system of patent period of drugs has been established in China.This paper,based on the problem orientation of the conflict between the extension of the patent period of drugs and the real conflicts between the generic pharmaceutical industry and public health,and based on the rule construction,system coordination and risk prevention,explores how to make the extension system of drug patent effective and encourage innovation while realizing the steady development of the generic pharmaceutical industry,Ensure the availability of medicines for citizens,and thus ensure the public health.Because the extension of the patent period of drugs is still a new concept in China,the first part of this paper mainly introduces the relevant theories of the extension of the drug patent period,and combs the legislative background of the extension of the drug patent period in China.The second part,from the specific provisions,institutional environment and social basis,analyzes the extension of the term of drug patent,the relevant supporting system,the structure of the drug market and the current situation of public health in China.It finds out the applicable conditions and scope of the extension of the patent period of drugs and the existing deficiencies of the relevant supporting systems,And the negative effect of extending the patent period of drugs on China.Based on the above analysis,the third part of this paper investigates the specific practice of drug patent extension in different modes outside the country,analyzes the rules of the establishment of the extension system,the perfect path of supporting system and the countermeasures to the negative effect of the extension of the patent period of drugs,so as to draw lessons from the useful experience for solving the problems existing in the extension of the drug patent period in China.Then,in the fourth part,the author puts forward suggestions on the improvement of the system and the negative effect of the extension of the drug patent period in China,including the basic value of the system of reconstructing the extension of the drug patent period,the improvement suggestions of the extension system of the drug patent period and the related supporting systems,and the countermeasures to extend the negative effect of the patent period of the drug.