Research On The Rules For The Registration Of Patent Information Of Listed Drugs In China

Since the outbreak of the COVID-19 pandemic,people around the world have realized the importance of drug accessibility.Drugs,as a special commodity,are not only a source of profit for pharmaceutical companies but also an essential daily necessity for the public.Both the main players in the pharmaceutical industry,innovative drug companies and generic drug companies,play a crucial role in the drug market.Innovative drug companies invest in research and development to promote national pharmaceutical development,while generic drug companies follow the footsteps of innovative drug companies,developing drugs with the same therapeutic effect,entering the market to enhance competitiveness,reduce drug prices,and increase drug accessibility.To further balance the interests of innovative pharmaceutical companies,generic pharmaceutical companies,and the public,countries such as the United States,Canada,and South Korea have designed patent linkage systems based on their pharmaceutical environments.Based on the experience of the aforementioned countries,China has established a patent linkage system with Chinese characteristics,and the basis for the smooth implementation of the patent linkage system— the registration rules for patent information of marketed drugs,are crucial.This thesis firstly expounds on the concept and legal basis of the registration rules for patent information of listed drugs,analyzing the legislative principles,legal value,and effectiveness of the registration rules establishment to lay the foundation for further improving the registration rules from the perspective of legal rule formulation.Secondly,it analyzes the different forms of drug patent registration in different time periods in China,up to the formation of the prototype of the existing registration rules for patent information of listed drugs.At the same time,through collecting data from China’s patent information registration platform for listed drugs for empirical analysis,it discovers several erroneous registration issues on the platform,reflecting the need for improvement in both the substantive and procedural aspects of China’s current registration rules for patent information of listed drugs.Then,through comparative analysis,it examines how the United States’ Orange Book system,Canada’s patent register,and South Korea’s patent list are continuously revised and improved in the process of actual implementation in their respective countries.Finally,based on the existing problems,a series of improvement measures are proposed,including: in the substantive aspect,maintaining consistency between the registration subject and the patentee,and clarifying relevant legal provisions and content;in the procedural aspect,further improving the patent information submission process,establishing coordination between departments,and constructing error correction mechanisms.Through the above research,ensuring that China’s registration rules for patent information of marketed drugs are further improved in substance and procedure will contribute to the smooth implementation of the patent linkage system,and balance the interests of innovative drug companies,generic drug companies,and the public.