Research On Compulsory Licensing System Of Drug Patent Under Epidemic Situation

The COVID-19 pandemic has sparked widespread discussion about ensuring access to medicines amid a public health crisis.As a response to the outbreak of public health crisis of national emergency strategy,patent compulsory license system for public health theory and the basic principle of intellectual property system as the foundation of legitimacy,national patent medicine is not only beneficial to improve accessibility,also prevent drug patent abuse,in turn,cause monopoly,help realize drug research and development technology in China.Drug patent compulsory license system in China,however,it is not yet mature,related regulations scattered distribution in different levels of legal documents,and part of the regulation system of international treaties only "used",does not conform with the actual situation of our country,based on the limited subject,applications for general,program trival,compensation standard fuzzy factors such as constraints,the system failed to smooth implementation in our country.To this,in response to the epidemic prevention and control at present stage,and the future similar crisis of public health emergency needs,it is necessary to properly draw lessons from the successful experience of extraterritorial drug patent compulsory license system,expanding the application subject,adjust the application matters,simplified application process,clear compensation standard,improve the drug patent compulsory license system in our country,in order to better safeguard the public health career development.In addition to the introduction and conclusion,this paper contains four parts:Part one: The legitimacy and necessity of compulsory drug patent licensing system in the context of epidemic.First,in the context of the epidemic,the implementation of compulsory drug patent licensing system is justified.The continuous improvement of the status of public right to health is the concentrated embodiment and inevitable requirement of the modern concept of human rights under the rule of law.From the perspective of the standard of the generation of rights,the public right to health is related to the survival and development of mankind as a whole,and occupies the primary position in human rights.Starting from the protection of rights,the government’s implementation of epidemic prevention measures and free vaccination for the public reflect the modern governance concept of taking people’s health and safety as the center.Starting from the basic principles of intellectual property system,whether it is the principle of balance of interests,the principle of priority protection of legal interests,the principle of prohibition of abuse of rights,all contain the value choice of legislators to protect social public interests.Secondly,in the context of the epidemic,it is necessary to implement compulsory drug patent licensing system.First,the system can reduce the price of patented medicines to some extent,making medicines affordable and accessible to ordinary people,thus alleviating the public health crisis caused by COVID-19.Second,the system is beneficial to eliminate the abuse of drug patent and prevent unfair competition.Thirdly,the system can make up for the lack of innovation in China’s drug industry to a certain extent and improve China’s drug research and development technology.Part two: The current situation and limitations of compulsory licensing system for drug patents in China.China’s relevant laws and regulations have considerable scale,but the system has never been practiced.The reason is that the current system of Our country has some limitations.First,the legislative content is scattered,the legislative level is staggered and there are problems of inconvenient application.Secondly,because of the exhaustive listing of the starting conditions of the system,the starting conditions such as "state of emergency","extraordinary circumstances" and "public interest" are relatively general,and the content and scope are not clear enough,so there are difficulties in application.Thirdly,the relevant system of China divides the reasons for compulsory license application into various specific situations,and in each case,the applicant is differentiated and restricted.The law requires the applicant to "have the implementation conditions",but for such implementation conditions,the relevant norms are not attached with quantitative assessment indicators.Fourthly,the application procedure of compulsory license system for drug patent is complicated.For sudden and urgent epidemic crisis,applicants may miss the golden opportunity to deal with the epidemic if they fail to pass the examination and approval within a short time.Fifthly,the compensation system of drug patent compulsory license system is stipulated as "payment of appropriate remuneration",which is too broad and often leads to no standard for compensation costs,which is not conducive to the implementation of the system.Part three: The application of compulsory licensing system for overseas drug patents and its reference.First,in developed countries,the U.S.government negotiated with Bayer to lower the price of ciprofloxacin,a proprietary specific drug,in order to deal with the anthrax outbreak.Secondly,Canada’s relevant system allows applicants to produce drugs for export to other countries,and sets clear regulations on compensation standards for compulsory licensing,which greatly improves the enthusiasm and participation of pharmaceutical enterprises and ushered in unprecedented development for Canada’s pharmaceutical industry.Again,in developing countries,India to allow any interested party based on the requirement of the public is not a reasonable price too high or the patent is not satisfied,patent implementation conditions,such as apply to the Patent Office for patent compulsory license,the applicant scope is broad,and the law gives the central government determine the power of the system implementation,India has become a "world pharmacy".Relevant systems outside the region can provide us with reference to improve the system.First,we should try to seek patent authorization of drug enterprises,and relevant systems can be used as "chips" in negotiations.Second,according to the national conditions of Our country,the law should be amended appropriately to give the law more interpretation space in the subject of application and application items.Third,the introduction of policies to improve the enthusiasm of pharmaceutical enterprises,participation.Part four: Suggestions on improving China’s drug patent compulsory licensing system under the background of epidemic.First,improve the legislative system,integrate the provisions on application procedures,and incorporate the provisions on the subject of application,application conditions,application procedures and time limit into the Measures for Compulsory Licensing of Patent Implementation.Second,expand the scope of application conditions and application subjects of compulsory license,do not need to be limited to the established preset conditions such as anti-abuse,anti-monopoly and emergency state,but can set broad application reasons such as "government use" and "public needs",reduce the restrictions on application subjects,and give patients the right to suggest statements.Third,simplify the application procedure for compulsory license,establish a quick review mechanism and a pre-application mechanism,shorten the time limit for stating suggestions and hearing applications.Fourthly,the compensation standard of compulsory license shall be clarified,and UNDP model or tiered use rate shall be adopted for individual cases.Fifthly,the period and scope of compulsory licensing shall be clarified,the scale of drug production shall be determined according to the spread of the epidemic,and precise quantification shall be made by referring to relevant data.The time range of licensing shall be limited to the end of the epidemic,and the scope of licensing shall be valid throughout the country,but the export shall be strictly restricted.