Research On Legislative Perfection Of Compulsory License Of Drug Patent In China

Compulsory licensing of pharmaceutical patents refers to the administrative measures that the national administrative agency allows others to pay the patent fee for pharmaceutical patents without the consent of the patentee of the patent to implement the patents that the patentee of the patent has obtained.Unlike general patent compulsory licenses,drug patent compulsory licenses are responsible for maintaining public health.In the context of globalization of population mobility,the spread of infectious diseases is getting faster and faster,and the spread is becoming wider and wider.At the same time,with the high incidence of basic diseases such as lung cancer and liver cancer,it poses serious challenges to public health in various countries.Demand for public medicine in China is increasing,the problem of high prices for patented medicines is becoming increasingly prominent,and public medicine accessibility has been significantly affected.After nearly 30 years of development,China's legislation has established and gradually improved the compulsory licensing system for pharmaceutical patents.Unfortunately,there is no practice on the compulsory licensing of pharmaceutical patents.The current status of implementation is no lack of mechanical legislation.Through analysis,it is found that the following problems exist in our legislation.First,the application subject is improperly covered,which is manifested in the general restrictions on the application subject and the different qualifications of the administrative agency as the application subject;second,the public health application is unclear;the administrative approval process is cumbersome and time-consuming;moreover,the patent fee Difficult to determine,lack of reference standards and unreasonable setting of procedures;Finally,lack of mandatory technology transfer clauses.In practice,many developing and developed countries have successfully used compulsory licensing of pharmaceutical patents to respond to their respective domestic public health crises.The successful practice of compulsory licensing of pharmaceutical patents in the United States and India has proved that the system is effective in addressing public health issues Yes,the United States is the country with the largest market share of original research drugs,and India is a country where generic drugs are popular and not regulated.The legislative experience of these two countries in compulsory licensing of drug patents is worthy of reference for China.To make the compulsory licensing of pharmaceutical patents fully play a role in China and effectively improve the accessibility of medicines for the people,the relevant legislation must be perfected.In terms of the application subject,the scope and qualifications of the application subject should be clarified.It is recommended to appropriately relax the scope of the application subject and confirm the application of the administrative agency qualification of the subject;on the grounds of licensing,the accessibility of medicines should be used to refine the grounds of licensing;the approval process can simplify the approval process for compulsory licensing of pharmaceutical patents in emergencies;at the same time,the standards and procedures for patent royalties must be set reasonably To provide a reference for clarifying patent royalties;for technical difficulties,consider adding a mandatory technology transfer clause in the Patent Law to implement the maneuverability of China's pharmaceutical patent compulsory license.