Research On China’s Pharmaceutical Patent Challenge System

In recent years,the COVID-19 pandemic has continued to spread,causing serious losses to people’s lives and property.The contradiction between drug patent rights and health rights is becoming more and more obvious in the context of the global public health crisis.How to strengthen patent protection to stimulate pharmaceutical technology innovation and promote the development of the pharmaceutical industry while improving the accessibility of drugs,meeting the needs of the public for drugs,and maintaining public health are the focus of academic circles.China’s population base is large,the aging phenomenon is severe,and the medical security system is facing major challenges.The drug patent challenge system originated in the United States and is one of the core contents of the drug patent link system,which means that the applicant of a generic drug submits a type Ⅳdeclaration against the drug patent information published on the drug patent information registered on the listed drug patent information-the declaration that the relevant patent is invalid or non-infringing,that is,it is regarded as a challenge to the drug patent.Practice outside the region shows that the effective operation of the drug patent challenge system can improve the quality of drug patents,promote the early listing of non-infringing generic drugs,maintain healthy competition in the pharmaceutical market,and help reduce drug prices and improve drug accessibility.The implementation of the drug patent challenge system in the United States has brought generic drugs into the market an average of three years earlier;after the introduction of the drug patent challenge system in South Korea,it has aroused the enthusiasm of generic drug manufacturers to challenge the original drug patents,and promoted the healthy competition between the original drug and the generic drug.At present,China’s "version 1.0" drug patent challenge system has just landed,theory and practice are still in its infancy,and the existing rules still need to find problems,resolve disputes and gradually improve in practice.The current drug patent challenge system in China mainly has the following problems:the patent information registration system for listed drugs is defective,the waiting period for the approval of generic drugs is too short,the exclusive period of the first generic drug market lacks an effective guarantee mechanism,and the lack of a restrictive mechanism for the abuse of the exclusive period of the first generic drug market.Drawing on foreign experience,based on China’s national conditions,and improving China’s drug patent challenge system should start from the following aspects.first,standardize the patent information registration system for listed drugs,improve the authenticity,accuracy and completeness of the registration of patent information of listed drugs,and provide reliable data support for generic drugs to challenge the patent rights of original drugs;second,rationally allocate the waiting period for the approval of generic drugs to provide institutional support for non-infringing generic drugs to be listed as soon as possible by challenging the patent rights of original drugs;third,establish a guarantee mechanism for the exclusive period of the first generic drug market Fourth,a clause is added to regulate the abuse of the exclusive period of the first generic drug market,restricting the generic drug manufacturer from exchanging improper interests with the original research drug manufacturer to harm the public interest.In this way,the implementation of the drug patent challenge system in China can better protect the balance of interests between generic drug manufacturers,original drug manufacturers and the public,and promote the sustainable development of the pharmaceutical industry.