Study On The Application Of Drug Patent Linkage System

Innovator drug and generic drug are two indispensable parts of the pharmaceutical industry.The former guarantees the availability of drugs and makes drug available to patients,while the latter improves the affordability of drugs by lowering the price of drugs.The innovator drug comes from huge capital investment and technological innovation.Therefore,it relies heavily on drug patents to obtain exclusive market share to recoup R&D investment and earn high profits,thereby supporting further research and development.Generic drug is generally required consistent with the innovator drug in terms of active ingredient,indication,etc.to achieve therapeutic effects equivalent to that of the innovator drug.This requirement makes it difficult for generic drug to circumvent core innovator drug patents such as compound patents and indication patents.Therefore,the patent disputes between the innovator drug and the generic drug appear to be inevitable.The drug patent linkage system provides a mechanism for handling drug patent disputes during the generic drug registration,which mainly includes four aspects:(1)the drug patent registration system,that is,submission of drug patent information by innovator drug companies to drug regulatory authority upon filing drug registration applications or receiving marketing approval,and publication of the drug patent information by drug regulatory authority,wherein the drug patent linkage system only deals with the disputes arising from the registered drug patents;(2)the drug patent dispute resolution mechanism,which involves types of statements generic drugcompanies can make with respect to registered drug patents,e.g.,there is no registered drug patent,the registered patent has expired,generic drug will not be marketed before expiration date of the registered patent,or the patent is invalid or will not be infringed by the generic drug,as well the legal basis for innovator drug companies to sue generic companies for patent infringement when the registered patents are challenged by the generic companies;(3)the stay period system,that is,after the innovator drug company filed a patent infringement lawsuit,the drug regulatory authority will set a certain period of time to wait for the outcome of the lawsuit,and the generic drug will not be approved within this period unless the generic drug company obtain favorable outcome within said period;(4)the first generic drug incentive system,which normally involves a certain period of market exclusivity granted to the first generic company that successfully challenged registered drug patents,during which period subsequent generic drug applications will not be approved.This paper analyzes the origin and development of the drug patent link system in the United States,introduces the transplant of the system into Canada and South Korea,and particularly analyzes the modifications made to the drug patent registration system,drug patent dispute resolution mechanism,the stay period system,and the first generic drug incentive system by Canada and South Korea when introducing the drug patent linkage system.Subsequently,this paper analyzes the basis of constructing patent linkage system in Chinese laws and regulations such as Chinese Patent Law and Drug Registration Regulations,and further analyzes the policy and legislative trends in the establishment of drug patent linkage system in recent years.On this basis,the author puts forward relevant suggestions for establishing and perfecting China’s drug patent linkage system.Firstly,the drug registration system is the foundation and core of the entire drug patent linkage system.The construction of the drug registration system can be based on three aspects: timeliness,rationality,and accuracy,in order to define a reasonable scope of patent registration,ensure the accuracy of the registration of patent information through the joint participation of the innovator drug companies,genericdrug companies and drug regulatory authority,and ensure that the patent information reflects the status change of the registered patents in a timely manner,thereby ensuring that the patents entering the subsequent steps of the patent linkage system are reasonable and accurate,and reducing the occurrence of non-essential patent disputes.Secondly,the establishment of the drug patent dispute resolution mechanism is the premise of resolving disputes through the drug patent linkage system.The statements regarding registered patents made by generic drug companies can be designed in a way that reflect the types of patent disputes faced by the generic drug companies,so as to provide generic drug companies more practical choices when submitting the statements.As for the legal basis of patent infringement lawsuit under the patent linkage system,in addition to directly adopting the artificial act of infringement,it may also be considered to limit the scope of the Bolar exception by means of legislative interpretation or judicial interpretation,so as to establish the legal basis of initiating patent infringement lawsuit by innovator drug companies.Thirdly,it may be considered to concentrate jurisdiction to the patent infringement lawsuits under the drug patent linkage system on selected courts with relatively short trial periods and rich experience in drug patent infringement cases,thereby shortening the stay period and reducing the impact of the stay period on generic drug approval.Finally,regarding the first generic drug incentive system,in view of the various problems arising from the practice of the market exclusivity system,it is suggested to providing incentives by providing the first generic drug some advantages in the process of drug bidding and the medical insurance catalogue inclusion,instead of adopting the market exclusivity system.Finally,the author believes that the drug patent linkage system should be established and improved based on the actual conditions of the country,so as to effectively protect the patent rights relating to innovator drugs,encourage the R&D and innovation activities of the innovator drug companies,help reducing the risks of patent infringement after the marketing of generic drugs,promote the healthy development of the generic drug industry,and ultimately enable the two to jointly guarantee the supply of medicines in society.