On Pharmaceutical Patent Linkage System

The Pharmaceutical Patent Linkage System originated in the United States.It is a dispute early settlement mechanism that the generic drug applicant should make a non-infringement statement on the ownership of the patent and time limit of the generic drug and corresponding original drug and notify the patentee of the original drug during the submission of application at the drug registration and approval stage.If the application of generic drug is suspected of infringing the patent of original drug,it may trigger a dispute,or even will not be approved for launching.The system is cored at the balance of interests among original drug,generic drug and the public,encourages the innovation of original drug and promotes the smooth launching of generic drug in order to seek a perfect balancing point of interests.In the premise of keeping the R&D enthusiasm of original drug enterprises,the generic drug enterprises can develop well under appropriate regulations and promote more drugs to enter the market,thereby reducing drug prices,improving drug accessibility,and ultimately safeguarding public health.At present,there is no mature pharmaceutical patent linkage system in China and most of them are only relatively general and broad regulations,lacking specific operability.China's relevant provisions on the patent linkage system are scattered in the Patent Law and the Drug Registration Management Measures which are considered to be the legal basis of China's pharmaceutical drug patent linkage system.In addition,China issued the Policy on Encouraging the Rights and Interests of Innovative Protection of Innovative Drugs for Medical Devices(Consultation Draft)(hereinafter referred to as “Opinion Draft”)and Deepening the Reform of Examination and Approval System to Encourage Innovation of Pharmaceutical Medical Devices Opinions(hereinafter referred to as "opinions")in 2017,suggesting that China will explore the establishment of a drug patent linkage system.As for China,a country whose pharmaceutical patent linkage system is not complete,it is particularly important to combine the selection and balance system of the specific national conditions in the pharmaceutical patent linkage system.It is not just an isolated system,but a complete legal regulation system involving constant dynamic balance and competition among various elements.China,as a large generic drug country,its pharmaceutical industry is mainly based on the generic drug industry by accounting for the majority.At the same time,it is worth noting that although the number of generic drugs in China is large,its quality is low.The low-level generic drug occupies the large part of medical market.The patent linkage system is developed in the United States whose generic drug and the original drug industry are all developed,which is significantly different from China's current conditions.As for the construction of China's pharmaceutical patent linkage,it's a top priority to use for the reference of foreign advanced system.However,it is not appropriate to transplant them for sure,but advisable to "adapt to local conditions" in the light of specific national conditions.The paper is divided into four parts to study the pharmaceutical patent linkage system.The first part studies the basic theory of the patent linkage system by staring from its cause.Based on the contradiction among generic drugs,original drugs and the public health,it also discusses theoretical basis and the value of realizing public health by balancing the interests of three parties.The second part analyzes the development and specific system design of the US pharmaceutical patent linkage system as the founder,and summarizes the problems and solutions in the process of the evolution of the US system firstly.Secondly,it studies the way of transplanting the American system in Canada and the specific content of its system design,discusses the effect of transplanting in Canada,which provides experience for the reference of system construction in China.Finally,by considering the EU and India's anti-drug patent linkage system,the paper probes into the solution and effect of its domestic related problems in the light of the specific national conditions of the EU and India,and provides reference for the construction of patent linkage system in China according to local conditions.The third part studies the present situation and existing problems of pharmaceutical patent linkage system in China from the current legal provisions and the contents of the relevant system design of exploring the establishment of patent linkage system in 2017 successively issued in papers.The fourth part illustrates the system design in China according to the actual condition and needs.And initially put forward specific suggestions on the selection of elements and the improvement of the system that are compatible with China's national conditions.