Research On Regulation Of Drug Patent Abuse

In 2020,the Central Committee of the Communist Party of China and the State Council issued "Opinions on Deepening the Reform of Medical Security System" and launched China’s new medical reform policy.The opinion clearly pointed out that in order to reduce the price of drugs,enhance the accessibility of medical services and benefit the people’s livelihood,the supply-side reform will take "supporting the development and use of high-quality generic drugs and promoting the substitution of generic drugs" as one of the main directions.With the implementation of the new medical reform policy,when the third batch of national centralized drug procurement was opened,most original drugs were not included in the candidate list because the product quotation was too high,and were replaced by domestic generic drugs.Facing the competition of generic drug companies,the original drug research companies have adopted various coping strategies,including the abuse of drug patents to exclude and restrict competition.At present,there are three typical forms of drug patent abuse: patent evergreen,reverse payment agreement and product jump.First of all,patent evergreen means that the original drug research enterprises will form patent barriers and increase the possibility of infringement by applying for secondary patents and creating patent jungle.The original drug research companies want to scare off generic drug companies in this way.Secondly,if the generic drug companies are not scared off,but insist on applying for listing generic drugs,the original drug research companies will increase the litigation cost and time cost of generic drugs through patent infringement litigation.During the litigation,some original drug companies will take the initiative to reach a reverse payment settlement agreement with generic drug companies.Through the reverse payment agreement,generic drug companies promise not to challenge the patents of the original drugs and not to enter the market within a specific period of time.If the generic drug company is the first generic drug company approved for listing,the original drug research company can not only stipulate that the first generic drug company will postpone listing,but also hinder the listing of other generic drugs.Finally,even if generic drug companies overcome patent obstacles and successfully go on the market,generic drug companies still need to maintain their price advantage and use the drug substitution system to occupy the ideal market share.At this time,the original drug research enterprises can also take the product jump behavior,cancel the drug code,revoke the marketing license and completely withdraw the original version of the drug from the market,so that generic drug enterprises can not make effective substitution by using the drug substitution system.In this case,generic drugs need to copy the new version of the original drug and apply for listing again.Even if the re-development is successful,the additional R&D and publicity costs in this process will make generic drugs no longer have the original price advantage.In this case,many generic drug companies with weak economic strength may give up the research and development of related generic drugs.The above three typical behaviors of drug patent abuse completely deviate from the original intention of drug patent protection,improperly extend the validity period of patents,exclude and limit the competition of generic drugs,and enable the original drug research enterprises to continue to maintain high prices,thus damaging the rights and interests of patients.Based on the anti-monopoly practice in the United States,Europe,India and other countries,this paper will sort out the methods to regulate the abuse of drug patents in order to provide reference for China to actively deal with the abuse of drug patents.In addition to the introduction and conclusion,the full text is divided into three parts:The first part mainly expounds the relevant definitions of drug patent abuse,analyzes the necessity and urgency of regulation in China,and lists three types of drug patent abuse in turn.This paper comprehensively analyzes the cause and effect of each behavior type from the aspects of its manifestation and characteristics,background and effect.The second part mainly studies the measures taken to deal with the abuse of drug patents outside the territory.This paper compares and analyzes the drug patent law and anti-monopoly law of India,the United States and the European Union,and expounds some enlightenments for regulating the abuse of drug patents in China by combining the typical cases of various countries and regions.The third part mainly analyzes the current situation,problems and related legal regulations of patent abuse in China’s pharmaceutical industry,summarizes and draws lessons from the research experience of foreign drug patent abuse,and provides perfect suggestions for China to actively deal with drug patent abuse.For example: first,from the perspective of patent law,it is suggested to improve the level of patent protection.Secondly,in the aspect of patent objection procedure,it is suggested to improve the procedure of modifying,adjusting and deleting the errors of patent registration information in China drug listing catalogue.Thirdly,starting from the patent linking system,it advocates extending the waiting period of litigation appropriately and establishing the penalty of automatic loss of exclusive period of the first imitation drug market.Fourthly,on the level of anti-monopoly law,it is proposed to clarify the nature of reverse payment agreement and product jump behavior,determine the corresponding anti-monopoly review principles and refine the corresponding anti-monopoly review framework.