Research On The Stay Period Of The Mechanism For Early Resolution Of Patent Disputes

As a special commodity of public nature,drugs are related to public health.This particularity requires that relevant laws,regulations and policies not only encourage the research and development of new drugs and treat emerging diseases,but also promote the marketing process of high-quality generic drugs and reduce drug prices.The COVID-19,which swept the world in 2020,once again made the public aware of the importance of drug research and development and access to medicines.Based on the characteristics of large investment in new drug research and development,long cycle and difficulty in innovation,monopoly protection is needed to recover its investment cost and stimulate the enthusiasm for subsequent research and development of new drugs.But another feature of the drug is that once it is developed,the subsequent production and manufacturing costs are relatively low.Therefore,the conflict of interests between generic drug manufacturers and original drug manufacturers is more obvious in the field of patents.Therefore,while encouraging R&D and innovation,it is also necessary to reduce the price of medicines and increase the availability of medicines.How to balance the interests of both sides of the imitation and innovation has become the common goal of the policies of all countries and regions in terms of drug market access.Although my country’s pharmaceutical industry started late,it has developed rapidly.Currently in the golden period of rapid development of pharmaceutical industry,the contradiction between the mass demand for the pharmaceutical market and the unbalanced and inadequate development of the pharmaceutical industry has become more prominent.The three consecutive policy documents issued by the state in 2017 all emphasize the gradual emphasis on exploring the establishment of a drug patent linkage system,followed by the ECONOMIC AND TRADE AGREEMENT BETWEEN THE GOVERNMENT OF THE PEOPLE’S REPUBLIC OF CHINA AND THEGOVERNMENT OF THE UNITED STATES OF AMERICA,and Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes(Trial)(Draft for Comment),Patent Law of the People’s Republic of China(2020Amendment)have all proved that measures to establish a drug patent linkage system are imperative.On May 18,2021,the Center for Drug Evaluation(CDE)of the National Medical Products Administration issued the "Notice on the Public Testing of the Patent Information Registration Platform Related to the Early Resolution Mechanism for Drug Patent Disputes",which means that my country’s drug patent disputes are early The settlement mechanism is about to open,and the protection of pharmaceutical patents is gradually being strengthened.The drug patent linkage is called the early resolution mechanism of drug patent disputes in China.It refers to the system that links the drug marketing approval process with the drug patent dispute resolution process.Its purpose is to adjust the relationship between the original research drug and the generic drug in the generic drug marketing application.A set of rules for the game of interests to promote the early resolution of disputes.The reason why the government manages the drugs is because pharmaceutical patents are not only technical or economic issues,but more importantly related to national health and public security.This particularity makes drugs subject to the dual constraint of the intellectual property field and the administrative field.Listed drugs not only need to satisfy the safety in the pharmaceutical sense,but also must not infringe the patent rights of others.In order to prevent generic drug applicants from being unable to sell on the market due to patent infringement after obtaining marketing approval from the drug regulatory authority,which would lead to wasteful R&D investment and administrative review work,a prescribed time limit was set before the generic drug listing application.To resolve the issue within the time limit,so as to smoothly promote or prevent the listing of generic drugs,for both parties and the general public,this kind of stable state of rights is beneficial.A sub-system of the drug patent linkage,stay period,is designed here.The system enables drug patent disputes to be resolved before generic drugs are marketed.It can not only reduce the time that generic drugs that have obtained market licenses are about to enter the market,but also because they are sued for infringement,and give the original research drug manufacturer a certain period of time within the restricted period.Market exclusivity to maintain its enthusiasm for research and development.At present,the provisions on the stay period are only embodied in a few documents.The newly amended Patent Law has only a few words on the stay period,and the Draft for Comments only makes preliminary provisions on the period,which means the specific rule refinement has not yet been seen.Therefore,this paper focuses on the stay period for early settlement of drug patent disputes.By clarifying the relationship between the system and its parent system,examining its legal value,practical significance,and the complexity and necessity of detailed rules,and then establishing a stay period through reference.On the basis of the regulations of major countries and regions,we propose ideas for constructing China’s stay period.The first chapter of the article is an analysis of the necessity of the design of the approval waiting period system.The first part is an introduction to the original research drug and generic drugs,the concept of the approval waiting period system and the relationship between the two;the second part is based on the theoretical basis and practical significance.Discuss the necessity of establishing an approval waiting period system from a perspective.The third part is to point out the three main problems with the current approval waiting period system in our country.The first is that the relationship between the lawsuits that fall within the scope of patent protection and the patent infringement is not clear;the second is that the patentee has an excessive self-monitoring obligation;and the last is that the length of the approval waiting period is unreasonable.The second chapter discusses the constituent elements of the approval waiting period system.This chapter is divided into three parts.The first and second parts introduce the conditions and duration of the extraterritorial approval waiting period system based on the three countries of the United States,Canada and South Korea.The third part analyzes the reasons for the abuse of the approval waiting period and introduces the regulatory methods of this behavior in major countries and regions.The third chapter is to put forward suggestions on the improvement of my country’s approval waiting period system.This chapter starts from two parts based on the problems pointed out in the previous article and the constituent elements in the corresponding legislation outside the territory.The first section is about setting up the approval waiting period.This article proposes that in addition to the registration application information submitted by the drug registration applicant on the marketed drug patent information registration platform,the notification obligation of the generic drug registration applicant should also be added.After the applicant has fulfilled the notification obligation,the period for filing an objection begins.If the patentee chooses to take action,he should formally enter the start-up approval waiting procedure from the day the people’s court or the patent administration department filed or accepted the case.At the same time,in order to avoid abuse of rights by the patentee,future legislation should limit its listing application for each generic drug to only start an approval waiting period.The second section proposes to reasonably stipulate the length of the approval waiting period and the consequences of abuse.After analyzing the time required for the trial of drug patent infringement disputes in my country and the time required for the administrative department to declare patent invalidation,combined with practical cases,it was determined that the currently proposed 9-month waiting period for approval may not be sufficient to resolve related disputes.Patent disputes are left until the listing,and it is recommended to extend the approval waiting period to 18-24 months.At the same time,it is also suggested that the compensation provisions for abuse of the approval waiting period can be increased through guiding cases or the Supreme People’s Court approval.The corresponding compensation standards can refer to the market size of the drug involved,the market share retained by the original research drug company,and the market share generic drug company should have gained.This article hopes that by improving the relevant content of the suspension period in the legislation,the protection level ofpharmaceutical patents will be improved,the original research pharmaceutical companies’ enthusiasm for innovation will be stimulated,and the optimization of the market structure of China’s pharmaceutical industry will be promoted.On the other hand,we should provide opportunities for more qualified,high-quality and low-cost generic drugs to enter the market as soon as possible.