The Development Of International Law Of Pharmaceutical Patent Term Extension System And China’s Countermeasures

Pharmaceutical Patent Term Extension System refers to the compensation for a certain period of time for patented drugs after the expiration of the drug patent protection term,provided that the statutory conditions are met,in order to make up for the loss of profits caused by the effective patent period occupied by the new drug marketing approval process.Since drugs are related to public health,in order to ensure the safety,effectiveness and quality control of drugs,countries often strictly control the marketing approval of new drugs,making new drugs need to go through lengthy trials and approvals before they can be marketed.Due to the First-to-File System for patent authorization,right holders often choose to apply for a basic patent at the initial stage of new drug development,that is,when a lead compound is discovered.In this way,the time span from patent authorization to the launch of new drugs is quite large,and the time for innovative pharmaceutical companies to monopolize the sale of new drugs on the market has been reduced due to the drug approval process,making it difficult to recover huge R&D investments.In response to this,the United States established Pharmaceutical Patent Term Extension at the legislative level in 1984,and Japan,the European Union and other countries and regions have successively established this system to encourage the development of local innovative pharmaceutical companies.The final text of the TRIPS agreement only stipulates a patent term of no less than 20 years from the date of filing,frustrating developed countries’ attempts to include Pharmaceutical Patent Term Extension in this agreement.Driven by national interests,the United States,Europe and other countries negotiated bilateral or regional free trade agreements and included TRIPS-PLUS clauses such as Pharmaceutical Patent Term Extension in these agreements,forcing developing countries to build their own systems for Pharmaceutical Patent Term Extension.As a result,the system has moved from one country to the world,and has shown a trend of global expansion,which has undoubtedly brought a certain amount of pressure to China.In recent years of patent drug import negotiations,China has been under pressure from developed countries to build a Pharmaceutical Patent Term Extension System.This system has been widely discussed by the academic community in our country since 2017,and policy makers have also issued a series of documents to carry out system trials and promote related legislation work.However,considering the real national conditions such as the insufficient development of China’s pharmaceutical industry,adequate system research is still needed,and the system has not been implemented for a long time.Until the beginning of 2020,China and the United States reached the Sino-US Economic and Trade Agreement,which signifies that China must fulfill its international law obligation to construct a system for Pharmaceutical Patent Term Extension.Relevant legislative work has been put on the agenda again and has been accelerated.Finally,the system framework for Pharmaceutical Patent Term Extension is stipulated in Article 42 Paragraph 3 of the Patent Law(Fourth Amendment)and some new rules in the Implementation Rules of the Patent Law(Draft for Comment),which will be officially implemented on June 1,2021.In view of this,it is necessary to explore the practical basis of China’s implementation of Pharmaceutical Patent Term Extension,study whether the system regulations to be effective are consistent with the Sino-US Economic and Trade Agreement,and learn from foreign legislation and practical experience to further improve China’s Patent Term Extension System to enhance its effectiveness.This article comprehensively uses a variety of research methods such as literature research,historical research,comparative research,and case research,and discusses the Pharmaceutical Patent Term Extension System in four parts.Chapter One is the connotation and legitimacy of Pharmaceutical Patent Term Extension System.First of all,this article defines the concept of Pharmaceutical Patent Term Extension System,and analyzes its connection and difference with Patent Term Adjustment System.At the same time,it combs its historical evolution to show the origin and development of the system.Subsequently,the legitimacy foundation and value of the system were clarified,using the theory of the balance of interests in intellectual property law as the methodology,to clarify that Pharmaceutical Patent Term Extension System made up for the shortcomings of the traditional patent term,and was constructed on the basis of the balance of interests.Chapter Two is the development of international rules for the system of Pharmaceutical Patent Term Extension.First of all,by combing through the changes in the international law of the provisions of the patent term and the international legislative background of Pharmaceutical Patent Term Extension,it is shown that this system was driven by interests from one country to the world,and was rooted in the domestic legal systems of each country.Secondly,it examines the evolution of the rules of Pharmaceutical Patent Term Extension in international agreements,clarifies its development trend,and lays the foundation for subsequent reviews of the rules.Thirdly,it clarifies that the international law rules of Pharmaceutical Patent Term Extension present the characteristics of imbalance of interests,which is not conducive to the development of the pharmaceutical industry and public health protection in developing countries.Compared with the prior free trade agreements,the relevant rules in the Sino-US Economic and Trade Agreement are more reasonable,but there is a larger policy space reserved.For this reason,China needs to further refine the legislation when constructing the system.Chapter Three is the background and current legislative status of China’s Pharmaceutical Patent Term Extension System.First of all,it points out the practical problems in the development of China’s pharmaceutical industry.The lack of pharmaceutical innovation capabilities has become a key factor restricting the development of China’s pharmaceutical industry.At the same time,it points out that China has a realistic demand for the construction of a system for Pharmaceutical Patent Term Extension.This system can not only stimulate the research and development of new drugs and promote the development of the pharmaceutical industry,but also conform to the essentials of China’s pharmaceutical innovation policy.Secondly,by comparing the Sino-US Economic and Trade Agreement with China’s relevant legislative provisions,China’s laws are basically consistent with this agreement.But there is still need for improvement in the grant of Pharmaceutical Patent Term Extension and the determination of the scope of protection during the compensation period.Chapter Four is about the improvement of China’s Pharmaceutical Patent Term Extension System.First of all,for the improvement of the factors of Pharmaceutical Patent Term Extension System,by examining the practical experience outside the territory,it provides reference for the interpretation and application of the relevant rules of Pharmaceutical Patent Term Extension.Secondly,for the improvement of the supporting mechanism of this system,feasibility suggestions are put forward for the problems existing in the Bolar Exception and the Patent Drug Price Negotiation Mechanism.