Research On The Intellectual Property Protection On Drug Test Data Under The Perspective Of International Law

Drugs not only related to the people's livelihood and public health,but related to the stability of millions of families and everyone's health,even life.So,governments of the world made strict regulations on the conditions for granting drugs the intellectual property rights.At the same time,countries have generally developed a generic drug system in order to promote public health,which simplified the generic drugs listing approval procedures.However,the simplified procedure for generic drug listing approval is unfair to original drug manufacturers who have made great efforts to obtain large amounts of test data for drug approval.Therefore,in order to overcome the drawbacks of the generality of generic drugs system,to alleviate the exclusive protection of drugs,to promote public health contradictions,and to coordinate interests between the drug R & D enterprises and generic enterprises,majority of countries have developed a drug test data protection system to provide a certain period of protection on the test data for drugs R & D enterprises in the approval process.Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights(hereinafter referred to as TRIPS Agreement)protected undisclosed drug test data obtained through considerable effort to prevent unfair commercial use.This was the first time that the drug test data protection system has been recognized by the Member States at the international level.In addition to national laws and TRIPS Agreement,many bilateral,free trade agreements(hereinafter referred to as FTA)have also been appropriate protection of drug test data,such as the Trans-Pacific Partnership Agreement(hereinafter referred to as TPP Agreement)signed on February 4,2016,provided a high standard of protection for drug test data in the Intellectual Property Section.Although China has not been able to join the TPP Agreement,and US President Trump has signed an administrative order to withdraw from the TPP Agreement on the first day of his appointment,on the one hand,from the TRIPS Agreement to the TPP Agreement,through the relevant provisions of the two international trade agreements,China is facing a huge challenge;on the other hand,it is a good opportunity that the United States to withdraw from the TPP agreement for the Pan-Pacific countries and regions,and it may be also a good one for Chinese government to more actively promote the regional comprehensive economic partnership(hereinafter referred to as "RCEP"),"The Belt and Road Initiative" and other construction of multilateral mechanisms in the future.Article 39.3 of the TRIPS Agreement specified that the test data protected by each Member shall comply with the conditions of the five "minimum standards" and that the purpose of protecting the data of the members was to prevent improper commercial use.But there are several vague places with these conditions.First,the definition of new chemical entity was unclear.Second,the extent of considerable effort was unclear.It was not clear that whether the type of "effort" includes both physical and mental effort,as well as time and money and the size of “considerable".There was no clear guidance on the scope of evidence for proof.Third,there was a big controversy with the "unfair commercial use",which the developed countries generally believe that Article 39.3 clearly established data proprietary rights,but developing countries generally considered TRIPS that it only provides the minimum standards for data protection,and does not provide for protection period and require members to explicitly grant data exclusive rights.Thus,in the absence of an authoritative interpretation of this problem,we can only think that the Article 39.3 established the minimum protection standard for drug test data for domestic legislation of different members.TPP provides "patent and undisclosed tests or other data" in Section F of Chapter 18 intellectual property rights,where specific provisions on the protection of drug test data are in Section C,"Drug-related Measures".Compared with the TRIPS Agreement,TPP Agreement on Drug Test Data Protection Terms protects drug data from "improper commercial use" and expanded the purposes of protection,and Article 18.50 of the TPP Agreement provided that no matter whether the test data will be used for legitimate commercial use,it is not allowed to use the test data without the consent of the data owner.At the same time,the scope of protection of the TPP agreement has been expanded.The TRIPS agreement required the listing of licensed products must use the "new chemical entity",which is taken in a positive way.In the case of Article 18.53 of the TPP Agreement,the article adopted a reverse provision,that is,"a drug that does not contain a chemical entity that has been licensed in that Party." Obviously,the scope of protection of drug test data under the TPP Agreement,which provided a reverse regulation,was greater than the scope of protection of the drug test data under the TRIPS Agreement.In addition,the TPP Agreement protected the period more clearly and actively protected public health.The Hatch-Waxman Act initially established the US drug test data protection system to provide five years' exclusive protection for NCE-containing drugs from the date of their approval and three years exclusive protection from the date of approval protection for the improved new drug.In the case of exclusive protection,the application for listing data,whether acquired by generic companies or obtained through other means,shall not be approved by the Food and Drug Administration(FDA)to approve the same or similar drugs reference.At the same time,the pediatric medication to provide 6 months of superposition protection(non-exclusive protection),to provide 12 years of exclusive protection for biopharmaceuticals data.In the 2004/27 / EC Directive,the EU established the "8 + 2 + 1" protection mechanism for drug test data,more strict regulations on pediatric use,and exclusive protection for orphan drugs.Japan has changed the domestic law within the framework of the TRIPS Agreement,which stipulated the retrial system of data protection period,which not only ensures the safety and efficiency of innovative drugs,but also increases the accessibility of drugs and achieves the unity of economic and social benefits.As a typical developing country,Brazil established criminal protection for the drug test data,but it is essentially a trade secret protection.Similarly,Thailand has also used commercial secrets to protect the drug test data were protected,and this provides for the corresponding criminal sanctions.The legislation of China's drug test data protection mainly related to 2002 Drug Administration Law Implementation Regulations and 2007 Drug Registration Management Measures,whose standard of the protection slightly higher than the minimum protection standard of the TRIPS Agreement.But there is a certain distance with the strict protection standards of TPP agreement.Although China did not join the TPP agreement,and the United States announced its withdrawal from the TPP agreement,the other members of the TPP agreement has not only geopolitical interests with China,but there are a lot of economic and trade exchanges.Among the members of the TPP Agreement,China is Japan's largest trading partner,the second largest trading partner of the United States,and has signed free trade agreements with seven countries,including Vietnam,Malaysia,Singapore,New Zealand and Australia.Therefore,China should rationally analyze the current international intellectual property protection standards of drug test data,and judge the future development trend of drug test data protection in a reasonable way.At the same time,it is necessary to think about the status quo of the pharmaceutical industry in China and the related legal system.It is necessary to demonstrate and clarify the model of anti-unfair competition protection model adopted by the TRIPS agreement or the model of exclusive protection adopted by the TPP agreement,especially to clarify the distinction between drug test data protection,patent protection and trade secret protection.There have been many scholars who have done a lot of research on the drug data protection system,but few have studied the data protection system in China under the background of the high-level drug protection requirements stipulated in the TPP agreement.This paper firstly analyzes the function and significance of the system of drug data protection from the perspective of reviewing the origin of drug data protection and comparing the national drug data protection system.The paper enumerates and analyzes the protection mode and the specific system design of the drug data protection taken by different countries and try to gain useful experience for China's drug data protection.Then it compares the TRIPS Agreement with the relevant provisions in the TPP agreement to show that the IP standards in international trade agreements have increased rapidly over the past two decades,and China face great challenges.And then this paper tries to analyze the relationship between drug data protection,trade secrets and patent rights from the theoretical and practical view,demonstrating that the drug test data protection should be different from the common commercial secrets and further clarifying the direction of drug data protection system development.And then through the review of the latest progress of China's biomedical industry and highlighting the subtle changes in the protection of intellectual property rights of drugs in China,this paper put forwards that China's current protection level is not suited to the status of the development of China's pharmaceutical industry,in which case to expand the scope of data protection,detail data protection period,clarify the content of protection and try to establish a drug test database and new drug monitoring platform for four aspects of the proposal to improve China's drug data protection system.