Study On Protection Of Pharmaceutical Test Data Under The TRIPS Agreement

This dissertation aims to study on protection of pharmaceutical test data under the TRIPS Agreement. After briefly introducing the issues which will be explored later and their significance, this dissertation will discuss this topic in following chapters.Chapter One discusses the theoretical issues about the protection of pharmaceutical test data. Firstly, Section one defines the intention and extension of pharmaceutical test data in the meaning of pharmacy and international obligations, which lay the preliminary theoretical foundation for the whole dissertation. Test data is the data acquired by pharmaceutical company through a series of laboratorial experiments and clinical trials in order to prove the safety and efficiency of pharmaceutical products before the company submitting the application for market authorization. The progress of acquiring test data is the same one of pharmaceutical innovation and development. Pharmaceutical companies have to spend a large amount of human resources and money to obtain test data. According to the TRIPS Agreement, test data being protected is the undisclosed data of pharmaceutical products utilizing new chemical entities, submission of which is a condition of approving the marketing of the products and the origination of which involves a considerable effort. Section two elaborates the character of pharmaceutical test data protection as a sui generis kind of intellectual property. As the TRIPS Agreement including pharmaceutical test data into the international intellectual property protection regime for the first time historically, it has the theoretical legitimacy to protect pharmaceutical test data as intellectual property. Further more, pharmaceutical test data protection is a sui generis mechanism which has common points as well as differences with traditional intellectual property protection regime. In the field of pharmaceutical intellectual property protection, the pharmaceutical test data protection plays the distinctive role in comparison with protection of patent and trade secret to improve pharmaceutical intellectual property protection system. The Section three discusses the relationship between pharmaceutical test data protection and public health. Considering pharmaceutical products as a kind of special goods which connect with human life and health, it is necessary to pay attention to the influence of pharmaceutical test data on public health. The protection of test data has both negative and positive effects to public health. As one of purposes for this study, it shall be found an approach to harmonize the pharmaceutical test data protection and public health.Chapter Two analyses the international obligation established by The TRIPS Agreement to protect pharmaceutical test data. The Section one traces back the origins of pharmaceutical test data protection under the TRIPS Agreements. It reviews the relevant articles of NAFTA— the blueprint of pharmaceutical test data protection rules of The TRIPS Agreement and the negotiation history of the TRIPS Agreement. It also analyses the relationships between Article 39.3 of the TRIPS Agreement and other articles of this Agreement to lay the foundation to understand the TRIPS obligation of pharmaceutical test data protection in Article 39.3. The Section two discusses the obligation of WTO Members to protect pharmaceutical test data against unfair commercial use, which is the essence of the obligation of pharmaceutical test data protection under the TRIPS Agreement. It is believed that the action of governmental agency approving generic drugs marketing application by relying on the test data of innovative drugs may be regarded as a violation of the TRIPS Agreement with affects of unfair commercial use for the generic drugs producers. The Section three discusses the obligation of WTO Members to protect pharmaceutical test data against disclosure. Non-disclosure obligation is the minimum requirement of pharmaceutical test data protection. The precondition and term of the non-disclosure have something to do with the understanding of unfair commercial use. The Section four discusses the non-reliance obligation which derives from the obligation against unfair commercial use. Non-reliance obligation is the optional obligation under the TRIPS Agreement. Through the analysis of Canada’s case, it concludes that government authority approving generic marketing application relying on test data of innovative drug in the test data protection period should be regulated under non-reliance obligation. The Section four analyses the exceptions of obligation of pharmaceutical test data protection. In two conditions WTO members are allowed to disclose pharmaceutical test data, one of which is to protect public interests, the other is to ensure the pharmaceutical test data against unfair commercial use.Chapter Three is focused on the domestic law of pharmaceutical test data protection of specific WTO Members from comparative perspective, in order to find out the legislation and legal practice of relevant WTO Members under international legal obligation. The Section one and Section·two respectively introduce the legislations of two WTO Members,Untied States and European Union, which have relatively well-established legal framework of pharmaceutical test data protection. Both of them have adopted the data exclusivity model to protect pharmaceutical test data. The Section three introduces pharmaceutical test data protection of Canada and the regimes of some developing WTO Members which have adopted data non-exclusivity model. They make use of the flexibility of the TRIPS Agreement to minimum the pharmaceutical test data protection obligation. The Section four compares and evaluates the different legal regimes and concludes the differences in term, extent and originates of pharmaceutical test data protection regimes of different WTO Members. The Section four also, in the aspect of China, puts forward to some references from the experiences of pharmaceutical test data protection of other WTO MembersChapter Four discusses the development trends of pharmaceutical test data protection from free trade agreements signed by WTO Members after enforcement of the TRIPS Agreement and the influence of these development trends on the international obligation. The Section one compares the test data protection clauses in post-TRIPS FTAs and those in pre-TRIPS FTAs and the TRIPS Agreement. The provisions of pharmacuectical test data protection in post TRIPS FTAs has some sigunificant diffrences than those in others. It also compares the diffrenct attitiudes of different WTO Members towards data protection in FTAs. The Section two introduces the pharmaceutical test data exclusivity rules in FTAs. Some WTO Members which insist strong pharmaceutical test data protection, as United States, impose data exclusivity model to developing countries via FTAs. Data exclusivity model is one kind of way to implement TRIPS obligation instead of a TRIPS-plus measure. The data exclusivity in FTAs weakens the developing countries’ ability to make use of flexibility of TRIPS, but favors to establish a worldwide uniform standard of pharmaceutical test data protection regime. The Section three introduces the development of test data protection of biological drugs. It is a kind of TRIPS-plus protection; however, with the significant development of biological drugs in pharmaceutical industry, the possibility to apply test data protection provisions to biological drugs has been concerned and discussed. The intention to disscuss biological test data protection in TPP negotiation has been one of the most concerned issues in this field. If it was possible, it will make a great influence on the international obligation of phamacuetical test data.Chapter Five studies the pharmaceutical test data protection in China. The Section one introduces China’s pharmaceutical test data protection regime based on international obligation. Under the background of Chinese pharmaceutical industry development, as well as Chinese pharmaceutical registration regulations and enforcement, it analyses the role of pharmaceutical tese data protection and the relationships between pharmacurtial tese data protection and other pharmacrutical administravie protection measures. The Section two discusses the problems existing in present legal regime as well as the necessity and possibility to improve the regime of pharmaceutical test data protection. Based on the condition of pharmaceutical industry in China, that needs to encourage the innovation research as well as the development of generics, it puts forward the suggestions to improve the relevant laws and regulations.