The Analysis Of Copyright Issues Of The Package Insert

In recent years, package insert copyright disputes, appearing in judicial activities have become more frequent. In such cases, the focus of the dispute between the parties is focused on whether the package insert is original. Therefore, it is the key to solve this kind of dispute to clearly define the meaning and criteria of originality.The meaning and criteria of originality are not defined in the current "copyright law" and its judicial interpretation. To a certain extent, it brings some obstacles to the judicial activities. Therefore, it is of great theoretical and practical significance to make a clear definition of the meaning and judgment standard of the originality. First of all, this paper is based on the comparative study of the Occident's meaning and criteria of the originality, integrated national legislation, judicial and theoretical circles on the status quo of the research and application of originality, the author puts forward the suggestion on the definition of the meaning and the judgment criteria of the originality. The paper consists of five parts:The first part introduces the basic circumstances of the case, summed up the focus of dispute is that whether the package insert is original or not from comments on the case from the court.From the perspective of comparative study, the second part introduces the definition of the originality's meaning and it's judgment criteria in the United States, United Kingdom, France, Germany. And analysis the reasons for the formation of different standards of the two major systems, focusing on the development process of the Originality Theory in the United States. Through the comparative study, it is helpful to deepen the understanding of the Original Theory, it also provides a useful direction for us to set up the meaning and criteria of the originality conforming to the national conditions.The third part introduces the status quo of the originality's meaning and its judgment criteria defined by the legislative, judicial and theorists. Firstly, analyzing the lack of legislation of the originality's meaning and its judgment criteria and the judicial chaos caused by the lack of legislation. Then, introducing the theoretical research of the Originality theory. On this basis, combined with the comparative study of the preceding chapters, the author put forward the recommendation of the definition on the originality's meaning and its judgment criteria, and analyses the reasons for such a definition.The fourth part is the analysis of the non-copyright of the package insert from the perspective of the originality space and the principle of balance of interests. Firstly, introducing the normative characteristics of the content and format of package insert. Draw the conclusion that the originality space is extremely limited by analyzing the content of the package insert, the character of the writing format and the nature of its content. Then, from the perspective of the benign development of the pharmaceutical industry from the perspective of the public policy of intellectual property rights, the analysis finds that if the drug instructions will be protected by the copyright law for the healthy development of China's pharmaceutical industry and public health caused by adverse effects.The fifth part is the legislative proposals for the problems reflected in the case. The proposal is to understand the originality of the two aspects of creativity and creativity, and establish a judgment of moderate originality height. At the same time, it is recommended increase excluding the generic package insert and remove reference package insert illegality clause in the pharmaceutical laws and regulations, in order to promote the development of the generic drug industry.