Study On The Package Insert Copyright Protection

Since becoming a WTO member in 2001, the rapid development of China's pharmaceutical industry up intellectual property as the pharmaceutical industry to enhance the competitiveness of the new strategy gradually attracted the attention of the relevant pharmaceutical companies. Since patent protection for pharmaceuticals and test data protection are short term in order to compensate for the lack of protection period, extended profit cycle, the developer of drugs attempt to find a new way that is the package insert claims copyright protection ways to extend its market occupancy period. To this end, the package insert copyright disputes in recent years increasingly become an important issue of the trial areas. Due to China's "Copyright Law" relevant works originality criteria specified vague, there is a big difference in addition to the qualitative problem theorists and practitioners of the package insert, the administration of justice during the trial relating to the package insert copyright disputes appeared " the same or similar cases, the court is very different, " the strange phenomenon. The vast differences on the judiciary, no doubt directly contrary to justice, profane judicial authority, reduce the judicial trust, it undermines the credibility of the judiciary. Legislation eventually lead to uncertainty judicial work is not unified, double defect judicial legislation has sounded the alarm for us, this paper select the specification of drug copyright protection issues in-depth study and research, it is desirable for China's pharmaceutical industry has been debated long thesis that works attribute drug instructions are given the perfect answer, unified judicial criteria, stable pharmaceutical market order.Based on the package insert copyright dispute case study, we chose one of the more typical two classic case- Wellman Pharmaceutical Co., Inc. v. Erye package insert copyright disputes and pharmaceutical companies Wellman v Hongxing pharmaceutical companies package insert copyright infringement case. Through the merits of a simple sort, extract case the focus of controversy, and thus leads to the topic of this article- the drug works is not a description of "Copyright Law" in the sense of? Whether copyright protection should be given? If you should be protected, how to protect?Follow the above writing ideas, the main part of the paper is divided into five parts.The first part: the issues raised. On the basis of a large number of study drug instructions on the copyright dispute cases, select one of the two typical cases, brief case, summarized the focus of controversy. Through the package insert copyright dispute case analysis found that the administration of justice in the trial of the problems that the problem of identification for the package insert property law, justice point of view is different, different standards.The second part: infringement of Justice Drug Instruction books about disunity cause analysis. First, from the "Copyright Law" itself to start to explore the root causes of the existence of judicial disagreement that China's "Copyright Law" on the works of originality criteria specified in ambiguity. Secondly, the article further particularity package insert, that is the law of the in-depth analysis. From static and dynamic content and format requirements for the formation process of amending the law, respectively, explain the impact of the drug specification properties identified two aspects.Part III: Works attribute specification of the drug. This part is mainly extracted from the judicial practice in the theoretical and practical circles two different views on the package insert works property, and the two views one by one demonstration, the article indicated that the final key point that drug instructions should belong to China's "Copyright law " on the meaning of the works should be given China's " protection of copyright law ".Part IV: Drug copyright protection specification. The article indicated that part of the position on the basis of how the package insert further elaborated by the risks that may exist in the process of conservation and protection, and a brief introduction about the relevant system package insert copyright protection and practices the United States and Taiwan of China, learning from them.Part V: Perfecting Drug Instruction Suggestions copyright protection system. The major part of the problem and the potential risks of drug instructions process of China's copyright protection exists for, the corresponding recommendations to address separately from the legislative and judicial aspects. Clear China's "Copyright Law" criteria work on "originality", the establishment of fair use system package insert to establish generic and original drug specification conformance system, to play a "whole finds partial protection" principle role, can be regarded as perfect favorable measures of the package insert copyright protection system.