The Scope Of Rights,Limitation And Protection In Gene Patent Research

Gene is the basis of transfer, expression and development for genetic information, and after years of controversy, the gene patents have been widely recognized. In addition to basic scientific research, genetic technology is also widely used in agriculture, ecology, medicine and so on, especially in drug research and genetic diagnosis. Projects like genetic diagnosis and therapy apply to human medicine, health and other industries, which is of great significance forthe prevention and treatment of cancer, and makes a profound impact on society.Gene medicine and genetic diagnosis is an important area of development in today’s medical and health industry, beyond that, gene patent is the core. As the upstream patents, genetic patents can easily affect all gene medicines. Through the effective analysis of the scope of rights and licensing standard, it can further enrich our legal basis, and is also conducive to promote the application of genetic engineering technology in the pharmaceutical industry. Furthermore, from the practice of the USA and Europe, like the application of research with a patented invention, compulsory license and parallel imports, we can absorb the advanced experience, which provides a reference for our judicial practice in such cases and conducts to the orderly development of China’s genetic pharmaceutical industry.In this paper, the scope of rights and licensing rights standards as the core, we shall discuss about the relevant provisions of disclosure obligation, claims, substantial elements, and take into a further research of the approach which should be taken with the practice of the USA and Europe. The paper is divided into five chapters.Chapter Ⅰ is a brief introduction on the whole of genetic patents. Through describing the definition, types and trends of gene patents and demand for generic drugs in public health issues of the world, it can present the basic situation of gene patents. It also shows the status of legislation of the world’s major countries, and focuses on the effects of the TPP agreement.Chapter Ⅱ is about the scope and licensing standards of gene patents. This part is not only the center of the whole thesis, but also a fundamental part of gene patents and related industries research. Scope of rights includes the disclosure obligation and the claims. Between them, the disclosure obligation is composed of definiteness, written description, enablement and the best mode, here we shall particularly analyze the written description and the enablement combined with typical cases, like Regents of the University of California v. Eli Lilly & Co.. On the other, claims of gene patents is quite special for functional claims and generic claims, for which leads to the expanding of the scope of patent rights, the mode of protection in gene patents evolves from "function-limited" protection into "function-limited" protection. Besides, in licensing standards of gene patents with the basis of utility, novelty and creativity, through a detailed analysis of typical cases over the past few decades, we shall reach a deep comprehension for substantive standards of patent examination.Chapter Ⅲ is for the restriction on the gene patents. In recent years, the US drops limit to a certain extent on gene patents, which mainly reflects in research with a patented invention and Bolar clauses. This part would gradually sort out these two non-infringement defense for application listed by the US courts, through the two typical cases of Integra v. Merck and Proveris v. Innovasystems. In addition, compulsory license and parallel imports also make big contributions in practice.Chapter Ⅳ discusses about the protection of gene patents. Depending on the object of the patents, the protection divides into product protection and detection protection. Product invention is mainly represented by transgenic microorganisms and transgenic animals. We can predict the future trend by analyzing the US and Europe in different periods. Detection invention is the main basic resource since natural nucleotide sequences have been declared invalid. The second part of Chapter IV shall analyze detection patents with review criteria and conditions issued by the US courts.Chapter Ⅴ is a summary for the whole thesis. Through the analysis of the previous chapters and the relevant cases, we can reach to a enlightenment from developed countries, and reflect for the unfit legislative provisions of China.