Patentability Of Biotechnology Under The TRIPS Agreement

The recently decided Myriad case by the Supreme Court of United States is the first case which is decided by the Supreme Court regarding to the patentability of human genes. The Supreme Court clarifies for the first time that the isolated DNA involved a naturally occurring segment of DNA, preclude patent eligibility, but synthetically created DNA known as cDNA was not naturally occurring, as would preclude patent eligibility. This decision has aroused great concern in the worldwide. Biotechnology including genetic technology is regarded as the basis for the emerging industry with considerable potential for development. Considering that the biotech industry possesses some specific characteristics of high risk and high input, patent protection is of vital importance. This dissertation is based on the fact that the bio patentability is the basis for bio patenting, and tries to explore from the perspective of patentability obligation under the TRIPS Agreement, especially the investigation on US legislative and judicial practices in respect of biotech patentability, for the purpose of enlightening the establishment and improvement of biotech patenting system in China.This dissertation is composed of three chapters. The first chapter will start from patentable subject matter under the TRIPS Agreement, analyzing the WTO system and relevant provisions of substantial and procedural treaties under WIPO, for the purpose of finding legal basis at the international law level for biotech patentability. WTO members’obligations under the TRIPS Agreement, as well as the connotation and denotation of biotechnology will also be analyzed. The second Chapter will firstly analyze in great detail about the regulations and Manual of Patent Examining Procedure of the United States whose biotechnology is the most developed in the world, then investigate the development of decisions relating to biotech patenting, especially the Supreme Court’s most recent case of Myriad relating to the patentability of human gene patents. Based on the above analysis, Chapter two will further analyze the positive and negative influence brought by biotech patents, also suggest the sharing mechanism of gene patent. The third chapter will focus on the practice of biotech patentability in China, analyzing in great detail about the scope and requirements for the performance of TRIPS Agreement. On the basis of analyzing the extension of the patenting scope for biotechnology though the modification of patent law, and also combining with the current situation of biotech patenting in our country, several biotech patenting suggestions will be put forward to further facilitate the patent protection of biotechnology in China.