A Study on the Patentability and Risk Management of Genetically Modified Organisms Especially Transgenic Animal and Plant

Given the technological transformation in Taiwan, what is next step in the future? We can observe that our government has paid more and more attention and expectation to the biotechnology industry recent years, especially genetically modified organism technology. Although we had spent a lot of money and resources in these areas, however, we cannot receive the equal earnings from them. Instead, we are in a dilemma.
To address this problem, this thesis wants to discuss why we failed to revise the protected scope and patentability of biological material by the draft of Patent Law in 2010, especially Article 24 (1) of Patent Law. Comparing to the different views and the history of developments on biotechnology patent, we can find that each country has its own set of criterion and values. Under Article 27.3 (b) of the TRIPS Agreement, members may exclude plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals from patentability. But members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. Therefore, there are still some free spaces for legislation under this legal framework, for example, the requirements of patentability and limitations of patent right.
Moreover, when developing GMOs patents, we cannot ignore the potential impacts and risks. Because the disputes of biotechnology patent and the issues of GM technology are related to ethics, public order and morals, biopiracy, the conflicts of disinterested parties and other issues. Some people think that patent law should not deal with the following administrative managements. But I think they are inseparable, since these issues continue to be raised for discussion in the course of biotechnology patent on the international law. That is the reason why I want to discuss these two themes together in this thesis.
Based on this point of view, this thesis will reference the experiences and developments of GM technology related law in advanced countries and international conventions. Considering the actual needs of biotechnology patent law and risk management laws of GMOs in Taiwan, we could do some amendments in related law and regulations. In the meantime, we should establish an authority to manage multifaceted and complex risk managements of GMOs integrally, and develop intellectual property strategies macroscopically.