Study Of Gene Therapy Patent System

The rapid development of biotechnology and accomplishment of Human Genome Project brought more and more new achievements to gene engineering , among which, gene therapy is growing quickly and disputed often. Gene therapy gives people new hopes, and at the meantime it brings a lot of issues. Gene therapy has begun to impact on some basic concept and principles of patent law and aroused the world's broad attention; every nation is making ceaseless adjustments and consummations to the Manual of Patent Examining Procedure and patent law according to technology development.For example: how to deal with the issue of social ethics, the consideration of juristic criterion and policies in patentability, the protection scope of patent, informed consent of the provider of gene resource and the principle of benefit distribution, etc. The article analyzes the trend of patents and patent applications on gene therapy in U. S. A, Europe and China, do some micromesh comparative research combined with the policy and regulations on their gene therapy patents, and provide some primary opinions and specific policies.Although we are making some great progress in certain aspects in gene therapy, considering the whole situation, we still have large gap with developed countries such as America and Japan. So the author advises to practice relevance strict utility standard in patent examination, As to adequate disclosure, we should make specific provisions , so that we can insure gene resources providers' exertion of the informed consent; and we should confine the scope of claims of issued gene therapy patents in order to avoid hindering the development of domestic gene therapy research.Above all, our patent law can't be the same with the world's developed countries blindly. Based on the situation of our country, appropriate patent systems should be arranged in virtue of the ethics issue and profit distribution etc, which will boost the rapid progress of gene therapy technology in our country.