Research On Legal Protection Of Human Gene Patent

The object of gene patent has gradually developed from early bacterial DNA molecules to animal and plant genes,and then to human genes.The richness of object brings new problems to the protection of gene patent.At present,China has not yet ushered in a period of rapid development of biotechnology,and the related conflicts have not become a significant social problem,but it does not mean that we can ignore these problems.In order to improve the patent protection of human genes and promote the healthy development of biotechnology in China,this paper analyzes the existing problems of gene patent protection in China and puts forward some suggestions.Firstly,we should make clear the patentability of gene.As a scientific research achievement,gene has the attribute of intellectual property.Gene has the novelty,creativity,practicality and negative elements stipulated by the patent law.At the same time,it naturally does not belong to the scope of copyright protection,and it is more difficult to protect it in the form of trade secret in application,so it should be protected in the form of patent.Secondly,through the data analysis of the current situation of gene patent in China,this paper combs the innovations in the human gene protection system in China: first,it is clear in the civil code that the illegal human gene editing should bear the tort liability;Secondly,the serious illegal editing of human genes is included in the criminal law amendment;Third,the patent examination guidelines appropriately absorb the classical scientific research results,such as the application of the 14 day principle of embryonic cells.At the same time,it also points out that there are some problems in the protection of human gene patent in China,such as lagging behind the latest scientific research progress,lack of protection of intellectual property rights in preventing the loss of resources,lack of special ethical review in patent examination,and no mention of benefit sharing.Thirdly,combing the historical development of human gene patents,human beings have entered the micro field from the early macro patent objects,and the separated and purified DNA molecules have become patentable objects,and then the active editing DNA molecules have become patentable objects.After decades of development,gene patent came to the field of human gene.At first,the dispute was limited within the biotechnology industry,but the related conflicts of interest broke out in the myriad case.According to its scientific and social development,the United States was the first to determine that the separation and purification of human gene is not patentable.Finally,it analyzes the reference significance of the protection system of new plant varieties which have certain internal relationship with genes for the protection of human gene patent in China.Among them,the special protection period,special authorization conditions,and the improvement of regulatory level embodied in the relevant system of new plant varieties are especially suitable for the protection of human gene patent;By analyzing and comparing the human gene patent protection systems of the United States,Japan and other countries,it is found that each country has adopted a protection mode suitable for its own development,and the scope of protection is positively related to R & D capability.China’s biotechnology industry is still in its infancy,and there is a certain gap with foreign countries in terms of output value,revenue and R & D capacity.Therefore,although the protection model of the United States is more open and more conducive to stimulating research enthusiasm,it is not fully applicable.Japan’s system is more conservative than that of the United States,but more in line with the needs of our country at this stage.On this basis,the paper puts forward some suggestions,such as fully considering the national conditions,timely adjusting according to the latest scientific research results,actively participating in the formulation of relevant international rules,further improving the work mode of ethical review,and benefit sharing is not the current concern,so as to support the development of human gene industry in China and maximize the protection of China’s interests.