Li Zhijun

The CPC Central Committee and the State Council have given a high concern to the study and application of transgenic technology. In July 2008, based on the state's 863 Program, 973 Program, the Program for the Study and Industrialization of Genetically Modified Plants, and the Program for the Industrialization of New and High Technologies, the executive meeting of the State Council deliberated and approved in principle the important technological program for cultivating new transgenic varieties. Since then, progress has been made in the culture of new transgenic varieties, the cloning of new genes, transgenic technology, bio-safety technology, and the industrialization of these technologies through continued efforts made by qualified personnel with integrated resources and technologies. In June 2009, the State Council issued Policies for Accelerating the Development of Bio-industry, in which it set forward the concept of "accelerating the building of bio-industry into a pillar hi-tech industry and one of the state's strategic emerging industries". The No. 1 Central Government Document of 2010 made the following requirements: "Continue to carry out important technological programs for cultivating new transgenic varieties; accelerate the development of functional genes and new biological varieties with high practical value and proprietary intellectual property rights; promote the industrialization of new transgenic varieties on the basis of scientific evaluation and administration according to law."

Efforts are being intensified and the legal system refined for the protection of the intellectual property (IP) of China's transgenic technology. The Chinese laws and regulations for this purpose mainly include the following: Article 25 of the Patent Law; a few sections in the State Intellectual Property Office's "Guidelines for Examination"; Regulations on Agricultural Transgenic Bio-safety; and Regulations on the Protection of New Varieties of Plants. Both the Outline of the National Intellectual Property Strategy issued by the State Council in June 2008 and the Policies for Accelerating the Development of Bio-industry distributed by the General Office of the State Council, which contain explicit rules on reinforcing bio-safety and IP protection, are related to the protection of the IP of transgenic technology. At present, the main problems in this respect are: imperfect legislation, which is disjointed and on a low level; inadequate macro-coordination between departments and weak law enforcement; insufficient popularization and public recognition of transgenic products and etc.

I. The New Circumstances Facing the Protection of the IP of China's Transgenic Technology and Its Effective Use

1. To promote the study and application of transgenic technology is an important strategic move for boosting agriculture through scientific and technological advances

Transgenic technology, which is essential to modern biotechnology, is known as "one of the major technologies applied most rapidly in human history". To use it to cultivate high-yield, high-quality, multiresistant and efficient new varieties can reduce the input of pesticides and fertilizers and is very meaningful for easing the resource constraints, protecting ecological environment, improving the quality of products, and expanding agricultural functions. There has been a rapid development worldwide in the study and industrialization of transgenic technology since the extensive cultivation of transgenic crops in 1996. Developed countries, enthusiastically followed by developing countries, have designated transgenic technology as a strategic focus for seizing the future commanding position of science and technology and enhancing the international competitiveness of agriculture. The development of life sciences, genomics, and information science has spurred the rapid progress of transgenic technology and a steady improvement in the means and equipment of research. Genetic cloning is advancing by leaps and bounds; new genes, properties and products are constantly emerging; the breeding of varieties shows intergenerational characteristics. At present, new transgenic varieties around the world are transforming from first-generation products such as pest/herbicide-resistant varieties to second-generation products with better nutrition and higher yields and third-generation products such as industrial products, medicine, and bioreactors. Compound properties based on the aggregate of multiple genes are becoming a focus of the study and application of transgenic technology. Meanwhile, the industrialized application of the technology is being rapidly expanded. 29 countries around the world have ratified the commercial use of 24 transgenic crops. The area of the cultivation of transgenic crops, typically soybeans, cotton, maize and rape, had increased from 25.50 million mu (1 mu = 1/15 ha.) in 1996 by 87 times to 2.22 billion mu in 2010.

How to feed China's enormous population of 1.3 billion is always of paramount importance. Scientific and technological innovation and application are the ultimate solution to the constraints of farmland, water and other resources, to national food security, and to the effective supply of farm produces. To promote the study and application of transgenic technology is an important strategy geared to future global competition and the specialization of industries, and a vital approach to ensuring national food security; it is also a major development strategy for boosting agriculture through scientific and technological advances and for enhancing scientific and technological competitiveness. It is necessary to conscientiously carry out the important programs for the cultivation of new transgenic varieties, try to seize the economic and technological commanding position, and accelerate the study and application of transgenic technology, in order to provide scientific and technological support for the sustainable development of China's agriculture.

2. International challenges posed to the protection and effective use of the IP of transgenic technology

First, the development of transgenic technology enables humankind to create new varieties beyond natural evolution. Thus it poses a serious challenge to IP law based on traditional property rights. As an emerging technology is radically different from traditional IP, transgenic technology has a major impact on traditional IP in terms of the subjects, objects, and contents of protection. The necessity for such processes as genomic sequencing and genetic segmentation during implementation makes it difficult to define the subject of rights to the genes or genetic segments in question. The line between the objects of legal relationship is blurred by the fact that transgenic technology combines the partial genes of microorganisms, plants, animals, and even humans by cutting or linking the genetic segments of different species.

Second, taking advantage of loopholes in WTO legislation, some developed countries restrict transgenic bio-products with green barriers, causing an unprecedented IP predicament for transgenic technology. The application of the technology has aroused universal concern because of the lack of a final conclusion about the safety of genetically modified organisms (GMOs) in the international community and the serious conflicts in legal concepts brought about by the technology. Given this situation, certain restrictions on transgenic bio-products have become an essential part of green barriers.

Third, regarding the development of transgenic technology, developed countries have powerful biotechnologies and bio-industries but a shortage of bio-resources. In contrast, the biodiversity resources in developing countries are yet to be effectively developed and protected due to economic and technological backwardness. The global IP protection system build around the GATT Agreement on Trade-related Aspects of Intellectual Property Rights has brought about an unprecedented development and unification of the global IP regime, but the global genetic resources protection system built around the Convention on Biological Diversity has just been launched and is less enforceable than the Agreement, hence the global situation of the strong protection of IP rights and the weak protection of genetic resources. Relying on their strong economy and research capabilities, developed countries voraciously prey on and take control of the genetic resources of developing countries, develop new varieties of crops with advanced technology, apply for patent protection, and gain huge profits by selling the results to developing countries as patented technologies and fruits at high prices.

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