The Effect Of Biotechnology Directive In Europe And Its Enlightment On China

Biotechnology is a complicated technology including gene engineering, cell engineering, enzyme engineering and fermentation engineering. Nowadays, biotechnology has become a new crucial technology of increasing economic development. Biotechnology has been widely applied in the fields of agriculture, pharmaceutical industry, medicine, energy resources and environment protection. However, the repaid development of biotechnology development challenged the tradition patent law. The characteristic of biotechnology makes it difficult to accord with some principles and definitions of patent law, for an instance that whether gene belongs to invention or discoveries. The development of embryo stem cell research aroused another dispute of morality. As to the lag of legislation of biotechnology in China, it is urgently necessary to strengthen the patent protection in the biotechnological industry.The Europe made much emphasis on biotechnology protection. In 1998, the European Community adopted Directive 98/44/EC on the legal protection of biotechnological inventions, after 10 years of dispute and in a form much modified from the original proposals. The Directive, which became effective in the Member states in July 2000, was implemented in the EPC regime in 1999. The current Directive was adopted without any reservations regarding the use of absolute product protection for genetics, ethical considerations, as well as the pharmaceutical and chemical inventions. In sum, Directive is a milestone in the development of patent law in Europe.To a great extent, the legislation of Chinese Patent Law was on the basis of the regulations of European Patent Law. So, it is meaningful to investigate the relevant document in Europe. The Chapter One of this paper examines the concept and characteristics of biotechnology, as well as the challenges which brought by it. All these give reasons to the necessity of increasing the patent protection of biotechnology in China. In Chapter Two, the paper first introduces the history and rationale of Directive, as well as the main content of Directive. Then, the paper focuses on some important changes compared to the previous regulations, which mainly revealed by the introduction of specific requirements with regard to human DNA sequence inventions, plant varieties, animal varieties and moral standard. Besides, the paper evaluates the influence of the effective of Directive in Europe. In Chapter Three, the paper analyzes the current situations and deficiencies of patent protection of biotechnology in China. From the above analyze, the paper gives some opinions on the revelation of European Biotechnology Directive to the lawmaking of biotechnology protection. In sum, through the introduction and analysis of Biotechnology Directive, the paper aims to give some advises to the legislation of Biotechnology protection in China.