On The Disclosure Of The Origin Of Genetic Resources In Patent Applications

Biological genetic resources are important strategic resources for the sustainable development of a country and the material basis of biological industry.At present,the number of patent applications and authorizations for products and methods derived from biological genetic resources is increasing year by year.However,due to the huge differences in the distribution of genetic resources among countries,developed countries tend to collect and utilize the genetic resources of developing countries at will to research and develop biological products,and achieve market and technology monopoly and obtain considerable commercial profits through the patent system,which has greatly damaged the interests of developing countries.Against this background,the Convention on Biological Diversity(CBD)was enacted in 1992,establishing the three principles of state sovereignty,prior informed consent and access and benefit sharing,which has become an important international legal basis for the equitable sharing of benefits arising from the use of genetic resources.In June 1992,China formally became a party to the CBD.In 2008,in order to implement the three principles set forth in the CBD,China’s Patent Law was amended for the third time with the addition of the disclosure system of the source of genetic resources,striving to realize the protection of genetic resources through the patent system.This paper aims to study the problems reflected in the practice of patent application and put forward corresponding suggestions.The first chapter of this paper firstly studies the scope of genetic resources targeted by source disclosure in patent application.In order to fulfill the obligation of disclosure stipulated in the Patent Law of China,it is necessary to clarify the contents of disclosure.This chapter is divided into three parts.The first part elaborates the choice of the concept of genetic resources in combination with the definition of the concept of genetic resources in foreign countries and the newly-adding disclosure system of the source of genetic resources in China’s Patent Law in 2008.The second part discusses whether human genetic resources should be included in the concept of genetic resources from the perspective of the latest legislation on human genetic resources.The third part studies the utilization scope of genetic resources by analyzing the Nagoya Protocol,that is,to explore the circumstances that will trigger the application of disclosure requirements for genetic resources.The second chapter firstly introduces the two legal consequences of the non-performance of the source disclosure obligation in the patent application at home and abroad,and then analyzes the considerations of whether the source disclosure requirement of genetic resources reflected in the different legal consequences should be related to the patent validity.As a country rich in genetic resources,China adopts the compulsory source disclosure obligation in patent application.Many developing countries,like China,strive to realize the purpose of genetic resources protection through the patent system.In the process of patent application and examination,if the applicant fails to fulfill the obligation of source disclosure,the patent application will be rejected or the patent will not be granted.Although the European Union and Norway support the compulsory disclosure of the source of genetic resources in the patent application,the non-disclosure does not hinder the validity of the patent application and the authorized patent.Developed countries,such as the United States,Japan,and South Korea,which tend to rely on the rich genetic resources of developing countries for the research and development of biotechnology,oppose to set any legal consequences affecting the validity of patents in the patent system,believing that maintaining the validity of patents is the basis for realizing benefit sharing.The third chapter mainly discusses the legislative defects of implementing the obligation of source disclosure in China’s Patent Law.The disclosure system of the source of genetic resources in China’s Patent Law includes the provisions of “illegal then non-authorization” and “source information disclosure”.In the absence of special legislation on the protection of genetic resources in China,such provisions are actually in a state of lack of implementation basis.Therefore,it is necessary to review the lack of higher-level law in China by summarizing the experience of other countries that have established relevant legal systems for the protection of genetic resources,especially the legislative practice of regulating the access and benefit sharing of genetic resources by special legislation on of genetic resources.The last chapter is based on the former three chapters which reflect the existing problems revealed in China’s patent application of genetic resources source and puts forward some feasible resolutions,including adjusting the scope of protection of genetic resources in the Patent Law,taking civil or legal consequences such as administrative punishment when fails to perform the disclosure obligation,and speeding up the genetic resources special legislation on the basis of prior informed consent.Besides,since the relevant discussions about genetic resources protection via patent system are from international organizations’ topics,the latest progress of the theory and practice also comes from international seminar,it is necessary to strengthen the participation of China in those international negotiations,so as to safeguard the interests of developing countries which is rich in genetic resources and to achieve the effective protection of genetic resources.