Access and Benefit Sharing Related to Genetic Resources
Patent & Trademark Attorney
A lot of microorganisms and plants existing in foreign countries whose climate conditions and environments are different from our country’s have unknown properties. Therefore, it is expected that they will be made good use of in such a field as manufacture of medicine, health food and industrial material.
After the Convention on Biological Diversity (CBD) entered into force in 1993, it is clearly stipulated that genetic resources are under the sovereignty of each country in which the genetic resources exist. Thus, a genetic resource user is required to obtain a prior agreement from the government of the country of origin. The user is also required to take a prescribed procedure compliant with the CBD when acquiring genetic resources from overseas and using them as research materials.
If a company obtains a patent concerning foreign genetic resources without taking such a procedure, the company may be accused of conducting business activities that can be regarded as so-called biopiracy.
In light of this, I will outline access to foreign genetic resources and explain the recent trends about it.
1. Requirements regarding access to foreign genetic resources
Foreign genetic resources must be accessed in compliance with the CBD and the Bonn Guidelines.
The Bonn Guidelines are voluntary guidelines adopted with the aim of realizing “Fair and Equitable Sharing of Benefits Arising out of their (genetic resources’) Utilization” stipulated in the Convention on Biological Diversity.
If a donor country of genetic resources has already placed restrictions on the use of genetic resources, traditional knowledge and the like as a result of domestic legislation, administrative measures or the like, priority is given to such restrictions.
The Japan Bioindustry Association (JBA) and the Ministry of Economy, Trade and Industry issued “Guidelines on Access to Genetic Resources for Users in Japan” in April, 2005. The guidelines comply with the Bonn Guidelines and provide a valuable benchmark for procedures related to access to foreign genetic resources. Such procedures were traditionally obscure in many respects.
Also, the above organizations enthusiastically hold seminars from place to place in a bid to make the guidelines widely spread and known.
The specific requirements are summarized below.
(1) Contact with domestic authorities in charge of access to genetic resources
You need to find out about the government liaison on the website of the Secretariat of the Convention on Biological Diversity (SCBD), and obtain information on the requirements for access to genetic resources from the domestic authorities which the government liaison referred to. The above authorities finally grant permission for access to genetic resources.
(2) Acquirement of an agreement based on prior information
When signing an agreement with an owner of genetic resources, you need to offer sufficient “prior information” on the object of a planned activity, risks that the activity would entail, and similar condition (required information varies depending on countries), to the parties concerned with the agreement and other stakeholders (the government, the indigenous society and the like) stated in the law or the like.
(3) Determination of “mutually agreed terms” of access and benefit sharing regarding utilization of genetic resources
You need to determine the terms of a material transfer agreement , the terms of benefit sharing and others among the parties concerned.
Described above is a simplified explanation. In reality, negotiations can be prolonged as it is unclear what sort of agreement is required (i.e., whether an agreement with the government will suffice or one with the local community or the indigenous society is required, etc), or a consensus cannot be reached about what “benefits” refer to.
These problems are causing decreased eagerness for access to foreign genetic resources in corporations and the like.
In view of this, the JBA has a liaison section for offering consultation services regarding access to genetic resources and benefit sharing, among others.
In 2005, they received 25 inquiries from businesses in the field of medicine, health food, cosmetics, biofuel and the like, universities and others. In 2006, 21 inquiries were received (see Reference 1).
Furthermore, it is a heavy burden for a single company to access genetic resources since how to access the genetic resources varies depending on countries. Hence, the importance of support mechanism has been increasing.
NITE (National Institute of Technology and Evaluation), which develops biological resources through collaborative research and establishes a network with other Asian nations with regard to microorganism genetic resources, has signed an agreement with Vietnam, Indonesia, Mongolia and others in connection with, among other matters, search for, collection of and transfer of new microorganisms.
A business corporation gathers plants and microorganisms with use of the scheme established by NITE. If the research result has led to a granted patent or product commercialization, the donor country receives part of the profits. Such access and benefit sharing complies with the CBD and the Bonn Guidelines, and various companies take advantage of it.
2. Recent trends at international conferences
Donor countries of resources represented by Brazil and India insist that such a legally binding international regime be established immediately that will ensure fair and equitable sharing of benefits arising out of utilization of genetic resources. Such donor countries are in conflict with developed nations.
Deliberation on an international regime is to be completed as early as possible within the time limit of 2010. Such a matter is to continue to be discussed as whether disclosure of the country of origin of genetic resources in patent application and an international certification system of genetic resources should be made mandatory.
An “international certification system of genetic resources” refers to a scheme under which a donor country of genetic resources issues a user a certificate of permission to use genetic resources. With use of the certificate, the genetic resources can be traced even after they are transferred to a foreign country. As a result, benefit sharing is ensured for the sake of the donor country.
With regard to a legally binding international regime, developed nations including Japan insist that such a regime not be established hastily, and the Bonn Guidelines only be strictly complied with.
I suppose the above-mentioned efforts of ours for obedience to the CBD and the Bonn Guidelines provide enough persuasiveness for the insistence.
As to whether disclosure of the country of origin of genetic resources should be mandatory in patent application, Japan objects to that idea. If such disclosure were to be made mandatory, an invention would be found unpatentable for not satisfying the disclosure requirement. Patent applicants might lose incentives for obtaining a patent if such a risk were to be imposed on them.
The United States also objects to the idea, citing that even if an additional requirement were to be imposed regarding information disclosure, such a requirement would not contribute to the achievement of proper benefit sharing.
In contrast, the European Union is in such a position that disclosure of the country of origin in patent application can be a topic to deliberate, and disclosure of the country of origin within the scope of the applicant’s knowledge is acceptable.
Disclosure of the country of origin of genetic resources in patent application would make it clear that an application includes genetic resources of a certain country. That idea is advocated by donor countries in the expectation of sharing the benefit with the applicant.
As described above, donor countries of genetic resources have great interest in benefit sharing, and are calling for establishing a legally binding scheme at an earliest possible time. I hope such a situation will be avoided that excessively many regulations on access to genetic resources would result in businesses and others having decreased enthusiasm for development, and benefit for donor countries would in turn be reduced.
The 9th Conference of the Parties is to be held in Germany this year (i.e., in 2008). I would like to pay close attention to how the discussions will go.
1. Report on commissioned operations of development of technology corresponding to the environment (promotional operations of access to genetic resources in compliance with the Convention on Biological Diversity) compiled by the Japan Bioindustry Association in March, 2007