Research on Intellectual Property Right Protection of Genetic Resources in China Under Benefit-Sharing

II.A. Fragmented and abstract legislation

China has not carried out special legislation on the IPR protection of genetic resources, and the relevant provisions are neither systematic nor concrete. In recent years, China has successively promulgated a number of policies and regulations on the protection of genetic resources, and the protection and management of genetic resources in China has also achieved certain results, but there is no special law on the IPR protection of genetic resources and the relevant laws and regulations are not systematic. ⁷ Although separate laws have been formulated on the protection of resources in individual areas, such as wild animal and plant resources, or new plant varieties, the protection of genetic resources in these individual pieces of legislation is different from the IPR protection. For example, the way to protect wildlife genetic resources in the Wildlife Protection Law is to establish a gene bank, but the law does not mention IPR protection. Moreover, the scope of this individual legislation is much smaller than that of “genetic resources.” These regulations seem to be related to the IPR protection of genetic resources, but most of them exist under the framework of other laws and regulations, and thus cannot form an effective IPR protection system for genetic resources.

In addition, although patent-related laws and regulations clarify the definition of genetic resources and related inventions and creations, and also stipulate the requirements for source disclosure, the legislative content is principled and abstract, with relevant provisions few and scattered. First of all, though China has clarified the definition of genetic resources in the Implementing Rules of the Patent Law, the scope of genetic resources has not been clearly defined; while there are many individual legal documents that seem to be able to be included in the IPR protection system for genetic resources, there is a lack of overarching documents, making it difficult to form a unified protection system. Secondly, although China has included the disclosure of the source of genetic resources as a requirement for the examination of IPR applications in the Patent Law and the Patent Examination Guidelines, this provision is relatively abstract and lacks operability and implementability ⁸ —it only requires the patent applicant to explain the source of genetic resources, but does not specify how to explain and what evidence needs to be provided, and also does not specify the specific requirements for the procedures and conditions for foreign entities to obtain genetic resources in China. This will make the implementation of the source disclosure review system limited in practice. On the one hand, the lower disclosure obligation makes the benefit-sharing of genetic resources unfounded, such as the possibility of fraudulent source, or the existence of the source but the absence of prior informed consent. On the other hand, the abstraction of disclosure obligations has led to a greater freedom for foreign entities to use the benefit-sharing and IPR system to obtain China's genetic resources; and since the gradual deepening of China's foreign cooperation and exchanges in the 90s, the export of China's genetic resources has basically been out of control, ⁹ leaving opportunities for genetic resource plagiarists.

II.B. Insufficient integration with international standards

Although China has acceded to a number of international conventions related to the protection of genetic resources, international provisions have not been translated nto domestic IPR protection of genetic resources, and the content of relevant laws and systems is not fully aligned with international standards. The Convention on Biological Diversity (CBD) is a landmark achievement of international legislation on the protection of genetic resources, establishing the basic principles of national sovereignty, prior informed consent, and benefit-sharing. ¹⁰ China signed and acceded to the International Convention as early as 1992, was one of the first parties to the International Covenant, firmly supporting its aims and objectives. After joining the CBD, China has also made certain amendments to its domestic laws—provisions on genetic resources have been added in Articles 5 and 26 of the Patent Law, and the interpretation of concepts such as genetic resources is basically consistent with the corresponding concepts of CBD. However, there are many specific provisions that have not been translated, and domestic laws and regulations on the IPR protection of genetic resources do not fully reflect the corresponding principles of CBD, especially the relevant provisions of prior informed consent and benefit-sharing.

As one of the objectives of CBD, the access and benefit-sharing regime has been supported by developing countries, including China, and China has ratified the Nagoya Protocol under the CBD framework, which emphasizes the fairness and rationality of benefit-sharing. However, China's domestic legislation has almost no reference to the benefit-sharing system and the relevant prior informed consent system in the field of IPR protection of genetic resources. Chinese Patent Law mainly stipulates the source disclosure requirements related to the benefit-sharing system, but does not directly stipulate the concept of “benefit-sharing,” nor does it make specific arrangements for benefit-sharing and prior informed consent in the IPR protection of genetic resources, nor does it make specific management provisions on the export, inward introduction, and international exchange of genetic resources. As a result, China's domestic laws lag behind relevant international legislation in the field of IPR protection of genetic resources, and cannot be truly integrated with relevant international conventions. At the same time, it has caused disorder in the international exchange and utilization of China's genetic resources as well as a large outflow of its own genetic resources, while China, as a major exporter of genetic resources, has not received reasonable and fair benefit-sharing arrangements.

III.A. IPR protection under technical restrictions lacks construction momentum

The exploitation and utilization of genetic resources is technical; that is, the exploitation and utilization of genetic resources must closely depend on the development of biological science and technology, which is the basic prerequisite for the exploitation and utilization of genetic resources and the realization of added value. ¹¹ If the level of bioscience and technology of the developer and user is limited, it is usually difficult to develop the genetic resources in the country on their own, or the scope, type, quantity and scale of the genetic resources that can be exploited and utilized will be limited. Moreover, the degree of development of bioscience and technology is positively correlated with the degree of value exploitation of genetic resources, and the value of genetic resources can be discovered with the help of bioscience technology and the relevant added value generated by them can be improved. China has a vast land and rich and diverse genetic resources, but its development of modern biological science and technology lags behind developed countries by several decades. Compared with developed countries, China's development and utilization of genetic resources still has problems such as low level of research and development, insufficient independent innovation capabilities, and lack of sufficient funds and advanced technologies required for development and utilization. ¹² This series of problems has affected China's use of genetic resources for invention-creation, resulting in China not having the motivation to formulate special laws on the construction of IPR protection of genetic resources in the past, and lacking a practical basis for refining the relevant IPR norms for invention-creation applications relying on genetic resources.

After nearly 20 years of development, China's biotechnology industry has made tremendous strides, has accomplished remarkable achievements in the development and utilization of its own genetic resources, and strengthened the demand and motivation for the construction of IPR protection of genetic resources. Under the benefit-sharing system, while other countries develop and utilize genetic resources in China, they also have a certain degree of positive impact on China's research and development of relevant technologies. At the same time, China itself has become more aware of the need to strengthen bioscience and technology research, and in order to accelerate the development of the biotechnology industry, it has always made biotechnology as a major national science and technology goal in recent years, and has greatly increased investment in biotechnology research and development. A series of biological science technologies such as transgenic technology, cloning technology, and biochip technology have been continuously developed, and the ability to use genetic resources for invention and creation has been continuously improved. Chinese enterprises related to the development and utilization of genetic resources are constantly emerging, and domestic entities relying on China's or other countries' genetic resources for inventions and creations also need to seek relevant IPR protection in their own countries. Therefore, in view of the current fragmented and abstract legislation on the IPR protection for genetic resources, as well as insufficient integration with international standards, China needs to accelerate the improvement of relevant IPR legislation and systems.

III.B. IPR protection may affect the fairness of benefit-sharing

The operation of the benefit-sharing mechanism for biological genetic resources involves the different interests of resource providers and users, and requires both parties to share benefits fairly and equitably in accordance with relevant international and domestic laws, ¹³ but users may control economic benefits based on genetic resources through the IPR system instead of preventing the resource provider from obtaining a reasonable benefit arrangement, or even compromising the benefits. According to the definition of genetic resources in relevant laws such as CBD, genetic resources have actual and potential value. The economic value contained in genetic resources stimulates the commercial and industrial utilization of genetic resources by entities with economic and scientific and technological strength. The negotiated determination of the benefit-sharing regime was originally based on a balance between two different interests: namely those represented by developed countries that are biotechnologically advanced but genetic resource scarce, and those represented by developing countries that are rich in genetic resources but biologically backward. ¹⁴ The original intention of the system was to reasonably balance the interests of stakeholders in biological genetic resources, maintain biodiversity, and explore the value of biological resources. However, after developed countries acquire and control genetic resources in developing countries free of charge (or cheaply) and develop new products, they often apply for IPR protection for the exclusive use of the results, then sell the results to developing countries in the form of patented technologies and patented products, obtaining high profits. This results in developing countries being unable to obtain the benefits arising from the exploitation of genetic resources. ¹⁵ In such cases, IPR protection becomes an accomplice to “biopiracy” by users of genetic resources, hinders the sharing of results by providers of genetic resources, and affects the fairness of benefit-sharing implementation.

Subject to the limited level of biotechnology development, China is positioned as a provider of genetic resources, ¹⁶ and given the IPR protection of genetic resources, may become an accomplice of developed countries in carrying out unfair monopolies regarding China's genetic resources, harming its own enjoyment of the benefits of genetic resources. China therefore needs to be more cautious about the construction of IPR protection of genetic resources. For a long time, Western-developed countries have obtained huge benefits globally by virtue of the commercial utilization of biological genetic resources seized in large quantities in China and the protection of the products they have developed through the IPR system, ¹⁷ while China, as a provider of biological genetic resources, has not received due benefits, causing major losses to its national interests. In the face of such unfair benefit arrangements and uneven distribution of benefits, the construction of IPR for genetic resources must set strict requirements for IPR applications that rely on genetic resources for invention and creation, so the legislation and system for IPR protection of genetic resources can be expanded and optimized in combination with international practical experience and national conditions.

IV.A. Systematic legislation to promote multiple protections

China's current IPR law has a certain feasibility for the protection of genetic resources, and a systematic and specialized IPR model can be established on this basis to comprehensively protect genetic resources. ¹⁸ First of all, the establishment of a special IPR protection model does not require the direct formulation of a special law on the IPR protection of genetic resources, but can use the IPR model as a means of strong protection, and, at the same time, formulate relatively complete and unified laws and regulations on the protection of genetic resources, and use the “summary + enumeration” approach to clarify the specific content of genetic resources and their derivatives. Because genetic resources objectively exist in nature itself and cannot be directly used as the object of IPR protection, but the specific content, such as products and information, generated by genetic resources may become the object of IPR protection, it is inappropriate to directly formulate a special law on the IPR protection of genetic resources. Moreover, the scope of the concept of protection of genetic resources is not specific yet, and the existing single legislative protection of genetic resources such as wild plants and wild animals, is partial and cannot cover all types of genetic resources. Therefore, a norm is formulated directly for the specific concept of genetic resources, the specific content of genetic resources and their derivatives is clear, and the provisions on registration and management in principle are unified, which is conducive to filling the gap that in the current relevant legislative protection cannot be fully covered, and can also play a certain guiding role.

Secondly, in the context of improving China's own level of biological science and technology so that it can carry out more development and utilization of its own genetic resources, the protection of the rights and interests of its developers and users of genetic resources is also conducive to restricting the illegal access of foreign countries to its genetic resources with the help of the benefit-sharing system. China can then make full use of existing patents, copyrights, trademark rights, geographical indications, trade secrets, and other types of IPR to protect the rights of domestic genetic resource developers and users, and thus indirectly protect domestic biological genetic resources. However, all of these approaches to protection must be based on the premise that the exploiters of genetic resources have made substantial investments in genetic resources and can generate commercial benefits, ¹⁹ because IPR protection is for intellectual results and requires a certain degree of human labor. Then, for the protection of some genetic resources that do not yet have commercial development value or for which the degree of investment does not reach the scope of IPR protection, it is necessary to resort to methods other than IPR protection, such as the constitution, criminal law, environmental protection law, forestry law, and other parts of the regulation involving the protection of genetic resources. ²⁰

IV.B. Align with international standards in stricter IPR application procedures

In view of the risk of “biopiracy” through the use of IPR under benefit-sharing, the application procedures for IPR such as patents should be tightened when building the IPR protection for genetic resources, and should further integrate with the relevant international legal system in the process of refining and tightening the IPR application process for genetic resource development results. The benefit-sharing system is widely recognized by the international community and is also in line with China's major national policy of building a community with a shared future for mankind, so when building an IPR protection system for genetic resources, China must adhere to the concept of benefit-sharing, but at the same time, it also needs to reasonably restrict the IPR protection of genetic resources development results under benefit-sharing. Source disclosure and prior informed consent are restrictive requirements for applying for IPR in genetic resource development results; China can learn from relevant international practical experience to improve legislation to safeguard the fairness and rationality of IPR protection of genetic resource development results under benefit-sharing.

Firstly, the breach of the source disclosure obligation stipulated in the claim for patent application for genetic resource inventions and creations should be regarded as the reason for patent invalidation. When the Patent Law was amended for the third time in 2008, China already had introduced the principle of disclosure of origin in the CBD International Convention by providing for a “disclosure of source” clause in Article 26.5. If there is a violation, there must be sanctions, for without sanctions, there will be no enforceablity. ²¹ Source disclosure regimes were proposed by developing countries to prevent unlawful access to or utilization of genetic resources by one country in a benefit-sharing environment. It could be used to verify the legality of access to or utilization of genetic resources, which would require sanctions for violations of disclosure provisions. The current Patent Law of China only stipulates that the legal consequence of violating the obligation of disclosure of source is the rejection of a patent application, but it is not the legal basis for invalidation after the grant of the patent right. ²² However, there are certain loopholes in the effect of such sanctions in practice, so that the source disclosure system needs to be strengthened in playing the role of testing the legitimacy of patent applications. According to relevant research, the main reason for not fulfilling the disclosure obligation to include the reasons for patent invalidation is that since the patent applicant dares to disclose, then the access or utilization of genetic resources is often legal, and universally, if there is illegal access or utilization, it will not be disclosed, defective disclosure or false disclosure. ²³ However, it has been found from practice that if a patent is granted through false disclosure due to the mistake of the patent examination authority or other reasons, then the erroneous act cannot be corrected according to the disclosure clause, and the purpose of the disclosure clause cannot be fully achieved. In addition, judging from the experience of typical countries outside the region, strict sanctions must be adopted for the legal consequences of failure to comply with disclosure obligations, which can then not only play an intercepting role at the patent application stage, but also play a supervisory role after the patent is granted. For example, the legal effects of a breach of the source disclosure obligation in India include refusal or invalidity. ²⁴ Based on the above, China, which is positioned as a provider of genetic resources, can include the violation of disclosure obligations as a reason for patent invalidation in the future, and strengthen the supervision and sanctions of other countries, for their illegal access to or utilization of genetic resources to a certain extent.

Secondly, the requirement of prior informed consent should be introduced as a restrictive condition for patent applications for inventions and creations of genetic resources, echoing the disclosure of source system. The disclosure of origin obligation requires that the patent applicant's access to or use of genetic resources must be lawful, and one of the important prerequisites for legality is that the consent of the benefit-sharing national authority or stakeholder has been obtained for the access or use. ²⁵ At present, China's patent law does not introduce the content of prior informed consent into the IPR application of genetic resources development results, which makes the subsequent benefit-sharing of genetic resources lack a legal basis; this is not conducive to the specific implementation of the source disclosure system. Therefore, it is necessary to add a prior informed consent system to the specification for patenting genetic resource development results in accordance with international conventions such as CBD ²⁶ and the Nagoya Protocol, ²⁷ as well as legislation and practical experience on prior informed consent such as India's Biological Diversity Act ²⁸ and Costa Rica's Biological Diversity Act. ²⁹ In addition, in combination with China's existing system, the relevant responsible authorities, operational mechanisms, relevant application and approval procedures for the implementation of the prior informed consent system are clarified, so as to give full play to the role of prior informed consent in balancing the interests of relevant subjects in benefit-sharing and supervising the legal access and utilization of resources. ³⁰