The WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge – from Asian/Pacific points of view on September 04, 2024
On September 04, 2024, AIPPI (Association Internationale pour la Protection de la Propriété Intellectuelle) organized a Webinar on “The WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge – from Asian/Pacific points of view”
The WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge (TK) is poised to influence global IP practices, particularly in regions rich in biodiversity and traditional knowledge. Recently, representatives from India, China, Japan, and Australia shared their perspectives on how this treaty aligns with their current practices and the potential impact on their respective countries.
Ms. Vidisha Garg, a partner at Anand and Anand and a seasoned expert in patent law, outlined India’s proactive stance on protecting traditional knowledge. India is renowned for its rich biodiversity and ancient traditional medicine systems, such as Ayurveda, Siddha, and Unani, dating back over a millennium. Consequently, India has long prioritized legal frameworks to safeguard genetic resources and traditional knowledge, exemplified by laws such as the Protection of Plant Varieties and Farmers’ Rights Act, 2001, and the Biological Diversity Act, 2002.
Since 1994, India has witnessed numerous instances where patents were granted in developed countries for inventions derived from its traditional knowledge. In response, the Indian government launched the Traditional Knowledge Digital Library (TKDL) in 2001. This digital platform archives traditional knowledge in Ayurveda, Siddha, Unani, and Yoga, facilitating the verification of novelty and the use of traditional knowledge in inventions.
Significant outcomes have followed, such as the 2010 decision by the European Patent Office (EPO) to cancel a patent on medicinal plants based on references from the TKDL. Additionally, amendments to the Indian Patent Act in 2002 added Section 10(4)(ii) which disclosure requirements for biological materials. It mandates that the applicant disclose the source and geographical origin of the biological material in the specification when used in an invention, and deposit biological samples of microorganisms at an International Depositary Authority. Such amended Patent Act addressed the non-patentability of invention pertaining to traditional knowledge under Section 3(p).
Currently, India is already aligned with the treaty concerning the disclosure requirements of genetic resources and is expected to soon amend the Indian Patents Act to conform to the treaty. The Indian Ministry of Commerce and Industry views the WIPO Treaty as an opportunity to enhance protection for India’s genetic resources and traditional knowledge on a global scale, despite some limitations compared to current practices. Notably, under current practice, non-disclosure of the source and geographical origin of the genetic resource is a ground for pre-grant and post-grant opposition and revocation. In contrast, the treaty only provides for sanctions where there is “fraudulent intent.” For example, there may be serious misuse of declarations as applicants could easily claim ignorance of the source/origin of genetic resources or traditional knowledge. Accordingly, developing countries will face challenges in monitoring such declarations.
Mr. Ke Ke, Deputy Manager of the Legal Affairs Department of Beijing office of China Patent Agent (H.K.) Ltd., highlighted China’s existing legal frameworks concerning genetic resources as stipulated in the Patent Law of the People’s Republic of China (2021) includes provisions on the acquisition and use of genetic resources and disclosure requirements of Genetic Resource and the Implementing Regulations of the Patent Law (2024) further clarifies definitions and examination of disclosure requirements related to genetic resources.
On the other hand, the Implementing Regulations of the Patent Law also refers to the outcome of failure to meet disclosure requirements for genetic. China’s current practices align closely with the WIPO Treaty’s requirements for disclosing genetic resources, with similar standards having been in place since 2009. The practice over the past years has shown that such requirements do not impose a heavy burden on patent applicants. However, China lacks specific legislation addressing traditional knowledge associated with genetic resources. It is expected that the treaty will likely be ratified by China and that rules like genetic resources will likely be adopted for traditional knowledge. It is also expected to lead to the development of additional legislation and information systems for traditional knowledge, posing challenges such as defining “traditional knowledge” and ensuring confidentiality while providing access to examiners. Additionally, patent examination standards concerning traditional knowledge as well as information systems for genetic resources and traditional knowledge will need to be established.
In Japan, Mr. Takeshi S. Komatani, currently principal litigation certified patent attorney at TAKASHIMA International Patent Office located in Osaka, Japan indicated that Japan does not have specific laws related to genetic resources or traditional knowledge. However, the country has joined the Convention on Biological Diversity (CBD) and signed the Nagoya Protocol, which addresses issues related to access to genetic resources and benefit-sharing. Consequently, Japan has decided not to participate in the new WIPO Treaty and has made no amendments to its domestic intellectual property laws.
The Ainu people, an indigenous group in Japan, are recognized culturally and historically through legislation enacted in 2019. However, this legislation does not include specific intellectual property protection measures for traditional knowledge.
There is a tendency in Japan to avoid filing patent applications in countries with stringent patent disclosure requirements. Additionally, there is a preference for using trade secrets rather than filing patents related to genetic resources. Japan participates in the International Nucleotide Sequence Database Collaboration (INSDC) program but does not include specific items related to traditional knowledge.
The Patent Office and the National Institute of Genetics (NIG) are ready to cooperate to improve databases and address issues related to genetic resources and traditional knowledge.
Daniel Posker, an experienced IP disputes lawyer and Special Counsel at Norton Rose Fulbright Australia highlighted that prior to British settlement in 1788, First Nations peoples in Australia adhered to customary laws and practices concerning their environment, including the management of plants, animals, and agriculture. Today, Australia’s legal system operates under common law, with IP laws governed by the Federal Government and environmental laws managed at both federal and state/territory levels.
Although Australia is not a party to the Nagoya Protocol, which aims to ensure fair and equitable sharing of benefits arising from genetic resources, current domestic measures are consistent with the principles of the Nagoya Protocol. For instance, the Environment Protection and Biodiversity Conservation Act 1999 mandates permits for access and benefit-sharing (ABS) and requires prior informed consent (FPIC) and mutually agreed terms (MAT). State and Territory statutes, along with common law protections, further safeguard genetic resources (GR) and traditional knowledge (TK).
In term of Patents and Plant Breeder’s Rights (PBR), Australia does not have specific requirements for disclosing GR/ TK in patent or PBR applications. However, failure to disclose such information, where it materially impacts the grant of a patent or PBR, may lead to revocation.IP Australia is exploring reforms through its Indigenous Knowledge (IK) Project. Proposed changes include establishing an Indigenous Advisory Panel, considering disclosure requirements for GR/TK in patents and PBRs. There is also potential for authenticity labelling to promote indigenous products.
Australia is poised to ratify the WIPO Treaty, which will be the first international recognition of Indigenous contributions to the global IP system. The treaty reflects Australia’s commitment to enhancing transparency and protecting First Nations Australians’ cultural knowledge while leveraging its economic potential.
According to surveys in Australia, most participants believe that patent disclosure would facilitate ABS and FPIC and improve transparency. However, there are also concerns about potential research impediments and increased administrative burdens. Furthermore, there have been proposals for establishing a national database for GR/TK. Many argue that such a database would provide evidence of custodianship and prevent inappropriate patent grants, while others express concerns about protecting secret/sacred knowledge, indigenous data sovereignty, and the risk of inadvertently disclosing traditional knowledge.
The WIPO Treaty represents a significant step towards establishing global standards for the protection of genetic resources and traditional knowledge. As countries like India, China, and Australia align their practices with the treaty, they are not only enhancing their IP frameworks but also addressing the complex challenges of preserving cultural heritage and biodiversity. Clearly, the treaty’s implementation will require ongoing dialogue and adaptation to ensure effective protection and equitable access for all stakeholders involved.
In our view, examining and studying the application of WIPO Treaty, as well as reviewing practices in some Asian countries, could assist Vietnamese authorities in making appropriate adjustments to the Intellectual Property Law based on the actual situation in Vietnam.
The issue of protecting genetic resources and traditional knowledge is regulated in Law on Biodiversity No. 20/2008/QH12, as amended by Law No. 35/2018/QH14. Additionally, a patent is fully invalidated in case the invention is directly derived from genetic resources or traditional knowledge related to genetic resources, but the patent application does not disclose or inaccurately discloses the origin of the genetic resources or traditional knowledge related to genetic resources contained in that application as stipulated in Article 96 of the amended Law on Intellectual Property in 2022.
However, the current Intellectual Property Law does not address the disclosure of genetic resources or traditional knowledge related to genetic resources in patent applications.Furthermore, there is a need for more specific guidelines on the information required to be disclosed in the description, how to assess the disclosed information during the patent invalidation process based on the aforementioned Article 96, digitizing genetic resources to international standards, and ensuring the capability to retrieve this data when necessary.
