Traditional Knowledge

This post was originally published on KEI Online by Thiru On 18 March 2025, the World Trade Organization (WTO) published a communication (IP/C/W/719) by Brazil, India, and Peru entitled, “Revising discussions on the relationship between the TRIPS Agreement and Convention on Biological Diversity“. Brazil, India, and Peru have called for the inclusion of a mandatory disclosure requirement in the TRIPS Agreement based on a 2011 proposal (TN/C/W/59) by Brazil, China, Colombia, Ecuador, India, Indonesia, Peru, Thailand, the ACP Group and the African Group in 2011 to amend Article 29 of the TRIPS Agreement. The paper makes no explicit reference to digital sequence information (DSI). While this topic was broached at the March 2025 TRIPS Council meeting, this topic will be addressed at the next TRIPS Council meeting (26-27 June 2025). In the chapeau of the March 2025 paper, the demandeurs (Brazil, India, and Peru) articulated the interplay between traditional medical knowledge, modern medicine, traditional and complementary medicine use, the misappropriation of genetic resources, intellectual property, and biopiracy: 2. A WTO-WIPO-WHO joint study of 2020 titled ‘Promoting Access to Medical Technologies and Innovation’ notes the profound influence of traditional medical knowledge on modern medicine. With 88% of WHO members acknowledging traditional and complementary medicine use, international trade in these products is growing rapidly. However, the study notes that this has come on the back of the rampant misappropriation of genetic resources (GR) and associated traditional knowledge (TK). Some prominent examples of biopiracy include neem (India), turmeric (India), kava (Pacific Islands-Fiji and Vanuatu), ayahuasca (Brazil), quinoa (Peru), and hoodia (South Africa). Assessing the economic loss to developing countries due to biopiracy is a complex task involving multiple factors, such as the loss of intellectual property (IP) rights, restricted access to genetic resources, negative impact on traditional industries, and discouragement of research and development in the country of origin. In relation to biodiversity, the co-sponsors of IP/C/W/719 quoted a WHO Global Report on Traditional and Complementary Medicine from 2019, “developing countries, especially those with rich biodiversity in Asia, Africa, and South America, supply approximately two-thirds of the plants used in western and global medical systems”. Furthermore, the demandeurs noted: While recent data is publicly unavailable, a 1999 report by the United Nations Development Program estimates that if a 2% royalty were charged on genetic resources developed by local innovators in the South, the North would owe over USD 300 million in unpaid royalties for farmers’ crop seeds and more than USD 5 billion in unpaid royalties for medicinal plants. In the 719 paper, Brazil, India, and Peru described the Convention on Biological Diversity (CBD) and the Nagoya Protocol as having a “significant shortcoming” noting that the CBD and Nagoya Protocol do not “link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context.” 4. The CBD (1992) marked the first step towards recognising the sovereign rights of states over their biological resources. It conditioned access to biological resources and associated traditional knowledge with prior informed consent (PIC) and access and benefit sharing (ABS) with local communities, who are the rightful holders of such knowledge. The Nagoya Protocol, which came into force in 2014, further developed the legal framework established under the CBD to operationalise the requirements of PIC and ABS. A significant shortcoming of the CBD and Nagoya Protocol is that it does not link these requirements with the patent system, resulting in the grant of erroneous patents to biopiracy-based inventions and lack of enforcement of the PIC and ABS commitments, particularly in a transboundary context. The 719 paper points to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge, adopted in May 2024, as the culmination of over two decades of work to address some of the shortcomings in the CBD and Nagoya Protocol. 6. The WIPO treaty requires patent applicants to disclose the source of the genetic resources and traditional knowledge on which their claimed invention is based. The disclosure requirement, if complied with by the applicant, would aid the patent office in conducting a prior art search. It would help prevent the patenting of inventions based on genetic resources and associated traditional knowledge that do not fulfil the requirements of novelty and inventiveness. Genetic resources and associated traditional knowledge obtained from one country are often used as a basis for seeking a patent in another. In such situations, the disclosure requirement would make the patent office the checkpoint to identify instances of transboundary utilisation of genetic resources and traditional knowledge. While hailing the WIPO Treaty on IP, Genetic Resources and Associated Traditional Knowledge, the 719 demandeurs are cognizant that the WIPO treaty “does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems”. The demandeurs call for the amending of the TRIPS Agreement to integrate the mandatory disclosure requirement into the WTO’s institutional architecture, including its binding dispute settlement system. 7. While a progressive instrument, the WIPO treaty could be further strengthened by integrating these commitments under the TRIPS Agreement. First, the WIPO treaty does not offer recourse to international dispute settlement if states fail to establish the disclosure requirement under their domestic patent systems. Second, the WIPO treaty does not address the requirements to obtain PIC under mutually agreed terms (MAT). Hence, even though the treaty introduces the disclosure requirement, it does not provide for compliance with the ABS requirements. The WIPO treaty shifts the burden to ensure compliance on the government agencies and local communities of the provider country, who must monitor published patent applications worldwide to ensure compliance and enforce ABS through PIC under MAT. Thus, amending the TRIPS Agreement to integrate the mandatory disclosure requirement could subject this commitment to the WTO’s legal framework. Further, the TRIPS Agreement could build on the WIPO treaty to require evidence of PIC and benefit-sharing arrangements as a prerequisite for patent grant or commercialization, thereby reinforcing the

by Chidi Oguamanam* First Published by ABS Canada here. Republished on Infojustice with the permission of the author. Delegates to the World Intellectual Property Organization Special Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions (WIPO-IGC) resumed and concluded their last deliberations for the 2024-2025 biennium on May 30-June 5. Most of the first day was used for the traditional opening statements through which major negotiating blocs and delegations signalled to one another their expectations for the 6-day meeting. No Appetite for Impasse The 51st session was unique in many ways. It was co-chaired by Anna Vuopala (Finland) and Erika Patriota (Brazil). Respectively, each of the two Chairs superintended over two failed IGCs – IGC 49 and IGC 50. Their co-chairing of the last and final sessions of the IGC for the biennium was expected to draw from their experiences from the two failed previous sessions in a row. The odds were in their favour. Neither of the hardliner demandeur nations or blocs nor their non-demandeur counterparts were disposed to filibuster negotiations. Any such outcome would potentially result in non-renewal of the IGC mandate for the next biennium (2026-2027).  It was clear to the delegates that mandate renewal was the biggest issue on the agenda listed under item 6 for the session (Taking Stock of Progress and Making a Recommendation to the General Assembly). Tension on Rights-based and Measures-based Approaches Remains Yet, despite the priority of mandate renewal, there was no let up to the tensions that partly led to the two failed IGCs. The United States, Japan and their Group B allies as well as CEBs, and Switzerland were bent on enumerating a litany of measures in the text in preference to rights. They construed a measures-based approach as having priority over a rights-based approach to the protection of TK and TCEs. At the 50th session, the US delegation, with the active support of Japan, Korea, Canada and Switzerland introduced the language of “safeguarding” to further entrench their measures-based approach and conceivably to water their expectation for a soft and non-binding instrument. This sentiment is also shared by the EU as a bloc. The attempt to center a measures-based approach stoked tension and resistance on the part of the broad coalition of the Indigenous Caucus, African Group, Group of Like-Minded Countries, China, the Group of Latin American and Carbbean Countries, some members of the Asian Pacific Group and New Zealand. It also nearly derailed the 51st sessions with demandeurs insisting on blocking those safeguarding aspects of measures-based languages regarding TK and TCEs. Nigeria deplored the deliberate attempt at regime duplication as a ploy to undermine the IGC mandate on TK and TCEs which is clear on effective protection of the subject matters. For Nigeria and the Africa Group, safeguarding of TK and TCEs is dealt with at the UNESCO. As a compromise, those textual drafts on safeguarding and measures-based were taken on board by the three facilitators of the 51st sessions (Ghana, US and Colombia) in an ambiguous procedural circumstance and kept in square brackets under “Alternative X”. This was to preserve the sanctity of the Facilitators’ Alternatives carried over from the IGC 49 texts (WIPO/GRTKF/IC/49/4; WIPO/GRTKF/IC/49/5 which was the default working document and same as from IGC 47) around which there remains a broad coalescing of understanding. Thus, the two texts (TK and TCEs) from the 51st session did little to close gaps. In sum, the delegations agreed on modest progress on the two texts of the TK and TCEs from the 51st sessions. The progress included modest striking out of a few texts that did not have the backing of any interested bloc as well as the bracketing of the US and allies-backed Alternative X.  The remaining two days were devoted to mandate negotiations. United States-led Charge to Weaken IGC Mandate The mandate was negotiated through a combination of deliberations at the informal sessions with ratifications at the plenary. The United States delegation left no doubt regarding their determination to limit the IGC meetings and to whittle down its mandate, a move that was strongly supported by Japan, Switzerland and some Group B allies. The United States went as far as proposing a maximum of two meetings, arguing for resetting the IGC for lack of progress. From the perspective of demandeurs, if there was lack of progress, the blame lies with non-demandeurs whose strategy for scuttling progress remained obvious. For the demandeurs, there was need to keep the momentum created by the two recent WIPO treaties of 2024 – the GR Treaty and the Riyadh Design Law Treaty. These developments called for more meetings and not less. Framing GRs in the TK/TCEs Mandate After GR Treaty In addition to different narratives of progress and dissonance over the number of meetings, another issue of contention for the mandate was how to frame GRs into the mandate given the conclusion of the GR treaty. For IPLCs through the Indigenous Caucus, the conceptual holism of TK, TCEs and GRs is not undermined by the fact that a GR treaty has been concluded within the framework of patents. For the Caucus, the Africa Group, GRULAC and LMCs and other demandeurs, discussions about GRs cannot be severed from TK and TCEs notwithstanding the conclusion of the GR treaty.  As a compromise position, delegates agreed that GRs will continue to be part of the IGC mandate, save that there will be no normative negotiations capable of reopening the GR text. Debate over an Evidence-based Method The next most prominent issue in the mandate negotiations was the palpable suspicion among demandeurs and non-demandeurs on the language regarding collection of evidence to inform negotiations.  Evidence-based methodology has been an integral part of the mandate and the work of the IGC. Demandeurs insisted that there is a deluge of real-world evidence and studies, now increasingly magnified by emergent national and regional regimes on the protection of GRs, TK and TCEs. They maintained that the tendency by non-demandeurs to fixate on an

Traditional Knowledge (TK) has become a key consideration in discussions on intellectual property. In May 2024 the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge was adopted, requiring patent applicants to disclose the source or origin of the genetic resources and/or the associated traditional knowledge in patent applications. A provision allowing countries to request disclosure of TK in Designs was also included in the Design Law Treaty. But is the prevailing approach to TK sensitive to the real needs of people in Africa and the Global South? In this theoretical intervention Professor Oguamanam challenges the TK paradigm and urges that we ask a deeper question about the function TK plays in the hierachy of knowledge governance. Oguamanam urges that we build on the Cradle Principles to protect the fundamental human rights of knowledge producers and users through equitable dispersal of benefits and to “combat unidirectional informational resource extraction and misappropriation that aggravates inequities and injustice.” The following talk was first presented at the Conference on Copyright and the Public Interest: Africa and the Global South in Cape Town. The video of the presentation below can be watched here. Asking the TK Question as a Reality Check: Echoes from the Cradle Principles* by Chidi Oguamanam** TK is inherently and all round borderless. TK’s defiance of epistemic borders is its reality before the current melding of all kinds of boundaries – disciplinary, conceptual and a lot more. The idea of TK is itself a colonial conceit. The qualification of other peoples’ knowledge as cynically traditional presupposes the existence of an authentic or a default knowledge system. The renewed escalation of interest and consciousness around TK globally and on our continent has never been more exciting as it is equally troubling.  TK is Africa’s significant factor endowment, a strong even if less celebrated, less articulated, and less harnessed continent’s competitive edge.  Its subsistence and survival in the digital age is now a stuff for our collective challenge. I propose that while there has been a remarkable shift around TK on the teleological realm, we run the risk of undercutting TK’s optimal and enduring potential for our continent. We need to first invest in theorizing TK and in tackling the conceptual morass that saddles it. For the privilege of this intervention, I intend to sow some provocative seeds around TK. First, do we ignore the epistemic conceit and the erroneous assumptions over the taxonomy of “traditional knowledge?” May be yes, because of the inherent risk of chasing a red herring.  Second, do we engage the biggest elephant in the room, which is the scope of TK? The last question unravels a very important opportunity. It requires a full consciousness at all times of TK’s defiance of conventional borders. There has been consistent attempt to trifurcate TK into TK, properly so called, Traditional Cultural Expressions and Genetic Resources. This trifurcation project is a signifier of colonial influences on our epistemic autonomy. In Africa, and some non-Western civilizations our knowledge systems which, for emphasis, includes our languages, are the windows to our worldview. That worldview is fundamentally holistic, serving as a glue to our identity and much more.   The trifurcation approach is deeply problematic. It has the danger to condition our thinking and our approach to TK in ways that serve the pragmatic purpose of fitting TK within established disciplinary boundaries and knowledge governance frameworks. Trifurcation is not only an exercise that happens at WIPO or the CBD or other places where TK is on trial before Western establishments. TK has been subjugated to the characteristic inclination of western knowledge systems (the western science) to dissect ideas into their minimalist compartments and to erect artificial and often highly politicized disciplinary boundaries. And in the paradigm of pitting the west with the rest, TK is often profiled within these molecular epistemic models. The consequence of this tendency is the disembodiment of TK from its custodians and its ultimate disempowerment as a knowledge system on its own merit and integrity. Here are a few examples, when TK is framed around Genetic Resources, we are forced to pigeonhole and defend it in the court and laboratory of the life sciences. This explains why we focus on TK in agriculture, in seeds; in health, in medicines, in pharmacology; ecology, botany, forestry, horticulture and environmental sciences, etc.  To further perpetuate the conceit in each of these fields or disciplines, TK is further devalued with the “ethno-prefix”, as a knowledge system that has little prospects for scaling. We know the opposite is true. Similarly, when TK is framed in the expressive repertoire, we locate it within the established canons of the humanities, the liberal arts and aspects of the social sciences. In this compartment we focus on TK in entertainment, music, storytelling, poetry, (folk songs, folklore); arts and crafts, cuisine, gastronomy, and other miscellaneous renditions that fit within western canons and disciplinary borders. From the prism of the TWAIL, we see a highly dedicated international legal, political and institutional order (with its municipal minions) invested in deepening the balkanization project in contrast to TK’s holistic essence. These powerful institutions have carved out TK in bite sizes reflecting their politically positioned structures with nuanced jurisdictional contestation over aspects and parts of TK in the guise of latter-day TK protectionism. In these institutions, the interests of TK holders are often subjugated to the institutions’ primary loyalty in the defence of their political and economic mandates.   In trying to understand the fraught conceptual challenge around TK and its strategic weakening, the biggest evidence is the superimposition of alien knowledge governance framework over TK. The superstructure of knowledge governance is western intellectual property. It was designed without regard to TK and its producers. The international order has never given any serious attention to an alternative knowledge governance model outside the western intellectual property system. TK and its holders are summoned to the court of intellectual property to plead their validity. Objection to this approach is symbolized by the marginal appeals

[et_pb_section admin_label=”section”] [et_pb_row admin_label=”row”] [et_pb_column type=”4_4″][et_pb_text admin_label=”Text”] By: Chidi Oguamanam Chidi Oguamanam, representative of Nigeria and University of Ottowa Professor of Law, provides analysis of the failure to endorse a new consolidated text by the 50th session of the World Intellectual Property Organization’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions (WIPO-IGC). The article was originally published by ABS Canada, and is reprinted here with the author’s permission.   Link to article Discord over Rights and Measures-Based Approaches to the Protection of TK and TCEs Scuttles WIPO IGC 50 By: Chidi Oguamanam Backdrop to the 50th WIPO IGC Session At the 50th session of the World Intellectual Property Organization’s Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Traditional Cultural Expressions (WIPO-IGC), delegates arrived with expectations for a better outcome. However, after one week of deliberations from March 3-7, 2025, experts and diplomats failed to achieve consensus over an improved working text of international legal instrument(s) for the protection of traditional knowledge and traditional cultural expressions (TK/TCEs). The last session of the WIPO-IGC (the 49th session) was stalemated because the majority of delegates agreed that they failed to narrow gaps in the working texts of TK and TCEs from the 47th WIPO-IGC session. At the 49th session, delegates resolved not to transmit any instruments to the 50th session, which meant that they would fall back to the text of the 47th session to the collective disappointment of the Committee and its Finnish Chair, Anna Vuopala, at the December 2024 meetings. The 50th WIPO-IGC session was chaired by Brazilian diplomat Ms. Erika Patriota, who was invested in breaking the jinx of the 49th session. Despite her best efforts through a methodology that relied heavily on informal sessions as well as drew from the facilitation skill of the Filipino Friend of the Chair, Anne Adlon, the session’s intended purpose to narrow gaps and deliver on an improved text of negotiating instruments was not met. A hopeful start on the first couple of days resulted in ridding the two working texts (TK and TCEs) of a few redundant and unsupported alternative articles. However, a methodological failure arising from not reining in delegates who were determined to contribute new textual language, and who were determined to even substitute in wholesale fashion some existing articles, pushed the Committee off-balance away from narrowing gaps. Rights and Measures-Based Approach is Now a Critical Schism There was a palpable ideological schism among delegates on the perennial high level conceptual question over the nature of the instrument in relation to intellectual property rights. On one side are demandeur delegations who favour negotiating the TK/TCEs instruments as sui generis, or what one delegate characterizes as “IP+.”  On the other side are those who prefer that the instruments be in sync with conventional IP rights – with term limits, elaborate exceptions and limitations, and accommodation of the so-called “vibrant public domain.” More prominently and equally worrisome at the 50th WIPO-IGC session was a palpable division among delegates along “rights-based” and “measures-based” approaches to the protection of TK and TCEs. In simple terms, the rights-based approach is premised on the recognition of inalienable and existing rights of Indigenous Peoples and Local Communities (IPLCs) to their TK and TCEs as a fundamental anchor for the protection of those rights and the premise upon which any consequential measures are based. On the other hand, proponents of the measures-based approach, who are mainly non-demandeurs led by the United States and its allies in Group B (Japan, Canada, South Korea, Switzerland, UK), the EU, the Central European and Baltic States (CEBS), etc., are inclined toward a measures-based approach. The latter group of proponents of the measures-based approach proactively emphasizes and promotes a list of policy, regulatory, persuasive, and non-binding measures to encourage the “safeguarding” of TK and TCEs. In the opinion of these proponents, a soft-law (i.e., non-binding) approach is the preferred nature of such measures. The argument is that, in accordance with its mandate, the Committee should not prejudge the nature of the instrument that will result from its work. For most non-demandeurs, a measures-based approach is a suitable pathway to a non-binding treaty. For the demandeurs, that is, IPLCs as well as mostly developing countries of the global south who coalesce around the mainly fluid category of like-minded countries (LMCs), the African Group, the Group of Latin American and Caribbean Countries (GRULAC), India, China, and some members of the Asia Pacific Group (APG), a rights-based approach is preferred. The demandeurs support a stronger and binding instrument in the nature of the already-concluded treaty from the work of the Committee – the 2024 WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge. For this group, the fact that the Committee is required not to prejudge the outcome of its deliberations does not preclude designing a binding instrument. For demandeurs, the narrow focus of non-demandeurs on a non-binding instrument misses the other consideration regarding the outcome of the Committee’s work, which relates to whether it would result in a single or multiple instruments. At the beginning, the Committee set out on a pathway to three instruments, namely, TK, TCEs and Genetic Resources (GRs).  It has agreed on only one instrument so far, which is the binding instrument on GRs. Cut-and-Paste Merger for Artificial Consolidation Despite a lack of consensus, the 50th IGC attempted to merge the two remaining negotiating instruments on TK and TCEs into one document, in contrast to their being negotiated in parallel, which has been the practice. It is not as if no attempt has been made in the past at consolidating the two remaining documents. In February 2023 and March 2023, the Jamaican Chair of the IGC, Lilly-Clair Bellamy, raised the Chair’s Consolidated Texts of TK and TCEs, which some delegations wanted to be used as a working instrument at the aborted 49th session of the IGC. The attempt at the equally aborted 50th session to merge both texts in a cut-and-paste merging approach reflects the potential inclination of delegations toward a consolidated instrument. The Committee appears

By Andres Izquierdo, Yara Misto, & Haddija Jawara The latest session of the WIPO Patent Cooperation Treaty (PCT) Working Group was marked by intense debate over agenda item 16, which addressed the implications of the recently adopted WIPO Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge (GRATK Treaty). Brazil formally appealed the Chair’s ruling on the matter, ultimately resulting in the indefinite suspension of the session due to a lack of quorum for a vote. During the 18th Session of the PCT Working Group, member states discussed document PCT/WG/18/16, which examines the potential integration of disclosure requirements for genetic resources (GR) and associated traditional knowledge (ATK) into the PCT framework. The discussions on PCT/WG/18/16 exposed a divide among WIPO members. Brazil, Colombia, and Egypt pushed for amendments to the PCT, stressing the importance of aligning its framework with the newly adopted GRATK Treaty. In contrast, Canada, France, and Norway maintained that such discussions were premature, arguing that any modifications should be postponed until the Treaty officially enters into force. With no consensus reached, the issue was deferred for future discussions. Brazil’s Procedural Appeal and the Deadlock Brazil objected to the closure of the agenda item, emphasizing its importance to multiple member states and interest groups. Invoking Rule 14 of WIPO’s procedural guidelines, Brazil asserted its right to appeal the Chair’s ruling, which—under WIPO rules—must be put to an immediate vote. The Chair’s decision would stand unless overturned by a majority of delegations. However, procedural complications arose when it became clear that the session lacked the necessary quorum to conduct a vote on Brazil’s appeal. Without the required quorum, the appeal remained unresolved. Acknowledging the deadlock, the Chair announced the indefinite suspension of the meeting, with the issue to be revisited in a future session. Statements from Member States & Brazil’s Appeal Below is the transcript of statements from member states and the full text of Brazil’s appeal: Colombia (GRULAC) “Madam Chair, Delegation of Colombia has the honor of presenting this statement on behalf of the majority of the country’s members of GRULAC.We would like to express our gratitude to the WIPO Secretariat, the Director General, for the initiative of having this agenda item and the preparation of the document PCT/WG/18/16.We appreciate their efforts to look into the challenges of the implementation of this Treaty on Genetic Resources and Related Traditional Knowledge within the PCT with regard to patents.The option in having the GRTK in 2024, it was a very great achievement for the majority of the GRULAC countries in order to guarantee that Intellectual Property Systems in our region reflect in a balanced way the interests of all stakeholders including states, indigenous peoples and local communities.In this context, we believe that it would be appropriate for the PCT Working Group to take the opportunity to see how the procedures of the PCT can be aligned with the established provisions of Article 7 of the GRTK Treaty.Obviously, we need to ensure that we facilitate harmonization and guarantee the applicability in effective terms.The Secretariat’s initiative is particularly relevant given that both the process leads to the amendment of any PCT process or provision can take a long time.It is, therefore, useful to have the technical discussions and an open debate so that we can have key information provided by Member States so that they are able to ratify the Treaty and also know what requirements may come up in terms of amendments to the PCT’s own regulations.So we would like to thank the IB and suggest that we do indeed come back at the next PCT meeting with a proposed amendment which would enable us to foresee challenges that may come up.We, therefore, call upon Member States to support the proposal made in 18/16 so that those modifications amendments that will facilitate the implementation, particularly with regard to diverging sources within the PCT system.” Namibia (African Group) “I thank you, Chair, for the floor.I’m taking the floor on behalf of the African Group.We join other Delegations in congratulating you on your appointment as the Chair and we are looking forward to a productive meeting.And on the onset African Group wishes to commend WIPO for their efforts and work done this far in ensuring implementation of international instruments for protection of patents.Patents are powerful tools in fostering innovation and providing economic value to businesses and investors.Patent protection helps to secure commercial benefits of new inventions and ultimately ensuring sustainable innovations.The WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge adopted in May 2024 marked a significant milestone in advancing legal instrument for protection or emerging issues of Intellectual Property law.The Treaty addresses the relationship between Intellectual Property and Genetic Resources as well as Traditional Knowledge as subject matter that has been at the center of multilateral discussion over the years.The Treaty emphasizes the need for a framework that respects the rights of Indigenous People and local communities over their Genetic Resources and Traditional Knowledge while promoting fair and equitable access and benefit-sharing conventions resulting from the use of those resources.Therefore, it is crucial for the Working Group to consider amendment to the PCT regulations to include the disclosure requirements prior informed consent and benefit-sharing mechanism in the PCT system.Those steps are vital to ensure that the use of Genetic Resources and Traditional Knowledge in patent applications acknowledges the rights of Indigenous People and local communities as well as the broader global objectives of sustainable development.To move forward, the Working Group must assess how those amendments can be integrated into the PCT framework to fulfill the objectives of the Treaty.” Japan “Thank you, Madam Chair.Japan would like to express our position on this agenda item.At this stage, the new GOA TK Treaty has not come into effect nor is there any clear prospect of when it will.Additionally, it remains uncertain how each potential contracting party will implement the Treaty in the national laws or rules.Therefore, Japan believes under these circumstances it is premature to consider amending the regulations.We are