On the 24th of May 2024, after 25 years of negotiations, WIPO Members finally reached an agreement on a Treaty on ‘Intellectual Property, Genetic Resources, and Associated Traditional Knowledge‘ (WIPO Treaty on IP and Genetic Resources/new WIPO treaty). In essence, the Treaty requires patent applicants to disclose the country of origin or source of genetic resources where the claimed invention in a patent application is based on genetic resources (Article 3). This new WIPO Treaty has already been discussed elsewhere (see for example here, and for Indian perspectives on the new treaty, see here, here, here, and there). Thus, the main focus here will be to assess the implications of this new treaty for two separate (though related issues): one, marine genetic resources; and two, digital sequence information (DSI) on genetic resources. Specifically, this post will address two key questions: 1. Does the scope of the new WIPO Treaty extend to marine genetic resources? 2. Does the new WIPO Treaty cover DSI on genetic resources?

To start with, it is important to contextualise the new WIPO Treaty in terms of other regimes and frameworks relating to the global governance of genetic resources. In this regard, it is worth noting that the issue of genetic resources is addressed in several international treaties and frameworks. These treaties and frameworks include: the Convention on Biological Diversity, the Nagoya Protocol to the Convention on Biological Diversity, the International Treaty on Plant Genetic Resources for Food and Agriculture, the WHO’s Pandemic Influenza Preparedness Framework (2011) for the sharing of influenza viruses and access to vaccines and other benefits, the Pathogen Access and Benefit-Sharing System (PABS System) in the proposed WHO Pandemic Agreement that is currently being negotiated at the WHO, and the Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas beyond National Jurisdiction (2023).

The preeminent treaty in this regard is the Convention on Biological Diversity (CBD). The CBD has as its objectives ‘the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources’. The CBD recognises the ‘sovereign right’ of states to ‘exploit their own resources’ and it defines genetic resources to mean ‘genetic material of actual or potential value’. It further defines ‘genetic material’ as ‘any material of plant, animal, microbial or other origin containing functional units of heredity.’ Building on the CBD, the Nagoya Protocol to the CBD has as its single objective ‘the fair and equitable sharing of the benefits arising from the utilization of genetic resources’.

The CBD/Nagoya framework implements an access-and-benefit sharing (ABS) system for genetic resources. Thus, Article 6(1) of the Nagoya Protocol provides that, unless otherwise determined, ‘access to genetic resources for their utilization shall be subject to the prior informed consent of the Party providing such resources’. Furthermore, Article 5(1) of the Nagoya Protocol provides that the ‘benefits arising from the utilization of genetic resources as well as subsequent applications and commercialization shall be shared in a fair and equitable way with the Party providing such resources’. The Protocol mandates that such benefit-sharing must be on ‘mutually agreed terms’. The Protocol equally mandates each party to ‘take appropriate, effective and proportionate legislative, administrative or policy measures to provide that genetic resources utilized within its jurisdiction have been accessed in accordance with prior informed consent and that mutually agreed terms have been established’ (Article 15(1)).

More importantly, Article 17(1) of the Nagoya Protocol requires states to ‘take measures, as appropriate, to monitor and to enhance transparency about the utilization of genetic resources’. It thereafter provides a non-exhaustive list of the different types of measures in this regard. Specifically, Article 17(1)(a)(i) of the Protocol requires ‘designated checkpoints’ which ‘would collect or receive, as appropriate, relevant information related to prior informed consent, to the source of the genetic resource, to the establishment of mutually agreed terms, and/or to the utilization of genetic resources, as appropriate’. This is where the new WIPO Treaty interfaces with the CBD/Nagoya Protocol framework. Crucially, by requiring patent applicants to disclose the source or country of origin of genetic resources, the new WIPO Treaty essentially transforms patent offices into ‘designated checkpoints’ for patent applications whose claimed invention is based on genetic resources. In this regard, Article 3 of the new WIPO Treaty is therefore a siginificant win for developing countries, especially those developing countries with an abundance of genetic resources within their territory.

It is also worth noting here that developing countries have, since at least the early 2000s, been demanding (without success) for a similar provision on the disclosure of origin of genetic resources in patent applications at the WTO (via the proposed Article 29bis to the TRIPS Agreement). It will thus be interesting to see how this new WIPO Treaty affects discussions at the WTO’s TRIPS Council regarding the proposed Article 29bis to the TRIPS Agreement. Nevertheless, even without the adoption of the proposed Article 29bis, there is nothing in the TRIPS Agreement that prohibits WTO Members from implementing the provisions of the new WIPO Treaty. Thus, the new WIPO Treaty creates a syngergy between the relevant provisions of the CBD/Nagoya Protocol and the relevant treaties in the field of international intellectual property law (specifically, the Paris Convention for the Protection of Industrial Property and the TRIPS Agreement).

Coming back to the two key questions raised at the beginning of this post, and starting with the first question (i.e. whether the scope of the new WIPO Treaty extends to marine genetic resources), it is perhaps helpful to initially consider what regime governs the issue of marine genetic resources in international law. Marine genetic resources are governed by the recently adopted Agreement under the United Nations Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas beyond National Jurisdiction (otherwise referred to as the BBNJ Agreement). The BBNJ Agreement defines marine genetic resources to mean ‘any material of marine plant, animal, microbial or other origin containing functional units of heredity of actual or potential value’. The main objective of the Agreement is ‘to ensure the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction’ (Article 2). Apart from the issue of marine genetic resources, the BBNJ Agreement addresses other key issues such as area-based management tools, environmental impact assessments, and capacity-building and the transfer of marine technology.

In relation to marine genetic resources, one of the key objectives of the BBNJ Agreement is the ‘fair and equitable sharing of benefits arising from activities with respect to marine genetic resources and digital sequence information on marine genetic resources of areas beyond national jurisdiction’ (Article 9(a)). To facilitate the achievement of this objective, the Agreement requires the notification of activities with respect to marine genetic resources and DSI on marine genetic resources to a Clearing-House Mechanism (Article 12) and it equally contains provisions on the fair and equitable sharing of benefits arising from activities with respect to marine genetic resources and DSI on marine genetic resources (Article 14). Unlike the CBD which only applies to genetic resources within the national jurisdiction of states, the BBNJ Agreement specifically covers marine genetic resources in areas beyond national jurisdiction.

So, does the new WIPO Treaty extend to marine genetic resources? To begin with, the text of the BBNJ Agreement does not expressly address the relationship between intellectual property rights and marine genetic resources (although earlier drafts of the Agreement did contain such a provision). Also, the BBNJ Agreement does not mandate parties to require patent applicants to disclose the origin of marine genetic resources in their patent applications (although it equally does not prohibit parties from implementing such a disclosure requirement). Furthermore, there is no explicit reference to marine genetic resources in the text of the new WIPO Treaty. Nevertheless, a strong argument can be made that the obligations in the new WIPO Treaty extends to marine genetic resources. This is because the disclosure requirement in Article 3 of the new WIPO Treaty applies to ‘the country of origin of the genetic resources’ or ‘the source of the genetic resources’. Article 2 of the new WIPO Treaty further defines ‘source of genetic resources’ in a non-exhaustive manner as ‘any source from which the applicant has obtained the genetic resources, such as a research center, gene bank, Indigenous Peoples and local communities, the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depository of genetic resources’ (emphasis added). This definition is broad enough to include marine genetic resources. Moreover, according to footnote 1 in the new WIPO Treaty, the only form of genetic resources specifically exluded from the scope of the treaty is ‘human genetic resources’. The new WIPO Treaty therefore provides an avenue to synchronise the provisions on marine genetic resources in the BBNJ Agreement with international intellectual property law. Thus, parties to the BBNJ Agreement can rely on the new WIPO Treaty to require patent applicants to disclose the source of marine genetic resources where the claimed invention in a patent application is based on marine genetic resources.

Concerning the second question, i.e. whether the new WIPO Treaty applies to DSI on genetic resources, it is necessary to first clarify what is meant by the term. It is important to note that the term DSI is highly contested and there is no agreed definition yet. However, DSI has been described as ‘a policy term that refers broadly to genomic sequence data and other related digital data’. It has equally been described as ‘biological data associated with, or derived from, genetic resources such as nucleotide sequences and epigenetic, protein, and metabolite data’. In the context of genetic resources, especially as it relates to developing countries, the issue of DSI is important because it has been observed that ‘new modes of misappropriation of [genetic resources] are evolving through the use of genetic sequence information and data of [genetic resources]’. In essence, DSI removes the requirement for physical access to genetic resources and this is problematic for existing ABS frameworks that rely on such physical access. In this regard, it has been suggested that ‘a new system for DSI should largely if not entirely decouple benefit sharing from access.’ There have equally been calls for a multilateral harmonized system for benefit-sharing from DSI.

The CBD and its Nagoya Protocol do not address the issue of DSI but, in December 2022, the Conference of Parties to the CBD adopted a Decision on DSI on genetic resources. In addition, although it does not define the term, the BBNJ Agreement explicitly includes DSI on genetic resources within the scope of the Agreement. However, unfortunately, the new WIPO Treaty does not address the issue of DSI on genetic resources. Considering the growing importance of this phenomenon in the context of genetic resources, it is somewhat disappointing that WIPO Members failed to address the issue of DSI in a treaty on genetic resources. The negotiations on the new treaty provided an opportunity for WIPO to take the lead on norm-setting in relation to DSI on genetic resources.

In conclusion, the new WIPO Treaty creates a synergy between international intellectual property law and other regimes and frameworks on the global governance of genetic resources such as the CBD/Nagoya Protocol and the BBNJ Agreement. Nevertheless, the omission of the issue of DSI on genetic resources coupled with the relatively weak provisions on sanctions for the failure to disclose the source of genetic resources (Article 5) makes one question whether the new WIPO Treaty will actually be able to fulfill its laudable objectives.