Towards A Legalised International Instrument for Traditional Knowledge and Genetic Resource

The text provides an overview of the upcoming diplomatic conference by the World Intellectual Property Organization (WIPO) regarding the potential creation of a legal instrument aimed at protecting traditional knowledge (TK) and genetic resources (GRs) from exploitation through mandatory disclosure of patent application.

First, Key Terms:

Traditional Knowledge (TK) refers to the developed and sustained knowledge, skills, know-how and practices that forms part of the tradition, cultural and spiritual identity within a community (or indigenous people) passed down from generations to generations.[1]

Genetic Resources (GRs) are genetic material of plant, animal, microbial or other origin containing functional units of heredity which are of actual or potential value.[2]

The key premise here is that it is imperative that inventions based on or developed using associated TK and GRs are not granted patent if such invention do not satisfy the patentability requirements which includes novelty and inventiveness. This is to prevent unauthorized use and gaining patent protection over inventions that are not new nor inventive.

Now, about the Conference:

In a bid to ‘enhance efficacy, transparency, and the quality of the patent system with regard to GRs and associated (ATK), and prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to GRs and ATK,’[3]  the World Intellectual Property Organization (WIPO) will convene a diplomatic conference in May 2024. This initiative follows over 20 years of discussions at WIPO (which has prior to now reached no conclusion), signalling a possibility of a legalised international instrument to prevent the exploitation of TK and GR through patent application.

The forthcoming conference has ignited discussions among intellectual property specialists, TK experts, and indigenous people/folklore experts regarding the intended and actual efficacy of such an instrument.[4] In anticipation of the legal instrument, WIPO has published the Basic Proposal (BP), prompting crucial questions to be addressed.

A working definition of TK: Establishing a clear definition is crucial to ensuring the effectiveness of any legal instrument. There is no internationally accepted definition of TK, and the Basic Proposal is equally silent. However, notably, the Proposal introduces the term ‘materially/directly based on’ ATK and GRs to denote the necessary relationship that will trigger the disclosure requirement. Further certainty, denoting the criteria and basis of protection beyond this term may be required to eliminate ambiguity.

Disclosure: The aim of the discussion and the intended legal instrument has been to create a system of mandatory patent disclosure of the sources of TK and GRs. The purpose the disclosure requirement is to ensure that patent is not granted for inventions with prior arts in TK/GRs, reducing the risk of erroneously granting patent and therefore curbing misappropriation of TK and GRs. An applicant, thus needs to disclose the origin (country, indigenous people or local community) or the source, and if unknown, declare it as such.

An important consideration might be the need to implement stricter requirements. As it stands, the BP does not burden the patent office to verify the information. Understandably, it could prove difficult, if impossible, to verify the information, but this relies entirely on the applicant. Further, the BP has no sanction strategy for non-compliance, placing the burden on participating parties’ national law to provide what is termed an ‘appropriate, effective and proportionate measure.’

This then raises the question of fragmentation, an associated problem with procedural laws on patent. Currently, WIPO member states have regimes addressing TK and GRs in place with significant differences in ‘terms of scope, content, relationship with access and benefit-sharing regimes, and sanctions,’[5] which creates legal uncertainties for users.[6] Similarly, the sanctions may vary from country to country, rigid or significantly flexible, and may act to sway applicants on the specific country to present application so as to take advantage of favourable rules.

Inclusive Provision – A major issue raised with the patent system is the need to avoid creating a one-size-fits-all approach which does not take into account the different needs of the subject.[7] As it may be impossible to address all of TK as specific to the indigenous people/local community, it is therefore necessary to tailor provisions inclusively, acknowledging diverse TK needs.

It may seem that the issue of protecting TK sits along the arguments of allowing public access and retaining monopoly. While the public access to the information for adaption, extraction and creating inventable solutions, the holders of the knowledge, with deeply entrenched traditional and sometimes spiritual connections may be more unwilling to part with this knowledge which may explain in part the mode of passing down this information (orally). Nevertheless, it is imperative to ensure that the TK and GRs are not exploited for commercial purposes without the right acknowledgment of the indigenous people/local community.

Information System/Database: Moreover, the establishment of accessible information systems for patent offices, as suggested in the BP, could contribute to a comprehensive database of TK/GR knowledge, complementing national efforts and recognizing rightful sources. The database will be available as evidence of prior art which could be used to defeat a patent claim based on such TK and GRs. This is lauded as a step towards improving the patent system.

Conclusion:

Overall, the proposed legal instrument is seen as a positive step towards better TK protection and facilitating benefit-sharing, while creating legal certainty in this domain. The patent system could also benefit from this endeavour, preventing misappropriation thereby encouraging innovation. While it may not resolve all challenges, it lays the groundwork for creating an efficient system which balances the several rights and interests of the knowledge provider and holder on the one hand and the user and commercial exploiter on the other. The outcome of these discussions is eagerly awaited, with the hope that it heralds a significant development in global IP regulation.

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[1] WIPO, https://www.wipo.int/tk/en/tk/

[2] WIPO, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore. Available at https://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_43/wipo_grtkf_ic_43_5.pdf

[3] Direct quote which encapsulates the aim of the legal instrument. WIPO, Executive Summary: Basic Proposal for an International Legal Instrument on Genetic Resources and Associated Traditional Knowledge available at https://www.wipo.int/export/sites/www/diplomatic-conferences/en/docs/executive-summary-basic-proposal.pdf

[4] Vane, M.-D. (2023) ‘Questioning the Potential of the Forthcoming WIPO’s Diplomatic Conference on Intellectual Property and Genetic Resources: Endless Negotiations Coming to a Successful End?’, LSE Law Review, 9(1). Available at: https://doi.org/10.61315/lselr.574.

[5] WIPO, Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore available at https://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_43/wipo_grtkf_ic_43_5.pdf

[6] ibid

[7] Dutfield  G. & Suthersanen, U. (2024) ‘Traditional Knowledge as Intellectual Property Subject Matter: Perspectives from History, Anthropology, and Diverse Economies’ Queen Mary Law Research Paper No. 418/2024  available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4709231