WIPO Treaty on TKGR 2024: Constructing Guidelines for Disclosure and ABS

Abstract

In May 2024, a new international treaty was adopted which introduced a new, and hitherto controversial, norm namely the international obligation for applicants to disclose the source or origin of genetic resources (GR) and/or the associated traditional knowledge (TK) in patent applications (Article 3). In its aims, this disclosure mechanism promotes: (i) “the efficacy, transparency and quality of the patent system”, while not unduly burdening patent offices, in addition to the requisite examination of novelty/inventive step that all patent offices must conduct under the global norms (TRIPs Agreement); (ii) preventing the grant of patents erroneously; and (iii) national compliance of obligations under international and national access and benefit sharing (ABS) regulations to ensure that users of TKGRs comply with the requirements for access to GRs, including prior informed consent and benefit sharing under mutually agreed terms.

However, the Treaty stresses that the sole fact of a failure to disclose will not allow Contracting Parties to “revoke, invalidate, or render enforceable” patent rights. (Article 5(3)). Post grant sanctions are allowed in cases of “fraudulent intent”. This ambivalent attitude towards sanctions permits contracting parties considerable flexibility in the implementation of the disclosure mechanism.

My presentation will focus on this ambivalence, especially in light of the following three questions. First, what is the trigger for the disclosure mechanism to apply? Specifically, what does “based on” TKGR mean in relation to a complex and multiple patent applications? Second, does the disclosure mechanism include digital sequence information (DSI)? (Articles 8 and 9). Finally, what is the point of the international disclosure mechanism without revocation or invalidity procedures/results? Specifically, how do we interpret the opaque references to “fraudulent intent” in disclosure? In looking at these questions, one should be cognisant of the readiness of national patent systems to incorporate such disclosure mechanisms (including the availability of accessible databases, monitoring, opposition proceedings, etc), the coherence of disclosure/sanctions mechanisms within this treaty, as well as the CBD/Nagoya protocol, the WIPO Patent Law Treaty (art. 10, PLT), and the lessons learnt from other patent systems (e.g. US Bayh-Dohl’s failure on disclosure requirements).

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About the Speaker

Professor Suthersanen holds a Chair in Global Intellectual Property Law and was the Director of the Queen Mary Intellectual Property Research Institute until 2024. Her research encompasses legal, socio-economic, and comparative aspects of intellectual and intangible property. Professor Suthersanen has served as a consultant and given evidence to international and regional bodies including WIPO, UNESCO, UNCTAD, European Parliament, European Commission, and the Governments of Israel and Singapore. More recently, she was invited to sit as a WIPO expert on the Ad hoc Committee on traditional knowledge and traditional cultural expressions, IGC 46, 2023 and served as a consultant to the WIPO Division on Traditional Knowledge during the Diplomatic Conference 2024 leading to the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge. 

Further reading is available via: https://www.qmul.ac.uk/law/people/academic-staff/items/suthersanen.html 

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