As experts and top diplomats count down to the WIPO Diplomatic Conference in Geneva, Switzerland (May 13-24, 2024) in a final push to birth a treaty on Genetic Resources (GRs) and Associated Traditional Knowledge (ATK), we at Access and Benefit Sharing Canada reflect on the anticipated outcome of the historic meeting, tapering expectations and offering some clarification. This intervention is provided in the context of existing curiosity amongst the rank and file of traditional knowledge (TK) stakeholders, mostly members and organizations associated with Indigenous peoples, local community groups, and variegated actors in the intellectual property (IP) ecosystem, including industries, researchers, and cross-sectoral policy makers in the life sciences sectors. There has been a fair bit of partisan interpretations; even misinformation, some verging on propaganda, especially over the impact of the treaty on the patent system, research and development, and innovation. The following are highlights of the significance of the anticipated treaty – what it is and what it is not; what to expect, and what not to expect.

1. Treaty’s Core Significance: The treaty will be perhaps the first major contemporary attempt to bring TK within the framework of WIPO and, by extension, the global IP system. Before now, such attempts have been marginal and indirect, mainly outside WIPO (for example, pursuant to the work program of the Convention on Biological Diversity, among others).

2. Parallel Instruments: The GRs-ATK instrument is the most advanced of the trilateral negotiations by the WIPO Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge, and Folklore. After the GRs-TK Diplomatic Conference, negotiations on two other parts of the IGC mandate, namely, TK and Folklore (also known as Traditional Cultural Expressions or TCEs) are expected to continue.

3. Transparency and Mandatory Disclosure:  The draft instrument on GRs-ATK is simply a transparency and, to a limited degree, accountability document. It strives to disburden rather than burden the patent system from its opaqueness. Essentially a patent instrument, the draft document has little to do with the idea of a sui generis approach to IP in relation to TK. At its core, it provides for mandatory disclosure of where the GRs and ATK underlying a particular innovation subject of a patent application is sourced from. Such a disclosure is expected to ensure that the patent system is transparent. It will assist patent examiners to check for prior art. It also would be instrumental to TK holders and GRs providers on the prospects of challenging the propriety of a dubious patent application. Lastly, it aims to empower TK holders and GRs providers to partake in potential partnerships and benefits of the innovation relating to their knowledge and GRs without being bypassed.

4. “Biopiracy”: This word is not mentioned in the instrument, even though the idea of transparency of the patent system is to ensure that GRs and ATK are not misappropriated through the abuse of the patent system. This is the essence of anti-biopiracy campaigns. Many industrialized countries are opposed to the use of the word “biopiracy” in the instrument, against the desires of GRs and ATK provider countries. Parties appear to have settled on confining the subject of biopiracy to the Convention on Biological Diversity (CBD) where it historically enjoys pre-eminence as part of the emerging regime complex on TK.

5. Access and Benefit Sharing (ABS): Like biopiracy, this phrase is not found in the text of the instrument for the same reason that biopiracy was tabooed. Yet again, a transparent patent system involving mandatory disclosure would be a crucial boost for ABS, which supports the aspirations of GRs and ATK providers to benefit equitably from innovations that build on their resources and knowledge. It is also evident that experts have confined ABS to the CBD for the exact same reason as they did for biopiracy.

6. Too Little, Too Late? The rapid pace of technological developments in the life sciences has disrupted how GRs and even ATK can be acquired. Such acquisition now happens through digital information systems, such as digital sequencing of information (DSI), without regard to GRs and ATK providers. The compulsory disclosure of source models under the proposed instrument and even under the Nagoya Protocol on Access and Benefit Sharing (to the CBD) is premised on physical access. This access model is quickly becoming obsolete. The anticipated treaty may be too little, too late as evident in the DSI debate now within the work program of the Kouming-Montreal Global Biodiversity Framework and other fora.  Interestingly, negotiators in their wisdom parried the issue of DSI. They found compromises on two counts under proposed Article 8 and Article 9 respectively: 1) implementation of the instrument shall be in a “mutually supportive manner” with other relevant international agreements; 2) review of the instrument shall be no later than 4 years upon coming into force in light of, among other things, “new and emerging technologies” relevant to its application.

7. Information Systems: The draft treaty makes elaborate provisions on the voluntary establishment of information systems such as databases of GRs and TK associated with genetic resources. Such databases are to be accessible to patent offices “for purpose of search and examination of patent applications” (Article 7.1, Article 7.2). This is one of the very sticky points on many grounds, including the nature and design of such a system and safeguarding against a counterproductive outcome. There is real apprehension regarding the risk that such a system could undermine or be a substitute to the compulsory disclosure requirement. The role of Indigenous peoples, local communities, other stakeholders, WIPO, and IP offices in the establishment and operationalization of the information system, including the question of free, prior and informed consent, have yet to be satisfactorily resolved.

8. Sanctions and Remedies: Many will be disappointed that the instrument does not impose any significant sanction for failure to disclose the source/origin of GRs and ATK in patent applications. Rather, patent applicants receive only a slap on the wrist. Revocation of patent is neither mentioned nor ruled out as part of post-grant sanctioning. Only “where there has been fraudulent intent in regard to disclosure requirement” (Article 6. 4) could revocation be possible albeit far-fetched.  Effort is to be made to encourage patent applicants to rectify disclosure discrepancy. Parties are encouraged to utilize dispute settlement to resolve non/disclosure matters. Ironically, in some national laws, not only is disclosure compulsory, but patent revocation is also part of post-grant sanctioning for non-disclosure.

9. Trigger for Disclosure: One of the lingering and yet unresolved issues is the question of what relationship the invention that is subject of the patent application would have with GRs and ATK  to trigger the obligation for compulsory disclosure. Surely, not all associations between GRs/ATK with a patent claim would require disclosure. Experts have long negotiated a range of options for the trigger language. Those considered include whether the invention must “use”, “make use of”, “utilize”, “be based on”, or “directly based on” or “materially based on” (etc.) GRs and/or ATK to trigger the responsibility to disclose. The two surviving trigger options are “[materially/directly] based on” (Article 3). The nature and interpretation of trigger language has implications for the scope of activities that come under the treaty. The barest logical approach appears to hinge on the ‘but-for test’, that is, but for the GRs/ATK, the invention would not have been made.  In reality, however, the trigger debate is more complex.

10. ‘Indigenous Peoples’, ‘Local Communities’, ‘Other Stakeholders’: Finally, unlike the pending instruments on TK and TCEs (as continuing works in progress), the GRs-ATK instrument has no provision that specifies the beneficiaries of the instrument. Consequently, the role of Indigenous peoples, local communities, and indeed “other stakeholders” remains a contentious issue. While the instrument is being negotiated by WIPO member states, such states are not custodians of ATK in many (but not all) cases, nor are they the exclusive curators of GRs. The legitimacy of those states and their role over subject matters which they have dubious control is on trial. Despite being observer to these negotiations, the Indigenous Caucus continues to insist on the need to mainstream the imperative for collaboration, consultation, and for securing the free, prior and informed consent of Indigenous peoples at every stage and process. Additionally, they insist on aligning the instrument with the United Nations Declaration on the Rights of Indigenous Peoples.

Whatever the outcome, the historic and symbolic nature of the WIPO Diplomatic Conference on Intellectual Property and Genetic Resources and Traditional Knowledge Associated with Genetic Resources is guaranteed. We are at the cusp of a major milestone in the quest to interface TK with the IP system. This quest has remained elusive since the evolution and globalization of the modern IP system from its European origin.