• Homepage
  • Blog
  • General
  • Combating Biopiracy by Fostering Coordination across the Environment, Intellectual Property and Trade Regimes

Combating Biopiracy by Fostering Coordination across the Environment, Intellectual Property and Trade Regimes

By Pallavi Arora
Published on 5 August 2024

The advent of biotechnology has raised concerns about biopiracy: the utilization of biological resources and traditional knowledge without permission from or compensation to the local communities who are the rightful custodians of these resources and knowledge. Over time, this issue has acquired a North-South dimension. Bioprospecting firms from advanced nations have been accused of misappropriating the traditional knowledge of local communities in the Global South by obtaining erroneous patents. In the process, benefits derived from commercializing inventions based on genetic resources and traditional knowledge of the Global South have not been equitably shared with these states and their communities.

The requirement to seek consent from local communities before accessing biological resources and traditional knowledge, as well as the fair distribution of benefits resulting from their commercial use, is based on the principles of equity, sustainable development, and the common concern of humankind. Treaty-making on this subject has evolved across the environment, intellectual property (IP) and trade regimes. The Convention on Biological Diversity (CBD), the Bonn Guidelines and the Nagoya Protocol are the key environmental agreements to establish a regime of prior informed consent (PIC) and access-and-benefit-sharing (ABS) concerning genetic resources and associated traditional knowledge. 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 (the BBNJ Agreement) extended the PIC and ABS requirements to marine genetic resources on the high seas. More recently, disagreements among states on the pathogen-related ABS mechanism led to a breakdown in the global pandemic treaty negotiations.

To reinforce the implementation of PIC and ABS, deliberations have been underway at the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) for over two decades with the purpose of linking these commitments with the patent system. In May this year, the WIPO adopted a modest yet landmark agreement to integrate intellectual property (IP) rights with the commitments under the CBD and other environmental agreements—the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (‘WIPO treaty’). Efforts have also been made at the World Trade Organization (WTO) to establish a linkage between CBD and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). However, these negotiations have been in a stalemate since 2011.

This post advocates for greater coordination between the environmental, IP and trade regimes to address the issue of biopiracy. It begins by highlighting the need to reinforce PIC and ABS through the IP system. It then identifies the limitations of the WIPO treaty and argues for leveraging trade policy to achieve this objective.

International Environmental Regime

The CBD (1992), Bonn Guidelines (2002) and Nagoya Protocol (2010) provide detailed procedures for PIC and ABS concerning genetic resources and traditional knowledge. These instruments are premised on a contract-based ABS system. Bioprospecting firms must secure consent from the providers of genetic resources or traditional knowledge, who could be a public authority or a representative of Indigenous Peoples or local communities. Access also requires a contract between the users and providers of genetic resources or traditional knowledge to ensure equitable distribution of research and development benefits.

A significant drawback of the contract-based ABS system is the lack of transparency and enforceability. The utilization of genetic resources and traditional knowledge often has a transboundary character. Genetic material or traditional knowledge may be obtained from one country (Country A), while a patent for an invention using these resources or knowledge is sought in another country (Country B). In this scenario, the patent office in Country B might not be aware that the claimed invention is based on the traditional knowledge of Country A, resulting in erroneous patents that do not meet the requirements of novelty and inventiveness. Further, it is quite likely that Country A, tasked with enforcing the benefit-sharing contract, may not have information about the patent application filed in Country B. This results in information asymmetry between the patent office in Country B and the entities responsible for enforcing benefit-sharing arrangements in Country A, potentially compromising the enforceability of benefit-sharing arrangements across borders.

International IP Regime

To address the above shortcomings, negotiations have been ongoing at the WIPO for over two decades to advance the conservation of genetic resources, traditional knowledge and traditional cultural expressions through the IP system. In 2000, the WIPO Intergovernmental Committee on IP and Genetic Resources, Traditional Knowledge and Folklore (hereinafter ‘IGC’) was tasked with concluding an international legal instrument to protect genetic resources, traditional knowledge and traditional cultural expression through the IP system. In May 2024, the WIPO treaty was adopted to increase the mutual supportiveness of the systems for the preservation of genetic resources and associated traditional knowledge and patent rights. Further negotiations will continue under the IGC on sui generis IP rights for traditional knowledge and traditional cultural expression.

The WIPO treaty requires patent applicants to disclose the country possessing the genetic resources in situ on which their claimed invention is based. If the country of origin is unknown, they must disclose the source of genetic resources. This may include a gene bank, research centre or other ex-situ collection of genetic resources. Additionally, applicants must disclose the Indigenous Peoples or local community that provided the traditional knowledge. If this requirement does not apply or the information is unknown, the applicant must disclose the source of traditional knowledge. If none of the above information is available, the applicant must declare so (Article 3). To minimize the burden on patent offices, the treaty does not require them to verify the authenticity of the disclosure (Article 3). There is also a provision for review to extend the disclosure requirement to sui generis IP rights for traditional knowledge and traditional cultural expression, and digital sequence information in the future (Article 8).

The disclosure requirement aids the patent office in conducting a prior art search. It helps 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 makes the patent office the checkpoint to curtail transboundary biopiracy. Further, the WIPO treaty calls on its Contracting Parties to establish information systems, such as databases of genetic resources and associated traditional knowledge, that would aid patent offices in discovering relevant prior art by improving the examination of patent applications (Article 6).

Despite being a progressive instrument, the WIPO treaty falls short on some counts. 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 establish a direct connection between the PIC and ABS requirements and the patent system. It appears to rely on government agencies and local communities to monitor published patent applications worldwide to enforce PIC and ABS. A better approach would have been to require evidence of PIC and benefit-sharing arrangements as a prerequisite for patent commercialization. Third, the treaty subjects non-disclosure to appropriate measures, as per the domestic law of Contracting Parties. However, patent applicants have the opportunity to rectify any failure to disclose the required information. Revocation of patents is only considered in cases where fraudulent intent in non-disclosure is established, setting a high threshold for revocation. Countries like India, South Africa and Namibia (see here) allow for the revocation of patents for non-disclosure of origin/source of genetic resources or traditional knowledge, regardless of fraudulent intent. Consequently, the treaty would require these countries to amend their patent laws to limit revocation on the grounds of non-disclosure to instances of fraudulent intent. One may argue that revoking a patent for non-compliance with the disclosure requirement would undermine the very foundation of benefit-sharing—namely, the patent. However, even without a patent, the potential for benefit-sharing from the commercialization of invention or grant of access still exists.

Notwithstanding the above weaknesses, the WIPO treaty still holds the potential to preserve genetic resources and associated traditional knowledge and influence the development of future norms on this subject.

International Trade Regime

Given the close relationship between IP and international trade, the TRIPS Agreement integrated the minimum standards of IP protection provided under the various WIPO treaties into the trading regime, with the underlying objective of extending the WTO’s binding dispute settlement, predicated on legally-supervised trade retaliation, to IP protection and enforcement. In 2001, at the behest of several developing countries, paragraph 19 of the Doha Ministerial Declaration mandated WTO Members to discuss the relationship between TRIPS and CBD as part of the TRIPS review under Article 27.3(b). Several developing countries have proposed an ambitious agenda for TRIPS-CBD linkage in the various proposals to the TRIPS Council, such as TN/C/W/52 and TN/C/W/59. This includes aspects like the mandatory disclosure of origin in patent applications, evidence of PIC and ABS as a pre-requisite for patent grant or commercialization, and legal implications of non-compliance, including patent revocation.

With the gradual demise of the Doha development agenda, negotiations on TRIPS-CBD linkage have been in a stalemate since 2011. Nevertheless, the adoption of the WIPO treaty could provide a fresh impetus to resume these negotiations. A recent submission by Bangladesh, Colombia, Egypt and India (IP/C/W/708) has called for reviving WTO negotiations on this issue as part of the TRIPS review under Article 71.1. Preserving genetic resources and associated traditional knowledge through trade policy will have two obvious advantages. First, the disciplines would be subject to the WTO’s compulsory and binding dispute settlement as compared to the WIPO treaty, which does not offer recourse to international dispute settlement. Second, it provides an opportunity to negotiate stronger disciplines and address the shortcomings of the WIPO treaty, especially since integrating trade and sustainability is currently a top priority for the WTO. For instance, in contrast to the WIPO treaty, the TRIPS could require evidence of prior consent and a benefit-sharing arrangement as prerequisites for commercializing a patent. This would strengthen the enforcement of the PIC and ABS commitments, especially in a transboundary context.

That said, given the WTO’s Appellate Body crisis and the challenges of multilateral negotiations, the preservation of genetic resources and associated traditional knowledge through trade policy should be pursued in parallel under other preferential trade agreements (PTAs).  While modern PTAs contain sustainability chapters that oblige parties to fulfil their commitments under the CBD and Nagoya Protocol (see here), the IP chapters of these PTAs have not effectively harmonized the PIC and ABS commitments with the patent system (see here). Thus, it is crucial to revitalize negotiations on preserving genetic resources and associated traditional knowledge through the patent system at both the multilateral level (WTO) and the bilateral/regional level (PTAs).

Conclusion

While the urgency to link sustainability objectives with trade policy is undeniable, this goal will gain political acceptance among developing countries only when issues of relevance to the Global South find as much resonance in the negotiating agenda. In light of this, the momentum gained from adopting the WIPO treaty must be channeled towards reviving negotiations on TRIPS-CBD linkage, thereby fostering greater harmony between the environmental, IP and trade regimes.