On 24^th May 2024, the World Intellectual Property Organisation (WIPO) approved the new WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge.¹ Once ratified by 15 contracting parties, the treaty will introduce a new disclosure obligation in international law for patent applicants whose inventions are based on genetic resources and/or associated traditional knowledge.² This is a key milestone because, since 1998, WIPO has taken actions towards the international protection of traditional knowledge.³

In 2000, the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) was established to address intellectual property issues relating to genetic resources, traditional knowledge (TK) and folklore.⁴ For more than two decades, the IGC has dedicated its efforts to exploring and deliberating ways to enhance the protection of genetic resources, traditional knowledge and traditional cultural expressions (TCE) within the intellectual property sphere.⁵ The new treaty culminates a 25-year journey that began in 1999 with a proposal by Colombia. Notably, this journey prioritized the inclusion of indigenous people and local communities.⁶

This treaty is significant because in recent years, there has been a growing demand from indigenous people, local communities and governments especially in developing nations, for intellectual property protection for traditional forms of creativity and innovation.⁷ These forms are typically considered to be in the public domain under the traditional intellectual property system allowing unrestricted use by anyone.⁸ However, indigenous peoples, local communities, and many countries reject the notion of TK and TCEs being relegated to the public domain, as they argue that this exposes them to undesired misappropriation and misuse.⁹ This treaty is likely to have significant implications for the biotechnology field, encompassing a wide range of industries such as pharmaceuticals, cosmetics, and agriculture. In light of this, this blog will build on our previous discussion of the implications of WIPO’s diplomatic conference on genetic resources and traditional knowledge, exploring the key aspects of the new treaty and its implications for the Kenyan legal landscape.

Key Treaty Provisions and Implications on Kenya’s Legal Landscape

Kenya’s Constitution mandates the State to protect genetic resources and biological diversity, ensuring that the environment and natural resources are utilized for the people’s benefit.¹⁰ Effecting this, the Protection of Traditional Knowledge and Cultural Expressions Act was enacted in 2016 with the aim to protect and promote traditional knowledge and cultural expressions.¹¹

To establish a foundation for understanding this treaty, we examine the key definitions within both Kenya’s law and the treaty. The Kenyan legislation broadly defines ‘genetic resources’ as microorganisms, plants, and animal materials with hereditary units, and ‘traditional knowledge’ as knowledge related to genetic resources, biological diversity, and traditional practices in architecture, construction, designs, and marks.¹² On the other hand, the WIPO treaty aligns with the Convention on Biological Diversity (CBD) by defining genetic resources (GRs) as ‘genetic material of actual or potential value,’ and it introduces unique definitions for ‘based on’ and ‘source of traditional knowledge associated with genetic resources.’¹³ The treaty clarifies that ‘based on’ means the GRs and/or traditional knowledge must be essential for the claimed invention, and it specifies that the source of traditional knowledge is any place the applicant obtained the knowledge, such as scientific literature, databases, or patent publications.¹⁴ Some scholars argue that GRs are central to the broader concept of traditional knowledge.¹⁵

The Kenyan law on TK guarantees the protection, exploitation and recognition of traditional knowledge holders,¹⁶ entitling them to fair and equitable benefit-sharing from commercial use, including non-monetary benefits like community development contributions.¹⁷ Significantly, the law mandates users to obtain prior and informed consent and acknowledgement for use of traditional knowledge¹⁸ to prevent the misappropriation, misuse or unlawful access and exploitation.¹⁹ Notably, it specifies that authorization to access protected traditional knowledge related to genetic resources does not extend to authorization to access the genetic resources themselves; access to the GR would be governed by other GR laws.²⁰

The Disclosure Requirement: Enhancing the Patent System?

The WIPO treaty aims to ‘enhance the efficacy, transparency and quality of the patent system with regard to genetic resources and associated traditional knowledge; and prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge associated with genetic resources.’²¹ These objectives are crucial for addressing the misappropriation and misuse of genetic resources (GRs) and traditional knowledge (TK), including instances of patent grants based on inaccurate claims.²² Several cases have been observed where patent offices, such as the European Patent Office and the United States Patent and Trademarks Office have issued patents for GRs, TK associated with GRs or TK-based inventions that do not meet the standards of novelty and inventiveness,²³ as seen with Maca, Ayahuasca and Camu Camu plants.²⁴ The patent examination process often fails to recognize previously known TK as prior art, making it challenging and expensive to contest patents after they are granted.²⁵ Moreover, indigenous peoples and local communities, unfamiliar with the IP system, face hurdles in seeking redress for these issues.²⁶

To achieve its objectives, the treaty requires patent applicants to disclose when their inventions are based on GRs or associated TK.²⁷ This includes revealing the origin of the GRs, the indigenous people or local community involved, and applies to all patent applications within a contracting party’s jurisdiction, even for foreign applicants.²⁸ Similarly, the Kenyan legislation requires a person who uses traditional knowledge outside its traditional context to acknowledge the owner of the knowledge, indicate its source, specify its origin, where possible, and use the knowledge in a way that respects the cultural values of the holders.²⁹

This disclosure helps combat biopiracy, where GRs and TK are taken without consent, particularly in developing countries.³⁰ It applies to researchers or companies who exploit GRs or TK to develop commercial products like medicines, and obtain patents without prior informed consent from the original TK or GR holders.³¹ For instance, in Kenya, the Digo community was not acknowledged as the source and holders of the knowledge in the collection of Maytenus Buchananii by the US National Cancer Institute (NCI), which was considered a potential treatment for pancreatic cancer.³² In another instance, Hoodia, a plant used by the San people, was patented without their consent, leading to legal threats by the San people.³³ This prompted the South African Council for Scientific and Industrial Research to recognize their ownership of the traditional knowledge related to Hoodia.³⁴

The treaty requires contracting parties to establish sanctions for non-disclosure but specifies that a patent cannot be invalidated solely due to a failure to disclose, unless there’s evidence of fraudulent conduct or intent.³⁵ However, these provisions are not retroactive and do not apply to patent applications submitted before the treaty’s enactment.³⁶ In Kenyan law unauthorized use and non-acknowledgment of the source of the TK are criminalized.³⁷ Furthermore, Kenyan law requires an authorised user agreement for commercial or industrial use of derivative works, such as patents, based on traditional knowledge.³⁸ This agreement must incorporate a fair benefit-sharing arrangement, identify and disclose the traditional knowledge source, and prohibit derogatory treatment of the utilized knowledge.³⁹

The WIPO treaty and Kenyan law both emphasize the importance of establishing databases for genetic resources and traditional knowledge. The treaty allows contracting parties to set up databases for genetic resources and traditional knowledge with input from indigenous groups and others.⁴⁰ Similarly, Kenyan law mandates the national government, in collaboration with the relevant county government, to establish and maintain a comprehensive Traditional Knowledge Digital Repository.⁴¹ These databases should be accessible for patent offices to search, aiding in prior art research.⁴² These databases serve as valuable resources for researchers and policymakers, aiding in the prevention of misuse and misappropriation of genetic resources and traditional knowledge.⁴³ However, challenges such as funding and data management must be addressed to ensure the effective implementation of these database requirements.

What Next?

While Kenya is among the few countries with a national law to protect TK, an international law is paramount. Given the international dimension of bioprospecting and patenting activities, national legislation is insufficient to address misappropriation and misuse of GRs and TK.⁴⁴ The WIPO treaty will provide additional protection for Kenya’s genetic resources and traditional knowledge, with its disclosure requirement ensuring proper acknowledgment by patent applicants.

Kenya, like other countries, will need to amend its patent law to enforce disclosure requirements and establish provisions for sanctions and remedies. Although the treaty is crucial for protecting indigenous communities and TK holders, it has some limitations. It should be reviewed to address gaps and create a fair balance for the indigenous communities and interested users of GR and associated TK. Successful implementation will depend on comprehensive legal reforms and active participation from all stakeholders. Additionally, policymakers must ensure that the treaty’s benefits reach the indigenous communities it aims to protect, empowering them through fair compensation and acknowledgment. Furthermore, it is crucial to explore the treaty’s impact for regulating the use of indigenous data in emerging technologies, with a focus on striking a fair balance between promoting innovation and honouring indigenous knowledge.

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