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Introduction
In a context where biodiversity and traditional knowledge play a central role in scientific and technological innovation, the question of patent law applied to genetic resources and indigenous knowledge has become a major legal and ethical debate.
The use of genetic resources and traditional knowledge is governed by several international agreements. The Nagoya Protocol of 2010, which implements the Convention on Biological Diversity (CBD) of 1992, is one of the key instruments. This protocol requires parties to ensure that access to genetic resources is done in compliance with prior informed consent from local and indigenous communities, and that the benefits derived from their exploitation are shared fairly. The European Union and France have fully ratified these international instruments.
The recent adoption of the WIPO Treaty on Intellectualproperty, genetic resources, and traditional knowledge on May 24, 2024, marks a historic milestone. Indeed, it is the first international regulation to explicitly address the use of genetic resources and traditional knowledge in conjunction with patent law.
This article aims to clarify for professionals, businesses, and institutions the interactions between patent law, genetic resources, and traditional knowledge, analyzing the legal and strategic implications of this emerging framework.
Conceptual framework and key terminology
Genetic resources and traditional knowledge
It is crucial to clearly define the concepts of genetic resources and traditional knowledge. According to the Article 2 of the Convention on Biological Diversity (CBD) of 1992, genetic resources are “genetic material of actual or potential value,” which refers to “materials of plant, animal, microbial or other origin containing functional units of heredity.” Traditional knowledge, in this context, refers to the knowledge, innovations, and practices passed down through indigenous or local communities, related to the characteristics or use of genetic resources. A well-known example is that of turmeric (Curcuma longa), a plant that has been used for centuries in traditional Indian medicine for its anti-inflammatory and healing properties. The turmeric root constitutes a genetic resource, while the medicinal knowledge transmitted within local communities falls under associated traditional knowledge.
The coexistence of these two concepts presents a legal challenge: it involves economic interests (research, innovation, patents) as well as ethical, cultural, and social issues (community rights, access to resources, and benefit-sharing from the use of those resources and knowledge). This dual dimension requires both patent holders and the communities possessing the knowledge or resources to approach the issue with rigor.
The role of patent law in this context
Patent law aims to encourage innovation by granting a temporary monopoly to the inventor. However, when an invention is directly or significantly based on a genetic resource or associated traditional knowledge, the patent system faces several challenges:
- The issue of prior art: Traditional knowledge may de facto represent undocumented or even oral prior art, complicating the assessment of novelty or inventive activity.
- Transparency of origin: If the source of the genetic resource or knowledge is not disclosed, a patent application may be contested for lack of adequate disclosure.
- The issue of equitable benefit-sharing: This is notably regulated by the Nagoya Protocol (2010) between the inventor and, inter alia, indigenous or local communities.
Thus, for a patent applicant, it is essential to address these issues from the outset of the invention process. Proper management often requires turning to a specialized firm to ensure its legal compliance.
Legal and strategic issues for patent holders
Risks of “biopiracy” and defense mechanisms for indigenous communities
The term biopiracy refers to the unauthorized appropriation of genetic resources or traditional knowledge for commercial gain without recognition or compensation. Some biopirates even go as far as filing patents.
For example, certain indigenous peoples have seen patents granted for products derived from medicinal plants or other biological resources, which they have had knowledge of for generations. Such situations typically arise from:
- Lack of prior consent from the concerned community.
- Failure to share the benefits (“benefit-sharing”), as required by the Convention on Biological Diversity (1992) and the Nagoya Protocol (2010).
- For the patent holder, ignoring these aspects can lead not only to litigation risks but also to reputational risks. Despite multiple regulations, biopiracy persists.
The WIPO has thus taken action to regulate this issue by adopting a treaty that strengthens the protection of indigenous communities and encourages fair access to genetic resources.
Obligation to disclose the origin: the new WIPO treaty
After more than twenty years of discussions, WIPO adopted, on May 24, 2024, the first international treaty explicitly regulating the relationship between intellectual property, genetic resources, and traditional knowledge. Among its key provisions:
- The requirement to disclose, in the patent filling, the origin or source of the genetic resource used in the invention.
- The obligation to specify, in the patent filling, which indigenous or local communities are the source of the traditional knowledge exploited.
- The establishment of an information system (database) accessible to intellectual property offices to verify the compliance of patent applications.
For an applicant, this means that their patent strategy must integrate the verification of the origin from the very start, obtain clear consent from the relevant communities, and document the access to the resources. Failure to comply with this obligation could result in rejection of a patent application, as well as financial compensation.
The WIPO Treaty adopted in May 2024 is however not yet in force; it will only enter into effect once it has been ratified by at least fifteen States. To date, only Malawi and Uganda have ratified it.
How to adapt your patent strategy to the challenges of genetic resources and traditional knowledge?
To secure the validity of a patent and avoid future disputes, several crucial steps must be considered when dealing with genetic resources and traditional knowledge. First and foremost, it is essential to document the exact origin of the genetic resource, specifying the country of origin, the indigenous or local community, and the sample used. This approach provides clear and transparent traceability, meeting legal requirements. It is also crucial to ensure that access to the resource and traditional knowledge is in compliance with both national and international obligations (e.g., access permits or harvesting permits).
In this context, obtaining prior informed consent (PIC) from the community holding the knowledge is an indispensable step, whenever applicable. This consent should be formalized to ensure the protection of the community’s rights. Furthermore, it is critical to include in the contract a provision for equitable benefit-sharing, whether financial or non-financial, in favour of the concerned communities, ensuring compliance with principles of fairness.
To meet the new obligations imposed by the WIPO Treaty, it is also recommended to include a disclosure statement in the patent application about the provenance of the genetic resources and/or traditional knowledge, ensuring full transparency. Finally, conducting a specific prior art search, focusing on traditional knowledge, local databases, and non-scientific publications, is crucial to minimize the risks of contested novelty.
By integrating these steps into their patent filling strategy, companies not only strengthen the legal robustness of their patent but also ensure compliance with the emerging ethical and legal obligations in this complex field.
Conclusion
Ultimately, the integration of genetic resources and traditional knowledge within the framework of patent law is becoming an increasingly structured area legally: the WIPO Treaty of May 24, 2024 is a testament to this. For any business or inventor, it is important to integrate enhanced verification, origin transparency, and equitable benefit-sharing from the early stages of the invention process. For holders of traditional knowledge, it is essential to structure their protection and engage in balanced partnerships.
Dreyfus & Associés assists its clients in managing complex intellectual property cases, offering personalized advice and comprehensive operational support for the complete protection of intellectual property.
Nathalie Dreyfus with the support of the entire Dreyfus team
FAQ
1. Does the 2024 WIPO Treaty also apply to other intellectual property rights?
No. The WIPO Treaty adopted in 2024 applies exclusively to patent law and does not introduce any specific obligations in the fields of copyright, trademarks, or designs. Members of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore continue to explore how to protect traditional cultural expressions and works derived from indigenous knowledge within the framework of copyright law. These ongoing discussions could eventually lead to the adoption of complementary international instruments aimed at better regulating the use and preservation of such traditional creations.
2. What does “disclosure of origin” mean in the context of a patent application?
In the context of the WIPO Treaty, this means the applicant must disclose the country or source of the genetic resource used, as well as the identity of the indigenous or local community from which the associated traditional knowledge originates.
3. Does the existence of traditional knowledge prevent the granting of a patent?
No, but this knowledge can constitute prior art, which can destroy the novelty or inventive step of the invention. Therefore, it is crucial to conduct thorough research into traditional knowledge and anticipate its impact on the patent strategy.
4. How does the Nagoya Protocol relate to patent law?
The Nagoya Protocol imposes obligations regarding access to genetic resources and the fair sharing of benefits. Although it doesn’t explicitly target patents, patent offices and applicants must ensure that access has been authorized and that benefits are shared in accordance with the protocol.
5. What impact does non-compliance with these obligations have on a company?
The company exposes itself to potential challenges to its patent, facing litigation with the communities concerned, being subject to financial compensation obligations, and suffering reputational damage. It is therefore essential to incorporate these aspects into its IP strategy.