After 25 years of negotiations, the Treaty on Patents, Genetic Resources, and Traditional Knowledge was adopted in May 2024 by the World Intellectual Property Organization (WIPO). The treaty introduces a mandatory disclosure requirement of the origin of any genetic resources and associated traditional knowledge present in claimed biotechnological inventions by patent applicants. It is the first treaty to bring genetic resources and the traditional knowledge of indigenous peoples into the purview of intellectual property law.
In the IP sector, genetic resources are defined as any plant, animal (excluding humans), microbial or organic item that contains genetic material that are used for functional purposes such as medicine. Often, the use of genetic resources is a part of the traditional knowledge of indigenous peoples. This treaty favors resource-rich and culturally diverse countries that are rich in genetic resources, as well as indigenous communities throughout the Americas. Historically, patents have been granted on inventions derived from their resources and traditional knowledge without the consent of indigenous groups who hold this knowledge, preventing them from obtaining a share in the benefits.
Core Principles of the Treaty
The core objective of the treaty is to ensure transparency and efficiency in the global patent system for the use of genetic resources and traditional knowledge. While a significant number of countries have already signed the treaty, it will only come into effect once 15 member states have formally ratified it.
Under the new regulations, patent applicants will be required to disclose the country of origin of any genetic resources used in their inventions, as well as any traditional knowledge on which it is “based.” “Based on” is defined by the WIPO treaty as a situation where the genetic resources or traditional knowledge are essential to the invention’s claims, and the claims themselves on the specific properties of those resources or knowledge. If the applicant is unable to determine this information at the time of filing, they must declare this lack of knowledge.
Impact and Challenges
The National Institute of Industrial Property (INPI) will be responsible for implementing the treaty in countries that have signed the treaty. This will involve establishing mechanisms for applicants to comply with the new disclosure requirements, potentially through new regulations and the creation of a database containing information on genetic resources and traditional knowledge.
The treaty is not retroactive and will not directly impact existing patents. It does allow sanctions to be placed on patent applicants for non-compliance with this requirement, but grants leeway to countries to define the appropriate legal and administrative measures to address violations. The most severe penalty under the sanctions region is the annulment of a granted patent, which can only be levied in cases where the applicant is proven to have acted in bad faith. An example of this is if the patent owner knowingly and deliberately failed to disclose the knowledge or resources essential to the inventions claims.
This treaty might lead to increased security measures within the global patent system to ensure that the traditional knowledge of indigenous communities is properly credited for IP protection. However, there is a risk that increased bureaucracy that may result from these additional mechanisms may slow down the patent application process and result in a loss of efficiency in patent prosecution.