The Impact of the New WIPO Treaty
“The new WIPO Treaty on Patents, Genetic Resources, and Traditional Knowledge has the potential to transform global biotechnology, promoting a fairer distribution of benefits and strengthening the rights of indigenous peoples and traditional communities.”
WIPO offices
Global biotechnology is poised for significant transformation with the recent approval of the World Intellectual Property Organization (WIPO) Treaty on Patents, Genetic Resources, and Traditional Knowledge. After 25 years of negotiations, representatives from various countries gathered at a diplomatic conference in Geneva, Switzerland, from May 13 to 24, 2024, resulting in the approval of this historic treaty. The main change brought by the treaty is the mandatory disclosure of the origin of genetic resources and associated traditional knowledge in patent applications.
The enactment of this treaty represents a milestone in the field of intellectual property, especially for megadiverse countries like Brazil and for traditional communities that have long fought for the recognition and protection of their ancestral knowledge. Historically, these peoples have been invisible in intellectual property laws and treaties, resulting in the granting of patents that utilize their genetic resources and traditional knowledge without proper consent or benefit-sharing.
Implementation and Compliance Challenges
The intense discussion in Geneva revealed two opposing fronts: developed countries, concerned about the potential impact on innovation and patents, and megadiverse countries, along with indigenous peoples, advocating for transparency and recognition of the origin of genetic resources and traditional knowledge. The first article of the treaty outlines its objectives, focusing on the efficiency, transparency, and quality of the patent system concerning genetic resources and traditional knowledge.
Although the treaty already has a significant number of signatories since its approval, it will come into effect three months after 15 member countries deposit their instruments of ratification or accession with the WIPO secretariat. When a patent application is based on genetic resources or associated traditional knowledge, applicants will be required to disclose the country of origin or the associated traditional communities.
WIPO defined “based on” as the necessity for genetic resources and/or traditional knowledge to be essential to the claim contained in the invention and that the claim depends on the specific properties of the genetic resources and/or associated traditional knowledge. If the applicant does not have knowledge of the necessary information at the time of the patent application, they must make a declaration to that effect.
The National Institute of Industrial Property (INPI) will play a crucial role in implementing the treaty, establishing the necessary means for applicants to comply with the new obligations, likely through new resolutions and the creation of a database with information on genetic resources and traditional knowledge. This database should be constructed in collaboration with indigenous peoples and traditional communities, ensuring their voices are heard and respected.
Sanctions for non-compliance with the treaty were one of the most controversial points during the negotiations. The treaty stipulates that each country will establish adequate legal and administrative measures to deal with any violations, with the annulment of the granted patent only possible in cases of proven bad faith by the applicant.
Future Prospects and Fair Benefit-Sharing
The treaty will not have retroactive effects, meaning it will not affect patents already filed, but it emphasizes that existing national laws, such as Brazilian legislation on access to genetic resources and benefit-sharing, remain in effect. For example, Brazilian legislation requires the applicant of a patent containing Brazilian genetic resources to complete an electronic registration prior to the patent application.
There is a clear connection between the new treaty and other international agreements, such as the Patent Cooperation Treaty (PCT), the Nagoya Protocol, and the Convention on Biological Diversity. The main objective is to increase transparency and quality in the patent system, preventing the erroneous granting of industrial property rights and reinforcing obligations for access and benefit-sharing.
With the implementation of this treaty, a significant increase in benefit-sharing is expected for both the provider countries of genetic resources and the holders of associated traditional knowledge. The treaty represents progress in protecting the rights of indigenous peoples and promoting a fairer and more balanced intellectual property system.
The entry into force of the treaty is only the first step on a long path that includes ratification by member countries and the creation of internal mechanisms for disclosing the origin of resources. It is crucial that these developments avoid excessive bureaucracy that could delay the analysis and granting of patents, hindering the balance between the rights of indigenous peoples, the development of biotechnology, and patent protection.
Final Remarks
In conclusion, the new WIPO Treaty on Patents, Genetic Resources, and Traditional Knowledge has the potential to transform global biotechnology, promoting a fairer distribution of benefits and strengthening the rights of indigenous peoples and traditional communities.
Viviane Kunisawa
Viviane Kunisawa is a partner with Daniel Law. She is highly proficient in the field of Regulatory Law for Life Sciences, including Agribusiness, and in matters related to access to […see more]
