NEWS AND PUBLICATIONS

The Biotechnology Revolution with the New WIPO Treaty

by | Jun 4, 2024 | Client Alert, Life Sciences

The new WIPO treaty requires the disclosure of origins in patents and promotes the sharing of benefits related to the use of genetic resources and traditional knowledge.

Global biotechnology is about to undergo a significant transformation with the recent approval of the World Intellectual Property Organization (WIPO) Treaty on Patents, Genetic Resources, and Associated Traditional Knowledge. After a quarter-century of negotiations, representatives from various countries gathered at a diplomatic conference from May 13 to 24, 2024, resulting in the approval of this historic treaty. The main change brought by this treaty is the mandatory disclosure of the origin of genetic resources and associated traditional knowledge in patent applications.

“The entry into force 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. The Brazilian government’s position prevailed during the negotiations,” says Viviane Kunisawa, a partner at Daniel.

The first article of the treaty outlines its objectives, focusing on the effectiveness, 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 force 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 traditional communities.

“WIPO defined ‘based on’ as the necessity for genetic resources and/or traditional knowledge to be essential to the claimed invention and that their specific properties depend on the associated genetic resources and/or traditional knowledge. If the applicant does not have the necessary information at the time of the patent application, they must make a declaration to that effect,” explains Kunisawa.

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 built in conjunction with indigenous peoples and traditional communities.

“The 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 appropriate legal and administrative measures to deal with any infringements, with patent nullification only being possible in cases of proven bad faith by the applicant,” highlights Viviane Kunisawa.

The treaty will not have retroactive effects, not affecting already filed patents, but it emphasizes that existing national laws, such as the Brazilian legislation on access to genetic heritage and benefit sharing, remain in force. Brazilian legislation, for example, requires the applicant of a patent whose invention was developed from the use of Brazilian genetic resources to perform an electronic registration before the patent application. It is important to note that national regulations do not provide for the nullification of an already granted patent for non-compliance with this obligation.

There is a clear connection between the new treaty and other international agreements, especially the Nagoya Protocol and the Convention on Biological Diversity.

With the implementation of this treaty, greater transparency and traceability are expected, leading to a significant increase in benefit-sharing for both the countries providing genetic resources and the holders of associated traditional knowledge.

The entry into force of the treaty is just 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 this construction avoids excessive bureaucracy that could delay the examination and granting of patents, thus harming the balance between the rights of indigenous peoples, the development of biotechnology, and patent protection.

In conclusion, the new WIPO treaty on Patents, Genetic Resources, and Associated Traditional Knowledge has the potential to transform global biotechnology, promoting benefit-sharing and strengthening the rights of indigenous peoples and traditional communities.

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