On May 24, 2024, the WIPO member states approved a new treaty titled, "TREATY ON INTELLECTUAL PROPERTY, GENETIC RESOURCES AND ASSOCIATED TRADITIONAL KNOWLEDGE." The first new WIPO treaty in more than a decade, this approval marks the culmination of efforts that began with a proposal by Columbia in 1999 and continued through lengthy negotiations within WIPO since 2001. Negotiations had been difficult because while some states considered this treaty to be an important step toward protecting local genetic resources and traditional knowledge of indigenous people and communities, other parties considered the proposed requirements to be unduly burdensome on patent applicants and argued the Nagoya Protocol, the current definition of prior art, and existing requirements such as the duty of disclosure in the United States Patent Office already address these concerns. Ultimately, the language of the treaty as approved is a compromise that reflects these differing views.
The core requirements of the Treaty are set forth in Article 3, reproduced below:
3.1 Where the claimed invention in a patent application is based on genetic resources, each Contracting Party shall require applicants to disclose:
(a) the country of origin of the genetic resources2, or,
(b) in cases where the information in Article 3.1(a) is not known to the applicant, or where Article 3.1(a) does not apply, the source of the genetic resources.
3.2 Where the claimed invention in a patent application is based on traditional knowledge associated with genetic resources, each Contracting Party shall require applicants to disclose:
(a) the Indigenous Peoples or local community, as applicable3, who provided the traditional knowledge associated with genetic resources, or,
(b) in cases where the information in Article 3.2(a) is not known to the applicant, or where Article 3.2(a) does not apply, the source of the traditional knowledge associated with genetic resources.
3.3 In cases where none of the information in Articles 3.1 and/or 3.2 is known to the applicant, each Contracting Party shall require the applicant to make a declaration to that effect, affirming that the content of the declaration is true and correct to the best knowledge of the applicant.
Although the Treaty imposes these new disclosure requirements on patent applicants, the Treaty also provides that, except in cases where fraudulent intent is shown, "no Contracting Party shall revoke, invalidate, or render unenforceable the conferred patent rights solely on the basis of an applicant's failure to disclose the information specified in Article 3 of this Treaty." Further, while a State may impose "appropriate, effective and proportionate legal, administrative, and/or policy measures to address a failure to provide the information required in Article 3," a State must (unless fraudulent intent is shown) give the applicant an opportunity to rectify a failure to disclose prior to imposing any penalties or remedies. Accordingly, accidental failures to disclose will be curable and will in no event cause a loss of rights.
The Treaty is not retroactive to patent applications filed prior to its entry into force (although it is noteworthy that the Treaty does not define whether "filed" refers to priority date or date of filing in the particular jurisdiction of concern).
The Treaty will enter into force three months after 15 eligible contracting parties have deposited their instruments of ratification or accession. The full text of the treaty as approved is available here: https://www.wipo.int/edocs/mdocs/tk/en/gratk_dc/gratk_dc_7.pdf.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.