After over two decades of negotiations, the World Intellectual Property Organisation (WIPO) Member States adopted a historic new Treaty related to Intellectual Property, Genetic Resources and Associated Traditional Knowledge today.
Following its initiation by Colombia in 1999, negotiations for the Treaty commenced at WIPO Intergovernmental Committee (WIPO-IGC) in 2001. As the Treaty does not cover all the topics initially introduced under the WIPO-IGC, it sets a foundation for further negotiations on the other topics including Traditional Knowledge and Traditional Cultural Expressions.
The Treaty will enter into force three months after fifteen (15) eligible parties have deposited their instruments of ratification or accession (Article 17). Eligible parties include Member States of WIPO, the European Union and approved intergovernmental organisations (Article 12).
The groundbreaking Treaty is the first WIPO instrument to cover the intersections of intellectual property, genetic resources and traditional knowledge and centre the interests of indigenous peoples and local communities.
According to the Treaty, genetic resources are genetic materials of actual or potential value, in line with the Convention on Biological Diversity (Article 2).
The Preamble to the Treaty acknowledges importance of the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP). It further provides for the establishment of an Assembly that includes participation of representatives from Indigenous Peoples and Local Communities as accredited observers (Article 10). The Assembly is tasked to invite Contracting Parties to consider financial arrangements for the participation of Indigenous Peoples and Local Communities.
Notably, as outlined in its objective, the Treaty is dedicated to fostering transparency of patent systems in relation to genetic resources and traditional knowledge associated with genetic resources. It seeks to improve the quality of patents by limiting the grant of patents for inventions that fail to meet the conditions of novelty and inventive step.
Objectives
The objective of the Treaty are to: enhance the efficacy, transparency and quality of the patent system with regard to genetic resources and traditional knowledge associated with genetic resources, and prevent patents from being granted erroneously for inventions that are not novel or inventive with regard to genetic resources and traditional knowledge associated with genetic resources.
Article 1.
Disclosure Requirement
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 resources, 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 applicable, 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.
3.4 Contracting Parties shall provide guidance to patent applicants on how to meet the disclosure requirement as well as an opportunity for patent applicants to rectify a failure to include the minimum information referred to in Articles 3.1 and 3.2 or correct any disclosures that are erroneous or incorrect.
3.5 Contracting Parties shall not place an obligation on Offices to verify the authenticity of the disclosure.Article 3
3.6 Each Contracting Party shall make the information disclosed available in accordance with patent procedures, without prejudice to the protection of confidential information.
However, the disclosure requirements are not absolute. The disclosure requirements are curtailed by sanctions and remedies. The Treaty provides for Contracting Parties to introduce appropriate, effective and proportionate legal, administrative, and/or policy measures to address the failure of full disclosure origin or source of genetic resources (Article 5). It allows rectification of the failure to disclose information both pre and post patent grant, except where there has been a fraudulent conduct or intent.
Beyond awaiting the entry into force of the Treaty, challenges ahead include its domestication. Like the flexibility in the Farmers Rights provisions of the International Treaty on Plant Genetic Resources for Food and Agriculture, the Treaty provides for Member States to determine the appropriate method for its implementation and encourages them to do so in a way that is mutually supportive of other relevant international agreements (Articles 7 and 9).