The Tension Between the Patent System and the Protection of Traditional Knowledge in Ecuador
Ecuador’s National Intellectual Property Service (SENADI) announced in July of this year that it has registered the first Certificate of Free, Prior and Informed Consent for research purposes, following the completion of the consent process carried out with the Kichwa Bajo Tálag Community in the Napo province of Ecuador.
What does this registration mean and what are its implications for the patent system?
The free, prior and informed consent (FPIC) of indigenous communities is a requirement established by Ecuadorian legislation for accessing research intended to be conducted based on or through the use of traditional knowledge and associated genetic resources. Once the process is completed, SENADI, as the competent authority, issues a certificate containing said authorization.[1]
The rationale for requiring free, prior and informed consent is the protection of indigenous communities’ rights over their traditional knowledge and a country’s genetic resources, as a response to several illegal actions carried out in the past by researchers. One negative experience worth mentioning is the case of the multicolored frog (Epipedobates tricolor), in which epibatidine—an analgesic compound derived from its skin—was patented using traditional medical knowledge from indigenous communities without fair recognition of their contributions.[2]
This FPIC requirement is not only grounded in Ecuador’s domestic intellectual property legislation, as detailed below, but also in international instruments such as ILO Convention 169 on Indigenous and Tribal Peoples (1989), which requires governments to implement prior consultation, and the Nagoya Protocol (2014), which regulates access to genetic resources and the fair and equitable sharing of benefits derived from their use for rightful holders.
From the Andean Community perspective, Decision 486 protects the traditional knowledge of indigenous, Afro-American and local peoples by requiring that every patent respect ancestral heritage, conditioning its approval on the submission of access contracts and legitimate authorizations from said communities. Additionally, Andean Community Decision 391 regulates access to genetic resources.
The Constitution of Ecuador (2008), the supreme law and foundation of the legal framework, recognizes in its provisions the right to free, prior and informed consultation for communities, peoples and indigenous nationalities, as well as the prohibition of undue appropriation. Article 322 expressly states: “Intellectual property is recognized in accordance with the conditions established by law. All forms of appropriation of collective knowledge in the fields of science, technology and ancestral wisdom are prohibited. Appropriation of genetic resources containing biological diversity and agro-biodiversity is also prohibited.”
In the specialized intellectual property legislation contained in the Organic Code of the Social Economy of Knowledge, Creativity and Innovation (COESCCI), we find: the mandatory participation of the State in the ownership of rights derived from the use of products or elements of the country’s biodiversity (Articles 93 and 94); the recognition of a benefit in favor of legitimate holders of ancestral knowledge belonging to indigenous communities and other minority groups such as the Afro-Ecuadorian or Montubio peoples (Article 513); and the necessary delimitation of what should be considered ancestral knowledge (Article 511).
Article 511 of this law defines ancestral knowledge as follows: “All collective knowledge, such as practices, methods, experiences, capabilities, signs and symbols belonging to peoples, nationalities and communities that form part of their cultural heritage and have been developed, updated and transmitted from generation to generation. Traditional knowledge includes, among others, ancestral and local wisdom, the intangible component associated with genetic resources, and traditional cultural expressions.”
Linking Ancestral Knowledge to Patents
In the chapter on patents of invention under Ecuadorian law, traditional knowledge is expressly excluded as patentable subject matter—meaning that the knowledge of an indigenous people alone cannot be patented. Notwithstanding the foregoing, Article 282 specifies that when the subject matter of a patent application involves the use of genetic resources and associated traditional knowledge, there is an obligation to disclose the origin and obtain the Certificate of Free, Prior and Informed Consent (FPIC).
The process for obtaining the aforementioned FPIC certificate is found in Article 530 of the COESCCI, which explains it as follows: “Free, prior and informed consent.— Legitimate holders, in accordance with their customary norms and legally constituted institutions of legitimate representation, through participatory mechanisms, have the exclusive authority to authorize a third party, freely, expressly and in an informed manner, to access, use or exploit their traditional knowledge through their free, prior and informed consent. Prior to obtaining consent, the interested party must provide sufficient information regarding the purposes, risks, implications, potential uses and future applications of the knowledge, establishing conditions that allow for a fair and equitable distribution of the benefits obtained from said knowledge.”
While the regulatory framework appears robust at both international and domestic levels, there are certain practical limitations and difficulties worth analyzing:
First, there is a significant operational difficulty in carrying out the process, as there are not only limitations in determining whether traditional knowledge qualifies as such, but also because access to and negotiation with communities is hindered by a lack of clear instruments and support from authorities.
Second, the lack of understanding of the patent system’s raison d’être—as a recognition of research, work and investment—constitutes an obstacle to obtaining new inventions and research in Ecuador, thereby discouraging foreign investment.
Finally, the illegalities committed in the past within the international patent system through the undue exploitation of traditional knowledge and national genetic resources set a precedent that, as a consequence, generates fear in communities and biodiverse territories that have safeguarded this knowledge for centuries.
However, it is important to consider that both these procedures and their practical application will improve over time through the use of new technologies such as artificial intelligence, gradually overcoming the legitimate concerns of ancestral people and providing them with the opportunity to obtain fair benefits from their knowledge.
[1] https://www.derechosintelectuales.gob.ec/senadi-registra-el-primer-consentimiento-libre-previo-e-informado-para-una-investigacion-de-la-espoch/
[2]https://www.eltelegrafo.com.ec/noticias/sociedad/6/ecuador-un-territorio-fragil-para-la-biopirateria-hace-40-anos-infografia-y-documentosHe
Author: Alysa Arcos Ziemer – Senior Associate
Firm: Perez Bustamante & Ponce PBP
Country: Ecuador
