Mexico: Genetic resources and traditional knowledge pose IP challenge
Mexico is a nation made up of diverse cultures supported by its indigenous people. The population that is considered indigenous represents 21.5% of the total population of the country.
Article 2 of the Political Constitution of the United Mexican States establishes, among other things, the right to preserve and enrich the indigenous people's languages, knowledge and all those elements that constitute their indigenous identity. Likewise, Article 4 recognises legal pluralism.
In the international arena, Article 27 of the Universal Declaration of Human Rights establishes that every person has the right to the protection of the moral and material interests that correspond to him by reason of the scientific, literary or artistic productions of which he is the author. Likewise, he has the right to gain from the protection of the moral and material benefits to which he is entitled due to his authorship. Notwithstanding the foregoing, indigenous peoples and communities are left unprotected, because intellectual property protection systems often leave them out.
There is a specific concern on the part of some communities and organisations with regard to access to genetic resources and traditional knowledge.
Mexico and several countries that have high biological diversity are visited by companies or people, who in their research and development process, enter the territory of a given community and manage to extract a biological resource (genetic organisms, plants or animals), supported in many cases by traditional knowledge contributed by the members of the original community. These biological resources, could be the basis for the development of any drug susceptible to protection through patent. However, after being obtained, the benefits derived from its exploitation are not shared with the communities and indigenous people where the natural resources are located or traditional knowledge related to them.
It is estimated that the market value of some pharmaceutical products derived from the traditional knowledge of indigenous people amounts to billions of dollars.
Mexico, as one of the most biologically rich countries in the world, is vulnerable in this regard.
As a result of the foregoing, the international community has recognised the right of indigenous peoples and communities to prior, free and informed consultation in the following cases:
1) each time that legislative or administrative measures are contemplated, which may affect indigenous people or communities (prior consultation with indigenous people covers not only the use of natural resources, but any measure that may directly affect these communities);
2) before undertaking or authorising any prospecting or exploitation programme of existing resources on their lands.
In the field of intellectual property, the right to prior consultation is particularly important because it affects areas such as trade marks, copyright, plant varieties, geographical indications and, particularly, patents.
The right to prior, free and informed consultation is foreseen in Convention No.169 "On Indigenous and Tribal Peoples in Independent Countries" of the Labor Organization (ILO), and constitutes the cornerstone on which the provisions are based.
Article 15 of this agreement establishes an obligation to provide special protection for natural resources that exist in the lands of people, which implies participation from indigenous people in the use, administration and conservation of these natural resources.
Around the world, efforts have been made to incorporate the right to prior consultation into intellectual property legislation.
In accordance with UNESCO's recommendations, intellectual property fulfils a social function in accordance with international human rights obligations and principles. One way to fulfil this purpose is to establish mechanisms for human rights-based examination and the possibility of challenging decisions taken under procedures for granting patents, utility models or copyrights.
There is broad international consensus that human rights are above rights associated with free trade. When intellectual property is considered a human right, the implementation of preventative measures to guarantee the right to prior, free and informed consultation with indigenous communities and the fair distribution of profits derived from their exploitation is of special importance. It is based on the recognition of creativity and human dignity.
There are various collaboration mechanisms through different international organisations to coordinate and harmonise the guidelines of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for the protection of human rights and for cases of abuse resulting from the lack of fairness and transparency exhibited by some companies or individuals, by not sharing the benefits of exploitation with local communities where natural resources are based or where traditional knowledge related to them exists.
There are several international agreements on the environment and biodiversity that incorporate the right to prior and informed consultation, such as the Convention on Biological Diversity of the United Nations signed on December 29 1993, The Rio Declaration on Environment and Development signed in 1992, the Cartagena Protocol on Biosafety of September 11 2003, and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization, dated October 29 2010, in Nagoya Japan.
Mexico is part of these international agreements and also recognises in its Constitution the right to prior, free and informed consultation. However, the federal government lacks a protocol for consultation with indigenous people and communities to enforce this principle in legal practice. This is coupled with the absence of regulations and institutions that are capable of responding to the fulfilment of this right.
While it is true that these international agreements focus on biodiversity, they interconnect with aspects of intellectual property. This is reflected in the legal provisions of various countries in the world, mainly related to the establishment of disclosure requirements for an invention in the field of patents (PDR), as a tool capable of providing legal certainty to indigenous people and communities when it comes to patent applicants.
Historically, there have been political tensions between patent law and legislation related to biodiversity, which have often been the subject of controversy.
To date, relevant intergovernmental discussions on biodiversity and intellectual property continue to be held within the Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore of the World Intellectual Property Organization (WIPO).
In 2002, the Conference of the Parties in the framework of the Convention on Biological Diversity (CBD) requested the World Intellectual Property Organization (WIPO) prepare a technical study on issues related to patent disclosure requirements (PDR) related to genetic resources and traditional knowledge. The resulting WIPO technical study was made available to the Conference of the Parties of the CBD in 2004.
Regarding inventions, it is believed that the requirements for obtaining existing patents should be further expanded through the so-called specific disclosure requirements for genetic resources and traditional knowledge.
Modern scientific research and the exploitation of genetic resources and traditional knowledge can offer great benefits to humanity. A new patent disclosure requirement related to genetic resources and traditional knowledge could help achieve that goal. Several countries have already implemented this. For example, Indian patent law was amended to include provisions on mandatory disclosure of the source and geographical origin of biological material and associated traditional knowledge used in the invention in patent applications.
The member states of WIPO have been discussing the possibility of introducing an internationally harmonised patent disclosure requirement related to genetic resources and traditional knowledge. Currently more than 30 countries have implemented these requirements through national or regional laws. Some others have expressed interest in doing so, while others have expressed their intention not to implement these requirements.
Several countries now require patent applicants to disclose, among other things:
the origin and/or source of genetic resources and/or traditional knowledge;
evidence of prior informed consent for its use by the provider country (and, in some cases, by indigenous peoples and local communities, in accordance with national laws);
evidence of having established a contractual agreement (on mutually agreed terms) for the fair and equitable distribution of the benefit derived from such use, if required by the national legislation of the supplier country.
Mexico has not yet incorporated into the Intellectual Property Law the requirement of disclosure. However, it has played an active role in the different international forums concerning this topic. In November 2016, Mexico hosted the Technical Workshop on Monitoring and Compliance under the Nagoya Protocol, which is an international agreement that concerns sharing the benefits derived from the use of genetic resources in a fair manner, taking into account related intellectual property aspects, specifically, the so-called patent disclosure requirements.
The purpose of the new patent disclosure requirements is to promote innovation and scientific progress through the patent system, on the one hand, and the objectives of the United Nations Convention on Biological Diversity, on the other.
In principle, the patent disclosure requirements could be used as a tool to help monitor the use of genetic resources and traditional knowledge, and therefore also help promote at least in some cases, compliance with biodiversity obligations.
One of the challenges faced by Mexico and various countries in the world is harmonising the laws of biodiversity and intellectual property laws, particularly the patent system.
Some opponents of the so-called patent disclosure requirements have shown their concern stating that they may create uncertainty in the patent system for the following reasons:
1) The patent system is not made to meet goals or objectives, such as biodiversity objectives, because it could compromise its integrity.
2) It would be burdensome and expensive for patent applicants and patent offices to implement new patent disclosure requirements (PDR).
3) Patent offices would not be equipped to judge whether information on the disclosure of the origin or source of a genetic resource or traditional knowledge was correct or accurate, and whether national biodiversity requirements had been met.
4) If an examiner had to perform a substantive examination of a patent disclosure requirement, the validity of the patent would no longer be a novelty function, inventive step and industrial application.
5) The need to obtain prior informed consent and mutually agreed terms confronts patent applicants with risk and greater legal uncertainty.
6) Patent disclosure requirements could reduce incentives to innovation generated by the patent system.
Notwithstanding the foregoing, several countries have incorporated into their legislation new requirements for obtaining patents related to genetic resources and traditional knowledge through the so-called patent disclosure requirements. This is because many of them are countries rich in biological diversity and maintain that the essence of a patent system is transparency and disclosure. In this way, the new patent disclosure requirements could represent a measure of transparency.
Negotiations are continuing within the Intergovernmental Committee on Intellectual Property, Genetic Resources, Traditional Knowledge and Folklore of the World Intellectual Property Organization (WIPO).
Although there is interest in the creation of an international treaty regarding this subject, WIPO has not yet announced a date for any diplomatic conference leading to the adoption of a treaty. The negotiations continue.
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