- Biological resources from plants and animals have long been used by Indigenous communities for medicinal and therapeutic purposes.
- Western science is quickly catching on, but in the process of developing drugs and other products from these resources, companies are locking that Indigenous-derived knowledge behind patent applications.
- A new study from Brazil makes the case that this system is inherently unfair to Indigenous communities, because it disregards their knowledge system as inferior to Western science, but then allows the appropriation of that very knowledge.
- Brazil, home to the biological resources on which many modern medicines are based, only last year set up a system to regulate access to this knowledge and ensure traditional communities benefit from sales of the products developed from it.
The Amazonian giant leaf frog, or kambô (Phyllomedusa bicolor) has bulging eyes and bright green skin. It’s perhaps best known for its skin secretion, a mucous substance with medicinal properties that several Amazonian Indigenous groups have used for centuries — and which is also attracting the attention of foreign biopharmaceutical companies.
A recent study by Marcos Vinício Chein Feres, a law professor at the Federal University of Juiz de Fora (UFJF) in Brazil’s Minas Gerais state, highlights the case of the kambô frog to illustrate a complex issue: the appropriation by companies in the Global North, through the patent rights system, of the associated traditional knowledge (ATK) that Indigenous peoples in the Global South have acquired over generations.
As a starting point, Feres said, it was important to understand “not only the chemical properties of the frog’s secretion, but also the traditional uses practiced by the Indigenous people.”
After reviewing the scientific literature on P. bicolor, Feres concluded that at least 15 Indigenous groups use the frog’s secretion for its analgesic, antibiotic and wound-healing properties, according to the study.
He then looked through patent records, and found 11 patents that had been granted specifically in connection with P. bicolor — all of them in countries of the Global North, including the U.S., Canada, Japan, France and Russia.
According to Feres, this shows how the process of appropriation of traditional knowledge associated with genetic resources of Brazilian biodiversity takes place: “This type of appropriation strengthens the inequality between developing countries, which are rich in biodiversity, and developed countries, which are rich in technology,” he said.
The Patent Cooperation Treaty of 1970 governs the applications of patents worldwide. In 2006, 41.5% of international biotechnology patent applications under the treaty originated in the U.S., 27.4% in the European Union, 11.9% in Japan, and only 4% in the BRIICS countries (Brazil, Russia, India, Indonesia, China and South Africa).
It was in Brazil, host of the U.N.’s 1992 Earth Summit, where the concept of sharing the benefits of biological resources was first enshrined, in the Convention on Biological Diversity (CBD). The convention established that each country would create its own rules to define the uses of the biodiversity under its jurisdiction.
To extrapolate this practice to the international level, the Nagoya Protocol was adopted in 2010, which aims to regulate the “access to genetic resources and the fair and equitable sharing of benefits arising from their utilization.” Brazil ratified the protocol in 2021.
Registering and benefit sharing
Under Brazilian law, any party that wants to make use of research and development related to any species of Brazilian fauna or flora must register in the National System for Management of Genetic Heritage and Associated Traditional Knowledge, known as SisGen. The process is self-declaratory.
When it comes to benefit sharing, only the manufacturers of the finished products must contribute. In general, 1% of the net revenue from the sale of products derived from these biological resources has to be deposited into the government’s National Benefit Sharing Fund. The fund then directs resources to Indigenous communities and traditional peoples. In some cases the benefits to these communities are in non-monetary form, such as the creation and development of environmental projects.
When there is a clear case that associated traditional knowledge was instrumental in identifying the key biological resource, authorization for the use of this knowledge and negotiations about the payment must come directly from the peoples and communities that hold that traditional knowledge.
But the Brazilian system as it stands currently presents an obstacle to users from abroad: SisGen is currently only available in Portuguese, and the rules state that foreign companies must undergo an adaptation period after the finalization of the translation of the platform into English.
‘What is the fair value?’
For lawyer Luiz Ricardo Marinello, coordinator of the Brazilian Intellectual Property Association’s (ABPI) Geographical Indications Studies Commission, the international treaties were created to level the playing field between countries in the Global North and the Global South.
“It is a way to bring these countries together and contribute to the eradication of poverty and the exploitation of natural resources, as well as the payment for benefit sharing or technology transfer,” Marinello said.
There’s a lot at stake, he added. “The developed countries don’t want to pay a high bill. What is the fair value for the American pharmaceutical industry to access an Amazonian asset? The discussion is more political than legal,” he said.
Perhaps the best-known case of an Amazonian biological resource finding its way into Western medicine is the drug captopril. One of the most widely prescribed medications for high blood pressure, it’s derived from a peptide found in the venom of the jararaca pit viper (Bothrops jararaca). The first research on the substance was published in 1965, and it’s estimated that worldwide sales of the drug to date exceed $8 billion.
Henry Novion, an analyst at the Ministry of Environment who contributed to the development of SisGen and drafting the rules around biodiversity resource sharing, said Brazil’s focus isn’t on patent registration.
“If a company is supposed to be registered in the system but isn’t, it’s an infraction. But we decided to focus on companies that will license [the end product] for several others, because in this case we will have dozens of products being sold by genetic patrimony,” Novion said.
He added that in the case of the kambô frog, a much-studied species, there shouldn’t be an issue with companies filing patents for derivative products.
“At the end of the day, how much of that patent universe is transformed into a product that generates value? If a patent does not generate any kind of commercial transaction, it is just an expectation of a right,” he said.
It becomes a problem, however, if the patent application appropriates associated traditional knowledge, Novion said.
“That hurts the rights of traditional peoples over that knowledge,” he said. “It goes beyond the property of those people, it is a heritage of all the Brazilian people. It is an obligation of the state to protect that knowledge.”
Knowledge and training
Regardless of when value is added to the research, the way the patent market works is detrimental to Indigenous people because of the way it has been developed, said Feres, the law professor.
“Traditional practices are disregarded by the conventional scientific paradigm. The result of this appropriation process is a monopoly authorized by law, which is the temporary exclusivity over a product, and that will end up being offered [for sale] to the countries from which this knowledge was extracted,” Feres said.
In 2021, the Escolhas Institute, a Brazilian nonprofit that advocates for sustainable development of natural resources, published a report on this very issue. Subtitled “Solutions to drive sustainable use of genetic resources and traditional knowledge in Brazil,” the report identified the current legislation as presenting a series of obstacles to unlocking this “bioeconomy.”
Stella Pieve, project coordinator at the Escolhas Institute, said the main obstacles are the lack of a systematized database of associated traditional knowledge that would identify knowledge holders and provide for the proper sharing of benefits; lack of training of users to meet and comply with current legislation, which can hinder the use of biodiversity for research and development; and lack of support for the implementation of the law by traditional communities, which makes it difficult to negotiate benefit-sharing agreements.
In its report, the Escolhas Institute proposed a training system for best practices for research that builds on genetic heritage and associated traditional knowledge.
“The international exploitation and commercialization of biodiversity resources in violation of the rules of a country is called biopiracy,” Pieve said. “Knowing the country’s legislation is essential so that researchers or companies don’t exercise irregular access to these resources and suffer the penalties.”
Feres, M. V. (2022). Biodiversity, traditional knowledge and patent rights: The case study of Phyllomedusa bicolor. Revista Direito GV, 18(1). doi:10.1590/2317-6172202205