Brazil has arguably the earth’s richest source of biological diversity, and it is fighting to get help at the international level to protect those natural resources from what it says is unfair exploitation through patents by companies and others in and outside Brazil.

While industry argues that the Brazilian law regulating the use of genetic resources is sufficient to safeguard against misuse, the government argues that people – mainly foreigners – are still disrespecting the law and there is a need for an international regime regulating the use of genetic material.

Some sources argue that because there is no international regulation on this, companies may be able to file for patents in third countries for inventions based on genetic resources. For example, they may avoid the Andean Community rules on disclosure and patent it in the United States instead, sources said.

The UN Convention on Biological Diversity (CBD) states that a nation owns and controls its genetic resources and that outsiders cannot just come and “take it” without some kind of agreement. Issues such as prior informed consent of the provider of the genetic resources as well as equitable sharing of these are elaborated in the Bonn Guidelines, which guide the CBD implementation process. Some regions and countries have implemented the CBD, and the Andean Community, Brazil, Costa Rica and India are among them, according to sources.

Brazil has national legislation but it is not preventing “biopiracy” from occurring, the government said. “The problem is that many, mainly foreigners, do not ask for the authorisation and disrespect the legislation, which makes the international regime essential,” Adriana Tescari of the division of environment in the Ministry of External Relations told Intellectual Property Watch.

The question is not only being pondered in Brazil, but in international organizations such as the World Intellectual Property Organization, the World Trade Organization and the United Nations Conference on Trade and Development (UNCTAD). In addition, the latest biannual meeting of parties to the CBD, held in March in Curitiba, Brazil, set a deadline of 2010 to possibly pursue negotiations on an international regime on genetic resources (IPW, Genetic Resources, 4 April 2006).

A recent paper from UNCTAD, penned by Sarnoff and Carlos Correa, argues that “there is a need for new international treaty provisions that would mandate disclosure of origin requirements in applications for intellectual property. The most appropriate treaty regime for adopting such requirements is the TRIPS [WTO Trade-Related Aspects of Intellectual Property Rights] agreement.”

Examples of ‘Biopiracy’ Growing

In international discussions of possible regulation of the use of genetic resources – such as using a plant from the Amazon to develop a medicine – countries such as the United States are calling for examples of misuse of genetic resources, implying that the problem may not be as big as countries such as Bolivia, Brazil, Cuba, Ecuador, India, Pakistan, Peru, Thailand and Venezuela have argued, according to a source.

But there are some reports of biopiracy in Brazil, according to sources such as Joshua Sarnoff, a law professor at American University (US). He cited muirapuama (touted for sexual performance) and quebra-pedra (for kidney stones) as examples.

Another case is described in the March 2006 report, “Out of Brazil: A Peanut Worth Billions (to the US),” published by the US-based Edmonds Institute.

At issue is a “disease-resistant peanut (or groundnut)” from Brazil, which is “the primary source of resistance to tomato spotted wilt virus in US peanut varieties,” which was detected in US peanuts in 1987. The gene is being used in new peanut varieties in the United States and is estimated to add at least $200 million annually to the US economy, the report says. But those who provided the germ plasm get little or nothing, it says.

The peanut was picked up by American academic Alan Beetle in 1952, the report says. “He deposited his collection of 94 seed samples, most of them grasses, with the US Department of Agriculture. Among the samples were four peanuts,” it states.

One kind, PI-203396, has been used in various peanut types and most of them have been developed by the universities of Georgia and Florida, “and plant breeder’s rights have been claimed over them under the US Plant Variety Protection Act,” the report says. It notes, however, that “no laws were transgressed,” and that it was a “pre-CBD biopiracy.”

Still another case involves the Ayahuasca (Banisteriopsis caapi) sacred vine from the Amazonian rainforest with long-standing religious associations. This was patented by the American scientist Loren Miller in 1986.

In March 1999, the Center for International Environmental Law (CIEL) filed a request for re-examination of this patent with the US Patent and Trademark Office (USPTO), according to CIEL. It did this on behalf of the Coordinating Body of Indigenous Organizations of the Amazon Basin (COICA) and the Coalition for Amazonian Peoples and Their Environment. COICA argued that the patent “purported to appropriate for a US citizen a plant that is sacred to many indigenous peoples of the Amazon, used by them in religious and healing ceremonies,” CIEL said.

In November 1999 the USPTO rejected the patent on the grounds that it was not distinctive or novel, CIEL said, adding that this decision was made “final” in April 2000. However, Miller continued to submit new “evidence,” said CIEL, and in 2001 the USPTO issued a certificate “allowing the patent to stand for the remaining two years of its term.” The patent expired on 17 June 2003 and cannot be renewed, CIEL said.

As for the economic value of genetic resources, it is too early to say as this would involve predicting how these resources would be used or which alternatives may evolve, according to Professor Frederick Abbott of Florida State University College of Law.

“Anecdotal references to a comparatively small number of ‘biopiracy’ cases are not a proper framework for evaluating the economic value of genetic resource stocks,” he said, but added that there is likely to be “material” value in them. “To the extent that developing countries are able to effectively exploit economic interests in genetic resources it is in the interests of the wider international community to support this,” Abbott said.

Brazil Publishes Pre-emptive List of Natural Products

There are also a number of trademark cases, for instance among Japanese people who have lived in Brazil and returned to Japan to trademark common Brazilian food names, one official said. But at least one source said these cases fall more under geographical indications as products deriving their names from a geographic place, than genetic resources.

On 22 May, dubbed World Biodiversity Day, the Brazilian government released a list with the scientific names of about 3,000 species of Brazilian flora, according to Agência Brasil. The list, with names such as cupuacu, kiwi, carambola (“starfruit”), pequí (“souari nut”), babosa (“aloe”), and catuaba, was the first such move by a country and was aimed at preventing foreign companies from registering the names popularly used in Brazil to refer to these plants, the news agency said.

The article cited a case of misappropriation of cupuacu, in which a Japanese firm won the right to commercialise the cupuacu name in Japan, Europe and the United States, leading to Brazilian cupuacu products being denied entry into those markets. Brazil managed to nullify the patent through an expensive court case, the article said.

The new list will be continuously updated, and will be widely circulated, including through diplomatic channels to foreign patent offices and international organisations such as WIPO.

Foreigners Disrespecting Brazilian Law?

Brazil implemented disclosure of origin requirements into its national law (Provisional Act 2186-16) in 2001. As part of this it set up the Genetic Heritage Management Council under the Ministry of Environment as “a regulatory and deliberate body, composed of representatives of federal government entities responsible for the various actions covered by this Provisional Act,” the law states.

The law covers genetic resources as well as associated traditional knowledge, but has been criticised for not containing enough information about the indigenous communities as the “rights holders,” one source said.

The law states that, “Access to genetic heritage existing in the country shall only take place with an authorization from the federal government and its use, commercialization and employment for any purpose shall be submitted to inspection, restrictions and sharing of benefits in the terms and conditions established in this provisional act and its complementary legislation.”

This means that nobody can make use of genetic material from Brazil without the permission of the state to use it, prior informed consent and a scheme for how the potential benefits will be shared.

The law also defines various terms related to genetic resources such as “bioprospecting,” which it terms, “an exploratory activity that aims to identify genetic heritage components and information on associated traditional knowledge, with potential for commercial use.” This could be a company looking for future material, which one source said.

“The management council has been giving authorisations every month,” Tescari, the environment ministry official, said. But there are others who do not obtain the proper authorisations.

Industry Stepping up Biodiversity Activity

The issue of genetic resources seems to be very important for the pharmaceutical industry at the moment as more representatives are attending conferences on the issue than was the case before, according to several sources. Some also have suggested that it seems to be more important to the US industry with new organisations such as the American BioIndustry Alliance making the biodiversity issue one of its main focuses during its first year in existence, sources say.

Graham Dutfield of Queen Mary University (UK) believes that this is more an area of opportunity for lobbyists, than sheer conviction.“I’m left to suspect that industry doesn’t really care that much [about disclosure of origin] and that lobbyists may be trying to seek work for themselves by scaremongering,” he said in an interview.

But major industry association such as the European Federation of Pharmaceutical Industries and Associations, the US-based Pharmaceutical Research and Manufacturers of America, and companies such as Novartis and Syngenta declined to comment.

Another sign that genetic resources is a hot industry issue at the moment is that the US-based Biotechnology Industry Organization (BIO) issued last year its “Guidelines for BIO Members Engaging in Bioprospecting.” It favours, as does the rest of the pharmaceutical industry, a contract-based approach and not that disclosure should be required in patent applications. But the guidelines “direct BIO members to take certain steps before they engage in bioprospecting, i.e., before samples of materials are collected.” BIO argues that the guidelines are “designed to correspond closely to the conditions and requirements of the Convention on Biological Diversity.”

There are also some examples of pharmaceutical companies that go “against the trend” and voluntarily adhere to disclosure requirements called for by developing countries. One example is the Danish biotechnology company Novozymes, a representative said.