Biodiversity, Biotechnology and Patents in Brazil

 

David Hathaway[1], September 1996

Copyright © David Hathaway 2000. Reproduced here with the author’s permission

 

I. The importance of Biodiversity

 

What do We Know About Life?

            Life has been evolving for millions of years on our planet. Human races, which appeared quite recently in the course of evolution of countless forms of life and ecosystems, like any other species depend entirely on their physical, energetic and biological surroundings.

            We perceive, order and classify the components of the environment in line with our own particular needs. Just as our environment takes on a diversity of forms and expressions, humanity itself has also diversified into differentiated cultures and classes, each with its own peculiar manner of perceiving and relating to the rest of the world.

            Our knowledge of nature has in fact progressed along the roads chosen by those who sustain scientific research (whatever form that activity may take in different cultures, classes or historical periods), and therefore what we actually know about nature depends on what we wish to know. Interpretations of nature arise out of particular relationships man has established with it. Fortunately, considering so many poorly-informed interpretations and veritable disasters caused by some of these relations with the environment, humanity has also diversified (not unlike the world it is part of) and does not think with a single mind.

 

Interpreting and Using Biodiversity

            Biodiversity is a relatively new angle in interpretations of nature. It refers to a virtue of groups of living things in ecosystems: their tendency to diversify into many species as well as into many varieties, races, breeds, etc. of a single species. This biological diversification and diversity is absolutely essential for the defense, evolution and sustainability of all forms of life which live together in communities and feed off of each other in ecosystems around the world.

            Biodiversity, as vital as it is for ecosystems, is of course nothing new. What is new is modern society's growing awareness of its importance. This awareness, however, did not fall from the sky, nor was it born spontaneously out of scientific research. Science has long been aware of the interdependence amongst different species and of the importance to them of diversification. But only recently have environmentalists, official agencies and even major transnational corporations begun promoting campaigns and even international conventions to defend it.

            Why so much talk about biodiversity all of a sudden? Two recent developments have been important. In the first place, not only scientists and ecologists, but economists too, have realized that nature is not an inexhaustible resource at man's service, and that uncontrolled consumption of resources provided by our natural endowment is actually a kind of self‑consumption. Special efforts should therefore be undertaken to protect major areas at risk. In this sense, there has been greater concern with the preservation of animals and plants as such, as biological resources.

            Secondly, industry has perceived the tremendous potential economic value of biological diversity itself, as it exists in abundance amongst the millions of species still available in untouched ecosystems, like most of the Amazon and what remains of the Atlantic Forest. New biotechnologies, and in particular genetic engineering, have revealed vast realms for world‑wide industrial applications of the endless variety of microorganisms, plants and animals. This approach looks less to the organisms themselves than to their genes: the information, instructions or genetic programming coded into chromosomes of the plants, animals and microorganisms that populate the ecosystems to be preserved.

            Access to the genetic information contained in the forests, the floodplains, the savannas and even semi‑arid regions, however, depends on the survival of these ecosystems. Almost overnight, forests have come to be worth more standing than cut down, and not only for local communities but for some of the largest industrial conglomerates in the world as well!

            For example, what is at stake in recent disputes over the Amazon, in simplified terms, is a conflict between many millions of dollars per year in exports of hardwood, minerals and electric energy (in the form of aluminum) by traditional industries which have been devastating ecosystems for decades, versus untold billions of dollars immobilized in the infinite, unknown genetic combinations present in the forest. Therefore, the Amazon Forest—preserved intact—is now being valued by certain corporate planners as a fixed asset to be conserved and appropriated by 21st‑Century high‑tech industries.

            Thus, the potential economic value of biodiversity as a genetic resource for the burgeoning global biochemical industry has brought new, and mighty, allies for traditional conservationists and idealistic ecologists in their no‑longer inglorious struggle to defend threatened species and fight the devastation of natural resources. Yet although there may be convergence in their political action for conservation, there is still a diversity of interests amongst these allies.

            For some, biodiversity should be preserved because of its own intrinsic value, because it is a mainstay for life on the planet and an endowment and potential resource for all of humanity. For others, however, the main thing is to be able to prospect, appropriate and exploit these resources—extracted in only small samples—for their own corporate strategies, while leaving the forest, the savanna or the semi‑arid brushlands standing and the ecosystems intact. Despite the provincial outcry of groups which still defend more conventional (and environmentally destructive) styles of development for the Amazon's resources, the most polemical issue today should no longer be whether to conserve (although little has actually been done), but rather for whom these resources should be conserved.

            These varying interpretations of biodiversity's usefulness underlie current international debates on the subject, particularly in UNCED's Agenda 21 (an environmental action plan for governments) and in the Convention on Biological Diversity, negotiated by governments under the aegis of the United Nations Environmental Program (UNEP). Conservation is no longer an exclusive concern of conservationists.

 

The State of Biodiversity: A Diversity of Concerns

            While public opinion is becoming more aware of biodiversity's environmental importance, few have perceived the economic interests at stake. It was transnational biochemical conglomerates like Ciba Geigy, Shell, Bayer, Rhone Poulenc (Rhodia in Brazil), Monsanto, Du Pont, ICI and a few others that pushed the governments of rich countries to put biodiversity on the agenda of environmental concerns and at international negotiations. In fact today's debates on the issue have become part of the official North‑South conflict and refer more to the transfer of biotechnologies and restrictions on access to genetic resources than to the nitty‑gritty of protecting natural ecosystems and biodiversity.

            Yet humanity's fundamental causes for concern over the state of biodiversity remain. While solutions still appear to depend on the resolution of disputes over who will reap the economic benefits and who will be able to use proprietary biotechnologies, our ecosystems, species and biodiversity are still at risk and the situation is heading downhill.

            Since the human species' overriding relationship with its environment has to do with the resources provided by nature, our culture now refers to life and to biodiversity, respectively, in terms of the two forms in which they are appropriated:

·    "biological resources"—plants and animals as such, gathered, harvested, raised or hunted for food, clothing, medicine, lumber, industrial inputs, etc., and

·    "genetic resources"—the information contained in the genes of living beings which can be manipulated through plant and animal breeding or, more directly, for certain industrial applications which substitute nature's own processes of production.

            The main sources for either biological or genetic resources are the same: complex and diversified ecosystems. The maintenance of these ecosystems and of their biological diversity is vital for the sustainable exploitation of both types of resources, no matter who appropriates them.

 

Animal Biological Resources

            The main concern with biological resources has been with wild plants and animals, rather than farm crops, livestock or animals bred in captivity, except as complementary components of strategies for the conservation of specific species. But even in the way we treat animals, this all‑so‑human way of seeing nothing more than natural resources in other living things can reveal the crueler side of mankind's alienation with regards to our natural environment and—all to frequently—with regards to other human beings as well.

            The situation of animals in Brazil has hardly been surveyed or studied. Our Constitution and laws on fauna are among the most advanced in the world, but they are rarely enforced. There is an absence of authority and public opinion is largely unaware. The Brazilian Environmental Institute, IBAMA, is the only enforcement agency, and even at that only for wild animals. Yet it does not have a fraction of the funds, personnel or equipment needed to carry out its gigantic mission.

            Scientists at the Goeldi Museum in Belém have estimated that, in the Amazon alone, hunters decimate more than 20 million animals per year. The situation is similar in other parts of the country. There are plans to authorize "recreational" hunting, but if IBAMA is unable to control the slaughter and traffic of wild animals on city streets and squares, then clearly it is also unprepared to control hunting in distant forests.

            Under existing animal‑protection laws, both hunting and trade in wild fauna are unbailable crimes, carrying sentences of two to five years in prison. Yet Rio de Janeiro is known as the world capital for the traffic and slaughter of wild animals. Domestic traffic is carried out in more than 150 open‑air markets in various cities of the State. It is estimated that 140,000 animals (90% of them ornamental or song birds) are captured each month, mostly in the Northeast and Southeast of Brazil, for sale in Rio de Janeiro alone, and that only 5% of these animals survive.

            In the Pantanal, domestic traffic is not of major proportions, but international traffic is enormous, in the same range of that in Rio de Janeiro. Two million alligators are slaughtered each year, while birds (a pair of blue macaws can be sold for $30,000 in the US), primates and other animals are smuggled by air through Paraguay, Bolivia, Argentina, Uruguay and directly from Brazilian airports. There have been denunciations that traffic in this region is also linked to the smuggling of both drugs and gold.

            The Amazon region is also one of the world's major sources for traffic in animals. The main routes to the northern hemisphere are by air through the Guyanas, Colombia, Peru and Brazilian airports. Traffic in this region as well is connected to drugs, and organized mafias are reported to operate on a large scale. Animals are also smuggled by river to the Iquitos market in Peru and to the Ver‑o‑Peso market in Belém.

            Most of Brazil's animal traffic, which victimizes an estimated 20 million animals per year, flows to markets in Europe and North America. These importing countries, therefore, are largely responsible for this attack on world biodiversity.

            Statistics from North America reveal that 70‑80% of the animals captured die either in the traps or during transportation. One shipment to the State of Illinois in the United States arrived with 12,000 dead birds, while a single Lufthansa flight carried another 5,541 dead birds. For each animal purchased alive, another 95 die.

            As for fishing, there is a considerable amount of legislation aimed at preserving species and protecting the natural breeding areas of ictiological fauna, in order to guarantee reproduction of the species and a stable fishing stock over time. Yet fisheries suffer from the same lack of law enforcement, a responsibility of IBAMA, violations of no‑fishing seasons, the use of predatory fishing techniques, poaching of eggs, illegal marketing, etc. This often causes significant impacts on ecosystems by hindering the normal development of species.

            These are the effects of human actions aimed directly against animals. Yet many other activities such as the clearing of forests and urban expansion have eliminated natural habitats of wild animals, the most well‑known case perhaps being that of the golden‑faced lion monkey which used to inhabit vast expanses of the Atlantic Forest. The destruction of habitats which are stop‑overs for migratory birds, for example along the State of Maranhão coastline, has also threatened species that play key roles in ecosystems of many other regions of the world.

            Polluting industries also kill off or drive away birds and other animals, and have eliminated not only fish but entire ecosystems. So‑called modern farming techniques which indiscriminately spray huge volumes of pesticides—frequently from dusting planes—are another constant threat to the fauna. Major farming regions in the South, for example, no longer hear the singing of birds or the nightly choruses of frogs, both of which used to be important in the natural control of insect pests. The indiscriminate eradication of insects with insecticides, on the other hand, eliminates both pests and their natural enemies. A vicious cycle is thus established, demanding the use of greater volumes of even stronger poisons, since the pest population springs back in the absence of natural enemies, which have indeed been successfully eradicated by both pesticides and the elimination of natural habitats.

 

Plant Biological Resources

            The timber industry, in 1996, is still carrying out large‑scale operations to extract valuable hardwood both for export and for Brazilian furniture and construction industries. In many cases, it works hand‑in‑hand with the clearing of virgin forest lands carried out by small farmers and, above all, by large ranchers in the Amazon region. Even when "selective" felling of native trees is practiced, however, major damage is caused by the opening of secondary and temporary roads, by the falling trees themselves and by the physical and cultural invasion of areas occupied by indigenous communities.

            The kind of reforestation carried out by the steel, iron and paper‑and‑pulp industries in Brazil's countryside is mostly a hoax, but even when it is implemented the results are mainly monocultures of pine or eucalyptus. These may hold back land erosion processes, but they contribute nothing to the recomposition of ecosystems or to the resettling of areas by native species of fauna.

            Brazil's forests and other ecosystems as well are also an invaluable source of medicinal plants for many human diseases. Pharmaceutical chemicals extracted from these plants have been isolated, analyzed and marketed around the world. Scientists estimate that only 5% of the world's flora has been systematically studied to identify is potential pharmaceutical value. Even so, a fourth of all medicines prescribed by doctors in the world are now based on plant compounds. The 7,000 different compounds now in use account for world‑wide sales of $40 billion dollars per year. The destruction of forests has therefore contributed significantly both to direct financial losses and to the deterioration of human health, because the extinction of hundreds of thousands of plants means that they will now never be studied by pharmacologists.

            Other social and institutional factors also block our access to the knowledge and use of valuable medicinal plants. The screening and selection of medicinal plants is rarely a haphazard process. Nearly always, the identification of potentially valuable plants is the result of surveys of the knowledge of indigenous or other local communities, who over centuries and many generations of applied research have identified not only the plants but also their various applications, procedures for preparation and even the appropriate doses and routes of administration for each particular ailment. The traditional knowledge reaped from these peoples is extremely valuable, and would be handsomely rewarded, had it been developed by modern corporate research laboratories.

            Global pharmaceutical companies are patenting and monopolizing the manufacture and sale of those very drugs. Based only on their efforts to isolate active ingredients and scale up their industrial production, they are turning over billions of dollars a year, but rarely does a cent go to the peoples who carried out all the initial selection and basic research. This will affect us all, because these peoples are beginning to open their eyes to this injustice and have begun shutting off access to outsiders, in order to demand equal footing in these relationships. Future progress in drugs based on medicinal plants may therefore depend on a solution to this demand raised by traditional peoples for a say in the use of (and a share in the profits from) their collective intellectual labor.

            One extreme, but certainly not uncommon, example of this situation is the case of a perennial plant known as Phyllanthus niruri Linn, or simply phyllanthus, which contains compounds useful in the treatment of hepatitis B. In 1985, phyllanthus was patented in the US and in 1986 throughout Europe, for use against hepatitis B by the Fox Chase Cancer Center, located in Philadelphia. The company's claim quotes ethnobotanical surveys published in India mentioning several medical applications for the plant, but not its anti‑hepatitis action, which it claims to have been its own patentable discovery.

            It so happens, however, that phyllanthus also exists in several regions of Brazil, and in the Amazon its traditional use against various kinds of hepatitis was recognized by a publicly‑owned pharmaceutical company, Far‑Manguinhos, which is part of the Oswaldo Cruz Institute in Rio de Janeiro. Far‑Manguinhos had planned to begin industrial production of a phyllanthus‑based drug precisely for that application. Under Brazil's 1971 patent legislation, the production of pharmaceutical products in Brazil cannot be limited by patents, but the Brazilian government has now had a law approved by Congress (Law 9279, May 14, 1996), to have industrial property rights extended to this industry, in response to direct pressures and explicit threats from the government of the United States.

            That US and European patent, therefore, may be able to prevent Brazil from developing and disseminating medicines based on its own native flora and traditional knowledge. The question this raises is: why should we invest our limited financial and human resources in the conservation of our biodiversity and biological resources, if their exploitation and use can be denied to us by patents obtained in other countries? Even if funds for this conservation are made available, who will guarantee that we will be able to enjoy the fruits of our own natural resources? There can be no doubt that we must conserve biodiversity for its own intrinsic value, but who will reap the benefits of the biological resources it contains?

 

Genetic Resources

            Genetic variations within species are one feature of living beings that allow them to evolve and adapt to their environments. Thousands of years ago, human societies began studying and developing methods to use this variability in the selective breeding of plants and animals, to make them adapt not only to environments but also to human needs. This was the beginning of the millenary labor—and art—of genetic improvement of biological resources.

            More than ten thousand years ago, when man presumably shifted his lifestyle from hunting and gathering to agriculture, societies began this process by domesticating and selecting varieties of plants and breeds of animals to meet their food, clothing and health needs. For a long period of time, these needs were met by a vast variety of species. Seeds, therefore, have historically been a key production factor in farming and, until recently, were always owned, produced, stored and traded by farmers themselves.

            In the 20th Century, agriculture has undergone several major transformations, including radical changes in technology. With the stated aim of eliminating hunger, genetically improved "high‑yield varieties" were developed for a few of the world's major crops. This process, known as the Green Revolution, was sponsored by governments and large corporations in the wealthy countries of the North. Along with its "miracle seeds" for corn, rice and wheat, the Green Revolution ushered in a new style of farming, based on the intensive use of chemical fertilizers, pesticides and machinery. With the support of an International Agricultural Research System, as well as abundant subsidized credit for farmers, high‑yield varieties and the technology they depend on were widely spread throughout Third‑World countries.

            One of the most significant aspects of this process is that farmers lost most of their autonomy in the farming process. They lost control over their seeds, for example, which became a market good rather than a resource of their own. The other side of the coin is that a veritable Green Revolution industry arose worldwide to produce and market the seeds, fertilizers, machinery and pesticides imposed by this new style of farming. These new markets were enhanced by the genetic characteristics selected under modern plant breeding standards, which emphasize volume yields over other virtues such as resistance to pests or to nutrient‑poor soil. Such standards were held to be feasible because modern fertilizer and pesticide industries were seen as capable of providing solutions to such problems.

            Assessments of this modernization of agriculture vary, depending on the eye of the beholder. World Bank reports praise the gains in wheat and rice yields in the Third World due to use of improved varieties. However the Asian Development Bank has stated that growth in total rice production in Asian countries has fallen short of promised levels. Setting aside disputes over statistics, there is consensus that the main problem the Green Revolution set out to solve still persists: hunger in the Third World has grown and these countries are much more dependent on food imports today than they were before the Green Revolution.

            As for biodiversity, the Green Revolution initiated a violent process of genetic erosion. Traditional varieties in the Third World gave way to monoculture export crops. Local varieties, the fruit of centuries of labor in domestication and selection, were replaced by high‑yield varieties containing much less genetic variability. Genetic resources developed over generations (including characteristics like nutritional value and tolerance to adverse environments, neglected by industrial‑style breeding) were exchanged for the homogeneity of Green Revolution varieties.

            The fragility of this model was not long in appearing. The new breeders themselves soon had to face a problem of their own making, when they realized that their most basic raw material—the genetic diversity present in local varieties or land races—was disappearing and that the new improved varieties were very vulnerable to the onslaught of bad weather, pests and blight and had to be substituted over very short periods of time. As a result, they began concentrating on the collection of seed samples of remaining "land‑race" varieties for major cash crops, to be stored in refrigerated seed banks. In the 1970s, the Ford and Rockefeller Foundations sponsored the creation of the International Board for Plant Genetic Resources (IBPGR) to help coordinate plant genetic resource collection and introduction, in cooperation with the UN's FAO (Food and Agriculture Organization).

            The motives which led the agents of this process of modernization to fund genetic resource preservation activities were clearly much more of a business nature than due to any recognition of the larger importance of conserving biodiversity.

 

II. Biotechnologies and Biodiversity

            The development of modern biotechnologies has made biodiversity an even more valuable economic resource. Techniques such as genetic engineering allow scientists to change the structure of living things by splicing characteristics from one species into another, for example from nut trees into soy beans or bacteria into cows. The expectation in agriculture is to be able to breed improved varieties much faster than through traditional breeding, and incorporate features from a much broader gamut of other species than has ever been possible. While the Green Revolution worked mainly with the major grain crops, biotechnology will potentially be able to intervene in all plant and animal species.

            This has meant the attribution of economic value to all strains, varieties and species of microorganisms, plants and animals as potential sources of germplasm (genetic information) for plant and animal breeding. There are myriad applications in other industrial sectors as well, for example the modification of bacteria to express the genes of cocoa, so that a company located in Japan or Europe can manufacture chocolate or cocoa butter in its own bioreactors, no longer depending on plantations in Brazil, Malaysia or Sierra Leone. The industries that come to monopolize these biotechnologies will thus have the power not only to reprogram farming itself in all crops, as the Green Revolution began to do, but also to actually replace farms with biochemical factories. This tendency may be disastrous for national and local economies that depend on the production and export of such crops.

            The new technologies are now concentrated in the hands of private companies in the First World, especially the corporations that already run the petrochemical, pesticide, pharmaceutical, seed and food industries. It would thus be ingenuous for us to expect results any different from those produced by the Green Revolution. They are making the same old promises, but with a few innovative touches. Biotechnology promises healthier and cleaner farming, in line with environmentalist concerns raised around the world. Yet most of the investments in farm biotechnologies so far are aimed at breeding plant varieties resistant to herbicides (rather than to pests or blight), thus encouraging farmers to use even more of the most powerful chemical weedkillers.

            The new Convention on Biological Diversity, signed during the UNCED proceedings in Rio de Janeiro in 1992, and now ratified by approximately 150 countries, arose from an international process of negotiations between rich and poor nations. It is the first attempt to create a legally-binding international agreement to deal with the issues of biological and genetic resources.

            There is general agreement that the planet's biological resources are at risk and that countries must take steps to conserve them. The disputes have centered on how to conciliate the interests of the rich countries, who want free access to the South's biodiversity, with the latter's interest in  making economic gains from their own genetic resources, while also gaining access to advanced biotechnologies which are protected by patents granted mostly to huge private corporations in the North.

            Genetic resources are not distributed equally around the world. They are most abundant and diverse in tropical and subtropical regions located in the Third World. Rich countries have argued that biodiversity is a common heritage for all of humanity, to maintain free access to the resources it contains. They also demand that the Third World countries where these resources are located change their patent laws to allow for "protection" of biotechnology products and processes. At the same time, they refuse to facilitate a process of technology transfer that in the medium term might offer the poor nations a better chance to benefit from the use of their own biodiversity to meet local needs.

            In short, the rich countries have advocated a one‑way relationship: free raw materials, technological domination and monopoly control over the products of other countries' biodiversity.

            To turn back the threats to biodiversity itself and to the fair exchange and use of the biological and genetic resources it contains, both national and global actions are needed. In this sense, the existence of an international convention on the conservation and use of biodiversity is of the utmost importance. Although it means facing up to the monopoly interests defended by rich countries, many organizations, social movements and political parties in the countries that control most of the planet's biodiversity have resisted pressures to grant patents for pharmaceutical goods and biotechnologies in general, fearing the threat to democratic and sovereign control over their biological and genetic resources, as well as more of the same the negative impacts on biodiversity initiated by the Green Revolution.

 

Trade-offs in the Convention on Biodiversity

            The attribution of economic value to biodiversity and to the genetic resources it contains generally refers to the direct (albeit potential) use value of these particular natural resources in the biotechnology industry. Ecologists also refer to the value of biodiversity in maintaining life systems in natural biomes, while spiritual traditions revere the intrinsic value of such myriad, dynamic and interrelated life forms as we find on our planet. These attitudes are of course not mutually exclusive, to the extent that they all lend strength to the need for conservation of biodiversity. Our reflections here center on the issue of genetic resources' economic value, but not only on their industrial use value.

            In the course of negotiations around the Biodiversity Convention and UNCED's Agenda 21, control over access to genetic resources was raised as an issue by governments of biodiversity-rich, developing nations such as Brazil, as an explicit trade-off for access to biotechnology to be transferred by biodiversity-poor, developed economies. Such transfers would, to put it simply, amount to a sort of payment for the use of hard-to-price natural biological specimens, while at the same time helping poor equatorial economies to develop their local "sustainable" capacities to add value to their own genetic resources.

            However ambiguous it may be, language to this effect was actually negotiated into the Biodiversity Convention. Nonetheless, ongoing controversies on US conditions for signing the convention reveal that the battle around this issue still rages on. A somewhat broader look at that negotiating process, however, places the vigor of that "battle" in more doubtful light and reveals an even greater—or at least different—economic value attached to genetic resources by governments such as Brazil's.

            During the biodiversity negotiations in Nairobi and at UNCED PrepCom sessions, Brazilian diplomats advanced a nationalistic posture, based on the perception of sovereignty over coveted genetic resources as their strong point in the bargaining process. International access to these resources could be conditioned to Northern concessions on a number of other issues. Advantages ostensibly sought by Brazil and other biodiversity-rich governments included:

            1) new and additional funding for the costs of conservation and of programs for the sustainable use of biodiversity;

            2) preferential access to new biotechnologies, even when patented in their countries of origin;

            3) guarantees regarding the environmental safety of these technologies and of other biological products to be transferred; and

            4) diverse financial mechanisms for these and other Agenda 21 activities, independent from the GEF and characterized by transparency and democracy (one country, one vote) in their international administration.

            NGOs in Brazil, meanwhile, raised several important criticisms on the stance taken by the Brazilian government:

            1) The government conditions the conservation of forests, biodiversity, etc. to the achievement of other, basically financial, objectives. The economic equation with which it appeared to be working seems to weigh the volume of foreign reserves to be gained in coming years from private investments in environmentally-destructive activities (such as the export of lumber, minerals, etc.) against the potential inflow of international assistance for conservation efforts. From this purely economic outlook, conservation must be first of all economically viable, and may also be used as a leverage factor for even greater gains. The problem is that no national initiatives at all are proposed by the government in the absence of foreign financial input.

            2) The demand for access to cutting-edge biotechnologies, on the other hand, simply is not to be taken seriously. As we will discuss below, the Brazilian government in April 1991 had already sent an industrial property bill to Congress which abdicated free access to any such technologies out of the public domain, and was perfectly aware that no Northern government, even if it wanted to, would be able to force private corporations to transfer any proprietary technology or products over which the latter wished to maintain in-house control. With that patent bill signed into law in May 1996, access to such technology will now depend solely on patent owners' interest in having their technology used in Brazil. In addition, overwhelming cut-backs in public spending on science and technology (and on many other areas victimized by neo-liberal, structural adjustment policies) have left the country with minimal prospects for absorbing any technologies that might actually be transferred, much less for developing its own. This demand for access to technologies through the Convention therefore has been interpreted as a bargaining chip to be played (and given up) at the right moment of negotiations on access to financing.

            3) The emphasis on access to cutting-edge biotechnologies belies the government's lack of interest in more accessible or appropriate technologies for socially and environmentally sustainable development programs.

            4) The biosafety demand, another major problem for US ratification of the convention, is another (secondary) bargaining chip in the government's fund-raising strategy, if seen in the domestic light of very recent and timid initiatives regarding biosafety and bioethics. A new biosafety law was signed late in 1994, is only recently beginning to be implemented, with the first preparatory meetings of the new National Technical Commission on Biosafety. In negotiations on the biosafety protocol, Brazilian representatives have been more aligned with northern government and industry proposals (for a minimal regulatory framework to legitimize the trade and use of what they consider to be quite safe technologies), than with the concerns of NGOs, many scientists and a number of the other southern governments.

            5) While the government maneuvers to gain transparency and democracy in international biodiversity funding mechanisms, the situation is quite different inside the country, where NGOs, social movements and civil society in general must fight tooth-and-nail even for information—to say nothing of participation—regarding overseas financing of development projects. The GEF continues to approve projects for biodiversity conservation and supposedly sustainable use in Brazil (for example through venture-capital companies set up in the Bahamas), with the approval of Brazilian authorities, but appears to be indifferent to the need for more open funding mechanisms that already exist and which provide for the participation of civil society in decision-making.

            A year of environmental torpor after UNCED, the government had promised that on June 5, 1993, an "Earth Day" package of environmental programs would be announced, including a National Biodiversity Program. On June 3, the launching of that initiative as drafted by the Environment Ministry was postponed, pending "further study" by other government authorities. It is known, however, that the biodiversity program is fundamentally limited to inventory and conservation-unit measures, largely dependent on as yet unraised international funding.

            With regards to the economic and other forms of perceiving and adding value to genetic resources, Brazil still has no laws regulating access to genetic resources, although at the initiative of environmental NGOs a bill was finally presented in the Senate late in 1995. Science-and-technology policies in one stabilization program after another, meanwhile, continue to look more like instruments for scrapping rather than building any local capacity for absorbing transfers or creating new technologies. And the current government simply followed the example of its predecessors by placing top priority in the industrial property bill on the patenting of biotechnologies.

 

III. The Patenting of Biotechnologies in Brazil

            The IPR bill sent to Congress in April 1991 was the result of a commitment made by President-elect Fernando Collor (impeached for corruption in 1993) during a visit to Washington in January 1990. Drafted in consultation with the US government, the bill bowed to transnational pressures for patenting of pharmaceuticals, food, life forms and biotechnologies. Ever since 1971, these areas have been unpatentable in Brazil, a situation allowed by international agreements such as the 1883 Paris Convention, of which Brazil is a founding member.

            However, since the 1980s, growing charges of patent "piracy" had subjected Brazil and other countries to trade retaliations from pharmaceutical transnationals and the US government in particular, under the "Super-301" provisions of the US Trade Act, which in Brazil had been suspended in response to President Collor's 1990 promises to the Reagan government. Such unilateral trade sanctions were the forebears of more recent US efforts to enforce its national laws beyond its own territory, such as in the Tuna-Dolphin dispute with Mexico and US economic blockades against Cuba, Iran and Libya.

            Industrial property was also the object of negotiations in the Uruguay Round of the GATT, where the Brazilian government has expressed no opposition to Arthur Dunkel's 1991 proposed "Final Agreement" on TRIPS (Trade-Related Aspects of Intellectual Property Rights). This proposed agreement was to effectively supersede the Paris Convention and create an international patent enforcement authority under what finally came to be known as the World Trade Organization (WTO), the successor of GATT. From the very beginning, however, the Brazilian government's bill went beyond the conditions conceded in TRIPS negotiations, and added additional benefits for transnationals such as pipeline privileges and patenting of transgenic plants and animals.

            Brazil's industrial property legislation covers much more than patent rights. Changes proposed in the 241 articles of the government's original 1991 bill affected areas ranging from inventions, utility models and industrial designs to trade marks, technology transfer and unfair competition.

            On biotechnologies, the original bill proposed that only "plant varieties" and "animal breeds" be excepted from patenting, with special separate legislation to be written on the protection of rights on both these areas. There was no mention at all, much less exceptions made, for biotechnological processes. Only "unmodified biological material found in nature" would be excluded from the category of "inventions" in the executive's initial version of the patent bill.

            The process by which bills are approved by Congress is quite similar to that of the US. The patent bill was first sent to the lower house, the Chamber of Deputies, which approved its version in 1993. The Federal Senate then made several amendments, voted in early 1996, after which finally a final compromise version was approved by the Chamber of Deputies in April, and signed into law by President Fernando Henrique Cardoso on May 14, 1996.

 

Discussions in the Chamber of Deputies (1991-93)

            As in the Chilean and Mexican experiences with their 1990s-version IPR bills, the Brazilian Chamber of Deputies was totally unaware of the implications of this initiative and unprepared to discuss it with any political or technical competence. Initial reactions by part of civil society (members of the scientific community, Brazilian pharmaceutical firms and—strategically—the Patent Office [INPI] Employees Association) led a handful of progressive/nationalist deputies to create enough of a commotion to derail official hopes for immediate approval.

            A Special Commission on Industrial Property was created in the Chamber of Deputies in October, and held public hearings in November and December of 1991. By June 1992, the Commission's raporteur had handed in two substitute drafts, modifying the original bill essentially to include further US demands. An impasse was created by the refusal of part of the center-right majority to endorse several of these points, and soon the impeachment proceedings against President Collor had put the IPR bill on ice, as far as the Congress was concerned, until early 1993. In March of 1993, the new government presented an alternate compromise draft at the same time that overt US threats to renew Super-301 sanctions were being brandished by the major national media, which condemned this draft as the product of "backwards nationalism." A theater of public hearings on the bill was combined with ramrod negotiations between the government, the political center and the right, and a final compromise was finally approved by the Chamber of Deputies on June 2, 1993.

            The Chamber of Deputies gave in on most of the foreign biochemical industry's demands (backed up by new USTR trade threats against Brazilian exports): the bill would approve patents on pharmaceutical and food products and processes, biotech processes and "microorganisms"; it extended patent validity from 15 to 20 years; and it brought the law into full force within one year after it's signing. However, it stopped short of US (and some Dunkel) demands in that the approved text would require local use of the patent (manufacture in Brazil) as well as allowing imports from legal licensees in other countries, compulsory licensing in the cases of dependent patent requests or of "public interest" and extension of "pipeline" rights on currently unpatentable subject matter only to products or processes which have never been disclosed anywhere in the world.

            With regards to biotechnologies, very clear language was approved in that version of the bill, providing that natural biological material and natural biological processes are not inventions, making them unpatentable. This was a tremendous advance compared to the government's first 1991 version (which said that only "unmodified biological material found in nature" was not to be considered an invention). However, as long as they can meet generic criteria for being inventions (novelty, inventive step, industrial application), all biotechnological processes were deemed patentable. Very confusing language, on the other hand, makes undefined "microorganisms" patentable, "as long as their use is only for a given process which generates a specific product" ("desde que sua utilização se dê unicamente para um determinado processo que gera um produto específico") . The proposal put forth by NGOs, many scientists, the Church and others was that biotechnologies and all biological material be declared unpatentable in this overall industrial property law, so that a longer process of discussion be allowed to define these IPRs in separate legislation. Even with the entry into force of the new GATT agreement in 1995, with its provisions for "Trade-Related Aspects of Intellectual Property Rights" (TRIPS), Brazil would have until the year 2005 to define how it would grant patents for microorganisms and for biotechnological processes.

            The NGOs' interpretation of these provisions was that, while natural or purified bacteria, fungi or cell-line isolates, for example, would probably not be patentable, nearly everything else modern biotech industries are patenting in the US will be, including the extension of biotechnological process IPRs to the plants and animals they are used to obtain. For government spokespersons and for center and right-wing politicians, however, it is enough that Brazil's natural products—and therefore its biodiversity—cannot be patented. While this is somewhat of an advance, strictly speaking, they have nonetheless absolutely refused to admit any discussion on the implications of patenting the biotechnological processes used to screen, develop and use Brazil's natural genetic resources. The economic value of such resources would belong to those controlling these patented technologies—mostly transnational corporations and a few foreign universities—rather than to Brazilians, who continue to furnish them for free.

            In short, in terms of policies on sovereignty over its biodiversity as the patent bill moved from the Chamber of Deputies to the Senate, the Brazilian government still had no plans to develop laws regulating access to genetic resources, while IPRs over biotechnologies and their products were being defined in terms deemed to be acceptable to transnational corporate interests. In May 1993, coincidentally, the Congress also began procedures for ratification of the Convention on Biodiversity. Yet these issues were never raised in the discussions on ratification. It would be up to NGOs, the scientific community and other forces in civil society to challenge this stance.

 

Discussions in the Senate (1993-1996)

            Senators were also under pressure from many of the same forces active in the Chamber of Deputies. The Government and the transnational biochemical companies (through their Interfarma lobbying organization) continued to push for approval of the bill, while also demanding additional and more extensive rights and fewer restrictions or obligations. Organizations from civil society, including unions, professional organizations, the Church, scientific societies, NGOs and the national pharmaceutical industry, continued their campaign centered on no patents for life forms and biotechnologies, but also with strong concerns around pharmaceuticals, "pipeline" and compulsory licensing provisions, patent validity terms and a longer transition period before the law comes into force. Over a thousand of these organizations had joined—and dozens were active—in an umbrella grouping coordinating these lobbying efforts with headquarters in Sao Paulo, called the Forum for the Free Use of Knowledge (Fórum pela Liberdade do Uso do Conhecimento).

            The bill spent over two and a half years in the Senate, and a number of amendments to the Chamber of Deputies' 1993 version were actually approved, thus demanding another vote in the Chamber of Deputies, which would have the final word on choosing between provisions in each of the two versions, before the bill could be sent to the President for signature, possible vetoes and publication.

            When it arrived in the Senate in mid-1993, the patent bill was sent to be examined for recommendations by two standing thematic commissions: the Constitution and Justice Commission (CCJ) and the Economic Affairs Commission (CAE). In late 1993, a public hearing was held by a joint session of the two commissions, and in mid-1994 another one was held shortly before Congress virtually shut down for the national election campaign.

            Since Brazil's ratification of the GATT agreement late in 1994 (there was actually heated debate precisely about TRIPs preceding the Senate vote), TRIPs has become the limit for all parties in the discussion. One could rant and rave against it, but only a foolhardy dreamer might imagine Congress approving language contrary to a binding international agreement it had just approved. ("Implementing legislation" was not included in the GATT ratification process.) Fortunately, the patent bill's first rapporteur in 1994 and his successor in 1995 both took very open-minded and nationalistic approaches, with highly competent support from their staff of aids. Those two rapporteurs and their aids were very receptive to contacts and suggestions from the multiple groups and social movements engaged in the fight against the bill (scientists, agricultural researchers, environmentalists, Church, unions, local pharmaceutical industry, etc.), unlike the experience in the Chamber of Deputies, where it had been a losing, up-hill battle against ignorance, a stacked-deck commission and a totally pro-PhRMA rapporteur.

            Under the new Clinton administration, Mickey Kantor and PhRMA (the US Pharmaceutical Research and Manufacturers' Association, represented in Brazil by the Interfarma) kept up all the pressure that Carla Hills and the PMA (PhRMA's predecessor, the Pharmaceutical Manufacturers' Association) had brought to bear before them during the Reagan and Bush years, while the successive governments in Brazil—Fernando Collor, Itamar Franco and Fernando Henrique Cardoso—all bent over backwards to be compliant. For the Brazilian government, the "patent issue" was essentially an uncomfortable thorn in the side of US-Brazil relations, a problem to be "put behind us" as expeditiously as possible. The Brazilian government at the same time was going out of its way to show "best behavior" on global issues ranging from patents and biodiversity to debt, GEF and peace-keeping forces in its bid for a permanent seat on a restructured UN Security Council. The only federal government agency that had worked closely and publicly alongside civil society (Embrapa/Cenargen) against the patenting of plants and animals, and for a separate piece of legislation to establish patent rules for microorganisms and biotech processes at a later date, was officially gagged early in 1995 by the President's Office.

            The approach in the Senate, therefore, was to "adapt" to TRIPs. The Senators certainly look to their own parochial political interests, but are intelligent and vain enough by-and-large to want to feel they have been convinced about what they're voting on. They generally shun being labeled either as "out-dated nationalists" or as wanting to "sell out the country", and appreciate being offered a "pragmatic middle ground", especially on such a complicated issue as patents. In this sense, convincing arguments were presented by representatives of broad-based social movements (who testified at the hearings, made personal visits to many Senators, sent hundreds of letters, faxes, etc.) proposing no pipeline, a five-year grace period, international exhaustion (parallel imports), local use, broader provisions for compulsory licensing, all TRIPs safeguards for reversing the burden of proof, etc.

 

Biotech Issues in the Senate

            On biotech, the movements sought to draw the clearest possible line between unpatentable plants and animals, on the one hand, and patentable "microorganisms" on the other. The article (10) approved by the Chamber of Deputies that places natural living beings and biological materials and processes outside the realm of inventions was seen as essentially acceptable.

            The main thrust of discussions in the Senate focused on article 18 of the bill, regarding "non-patentable inventions." Here the intention of civil society's lobby was, on the one hand, to maintain the linkage between a microorganism and a specific process and product (as somewhat of a limitation) and, on the other, to define as clearly as possible what a patentable microorganism actually is. This definition first of all would have to exclude the "whole or parts of plants and animals". It would also state that only "transgenic microorganisms" are patentable, and that transgenic means undergoing direct, human intervention at a molecular level in the microorganism's genetic composition in order to express a novel characteristic. This would amount to explicit criteria for the "inventive step" requirement in the case of microorganisms. Various formulations appeared in different drafts in the Senate commissions, but there was a consensus amongst the Senators of all political shades that language very close to this should be approved, in order to avoid patents on plants and animals.

            There were also two other important articles on biotech. One was on the rights of the patent owner (article 42, regarding the products of patented processes, which should make an explicit exception for products which are not patentable themselves under articles 10 or 18). The other was in the final and transitional provisions of the bill regarding the so-called "pipeline," to assure that outstanding biotech patent applications already filed at the Patent Office would not be granted when the new law comes into force. Another point raised in the rapporteur's amendments was that microorganism patent disclosure shall (rather than "may") be accompanied by the deposit of material in one of the centers recognized by the Budapest Treaty or by the Brazilian patent authority (INPI). In case the definition of microorganism were to be weakened or vetoed by the President (also a fear), there are also two items (in article 43) to establish the farmers' privilege and the breeders' exemption for patented "biological material." A third paragraph proposed for that same article would also have assured that the transfer of components of a patented microorganism to a non-patentable organism would not transfer the former's patent rights to the latter.

            In the Constitution and Justice Commission (CCJ), the first of the two Senate commissions to give its opinion, the original nationalistic rapporteur (Sen. Antônio Mariz) was elected governor of his State in 1994, and left his post to his substitute, Sen. Ney Suassuna, with the political mission to continue working on the patent bill with the same orientation. Sen. Suassuna presented his proposal for an entirely new bill in April 1995, and it was negotiated and approved on May 17 in the CCJ. This version of the bill was very good from the point of view of the Forum for the Free Use of Knowledge on all but two of the points mentioned above: it only provided a one-year grace period, and it contained no definition for transgenic microorganisms.

            On September 27, 1995, the Economic Affairs Commission (CAE) voted and approved its own new version of the bill, in essentially the same terms proposed by this commission's rapporteur, Sen. Fernando Bezerra, in his own substitute bill presented a few weeks earlier. Sen. Bezerra had drafted a "TRIPs-Plus" bill which was totally acquiescent to the most pro-industry interpretation of TRIPs, plus everything that the US government and the PhRMA were demanding in addition (particularly the broad, retroactive "pipeline" provisions). The government and its leader in the Senate managed to approve this version in the CAE, but—very significantly—felt the need to give in on one point: they accepted the critics' definition of transgenic microorganisms, excluding plants and animals, etc.

            So by October 1995, there were three versions of the bill: (1) the bill approved by the Chamber of Deputies in 1993 which is mostly bad on nearly all points, (2) the CCJ bill which was mostly acceptable—as far as TRIPs might allow—except for "microorganisms" and grace period, and (3) the CAE bill which is mostly very bad, except for "microorganisms". All three versions were presented in the Senate plenary on October 10, when a number of further amendments were presented by several Senators. With the new amendments, the whole package was sent back to the two same commissions, for a final opinion to be given by each, to be followed by a final vote by the full Senate.

            The same two Senators were maintained as rapporteurs in their respective commissions, and by the end of November had both presented their new reports. Sen. Suassuna in the CCJ essentially maintained the proposal approved in May by that same commission, and—with the support of the movements involved in this struggle—introduced two major innovations: a good, restrictive definition of microorganisms, and a five-year grace period (the same as had recently been approved in Argentina). Sen. Bezerra, in the CAE, presented some minor changes, including a watering down of the restrictions on microorganisms, but essentially maintained all his TRIPs-Plus provisions.

            On December 7, 1995 came the most significant breakthrough for critics of the bill in four and a half years of Congressional debate. The CCJ voted unanimously to accept Sen. Suassuna's new proposal. To put this victory in as realistic as possible terms, the CCJ's version of the patent bill contained everything that the movement had been able to formulate in the fight for elbow-room within the straight-jacket of TRIPs. There would be no pipeline at all, there would be a 5-year transitional period before the law takes effect, local production is required within 3 years after the patent is issued, parallel imports were to be allowed, compulsory licenses could be granted (within TRIPs limits) as an administrative (rather than judicial) decision, the patent office (INPI) would keep its authority to approve all international technology-transfer contracts, and the burden of proof could only be reversed by a court decision.

            For biotech and life patents, the CCJ's new version of the bill was also fairly restrictive. Naturally-occurring life forms and biological materials and processes were also explicitly considered to be non-inventions, and therefore not patentable (art. 10). In article 18, the whole or parts of plants and animals would not be patentable even if they qualified as "inventions", since they were explicitly excluded from the definition of "transgenic microorganisms" (as described above), which were to be the only patentable "living beings". Process patents (art. 42) would not grant the patent holder rights over unpatentable products. Patentable biotechnological processes (this draft bill's version of "non-essentially biological processes") were also defined restrictively to be "any concatenation of actions, except for that of natural biological processes, which use living organisms to elaborate or modify products, to improve plants and animals or to obtain, develop and modify a specific microorganism." Finally, patent rights over genes in transgenic microorganisms would have no effect when they are spliced into unpatentable plants or animals (art. 43).

            It was politically very important that even the government's leader in the Senate recognized the GATT legality of Sen. Suassuna's version of the bill as approved by the CCJ, as this raised hopes that further debate would be defused at least on this issue. The other main political argument used by the government for a "TRIPs-Plus" patent law, namely how much US retaliations will cost in terms of Brazilian exports, caused as much indignation as it did fear in the Congress and thus could cut either way. (Significantly, the paper and pulp industry, slated to be hit by Section-301 sanctions, was heard to be less worried about immediate US surcharges on its exports than it was about biotech patents that might hinder technological advances in the long-term development of its huge eucalyptus plantations. But representatives of that sector did not come to Congress to actively make their point.) The unanimity of the vote in the CCJ was certainly a surprise to all observers. Yet, whatever the government's motives were for backing down on December 7, the fact is that it changed its approach entirely when the vote finally came before the Economic Affairs Commission. Initially scheduled to vote on Sen. Bezerra's report on December 12, the final decision was put off until late January, at which time the pro-government and PhRMA forces had seduced or collared a majority of the CAE.

            When the Economic Affairs Commission (CAE) reported out Sen. Bezerra's version of the bill, with its essentially "TRIPs-Plus" approach on everything but the definition of microorganisms, the vote was not unanimous (18 to 7 for the Bezerra draft), raising some hope that Sen. Suassuna's more progressive version might fare better in the final vote on the Senate floor. However the government's "steam-roller" tactics to keep its majority in line were successful and the CAE's vote was upheld by the Senate as a whole, by a vote of 46-16 on February 29.

            Yet the definition of transgenic microorganisms had also been left vulnerable in the Senate's final version of the bill. Article 18, item III, stated that "the whole or part of living beings, except for microorganisms that meet the three requirements of patentability - novelty, inventive step and industrial application - provided by Art. 8 and that are not mere discoveries" would not be patentable. Although this might sound adequate at first sight, item III had unexplainable left out the word "transgenic" as an adjective for patentable microorganisms. The definition of "transgenic microorganisms" in a separate paragraph to the same article was thus left hanging on a concept that was simply not used in the rest of the law.

 

Final Approval in the Chamber of Deputies (1996)

            When the bill returned to the Chamber of Deputies with the amendments from the Senate, the voting was on each of the Senate's amendments, posed against the lower house's original provisions on each point. No new language or amendments could be written at this point. When the President finally signed the bill into law, he would be able to veto whole articles, paragraphs or discrete sub-items, but not words or phrases. This was the final stage of the fight.

            Specifically with regards to "transgenic microorganisms," as voted by the Senate, the whole definition could possibly be vetoed, as was gleefully pointed out by some of its opponents who hoped to patent transgenic plants and animals. While it was conceivable that such a veto (which would also potentially imply the patenting of human beings and our components) could later be overridden by Congress, this would be difficult. ("Hindsight" even suggested that a better tack might have been to provide simply that non-patentable inventions include simply "the whole or parts of plants and animals," rather than also going into complicated definitions of "microorganisms". But no such amendment had been presented on the Senate floor when the bill was read there in October 1995, so this option was no longer a possibility.) It might have been costly in political terms for Fernando Henrique to veto Congress' final word on one of the most polemical and hotly-contested items in this entire law, but he would have a convenient technical argument to stand on: that the definition in the paragraph did not correspond to the "microorganisms" mentioned in item III.

            In their haste, the pro-patent congressmen responsible for getting the new law on the books had not actually noticed this "error,"  until it was brought to the attention of rapporteur Ney Lopes (by a colleague sympathetic to the bill's critics) on the floor of the Chamber of Deputies as the final vote was about to take place. The rapporteur, who had been instructed (and ingenuously believed) that the bill was not to patent plants and animals, accepted the suggestion and endorsed approval of a "corrective" amendment to include the word "transgenic" in item III, thus assuring coherence with the definition. The bill as a whole was immediately voted and approved as proposed by the rapporteur, on the evening of April 10, 1996.

 

The Patent Bill Signed into Law

            There were indignant reactions by proponents of biotechnology patents to the "correction" voted by the Chamber of Deputies. Their plan to justify a veto of the restrictive definition of transgenic microorganisms had been thwarted by a last-minute – but entirely legal – parliamentary maneuver which was entirely acceptable to all members of Congress, who had been led to believe by the government that there would be no patents on plants or animals.

            Yet the overall official reaction to Congress' final vote on the Patent Bill was of course a major celebration. On May 14, 1996 President Fernando Henrique Cardoso finally signed the bill into law, at a gala ceremony covered extensively by the national press. The new "Industrial Property Law" (Nº 9.279/96) was published by the official gazette (Diário Oficial da União) on May 15, five full years after it had first been sent to Congress.

            Now, the country was assured by its leaders, Brazil had resolved all its major outstanding points of conflict with the United States and would be free to join global markets, attract foreign technology and investments and some day achieve First-World status.

            In terms of the new law's more general provisions, all the important demands from Northern governments and investors were satisfied. As demanded by the GATT/TRIPs agreement, previously excluded areas, including medicines and food, are now patentable, as well as the entire range of modern biotechnologies and transgenic microorganisms that qualify as inventions (art. 18). Entrepreneurs sued in Brazilian courts for patent violations will also have to bear the burden of proof against any accusations brought against them (art. 42/2º).

            Other provisions, however, go even farther than anything demanded by GATT. The law becomes effective immediately for the chemical and pharmaceutical industry's new retroactive "pipeline" rights, and only one year later for all other provisions (art. 243). The pipeline will probably be the most expensive imposition for Brazil in the short term, since the country will now have to pay royalties for several years to use products and technologies that had previously been in the public domain (art. 230). Brazil's industrial property office (the INPI) will lose its power to approve or reject contracts involving international technology transfer agreements based on the country's own development interests (art. 211), but in compensation will gain the power to decide on the legitimacy and the technical and economic capability of Brazilian companies interested in the local production of patented goods that are simply imported by transnationals (art. 68/2º).

            On the controversial provisions for patents on life forms and biotechnologies, pressure from social movements (scientists, environmentalists, Churches, etc.) at least achieved more stringent limits on this "right" than the government and the transnationals had originally intended. This means that natural biological products and processes, as well as all plants and animals, are not (at least directly) patentable. Most new patent laws in southern countries have not included even these restrictions, but hopes that the law could go even further in this area were frustrated.

            Patents on biotechnological processes under the new law, in the absence of any control whatsoever over access to the country's genetic resources, mean that real access to the potential economic value of these resources may depend on licenses to be granted (or withheld) by northern patent-holders who control the technology for their study and manipulation. Their techniques are now well protected, but Brazil's genetic resources will still be free for the taking, until a new law proposed by NGOs to control this access is approved.

            The law will also provide two kinds of "virtual" patents over unpatentable plants and animals. Process patents, first of all, will grant patent rights over the products – even transgenic plants and animals – they are used to create (art. 42/II), while plants and animals will likewise be subject to patents on any genes spliced into them from transgenic microorganisms. With this "virtual" patenting of transgenic plants, the government's Plant Breeders' Rights bill is now being seen as complementing – rather than substituting – plant patents.

            The specific impact of the retroactive "pipeline" provisions (art. 229) for biotechnologies, on the other hand, may well be a major setback for many projects already underway in Brazil, since foreign patent-holders will now be able to charge for, or even to force suspension of, the use of now patentable technologies (such as PCR, gene guns, etc.) which have been in use for many years in a number of public research institutions. (The text of these and related articles have been translated in Appendix II.)

            The only arguments offered by the Brazilian government to justify its celebration of the new patent rules imposed by GATT and the US government make one wonder if this is really the way a country can hope to gain "respect" in the world:

1.   the end of the Brazilian pharmaceutical industry's "piracy" of modern drugs (although this sector was never benefited by the kind of incentives and subsidies that North American companies continue to receive from their own government),

2.   the presumption that advanced technologies will now be transferred to Brazil (although the US refusal to sign the Biodiversity Convention in 1992 made it crystal clear that patents are to preserve and not to share technological power), and

3.   the suspension of US threats of reprisals against Brazilian exports (brandished unilaterally by that government in flagrant violation of the new GATT's multilateral dispute settlement provisions, despite the recognition of all TRIPs provisions even by the Brazilian opposition).

            Throughout the five years it took to have the patent bill approved in Congress, very few members of Congress ever came to understand even two or three of its technical points, much less their political meaning. The vast majority simply voted with their party leaders. The government's own spokespersons sent to testify and lobby for the bill were generally much more persuasive in their political than in their technical arguments. Outside Congress in civil society, however, all the national organizations that sat down to study and take a position on the patent bill came out clearly against it. There has long been a pat phrase in Brazilian politics about "hidden interests", and in fact no one has been able to explain the past three governments' obsession with obeying Washington's dictates on this law.

 

IV. Civil Society's Participation in the Patent Lobby

            It is both heartening and frustrating to conclude that Brazil's new industrial property law is probably not as bad as it might have been. The experience here has been quite different from that of other Latin American countries in pushing through new patent laws this decade. In Mexico, Chile and the Andean Pact, these laws were passed before most of those countries' movements even knew what was going on, much less what was at stake, and only the Colombians have tried to make up for their losses on patents (and PBRs) with their new law on access to genetic resources. In Argentina, there was much discussion on patents, but mostly on the behalf of the local pharmaceutical industry, with virtually no broader social or environmental movements active on issues like biotech and life patents.

            Brazil has not put hundreds (much less hundreds of thousands) of farmers and activists on the streets against GATT and patents on life, but there has really been a broad-based lobbying movement directed at members of Congress since 1991, with a loose-knit Branca Leone Army of activists frequently visiting them personally, and attending, leafleting and/or speaking at public hearings, in addition to doing direct mailings (normal and eMail) to hundreds of organizations and trekking around the country to give talks and encourage the sending of letters, faxes, resolutions, etc. Such lobbying is still a new thing in Brazil, ten years after the end of a 20-year dictatorship (and with civil society at a very different stage in its evolution than in the early 60s), so it was at the very least a major learning experience for all.

            The Brazilian movements and organizations active in fighting the government's proposals for patents on life and biotechnologies had arrived very early at the conclusion that any alternative proposals in this area would have to face up to several real-world considerations. The Brazilian constitution guarantees a "temporary privilege" for use of industrial inventions, and most of the country's scientific community does feel that there is inventiveness to be rewarded in the field of biotechnologies, the problem being a need to clearly define the scope and timeliness of patent coverage. On the other hand, the balance of power in international relations—as evidenced in the 1991 "Dunkel Draft" for the Uruguay Round, followed by GATT's Final Agreement reached in 1994—swayed towards the establishment of new global rules and authority not only for patents but for a tidal wave of vital concerns ranging from the international division of labor to the environment, consumer rights and deep-rooted issues of national sovereignty, democracy and the decentralization of national power. Under the humble assumption that they may not be able to immediately turn this tidal wave back, and considering that a new patent law would in fact soon be approved (and had to be, since the current law by its omission could be used to approve biotech patents), all these sectors found it best to forward amendments on the patent bill that the current Brazilian Congress would be prepared to accept.

            An all-or-nothing approach, advocating a total ban on life and biotech patents, would most likely be frustrated as impractical or utopian, at least in the short run. Negotiating the technicalities with the politicians to establish "acceptable" or "consensus" limits, on the other hand, constantly ran into the concrete problem of a lack of comprehension on the part of the members of Congress, very few of whom ever took the time to delve into this particular aspect of contemporary IPRs (and all of whom want a quick solution), and also of a lack of clarity anyplace in the world on what all this language really means or implies in practical terms, where rights over biotech patents actually begin and are exhausted, etc.

            There exists in Brazil, if not a consensus, at least an overwhelming majority opinion amongst NGOs, the Church, the breeders' and scientific communities that plants and animals should not be patented, and that patents should not be used to alienate control over Brazil's biodiversity. The right-wing rural oligarchy's representatives in Congress have in fact come to understand that patented seeds, cattle, horses, etc. are also a threat to local seed companies run by big farmers and cooperatives, and to ranchers who are also animal breeders. The problem was how to write this into a succinct, politically expedient article that everyone can understand and be sure of what it will mean in practice. In the process of negotiations leading up to the June 1993 vote in the Chamber of Deputies, a majority was formed around this intention, but the language approved—as discussed above—does not really live up to their hopes.

            The proposal put forth by NGOs, and supported by the other social forces critically involved in this effort, was that the entire issue be left to a separate law, since the implications of patents on life and biotechnologies are too momentous to be left to a hurried process of political negotiations. Arguments in favor of this proposal were basically that the matter is too complex for either scientists or politicians to grapple with and resolve immediately, that the patent system itself is poorly adapted to protecting both the inventor's and society's interests in the case of biotechnologies (for that very reason, alternative approaches have already been established for software and electronic circuit topographies, for example), that there are other issues to be resolved in tandem with biotech IPRs (access to genetic resources, intellectual property rights of indigenous peoples, etc.), that the granting of biotech IPRs should still be held as a bargaining chip by Brazilian negotiators in the unfolding negotiations around implementation of the Biodiversity Convention and, finally, that the TRIPS chapter in the GATT Agreement would allow developing countries like Brazil a period of ten years to extend patent coverage to areas currently exempted from patentability—so what's the hurry? If the European Parliament has taken so many years to come up with a law to protect biotechnological inventions (not that we like what they may approve), why couldn't we?

            The hope behind this proposal was not only to gain time to educate scientists, politicians and society at large about what this all means, but also that internationally new proposals might appear and gain legitimacy, that a new plateau be achieved for informed discussion and negotiations. The problem was that this proposal would mean writing a ban on patenting all life forms and all biotechnologies into this industrial property bill, and that simply sounded very radical to most politicians, accustomed as they are to always maneuvering into some kind of a middle-ground solution. To them, the idea that a total ban on biotech IPRs today is itself a middle-ground solution, to be able to write a better law in the future, looked like a trick. As a result, the small group of activists most directly engaged in this lobbying effort, even though supported by a myriad of social movements and organizations, were unable to convince a majority of members of Congress that this solution would be in Brazil's best interest.

            Several of the organizations active in the national movement against this law now believe that its negative impacts will become apparent within a very few years (in the prices of medicine and processed food, in technological dependency and lags, growing royalty payments on the balance of services, etc.), and that it will then be possible to speak of the need for amendments, not only in Brazil but in many other countries whose government's have also rushed into this game without stopping to consider alternatives. Even today, however, there are three other major bills in Congress which bear a direct relation to industrial property rights, and in which issues of national interest are at stake.

 

V. Outstanding Legislative Initiatives

            The three bills currently under discussion in the Brazilian Congress refer specifically to (1) establishment of a regime for access to genetic resources, (2) rights of indigenous peoples in general, including their intellectual rights and (3) plant breeders rights for commercial seed companies. The first two of these bills (access and indigenous rights) are important initiatives of Brazilian civil society to protect national and social interests in key areas affected by the expansion of patent rights. The third bill (PBRs) comes from abroad, an initiative being pushed by the same transnationals that imposed the new IPR law, to complement their patents on agricultural plants.

 

Access to Genetic and Biological Resources

            This bill (PL Nº 306/95) was presented in the Federal Senate in October 1995 by Senator Marina Silva, a member of the Workers' Party (PT) from the Amazonian State of Acre. The initiative for the bill came at the suggestion of NGOs active against the patent bill, who were concerned that the Brazilian government had shown no interest in implementing provisions of the Convention on Biological Diversity for control over access to the country's genetic resources. It is currently being discussed by the Social Affairs Commission of the Senate, and once approved there will still have to go through a vote on the Senate floor and then obtain approval of the Chamber of Deputies, before being signed into law by the President.

            The suggestions presented during a series of public hearings, as well as discussions amongst NGOs, scientists, government officials and others may lead to the publication of a new version of the bill by the end of this year. There is some hope that the bill can make its way through the two houses of Congress and become law by the end of 1997.

            This bill's major objective is to create rules and conditions for the granting of access to genetic and biological resources in Brazil, when these are to be used for commercial purposes other than their immediate sale or consumption. A key target is the valuing of genetic resources such as plant, animal and microbial genetic information through the use of biotechnologies, to assure some economic and technological gain for Brazil, as provided particularly by articles 15 and 16 of the Convention on Biological Diversity (currently ratified by over 150 countries). The approach being taken is to require the signing of a contract amongst all interested parties (the governmental authority, bioprospectors whether Brazilian or foreign, Brazilian counterparts of foreign bioprospectors, and when appropriate, local communities whose knowledge of these resources is to be used). The contract must contain provisions established by the new law.

            At the same time, conditions will be established whereby the "intangible component" of genetic resources will also be valued to the benefit of indigenous and other local communities such as farmers and forest communities, whose knowledge of the properties of medicinal plants, plant varieties used in agriculture, etc. is of great economic importance to industries that consume the genetic resources. But the fact that this freely shared contribution has recently gained such tremendous market value calls for the creation of mechanisms to directly repay these communities when this is possible, and to promote the survival and well-being of the communities which continue to conserve and live off the biological diversity in their surroundings. The frustrating experience of the FAO's toothless (and penniless) mechanisms to defend "farmers' rights" through international agreements may therefore begin to find a way to become reality for a diversity of excluded social sectors through national legislation.

 

Indigenous Societies Statute

            This bill was introduced in the Chamber of Deputies five years ago (PL Nº 2.057/91), and has been dormant since June 1994. Its overall aim is to regulate in law the provisions created by Brazil's new 1988 Constitution regarding the rights of indigenous societies. The broad objectives cover the legal situation of Indians and their communities and protection for their customs, culture and territorial rights, include specific means to protect the "indigenous heritage" and also their "intellectual property".

            The current version of this bill was approved by the Chamber of Deputies and should already have been sent to the Senate. Political contingencies, however, have led the government to hold up the process in order to continue to work under current legislation. When this deadlock will be broken is still in doubt.

            Discussions on the above-mentioned bill on access to genetic resources, however, have provided much-needed insights for the indigenous movements and the NGOs which support them with regards to this bill's 16 articles on indigenous heritage and intellectual property rights. There is an understanding that the two bills must be made entirely compatible, and that–conceptually–the notion of intellectual property should be replaced by a broader approach covering community intellectual rights, since property rights in this area are now seen as a straight-jacket for the implementation of rights over knowledge that is held and used collectively.

 

Plant Breeders' Rights

            While the two previous bills (access and indigenous societies) arose from initiatives by Brazilian civil society and specific social movements, the "Cultivars Act" presented by the government in January 1996 (PL Nº 1.46/96) in the Chamber of Deputies, is a direct (and compliant) response to international pressures from the same transnationals that imposed the new patent law.

            The purpose of this bill, as presented, is to create industrial property rights similar to patents over seeds used in agriculture, in order to assure commercial plant breeders a monopoly over the new plant varieties (or cultivars) which they put on the market. This monopoly is the backbone of what is known internationally as "plant breeders' rights" (PBRs).

            While the law would provide some exceptions to normal patent rules for farmers (to plant back seeds on their own farms) and for other breeders (to use protected varieties in their own breeding activities), it does create a clear monopoly which will transform the currently competitive seed sector, as well as requiring degrees of genetic homogeneity in crops which fly directly in the face of modern agronomic considerations favorable to diversity.

            The Brazilian government believes that Brazil must implement this legislation in order to be able to join an international convention called the International Union for the Protection of New Plant Varieties (UPOV). The UPOV, although it has been in existence for 35 years, has yet to gain more than 35 countries in the world as members. This is quite a different situation from the Convention on Biological Diversity, which has gained over 150 members in less than four years. The reason for this situation is that UPOV has historically been limited to northern industrialized countries which are headquarters to the world's seed industry. The advent of plant applications for biotechnology has consolidated a trend in which the world's largest pesticide companies have been taking over seed companies since the 1970s. Since these are also the same companies that dominate global pharmaceutical production as well as the marketing of new biotechnological products in general, there has been a convergence of pressures by those governments and companies for Southern countries to adopt PBR laws to complement the new patent laws.

            This bill has been under discussion since June 1996 by a Special Commission created in the Chamber of Deputies. The Special Commission will probably report the bill out the floor of the Chamber of Deputies before the end of the year, after which it will still have to be approved by the Senate (precisely the same procedure as in the patent bill). The government is exerting major pressure on its majority of supporters in Congress to have this bill passed into law as soon as possible, however counter-pressures from agricultural-related NGOs, such as those in the PTA Network headed by the AS-PTA, are beginning to sow doubts in the minds of many members of Congress. It may be possible at least to incorporate major changes into the bill to safeguard the interests of farmers and Brazilian seed companies, as well as assuring protection for "farmers' rights" over seeds provided to commercial breeders.

 

Appendix I

 

Biotechnology and Life Patents in the Bill Approved by the Chamber of Deputies (1992)

            Following are the industrial property bill's main relevant provisions regarding patents on biotechnologies (processes) and life forms (products) as it was approved by the Chamber of Deputies in June 1992. Article 42, on the rights conferred by the patent, is also included here in its entirety, to show how the text goes far beyond current GATT/TRIPS requirements (e.g., control over exports, reversal of the burden of proof).

 

ARTICLE 10. The following are not considered inventions or utility models:

            (...)

            IX - the whole or part of natural living beings and biological material found in nature, or even if isolated from it, including the genome or germplasm of any natural living being and natural biological processes.

 

ARTICLE 18. The following [inventions or utility models] are not patentable:

            (...)

            III - living beings, including microorganisms when isolated from an industrial process.

            Sole paragraph - The prohibitions in this article, aside from the provisions of article 10, item IX, do not pertain to patent claims for inventions related to microorganisms, as long as these are used only for a particular process which generates a specific product.

 

ARTICLE 42. The patent grants its owner the right to prevent third parties not having his consent from making, using, selling, presenting for sale, buying, offering, importing, exporting or storing:

            I - the product which is the subject matter of a patent;

            II - the process or product obtained by a patented process;

            III - components of a patented product, or material or equipment for the use of a patented process, when the final application of the component, material or equipment necessarily leads to use of the protected invention or model.

 

ARTICLE 43. The provisions of the preceding article to not apply:

            (...)

            V - to third parties who, in the case of patents involving living matter, use, without economic objectives, the patented product as an initial source of variation or propagation to obtain other products; and

            VI - to third parties who, in the case of patents involving living matter, use, place in circulation or market a patented product which has been lawfully introduced into commerce by the patent owner or by a license holder, as long as the patented product is not used for the commercial multiplication or propagation of said living matter.

 

            The bill as approved by the Chamber of Deputies thus would have allowed the patenting of "microorganisms" (with dubious and, at the very least, original qualifications) and of all biological and biotechnological processes that can qualify as inventions.

            Many comments could be made on implications of the provisions in the articles transcribed above, but most of these are discussed in relation to the final text of the new patent law, in Appendix II, and thus not repeated here.

 

1) HALF-BAKED SPECIFICITIES: In Article 18, the Chamber of Deputies' version of limits on the patenting of microorganisms is questionable, especially in the void of precedents for this kind of "half-baked" protection. Except in the case of so-called "use patents"—which the bill does not explicitly provide for—a product is either completely patented or else completely in the public domain. At the same time, how specific does "specific" have to be? "Specificity" could be stretched to cover even the plant cells in Grace's "species-specific" soy-bean or cotton patents, if we consider plant cells as "microorganisms" and if we argue that the species involved and also what differentiates a process for obtaining transgenic cotton from processes for some other species make them both "specific" enough to fit into these criteria.

 

2) WHAT IS A MICROORGANISM? The "microorganisms" made patentable by Article 18, given the lack of any clear definition, may include not only microorganisms in the classic biological sense (bacteria, viruses, some or all funguses or algae, etc.) but also genetic material, plant and animal cells, tissue cultures and even seeds. This is the most likely result since the only reference for the INPI or the courts to use in defining microorganisms is jurisprudence established in other countries. Human cells used in industrial processes (to produce an enzyme-based drug, for example) could easily be patented as microorganisms. Seeds used for the production of plants would equally qualify (agriculture is explicitly classified as an "industry" in the same bill's Article 15), and so on, and so on.

 

Appendix II

 

Biotechnology-related sections of Brazil's new Patent Law

Law Nº 9.279; May 14, 1996

 

SECTION I - PATENTABLE INVENTIONS AND UTILITY MODELS

 

Art. 8. An invention is patentable when it complies with the requirements of novelty, inventive step and industrial application.

 

Art. 10. The following are not considered inventions or utility models:

            I - discoveries, scientific theories and mathematical models;

            II - purely abstract conceptions; [...]

            VIII - surgical techniques and methods, as well as therapeutic or diagnostic methods, for use on a human or animal body; and

            IX - the whole or part of natural living beings and biological materials found in nature, or even if isolated from it, including the genoma or germplasm of any natural living being and natural biological processes.

 

SECTION III - NON-PATENTABLE INVENTIONS AND UTILITY MODELS

 

Art. 18. The following are not patentable:

            I - anything contrary to morality, to ordre public and to public safety, order and health;

            II - substances, materials, mixtures, elements of products of any nature, as well as the modification of their physical-chemical properties and the respective processes for obtaining or modifying them, when resulting from the transformation of the atomic nucleus; and

            III - the whole or part of living beings, except for transgenic microorganisms that meet the three requirements of patentability - novelty, inventive step and industrial application - provided by Art. 8 and that are not mere discoveries.

            Sole paragraph - For the purposes of this law, transgenic organisms are organisms, excepting the whole or part of plants or of animals, which express, through direct human intervention in their genetic composition, a characteristic not normally attainable by the species under natural conditions.

 

CHAPTER III - THE PATENT APPLICATION

SECTION II - CONDITIONS FOR APPLICATION

 

Art. 22. The application for a patent on an invention must refer to a single invention or to a group of inventions that are inter-related so as to comprehend a single inventive concept.

 

Art. 24. The report must clearly and sufficiently disclose the subject matter, so as to allow it to be performed by a person skilled in the art, and indicate, when applicable, the best mode in which to carry it out.

            Sole paragraph - In the case of biological material essential to the practical performance of the object of the application, which cannot be described as provided in this article and which is not accessible to the public, the report shall be supplemented by the deposit of the material in an institution authorized by the INPI or named in an international agreement.

 

SECTION III - THE PROCESS AND EXAMINATION OF THE APPLICATION

 

Art. 30. The patent application shall be kept confidential for 18 (eighteen) months following the date of its deposit or of the oldest priority, if applicable, after which it shall be published, with the exception of the case provided for in Art. 75.

            Paragraph 1 - The application may be published earlier at the request of the applicant.

            Paragraph 2 - The publication must contain data which identifies the patent application, and a copy of the descriptive report, the claims, the abstract and the drawings shall be made available to the public at the INPI.

            Paragraph 3 - In the case provided for by the sole paragraph of Art. 24, the biological material shall be made accessible to the public along with the publication provided by this article.

 

CHAPTER V - PROTECTION GRANTED BY THE PATENT

SECTION I - RIGHTS

 

Art. 41. The extent of the protection conferred by the patent shall be determined by the content of the claims, as interpreted on the basis of the descriptive report and of the drawings.

 

Art. 42. The patent confers its owner the right to prevent third parties, without his consent, from making, using, offering for sale, selling or importing for these purposes:

            I - the product which is the subject matter of the patent;

            II - the process or the product obtained directly by a patented process [CCJ: subject to the provisions of Arts. 10 and 18]*.

 

Art. 43. The provisions of the preceding article do not apply:

            I - to acts carried out by unauthorized third parties, in a private fashion and without commercial objectives, as long as they cause no damage to the economic interest of the patent owner;

            II - to acts carried out by unauthorized third parties, with experimental objectives, related to scientific or technological studies or research;

            III - to the preparation of medicines following a medical prescription for individual cases, carried out by a qualified professional, as well as the medicine thus prepared;

            IV - to a product made in accordance with a process or product patent which has been placed on the domestic market directly by the patent owner or with his consent;

            V - to third parties who, in the case of patents involving living matter, use, without economic objectives, the patented product as an initial source of variation or propagation in order to obtain other products; and

            VI - to third parties who, in the case of patents involving living matter, use, put into circulation or market a patented product that has been lawfully introduced into commerce by the patent owner or by a license holder, as long as the patented product is not used for the commercial multiplication or propagation of said living matter.

            [CCJ: VII - to the components of patented transgenic microorganisms, once transferred to or expressed in non-patentable living organisms, as provided by Arts. 10 and 18.]*

 

TITLE VIII - TRANSITIONAL AND FINAL PROVISIONS

 

Art. 229. Outstanding applications shall be treated under the provisions of this Law, except for the patentability of substances, materials or products obtained by chemical means or processes, of food, chemical-pharmaceutical and medicinal materials, mixtures or products of any kind, as well as the respective processes for obtaining them, [CCJ: and for living beings and biotechnological products and processes]* which shall be subject to privilege under the conditions established by Arts. 230 and 231.

 

Art. 232. The making or use, in the terms of the previous legislation, of substances, materials or products obtained by chemical means or processes, of food, chemical-pharmaceutical and medicinal materials, mixtures or products of any kind, as well as the respective processes for obtaining them, even when protected by a product or process patent in another country, in accordance with a treaty or convention in force in Brazil, shall continue, under the same conditions holding previous to approval of this Law.

            Paragraph 1 - No retroactive or future charges shall be allowed, in whatsoever value, for any reason, regarding the products made or the processes used in Brazil in accordance with this article.

            Paragraph 2 - Charges such as those provided for in the preceding paragraph shall equally be disallowed if, in the period preceding the entry into force of this Law, significant investments have been made for the use of a product or process referred to in this article, even if protected by a product or process patent in another country.

 

 

Comments on the patenting of life forms and biotechnologies in the new law

            The predominant opinion amongst the members of Congress who voted to approve this law was that it would exclude at least plants and animals from patentability. They were also convinced that the nation's biodiversity would be protected from foreign usurpation, since natural biological processes and products would also remain unpatentable (as non-inventions). They are mistaken however, as many of them have already recognized, now that the government is defending its "Cultivars Act" as a necessary complement to patents on agricultural seeds for many of Brazil's major crops.

            These considerations, brought to the fore by the Church, NGOs and others in debates in the Chamber of Deputies, actually came to be important issues to right-, center- and left-wing politicians in Brazil. The confusion surrounding what the new law actually says, however, gives weight to the feeling of many members of Congress that application of a law in these terms might not be exactly what the majority had in mind. Enforcement will be a matter of interpretation: first by the supplementary regulations to be established by the National Industrial Property Institute (INPI) for its evaluation of patent claims and later—depending on the INPI's interpretation—in the courts where suits may be filed by claimants or others who feel prejudiced by official decisions.

            Nonetheless, two areas regarding biotechnologies and life forms in the newly-approved patent law are at least much more restrictive than are the provisions in patent laws or court decisions in industrialized countries, or even in other southern countries that have changed their laws in recent years.

 

1) Natural biological products and processes, first of all, are declared to be non-inventions (art. 10/IX), and therefore not patentable, even when isolated from their natural conditions, and specifically including their genoma or germplasm.

            It was also significant that item X of this article was maintained, meaning that "surgical techniques and methods, as well as therapeutic or diagnostic methods, for use on a human or animal body" will remain unpatentable in Brazil under the new law. This issue was not the subject of any heated political debate, but there were some crude attempts in the Senate by the CAE's rapporteur (or his "aids" on the behalf of pharmaceutical transnationals) to have this subject matter moved into the category of "inventions".

 

2) PLANTS AND ANIMALS: Patents available on living beings or biological material will be restricted to "transgenic microorganisms" (art. 18/III and its sole paragraph) which express novel characteristics as the result of direct human intervention in their genetic composition, and excluding the whole or part of plants and animals. Presumably, patents will therefore not be allowed on components of plants, animals or human beings, such as genes, enzymes or proteins. (The qualifier "presumably" is used to indicate a margin of doubt with regards to what the transnationals' lawyers will be able to convince judges of in Brazilian courts.)

 

            All of civil society's other proposals to place limits on "life patents," however, were unsuccessful. Some of the major points are briefly discussed here:

 

1) LIMITS ON WHAT IS "NATURAL": Article 10 establishes no clear limit between what is natural and what can qualify as an invention for living beings, their components or the biological processes they carry out. It is conceivable, for example, that in addition to "isolating" a biological molecule, a company may simply crystallize the substance using conventional techniques and then claim that it is an "invention." Even more significantly, any "naturally occurring gene" transferred along with a promoter (as they so often are in genetic engineering) to some other organism will be classified (gene + promoter) as "novel," and therefore as an invention potentially subject to a patent.

 

2) PATENTED TECHNOLOGIES, FREE GENETIC RESOURCES: Since article 18 is the only place in the law that lists non-patentable inventions, the absence of any mention of biotechnological processes in this article means that these techniques will be patentable under the same terms as any other mechanical or chemical process. This decision represents an act of political submission for Brazil, because the Convention on Biological Diversity of which Brazil is a full member (or "party") guarantees access to, and the transfer of these technologies – even when patented – to countries that allow access to the genetic resources in their national biodiversity (articles 15 and 16 of the Convention). The Brazilian government's science and technology policy, however, placed absolute priority on the patenting of foreign technologies, while never taking any initiative at all to regulate terms for granting access to those resources (of fundamental importance and value as raw materials in global biotechnology industries). With the new patent law in effect, it will be very difficult for Brazil to make any real use of biotechnologies to develop its own genetic resources.

            This has been one of the most hotly disputed issues in international negotiations ever since the Biodiversity Convention was still a promise. While the Convention's final compromise text does oblige states to recognize intellectual property rights in this area, this obligation is phrased in tandem with the requirement that (northern) governments take measures to assure that "developing countries, which provide genetic resources are provided access to and the transfer of technology which makes use of those resources ... ." Brazil's new patent law makes no provisions to this end, quite the contrary. The result may well be that the genetic resources in Brazil's "unpatentable" biodiversity will end up being prospected and developed exclusively for 20 years by those who now hold patents on today's biotechnological processes (no Brazilians are known to be amongst them) and by those who invent new processes to use these resources in the future (with certainly few Brazilians amongst them, given the scrapping of Brazil's R&D capacity under current "stabilization"-inspired cutbacks).

 

3) "VIRTUAL" PATENTS FOR PLANTS AND ANIMALS: Contrary to the belief of credulous members and leaders in Congress who thought they were banning patents on plants and animals in article 18, the new law only forbids direct patents on plants and animals as such, while purposely leaving the door open for indirect patent rights on these higher organisms. There are two means in the law for the creation of indirect (or "virtual") patents over plants and animals. Amendments were approved by the CCJ commission in the Senate which would have eliminated these "loopholes," but both were removed by the rapporteur of the CAE in his January 1996 report, and never again discussed.

            First of all, patents on biotechnological processes for the creation of transgenic plants or animals grant the patent owner the same rights over the new plant or animal as they do over the process itself (art. 42/II). This means that the company that patents the technology for splicing a gene into a plant will be able to monopolize the transgenic plant too (even though the plant itself is unpatentable), along with its seeds, components and products that contain a gene spliced with that technology.

            Secondly, there is no limitation (or "exhaustion") in the law with regards to patents on genes from patented transgenic microorganisms, when these genes are transferred or spliced into a plant or animal (an amendment was proposed to art. 43 to create this exhaustion). Therefore, all unauthorized reproduction of transgenic plants or animals will be forbidden, since this would also necessarily imply the (illegal) reproduction of their patented genes. The transgenic plants themselves remain unpatented, but the presence of patented genes in their genomes places them under the same restrictions to free use as would any patent.

            One hypothetical example of a virtual patent is a transgenic bacteria patented along with its "novel" genetic components and used "in the process of obtaining transgenic plants". The bacteria will no longer be present in the plants obtained, but its patented genes will, and at each planting these genes will go to work to reproduce a new generation of transgenic plants. All uses of these supposedly unpatentable plants (in planting, breeding, processing or final retail sale of products) could thus be subject to the rights of the bacteria's patent holder. That's the way the patent system works, whether its subject matter is mechanical, chemical or biological.

 

4) IMPACTS ON (VIRTUALLY) PATENTED SEEDS: Article 43 confirms earlier fears regarding the absence of any "breeder's exemption" or "farmer's privilege" regarding the use of patented (or virtually patented) plants and seeds.

            a) Item V of this article gives breeders the right to use a directly or indirectly patented plant to obtain new varieties, but only if the breeder has no "economic objectives." In other words, all commercial results of the breeders' work will belong exclusively to the person with patent rights over the initial variety and/or its genes.

            b) According to explanations given by the bill's rapporteur in the Chamber of Deputies, item VI of article 43 is intended to allow farmers to save patented seeds from their harvest, in order to plant them back the next year. This in fact amounts to implicitly admitting that plants (at least transgenic plants) indeed will be patentable. A closer look at the text, however, reveals that even this right, or "privilege," need not be respected. Farmer may freely use, distribute or sell the patented seed he/she has purchased, but only "as long as the patented product is not used for the commercial multiplication or propagation of said living matter." This means that the farmer cannot actually sell the harvest from a second planting of seeds from the (virtually) patented variety without obtaining the patent owner's consent, because the "commercial multiplication or propagation" of plants is much more far-reaching than the commercial production of seeds; it is what modern farming is all about: planting, reaping and selling.

 

 

5) PIPELINE FOR BIOTECHNOLOGIES: Many Brazilian scientists will lose the right to continue using the modern biotechnologies on which important projects may depend. The impact of article 229, to paraphrase the text, is simply that outstanding patent applications for patents on biotechnologies will be dealt with under the provisions of the new law. The rest of the same article opens exceptions for other sectors and technologies (drugs, chemicals, food) to continue their free use of processes and products which only became patentable upon publication of the new law. Articles 230-232 also elaborate on those exceptions. But there is no exception for biotechnologies. (Again, an amendment to this effect was passed by the Senate's CCJ, but rejected by the CAE.) Shortly, many public laboratories currently using gene guns, PCR and other techniques over which patents have been filed at the federal patent office (INPI) in recent years, will have to start planning how to adapt to the new law. They will have to negotiate and obtain specific licenses from the patent owners, and include an item for royalties in their shrinking research budgets. In addition, the law makes it perfectly legal for patent holders to demand retroactive royalty payments for use of these technologies ever since they first filed for protection. To make matters worse, the fact that all public laboratories in Brazil are being pushed into "market-oriented" research means that even the "scientific research exemption" in article 43/II will provide Brazilian scientists will little leeway to continue using what have been public domain technologies in their work, except for applications with no commercial value.