Biopatenting and the Threat to Food Security, February 2000

Part 1 - Biopatents: A Christian and Development Perspective

What are patents?

Like other forms of intellectual property rights (IPRs), such as copyright and trademarks, patents are a form of incentive and reward for inventions. They are designed to encourage commercial innovations, while allowing the knowledge behind them to be shared. Patents give inventors a temporary monopoly over new inventions which they can commercially exploit, in return for publishing information about the invention. In this way, inventions do not "die with the inventor", and others can try to invent something better, but sufficiently different so as not to infringe the claim of the original patent.

To be patentable, an invention, either a product or a process, must be:

• non-obvious for someone skilled in the art, i.e. not simply an extension of something that already exists but requires an inventive step;
• novel, i.e. not previously known;
• industrially applicable (or useful) in some way.

A patent right lasts for a fixed time (20 years minimum under the TRIPs Agreement, a long time given the pace of technological change) after which anyone can use the invention. The precise terms applying to patents vary from country to country and patents only apply in the country/ries in which they are granted.

IPRs have traditionally been associated with industrialised and market-based economies. Until the development of commercial plant breeding, they were little used in agriculture, as innovation largely resulted from farmers freely sharing seeds and inter-bred animals to produce a wide range of varieties and breeds suitable for differing climatic conditions.

Moreover, until 1970, discoveries in nature could not be patented, even if the inventor found some synthetic way to make a naturally occurring product which merited being called an invention instead of a discovery. Since 1970, this distinction has been gradually eroded, under economic and scientific pressure to allow living organisms, their parts and biological processes to be patented as "inventions" in some countries. Genetic modification is now providing radically new ways of manipulating biological resources, thus giving rise to immensely profitable industrial processes. In principle, genes can now be exchanged among plants, animals and micro-organisms regardless of their sexual compatibility.

Companies engaged in biotechnology have therefore pressed for the adaptation of classical intellectual property law to cover life forms, as being no different from any other form of technology. One reason for this is that unlike chemicals, living organisms can reproduce themselves after they have been sold. This limits the potential profitability of "biological inventions" for anyone who seeks to appropriate them or monopolise their use and sale. Demanding patents on plant varieties thus became an obvious option for companies to protect the revenues that such new technology promises.

In the USA, limited patents on some plant varieties were first allowed in 1930. In 1980, as modern biotechnology began to shape the development of intellectual property law, the US Supreme Court ruled that a genetically modified oil-eating micro-organism could be patented. In 1985, the US Patent and Trademark Office allowed genetically modified plants, seeds and plant tissue to be patented. The Office extended this ruling to animals in 1987 by allowing a patent on a mouse genetically modified to develop cancer. This move toward patenting life forms or biopatenting has more recently been mirrored in Japan and in the European Union (EU).

Patents and other forms of IPRs (such as Plant Breeder Rights which were developed in Europe as a less rigorous alternative to plant patents) will affect the future of global food security. Control of plants and animals through patents will largely determine who controls food systems.

According to a study for the International Service for National Agricultural Research(3) patents and other forms of IPRs are increasingly being used by companies to expand their market share, to prevent competitors from becoming active in particular countries, or as a bargaining tool to negotiate favourable local agreements.

Since the mid-1980s, there has been pressure from corporate interests in EU member states to allow biopatenting. It was argued that a failure to do so would harm Europe’s competitive position in the rapidly developing field of biotechnology - an area "of fundamental importance for the Community’s industrial development". This led to a hotly contested directive on the legal protection of biotechnological inventions. Rejected by the European Parliament in 1995, it was resubmitted with minor changes, and passed in a controversial vote in 1998, after much lobbying by industry and certain governments, which focused particularly on its importance for medical research. The Dutch, Italian and Norwegian governments have challenged the validity of this Patenting Directive on several grounds. Some concern legal technicalities, but one argues that the Directive poses a breach of fundamental human rights as it would make it possible to patent parts of the human body.

Following this change in patent law, the European Patent Office altered its implementation regulations under the European Patent Convention to allow for patenting of human cells as well as transgenic plants and animals. This came into effect in September 1999, thus paving the way for Europe to join the US in granting patents on life forms. This change to the European Patent Convention has occurred even though it contravenes article 53.b of the same Convention which exempts plant and animal varieties from patenting. This has already caused controversy(4).

Although the EU Patenting Directive bans the patenting of plant and animal varieties in one sentence, elsewhere it states "inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety". This means that genetically modified changes in a plant or animal’s general functions are patentable and this covers their use in all varieties of that plant or animal, and any offspring or product produced from them. It also allows genes to be patented as if they were inventions.

A significant political effect of the Patenting Directive which brings the EU into line with the USA, is to increase the pressure on developing countries to accept similar provisions on patenting.

The move to incorporate IPRs in the General Agreement on Tariffs and Trade (GATT) Uruguay Round was led in the mid-1980s by a global alliance of TNCs which argued this was needed to stop the "trade-distorting" effects of piracy of intellectual property assets, e.g. production of counterfeit goods. By placing IPRs in the WTO, the successor to GATT, they became subject to its legally binding dispute settlement procedure (see Box 1).

Although revising trade rules is a complex and technical process, it is also largely a power play between different interests, both national and corporate. Industrialised countries which favoured TRIPs dominated the GATT negotiations, with the USA and Europe the key players in negotiating biopatenting. Both pharmaceutical and agrochemical companies in these countries wanted the TRIPs Agreement to include biopatenting.

Under the TRIPs Agreement, WTO members (135 as of late 1999) must allow all inventions to be patentable, with a few exceptions (see Box 2). As in the USA, life patents were permitted, with an additional stipulation that a sui generis (of its own kind) system of protection for plant varieties be included, reflecting Europe’s interests. A sui generis system is a unique or special system of national IPR legislation that covers a particular subject matter.

Developing countries had until 1 January 2000 to implement the TRIPs Agreement and the least developed countries have until 2006, with the option of applying for further extensions. New members of WTO, some of whom are in the category of least developed nations, however, do not necessarily enjoy transition periods. Objections to Article 27.3(b) from some developing countries were partly taken into account by leaving open the kind of system to be adopted for plant variety protection.

Most developing countries, however, signed up to TRIPs as part of a package deal, a trade off for elements in other WTO agreements, rather than because they wanted it. Although some objected strongly to Article 27, many signed it without any clear analysis of its implications – in part due to the binding capacity constraints facing poor countries in taking part in such technically complex, multi-faceted negotiations.

None of the main terms used in the Article, such as micro-organisms, essentially biological processes, effective, and sui generis system, were defined in the Agreement which makes various interpretations and disputes over them likely. WTO members can define what "invention" means and many developing countries, including Argentina, Brazil and the Andean Pact countries, exclude from patentability materials found in nature, even if isolated from it. There is also flexibility in interpreting novelty and inventiveness and the scope of claims that will be admitted.

The TRIPs Agreement globalises patents as every WTO member must have a patent system covering products and processes, which hitherto was not the case for many developing countries. It allows the owner of a patented product to prevent third parties from making, using, offering for sale or importing it without their consent. Owners of a patented process can prevent the use of the process as well as the commercialisation of a product made using that process. Thus, if a process to produce a plant (e.g. a genetically modified plant) is patented, the owner of the patent has exclusive rights over the plants obtained using the process. Farmers are not allowed to use any seeds coming from such a plant. Most importantly, in contrast with normal legal practice, the TRIPs Agreement shifts the burden of proof in a dispute over process patents to the defendant who must show that a product is not being produced by the patented process.

The TRIPs Agreement also extends plant variety protection globally. Countries are allowed to design their own IPR systems for this provided the protection is effective. However, what is considered effective is not defined. The UPOV system of Plant Breeders Rights (PBRs) is such a sui generis system (see Box 3). However, it was developed for institutional, commercialised breeding in developed countries in which farmers have to pay royalties on such seed and may not suit all countries.

Only varieties which are distinct, uniform and stable are eligible for "protection" under UPOV. Widespread use of such plants in developing countries has led to genetic erosion and reduced biodiversity. More than 75% of agricultural crop varieties and over 50% of domestic livestock breeds have disappeared from farmers’ fields in the last century(5).

According to the International Plant Genetic Resources Institute (IPGRI), a system suitable for intensive, industrialised farming systems is unlikely to be suitable or appropriate where there is a lot of subsistence farming. This is true in many developing countries and various governments are developing national legislation for protecting plant varieties appropriate to their situation. However, this is a challenging, time-consuming task requiring substantial capacity and resources(6).

Patenting is a process which seeks to reconcile two conflicting ethical principles:

1. A person who invents something, and wants to profit from selling it needs protection from someone who might sell the invention as their own. This is true both for individuals and organisations.

2. The technical aspects involved in the invention should be open and accessible.

The first principle is met by granting the inventor an exclusive right to sell the invention for a certain period of time. During this time the invention is regarded as the inventor’s "intellectual property". The second principle is met by making the knowledge of the invention available to all. This worked fairly well when patenting was applied mainly to mechanical inventions and chemical processes, and within industrial societies. Although people could abuse the system, ethical questions arose only rarely, e.g. in cases like a letter bomb, where it was felt that to publish information or produce the invention would violate general public morality – the French expression ordre publique.

Two important factors have changed the picture:

1. Patents were extended to biological material.

2. Patents became a key element in the globalisation of trade and technological advances, in food, agriculture and medicine, with an increasing trend towards the corporate use of patents to attempt to secure long term monopolies over large sectors of food production worldwide.

Neither biblical nor subsequent Christian theological reflection could have anticipated the advances in biotechnology and the choices which such advances have created. Nevertheless these reflections can stimulate moral discourse and prompt the sort of questions that we should be asking about biotechnology and intellectual property rights as well as the values which should inform policy on biopatenting and biotechnology.

Diversity

At the beginning of the 21st century we inherit a natural world immensely depleted in its resources and diversity; we inherit a greater – but still very incomplete – understanding of this world in all its dimensions than ever before; and we inherit social and economic systems that are signally failing to manage this world with equity or good stewardship. Our world has been changed in multiple ways by humans in the course of human existence, but we have a duty to preserve it in such a way that future generations can benefit from the wealth of biological diversity and resources which we are only beginning to understand and value. We know that each "improvement" in farm crops – whether by hybridisation or genetic modification – tends to reduce biodiversity and marginalise those crops (and their genes) which in the present agricultural and economic context are regarded as unprofitable. These varieties are also the landraces on which the poor depend.

Stewardship

Women and men are made "in the image and likeness of God". Animals and plants are also creatures of God. From this, we derive the principle of treating creation with respect. This is summed up in the concept of stewardship.

Stewardship includes both the preservation and adaptation or modification of creation. Technology, including biotechnology, can be seen as a valid expression of our God-given rationality in our relationship with nature. Both our rationality and nature belong to the created order. That created order, however, is marred by sin. We know for example, that technology has at times released very powerful forces with severe consequences both social and ecological (e.g. nuclear weaponry). It is clear that our fascination with the technical sophistication of an innovation is no substitute for ethics. So exercising our technical rational capability is not ethical in and of itself. It only becomes ethical when it is exercised in a way that respects right relationships with our fellow human beings, creation itself and most profoundly God.

We know human beings are limited and finite in their understanding; that our understanding is rooted in and contingent upon the time and context in which we live; and that we are capable of making mistakes. The nuclear power industry, once acclaimed as a source of inexhaustible, cheap energy, is only one illustration of our capacity to make technological mistakes. Biotechnology is such a new field, with potentially far-reaching consequences, that we should proceed with caution and humility before embedding any technology in mainstream economic life and the legislation that governs it. David Byrne, EU Commissioner for Health and Consumer Protection recently said: "because biotechnology, in terms of genetic engineering, is such a new area, I believe we must be prudent and, in the case of scientific uncertainty, adopt a precautionary approach."(7)

This humility should also inform our approach to problem solving. Large claims are made for genetically modified farm crops but we do not know yet whether the solution of one problem – multiple spraying of herbicides, for example – by modifying plants to be tolerant of one particular herbicide, will lead to other more intractable problems. The principle here is that one should not attempt to solve problems in such a way that the solution gives rise to further problems which are even more difficult to overcome than the original one.

The Gospels require us never to overlook the poorest and most vulnerable members of society, telling us again and again that they are our sisters and brothers, and more, to ask not only what impact any particular measure will have on them but to discern what they have to contribute in insight, learning and inventiveness.

The preferential option for the poor(8) of Catholic social teaching makes the poor the starting point, emphasising that it is our responsibility to ensure that all can be full actors, something that is denied by the poverty, hunger, disease and lack of education afflicting so many millions in the developing world. This teaching recognises that the capacity of the poor to satisfy their needs and to develop fully as human beings by means of access to health and education is held back by structures controlled by the rich. Common values can also be identified across religions and political analyses. For example the Gospel of Jesus, enriched by Catholic social teaching, shares values with the talisman of Gandhi, which is nothing else but the face of the poorest man. Ganhdi taught that one should decide on the ethics of an action as if every decision was made keeping before one the face of the poorest man.

If granting patents on biological material leads to further disadvantage and vulnerability for the poor of the developing world, then patenting, which was once a response to potential injustice against the person of the inventor, now represents a real threat of injustice against the world’s poor. This can happen:

• by privatising genetic material to which they would otherwise have free access;
• by failing to recognise the collective achievement of previous generations of mainly poor farmers in identifying and isolating plant varieties and thus contributing to the sum of human knowledge and wellbeing; and
• by denying them access to biological inventions which could mean the difference between hunger and an adequate livelihood.

The Pontifical Council for Justice and Peace highlighted a number of ethical concerns based on the principle that the earth is ultimately a common heritage, whose fruits are for the benefit of all. The Catholic Church has always emphasised that "God intended the earth and all it contains for the use of all men and peoples, so created goods should flow fairly to all, regulated by justice and accompanied by charity. Whatever form property may take according to legitimate custom and changing circumstances, this universal destiny of the earth’s resources should always be borne in mind"(9).

With this understanding of nature, humanity and creativity we must look critically at intellectual property and trade. Since all creation starts with God, no human being has an absolute right of ownership. Creation is delegated to all humanity in a spirit of stewardship. We may own a cow, but the cow remains a creation of God. What we call ownership is more to do with grace and responsibility than personal rights. At the same time, the seventh and tenth commandments(10) (one shall not steal or covet) set out principles which honour what a person owns or has produced. These must not be infringed by another person. As far as property may be part of a person’s livelihood, due protection is needed so that one person’s means of sustenance is not stolen by another.

Property rights, therefore, can exist for an individual or a group such as a company, but they are constrained by a wider social responsibility. All individuals have a duty to protect the rights of other individuals and thus contribute to the common good. This social duty, however, is limited and shaped by individual human rights. The frontiers between social responsibilities or duties and individual rights are under constant renegotiation as the world changes. Nevertheless we can say that the goods of creation are destined by God for the welfare of the whole human community. Yet in economic terms we tend, however, to use both people and creation as mere instruments of our purposes and powers. This distortion can lead to IPRs being used primarily as a means of wielding power over others, or to restrict access to the bounty of God’s creation to certain groups in society. As PBRs take precedence over farmers’ rights, wealth will become increasingly concentrated.

When this happens, a conflict arises between the rights and the social responsibilities of the patent holder. A patent is no longer ethical if the protection given to a few causes many to be denied the achievement of their humanity, and especially when it applies to having food and a basic livelihood.

A further responsibility that comes with having a property right is what Pope John Paul II has called the "social mortgage" on property. Shortly before the 1999 annual general meetings of the World Bank and IMF, John Paul II stated that "the Church has consistently taught that there is a ‘social mortgage’ on all private property, a concept which today must also be applied to ‘intellectual property’ and to ‘knowledge’. The law of profit alone cannot be applied to that which is essential for the fight against hunger, disease and poverty."(11)

From an ethical point of view this social mortgage arrives from the fact that property rights must be justified in terms of rights to a fully human life. Because human rights are universal the obligation for those with an unequal share of property rights is to address the needs of those without sufficient possessions to live, or to live fully. The social mortgage is a responsibility which exists at the same basic level as property rights. It is not an additional or optional qualification of property rights because both rights and responsibilities are justified in terms of the same rights to a fully human life.

Such an understanding of social responsibility calls the patent holder to examine the wider effects of the claim to exclusive use of the invention. The patent holder cannot be oblivious to the consequences of the patent. Where it would clearly lead to injustice, then the higher principle of social justice must take precedence. This should be especially so for companies whose power and influence is generally far greater than that of the individual(12).

Patenting must therefore be seen in its social, environmental and ethical context. This includes the promotion of human welfare and safety, a special concern for poverty and disease in the developing world, and removing injustice from society, animal welfare and care for creation. From a Christian point of view, these factors set limits to the importance of a commercial reward for inventiveness.

A turning point occurred when patent applications involving living organisms began to be filed on a regular basis. Although there was already a predisposition to regard patenting biological resources as no different from patenting anything else, the decisions of the US Supreme Court in the landmark Chakrabarty case(13) established a principle that "the relevant distinction was not between living and inanimate" things but whether living products could be seen as "human made inventions". This was part of a major but invisible cultural change, expressed by a senior UK patent expert, R S Crespi(14):

In almost all ethical systems, however, a vital distinction is made between how we treat what is living and what is not. Firstly, animals and plants are creatures that have a life of their own. They are not merely products of industry, or mere objects for human use. The shift of perception from product of nature to product of industry is part of a process of commodification which, carried to its logical extreme, would reduce all creatures to their mere functional use by humans. It denies their essential inherent value.

The EU Biopatenting Directive strongly affirmed the principle of patenting almost everything biological. It merely added a set of arbitrary exclusion clauses for applications such as human cloning known to be politically sensitive to the European Parliament. It did not respond appropriately to the full range of relevant ethical concerns, and made clear that its prime concern was European economic growth and competitiveness. This drive to patent everything biological turns the commercial paradigm into an idol.

The second distinction concerns what has been invented. Where genetic modifications to an animal or plant are an issue, the addition of two or three genes to an animal with perhaps 100,000 genes does not turn the animal into a human invention. The inventive step is to add the new gene construct to the animal. The novel construct might be rewarded by a patent, or the inventive application of a modified animal to a specific purpose.

The Church of Scotland (15) put its opposition to patenting living organisms like this:

The same applies to a gene. It may take great intellectual effort to decypher a gene and identify its function, but the gene is just as much a product of nature as the animal. Despite the considerable investment involved, the identification of a gene’s function is not an ethical ground for claiming inclusive rights. Even though intellectual effort has been used, it is of the nature of discovery, not of invention. However, the EU wanted to find a premise to patent human genes. The Biopatenting Directive states that genes are patentable inventions because they have to be copied, using bacteria or chemicals, in order to be isolated and identified.

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