by Steve Emmot | 20 Mar 1997

March 1997



Steve Emmot

Two years ago, to everyone's surprise, the European Parliament voted down the Life-Patents Directive. Although opponents knew that the Directive would be back, the Parliament's decision was taken as a rare moral victory of common sense over commerce. Sure enough, the Directive has risen again, and the Parliament will reconsider the new draft in the coming months. Steve Emmot compares the new Directive with the old one and concludes that there is still a great deal - in fact, even more - for politicians to worry about, especially in the light of new developments in case law and the arrival of Dolly, the cloned sheep from Scotland.


In March 1995, the European Parliament (EP) rejected the proposed Directive on the "legal protection of biotechnological inventions", better known as the Life-Patents Directive. This was the first time the Parliament had taken such a step and the move represented a considerable flexing of its new legislative muscles granted under the Maastricht Treaty. NGOs, which had long campaigned against the Directive, were jubilant and claimed a victory for common sense over commerce. The biotech industry, the driving force behind the creation of the Directive, was not happy. Nevertheless, it put on a brave face, claiming that this was not a particularly significant event. It would continue to use the patent regime established under the European Patent Convention (EPC) to obtain protection for its inventions from the European Patent Office in Munich (EPO).

Nine months after the vote, the Commission tabled a "new" draft life-patents Directive. Like the first draft, it was presented simply as a harmonisation measure - a technical tidying up to bring patent law in all member states of the EU into line. In fact, all 15 countries are already signatories to the EPC and therefore have a common patent framework. However, the interpretation of EPC patent rules varies from country to country, and the EPO decides patent approvals on a case by case basis, without providing clear guidelines as to what is patentable. As distinct from the EPC, the EU Directive would be a regulatory framework to which national patent legislation of EU member states would have to be adapted. Such a move is obviously much favoured by industry.

George Poste, Chair of Research and Development at SmithKline Beecham tried to reassure Members of the European Parliament (MEPs) in a recent letter that "this Directive does not extend patent simply translates the European Patent Convention and current legal practice into European Union law. All that industry is seeking is to continue what has been possible since the first gene patents were granted 20 years ago". His position is typical of industry representatives, who hope MEPs will not notice the major changes the Directive really implies. In reality, the Directive seeks to change the terms of reference for patenting, and if agreed, will significantly broaden the scope of products and processes that are deemed patentable in Europe.

This time, the biotech industry has learnt that it cannot take success for granted and has mounted a major lobbying offensive led by the pharmaceutical companies. This is because the industry believes that the potential benefits of medical research are the most compelling arguments for gaining public acceptance of biotechnology. The new Directive, like the old one, would give industry patent control of the whole "supply chain" from the basic genetic material, through the processes which make use of genes and gene sequences, to the products which result, to successive generations which carry the genes and into other products which incorporate or express the same genetic information. No wonder that Poste believes that "Genes are the currency of the future."

The new Directive resembles the old one in many ways. Although there is some tightening up, such as in the arena of germ line therapies, overall the new text is more liberal than the old one in what it deems patentable. In a number of instances it seeks to reverse EPO case law, particularly the EPO's recent ruling that plants and animals are not patentable.

Mother's Ruin: Biocyte's umbilical cord patent

The US-based Biocyte Corporation has been granted a European patent (EP 343 217) on the blood cells of the umbilical cord of foetuses and the newborn. The patent holder has done nothing except show that these cells can be isolated and deep frozen. The patent gives Biocyte monopoly control over the extraction and use of the cells and over any therapies developed in connection with them.

The patent has been challenged by European NGOs, on the grounds that it aims to patent an unpatentable process (the European Patent Convention states clearly that therapeutic and diagnostic processes are exempt from patentability); that it is a discovery, not an invention; that there is no inventive step; and that it is an offence against morality and public order. It has also been challenged by transplant doctors through an alliance known as EUROCORD, which notes that the International Society of Transplantation states that "no part of the human body can be commercialised and that organ or cell donation should be free and anonymous". EUROCORD states that "We deplore any attempt to patent a non-pharmacological method of treating patients with haematological diseases and recommend that clinicians and scientists disassociate themselves from patents of this type, be they already granted or only in application form."

The granting of this patent means that Biocyte can refuse the use of these blood cells and any therapeutic products derived from them to anyone unwilling or unable to pay their fees. This situation is made even more unpalatable in that the patent does not require the consent of the subjects from whom the cells are taken. The cells are taken from newborn infants and their mothers, and then sold back to them - no doubt at quite a price. The patenting of human cells adds a whole new dimension to the biopiracy issue.

If the latest draft of the Life-Patents directive is adopted, it will be much harder to challenge this kind of patent, since Article 3.2 stipulates that "The subject of an invention capable of industrial application which relates to an element isolated from the human body ... shall be patentable, even if the structure of that element is identical to that of the natural element".


Human Genes and Germ Line Therapy

The most compelling issue which persuaded parliamentarians to vote against the Directive was the question of patentability of human genetic material and germ line gene therapies. MEPs were very clear that human genes and gene sequences should be placed outside the scope of patentability. They had three basic grounds for such objections. Firstly, that on philosophical, moral or religious grounds, humans and their genetic make-up are not to become commercial commodities. Secondly, that human genetic material already exists and is there to be discovered. It cannot therefore be invented. This is a long-established principle of patent law. Thirdly, that granting a monopoly patent on a gene to one company or institution effectively stops others from using that knowledge to develop other beneficial products such as medicines or treatments.

Although the first draft Directive ruled that parts of the human body should be unpatentable in not. The new text is much more explicit, stating that "an invention capable of industrial application which relates to an element isolated from the human body or otherwise produced by means of a technical process shall be patentable, even if the structure of that element is identical to that of a natural element." With these words, the Directive deliberately blurs the boundaries between the two distinct acts of discovery and invention. The technical processes of isolating the gene and replicating it in the laboratory may well be patentable inventions, but to proclaim that the result of applying these processes and reproducing an identical human gene gives a patent right over the gene is a breathtaking leap of illogicality. It is like claiming copyright for a photocopy of another author's manuscript.

In 1994, the French changed their patent law to prevent this very situation arising. Its new law says that on grounds of public policy and morality "the human body, its elements and products and knowledge relating to the overall structure of a human gene or element there of may not, as such, form the subject matter of patents." The Commission cites this as an example of the legal uncertainty which arises from the lack of a Directive. In practice it is seeking to override the French law.

The EPC has nothing directly to say on the subject of patenting human material, having been drafted before such possibilities existed. In practice though, the EPO has begun to accept such patent applications in an ad hoc way. It recently granted a patent to the US firm Biocyte for human stem cells derived from umbilical cord blood and all medical treatments which use the composition. There appears to be nothing inventive in the specification which describes collection and freezing techniques which are not themselves new (see Box). The gene coding for the hormone relaxin (used to assist in childbirth) was patented by Australia's Howard Florey Institute and still stands despite a challenge from the Green Group. Recently, SmithKline Beecham filed an application for a patent on the calcitonin gene and its proteins and mutations despite being unable to specify any application for them.

Patents granted by the EPO remain valid until successfully challenged, which takes several years. Leaving the EPO to develop its case law based on the hazards of the appeal process is an inefficient and energy-consuming process. A clear legal statement of the limits to patentability of human genetic material is needed. A Green Group initiative in the Environment Committee of the EP, which has advisory powers, has drawn up a formula which would help make clear the important distinction between discovery and invention, which is a useful step forward. However, in the light of recent announcements from the Roslin Institute in Scotland of the successful asexual cloning of a sheep and the probability that human cloning could be achieved using the same techniques, the whole question of patenting "inventions" involving human genetic material now needs to be re-examined and could lead to a much more comprehensive ban.

Germ line therapy was one of the key areas which parliamentarians felt was not dealt with satisfactorily last time. This is one of the few areas where the Directive has been strengthened rather than weakened. The Commission has now made the ban more comprehensive and the new text states clearly that "methods of human treatment involving germ line gene therapy" are unpatentable. However, the EPC contains provisions also excluding methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body. A limited version of this appeared in the old Directive but is not mentioned in the new one. The Commission argues that since this issue is covered by the EPC, it is not necessary to reproduce it again in the Directive but in view of the wholesale changes being introduced, this is spurious logic and raises the possibility of further moving the boundaries to include patents on non-germ line therapies.

Plants and Animals

Although under the World Trade Organisation's (WTO)Trade-Related Intellectual Property Rights (TRIPS) agreement, signatories are not obliged to extend the patent regime to plants and animals, the Commission has not changed its position on this issue. Article 4.2 has been expanded to read "Biological material, including plants and animals, as well as elements of plants and animals obtained by means of a proc
ess not essentially biological
, except plant and animal varieties as such, shall be patentable" (changes in italics).

The "not essentially biological" qualification seems inoffensive enough, but it represents a further redefining of boundaries. The opposite to biological, in patent law, is a microbiological process which is prima facia patentable under the European Patent Convention (EPC). Here again the Commission has extended the demarcation lines, stating that products as well as microbiological processes shall be patentable.

The significance of these provisions is that they seek to reverse the current case law of the EPO. In a landmark case brought by Greenpeace against the Belgian company Plant Genetic Systems (PGS) the EPO decided that using genetic engineering techniques to modify the genome of a plant (a microbiological process) did not outweigh the essentially biological processes of regeneration and growth inherent in obtaining a plant. Plants (and seeds) could not therefore be claimed for patentability under the microbiological processes heading. As products though, they could be, under the new Directive. The same logic should apply to animals. The result of an opposition to the cancer-mouse patent is still outstanding, but one of the senior examiners in that case was reported recently as saying "Currently, the EPO does not patent plants or animals". The result is a curious state of affairs where the law on plant and animal patents is more restrictive than on humans.

Plant and animal varieties remain unpatentable "as such". However, the decision in the PGS case referred to above also involved the EPO in giving its interpretation of the extent of this restriction. They found that transformed plants and seeds effectively become a new plant variety because they are distinguishable from all other plants by their new characteristics which are transmitted in a stable manner to the next generation. This provided further grounds for the EPO to declare that plants (and by analogy animals) could not be patented. The Commission has made it clear that they do not like the PGS decision, and its new Article 4.2 sets up an explicit conflict between the EPO decision, with its wide interpretation of the concept of a variety, and the narrow wording of the Commission text.

Farmers' Privilege

The new Directive reflects the acceptance by the Commission that there should be a derogation for farmers who breed to replenish their livestock as well as a plant propagation privilege, which was outlined in the earlier Directive. This still represents a very limited concession to farmers and prohibits off-farm exchange or the co-operative sharing of seed or livestock without attracting royalty payments. But the reality is likely to be even less rosy for farmers. To get round such restrictions, we are likely to see the growth of strict contractual arrangements imposed by the seller on the farmer along the lines of those now being used by Monsanto in the USA for its RoundupReady soybeans (see p18.). The Monsanto contract imposes a technology fee, and requires an undertaking from the farmer not to re-use farm-saved seed for further propagation, to use only Monsanto's own branded herbicide and to pay predetermined legal damages for any breach of the contract terms. Such contracts completely by-pass the attempt to write a farmers' privilege into patent law.


As with human genes, the Environment Committee of the EP adopted a clearer statement on where the dividing line should be drawn on the patentability of plants and animals. In its proposed amendment to Art. 4.2 and Art. 8 it says:

"Art 4.2: Biological material as such including plants and animals, elements of plants and animals and plant varieties and animal breeds are not patentable in accordance with article 8.

Art 8.1: The subject of an invention concerning a biological material shall not be considered a discovery or lacking in novelty merely on the grounds that it already formed part of the natural world; however the living organism and its elements are not patentable even when they are included within a patent specification.

8.2 Notwithstanding paragraph 1, an invention which makes use of elements, products or knowledge of the living organism can be patentable."

Again, this formulation may not be perfect but it sets out the distinction between the non-patentable living organism and the patentable invention which uses genetic information. However, the submission of a patent application for the cloning process used to create Dolly may well cause the EP to look more closely at the whole question of animal patents.


One of the most serious, but least understood or debated, issues of concern related to the Directive is the question of biopiracy: the appropriation of peoples' knowledge and genetic resources by corporations and the consequent privatisation of both through the application of patents. Most of the world's existing wisdom in the fields of agriculture and medicine has come about throught the free exchange of knowledge and resources between communities, individuals and countries. The biotech industry would have us believe that strong intellectual property right regimes are essential for innovation to thrive: yet reality belies the theory.

Some of the consequences of biopiracy are that it:

· Stifles innovation and suffocates the progress of R+D, in both the formal and informal sectors.

· Robs farmers and communities of the resources they need to survive and thrive.

· Downgrades farmer and community knowledge and wisdom, while overglorifying technological skills.

· Disempowers farmers, healers and other researchers in the informal sector.

· Concentrates genetic and financial resources in the hands of corporations.

· Threatens biodiversity and food security.

· Violates many communities' moral, ethical and spiritual codes.

Apart from its small concession of the farmer's privilege, the draft Directive does not address the implications patenting plants and animals has for farmers and communities around the world. It contains no reference to the principles set down in the Convention on Biological Diversity which provide for the equitable sharing of benefits arising from the knowledge of local communities, their innovations and practices. It does not address the issue of prior informed consent for the use of genetic resources collected from their territories. Nor does it consider the implications for farming systems and agricultural innovation which will be stifled by the privatisation of agricultural resources.

Patenting their own resources in order to protect their livelihoods, even if they were interested in doing so, is way beyond the means of most farmers and innovators in developing countries. At present, many people give away their seeds, their plants and their knowledge without realising that these may become the proprietary rights of some industrial company. Even if they are aware of this situation and could afford to get caught up in the patenting game, for many communities privatising genetic resources is simply not an acceptable path to follow. It is often against their moral, spiritual and ethical beliefs.

Animal Welfare

One of the concessions obtained by the EP in the conciliation process last time was the introduction of a ban on patenting processes for modifying animals in a way which would cause them suffering or handicap. It was, however, subject to an over-riding "cost/benefit" test which opened the door to such patents if there was "substantial benefit to man or animal" and/or the suffering was disproportionate to the objectives being pursued. The Commission has retained this text more or less unaltered. The Environment Committee proposed to drop the double tests and to make it an absolute prohibition.

Bt Bites Back

The Bt gene is a very clear example of biopiracy. The gene was isolated from the naturally-occurring soil bacterium Bacillus thuringiensis (Bt), which produces a protein that destroys the gut wall of a number of common insect pests. Because of these properties, Bt has been used as a biological pesticide by organic farmers since the 1960s. In the face of regulatory constraints and consumer opposition to conventional chemical pesticides, the environmental-friendliness of Bt has recently caught the eyes and investments of several large agrochemical companies. Scientists have isolated the Bt gene and inserted it into a range of crops, including maize, soybean, cotton, rapeseed, potato, tobacco, rice and tomato.

Numerous patent applications have followed in the wake of these transformations. By March 1995, there were no less than 440 patents granted or pending related to Bt, 88% of which were being claimed in the private sector, and 44% by only 10 companies. Bt corn, cotton and potato have all received patent approval in the US. In Europe, the approval of Novartis' Bt corn has been stalled over the presence of a marker gene which codes for antibiotic resistance. There is a good deal of conflict over who really owns what. For instance, Plant Genetic Systems has been granted a US patent for all transgenic plants containing Bt, and Mycogen has been issued a European patent which covers the insertion of any insecticidal gene in any plant. Such driftnet patents conflict with many narrower spectrum claims.

In the US, legal wrangles over ownership of Bt technology are consuming vast amounts of time and resources amongst many of the leading agrochemical companies. In their eagerness to cash in on the toxin before their competitors, companies are rushing new products to market and out into farmers fields as fast as they can. So quickly that the research on the safety and environmental implications of the newly transformed crops is coming in after the stable doors have already closed. Recent studies have shown that the potential for resistance to develop in the targeted insects is dramatically higher than was predicted. (See Sprouting Up)

This means that the farmers who used Bt initially not only face having the product they have carefully developed taken from them without any recognition of, or remuneration for, their role in developing it, but they are also robbed of a very important pest control tool. The Bt story also illustrates how stifling patenting is to the process of innovation which is so essential to agricultural development. Farmers all over the world have always insisted on the free flow of seeds and knowledge in order for agriculture to thrive and develop. Allowing the patenting of agricultural produce is causing companies to spend more and more time and money in law-suits, rather than putting their energies into innovation and development.

Next Steps

The EP's Legal Affairs committee has again been charged with responsibility for this Directive and the Rapporteur is the same Herr Willi Rothley, German Socialist. His response to the Directive and all its shortcomings has been to delete many of its provisions, both the good bits and the bad, and to substitute a short list of patentable and non patentable items. His list is heavily weighted towards industry's demands and does nothing to meet the objections described above. This approach has already been criticised by some of his colleagues on the committee and it remains to be seen whether it will survive in its present form.

Except for the extracts discussed above, the new draft Directive remains essentially the same as the old one. If Parliament could agree to the changes adopted by the Environment Committee together with an explicit ban on cloning techniques for animals and humans then we would have made significant progress towards a workable set of restrictions on life-patents. If not, then we should campaign, as before, for rejection of the Directive and for a full revision of the European Patent Convention.


GRAIN is against patents on life and campains for the rejection of the patent Directive. Steve Emmot works for the Green Group in the European Parliament and monitors the developments of the Life-Patents Directive very closely. He can be reached at The Greens at the European Parliament (32-2) 299 11 11. This article was edited and enriched with Boxes by Janet Bell.



Even CNN and The Economist picked it up. Since late January, 20,000 of Thailand's poor have descended onto the front lawn of the Government House in central Bangkok. Most of them are farmers from the North and Northeast, where the missing chapters of Thailand's economic boom are being written. Others joining their ranks are slum dwellers and workers. Their name? The Forum of the Poor.

Forum of the Poor set roots with the action of Northeast farmers against a eucalyptus planting programme and the role of big business in shaping the National Agriculture Committee's bill in 1992. This small group of farmers won the support of many farming communities living in reserved forest areas in the region and became known as the Northeast Small Farmers Forum in 1993. This became Forum of the Poor (FOP) last year and held its first rally in Bangkok in April 1996, with 6,000 demonstrators drawing attention to the flip side of Thailand's highly flaunted development story.

Last year, the movement's agenda was dam issues, the right to the land and community forestry. However, the movement is now building up and broadening as other groups join in, especially Thailand's vast Alternative Agriculture Network (AAN). The agenda carried by FOP now covers 91 points on forest and land conflicts, 15 on dam projects, five on state development projects, eight regarding slums, one on occupational health, another on alternative agriculture and two directly addressing national legislation.

The history of the poor's movement comes from the debacle of the Green Revolution in the rural areas. Farmers face the problem of debt and losing their land. The failure of the government's land reform programme is driving more and more landless farmers to live in the reserved forest areas. It is estimated that there are nearly ten million impoverished Thai farmers living in these conflict zones now.

The Forum's proposal to solve this problem is tripartite: provide compensation to the people for lost land or else stop some of the government's encroaching projects; allow farmer participation in natural resource management and rural development programmes; enact legislation on community forestry and farmers' rights. Of these demands on the government, two breaktrhoughs were recently reached on sustainable agriculture and farmers' rights. Regarding sustainable agriculture, the government agrees to embrace it within Thailand's Eighth National Economic and Social Development Plan for 1997-2001. The Ministry of Agriculture has accepted that both AAN and FOP should play a direct role in the planning process. As a result, 20% of Thailand's agricultural lands (around four million hectares) will now be devoted to sustainable agriculture systems such as integrated farming, organic farming, natural farming and agroforestry. The Ministry also agreed to set up a people's monitoring committee for implementation of the Plan and will provide 1,000 million baht (US$ 40 million) for AAN to pursue a parallel agricultural development programme, fully managed by the poor farmers, over the next five years.

Regarding farmers' rights, last 5 March the Prime Minister appointed a Plant Protection Act Drafting Committee composed of 21 people: three cabinet secretary officials, six from the Department of Agriculture, five from the Department of Intellectual Property and seven from the AA Network and Thai Working Group on Traditional Medecines & Genetic Resources. The Committee will integrate two draft bills from the Departments of Agriculture and Intellectual Property, and expand the protection of plant varieties to cover farmers' and local varieties. This will go on in parallel to a previously launched initiative to draft a Traditional Medecine Bill started by the Thai Institute of Traditional Medecine in the Ministry of Public Health.

Forum of the Poor has been sitting in front of Government House - the Prime Minister's Office - for more than six weeks now. FOP spokespeople say they will remain there for up to three months, to ensure conclusion of their negotiations and its full acceptance by the government. Not in vain, perhaps. The Prime Minister, General Chavalit Yonghaiyudh, met with 150 Thai NGOs on 11 March to affirm that he sincerely wants to solve the problems of the poor. The negotiations roll on...

Source: Witoon Lianchamroon, Alternative Agriculture Network, Thailand

Author: Steve Emmot