Swati Gola*
Introduction
Agriculture is an important part of world economy, both in International and Domestic markets so much so that agriculture reforms remain in the very heart of the world trade talks. It is also one of the areas in which negotiations on trade liberalisation are mandated in World Trade Organisation (WTO) agreement. The new order of world trade in agriculture products is highly demanding and full of challenges in the form of non-trade barriers. The Doha round of Trade Negotiations in 2001 mandated for elimination of all forms of export subsidies and a variety of export incentives. The three pillars of agriculture- export subsidies, support and market access- which are interrelated, are subject to further negotiations. A strong WTO institutional mechanism oversees stratified general provisions, standards concerning availability, scope and use of IPR , control of anti competitive practices in contractual licences, enforcement, acquisitions, maintenance, related inter partes procedures, dispute prevention and settlement procedures and institutional and transitional arrangements for adoption and application by its Member countries .
TRIPs and Agriculture
The Trade Related Aspects of Intellectual Property (TRIPs) agreement under WTO recognises Intellectual Property Rights as private rights. As early as in Uruguay round of General Agreement on Tariff and Trade (GATT) negotiations, agriculture was seen harmonious with Industrial Property Rights and has been brought at par with other industrial trade sectors in terms of common institutional framework for conducting trade relation among members, protection of IPR and services. The system to promote the invention by providing incentives in terms of Intellectual Property Rights protection to investors, who takes the risk of investing in an idea that might fail, was good so far as it covered only inventions and not discoveries. It started to be unfair, since it came to be applied to living things, as nobody has yet learned to create living things. Now the industrialised countries are patenting living things as if they have invented them. The TRIPS Agreement of the WTO includes three items related to agriculture: Geographical indications (Art 22-24); Patent protection of agricultural chemical products (Arts. 70.8 and 70.9); Plant Variety Protection (Art 27.3(b)). Patents and Plant Variety Protection (PVP) are two different forms of IPRs. Both provide exclusive monopoly rights over the creation (such as new plant variety) for commercial purposes over a period of time. The provision for patenting on life form is the most contentious issue within TRIPS. A patent is a right granted to an inventor to prevent all others from making, using and/or selling the patented invention for 20 years. The criteria for a patent are novelty, non-obviousness and utility. PVP provides patent like rights to plant breeders. What gets protected in this case is the genetic makeup of a specific plant variety. The criteria for protection are: novelty, distinctness, uniformity and stability. PVP laws can provide some exemptions for breeders, allowing them to use protected varieties for further breeding, and for farmers, allowing them to save seeds from their harvest. For the seed industry, PVP is regarded as the weaker sister of patenting mainly because of these exemptions .
Commercial interests in the new developments in biotechnology led to pressure being exerted on WTO member states to provide better patent protection in this area. The text of Article 27.3(b) is the result of the attempt by certain Northern countries and the biotechnology lobby to impose private, monopolistic rights over biological resources. Article 27.3(b) represents a major new development in IPR law; since it blurs the distinction between "inventions", which are patentable under traditional patent law, and "discoveries", which are not. The majority of the developing countries, during the TRIPS negotiations, objected to the notion of the patentability of biological resources.
TRIPS is the first international instrument to require IPR protection for life forms. The obligation at present is limited to micro-organisms and plant varieties, that is to say that WTO member states now have a discretion not to allow for IPR protection of plants and animals, save for micro-organisms, plant varieties, non-biological and microbiological processes. The obligations under Article 27.3(b) can be broken down into three components, viz.:
A country may exclude from patentability plants, animals and essentially biological processes for the production of plants and animals;
A country must allow patents for micro organisms and non-biological and microbiological processes for the production of plants or animals; and
A country must provide protection for plant varieties, either by patents or by an effective sui generis system or a combination thereof .
This sui generis system would be based upon an internationally recognised system of PBRs — plant breeders rights; or PVPs — plant variety protection measures. The United States is trying to get Southern governments to accept the sui generis guidelines laid down by the Geneva based Union for the Protection of New Varieties of Plants (UPOV) as the best way to fulfil their obligations under TRIPS. The UPOV system operates under two conventions –one set up in 1978 and the other established in 1991. Under the original UPOV statement, the South’s biodiversity was understood to be part of the heritage of mankind, and therefore freely available to all for scientific or commercial use. This allowed private interests such as multi-national pharmaceutical and agro-business enterprises to plunder the South’s genetic material without compensation. These corporations could then develop an "improved" variety and claim property rights on the basis of having made an "invention". Having done this, the "free heritage of mankind" plundered from the fields and forests of local communities could be sold back to them as a commodity.
The plant protection system initiated under TRIPs are likely to encourage Genetically Modified crops, putting premium on food reproduction through biotech methods. Agricultural biotechnology encompasses a range of research tools scientists use to understand and manipulate the genetic makeup of organism for use in agriculture: crops, livestock, forestry and fisheries. However, genetic engineering, particularly in the crop sector, is the area in which the biotechnology is most directly affecting agriculture in developing countries and in which the most pressing public concerns and policy issues have arisen. Supporters hail genetic engineering as essential to addressing food insecurity whereas the opponents claim it will wreck environmental catastrophe, worsen poverty and hunger and lead to corporate takeover traditional agriculture and the global food supply. This might mean that varieties traditionally grown in developing countries may be genetically changed, and that these new varieties will end up substituting the plants from which they were derived. There are many reasons to be believed that this trend has grave implications for future food security. The first and most important thing to bear in mind here is that control over new seed varieties rests in the hands of a few large companies investing vast sums into research and development. The development of genetically engineered crops is therefore not being driven by the needs of poor and vulnerable farmers, but by large multinational companies with two essential motives: -
1) To generate profit; and
2) To ensure the continuation of that profit by consolidating their control over the international agriculture sector.
This is plain enough when one looks at the trends in crop research and development. Rather then focusing on improving yields in marginal lands, nearly all research into GM crops is going into improving food processing qualities, transport durability, appearance and shelf-life – traits favouring sales in Northern consumer niche markets rather than meeting food needs in the South. Even where research has been geared towards developing countries, the emphasis tends to be on export crops at the expense of subsistence crops.
Furthermore, most GM crops are geared towards intensive agriculture unsuited to the diversified farming systems practised by millions of resource-poor cultivators. Like the hybrid varieties pioneered at the international crop research centres during the 1960s, GM crops generally require intensive farming methods; necessitating a departure from traditional techniques such as multiple cropping, intercropping, and nutrient recycling. This trend will further disempower and marginalise farmers in the local and national food production process .
Both UPOV conventions ignore altogether the rights of millions farmers who have been engaged in seed breeding and development for generations, the innovative contribution of the local communities and give protection only to the commercial breeding sector. Unlike its predecessor, UPOV 1991 also gives exclusive rights of sale and reproduction to the patent holder, denying farmers the rights to replant and exchange seeds. In fact, many critics point out that the entire regulatory process under UPOV reflects a trend of ever-greater protection of the interests of commercial plant-breeders and fewer and fewer rights for traditional farmers. Critics argue that if developing countries enter into the UPOV 1978 convention they will, according to the Crucible Group, be entering "…a political and policy treadmill leading inevitably to UPOV 1991 and then onward until UPOV is indistinguishable from the most monopolistic elements of the utility patent system".
Plant Variety Protection: Developing Countries’ Concerns
Developing countries are concerned that the control of the nature and distribution of new life forms by Transnational Corporations (TNCs) may affect their food security and development prospects. It had previously been thought that private monopolistic rights could not and should not be imposed over biological resources, the source from which the basic food and medicine requirements of human life are derived. There are major economic, environmental and ethical concerns about life patenting, such as its negative impact on consumer rights, biodiversity conservation, environmental protection, indigenous rights, scientific and academic freedom, and ultimately, economic development of many developing countries dependent on new technologies. For these reasons, many WTO member states still prohibit the granting of life patents under national laws, although the present trend in countries such as the US and the EU has been to accord patent protection for biotechnological inventions.
However, the TRIPs member states are under an obligation to implement Art 27.3(b) either through patents or effective sui generis system, with the least developing countries to develop such system by 2005. There is, however, a clause under Article 27.2 which makes allowances for patent exclusions where necessary to protect “…human, animal or plant life or health or to avoid serious prejudice to the environment…” There have been attempts to redress the imbalance between plant breeder’s rights versus farmers’ rights.
PVP in India
Capitalising on the TRIPS flexibility to adopt the sui generis system for PVP and maintaining a balance between the rights of farmers and breeders, India have formulated farmer friendly PVP laws. The Protection of Plant Varieties and Farmers Rights Act, 2001 of India, for the very first time, put in place a law to grant Plant Breeder’s Rights on new varieties of seeds as well as grants Farmers rights. The other related Acts include the Patents Act, 1970; the Geographical Indications (Registration and Protection) Act, 1999; the Biological Diversity Act, 2002; the Environmental protection Act, 1986; and the Seeds Act 1966. The Patent Act 1970, amended twice in 1999 and 2002, is in harmony with the TRIPS Agreement. Product patent on genes however remains a grey area.
The Protection of Plant Varieties and Farmers’ Rights Act, 2001, hailed as a progressive and pro-developing countries legislation provides for well-defined Breeder’s rights as well as strong and proactive Farmers’ rights. Its intent is the establishment of an effective system for protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants. The Act recognises the necessity of protecting the rights of farmers in respect of their contribution made in conserving, improving and making available plant genetic resources for the development of new plant varieties. In addition, there are clauses to protect the rights of researchers as well as public interest. The Indian law actually grants very restricted rights to researchers because of the acknowledgement of Essentially Driven Varieties, EDV for which breeder’s authorisation is needed. To secure public interest, certain varieties may not be registered if it is felt that prevention of commercial exploitation of such variety is necessary to “protect order or public morality or human, animal and plant life and health or to avoid serious prejudice to environment.” The Act also provides for the granting of compulsory licence to a party other than the Breeder if it is shown that the reasonable requirements for seeds have not been satisfied or that the seed of the variety is not available to the public at a reasonable price. The Indian legislation is the first in the world to grant formal rights to farmers in a way that their self-reliance is not jeopardised .
Emerging Issues
What are the possible implications of the new IPR regime in India, which are enacted in an attempt to fulfil the obligations under WTO? There are many issues emerging in the area of agriculture with respect to agricultural biotechnology esp. G M crops, which may have grave significance over agriculture in future that need to be looked into in time. For example Indian Protection of Plant Varieties and Farmers’ Rights Act simultaneously protects the rights of breeders, farmers, researchers and public interest as well. What are the possible implications of establishing such a system of multiple rights on the utilization and exchange of genetic resources among various actors? Could the attempt to distribute ownership rights to various stakeholders pose the threat of an ‘anti-commons,’ where resources are under utilized due to multiple ownership? Although the Multiple Rights system aims to equitably distribute rights, it could problems of overlapping claims and result in complicated bargaining requirement for utilization of varieties. A potential implication is an ‘anti-common tragedy’ where too many parties independently possess the right to exclude giving rise to underutilisation of resources. India and other developing nations, in seeking to achieve the important goal of recognising the farmer’s rights, must not overlook the need for promoting exchange of agricultural resources .
Similarly the question of grant of broad-spectrum patent requires to be explored. The European Patent Office at Munich recently ran into opposition to a broad-spectrum patent granted on all GM soybean varieties to a Monsanto owned company. Similarly a patent has been granted in the US to a biotechnology company, Sungene, for a sunflower variety with very high oleic acid content. The claim was for the characteristic (i.e. high oleic acid) and not just the genes producing the characteristic. Sungene has notified others involved in sunflower breeding that the development of any variety high in oleic acid will be considered an infringement of its patent . The impact of such broad patents extending to all plants will become a grave impediment to the ability of developing country researchers to access new crop improvement technologies and to breed new crops for their regions. Patents per se and such broad patents particularly have grave implications for farmers in developing countries. Restricting access to seed can strike at food and livelihood security by limiting the ability to access new seeds that can help to cope with biotic and abiotic stress situations that occur from time to time in agriculture. Patents of the kind being claimed and granted on biological materials and seeds are in essence faulty and cannot be defended since variability is a central feature of biology and the innovation is not reproducible. Every plant in a field of any crop variety will be different to the others .
Another important area of concern is the implication of GM crops on the food security in developing countries and the threats that new genetic constructs entail in terms of damage to Biodiversity and Wildlife, Environmental Pollution, Unstable Construct and Cross Pollination in the Fields etc. The biggest-ever scientific research trials, and that too carried by the British government science agencies, have established what was widely known and feared: GM crops do an irreparable damage to wildlife and biodiversity. Cross-pollination between GM plants and their wild relatives is inevitable and could create hybrid superweeds resistant to the most powerful herbicides. The results of the research trials, which too were rigged, were so obvious that scientists were actually unable to hide them any longer. And two years later, after the controversy shrouding the contamination of maize - one of the world's most important food crops -- in its centre of origin in Mexico broke, the Mexican government (and also the scientific community) have now acknowledged that Mexico's traditional maize crop is contaminated with DNA from GM maize despite a government prohibition on the planting of GM seeds. The contamination is more widespread than what was earlier reported. Isn't it therefore worrying that despite the known facts, the Department of Biotechnology has given a green signal for research on GM corn in India ?
Another area of controversy is the legal consequences of Cross-pollination between GM plants and the local varieties of the same crop growing in the nearby fields. In March 2001, a Canadian Judge ordered a farmer Parcy Schmeiser to pay Monsanto (one of the worlds biggest biotech company) thousands of dollars because a genetically modified (GM) canola variety patented by Monsanto was found growing on his field. This decision was reached even though Schmeiser consistently stated that he did not grow these seeds voluntarily, but that his crops were cross-pollinated by modified plants from another farm. Although several similar lawsuits have been filed against farmers in North America, this is the first case that ended up in a trial. He was quoted as saying, “I've been using my own seed for years, and now farmers like me are being told we can't do that anymore if our neighbours are growing (genetically modified) crops that blow in. ... Basically, the right to use our own seed has been taken away.” In another case, Imagio Nursery vs. Daina Greenhouse, the US District Court for Northern District of California ruled that a plant patent can be infringed by a plant that merely has similar characteristics to the patented plant.
These cases underline the world-wide increasing tension between farmers and large biotech companies, which with their introduction of patented gene intend to change traditional agriculture pattern forever. These kind of precedents based on product patents can be disastrous if the original donor of the biodiversity that give rise to these properties are accused of piracy in the absence of laws on traditional knowledge. The impact of these changes on farming communities worldwide could be tremendous. In the South, where people will likely not be able to afford high-tech seeds and the associated chemical inputs year after year, the introduction of GM seed varieties presents a particularly grave threat to the food security and food sovereignty of thousands of local and indigenous farming communities . The German parliament passed a legal amendment in November 2004 that will protect farmers who grow conventional crops from any contamination by genetically modified versions. It means that GM farmers will be financially liable for any economic damage caused if their crops contaminate neighbouring non-GM products. Environmentalists welcomed the law stating that this law should now be the benchmark for similar legislation in other EU member states .
Which protection shall GM crops be granted, shall they be patented or shall they be protected as a plant variety. The USA already provides the most liberal scenario, providing both patent and PVP option to protect plant and plant varieties. The European Union has also issued a Directive on the legal protection of biotechnological inventions to clarify how patent laws should be applied to biotechnological inventions . The genes used for transforming the transgenic varieties may be construed to be biotechnological inventions and considered eligible for patent by some countries. However, others may not consider gene as ‘invention’ but only ‘discovery’, which cannot be patented. Judgement would rely only on the respective national patent laws . The scenario granting IPR protection in India also remains a grey area as the amendments in Patent Act create a different scenario. The 2nd Amendment making changes in the definition of what is not an invention has opened the floodgates for the patenting of genetically engineered seeds.
In the amended Section 3(i) the mention of “plants” have been deleted from what is not invented. This deletion implies that a method or process modification of a plant can now be counted as an invention and therefore can be patented.
The Patent Ordinance which came into force on December 27, 2004 to comply with the provisions of TRIPs, has also added a new section 3(j), which allows for the production or propagation of genetically engineered plants to count as an invention. Though this section excludes as inventions “plants and animals including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”, plants produced through the use of new biotechnologies are not technically considered “essentially biological”. This loophole, couched in the guise of scientific advancement, thus allows patents on GMOs and hence opens the floodgate for patenting of transgenic plants. While, Art 27.3(b) is under review, the Indian government should have insisted on the completion of the review instead of changing India’s Patent Law .
While having already an explicit law providing protection on plant varieties in the form of Protection of Plant Varieties and Farmers’ Rights Act, 2001, what was the need to provide product patents on seeds through amendment of the Patent Act ? It is not clear which protection shall be granted to seeds of Genetically Modified crops. Shall they be patented as biotechnological inventions or shall they be protected as a plant varieties? It seems that providing both patent and plant variety protection to seeds of Genetically Modified crops defeats the very purpose of the Protection of Plant Varieties and Farmers’ Rights Act.
The most important aspect relevant to stakeholders is the right to information and public policy. In 2003, a symposium organised by the NGO Gene Campaign in New Delhi resulted in the environmental community asking for direct engagement with the Bio-tech and environmental ministries for a better regulatory and monitoring system for genetically modified crops. Few, even the proponents of GM, would argue with the need for an effective and efficient regulatory system; agricultural and public health concerns automatically require that the introduction of modified genes be well regulated. But even on this important issue, New Delhi isn't pro-active, and in February, the NGO had to file a PIL in the Supreme Court demanding a proper regulatory framework . The PIL also challenged the validity of the rules made for Genetically Modified Organisms (GMO) and seek a moratorium on commercial release of GM crops until an ‘effective’ oversight mechanism is put in place. The decision of Supreme Court is yet to come.
In November 2003, Gene Campaign organised a two-day symposium on “Relevance of GM Technology to Indian Agriculture and Food Security”, all the speakers pointed out the appalling state of Regulatory Framework in India and the urgent need to change it. A series of recommendations emerged which were forwarded to the Government’s Task Force on Biotechnology, the GEAC, the Department of Biotechnology, the Minister of Science and Technology, the Indian Council of Agricultural Research and the Ministry of Agriculture, the Ministry of Environment as well as the Prime Minister’s Office . Some of the recommendations are given as follows:
A distinct law should be enacted to oversee Genetic Modification Technology and its implementation. This law must harmonise with other laws and national and international agreements.
A comprehensive biotechnology policy should be developed in consultation with all stakeholders.
A statutory National Bioethics Commission must be set up.
There should be a consultative and participatory process to prioritise crops and traits for genetic improvement through biotechnology with the goal of addressing the needs of small farmers and Indian agriculture.
Investment in public sector research should be increased and strengthened. Novel gene discovery in crops of relevance to India should get highest priority.
Alternatives to the GM approach must be carefully evaluated in each case before deciding on the GM route. A cost and risk benefit analysis must be conducted before deciding on a GM product.
Protocol for food safety tests must be vastly improved and mechanisms for long term monitoring of human health (post GM food release) be put in place.
Develop a stringent protocol to assess environmental and ecological impact.
There should be provisions for post-market surveillance and monitoring of GM products.
Have a policy to deal with bio terrorism urgently.
Make GEAC more competent, transparent and accountable. Post data on research and development of GM crops and products on websites and local newspapers.
Conduct a scientifically sound study to assess attitudes and perceptions about GM technology among stakeholders in India.
Undertake a program of awareness about GM technology to educate the public.
There should be a moratorium on commercial cultivation of GM crops until the regulatory system is demonstrably improved. Research on GM crops, however, should continue.
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* LL.M, University of Delhi, presently working as Research Officer with Indian Institute of Public Administration, New Delhi. Email
golaswati@rediffmail.com End Notes:
Kochhar, Sudhir, “System Perspective for IPR Protection in The Plant Kingdom”, Journal of Intellectual Property Rights, Vol 9, July 2004, p 343.
Adhikari, Kamlesh, “Protection of Farmers’ Rights within TRIPS”, The Rising Nepal, Oct 3, 2004.
Art 27.3. Members may also exclude from patentability...
(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.
Cecilia Oh, “ Article 27.3(b) of the TRIPS Agreement: Review Options for South,” available at www.twnside.org.sg
Julian A. Oram, “The TRIPS Agreement And Its Implications For Food Security”, Sep 1999
Sahai Suman, “Protecting farmers, freeing the breeders”, available at
http://www.indiatogether.org/2003/may Ramanna Anitha, “ India’s plant variety and farmers’ rights legislation,” No 96, EPTD discussion papers from International Food Policy Research Institute, available at
http://econpapers.hhs.se/paper Infra no. 15
“Challenging Broad Spectrum Patents”, India Together, May 2003 available at www.indiatogether.org
Sharma Devinder, “ No GM Please, We’re British,” December 2003 available at
http://www.indiatogether.org/2003 Juan Lopez Villar, “Who really owns seed?” LINK, April-June 2001
“German farmers to be liable for GM contamination”, 26th November 2004, NewScientist.com news service
EU Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, available at
http://europa.eu.int Supra No. 1
Shiva, Vandana, “ The Seed Act & Patent Act: Sowing The Seeds of Dictatorship,” dated 15th February 2005, available at www.imcindia.org
The Patent (Amendments) Bill has been passed by the Parliament of India in April 2005 to replace the Ordinance.
India Together editorial, “Information and public policy”, March 2004
Sahai, Suman “GM, agriculture, and food security”, December 2003 available at
http://www.indiatogether.org/2003/dec/agr-gmconf.htm References
1. Adhikari, Kamlesh, “Protection of Farmers’ Rights within TRIPS”, The Rising Nepal, Oct 3, 2004
2. Cecilia Oh, “ Article 27.3(b) of the TRIPS Agreement: Review Options for South,” available at www.twnside.org.sg
3. EU Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, available at
http://europa.eu.int 4. India Together editorial, “Information and public policy”, March 2004
5. India Together, “Challenging Broad Spectrum Patents”, May 2003 available at www.indiatogether.org
6. Juan Lopez Villar, “Who really owns seed?” LINK, April-June 2001
7. Julian A. Oram, “The TRIPS Agreement And Its Implications For Food Security”, Sep 1999
8. Kochhar, Sudhir, “System Perspective for IPR Protection in The Plant Kingdom”, Journal of Intellectual Property Rights, Vol 9, July 2004, p 343.
9. NewScientist.com news service, “German farmers to be liable for GM contamination”, 26th November 2004
10. Protection of Plant Varieties and Farmers' Rights Act, 2001
11. Ramanna Anitha, “ India’s plant variety and farmers’ rights legislation,” No 96, EPTD discussion papers from International Food Policy Research Institute, available at
http://econpapers.hhs.se/paper 12. Sahai, Suman “GM, agriculture, and food security”, December 2003 available at
http://www.indiatogether.org/2003/dec/agr-gmconf.htm 13. Sahai Suman, “Protecting farmers, freeing the breeders”, available at
http://www.indiatogether.org/2003/may 14. Sharma Devinder, “ No GM Please, We’re British,” December 2003 available at
http://www.indiatogether.org/2003 15. Shiva, Vandana, “ The Seed Act & Patent Act: Sowing The Seeds of Dictatorship,” dated 15th February 2005, available at www.imcindia.org
16. TRIPS
17. Union for the Protection of New Varieties of Plants (UPOV) convntion of 1978 and 1991