Intellectual Property and Food Security Professor Michael Blakeney, Australian Global Studies Research Centre, UWA

Food Insecurity World Food Summit convened in Rome in 1996, by the FAO reported that more than 800 million people, particularly in developing countries, do not have enough food to meet their basic nutritional needs. It was estimated that some 400,000 people were killed by malnutrition daily.

World Food Summit, 5 Years Later, June 2002 Noted “that the average annual rate of reduction in the number of undernourished people in the world was eight million and that if this trend continues, the WFS target of reducing the number of the undernourished by half by 2015, reaffirmed by the Millennium Declaration, will not be attained”

High Level Conference on World Food Security, convened by the FAO in June 2008 Noted that during the first three months of 2008, international nominal prices of all major food commodities reached their highest levels in nearly 50 years while prices in real terms were the highest in nearly 30 years. The High Level Conference observed that the constriction of food supplies was caused by the shift of farmers into the production of biofuels and also the impact of global warming on food supplies. The Declaration issued by the High Level Conference requested an immediate response to requests for food assistance by affected countries and in the longer term to enhance investment in agriculture.

L’Aquila Joint Statement on Global Food Security, 10 July We, Heads of State, Government and International and Regional Organizations convened in L’Aquila, remain deeply concerned about global food security, the impact of the global financial and economic crisis and last year’s spike in food prices on the countries least able to respond to increased hunger and poverty.

L’Aquila Joint Statement on Global Food Security 4. Food security is closely connected with economic growth and social progress as well as with political stability and peace. The food security agenda should focus on agriculture and rural development by promoting sustainable production, productivity and rural economic growth.

L’Aquila Joint Statement on Global Food Security 10. Sustained efforts and investments are necessary for enhancing agricultural productivity and for livestock and fisheries development. Priority actions should include improving access to better seeds and fertilizers, promoting sustainable management of water, forests and natural resources, strengthening capacities to provide extension services and risk management instruments, and enhancing the efficiency of food value chains.

L’Aquila Joint Statement on Global Food Security 12. We are determined to translate these principles into action and take all the necessary measures to achieve global food security....in particular to increase food production, improve access to food and empower smallholder farmers to gain access to enhanced inputs, technologies, credit and markets.

Policies for countering chronic food insecurity The earliest policy approach to dealing with the question of food security addressed technological improvements in agriculture. The massive increases in food productivity in the 30 years between 1960 and 1990, which is described as the Green Revolution, was achieved by developing high-yielding crop varieties. The productivity of cereals was also enhanced by expanding the area of arable land and by massive increases in fertiliser and insecticide use. Publicly funded national and international agricultural research institutes played a significant role in the development of these new varieties. Four fifths of agricultural research was then undertaken at publicly funded research institutes.

The Impact of Intellectual Property (IP) At the time of the Green Revolution there was no consideration of any role which IP might play in agricultural innovation. It was largely, the development of the new biotechnology based upon genetic engineering which precipitated IP into the food security arena. These technological developments were underpinned by changes to the international intellectual property landscape effected by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

The Impact of IP-continued The TRIPS Agreement in Article 27.1 extended patent protection to inventions in all fields of technology (including agriculture). Judicial determinations in the USA and legislation in Europe treated the modification of genetic material as inventions, thereby creating the possibility of the patenting of genetic material and of enabling technologies. This intrusion of IP into agriculture been paralleled by a significant diminution of the role of publicly- funded research institutes in agricultural research.

Contribution of patenting and plant variety rights protection to agricultural innovation Selective breeding and genetic engineering has permitted the expeditious introduction of a wide range of desirable traits into plants. These include: pest control traits such as insect, virus and nematode resistance as well as herbicide tolerance; post-harvest traits such as delayed ripening of spoilage prone fruits; agronomic traits such as nitrogen fixation and utilisation, restricted branching, environmental stress tolerance, male and/or seed sterility for hybrid systems; and output traits such as plant colour and vitamin enrichment.

Enabling technologies Genetic engineering is facilitated through a number of proprietary enabling and transformation technologies that include: methods of transformation of plant cells by insertion of a gene coding for a specific characteristic into plant cells, Promoters to control expression genes in plants Genes serving as selectable markers to determine which plant cells have been successfully transformed Gene silencing or regulating technologies.

Second Green Revolution It has been reported that by 2020 “cereal production will need to increase by 41%, meat by 63% and roots and tubers by 40%...without any significant expansion of agricultural area.” C. Spillane, Recent Developments In Biotechnology as they Relate to Plant Genetic Resources for Food and Agriculture, FAO Commission on Genetic Resources for Food and Agriculture, Background Paper No. 9, April 1999, 49.

Second Green Revolution A second Green Revolution to meet the modern challenge of increasing food insecurity will have to deal with the new economic reality of the dominant role of the private sector which seeks to commercialise its agricultural innovations. Exacerbating this problem is the fact that as food insecurity is grounded in poverty a way has to be found to secure for poor farmers the productivity benefits of the new biotechnology, while satisfying the share-holders of the life-sciences companies which are investing in this technology.

Civil Society/Developing Country Concerns 1.The privatization of nature through IP protection is ethically questionable 2.IPRs facilitate “biopiracy” (the privatization of the biological resources of developing countries) 3.IPRs facilitate anti-competitive restraints 4.The agricultural priorities of private rights holders are not usually those of developing countries

Ethical Concerns-John Locke, Concerning the True, Original, Extent, and End of Civil Government 1690, ch.5, sec 26. “Though all the fruits [the earth] naturally produces, and beasts it feeds, belong to mankind in common, as they are produced by the spontaneous hand of Nature, and nobody has originally a private dominion exclusive of the rest of mankind in any of them, …, yet being given for the use of men, there must of necessity be a means to appropriate them someway or other before they can be of any use, or at all beneficial, to any particular men.”

Ethical concerns “whatsoever then he removes out of the state that nature hath provided, and left it in, he hath mixed his labour with, and joined to it something that is his own, and thereby makes it his property.” Locke, ibid., at sec. 27.

19 EC Directive on the Legal Protection of Biotechnological Inventions, Art 3.2 “Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature”.

TRIPS Agreement Article 27.2 Members may exclude from patentability inventions, the commercial exploitation of which “is necessary to protect ordre public or morality”

Greenpeace v Plant Genetic Systems NV OJ EPO 8/ Opposition to an application for a patent directed to transgenic plants engineered to be resistant to the herbicide BASTA, Greenpeace argued that it was immoral to “own” plants which were the common heritage of humankind. The Technical Board of Appeal of the EPO stated that plant biotechnology per se could not be regarded as being more contrary to morality than traditional selective breeding, since both involved the introduction of novel genetic material in order to change plant properties.

Novartis/Transgenic Plants Decision G0001 of 20 December Patent application contained claims to transgenic plants comprising in their genomes specific foreign genes, the expression of which resulted in the production of antipathologically active substances and to methods of preparing such plants. The EPO Board noted that the Biotechnology Directive was an indication that the European Parliament considered there to be some benefit in genetic engineering.

The Netherlands (Italy and Norway, intervening) v. European Parliament and EU Council (E.C. Commission, intervening) Case C-377/98. Netherlands et al unsuccessfully sought the annulment of the Biotechnology Directive on grounds that it was in breach of the fundamental right to respect for human dignity and that the ordre public/ morality exception in Art 6 gave insufficient guidance and was too general and equivocal.

Biopiracy_and_bioprospecting Biopiracy is a negative term for the appropriation, generally by means of patents, of legal rights over indigenous knowledge - - without compensation to the indigenous groups who originally developed such knowledge. classic case is that of the Rosy Periwinkle (Madagascar Periwinkle). [ Research into the plant was prompted by the plant's traditional medicinal role and resulted in the discovery of a large number of biologically active chemicals, including vincristine, a lucrative agent useful during leukemia chemotherapy. A method for purifying vincristine was initially patented and marketed by Eli Lilly. It is widely reported that the country of origin did not receive any payment. patents Rosy PeriwinkleMadagascar Periwinkle [vincristineleukemia chemotherapyEli Lilly

25 UC Davis Blight Resistant Rice Blight resistant rice from Mali crossed by International Rice Research Institute (IRRI) with high-yielding varieties. Patent registered by UC Davis claiming (gene Xa21) “Nucleic acids, from Oryza sativa, which encode leucine-rich repeat polypeptides and enhance Xanthomonas resistance in plants” (U.S. patent 5,859, Jan 1999).

26 Cupuaçu Native to Brazil similar to cocoa, traditionally used for juice, ice-cream, marmalade and cakes

27 cupuaçu patents

28 International proposals to deal with biopiracy Convention on Biological Diversity (CBD) 1992 prior informed consent for bioprospectors Equitable benefit sharing Technology transfer to source countries Problem: bio-exploiting countries have not ratified or implemented CBD

29 Doha Declaration We instruct the Council for TRIPS, in pursuing its work programme … to examine, inter alia, the relationship between the TRIPS Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore, and other relevant new developments In undertaking this work, the TRIPS Council shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.

Competition concerns Market concentration ‘Enclosure of the commons’ Patent thickets Access to proprietary technologies of public research institutes

Nuffield Council on Bioethics, Genetically Modified Crops: The Ethical and Social Issues, 1999, para 3.36 There are six major industrial groups who between them control most of the technology which gives the freedom to undertake commercial R&D in the area of GM crops

Eg Monsanto 2004, Monsanto biotech seeds and/or trait technology accounted for 88% of the total GM crop area worldwide GM Soybeans – 91% GM Maize –97% GM Cotton % GM Canola - 59% ncentration_2005

M. Heller, and R.S. Eisenberg “Can Patents Deter Innovation? The Anticommons in Biomedical Research” (1998) 280 Science. 280, 698 at 699. “The tragedy of the anticommons refers to the more complex obstacles that arise when a user needs access to multiple patented inputs to create a single useful product. Each upstream patent allows its owner to set up another tollbooth on the road to product development, adding to the cost and slowing the pace of downstream biomedical innovation.”

Holman and Munzer, ‘Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags’, (2000) 85 Iowa L. Rev. 735 Expressed Sequence Tags (“ESTs”) are fragments of DNA which can be used as tools to search for full- length genes. A typical EST is 400 to 500 nucleotides in length compared with a typical gene of 2,000 to 25,000 nucleotides in length. Thus a number of ESTs may be patented on the same gene. A researcher wishing to use the full- length gene, the patentee would need to first obtain a license from the owners of the EST patents.

Patent Thickets ISAAA briefing paper, “The Intellectual and Technical Property Components of pro- Vitamin A Rice (GoldenRice™): A Preliminary Freedom-to-Operate Review.” Identifies 70 patents and 16 tangible property constraints (Material Transfer Agreements- MTAs, licences, agreements, etc.) that could have implications for the commercialization of Golden Rice.

C. Nottenburg, P. G. Pardey and B. D. Wright, ‘Accessing other people’s technology for non-profit Research’ (2002) 46 Australian Journal of Agricultural and Resource Economics 389 at “a web of proprietary claims now envelops the transfer and use of patented agricultural biotechnologies, thereby limiting the freedom to operate of public and private agencies alike.”

Binenbaum, et al ‘South-North Trade, IP Jurisdictions, and Freedom to Operate in Agricultural Research on Staple Crops’ (2003) 51 Econ. Dev. and Social Change 309 at 314. Gave as an example of a company blocking applications of its proprietary technology, the difficulty which the Centre for Legumes in Mediterranean Agriculture, (CLIMA) has had in commercialising the transgenic lupin cultivar which it developed with tolerance to the herbicide BASTA. Apparently it was unable to reach agreement with Agrevo (now Aventis) the developers of BASTA.

Recommendations for Action Policy Capacity Building IP policies are currently being formulated by international and inter-governmental organizations as diverse as the WTO, WIPO, FAO, WHO, CBD, UNCTAD, UNEP, UNESCO and WHO, countries have to construct IP policy capacity in the areas of: food security (patenting and plant variety protection); agricultural research (access to proprietary enabling technologies, development of IP assets; genomics and bio-informatics, bio-prospecting and access to genetic resources); agricultural trade (patenting, plant variety protection, geographical indications); technology transfer (approval of technology transactions, technology packaging, control of restrictive licences, remuneration)….

Implementation of the FAO International Treaty on Plant Genetic Resources for Food and Agriculture The use of the Standard Material Transfer Agreement, which has been developed under the Treaty, in particular its provisions restricting the availability of intellectual property rights in germplasm, will preserve the accessibility of that germplasm for future crop development.

Implementation of the Informed Consent and Benefit Sharing Principles of the Convention on Biological Diversity This would include the recognition of the rights of source countries where IP rights are obtained over biological materials

Recognition of the Protection of Traditional Agricultural Knowledge Eg through the implementation of the Farmers Rights provision of the International Treaty on Plant Genetic Resources for Food and Agriculture.

Technology Transfer in Support of Food Security Professor L. Jackson has proposed the establishment of a Genetic Resource and International Trade Institute “to provide technical assistance training and research on genetic resources management and the rapidly changing policy environment to developing countries”. L. Jackson, ‘Agricultural Biotechnology and the Privatization of Genetic Information. Implications for Innovation and Equity’. (2000) 3 The Journal of World Intellectual Property, 825.

Clearing House Mechanism (i)A repository for national and community registers of indigenous knowledge, which would be maintained under strict obligations of confidentiality; (ii)a catalogue of knowledge and innovations which are available for sale or licensing, as well as identifying that traditional knowledge which is unavailable; (iii)a register of legal experts who are available to assist traditional communities in negotiations

Clearing House Mechanism iv) representing the stakeholders in national government and intergovernmental negotiations; (v) monitoring the use, eg patenting of traditional knowledge; (vi) a dispute resolution facility between stakeholders; (vii) promulgating industry bioprospecting standards, and contract terms Drahos, ‘Indigenous Knowledge, Intellectual Property and Biopiracy: Is a Global Bio-Collecting Society the Answer?’ (2000) 22 European Intellectual Property Review 248.

Open Source Licensing CAMBIA has prepared a model license “BiOS (Biological Open Source)” as a “legally enforceable framework to enable the sharing of the capability to use patented and non-patented technology, within a dynamically expanding group of those who all agree to the same principles of responsible sharing, a “protected commons” under which subscribers “agree not to assert IP rights against each other's use of the technology to do research, or to develop products either for profit or for public good.”

Open Source Licensing Public Intellectual Property Resource for Ag Provide an IP clearinghouse for access to public-sector patented technologies; provide a resource for the analysis of patented technologies for implementation of specific projects develop gene transfer and gene-based-trait technologies that have maximum legal freedom to operate

Establishment of a World Agriculture Organization The establishment of a World Agricultural Organization (WAO) with a focus on: the poorer developing countries with weak agricultural research and extension programs, and crops of specific importance to resource poor and subsistence farmers.” Krattiger, ‘How can intellectual property rights contribute to the food security of an increasingly globalized world while meeting the demands of farmers and breeders?’ symposium/documents/Paper_Krattiger.pdf. symposium/documents/Paper_Krattiger.pdf

References M. Blakeney, Intellectual Property Rights and Food Security Wallingford, Oxon, CABI, ISBN: