Trade Related Aspects of Intellectual Property Rights (TRIPs)
Any country ratifying the Global Agreement on Trade and Tariffs (GATT) and becoming a member of the World Trade Organization (WTO) agreed to establish minimum standards for intellectual property rights. Under TRIPS Article 27.3, members must provide various forms of intellectual property, many of which are relevant to animal genetic resources and animal products, including indications of geographical origins, trademark, trade secrets and patents. It provides that member countries must grant patents on all products and processes, except that they may exclude from patenting the plants, animals and essentially biological processes, other than microbiological ones. Provision is made for plant variety protection under patents or a sui generis system, or a combination of both. There is no comparable system for animals. Under TRIPs neither prior informed consent (or benefit sharing) nor is protection of traditional knowledge mandated. TRIPs do not offer sufficient recourse for balancing the rights of the owners of AnGR. Animal patenting, even in countries where it is permitted, is so far largely a phenomenon of medical and pharmaceutical research, rather than of livestock agriculture, though this may change with the introduction of transgenic production of animals. Patents and trade secrets are relevant to animal biotechnology research and development. In the animal sector, it is considered that contractual arrangements, trade secrets, trademarks and patents have relevance.
Trademarks are signs or symbols registered by a manufacturer/producer or merchant to identify goods and services. Genetic material per se can not be protected or covered by a trademark. A trademark can be a useful tool in livestock sector as means of value addition tool. The trademark can improve the value of a product. For example, semen straws from a reputed company with trademark may fetch higher price.
Geographical Indications (GIs) are signs or expressions used to indicate that a product or service originates in a country/region or specific place. Both Trademarks and GIs are used to identify the products. A Trademark puts emphasis on the producer or a manufacturer of a product whereas a GI highlights the geographical origin of a good and the characteristics derived from it. GI does not protect the breed or genetic material per se but add commercial value to the animals of breed reared in a particular region. They may be used as a value addition mechanism. Geographical indications prevent all others other than the producers of goods from the original region from using that particular geographical indication incorrectly as a trademark for other products than those from the area. In France Bresse breed of chicken is produced in the Bresse geographical area only as defined by law under protected designation of origin2 and sold at 50-60% higher price. Similarly, to save the Sambucana sheep from extinction, a consortium was set up and a special brand name for guaranteed Sambucana meat was set up in Italy. Chilika buffaloes with typical curd made from its milk, and Banni and Dharwari buffaloes with typically flavoured milk products are other examples which could be considered for protection. Under GI, the production system is characterized by natural conditions and a production system unique for that area. There is scope for utilizing GI based on unique characteristics of products produced from a breed in a geographical area due to natural conditions and unique production system.
Trade Secrets provide protection against unauthorized disclosure or use of confidential information (of a technical or commercial nature). Trade secrets are important in livestock breeding where commercial breeders want to keep their nucleus stock and the pedigree information (and other information) away from their competitors. Sometimes the right to use the animal in breeding is determined through formal or informal contract. In the case of dogs, in many places an informal contract is followed whereby the male dog owner gets one male pup after successful breeding.
Patents can be defined as Government-granted limited duration “ownership” of an invention in exchange for its full public disclosure. In general, patenting of life forms is a new phenomenon in most of the countries including India. The Diamond vs. Chakrabarthy case where the question was whether the genetically engineered bacterium could be patented, in US Supreme Court in 1980 opened the flood gate, where the US Supreme Court made the observation “anything under the sun created by man is patentable”. This judgment had lot of impact world wide in patenting of living organisms. Patenting of living organisms is a contentious issue among the WTO member states. Patentability, scope of protection and exclusions are dealt in detail in TRIPS agreement. Mega-biodiversity countries want disclosure of source and country of origin of the biological resource and of the traditional knowledge used in the invention, disclosure of evidence of prior informed consent under the relevant national regime and disclosure of evidence of benefit sharing under the relevant national regime to be included in the patent application. Before Doha, under “Implementation”, India gave a proposal to the effect that the patents inconsistent with CBD should not be granted. However, it is yet to be accepted.
Even if one can identify an animal carrying unique gene/gene combinations utilizing such unique genetic characteristics is extremely difficult due to long generation intervals, low reproductive rates, high cost and low success rate of identifying and transferring unique genes in animals. Due to difficulties in bringing about genetic progress and its dissemination, the management of AnGR is more complicated and costly than in plants. Even in developed countries, the commercial breeding activity is concentrated for poultry and pigs just as in major crops in plant sector.

Import and Export of animals
The movement of livestock across the globe is regulated due to strict sanitary regulations and high cost involved. Import and export regulations will have a bearing on exchange of AnGR. Many countries have legislation on the importation of animals or breeding stock, as well as on the health status of imported animals3. Agreement on Sanitary and phytosanitary measures (SPS) deals with human and animal health as well as plant health that also have a bearing on movement of breeding stock and genetic material. The Office International des Epizooties (OIE) standards are relevant to the management of AnGR with respect to import-export. In many countries including India there are strict regulations regarding import and export of live animals, semen, ova and embryos between the countries with an aim to prevent introduction of new diseases. Breed associations and herd books play a role in breed improvement and conservation. In our country import of AnGR has helped in improving production of animal products. However it has also brought in many problems. In many cases small and marginal farmers and the landless labourers are not able to sustain the high-input high-output livestock production system. Moreover, food safety issues are likely to become major issues with widespread use of genetically modified animals in the times to come. Patent laws apply to all the areas including innovations in the field of AnGR. The concern for AnGR is that it may lead to monopoly by few companies at the cost of small and marginal farmers and their systems. In TRIPs agreement there is provision for an effective sui generis system for the protection of plant varieties as an alternative to providing patent protection to the same subject matter. Sui generis has yet not been implemented to the benefit of farmers and stakeholders of AnGR.

IPR issues in Animal Biotechnology
In the field of animal biotechnology it is difficult to make clear distinction between discovery and invention. Different national laws use different criteria for patentability of biotechnology inventions. The granting of patent for transgenic animals in 1988 in United States of America raised hue and cry. Whether an invention covering a transgenic animal was contrary to public order and morality is the question. Multinational Companies and corporations want to safeguard their claims to animal breeds with patents. Patenting and monopolizing breeds of livestock may lead to loss of biodiversity and aid in development of genetically modified breeds. The corporations like PIC, Genus and Monsanto who are major players in animal breeding sector have already filled large number of patent applications. The European patent on genetically manipulated dairy cows granted in 2007 (Patent Number EP 1330552) to inventors from Belgium and New Zealand, is concerned with processes for breeding cows which give more milk or milk with altered constituents. The cows are produced either based on marker assisted breeding or by having more genes additionally incorporated into their genome. Monsanto in 2005 filled two patent applications with World Intellectual Property Organization (WIPO) for extensive patents on pig breeding, one of which (WO 2005/015989, EP 1651030) deals with business ideas for combing breeding methods already practiced. The applications became the subject of hot discussions in US and Europe and led to diluting of claims in the application. Similarly a large number of examples are available from US and Europe in the field of livestock agriculture.

Implications of TRIPs
Mega biodiversity countries provide genetic resources for modern animal breeding and biotechnology industry. Traditional livestock keepers have greatly contributed and are contributing for the improvement of AnGR and also to the maintenance of genetic diversity. The genetic resources have been transferred freely to other countries in the past; under the understanding that these are common heritage of humanity. With the development of modern biotechnology, there is possibility that our breeds/varieties may be genetically altered and the new variety/breed may later be substituted for the original breed/variety from which it was developed particularly in poultry and pigs. If proper controls and checks are not included in the system of IP protection relating to AnGR, there is a danger of Multi National Companies (MNCs) becoming owners of breeds/varieties originating in India.
Though plant varieties are protected through a sui generis system in many countries since 1920s, no such system is available for AnGR. Biotechnology firms are interested in patenting processes and genes used in animal breeding as such. The recognition of patents on AnGR would result in banning of breeding protected variety/breed. Patent protection will discourage the natural selection that, at present, takes place at farmers’ level. The patenting of broad traits like increased milk yield or broad claims on genes/animals may lead to monoculture and monopoly which would result in suffering to the pastoralists, small and marginal livestock keepers. The proponents of patents are of the view that patent based approach is essential to provide incentive for innovation and to increase flow of funds to R & D in animal agriculture. They claim that possible negative balance will be outweighed by benefits likely to be derived in terms of new varieties/breeds. The advantages and disadvantages with the patent system clearly indicate that a sui-generis system is likely to be an appropriate approach for India.

Bioprospecting and biopiracy
Bioprospecting is the exploration, extraction and screening of biodiversity and traditional knowledge for commercially valuable genetic and biochemical resources. Commercially important products derived from biodiversity are of great economic value. Biopiracy is stealing of knowledge from traditional and indigenous communities or individuals. The Action Group on Erosion, Technology and Concentration (ETC group, Canada) defines biopiracy as the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions seeking exclusive monopoly control over these resources and knowledge. There is likelihood of MNCs collecting genetic material from biodiversity rich countries in order to cross-breed with some other breed(s) to develop a variety/ breed with unique trait like resistance to a particular disease and claim that they have developed something new and useful and patent them. Thus there is fear of loss to the stakeholders of AnGR and the real custodians of the associated TK.

National scenario
In order to fulfill the obligations under WTO, the Patents (Amendment) Ordinance, 2004 was issued by the Indian Govt. on December 27, 2004 and this came into effect from January 1, 2005. The Ordinance amends the Indian Patents Act, 1970 for the third time to introduce product patent protection for drugs, food and chemicals. In developing countries including India there is limited public investment in animal biotechnology and only modest support for more conventional livestock research and development to improve productivity, nutrition and health of farm animals. Very few livestock breeding programmes exist in India where there is possibility of applying molecular marker assisted selection and gene based selection as an aid in selection of superior breeding stock. Additional public sector investments are especially required, in developing and applying biotechnologies strategically in the characterization, sustainable use and conservation of animal genetic resources. Private sector investment is unlikely to be commercially attractive in the short and medium term in the field of animal production. However in the modern IPR regime, there exists possibility of private funding for research in the area of improved diagnostics and therapeutics, particularly vaccines against the major livestock diseases, where information coming from the study of pathogen genomes can help to develop more effective disease control measures. Harmonization of IP regimes, access to technologies required for biotechnological research and development through easy licensing and/or patent exemptions especially for public goods oriented research would pave way for making private investment or private-public participation attractive.
In India private ownership of livestock is common and the public ownership is rare. The owner of the animal has the right to use the genetic resources in breeding and can have control over who is receiving genetic material from his/her animals. However, it is difficult in secondary and further generations to have control over gene flow. In case of poultry, generally farmers are given hybrids by commercial producers. The owner of the animal has the property right to breed the next generation, sell, gift or exchange the animal, and use or sell the products.
Trademarks and geographical indications could be used for value addition and thus aid to protect registered breeds. In India the problem is that there is no authority for registering livestock breeds. There is an urgent need to establish Animal Genetic Resources Authority of India which can take care of breed registration and protect the rights of livestock keepers, besides advising for improvement of breeds4,5. There is scope for regional co-operation in the harmonization of regulatory systems, and the development of regional capacities, legal instruments and regulatory procedures.

Options at the national level
For decades India could get along without a strong IPR policy in the area of agriculture and allied sector because it relied heavily on its own public sector scientists and government extension agents, rather than private investors or international private companies, to stimulate innovation in the area of agriculture and allied sector. India operated without a plant variety protection law, and its 1970 Patent Act specifically excluded patenting of life forms including plants and animals. As a result of New Seed Policy (1988) multinational seed companies began making significant investments in seed sector through India's own private sector companies. Patents and Plant Variety Protection (PVP) provide exclusive monopoly rights over the creation (such as new plant variety) for commercial purposes for a limited period. PVP provides patent like rights to plant breeders. The Protection of Plant Varieties and Farmers’ Rights Act, 2001 and PVP and FR Rules 2003 of Indian Government provides for well-defined Breeder’s rights as well as strong and proactive Farmers’ rights. The Act recognizes 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. The Indian Protection of Plant Varieties and Farmers’ Rights Act has many unique features such as opportunity for registration of extant varieties, registration of farmer’s traditional varieties by communities or NGOs on their behalf and constitution of National Gene Fund. A comparable law which gives emphasis on special nature of animals is required for AnGR to bring about improvement of livestock sector in our country.

Biological Diversity Act (2002)
The main objectives of the Biological Diversity Act (2002) which complies with CBD are conservation of biological diversity; sustainable use of its components and fair and equitable sharing of the benefits arising out of the use of biological resources and knowledge. Traditional knowledge associated with biological resources including livestock are integral part of the resource itself. In India patent applications have to disclose the source of genetic material and associated TK in relevant cases. According to the Biodiversity Act (2002), Non–Indian citizens, Non Resident Indians and Association or Organization which is not incorporated or registered in India or registered and incorporated in India but having any Non-Indian participation in its share capital or management are barred from any biological resources of India or knowledge associated thereto for research or for commercial utilization or for bio-survey and bio-utilization without prior permission of National Biodiversity Authority (NBA). TRIPS Agreement allows the exclusion of plants and animals and of essentially biological processes for their reproduction from patent grant. Under the provisions of the Patents Amendment Act (2002) plants and animals in whole or any part thereof other than microorganisms and essentially biological processes for production and propagation of plants and animals are not patentable. In Patent amendment Act (2002) the role of traditional knowledge is recognized.
Biodiversity along with the associated local expertise is a valuable asset as a raw material for research and is an insurance against environmental change. Traditional knowledge associated with AnGR is by and large collective, developed over a period and may either be codified in text or held in oral traditions over generations and often held in parallel. TK has the potential of being translated into commercial benefits by providing leads for development of useful products and processes. Hence, creators and holders of TK must get a share of benefit. It might be worth giving attention to the need and possibility for developing a “clearing-house” mechanism to operate at the Dept. of Animal Husbandry and to the possibility of conducting an IPR audit. It is not only formal IPR measures which need to be addressed (patents, variety protection, copyright, trade secrets etc.) but also the system needs to come to grips with the protection, and recognition, of “informal” innovation and indigenous traditional knowledge. The issues relating to ownership, access, benefit sharing, livestock keepers’ right and intellectual property relating to AnGR and associated TK needs further attention not only at the national level but also at the international level.

Need for a sui generis system for AnGR
In spite of significant contribution of animals to the food security and nutrition, laws and policies including intellectual property protection on genetic resources at the national as well as international level so far has focused only at plant genetic resources. There is a need for legally binding internationally accepted system for access and sharing of benefits from the use of AnGR and associated traditional knowledge. There is a need for recognition of community rights over knowledge and biodiversity. Considering the special characteristics of AnGR it is essential to develop a suitable sui generi system for AnGR for protection of intellectual property rights (Ramesha et al., 2007a, b). In case of animal breeding most of the cases superior individual animal or its germplasm is more important than providing protection for a breed/ variety. The major problem lies in identifying characteristics that could be used as a standard description of the subject matter. Breed associations and herd book registration will help in breed conservation and intellectual property protection. A sui generis system linked to special geographical related characteristics of the animals or their products aimed at preventing misappropriation of AnGR and associated knowledge held by livestock keepers needs to be developed. Livestock keepers’ rights could include production and grazing rights as well as protection of traditional knowledge1.

Need for an International Treaty on Animal Genetic resources
The Bilateral exchange agreements, legally binding regional or multilateral agreements aiming at AnGR exchange will be useful for effective utilization of AnGR. The “Bonn Guidelines” of CBD are a voluntary agreement on the conduct and practices of access and benefit sharing (www.biodiv.org/programmes/socio-eco/benefit/bonn.asp). The Karen Commitment (2003) by indigenous livestock breeding communities calls for an internationally binding agreement recognizing the historical contribution of pastoralists and other communities to the development of domestic animal diversity6.
Livestock biodiversity is a valuable asset and is a matter of insurance and investment necessary to sustain and improve livestock production and to keep open future options as a buffer against environmental change and as a raw material for scientific innovation. Though TRIPS were brought under the preview of GATT only in 1994, in 1961 itself a sui generis system to protect new plant varieties was framed in the form of an International Union for the Protection of New Varieties of Plants (UPOV). The International Treaty on Plant Genetic Resources finalized in 2001, signed by more than 80 countries aims to maintain and conserve the plant genetic resources. Since the signing of the International Treaty on Plant Genetic Resources, there have been attempts to negotiate an equivalent agreement for animal genetic resources with an aim to provide level playing field between low to medium input systems which conserve genetic diversity without any additional benefit and intensive system of rearing which erode genetic diversity.
The need for a legally binding instrument was discussed during the World Food Summit in June 2002. During the 3rd Session of the Inter-governmental Technical Working Group on Animal Genetic Resources in spring 2004, a number of developing countries proposed initiating negotiations on an international treaty on animal genetic resources7. Due to the resistance from industrialized countries, starting of negotiations have been postponed until the First Report on the State of the World’s Animal Genetic Resources is completed, which is expected within 2007. The First International Technical Conference on Animal Genetic Resources to be held in Interlaken, Switzerland during September 2007 is likely to address many of the issues.
Without internationally recognized legally binding instrument, billion of dollars is being spent worldwide in the area of livestock genomics and proteomics research with an aim to identify novel genes, expressed sequence tags (ESTs), single nucleotide sequences (SNPs) etc. Livestock keepers’ have the risk of losing their intellectual property rights, while biotechnology firms require a legal framework to operate. Thus, there is an urgent need for internationally recognized legally binding instrument which gives right to livestock keepers including rights over associated indigenous traditional knowledge.
Indigenous cattle are bestowed with many unique characteristics. Identification of genes for unique characteristics like disease resistance, heat tolerance, ability to survive and thrive under stressful and low input conditions in local breeds will go in a long way not only in the advancement of science and livestock production, but also pave way for patenting of gene sequences for these traits. If proper internationally accepted legal system is developed with respect to use of animal genetic resources, patenting of novel genes will bring about economic benefit to the livestock keepers in the IPR regime through benefit sharing.

References:
1. Tvedt, M.W., Hiemstra, S.J. and Drucker, A.G., Louwaars, N. and Oldenborek, K. 2007. Legal aspects of exchange, use and conservation of farm animal genetic resources. FNI Report 1/2007.
2. Verrier E., Tixier-Boichard M., Bernigaud R. and Naves, M. 2005. Conservation and value of local livestock breeds: usefulness of niche products and/or adaptation to specific environments. Animal Genetic Resources Information. 36.
3. FAO, 2005. The legal framework for the management of animal genetic resources. FAO Legislative Study 89. Authours.Ingressia, A., Manzella, D. and Martyniuk, E. ISBN 978-82-7613-504-6, 1-33.
4. Ramesha K.P., Pourouchottamane, R., Kataktalware, M.A. and Sarkar, M. 2007a. Intellectual property Rights (IPR) issues in livestock biodiversity –Indian perspective.58-66. Proceedings of the National Symposium on “Role of animal genetic resources in rural livelihood security”. Feb 8-9, 2007. Ranchi, India.
5. Ramesha K.P., Pourouchottamane R and Bhattacharya, M. 2007b. Role of indigenous livestock genetic resources in the era of modern Intellectual Property Rights. Indian Dairyman (In press).
6. Kohler Rollefson,I. 2005. Indigenous Breeds, Local communities-documenting animal breeds and breeding from a community perspective. ISBN. 81-901624-1-1.
7. FAO., 2004. Report by the Commission on Genetic Resources for Food and Agriculture on the Intergovernmental Technical Working Group on Animal Genetic Resources for Food and Agriculture, Third Session, 31 March–2 April 2004. Food and Agriculture Organization of the United Nations, Rome.

*For correspondence. Senior Scientist, NRC on Yak, Dirang-790101, Arunachal Pradesh, India. Phone: +91-03780-242220, Mobile: +91- 9436225170, e-mail: kerekopparamesha@gmail.com
Principal Scientist, NBAGR, Karnal-132001,India. Phone: +91-9416030654,
e-mail: sadana@nbagr.hry.nic.in
*For correspondence