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The Trade Related Intellectual Property Rights (TRIPS) Agreement is now the key international agreement promoting the harmonization of national IPR regimes. The Patents Section in TRIPS Agreement has been a subject of considerable debate. According to Article 27 (Patentable Subject Matter), patents shall be available for any investors, whether products or processes in all fields of technology provided they are new, involve an inventive step and are capable of application.
Article 27 (2) stipulates members to exclude from patentability of certain inventions in order to protect public order or morality, human, animal or plant life or health or to avoid serious prejudice to environment. Article 27(3) is more relevant to animal related patents point of view, which allows members to exclude from patentability inventions related to diagnostic, therapeutic and surgical methods for treatment of animals and humans. It also allows exclusion of plants and animals other than microorganisms and essentially biological processes for production of plants and animals other than non-biological and microbiological processes. This means, that members are obliged to give patent protection to microorganisms, non-biological and microbiological processes. It also means that the subject matters are crucial in the field of biotechnology so that they have to be protected for further technological advancement and provide sources of the knowledge to the public. For this purpose, microorganisms including bacteria, fungi, viruses, mycoplasma, protozoa, etc. may be reckoned as organisms not classified as plants or animals. Similarly, the term non-biological refers to those processes where human intervention plays an important part in controlling the final results or outcome of the process. According to the European Patent Office (EPO) guidelines, the term 'microbiological processes' is defined as processes using microorganisms and processes for producing microorganisms.
The TRIPS Agreement allows patenting of all life forms including plants and animals. The provisions of the agreement stipulates that member nations must provide intellectual property protection to plant and animal varieties either by patents or by an effective sui generis system.
Potential intellectual property and patentable areas of farm animals:
India is classified among the 12 mega diversity centers of the world. It is bestowed with rich domestic animal biodiversity having a total of 30 breeds of cattle, 10 buffalo, 42 sheep, 20 goats, 8 camel, 6 horse and 18 poultry breeds in addition to other species like pig, donkey, mithun, yak, turkey, duck, etc.
There are unique traits of the farm livestock species inhabiting Indian sub-continent which hold considerable potential application or utilization through bio-technologies. The distinctive attributes or breeds can be exploited for profits by getting some form of Intellectual Property Rights or protection. The notable areas for IPRs could be the following in Indian context:
1. Alleged disease resistance
Livestock diseases cost farmers millions of rupees annually in terms of morbidity and mortality. The recurrent losses due to morbidity cause loss of production and body condition. Unthrifty animals require more food and take longer time for growth than healthy stock. A number of infectious and non-infectious diseases are responsible for causing ill health in livestock. In terms of susceptibility of some of these diseases, the indigenous livestock and poultry are known to possess a reduced degree of susceptibility or some degree of resistance. For example, zebu cattle are comparatively less susceptible to blood protistan diseases and tick infestation. The alleged disease resistance has also been well recorded in diseases like mastitis in cattle, Mare'ks disease, Ranikhet disease, infectious bursal disease, coccidiosis, etc. in poultry breeds such as Nicobari fowl, Naked neck fowl and Frizzle fowl (Ahlawat et al., 2000; Chatterjee et al., 2003). However, little is known about the genetic make-up of these native stock vis-à-vis this alleged disease resistance trait.
2. Adaptation to withstand tropical heat and far greater climatic fluctuations
Domestic animals, depending on the species and level of productivity, have optimal growth, lactation and reproductive functions in the zone of thermo-neutrality. Livestock can maintain, by physiological and metabolic mechanisms, a fairly constant body temperature and efficient level of growth, lactation and reproduction. Reduced performance under heat stress is associated with effects on thermal regulation, energy balance, water balance and endocrine changes among other factors.
In a thermal environment in which the animals heat production exceeds heat loss, an increasing amount of heat is stored in animal's body, resulting in increased body temperature. When the body temperature is significantly elevated, a number of homeothermic events are initiated. These events include increase in evaporative heat loss by respiration and skin, and increase in urine excretion, which may aid in conductive connective cooling. However, when high temperatures and radiation lessen the ability of the animal to radiate the heat, feed intake, metabolism, body weight and milk yield decrease to help in alleviation of heat imbalance.
In comparison to many exotic pure breeds and crossbreds, our indigenous dairy cattle also known as Brahmans abroad, for example Haryana and Sahiwal, show a greater degree of heat tolerance with minimum loss of body weight during exposure to stress, nutritional deficiency, transport, low mortality rate and good reproduction rate and longevity (Finch, 1985; Thomas and Pearson, 1986; Singh and Mishra, 1980; Upadhyay and Madan, 1987). Similarly, the Indian Red Jungle fowl (Gallus gallus), Frizzle fowl and Naked neck fowl are better known for heat tolerance quality. Among the different genetic groups of sheep, Malpura and Chokla show a greater degree of heat tolerance value (Singh et al., 1980).
3. Better potential to utilize course quality feed and fodder resources
Out of a total land area of 297 million ha in the country, about 4% (12m ha) is under pasture, 22% (67.9m ha) is under forest and wood land and the rest of the land is utilized for crop production. The livestock production in our country is mainly in the hands of small and marginal farmers mostly confined to rural areas. It is a common practice to feed the animals on straw/stovers and other crop residues along with little grazing/cut/carry grass. Because of the socio-economic conditions of the livestock farmers, the animals are mostly fed on good quality roughages and unconventional feeds with little or no concentrates. Yet the animals show a better potential to utilize the course quality feed and fodder resources and express their full potential to survive and produce on crop residues. The continuous exposure of the animals to the low quality forages and unconventional feeds understandably, has resulted in better adaptation for survival and limited production, possibly by modifying the microflora of the rumen to digest and resist from the harmful factors present in these feeds and fodders (Ranjan, 1993).
4. Better survivability under more recurrent drought conditions
Although very little is known about the genetic endowment of the indigenous livestock, they are better known to adapt to harsh natural habitats and survive even under recurrent draught conditions. Due to wide gap existing between the availability and requirement of conventional feeds and fodders, a number of unconventional feeds and byproducts are increasingly being recommended as animal feeds during scarcity periods. Alternatively, compressed complete feed blocks (Verma et al., 1996) and urea molasses liquid diet (Verma et al., 1994) developed at Indian Veterinary Research Institute have shown great promise.
With further advances in bio-technologies and processing techniques many more IPR relevant areas would emerge.
5. Superior growth and higher fecundity in some species/breeds
In the expression of certain traits, the heredity and environment may interact so that the phenotype is something different from the additive effect of both. Among the economic traits of livestock, superior growth and fecundity are two important quantitative traits directly related to profitable livestock production system. The Garole sheep of West Bengal has the unique characteristics of multiple births. Similarly, the Black Bengal breed of goat has also a high reproductive efficiency. Although no information is available in the Indian context, the gene family related to Booroola fecundity in sheep has been identified else where.
6. Potential to yield certain unique products which have economic potential after value - addition or de novo technologies processing
Value addition is an important avenue for efficient utilization of livestock resources with increased demand and higher returns. In addition, employment potential would be substantial. Value addition in livestock sector involves a larger component of labour where India is at advantage with nearly lowest labour cost in the world. Higher growth in demand for meat, eggs and milk in developing countries would be a positive attribute for Indian livestock sector with increased trade opportunities.
Simple technologies developed at IVRI for nugget production from different meats and combination of meats and byproducts have immense potential for exploring lucrative market avenues. Further the unique animal products obtained from animals need to be explored, for example the hides form cattle of Sita Marhi (Uttar Pradesh) have reputation of yielding higher economic returns for the superior hide value.
Developing countries including India are likely to loose out on quality and safety criteria unless they can ensure that all dairy products for export are manufactured using internationally recognized systems of quality assurance such as, hazard analysis critical control point (HACCP) based system. It is imperative that the principles of HACCP system, code of practices on good animal feeds, good hygienic practices (GHP) and good manufacturing practices (GMPs) and cold chain system are followed sensu stricto.
7. Geographical appelations of breed(s)associated with traits or products
Majority of the indigenous breeds of farm animals and poultry were given some sort of accreditation (identification) between 20s and 30s based on recordings by imperial civil and military officials. However, the descriptions were not based on extensive surveys designed to reveal the extent of variability in the animals of a breed. The breed inventories are sketchy and reveal many discrepancies. Many types (or breeds) having distinctive attributes remain omitted, while in some other cases perceptible differences have not been recorded among closely related types; yet they possess different names. Apart from these discrepancies, new breeds have been described in the publications emanating from State Animal Husbandry Departments without proper surveys and back-up laboratory analysis of gene marker traits. Accreditation of indigenous breeds by State Governments by way of registration is warranted. The registration programme should be expanded for all breeds and strive to identify animals with higher productivity. Field recording of performance of the animals should be carried out by State Governments with help of other agencies and State Animal Husbandry Departments.
8. Utilization of unique genes through biotechnologies for novel use
Most of the economically important characters in farm animals like milk production, rate of gain (growth), efficiency of gain, carcass quality, etc are quantitative traits. These traits are controlled by a large number of genes which may act adaptively, multiplicatively and interact epistatically with each other or exert dominance. Identification of quantitative traits loci (QTLs) and exploitation of these poly gene characters using biotechnologies has immense potential
9. Indigenous technical knowledge on animal husbandry which can be further upgraded through research and intervention technology
The concept of sustainable agriculture in Indian agricultural scenario has aroused interest in indigenous technical knowledge (ITK). These ITKs are based on experiences which gathered momentum through generations and are being developed and improved through informal experimentation. Thus, ITKs are based on the experiences, tested in most cases over centuries, and endowed with best adaptability to local environment. These are dynamic, holistic, eco-friendly and sustainable and interwoven and assimilated in the cultural life of the people.
As a part of the Indian Council of Agricultural Research sponsored Mission mode Project on Collection, Documentation and Validation of Indigenous Technical Knowledge, as many as 140 ITKs are being validated in agriculture of which 48 are related to livestock sector. At IVRI, 16 ITKs have been taken up for validation. Validation of these ITKs and grassroot level inventions generates esteem and thereby increases the probability of the knowledge innovation or practices developed or practiced greater attention and experimental opportunity, besides their unique value in the IPR regime.
Absence of a System in farm species comparable to sui generis
Under the GATT agreement (of which India is a signatory), members must provide for protection of a plant variety either by patent or by an effective sui generis system. The latter is a milder form of patent and provides a framework for safeguarding plant breeder's rights. It covers privileges of the farmer's and researcher's rights. In respect of domestic animals, no comparable system for the protection of varieties or breeds exists in any part of the world. To comply with the obligations under the TRIPS Agreement in the permissible time limits to developing countries, in the context of Indian livestock resources and trade, it calls for an action plan on key issues. Livestock as an industry needs safeguards. We need to frame our patent laws with utmost care. Foremost is the need for a registration system for encouraging protection of local livestock breeds. A National Register must be developed for documentation of the existing breeds of livestock. A national database with systematic documentation of local or indigenous knowledge, innovations and practices of the farmers on the lines of CSIR compiled "National Wealth of India" has great relevance today. In theory, such knowledge is patentable. National Patent Offices can access these databases when testing patent applications for novelty and inventive step. Trade and protected breeds particularly of transgenic nature requires strong biosafety regulations and implementation capacity at various levels ranging from a research laboratory to the national level. At the same time, we have to strengthen SPS measures to prevent import of diseases in the wake of liberalized import of animal products from abroad. Along with biosafety protocol, there is an urgent need for the constitution of Bioeithics Committees overseeing the test on transgenic animals by domestic, as well as, international procedures. However, in America, Australia and some European countries, the distinctive animals which meet certain clearly laid specifications of breeds are permitted for registration. The breed registration, however, does not provide in any manner IPR's to the community or individuals. However, a breed registration act is under formulation.
REFERENCES
Ahlawat, S.P.S. Padhi, M.K., Senani, S. Shome, B.R., Saha, S.K., Shome, R., Rai, R.B., Venkatesubramanian, 2000. Indigenous poultry germplasm of Andaman & Nicobar islands. Folder, CARI, Port Blair.
Chatterjee, R.N., Ahlawat, S.P.S., Rai, R.B. 2003. The scavenjing poultry of Andaman and Nicobar islands. Livestock International, 7: 20-22.
Finch, V.A. 1985. Comparison of non-evaporative heat transfer in different cattle breeds. Australian Journal of Agricultural Research, 36 : 497-508.
Ranjhan, S.K. 1993. Modern approaches of feed evaluation and their application in India. In Feeding of ruminants on fibrous crop residues. Eds. Kiran Singh and J.B. Schiere ICAR, New Delhi.
Singh, A.S., Mishra M. 1980. Physiological responses and economic traits of Holstein, Jersey, crossbred and Haryana cows in hot and humid environment. Indian Journal of Dairy Science, 33: 174-181.
Singh, M., More, T. Rai A.K. 1980. Heat traits of genetic groups of sheep exposed to elevated temperature, food intake and heat tolerance of Brahman and Brahman Friesian cattle working on treadmills. Animal Production, 43: 83-90.
Upadhyay, R.C., Madan, M.L. 1987. Bovine work production under tropical conditions - termoregnlatory responses. Indian Journal of Dairy Science, 40: 23-27.
Verma, A.K., Mishra, U.R., Dass, R.S. Singh, A. 1996. Nutrient utilization by Murrah buffaloes (Bubalus bubalis) from compressed complete feed block. Animal Feed Science Technology, 59: 255-263.
Verma, A.K., Dass, R.S. Mehra, U.R., Varshney, V.P. 1994. Response of feeding urea molasses liquid diet on nutrient utilization, growth performance and thyroid gland activity in crossbred heifers. World Review of Animal Production, 29: 102-107.
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