Intellectual Property and Its Management for Animal Resources in India
Intellectual property right (IPR) is a lawful right of an individual granted by government for a specified period on the ownership of the property created through his intellect. It is for effective use of knowledge for economic growth. Intellectual Property is the product of mind- It is a class of property emanating primarily from human intellect. Such inventions, publication and other scholarly works are intellectual properties. These properties can be protected through copyrights, trademarks, patents, plant variety protection/plant breeders rights, geographical indicators, layouts, designs, and undisclosed information’s provisions. Of late, protection of Plant Varieties and Farmers’ Rights Act 2001 has been implemented to protect the plant varieties.
Intellectual property (IP) refers to creations of the mind which includes inventions, literary and artistic works, and symbols, names, images, and designs used in commerce. Intellectual property is divided into two categories such as Industrial Property includes patents for inventions, trademarks, industria designs and geographical indications (WIPO, 1970). Intellectual Property Rights (IPR) is an exclusive right over the creations of the mind. Intellectual property includes patents, trademarks, industrial designs and geographical indications and copyright (Groombridge, 1992). The IP rights are outlined in Article 27 of the Universal Declaration of Human Rights, which provides for the right to benefit from the protection of moral and material interests follow-on from authorship of scientific, literary or artistic productions. The treaties administered by the World Intellectual Property Organization such as Paris Convention for the Protection of Industrial Property (1883) and the Berne Convention for the Protection of Literary and Artistic Works (1886) distinguished the importance of intellectual property (WIPO, 1970).
Intellectual Property (IP) is a category of property that confers rights over intangible creations of human intellect. The patent system added the fuel of interest to the fire of genius (Abraham Lincoln, 1849). IPRs relate to pieces of information that can be incorporated in tangible objects. Since, IPRs are normally exclusive rights and since these rights are exercised through the products having the protected information. IP rights as a collective term includes patents, trademarks, geographical indications, trade secrets and copyright. IPR are largely territorial in nature except copyright, which is global in nature. At the international level, Convention on Biological Diversity (CBD) of United Nations and Trade Related Aspects of Intellectual Property (TRIPs) Agreement of World Trade Organization are the two major agreements governing access and rights over genetic resources. As India is signatory to both CBD and TRIPs, there is a need to assess the issues at hand with a global perspective and also narrate and evaluate the options for the typical livestock production situation existing in the country.
In developed countries the IPR portfolio has now become an effective platform for benchmarking of intellectual assets and enhancing innovative capabilities of institutions, business entrepreneurs and researchers. This is being used extensively in today’s world for acquisitions, strategic alliances, licensing arrangements and venture capital funding in industries. Infact, industries have now realized that the patented technologies have potential for their industrial growth as they are time appropriate and can be marketed easily. So they look for such technologies. It is important to appreciate the salient features of IPR and integrate them in institutional working so that one can not only create new and useful inventions that go into products and processes but also generate appropriate IPR and enforce them. India has already started working on bilateral trade agreements keeping in view the IPR issues.
Role of TRIPS Agreement
After the Uruguay round, the GATT became the basis for the establishment of the World Trade Organization. Because ratification of TRIPS is a compulsory requirement of World Trade Organization membership, any country seeking to obtain easy access to the numerous international markets opened by the World Trade Organization must enact the strict intellectual property laws mandated by TRIPS. For this reason, TRIPS is the most important multilateral instrument for the globalization of intellectual property laws. Trade related Intellectual Property Right (TRIPS) specifies enforcement procedures, remedies, and dispute resolution procedures. The agreement covers four broad issues: • How basic principles of the trading system and other international intellectual property agreements should be applied. • How to give adequate protection to intellectual property rights? • How countries should enforce those rights adequately in their own territories? • How to settle disputes on intellectual property between members of the WTO special transitional arrangements during the period when the new system is being introduced?
TRIPS Agreement and WTO
Most of the WTO agreements apply to all WTO members. The members each accepted all the agreements as a “single undertaking”. But the agreement allows countries different periods of time to delay applying its provisions. These delays define the transition from before the agreement came into force (before 1 January 1995) until it is applied in member countries.
The main transition periods were:
- Developed countries were granted a transition period of one year following the entry into force of the WTO Agreement, i.e. until 1 January 1996. • Developing countries were allowed a further period of four years (i.e. to 1 January 2000) to apply the provisions of the agreement other than Articles 3, 4 and 5 which deal with general principles such as non-discrimination. • Transition economies, i.e. members in the process of transformation from centrallyplanned into market economies, could also benefit from the same delay (also until 1 January 2000) if they met certain additional conditions. • Least-developed countries were granted a longer transition period of a total of eleven years (until 1 January 2006), with the possibility of an extension. For pharmaceutical patents, this has been extended to 1 January 2016, under a decision taken by ministers at the Fourth Ministerial Conference in November 2001.
The role of the TRIPS Council
The TRIPS Council comprises all WTO members. It is responsible for monitoring the operation of the agreement, and, in particular, how members comply with their obligations under it. • Monitoring: Members will review each other’s’ laws. • Consultations: On any TRIPS issue. • Technical cooperation: Awork programme. • Reviews and negotiations on specific subjects. • Review of TRIPS agreement.
IPRs protected in India
- Patents: The Patents Act, 1970 and was amended in 1999 and 2002. The amended Act after the amendments made in 2002 came in to force on May 20, 2003. Patent is exclusive right given to the inventor for his invention, it represents a legal monopoly granted by the respective country’s government to an inventor (specific to a geographic region. Patent protection means that the invention cannot be commercially made, used, distributed or sold without the patent owner’s consent. These patent rights are usually enforced in a court, which, in most systems, holds the authority to stop patent infringement. Conversely, a court can also declare a patent invalid upon a successful challenge by a third party. A patent owner has the right to decide who may – or may not – use the patented invention for the period in which the invention is protected. The patent owner may give permission to, or license, other parties to use the invention on mutually agreed terms. The owner may also sell the right to the invention to someone else, who will then become the new owner of the patent. Once a patent expires, the protection ends, and an invention enters the public domain, that is, the owner no longer holds exclusive rights to the invention, which becomes available to commercial exploitation by others. Patents provide incentives to individuals by offering them recognition for their creativity and material reward for their marketable inventions. These incentives encourage innovation, which assures that the quality of human life is continuously enhanced. Patents must meet certain criteria which include non- obviousness or the inventive step which requires that there be a real invention and not a simple result from some obvious extension of existing technology. Novelty, which refers to something created that is new and utility or usefulness of the invention. Patents may be related to a process, a product produced by a process. In animal sciences, patent can be granted for a product (gene sequence, protein), process and research tool (receptors or antibodies, apparatus (PCR machine). Technologies in animal breeding that qualify for IP protection include statistical methods, DNA markers, methods to measure traits, methods to identify animals and computer software (Ramesha et al., 2010, Matthew Rimmer, 2008). Diamond vs. Chakrabarty law case open the ways for patenting of higher forms of life. First animal patent is for “Onco mouse” by Harvard University (1984). (Lessor, 2002 and Rothschild, 2002). In India, Patents are granted for products or processes that are novel, useful, and in respect of which an inventive step can be demonstrated.
The following are considered as nonpatentable inventions
- Plant variety 2. Animal species 3. Any part of a plant or an animal [including seeds] 4. Essential biological processes 5. Traditional knowledge component or a group of components 6. Methods of treatment of animals either to increase their value or to increase the value of the derivable products of that animal 7. Methods of treating the animals to make them disease resistant etc., 8. Bioinformatics 9. Any inventions which may be frivolous, against to the established natural laws, affecting the plant or animal life or the environment 10. Discoveries of scientific principles and thermos 11. Inventions related to obscenity (any statement or act which strongly offends the prevalent morality of the time) 12. A method of agriculture and horticulture.
The patentable inventions-———
Genetically modified microorganisms 2. Nucleotide sequences and Amino acid sequences 3. Methods of extraction of bioactive compounds from plant or animal kingdoms. 4. Methods of making the disease resistant, drought resistant plant varieties 5. Processes of making the genetically modified plants with desirable characters. 6. Herbal extracts and methods of obtaining them 7. Cultures and methods of culturing and Nutrition mediums etc.,
Copyrights
Copyrights are another form of IP which is used to protect IP that includes articles, books, softwares and also music. In general, copyrights involve limited formal procedures. In many cases the creative work can be copyrighted by simply adding the symbol, but registering the mark provides formal legal protection.
Trademark
Trademarks are used to protect the identifications of source of the owners’ goods, products or services and it can be informal (simply using TM) or formally registered (®). Trademarks applied to specific products that are required to be from a certain origin and have a specific level of quality (Lesser, 2002). For example a specific pork product from Berkshire is protected by the trademark “Berkshire Gold™” and PICmarqTM suggestive of gene marker which used in selection of pigs by PIC organization. (Nebel et al., 2002).
Trade secret
A trade secret represents IP that is not revealed by the owner and therefore confers some competitive advantage. Trade secrets have no time limits. For examples the specific information to make specialized synthetic lines or specialized selection programs, indexes and seed stock are protected under Trade secret.
Bioprospecting and biopiracy
Bioprospecting is the exploration, extraction and screening of biodiversity and traditional knowledge for commercially valuable genetic and biochemical resources. Frequently, the term bioprospecting refers to the use of traditional knowledge in finding leads for pharmaceutical research. Biopiracy is thieving of knowledge from traditional and indigenous population or persons. An example for Biopiracy is the unique genetic quality of high milk fat content ranging from 6.02 to 7.86 per cent of Indian dwarf cattle breed ‘Vechur’. Roslin Institute and the PPL Therapeutics (Scotland) Ltd have 14 patent applications at the European Patent Office and one of these (EP 0765390) for the gene construct of bovine alpha-lactalbumin. So there is an immediate need for biodiversity rich countries like India topromote bioprospecting and to prevent biopiracy (Ramesha et al., 2008).
- Design: A new Design Act 2000 has been enacted superseding the earlier Designs Act 1911. • Trade Mark: A new Trademarks Act, 1999 has been enacted superseding the earlier Trade and Merchandise Marks Act, 1958. The Act came in force from September 15, 2003. • Copyright: The Copyright Act, 1957 as amended in 1983, 1984 and 1992, 1994,1999 and the Copyright Rules, 1958. • Layout Design of Integrated Circuits: The Semiconductor Integrated Circuit Layout Design Act 2000. • Protection of Undisclosed Information: No exclusive legislation exists but the matter would be generally covered under the Contract Act, 1872. • Geographical Indications: The Geographical Indication of Goods (Registration and Protection) Act 1999.
Need for an international treaty on animal genetic resources——-
In the modern biotechnology era, there is danger of animal genetic material from biodiversity rich countries being exploited by others, including large international companies. The development of a legal binding ‘International Framework on Animal Genetic Resources’ is therefore, a matter of urgency (http://dad.fao.org) on Animal Genetic Resources held at Switzerland delegates from 109 countries including India adopted a Global Plan of Action for Animal Genetic Resources, the first internationally agreed framework to halt the erosion of livestock diversity and support the sustainable use, development and conservation of animal genetic resources.” In future, IP protection is likely to influence pricing and international trade of livestock products in a significant way. 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 (FAO, 2004 and Rothschild, 2002). Development and diffusion of knowledge intensive technologies in all livestock sector are greatly influenced by IPR system. Among various types of IPR, patents, trademarks, trade secrets and geographical indications are relevant to the livestock sector. Each of these forms of IPR has different requirements and grants different legal status. The full scope of patent protection in the field of animal breeding has not yet been determined. The application of patents to this field of innovation is fairly recent, and there is a need for more in-depth analysis of the probable consequences of introducing patents to animal breeding. Several observations are need to be made on how the special field of animal breeding calls for adaptation of the general patent laws to this particular field of technology. Patent has been identified as a major tradable asset of enormous importance in the modern knowledge regime. Patent law has potential to alter the existing legal conditions for competition and investments in the field of animal breeding, and needs therefore a higher level of awareness among policy-makers, animal breeders and farmers. The effects of IPRs on animal genetic resources, genetic diversity, genetic improvement and the livelihoods of livestock keepers have scarcely been analysed, but are in urgent need of exploration. Protection of native livestock breeds and associated traditional knowledge through appropriate sui generis system is essential for conservation and their sustainable use in the modern IPR system. The internationally accepted legal system is need to be developed with respect to use of livestock biodiversity, then the IPR in animal sciences will bring economic benefit to the livestock keepers.
Potential patentable areas in animal sciences
There are unique traits in the native farm livestock species of Indian subcontinent, which can be harnessed or exploited through biotechnologies. The distinctive attributes of 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. Superior disease resistance. Adaptation to withstand tropical heat and far greater climatic fluctuations. Better potentials to utilize coarse quality feed and fodder resources. Better survivability under more recurrent drought conditions. Superior growth and higher fecundity in some species / breeds. Potential to yield of certain unique products, which have economic potential after value addition. Therapeutic and nutritional value of certain livestock products. Geographical application of breeds associated with traits or products. Indigenous technical knowledge on animal husbandry. Utilization of unique genes through biotechnologies for novel use. With further advances in biotechnologies and processing techniques, many more IPR relevant areas would emerge.
The reasons for promote and protect intellectual property are———
IPR give creators exclusive rights to their creations, thereby providing an incentive for the author or inventor to develop and share the information rather than keep it secret. The legal protection of new creations encourages the commitment of additional resources for further innovation. The promotion and protection of intellectual property encourages economic growth, creates new jobs and industries, and enhances the quality and enjoyment of life. An efficient intellectual property system can help all countries to realize intellectual property’s potential as a catalyst for economic development and social and cultural well-being. The intellectual property system helps strike a balance between the interests of innovators and the public interest, providing an environment in which creativity and invention can flourish, for the benefit of all. IPR enhances the value and profitability of a business. It signifies a certain standard, method or competitive edge and lays the groundwork for maximizing on the commercial results of its ownership (Sharma, 2014).
Livestock Biodiversity
Indian subcontinent is a rich source of diverse animal germplasm, and only very few countries have such a large number of breeds of farm animals with such a wide genetic diversity. While India’s gift of its animal wealth to the world’s economy has not undermined our own sovereignty over this wealth with such a wide genetic diversity. Emergence of germplasm patenting and biopiracy create a major threat to India’s sovereignty over its biodiversity. India is one among the few countries in the world, which has contributed richly to the international livestock gene pool and improvement of animal production in the world. India is bestowed with rich domestic animal biodiversity with 50 breeds of cattle, 17 breeds of buffalo, 44 breeds of sheep, 34 breeds of goat, 9 breeds of camel, 7 of horse and 20 breeds of poultry in addition to other species (NBAGR, 2016). However, recent decades have witnessed a loss of several breeds/populations due to (a) Negligence (b) Urbanization and (c) Use of new technology or machine instead of animals for agricultural work. Livestock genetic diversity has been constantly neglected as well as threatened. Livestock genetic resources with high diversity are essential for food security, to utilize environment unsuitable for crop agriculture and to respond to changes in production systems, impending climatic change, emergence of new diseases and market demand. The level of biodiversity, which is of concern here, is that of breeds and even populations within breeds. In fact, within breed, diversity accounts for 50 to 70 per cent of total genetic variance. Many of the indigenous breeds of livestock in India face the threat of extinction. It is difficult to save them, unless they are economic under the prevailing production systems. For example, the cattle breeds breed, Krishna Valleyis on the verge of extinction due to change in the agricultural production system and lack of efforts to make the breed respond to the changing production system (1). It has been reported that over the past seven years, at least one livestock breed has become extinct each month and further that around 20 percent of the world’s livestock breeds are at risk of extinction(2). Indigenous livestock are bestowed with many unique characteristics. Darwinian adaptations of indigenous cattle in relation to their ability to tolerate heat, Bacterial, Viral, Fungal, parasites and metabolic diseases.
Few More Breeds at The Risk Example—–
Cattle ——-Red Sindhi, Vachur, Punganur, Mewati, Kankatha, Kharigarh, Bargur, Panwar, Siri
Buffaloes———— Nilli- Ravi, Toda, Bhadawari
Sheep—————– Bhakarwal, Gurez, Karnah, Kashmir Vally, Poonci, Munjal, Hissar dale, Muzaffarnagari, Malpura, Chokala, Jaisalmeri, Magara, Lohi, Pugal, Nilgiri, Bonpala, Changthangi.
Goat—————- Beetal, Barbari, Jamunapari, Surti, Jhakarana, Chegu, Changthangi
Camel ————–Double hump, Jaisalmeri, Sindhi
Horse ——————– Bhutia, Manipuri, Spiti, Zanskar
Poultry—————All Breeds
Indian breed may survive under harsh conditions and poor quality feed and fodder so better genotypic makeup of local breeds is better for upgradation. The genetic secrets of these breeds have commercial value in the IPR era. Genes responsible for disease resistance, adaptation to with stand tropical heat and far greater climatic change, ability to utilize poor quality feed and fodder resources, better survivability under morerecurrent drought conditions, superior growth and higher fecundity in some species/breeds, and potential to yield certain unique products in indigenous livestock could be identified and protected through appropriate IPR. If a proper internationally accepted legal system is developed with respect to the use of animal genetic resources, patenting of novel genes will bring about economic benefit to the livestock keepers through benefit sharing (3). The natural resistance/susceptibility of various breeds will be highly useful in breeding for disease resistance. The United Nations proclaimed 2010 to be the International Year of Biodiversity, and people all over the world are working to safeguard this irreplaceable natural wealth and reduce biodiversity loss. Livestock genetic diversity and associated traditional knowledge (TK) are vital for current and future human well being and has to be protected in the modern IP regime. It is very essential to maintain genetic diversity to respond to situations like climate change and emerging diseases and to adapt to production systems. Their values are derived from the private functions for the household plus the functions of public interest (4). Identification and utilization of such genes / sequences could have economic implications if India could utilize the provisions under Convention on Biological Diversity (CBD) in an effective and efficient manner. Pastoralists, small and marginal livestock farmers conserve livestock genetic diversity and thus provide a service to humanity that is currently not rewarded by market forces (5). The conservation of animal genetic resources (AnGR) through livestock husbandry by the poor is a hitherto unrecognized and unrewarded service to society (6). An international legal framework on AnGR could provide support and incentives to those conserving genetic diversity. It is reasonable to expect that in the near future, niche products from livestock are likely to get lucrative through proper branding and increased demand for organic livestock products in the IPR era from a health conscious population. Livestock and agriculture is the only way to produce food in many of the world’s harshest environments like deserts, steppes and mountains. Widespread use of cross breeding, destruction of traditional production system which relies on greater inputs placed a significant proportion of the world’s limited genetic pool under threat. Sound utilization of AnGR particularly important livestock species under the changing environment is important due to high cost of animal and long generation interval (7). Worldwide rising income leads to rising demands for specialized food generated by diversification of animal production systems (8). Rising human population leads to higher demand for food which can be met by more and more use of dry land-which can be used effectively only for raising livestock breeds that are well adapted to these conditions. Pastoralists in semiarid areas are losing their livelihood because their grazing areas are being used for other purposes like irrigated cropping, rainfed farming, nature reserves and wildlife parks (6). Pastoralists, small and marginal livestock farmers conserve livestock genetic diversity and thus provide a service to humanity that is currently not rewarded by market forces. An international legal framework on animal genetic resources could provide support and incentives to those conserving genetic diversity. Industrialization of livestock agriculture is resulting in loss of valuable breeds developed over countries. Biodiversity of farm animal genetic resources has been rapidly declining. According to FAO (2000) (9), about 1000 of the 6400 recognized breeds have extincted during the last 100 years. One- third of these became extinct between 1985 and 2000 (10). Many of the indigenous breeds of livestock in India are under the threat of extinction. It is difficult to save them, unless they are made economical under the prevailing production systems. Krishna Valley in Maharasthra and Karnataka is on the verge of extinction due to change in the agricultural production system and lack of efforts of making the breed to respond to the changing production system (1).In the case of Australia in terms of patent ability of higher life forms, such as animals, they are not treated any differently by the Australian Patent Office from the way in which lower life forms are treated. This is probably the reason why the East African Boran cattle breed could be patented in Australia.
Intellectual Property and Its Management
PK KRISHNAN, TRADE CONSULTANT, BENGALURU
