Biodiversity and intellectual property Arjava Sharma ICAR-National Bureau of Animal Genetic Resources Karnal -132001 (Haryana)

Farm animal genetic resources (FAnGR) diversity has been generated much through continuous artificial selection carried out by animal keepers as per their need and natural selection in local environment (adaptation) during hundreds and thousands of years. For farm animal diversity, ‘breed’ is considered, in general, as a referral point and can be defined as “sub-specific group of domestic livestock with definable and identifiable external characteristics that enable it to be separated by visual appraisal from other similarly defined groups within same species”. Moreover, breed is a group for which geographical and/or cultural separation from phenotypically similar groups has led to acceptance of its separate identity. Our country is a big and enriched repository of farm animal diversity, possessing the largest number of livestock as well as their breeds in the world. Among 15 non- carnivores domesticated by mankind, 12 of the species are found in the country. A range of agro-ecological zones in India has also helped to develop this large number of breeds of various livestock species. The livestock greatly contribute in terms of milk, meat, egg, wool, draught and manure and provides an alternate but important source of income for millions of rural families of our country.

Farm Animal Genetic Resources Dynamics At present, the country possesses 512 million livestock and 729 million poultry population (Livestock Census 2012). The country had recorded 3.3 percent reduction in total livestock population, 12.4 percent increase in poultry population during 2007 to 2012. From the time of independence, the cattle population has been increased by quarter on other side buffalo population increased by almost one and half times. Although, the cattle population is showing continuous growth, however, proportion of cattle in total bovine population is decreasing year after year. There is a rapid decline in some of the species like equines, camel, yak and mithun can erode some of best germplasm of indigenous horse from the country, if no corrective measures are being taken.

Farm Animal Genetic Resources Diversity The vast domestic animal diversity can be reflected through a total of 151 registered farm animal breeds comprising of 39 breeds of cattle, 13 of buffalo, 40 of sheep, 24 of goat, 9 of camel, 6 of horse, one of donkey, 3 of pig and 16 of poultry. In addition, numerous lesser known breeds, strains and new genetic populations of different farm animal species exist which have not been properly studied and documented. Cattle In country, there are 39 registered breeds of indigenous cattle. Among these, four breeds are milch type, 22 draft type and remaining breeds are dual type. There is still huge population, which is undefined. Most of the Indian native cattle breeds can survive in extremes of agro-climatic conditions and are known for its adaptability to high temperature, powerful draught capacity and resistance to tick borne diseases. Important native breeds like Ongole, Gir, Sahiwal had attracted several countries including Brazil, USA, Argentina,

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Mexico to import this germplasm for increasing resistance to diseases and heat in their native breeds. Buffalo The country possesses the rich germplasm of buffalo. Some best buffalo breeds of the world are found in India. There are 13 registered buffalo breeds -Murrah, Nili-Ravi, Jaffarabadi, Mehsana, Nagpuri, Pandharpuri, Bhadawari, Surti, Toda, Banni, Chilika and Kalahandi. Murrah is acknowledged as best breed in the world and imported by many countries. Bhadawari is known for high fat in milk. Goat There are 24 registered goat breeds, which can be classified into large, medium and small according to their body size. Beetal, Jamnapari and Jakhrana are the large-sized animals where Black Bengal, Barbari, Changthangi, Chegu, belong to small-sized category. Sheep Presently country possesses 40 indigenous breeds of the sheep. Sheep breeds of Northern region produce good quality carpet wool as well as medium fine wool. Magra sheep is famous for the high luster in wool and appreciated worldwide. The breeds from Southern peninsular region are most important for mutton production.

Table 1: Livestock population and trends

Livestock population (in million) Trend (Annual in %) Species Category (1997- (2003- 2007- 1997 2003 2007 2012 2003) 07) 12 Crossbred 20.10 24.69 33.10 39.73 3.49 6.04 20.18 Cattle Indigenous 178.78 160.50 166.01 151.17 -1.78 0.68 -8.94 Total 198.88 185.18 199.08 190.90 -1.15 1.46 -4.10 Buffalo 89.91 97.92 105.34 108.70 1.48 1.47 3.19 Crossbred 3.11 5.73 3.73 3.78 10.72 -8.23 1.37 Sheep Indigenous 54.38 55.74 67.83 61.29 0.41 4.00 -9.64 Total 57.49 61.47 71.56 65.07 1.15 3.09 -9.07 Goat 122.72 124.36 140.54 135.17 0.23 2.48 -3.82 Crossbred 2.25 2.18 2.39 2.46 -0.53 1.86 2.80 Pig Indigenous 11.04 11.34 8.74 7.84 0.45 -5.08 -10.37 Total 13.29 13.52 11.13 10.29 0.28 -3.82 -7.54 Donkey 0.88 0.65 0.44 0.32 -4.35 -7.51 -27.17 Horse 0.83 0.75 0.61 0.63 -1.6 -4.05 2.12 Mule 0.22 0.18 0.14 0.196 -3.03 -4.90 43.07 Camel 0.91 0.63 0.52 0.40 -5.13 -3.77 -22.63 Yak 0.06 0.07 0.08 0.077 2.78 2.71 -7.64 Mithun 0.18 0.28 0.26 0.298 9.27 -1.47 12.88 Poultry Chicken 315.43 408.02 617.73 692.65 4.88 8.64 12.13 Duck 32.18 32.67 27.64 23.53 0.25 -3.32 -1485

Horse There are six registered breeds of horses and ponies in India. Two are large sized namely Marwari and Kathiawari. They are mainly used for riding, sports, transportation and safari.

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The other four breeds, Zanskari, Spiti, Bhutia and Manipuri are small sized ponies. Zanskari, Spiti, Bhutia ponies are known for their ability to work tirelessly in high altitude regions. The Manipuri ponies are referred to as original polo ponies. The Indian horse breeds have unique traits such as sturdiness, endurance potential, relative disease resistance etc. Camel There are nine registered breeds of camel in the country namely Bikaneri, Jaisalmeri, Mewari, Katchi, Marwari, Mewati, Jalori,MalviandKharai. The camel is utilized for transportation and drought purposes in desert and arid areas of the country. Bikaneri camels are considered best for load carrying and pulling capacity. The Jaisalmeri camels have been recognised for their racing abilities. Pig There are three registered breeds of indigenous pig- Ghoongroo Niang Megha and Agonda Goan. Still there are large unique populations which can be defined as breed particularly in North Eastern region of the country. Yak and Mithun Yak and Mithun are Bovines, very close to cattle. In India, yak and Mithun have very small proportion among the total number of livestock population. Mithun is reared as meat animal in the northeast region of the country. Compared to yak, mithun is found at lower altitude region. Mostly yaks are mainly used for milk, meat and fiber production. Yaks thrive well in climate and low oxygen availability of high altitude regions. There is no defined breed of yak and mithun. Poultry India is considered to be the original home of the Red Jungle Fowl (Gallus gallus) the progenitor of present day domestic birds. Total 15 breeds of poultry have been registered.

Table 2: Indigenous livestock breeds and their breeding tracts Cattle breeds Buffalo breeds Sheep breeds Goat breeds Breed Breeding tract Breed Breeding tract Breed Breeding tract Breed Breeding tract Amritmahal Karnataka Bhadawari Uttar Pradesh and Balangir Odisha Attapady Kerala Madhya Pradesh black Bachaur Bihar Jaffarabadi Gujarat Bellary Karnataka Barbari Uttar Pradesh and Rajasthan Bargur Tamil Nadu Marathwadi Maharashtra Bhakarwal Jammu and Kashmir Beetal Punjab Dangi Maharashtra and Mehsana Gujarat Bonpala Sikkim Black Bengal West Bengal Gujarat Deoni Maharashtra and Murrah Haryana Changthangi Jammu and Kashmir Changthangi Jammu and Kashmir Karnataka Gaolao Maharashtra and Nagpuri Maharashtra Chokla Rajasthan Chegu Himachal Pradesh Madhya Pradesh Gir Gujarat Nili Ravi Punjab Chottanagpuri Jharkhand Gaddi Himachal Pradesh Hallikar Karnataka Pandharpuri Maharashtra Coimbatore Tamil Nadu Ganjam Odisha Hariana Haryana, UP and Surti Gujarat Deccani Andhra Pradesh and Gohilwadi Gujarat Rajasthan Maharashtra Kangayam Tamilnadu Toda Tamilnadu Gaddi Himachal Pradesh Jakhrana Rajasthan Kankrej Gujarat and Banni Gujarat Ganjam Odisha Jamunapari Uttar Pradesh Rajasthan Kenkatha UP, MP Chilika Odisha Garole West Bengal KanniAdu Tamil Nadu Kherigarh Uttar Pradesh Kalahandi Odisha Gurez Jammu and Kashmir Kutchi Gujarat Khillar Maharashtra and Hassan Karnataka Malabari Kerala Karnataka Krishna Karnataka Jaisalmeri Rajasthan Marwari Rajasthan Valley Malvi Madhya Pradesh Jalauni Uttar Pradesh and Mehsana Gujarat Madhya Pradesh 3

Mewati Rajasthan, Haryana Karnah Jammu and Kashmir Osmanabadi Maharastra and Uttar Pradesh Nagori Rajasthan Kenguri Karnataka Sangamneri Maharastra Nimari Madhya Pradesh Kilakarsal Tamil Nadu Sirohi Rajasthan and Gujarat Ongole Andhra Pradesh Madras Red Tamil Nadu Surti Gujarat Ponwar Uttar Pradesh Magra Rajasthan Zalawadi Gujarat Punganur Andhra Pradesh Malpura Rajasthan KonkanKany Maharashtra al Rathi Rajasthan Mandya Karnataka Berari Maharashtra Red Kandhari Maharashtra Marwari Rajasthan and Pantja Uttarakhand & UP Gujarat Red Sindhi On organized farms Mecheri Tamil Nadu only Sahiwal Punjab and Muzzafarnagri Uttar Pradesh and Rajasthan Uttarakhand Siri Sikkim and West Nali Rajasthan Bengal Tharparkar Rajasthan Nellore Andhra Pradesh Umblachery Tamilnadu Nilgiri Tamil Nadu Vechur Kerala Patanwadi Gujarat Motu Odisha, Poonchi Jammu and Kashmir Chhattisgarh and Andhra Pradesh Ghumusari Odisha Pugal Rajasthan Binjharpuri Odisha Ramnad White Tamil Nadu Khariar Odisha Rampur Bushair Himachal Pradesh Pulikulam Tamilnadu Shahbadi Bihar Kosali Chhattisgarh Sonadi Rajasthan MalnadGidda Karnataka Tibetan Arunachal Pradesh Belahi Haryana& Tiruchi Black Tamil Nadu Chandigarh Gangatiri Uttar Pradesh Vembur Tamil Nadu Katchaikatty Tamil Nadu Black

Threats to Livestock Diversity Domestic animal diversity is under threat, globally. As per FAO, almost one breed is being extinct every month in world. Needless to say by losing a breed, we are losing the specific gene pool generated through long evolution in specific ecological niche. Situation is much severe in developing countries like in India, where rapid urbanization and mechanization; and high production pressure in lieu of bourgeoning human population. This has almost altered the conventional utility pattern of indigenous livestock and today, exceptions for few, most of the native breeds of farm animals are facing serious threat. It is imperative, the breeds loosing utility are nowhere to stand, unless, some important measures are not being taken to protect them. In recent past, the changes in utilization pattern have overburdened some of the livestock breeds, whereas posed the threat to others. Our indigenous livestock diversity has become more vulnerable due to increasing pressure of high production. In turn, it led to rearing of few and mostly exotic high performing breeds specifically in cattle, pig and poultry. High demand of milk has attracted high producing exotic breeds of cattle, which caused severe and rapid dilution of our cattle genetic stock. Change in utilization in form of farm mechanisation has posed serious threat to some of the livestock breeds best known for their draft power. Over the years, intensification of animal husbandry and widespread introduction of exotic breeds have completely altered Animal Genetic Resources scenario. In buffaloes, excessive use of 4

Murrah breed in most of the states has posed great threat to the local buffalo breeds of these states. Social changes have also negatively influenced the AnGR diversity. In case of sheep and goat, present generation in society may not take much interest in continuing their ancestral occupation of rearing livestock in migratory system of grazing. Non-access to resources, overgrazing and resource degradation have also adversely affected animal genetic resources. As a result of these developments, several indigenous livestock and poultry breeds over the years have suffered decline. Emerging diseases, changing markets, changes in consumer demand, cultural and historical reasons, migration, indiscriminate slaughter, trans-border illegal export of AnGR, changes in production system, continued decreasing land under fodder production, habitat erosion, loss of grazing land and disasters (drought, floods disease epidemics etc.) are other reasons for livestock diversity erosion.

Need for Characterization, Conservation and Utilization of AnGR The need for identification, characterization, sustainable utilization and conservation of animal genetic resources has been accepted globally. Characterization is generally carried out to identify new breeds. Characterization, particularly, phenotypic is intended to document animal genetic resources, geographical distribution and status of breeds in terms of population, characteristics, etc. in native environments. It documents the unique characteristics of the breed; to identify elite animals.As per census, about 12% cattle population is described as a breed, whereas, 70% population is non-descript, remaining population of cattle is crossbred type. About 56% buffaloes are non-descript type. A total of 22 new livestock breeds have been added in the breed register during last eight years. The conservation of Animal Genetic Resources is now a multidimensional activity, which encompasses not only preservation and maintenance of existing breeds but also their improvement and proper management. Two types of conservation strategies are adopted-in situ conservation or as ex situ conservation. In situ conservation primarily involves the active breeding of animal populations in such a way that diversity is optimally utilized in the short term and maintained for the longer term. In situ models of AnGR conservation can be done by providing technical inputs and incentives to the farmers/breeders in the breeding tract of respective farm animal breeds. Ex situ, conservation away from the habitat and production systems where the resource developed is another way for conservation. Both kinds of conservation programmes need the collaboration of different agencies, organizations as well as stakeholders i.e. livestock keepers and their communities. In fact, many indigenous breeds are indeed no longer profitable at present scenario, therefore, initiation of costly conservation programmes are indispensable in order to maintain diversity. Another way for conservation may be to make such breeds more sustainable through value addition of their products. Further, finding niche markets for their products is also important to ensure the survival of these breeds, so that the people who keep them to earn more from these animals.Conservation and utilization of AnGR can be best achieved through a joint approach by involving all stakeholders. These should understand and participate in all activities relating to management of AnGR like implementation of improvement and conservation programmes, animal identification, performance recording, marketing and branding of animal products, development of pasture lands, fodder production, etc. It is always recommended to combine live animal conservation with cryo-conservation. It is possible now to store a wide variety of living cells / germplasm (semen, ova, embryo and somatic cell). Genomic DNA, tissues, stem cells and

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whole blood may also preserved for posterity. First National Gene Bank of the country has been established at NBAGR, Karnal. More than 1.32 Lakhs frozen semen doses of different breeds of cattle, buffalo, sheep, goat, camel, yak and equine have been preserved at National Gene Bank.

Intellectual property and biodiversity IPR-related scandals that periodically shock the world, such as:  US Patent (No. 5,401,504) given to the healing properties of turmeric which is known to Indians since long time ago,  US plant patent (No. 5,751) on the 'ayahuasca' plant, considered sacred and used for medicinal purposes by Amazon's indigenous peoples;  Basmati rice by Rice-Tec Corporation in the US (Patent No. 5,663,484);  Plant breeders' rights or patents on entire taxa rather than specific varieties or breeds, e.g. on all transgenic cotton or soybean granted to the company Agracetus; and  US Patent No. 5,723,765 granted to Delta and Pine Land Co., nick-named the Terminator Technology for its potential of stopping plant regeneration after the first generation. IPRs are the rights to ideas and information, which are used in new inventions or processes. These rights enable the holder to exclude others from marketing such inventions or processes for a specified time; in exchange, the holder is required to disclose the idea behind the product/process. The effect of IPRs is therefore monopoly over commercial exploitation of the idea/information, for a limited period. The stated purpose of IPRs is to stimulate innovation, by offering higher monetary returns than the market otherwise might provide.

GATT trade rounds Eight Major International Negotiations were held aimed at reducing tariff and non-tariff barriers to trade under the GATT auspices. 1947 – Geneva; 1949 – Annecy, France ; 1951 - Torquay, England 1956 – Geneva; 1961 – Geneva ( The Dillon Round). - All for Tariff Reductions 1964-67 - Geneva (The Kennedy Round) - For Reduction of Industrial Tariff by one third; Anti-dumping Measures. 1973-79 - Geneva (The Tokyo Round) - Non-Tariff & Framework Agreements. !992 – Earth summit at Rio de Janeiro – Convention on Biodivrsity (CBD) – 150 countries – presently 193 1986-93 - Geneva (The Uruguay Round) - Market Access Concessions; Trade In Services (TAS); Intellectual Property Rights (TRIPS).

The WTO, Uruguay Round Agreements and Agriculture The Uruguay Round of Multilateral Trade Negotiations, which was concluded in 1994, established the World Trade Organization (WTO) to replace the General Agreement on Tariffs and Trade (GATT). The Uruguay Round negotiations were the first to deal with the liberalization of trade in agricultural products, an area excluded from previous rounds of

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negotiations. They also included negotiations on reducing non-tariff barriers to international trade in agricultural products and concluded with two binding agreements: The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) The Agreement on Technical Barriers to Trade (TBT Agreement). Members of WTO will apply these agreements and the general terms are also applicable to countries that are not WTO members. WTO's Mandate  Administering and implementing the multilateral and plurilateral trade Agreements which together make up WTO.  Acting as a forum for multilateral trade negotiations.  Seeking to resolve trade disputes.  Overseeing national trade policies.  Cooperating with other international institutions involved in global economic policy- making.  Protection Of Intellectual and Inherited Assets Have Various Dimensions. They include both Intellectual Assets And Bio-Assets.

The Patent Cooperation Treaty (PCT) It is an international patent law treaty, concluded in 1970. It provides a unified procedure for filing patent applications to protect inventions in each of its contracting states. A patent application filed under the PCT is called an international application, or PCT application. PCT signed in Washington D.C. Uruguay Round completed.

Indian Patents Act 2005 In 1930, the U.S. Plant Patent Act was passed, which gave IPRs to asexually reproduced plant varieties. Several other countries subsequently extended such or other forms of protection to plant varieties, until in 1961, an International Convention for the Protection of New Varieties of Plants was signed. Most signatories were industrialized countries, who had also formed a Union for the Protection of New Varieties of Plants (UPOV). This treaty came into force in 1968. Plant varieties or breeders' rights (PVRs/PBRs); give the right-holder limited regulatory powers over the marketing of 'their' varieties. Till recently, most countries allowed farmers and other breeders to be exempted from the provisions of such rights, as long as they did not indulge in branded commercial transactions of the varieties. Now, however, after an amendment in 1991, UPOV itself has tightened the monopolistic nature of PVRs/PBRs, and some countries have substantially removed the exemptions to farmers and breeders. In 1972, the U.S. Supreme Court ruled that microbiologist Ananda Chakrabarty's patent claim for a genetically engineered bacterial strain, was permissible. This legitimised the view that anything made by humans and not found in nature was patentable. Genetically altered animals, such as the infamous 'onco-mouse' of Harvard University (bred for cancer research), were also soon given patents. Finally, several patent claims have been made, and some granted, on human genetic material, including on material that has hardly been altered from its natural state.

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Table: Comparison of the acts of UPOV 1978, UPOV 1991 and PPVFRA 2001 UPOV 1978 ACT UPOV 1991 Act PPVFRA Protection Varieties of Varieties of all Varieties of all Coverage species defined species Species by a country Requirement Distinct, uniform New, distinct, New, distinct, for protection and stable (DUS) uniform and stable uniform and stable Scope of Production and Production, Production, breeders marketing of marketing export, marketing rights propagation import and stocking export, import material (only of all material (seed and stocking of seed) and other parts) all material

Minimum 15 years 20 years 15 years (plants/ duration of crops) protection 18 years (tree / vines) Breeders’ exemption Yes Not for essentially Not for essentially derived varieties derived varieties Farmers privilege Yes (in Optional; to be Yes practice) governed by national laws Double protection No Yes ― (possible or not) Compulsory license In case of In case of In case of public interest public interest public interest

Protection of IPRs Intellectual Property Protection Patents Trade Marks Copy Rights Designs Trade Secrets (undisclosed information)

Bio-Assets Protection Biodiversity Germplasms Geographical indications Plant varieties

CBD & TRIPS The Convention on Biological Diversity (CBD) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the World Trade Organisation (WTO). CBD is an 8

instrument to protect the property in public domain over which no one can have the proprietary rights of any kind. TRIPS stood for protection of intellectual property generated through human ingenuity. TRIPs vs. CBD in India India is currently considering two laws to follow up TRIPs and CBD: the Plant Varieties and Farmers' Rights Bill (PVFRB) and the Biological Diversity Act (BDA), respectively. The PVFRB is supposed to be India's sui generis plant variety protection regime (as per Article 27(3)b of TRIPs). However, in several ways these two are not in harmony: Whereas the BDA provides for the protection of local community rights in a broad sense, the PVFRB contains only a narrow definition of farmers' rights (the right to reuse, exchange, and sell (except as branded product) protected plant varieties; it does not provide for the protection of farmers' own varieties (which are unlikely to pass the stringent tests of novelty, distinctiveness, etc.) but rather focuses on benefiting formal sector plant breeders; Whereas the BDA explicitly provides for benefit-sharing measures with local communities, the PVRFB has no such provision; Whereas the BDA attempts to include local community representatives at various levels of decision-making, the PVRFB almost completely excludes them, giving decision-making powers largely to bureaucracies; Whereas the BDA requires impact assessments to ensure that all developmental activities are in harmony with biodiversity conservation and sustainable use, the PVRFB does not require any such assessments for plant variety protection applications; The contradictions between the two proposed laws are yet to be resolved, though they have been pointed out by NGOs and activists (Kothari 1999).

Geographical indications Some products of particular regions do have some superior qualities either because of climate, recipes or food processing techniques that are local to a region or indigenous manufacturing skills and are found to be more saleable in the market than comparable products from other region. In order to take advantage of the commercial attractiveness of these local reputations, quality and attributes associated with geographical origin, some laws were passed by local legislators preventing adulteration of local produce and introduction of certification systems for quality and this paved the way to the development of a new branch of Intellectual Property Rights known to be Geographical Indications (GI). GI indicates that particular goods originate from a country, region, or locality, and have some special characteristics or qualities, or reputations, that are attributable to its place of origin and are part and parcel of the cultures and traditions of a country. They contribute to the reputation of the products concerned and create goodwill among consumers and are therefore, of considerable importance for both developed and developing countries. GIs such as Champagne, Scotch whisky, Havana cigars, Antigua coffee, Basmati rice, Darjeeling tea and Feta cheese are all well-known today because of sustained efforts by individuals and organizations to keep their mystique and aura in existence, to promote and preserve the quality of these products and to elevate them to a pedestal where they have become synonymous with their geographical origin. Indian Case Studies on GIs include Darjeeling Tea, Aarogyappacha, Basmati Rice, Banaras Sarees and Brocades, etc... According to R.W Benson, “when a product’s geographic name becomes as signifying the type of product, rather than its geographic source, the name is

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considered generic and becomes part of the public domain and hence such geographical indications cannot be claimed to be intellectual property rights. Examples of generics include, “French fries” and “Bermuda shorts”.

GI protection International Jurisprudence and forms of Protection available to GIs include Paris Convention for the Protection of Industrial Property, 1883: Madrid Agreement for the Repression of False or Deceptive Indications of Source of Goods, 1891 and Lisbon Agreement for the Protection of Appellations of Origin and their Registration, 1958. GI can be protected by way of registration that includes certification trademark, collective mark and by way of a sui generis legislation for GIs for the product concerned. A significant feature of some free trade agreements, such as the North American Free Trade Agreement between the United States, Canada, and Mexico (1992) is that the intellectual property provisions included often provide for a higher level of protection than provided for by the TRIPS agreement. Section 9 of the Geographical Indications of Goods (Registration and Protection) Act, 1999 prohibits the registration of geographical indications that are determined to be generic and has been criticized by many because it broadens the scope of determining a product as generic by adding the area of consumption of goods. India is under no obligation to consider areas other than the place of origin in determining whether a name has become generic or not. It may prove to be a serious blow to Indian producers because producers in the consumption areas may have also started producing those goods on a large scale and selling them to consumers using the original geographical name or indication – a practice which is not prohibited by TRIPS so long as the consumers are not misled.

GI and trademark GIs are often confused with trademarks and can be avoided if one can differentiate trademarks as a private monopoly right and GIs as a collective public right. Trademarks identify the source of the product whereas GIs, apart from identifying the geographical origin of a product, also indicate that the product possesses certain characteristics or qualities which are inextricably linked to the geography concerned and hence trademark rights may be assigned while that of GI may not.

Conclusion Natural resources from the developing and less developed countries have been plundered and used by many of the developed nations without paying any royalty to the source countries at all. The stealing of biological resources and indigenous knowledge would affect food security and livelihood of indigenous people. Biopiracy in India was observed in the common plant varieties like Haldi, Basmati, Neem etc. In livestock sector we have faced many issues related to gir and ongole cattle, garole sheep and in many other species of India. In India, the food supply is dependent on a small number of edible plant resources, mainly wheat, maize, rice, and potato, which are fundamental to food security. Patenting of these plants varieties will definitely pose threat to the consumers. However, in the past few years, developing countries have become more vocal in the international arena to protect their own genetic resources. This would help developing countries in the political bargaining with developed countries and can help to solve the problem of biopiracy.

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IPR issues related to indigenous domestic animal germplasm Dinesh Kumar1, Dr R. Kalpana Sastry2 & J R Rao2 1Centre for Agricultural Bioinformatics, IASRI, New Delhi – 110012 2ICAR-National Academy of Agricultural Research Management, Hyderabad

The term "sovereignty” used here is in legalistic sense which means exclusivity of its rights regarding indigenous native germplasm of the country. In global context of intellectual property right its legal infringement on exclusivity by other competing parties/nations. With advent of advancing biotechnology the germplasm improvement and global marketing has been touching the sensitive fabric of germplasm sovereignty across countries especially from IP (Intellectual Property) perspective. This talk will be raising issues of sovereignty based on selected case studies of native indigenous domestic animal germplasm where it needs attention at national level. First case cites the example of encroachment by widest claim in aggressive patent filing by other countries. This is evident in several abroad patents claiming Bos indicus (of India) or all bovids for the inventions on Bos taurus blocking other species on which no experiments have been carried out. Contrary to first case, second case describes the Indian inventor’s patent with narrower claim rendering rooms for others for encroachments in our AnGR sovereignty. Here we are discussing the case of CSIR/ Lucknow-Sahilwal milk patent case claiming antibacterial property. Third case describes the vehement subtle non-disclosure of origin of germplasm in foreign patent now contravening present CBD provisions. Here the case of Indian Garole micro sheep breed of Sundarban region of West Bengal having gene of multiple birth (twinning) called Boooroola patent by foreign country is discussed. We have published evidences by third party (neutral party) that Garole sheep was transported to Australia/New Zealand. Even patentee has written in published paper that Boroola gene has originated from Bengal sheep (Garole). We have two interesting evidences showing direct link of Garole/Booroola gene encroaching sovereignty of our germplasm. Surprisingly, in the patent document of Booroola gene the origin of germplasm is not disclosed by foreign inventors but in paper it has been disclosed (paper submitted after filing of patent, unscrupulously) by the very same inventor as author that gene has originated from Bengal sheep. Recently West Bengal Government Biodiversity Board & NGO have raised this issue and matter. The fourth case describes GI claims by other nations on registered GI of Indian domestic animal product. Here we are describing the product of Indian goat breeds yielding Pashmina (goat breed Changithangi & Chegu) claimed by other neighbouring nations. We have evidences that both these nations have claimed GI on Pashmina challenging sovereignty of GI of indigenous germplasm product. Our simple concern here is when French Champagne has special protection of GI for its name also, why not the same is possible for Cashmere Pashmina. Is it possible to have GI of multiple countries? How other countries can have claim on GI with name Pashmina when India has already registered GI of it. Can a pashmina raw material importing country can claim GI on/of their handicraft work disguisedly widening their non-originated geography and encroach on GI’s sovereignty of other countries? The fifth case describes the case of Sheep SNP chip available in global market which is now available in Indian market also. The chip is based on pooled SNP data of 3004 domestic 11

sheep DNA samples from 71 breeds. Breeds were collected from Africa, Asia, South America, Europe, the Middle East, Australasia, the USA and Caribbean. Out of these 71 breeds, three Indian sheep breeds viz Garole, Deccani and Changthangi were covered in SNP discovery and sheep hap map panel. These three sheep breed represent three divergent agro- climtaic/ecological zones possessing unique genotypes related to divergent adaptations and disease resistance. Do we have any IP sharing benefit based on Nagoya Protocol of ABS? Do we have discount in buying these sheep chip with respect to other nations who have not contributed but going to reap the benefit? The sixth case describes recent reports of 2011 on cattle germplasm and its illegal movement across border which is under investigation by National Biodiversity Board (NBD). Andhra’s Ongole bulls are prized as they are said to be resistant to mad cow disease. It’s a serious national concern about illegal acquisition of genetic material. There is report that a middleman paid Rs 35 lakh for a bull. Healthy bulls sell for crores in Brazil. There is a great demand also for Gir and Kankrej species of cattle from Gujarat for their high milk yield. It’s reported that a good Gir bull in Brazil can fetch more than a million USD (over Rs 4.5 crore). In year 2011, Gujarat Biodiversity Board has initiated an inquiry into the incident where embryos of the Gir cows were exported to Brazil without the requisite permission from the National Biodiversity Board (NBD). In year 2010, report has come that a Bhavnagar based public charitable trust had exported embryos of 569 bovine of Gir breed to Brazil. It’s reported that two containers with embryos of the breed were flown to Brazil to improve the stock of cows there. The embryos were developed in a laboratory in Bhavnagar which has been funded at a cost of Rs 2 crore by cattle breeders of Brazil.

Based on these case studies following points are recommended. 1. Biodiversity of India is unique and precious due to diverse climate and lack of much selection thus genotype diversity is gold mine from commercial angle. The utilization of SNP data generated needs much more skilful deals and strategic planning in dealing with international consortium. Consortium is always beneficial to each party in principle but benefit sharing cannot and should not be compromised. 2. While patent filing on indigenous germplasm related inventions the strategic angle of widest claim must be followed to block the potential area of future infringements by third parties. 3. Greater IP surveillance especially in area of animal science is needed to raise the issues without delay and compromising sovereignty of our domestic animal germplasm. 4. Bureau’s role in keeping and investigating such cases in form of information and its flow to concerned authorities is becoming of paramount importance thus all bureaux linked with germplasm must be strengthened in terms of statutory power and its functioning in the context needed to report such cases. 5. The need of germplasm sovereignty sensitisation in IP perspective is needed for common public in general but more emphatically its need for researchers of both public and private sectors as well. 6. Germplasm information flow data by organisations must be kept in public domain using information technology to have a public awareness/check. It would also avoid controversies and rumours. 7. All research/business consortium partners from India must make a

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statement/disclosure for cases especially where ABS(Access Benefit Sharing) issues are involved. This paper might be a curtain raiser for researchers, policy makers and germplasm managers in light of WTO regime to transform/rationalise the current documentation endeavour of AnGR as well as research/patent filing etc perhaps hitherto missing of which might have led/paved the pathway of encroachment on sovereignty AnGR of India.

Acknowledgment: These case studies have been carried out as part of project work in Post Graduate Diploma in Technology Management in Agriculture, a joint course of University of Hyderabad and NAARM. The sponsorship of DK for this study by Director, ICAR-NBAGR is thankfully acknowledged.The opinion cited by authors is their personal scientific opinion and does not represent the official/government of India opinion or gesture. RKS and JRR were thesis Supervisor and Co-Supervisor, respectively.

About the Authors: DK: Working as Principal Scientist (Biotechnology) at Centre for Agricultural Bioinformatics (CABIN), ICAR-IASRI, New Delhi. Masters and PhD in Biotechnology from BHU, Varanasi, ARS 1997 batch, Gold Medalist in Post Graduate Diploma in Technology Management in Agriculture from Central University Hyderabad. Author is Law Graduate with specialisation in Intellectual Property Right and Cyber Law and has Post Graduate Diploma in IPR from IGNOU & WIPO. JRR: Former Professor Emeritus, ICAR-NAARM, Hyderabad. RKS: Joint Director,ICAR-NAARM, Hyderabad.

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Registration of Livestock and Poultry Breeds in India P.K.Vij ICAR-National Bureau of Animal Genetic Resources Karnal -132001 (Haryana)

India possesses huge as well as diverse livestock population distributed over a large range of geographical, ecological and climatic regions, and is globally acknowledged as one of the largest livestock diversity centre. Farm animal population comprises of 512 million of livestock and 729 million of poultry (Livestock Census, 2012). There are 160 well defined registered indigenous breeds in the country but there are still many animal populations that are not assigned to any breed. The populations which have not been characterized and accredited so far, are commonly referred to as “non-descript” or “traditional”. Even though parts of these “non-descript” populations are known to be multiple crosses of recognized breeds, some animals may belong to homogenous groups distinguishable from other populations on the basis of identifiable and stable phenotypic characteristics that warrant their being distinguished as separate breeds. The advent of new era of national sovereignty over genetic resources under Convention on Biological Diversity (CBD) requires a new approach to describe and catalogue livestock and poultry breeds. The objective of sustainable use of genetic resources as one of the main goals of the CBD as well as sustainable development could be achieved only through ensuring “wide access to animal genetic resources, for farmers, herders, breeders and researchers”. The intent of the Nagoya Protocol for ensuring fair and equitable benefit sharing arising from the utilization of genetic resources, the global scenario of World Trade Organization (WTO) and Intellectual Property Rights warrant protecting the local animal genetic diversity and provide recognition to the livestock keepers. This in turn demands an authentic national documentation system of valuable sovereign genetic resources with well defined characteristics. Registration is nothing but a documentation of the knowledge, skills and techniques (KST), and biological resources of local communities. The registration process is a critical pathway for public description and documentation of genetic materials. Of utmost importance, once registered, these genetic materials are incorporated into the public domain. Recognising the need for an authentic national documentation system of valuable sovereign genetic resource with known characteristics, Indian Council of Agricultural Research (ICAR), in the year 2007, initiated a mechanism for “Registration of Animal Germplasm” by giving temporary authority to National Bureau of Animal Genetic Resources (NBAGR), Karnal. Subsequently in 2008, ICAR constituted a Breed Registration Committee under the chairmanship of Deputy Director General (Animal Science), ICAR. It include Assistant Director General (AP&B), ICAR; Assistant Director General (IP&TM), ICAR; Animal Husbandry Commissioner or his nominee; representative of National Biodiversity Authority; and Director, NBAGR as permanent members. A Principal Scientist from NBAGR functions as member secretary. The Other members are co-opted as per the advice of the chairman. There is a provision (with the approval of the chairman) for adoption of need based species specialist with reference to the breed under consideration. This would provide protection to the valuable animal genetic diversity and facilitate its access for genetic improvement of animal breeds. This mechanism is the sole recognised process for registration of “Animal Genetic Resources” material at national level. 14

Guidelines for Registration Registration of New Breeds: The registration of Indian livestock and poultry genetic resources revolves around the concept of a breed. Distinct populations within species are usually referred to as breeds. Cultural and ecological aspects of livestock keeping also serve as a means of identifying populations that merit being treated as separate breeds. It is difficult to exactly define a breed. The broad definition of the term “breed” used by FAO is a reflection of the difficulties involved in establishing a strict definition of the term. According to this definition, the breeds are either (a) a sub-specific group of domestic livestock with definable and identifiable external characteristics that enable it to be separated by visual appraisal from other similarly-defined groups within same species; or (b) a group for which geographical and/or cultural separation from phenotypically similar groups has led to acceptance of its separate identity. Eligibility Criteria for Registration: 1. Populations of domesticated animals, which are unique, stable and uniform, and has potential attributes of academic, scientific or commercial value can be registered as breeds. 2. Any population having at least 1000 animals will be considered for registration as a breed. These animals may be maintained by the applicant/ breed society/ NGO/ Govt. Agency/ farmers in field conditions. 3. All claims concerning the material submitted for registration should accompany scientific evidence for uniqueness, reproducibility and value in the form of- i. Publication in standard peer reviewed journal (a copy of reprint to be submitted). AND/ OR ii. Evaluation data for at least three years under research programmes like All India Co- ordinated Research Project (AICRP), Network Project, Adhoc Schemes, etc. supported with relevant extracts of the documents or verification by concerned Director/Project Director (PD)/Project Coordinator (PC) AND/ OR iii. Publication of information on potential value of germplasm in institute annual report or any other such reports AND/ OR Recommendation of the State Animal Husbandry Department/Livestock Development Board regarding the novelty and uniqueness of the breed claimed. Who can Apply: Application can be submitted by any citizen of India / breed society registered as per constitution of India / NGO / Govt. agency. Validity of Registration: The period for validity of registration shall be 25 years. Notification of Registered Materials: All breeds approved for registration would be officially notified to the applicants along with Registration Number. A certificate will also be issued to this effect to the applicant. Official Notification will be published along with brief description of not less than one page in the subsequent issue of i. Indian Journal of Animal Sciences - Published by I.C.A.R., New Delhi – 110 012

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ii. An abstract form of the registered breed will also be published in following publications: a. NBAGR Newsletter, Published by the Director, NBAGR, Karnal-132 001 b. ICAR News - Published by the Publication and Information Division, Krishi Anusandhan Bhavan, ICAR, New Delhi – 110 012 c. NBAGR, ICAR Website De-notification: De-notification shall be done by the Registration Committee in case of false claim(s) or disputed IPR claim. Appeal for counter claim, if any, should reach the Registration Committee within a period of three months or the publication of Notification in Indian Journal of Animal Sciences - Published by the I.C.A.R.

Procedure for Submission of Proposal for Breed Registration 1. Submission of Application and Material: All applications for registration of proposed breeds should be submitted to the following address: The Director, ICAR-National Bureau of Animal Genetic Resources, P.O.Box. 129, Karnal – 132001, Haryana. Phone: 0184-226 7918, Fax: 0184-226 7654, Email: [email protected] 2. The applicant should submit 3 copies of the application along with relevant documents, literature, no matter how small (even one page), for the proper evaluation of the breed and softcopy of the application, descriptor and original photographs. 3. The application must be signed by the applicant and countersigned by Director, Department of Animal Husbandry of the concerned state or his representative with rubber seal. 4. The application must be accompanied by complete description of the breed using standard descriptors (as per concerned species). 5. Submit a detailed history of the breed. 6. List the difference, distinction and details that are specific for that breed in comparison to other breeds in the vicinity or elsewhere. 7. Submit representative photographs of the breed (male, female, young ones and herd /flock). 8. Submit a list of the registered animals of the breed that are conforming the breed standards laid out by the applicant or his organization. 9. The breed must have completed a minimum of 10 generations. 10. Submit letters from at least three different breeders/owners of the breed, explaining:  Why they believe it should become a recognized breed?  How long they have been breeding the breed?  Spell out the reasons for recognition of the breed as a separate identity.  What has been done to establish this breed- breeding strategies, parental stock etc?  What are the suggestions to further improve this breed in a long term perspective?  What makes this breed clearly different and distinctive from all other breeds? Registration of Varieties/Strains/Lines of chicken 1. Submission of Application along with documents All applications for registration of proposed Varieties/Strains/Strains should be submitted to the following address: 16

The Director, National Bureau of Animal Genetic Resources, P.O.Box. 129, Karnal – 132001, Haryana. Phone: 0184-226 7918, Fax: 0184-226 7654, Email: [email protected] 2. The applicant should submit 3 copies of the application along with relevant documents, literature, no matter how small (even one page), for the proper evaluation of the Variety/Strain/Line and softcopy of the application, descriptor and original photographs. 3. The application must be signed by the applicant(s) and countersigned by the Head of the Organization with rubber seal. 4. The application must be accompanied by complete description of the Variety/Strain/Line using prescribed descriptors. 5. Submit a detailed history of the development of the Variety/Strain/Line. 6. List the distinctiveness characteristics of the Variety/Strain/Line in comparison to other Varieties/Strains/Lines available in the country. 7. Submit representative photographs of the Variety/Strain/Line (male, female, young ones and flock). 8. The Variety/Strain/Line must have completed a minimum of 8 generations. 9. The Applicant must certify that:  The Variety/Strain/Line is distinct from other Lines/Strains whose existence is a matter of common knowledge at the time of filing of application  It is sufficiently uniform and stable Eligibility Criteria for Registration: Any population having at least 1000 birds will be considered for registration as a Variety/Strain/Line. All claims concerning the material submitted for registration should accompany scientific evidence for uniqueness, reproducibility and value in the form of- (I) Publication in standard peer reviewed journal (a copy of reprint to be submitted). AND/ OR (II) Evaluation data for at least three years under research programmes like All India Co-ordinated Research Project (AICRP), Network Project, Adhoc Schemes, etc. supported with relevant extracts of the documents or verification by concerned Director/Project Director (PD)/Project Coordinator (PC) AND/ OR (III) Publication of information on potential value of germplasm in institute annual report or any other such reports

Status of Registration  Accession numbers have been given allotted to all the 129 extant breeds of livestock and poultry. These have been published in The Indian Journal of Animal Sciences, 78(1): 127-130 (2008). (http://www.nbagr.res.in/Accessionbreed.html)  Guidelines, descriptor formats and application form have been prepared for registration of new breeds (http://www.nbagr.res.in/guidelines.html) and for varieties/strains/lines of chicken (http://www.nbagr.res.in/guide.pdf).  31 new breeds and one line of chicken have been registered

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New Breeds Registered Thirty one new breeds of different species of livestock and poultry have been registered so far. This includes 10 breeds of cattle, 3 of buffaloes, 5 of goat, 6 of pig, and 3 of sheep, 2 of chicken, 1 of camel and 1 of donkey. After including these newly registered breeds, total number of indigenous breeds in the country now is 160, which include 40 for cattle, 13 for buffalo, 26 for goat, 42 for sheep, 6 for horses & ponies, 9 for camel, 6 for pig, 1 for donkey and 17 for chicken.

S.N. Breed Home Tract Accession number CATTLE 01 Motu Odisha, INDIA_CATTLE_1526_MOTU _03031 Chhattisgarh and Andhra Pradesh 02 Ghumusari Odisha INDIA_CATTLE_1500_GHUMUSARI _03032 03 Binjharpuri Odisha INDIA_CATTLE_1500_BINJHARPURI _03033 04 Khariar Odisha INDIA_CATTLE_1500_KHARIAR _03034 05 Pulikulam Tamilnadu INDIA_CATTLE_1800_PULIKULAM_03035 06 Kosali Chhattisgarh INDIA_CATTLE_2600_KOSALI _03036 07 Malnad Gidda Karnataka INDIA_CATTLE_0800_MALNADGIDDA_03037 08 Belahi Haryana and INDIA_CATTLE_0532_BELAHI _03038 Chandigarh 09 Gangatiri Uttar Pradesh INDIA_CATTLE_2003_GANGATIRI_03039 and Bihar 10 Badri Uttarakhand INDIA_CATTLE_2400_BADRI_03040

BUFFALO 01 Banni Gujarat INDIA_BUFFALO_0400_BANNI_01011 02 Chilika Odisha INDIA_BUFFALO_1500_CHILIKA_01012 03 Kalahandi Odisha INDIA_BUFFALO_1500_KALAHANDI_01013 GOAT 01 Konkan Maharashtra INDIA_GOAT_1100_ KONKANKANYAL _06022 Kanyal 02 Berari Maharashtra INDIA_GOAT_1100_ BERARI _06023 03 Pantja Uttarakhand and INDIA_GOAT_2420_ PANTJA _06024 Uttar Pradesh 04 Teressa Andaman & INDIA_GOAT_3300_ TERESSA _06025 Nicobar 05 Kodi Adu Tamil Nadu INDIA_GOAT_1800_ KODIADU _06026 Sheep 01 Katchaikatty Tamil Nadu INDIA_SHEEP_1800_KATCHAIKATTYBLACK_ 14040 Black 02 Chevaadu Tamil Nadu INDIA_SHEEP_1800_ CHEVAADU _ 14041 03 Kendrapada Odisha INDIA_SHEEP_1500_ KENDRAPADA _ 14042 Camel 01 Kharai Gujarat INDIA_CAMEL__0400_CAMEL_02009

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PIG 01 Ghoongroo West Bengal INDIA_PIG_2100_GHOONGROO_09001 02 Niang Megha Meghalaya INDIA_PIG_1300_NIANGMEGHA_09002 03 Agonda Goan Goa INDIA_PIG_3500_ AGONDAGOAN _09003 04 Tenyi Vo Nagaland INDIA_PIG_1400_ TENYIVO _09004 05 Nicobari Andaman & INDIA_PIG_3300_ NICOBARI _09005 Nicobar 06 Doom Assam INDIA_PIG_0200_ DOOM _09006 Donkey 01 Spiti Himachal INDIA_DONKEY__0600_SPITI_05001 Pradesh Chicken 01 Mewari Rajasthan INDIA_CHICKEN_1700_ MEWARI _12016 02 Kaunayen Manipur INDIA_CHICKEN_1200_ KAUNAYEN _12017

Lines Registered S.N. Name Developed by Accession number Chicken-Synthetic 01 PD1 (Vanaraja ICAR-Directorate INDIA_CHICKEN_001_PD1_13001 Male Line) of Poultry Research, Hyderabad

Indigenous pig and donkey breeds, and a line of chicken have been registered for the first time. This documentation process has helped creating awareness and enhancing sense of ownership among local communities, policy makers, and research and development organizations. There may still be many domestic animal populations having distinct characteristics which have not been recognized as breeds so far. These need to be documented and registered as breeds to protect and exploit benefits of IPRs, if any, arising out of these resources.

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Basics concepts of Patent Jayakumar S, Karan Veer Singh and Dr Reena Arora ICAR-National Bureau of Animal Genetic Resources Karnal -132001 (Haryana)

The word ‘Patent’ is derived from the Latin word ‘Patere’ which means, “to open”. The patent can be granted to an individual, Institution, or organization, for his invention, for a period of 20 years and in limited territory, but, in turn, the inventor should fully disclose the details of his inventions. Ideas can’t be patented. Patent provides to owner of the patent an exclusive right that prevents the third parties without the consent of the patent holder, to make or sell using the patented product or technology. It is a negative right that prevents others from using the patented information without the legal consent of the inventor or patent holder. Any individual residing in a country where the patent has not been filed, can be able to exploit the patent for commercial purposes in that country, without any restrictions.

Types of patent 1. Standard Patent Also called as an ordinary patent. 2. A Patent of Addition This type of patent is granted for any improvement or modification of the invention that has been already granted with a patent and remains in force only till the original invention remains in force. 3. Utility Model Patents These are patents granted for a short period for simple devices, in some countries such as Australia, China, Japan, etc. 4. Plant Patents It’s been granted in some countries like USA.

Basic requirements for patenting an invention 1. Novelty An invention is novel when it has not been known to the public anywhere in the world on the date of patent application. 2. Non-obviousness The invention must be non-obvious to a person skilled in the art. 3. capable of industrial application 4. First to file

Patent can’t be applied for the following things i) Any frivolous inventions which are contrary to the well-established natural laws; ii) An Invention for which the primary use would be contrary to law, public order or morality or causes serious prejudice to human, animal or plant life or health or to the environment or which is injurious to public health; iii) The mere discovery of a scientific principle iv) Discovery of any living thing or non-living substance occurring in nature iv) A substance obtained by a mere admixture. 20

Stages in grant of patent The application procedure related to securing a patent has been discussed in detail in Chapter III and IV of the Patents Act, 1970 and in Chapter I and II of the Patents Rules, 2003. The following stages are involved in obtaining a patent: a) Filing of an application b) Publication c) Request for examination by the applicant or interested person d) Examination and issuance of examination report to the applicant e) Meeting of objections and disposal of pre-grant opposition (if any ) f) Grant of patent and issue of certificate of patent g) Payment of renewal fees.

Types of patent applications i) Ordinary application – are those applications where no priority is claimed ii) Convention application - are those applications where one or more priorities are claimed iii) National phase application - are those applications that enter national phase under Patent Cooperation Treaty (PCT) iv) PCT international applications - are those applications which are filed under Patent Cooperation Treaty (PCT) v) Divisional application - are those applications which are divided out of the parent application containing plurality of distinct inventions. vi) Patent of addition – are those applications where invention pertains to improvement of the existing application or patent.

Patent application Application for grant of a patent is to be made on Form 1 as prescribed in the Second Schedule of the rules: a) Particulars to be given for all types of application 1) Name, nationality, address of the applicant 2) Name, nationality, address of the inventor(s) 3) Title of the invention 4) Address for correspondence of applicant /authorized patent agent in India b) Additional particulars to be given depending on the type of application For convention application Priority particulars of the application filed in the convention country For national phase application Particulars for filing Patent Cooperation Treaty (PCT ) National Phase Applications For divisional application Particulars of original application- number and date of filing For patent of addition Particulars of main application/ patent number and date of filing c) In addition, following declaration(s) should be given a) By inventors that they are true and first inventors of the invention or the applicants are their assignee/legal representative

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b) By the applicants in the convention country that applicants are their assignee or legal representative (For Convention application) c) By the applicants that: - they are in possession of the invention, - the application is accompanied by provisional /complete specification, - there is no lawful ground of objection to the grant of patent, - necessary permission from competent authority for use of biological materials, - applicant is the assignee or legal representative of first inventor, - application in India is based on International application filed under PCT (For national phase application), - application is divided out into the original application, particulars of which are given in para-7 of Form1 and pray that this application is treated as deemed to be filed on (date of the original application) under section 6 of the act (For divisional application), - said invention is an improvement in or modification of the invention particulars of which are given in para -8 of Form1 (For patent of addition). d) Each application should be accompanied by the following attachments a) Provisional specification /complete specification stating number of pages and claims b) Drawings (if any) stating number of drawing sheets c) Priority documents d) Translation of priority document/specification/applicant is not legally bound to submit e) Statement of undertaking of corresponding applications on Form 3 f) Declaration of inventorship on Form 5 g) Sequence listing in electronic form h) Abstract of the invention in 150 words i) Power of authority.

For each of the invention, separate application need to be made and should be signed by the applicant in whose favour power of attorney has been executed. Each application must be filed at the appropriate office along with the fee as prescribed in the first Schedule of the rules.

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Patent Potential in Biotechnology Research Y.S.Rajput, Emeritus Scientist, ICAR-National Dairy Research Institute, Karnal

In order to understand patent potential in particular field such as biotechnology, it is imperative to first understand what patentable invention is. This question is always pertinent and requires understanding of both patentable and non-patentable research. General criteria of patentable research are common across the countries and also holds good even for biotechnology research. These criteria include novelty, non-obviousness and commercial value of said invention. The novelty is to be proved on global basis and the said invention is said to be novel if there is no prior art. Prior art is essentially existing knowledge in field of invention and the cut off date for determining existing knowledge is the date on which patent application is filed. The said date is called priority date and patent rights are covered from priority date. Traditional knowledge can be considered as prior art. Results included in dissertation submitted before filing patent application forms prior art. A patentable research is never to be disclosed in any form (annual report, newsletter, magazine, conference abstract, and publication) before filing patent application. If invention is covered in prior art, the said invention is not novel in patent laws. The other important criterion of patentable research is non-obviousness which is defined as invention lacking obviousness. Obviousness and non-obviousness terms should be clearly understood by inventor for taking decision in filing patent application. Two individuals can always argue for obviousness or non-obviousness for same invention because the knowledge level of two individuals could be very different in the field of invention. The said invention should be non-obvious to skilled person and skilled person is the one who has comparable knowledge in the field of invention. To make this point further clear, person having master or doctoral degrees in microbiology can be skilled person for invention in the field of pathogen. Thus, it should be clear that said invention should be non-obvious to skilled person and if so, said invention is said to be have inventiveness in it. The last criterion is potential of said invention for commercial use. Besides these three criteria, the said invention should not fall fields of invention which has been denied in patent act. Examples in this category include invention in field of atomic energy, natural laws, method of agriculture, organisms existing in nature, eradicating plant and human life and many others. Patent laws across countries were made prior to development in biotechnology and innovation in biotechnology involves ethical issues. Ethical issues have far reaching consequences of biotechnology. Biotechnology generally concerns the application of cellular and molecular biology to make or modify products or processes. It includes scientific and industrial disciplines focused on understanding and manipulating living or biologically-active material at the molecular level, often involving DNA techniques and the analysis of genetic information. Modern biotechnology is expected to lead to important breakthroughs in many fields, such as health, food, energy, and the environment. While the patentability criteria prescribed in patent laws apply to inventions in all fields of technology in the same manner, the application of patent law to biotechnological inventions has to deal with a number of particularities that may not exist in the same way in other areas of technology. Issus on patentability of biological material is still debated. Some argue

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that such biological materials are mere “discoveries”, and therefore not patentable, while others argue that they are “inventions” and patentable. With respect to industrial applicability (usefulness) and sufficiency of disclosure, the exclusive patent rights may be granted only where an appropriate level of concrete and practical use of the biotechnological invention is disclosed in the patent application. The debate addresses the importance of ensuring that claims are not broader than is justified by the invention disclosed in the patent application, in particular, where it is an early and fundamental stage of innovation or a new gene with its future application still not determined. Biotechnological inventions result from the fact that biological material is capable of reproducing itself. This requires determination of scope of legal protection of future generations; special rules for plant and animal breeders or farmers; the possibility of overlap between plant variety and patent protection even in countries where patent protection for plant varieties is excluded. A biological patent is a patent on an invention in the field of biology that by law allows the patent holder to exclude others from making, using, selling, or importing the protected invention for a limited period of time. The scope and reach of biological patents vary among jurisdictions, and may include biological technology and products, genetically modified organisms and genetic material. The applicability of patents to substances and processes wholly or partially natural in origin is a subject of debate. Natural genes cannot be patented in Australia and USA. In the United States, up until 2013 natural biological substances themselves could have been patented if they were sufficiently "isolated" from their naturally occurring states European Union directive 98/44/EC (the Biotech Directive) allows for the patenting of natural biological products, including gene sequences, as long as they are "isolated from their natural environment or produced by means of a technical process. The European Patent Office has ruled that European patents cannot be granted for processes that involve the destruction of human embryos. Japan Patent Office (JPO) explicitly lists “medical activities” among inventions that fall outside the scope of industrially applicable inventions, meaning that methods of surgery, therapy, and the diagnosis of human diseases cannot be patented. Another area of controversy in genetic patenting is how gene samples are obtained. Prior consent is required to collect genetic samples, and collection of samples from people requires consent at the national and community levels as well as the individual level. Conflicts have resulted when consent is not obtained at all three levels. The question of benefit sharing also arises when obtaining genetic samples, specifically the potential responsibility of the collector to share any benefits or profits of the discoveries with the population or person from whom the sample came.

Biotechnology and Ethics Invention which is contrary to public order or morality can not be patented. These include (i) human cloning, (ii) modification of genes in human sex cells; (iii) industrial use of human cloning and (iv) modifications of genes in animals that cause them suffering without significant medical benefit to humans or animals.

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The use of human embryos for industrial and commercial purposes” must be excluded from patentability. Methods which use human embryos, such as the production of embryonic stem cells, are therefore not patentable. Biotechnology involves technical applications of biological processes in microorganisms, plants or animals. We benefit from biotechnology in the food industry, agriculture and medicine. Biotechnology includes any technique that uses living organisms or parts of organisms to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses. Mankind has used forms of biotechnology since the dawn of civilization. However, it has been the recent development of new biological techniques (e.g., recombinant DNA, cell fusion, and monoclonal antibody technology) which has raised fundamental social and moral questions and created problems in intellectual property rights. Intellectual property protection for biotechnology is currently in confused state. Whilst it used to be the case that living organisms were largely excluded from protection, attitudes are now changing and increasingly biotechnology is receiving some form of protection. These changes have largely taken place in the USA and other industrialized countries, but as other countries wish to compete in the new biotechnological markets, they are likely to change their national laws in order to protect and encourage investment in biotechnology. There are currently two main systems of protection for biotechnology: rights in plant varieties, and patents. Both systems provide exclusive, time-limited rights of exploitation and are described in more detail below.

Rights in plant varieties Prior to the mid-1960s only a few countries (e.g., Germany, USA) gave any intellectual property protection to plant varieties. Because of pressure from their plant breeding industries, 10 western European countries entered into a diplomatic process in the early- 1960s which eventually culminated in the formation of an International Union for the Protection of New Varieties of plants (UPOV) and the signing of a Convention (the UPOV Convention 1961). Since that time a number of other countries have become parties to the UPOV Convention. Amendments were made to the UPOV Convention in 1978, principally to facilitate the entry of the USA.

Patents for biotechnology Whilst the majority of countries provide some form of patent protection, only a few provide patent protection for biotechnology (these include: Australia, Bulgaria, Canada, Czechoslovakia, Hungary, Romania, Japan, the Soviet Union and the parties to the European Patent Convention). The reasons for this may differ, but generally it has been because biotechnology has been thought inappropriate for patent protection, either because the system was originally designed for mechanical inventions, or for technical or practical reasons, or for one or more ethical, religious or social concerns. In all the National Patent Offices where patents are granted for biotechnology there is a considerable backlog of pending applications. It has largely been the USA which has broken new ground in providing the possibility of patent protection for "anything under the sun that is made by man". Patents have been granted for plants since 1930 in the USA, under The Plant Patent Act. However, prior to

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1980, the US Patent Office would not grant utility patents (separate from The Plant Patent Act) living matter because it deemed products of nature not to be within the terms of the utility patent statute. That was until the landmark decision of the US Supreme Court in Diamond v Chakrabarty (from which the above quote is taken), which held that a particular genetically engineered bacterium was statutory subject matter for a utility patent. This decision has been the basis upon which patents have been granted for higher life forms. Subsequently it has been held that a utility patent may be granted for plants and a patent has been granted for an animal. Polyploid oysters, not naturally occurring, were held to be patentable subject matter and US Patent No.3,736,866, was issued in respect of a "transgenic nonhuman mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into the said mammal, or an ancestor of said animal, at an embryonic stage" - popularly known as the 'onco-mouse '. Elsewhere, the treatment of applications for patents for living matter is far from certain. Whilst patents are granted in many countries for plants and microorganisms, it has been the issue of patents for animals which has been most controversial. The EPC is a regional arrangement entered into by 14 European countries for the purpose of making multiple applications for any of the member countries a great deal easier and to introduce a common system for patent protection. An application under the EPC is for a European patent, or Euro-patent, for short. If a Euro-patent is granted by the European Patent Office (EPO) it has the same effect, and is subject to the same conditions, as a national patent in each of the member countries designated in the application. In other words, through a single application a bundle of national patents can be obtained. The EPC provides that "plant or animal varieties or essentially biological processes for the production of plants or animals" are excluded from patent protection (although the exclusion is expressly stated not to apply to microbiological processes and products). These exclusions would appear to place unequivocal prohibition on Euro-patents for macro biotechnology. However, the EPO has been taking an increasingly narrow view of these exclusions, and has held that they do not exclude all plants and animals per se, but only claims for varieties of plants or animals and that a process is not "essentially biological" if there has been substantial interference by man.

Patentable biotechnological inventions  Methods for producing or analysing proteins and their use in an analysis method or in a medicinal product.  Proteins, DNA sequences, microorganisms and constituents of the human body (for example, cells) which already exist in nature, if they are isolated from their natural environment or produced by a technical procedure, and have not been described previously.  A gene, which is isolated and given a new task as a medicinal product or diagnostic tool.  Genetically modified products, such as plants and animals.

Non-patentable biotechnological inventions  Pure discoveries such as discovered but not isolated or further described parts of animals, plants or microorganisms.  Plant varieties and animal breeds.

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 Inventions thatare contrary to public order or morality, which society regards as unethical and unacceptable. For example, it is not possible to patent a method for reproductive human cloning as it is contrary to public order and morality.  Something that is only a discovery, such as the identification of a new gene, is not patentable. But if you have studied further what the gene's function is if it is used as a medicinal product or diagnostic tool, then it is an invention that can be patent protected. The protection is often defined as “isolated DNA molecules with (a certain) nucleotide sequence”. In other words, the protection cannot be said to cover DNA in nature, only artificial DNA molecules or DNA which is isolated from the human body and cut down to the piece you are interested in.

Plants and animals? An invention relating to plants and animals can be patented, if the implementability of the invention is not limited to a certain plant variety or animal breed. Even a microbiological procedure and products of such a procedure, for example plants and animals, can be patented. However, methods consisting of biological procedures, such as cross-breeding and selection, for producing plants and animals cannot be patented.

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Patenting the genes, gene sequences and Genetic Resources – possibility and its impact in India Jayakumar S1 & Dinesh Kumar2 1ICAR-National Bureau of Animal Genetic Resources, Karnal -132001 (Haryana) 2Centre for Agricultural Bioinformatics, ICAR-IASRI, New Delhi – 110012

Introduction With the increasing importance of patents, it is advantageous for scientists and business developers to be versed in the field of intellectual property to fully comprehend business opportunities, particularly in the area of agriculture. It has now become possible to patent the life forms. Patents could hamper the research and development by other companies or individuals because of the high cost of getting the right to carryout research on the patented genes. Granting patents on partial or uncharacterized DNA sequences will reward those who make routine discoveries but penalize those who determine the biological functions of the DNA. There will be multiple patents issued on the same gene, first as a short string, then as a longer one, then the full gene and then the gene and its function. Multiple patents increase the cost of any new plant, animal or drug. Often, the third world countries contribute rare and novel genetic material to animal and plant breeders. The breeders in the developed countries are now using those genetic materials to develop GMOs. It will not be fair to turn around and charge third world farmers for the new GMO varieties that they may have helped develop but haven't been paid for. By 2009, the National Institutes of Health estimated that at least 20 percent of individual human genes had been patented already or had been filed for patenting. As a result, research on certain genes was restricted to the corporations holding the patents, and diagnostic genetic tests carried huge price tags. The basic fact about genes/gene products being patentable is that when a genetically engineered gene/DNA/amino acid sequence is novel and holds an inventive step thereby ensuring its industrial application, the patents can be claimed as: Gene sequence/amino acid sequence; a method of expressing the above sequence; an antibody against that sequence/protein and as a kit made from the antibody/sequence.

Genes and disease Scientists typically chase after genes linked to diseases, and then identify and sequence them, often using government funds for their research. Companies subsequently buy exclusive licenses from the university in which the researcher is based and create diagnostic kits for the public who have to pay to get tested for the gene. This exclusivity leads to diagnostic monopolies provided by the patent and rakes in money for the firm. In the case of Myriad Genetics, it is estimated that last year alone the company's revenues from molecular diagnostics grew by a little less than fifty per cent to U.S. $326.5 million and breast cancer gene tests accounted for the largest portion of the profits. (Myriad and the University of Utah jointly own the patents for the BRCA1 and BRCA2 genes although it should be clear that by some estimates up to a third of the research on BRCA1 was funded from federal research grants). There is a larger context within which these developments have been taking place. The sequencing of the human genome confirmed that the gene-disease connection is complex and that scientists would have to revise their simplistic model linking specific genes with 28

proteins and thereby with traits or diseases. Nevertheless, within the prevailing genetic deterministic paradigm, the proliferation of research on identifying genes linked to specific conditions has led to an eagerness to learn what "disease genes" one has - even if the link to a disease may be tenuous or absent. It is in such a climate that tests with little value, many which have not been validated by the U.S. Food and Drug Administration, have multiplied. The corporatization of university research was accelerated by the U.S. Bayh-Dole Act of 1980. Among other things, this law allowed institutions to transfer rights from publicly funded research to inventors and commercial partners. India is under internal and external pressure to pass legislation similar to the Bayh-Dole Act and needs to heed these impacts along with other problems before making any changes to existing law. A gene itself contributes to a disease only to a certain extent. There may be other genes, proteins, cellular conditions, environmental factors, immune states, etc., that determine the actual expression of a disease. In the case of breast cancer, for instance, about 85 to 90 percent of breast cancer is a result of non-hereditary causes. The remaining 10 to 15 percent, however, appear to run in families as in the case of Ashkenazi Jews, where mutations in the BRCA1 and BRCA2 genes increase the risk of breast and ovarian cancers significantly. Persons in such families get tissue samples tested by Myriad Genetics for mutations in these two genes, paying over U.S. $3000 per test. When the disease runs in families, people make decisions on prophylactic options such as whether to undergo mastectomy, take hormone therapy or other kinds of treatment to reduce their odds of getting these cancers. Further, some treatment options for patients with the disease may also rely on the test results.

History In 1980, the United States Supreme Court in Diamond v. Chakrabarty authorized the patenting of a genetically-engineered living organism. The Court indicated that this was an invention, not a product of nature and said that “The laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.” Nevertheless, in an erroneous application of the case, the United States Patent and Trademark Office (USPTO) began allowing patents to be issued on genetic sequences when “isolated from their natural state and purified”. The proponents of gene patents claim that legal precedents allowing the patenting of isolated and purified products of nature justify the patenting of genetic sequences in which the non-coding regions of the genetic sequence have been removed. They claim that the remaining genetic sequence is an “invention” since it has been “isolated” (taken out of the body) and “purified” (had non-coding regions removed).

Patent laws on Genes and Gene Sequences Advancement in science and genetic application, with enhanced knowledge of Human Genome has been the main focus in the field of medicine and biotechnology areas. Continuous and ongoing researches in genome project, identifying specific target genes and their respective response and functional activities, have evolved genetic therapeutics in treatment of multifactor disorders such as heart disease, diabetic, neurological disorders, muscular dystrophy and so and so forth. Gene patents have been the most debated matter since years. The economic and policy issues surrounding patents on genes, gene sequences, nucleotide sequences, expressed

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sequence tags (ESTs), single nucleotide polymorphism (SNPs) have posed the potency to present unique challenges in science, innovations and legal fraternity around the globe.

Grant of Patents on genetic sequences Contrary to U.S. Supreme Court precedent, the current policy of the United States Patent & Trademark Office (USPTO) is to grant patents for human genetic material, including full length gene sequences, gene mutations, and fragments of genetic material. The theory of the USPTO is that the act of isolation and purification of this material from the human body removes it from the unpatentable “products of nature” realm (1). According to the USPTO, “while descriptive sequence information alone is not patentable subject matter, a new and useful purified and isolated DNA compound described by the sequence is eligible for patenting, subject to satisfying the other criteria for patentability (2). A patent application for a DNA sequence must be distinguished from its non-patentable naturally-occurring counterpart, in that the “patent application must state that the invention has been purified or isolated or is part of a recombinant molecule or is now part of a vector (3).” In 2001, in its Utility Examination Guidelines, the USPTO stated: “Thus, an inventor’s discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it (4)”. Patents on human genes or gene parts differ in terms of whether the inventors could credibly argue that they have “isolated and purified” the gene. In some instances, the patent holder has merely patented a gene mutation exactly as it occurs in nature, in clear violation of the “product of nature” doctrine. In others, the patent applicant has removed the non-coding region, but the remaining genetic sequence still has the same effect as the naturally-occurring gene (5). For example, not only could the patented (“isolated and purified”) sequence be used for diagnosis of a particular disease, so could the original whole sequence as it occurs in nature. While the current policy of the USPTO is to grant patent rights for genetic material, the U.S. Supreme Court has not yet made a determination on the issue of whether human genetic material is patentable subject matter. In fact, U.S. Supreme Court precedent is to the contrary. Article 1, Section 8, Clause 8 and U.S. Patent Law Article 1, section 8, clause 8 of the United States Constitution provides that Congress shall have the power “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;…”

Patenting of genetic material Relying on the precedent of the out-dated and erroneous adrenaline case, proponents of human gene patents have successfully argued that the “isolation and purification” of a gene or other genetic material transforms it from a naturally-occurring product of nature to something new and useful for a specific purpose or function that does not naturally exist in nature. Amgen, Inc. v. Chugai Pharmaceutical Co. involved patent rights over the DNA sequences that encode human erythropoietin (EPO), a protein that stimulates red blood cell production (6). The patent applicant claimed an isolated and purified form of a gene that codes for EPO, where “isolated and purified” meant that the applicant had identified and reproduced the coding region of the DNA outside of its natural environment (7). The case

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focused on the issue of conception with regard to the specific requirement of written description, where an applicant must have a mental picture of the chemical structure or be able to define it by the method of preparation (8). The Federal Circuit said that where an inventor is not able to envision the “detailed constitution of a gene so as to distinguish it from other materials, as well as a method for obtaining it, conception has not been achieved until reduction to practice has occurred, i.e. until after the gene has been isolated (9). While acknowledging that the patent holder had not invented either EPO or the EPO gene, the court held that because they had “isolated and purified” the gene, they had fulfilled the patentability requirements of U.S.C. § 102 and 112 (9). However, the court failed to conduct the appropriate patentable subject matter inquiry under§101. If U.S. Supreme Court precedent had been followed, the case would have resulted in a threshold finding that the sequence was in fact a product of nature and therefore not patentable subject matter. The only distinguishing factor between the claimed sequence and the sequence in human cells that code for EPO was the presence of the words “isolated” and “purified” within the patent claims, defined as removing the coding region of the relevant DNA (7). Subsequent federal cases, following Amgen, have continued to assume that specific patents covering human gene sequences are patentable where the applicant “isolated” and “purified” the gene. Similar to the decision in Parke- Davis, the Amgen case and its progeny fail to even consider the product of nature doctrine explicitly and disregard the line of U.S. Supreme Court precedent that dictates that products of nature, even where purified, are not patentable subject matter under §101. Recent U.S. Supreme Court case law suggests an additional reason that genetic sequence patents might be vulnerable to a legal challenge. In 2007, the U.S. Supreme Court in KSR International Co. v. Teleflex, Inc., clarified the standards by patent applicants must meet to show their invention is non-obvious.

Patent Issues regarding Gene Patents: A number of gene/DNA sequence patents grew dramatically during the Human Genome project. Researchers have obtained patents for isolating genes or gene sequences that occur in nature. Whether this should be permitted or not is still an open debate since decades. Generally to seek a patent-protected gene, there are certain issues that a researcher comes across. (1) Stop or avoid researching the particular gene; (2) License the rights to research the gene from the patent holder; or (3) Continue research regardless of legal liability. Indeed, the choice made is often dependent on the DNA sequence in question and the line of research pursued. Regardless, the exercise of any of these three options could potentially work to reduce fundamental R&D in human genetics. Considering an instance of gene patent invalidation of Myriad Genetics by US federal court. The American Association of Pathologists and others have challenged several patents relating to the breast cancer genes BRCA1 and BRAC2 held by Myriad Genetics and the University of Utah Research Foundation. BRCA1 and BRCA2 genes are associated with an increased risk of breast and ovarian cancer. The patent claimed products of nature, law of nature and naturally occurring phenomena. The US district court for the Southern District of New York upon decision by Judge Robert Sweet, invalidated Myriad’s patents. The decision that isolated but otherwise unaltered DNA should not be patentable is now being appealed by Myriad.

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The US Government stated that: “The fact that a particular segment of the human genome codes for the BRCA1 protein in a human cell, for example, rather than for adrenaline or insulin or nothing at all, is not within the power of science to alter. Such basic natural relationships may not be the subject of a patent”(Case 1:09-cv-04515-RWS). Secondly, it is been argued that Myriad patents and it being the sole provider of BRCA1/2 testing has highly hindered cancer patients to receive cancer genetic testing. It is impeded that genes are the natural heritage of animals and/or human and its use should not be restricted by patent protection.

Why Haven’t Gene Patents Been Challenged? It is likely that if the U.S. Supreme Court were to hear a case involving genetic sequence patents, the Court would find them to be unpatentable products of nature. However, it is difficult for such a challenge to arise under U.S. law. The actors in the gene patent drama do not have an incentive to challenge the patentability of genes. The litigation about gene sequence patents generally has involved two parties who each claim to be the inventor of the genetic sequence. Both sides want genetic sequences to be patentable. There are numerous scientific organizations and consumer groups in the United States that believe that genetic sequences are unpatentable products of nature (10). But under U.S. law, generally only someone who is infringing the patent can challenge the patent (by arguing the invalidity of the patent as a defense to the infringement). Plus, the average patent lawsuit costs almost five million dollars (11). In Europe, members of the public (rather than just competing companies who infringe a patent) do have a voice in the patent application process or the right to challenge existing patents. In Europe, as a result of the opposition procedure which can be initiated by third parties, the patent was revoked in approximately 41% of the cases, and in 30% of the cases the patent rights were restricted. (12).

US patent law The patent and copyright laws in the United States were developed in order to support the creation and sharing of ideas with an aim to distributing that knowledge to all citizens. The drafters of the Constitution, Article 1, section 8, clause 8 sought to give Congress the power to promote this widespread distribution of knowledge in the most effective way possible. The idea was to promote a large number of inventions in order to encourage other inventors to build on that knowledge and benefit society as a whole through dissemination of the information. However, patents for human genetic material directly threaten that idea, impeding further Innovation. James Madison, writing in the Federalist (No. 43), argues that Article 1 and the development of patent laws would add to “the public good” (13). It would be very difficult to argue that the granting of patents on genetic sequences has added to the public good. Patent law is supposed to be a bargain in which the patent holder gets the exclusive right to make, use, or sell the invention in exchange for publishing in the patent the description of the invention. Under U.S. patent law, the inventor can exclude anyone else from making, using, or selling the invention for 20 years. The inventor also has a right to charge a royalty to anyone who uses, makes, or sells the invention. However, the system breaks down if what you patent is information – such as the sequence of a gene. Then you have a right to prevent others from using that information entirely. Innovation is stifled and the basic patent bargain (exclusivity

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in exchange for information) is thwarted. If a researcher wants to study a gene, he or she must obtain a license or infringe and risk treble damages. In fact, the researcher may have to obtain multiple licenses if patents have been granted on mutations in the gene. Some gene patent holders have stopped research on “their” genes by researchers at top universities, such as Yale, U.C.L.A. and the University of Pennsylvania. This is contrary to the purpose of the patent law – which is to stimulate innovation, not retard it. In countries where the breast cancer genes and hemochromatosis genes were not patented, and thus were freely available for all researchers to analyze, more mutations were discovered, allowing for better diagnostic testing. According to a study published in 2006, the test Myriad employs to detect breast cancer risk can miss mutations that help cause the disease (14). Myriad’s protocol was to “sequence the exons and flanking regulatory regions of each gene and to test for 5 specific larger mutations in RCA1” (15). Because many mutations are inherently undetectable by short- range polymerase chain reaction (PCR) - the process Myriad used - Myriad’s test was unable to detect them (15). In the study, researchers sampled DNA from 300 members of high-risk families in which four or more members had been diagnosed with either breast or ovarian cancer. (15). All 300 patients had received negative test results from Myriad (15). The research team used six methods to search DNA for breast cancer gene mutations (15). The researchers found that 12% of the patients studied carried rearrangements of BRCA1 or BRCA2 that were not included in Myriad’s array (15). Some believe the number of missed mutations to be even higher (16). According to Institute Curie geneticist Dr. Dominique Stoppa-Lyonett, the Myriad test may miss up to 20% of the expected BRCA1 mutations. (16). Myriad’s patents extend to all methods of diagnosing risk for hereditary breast and ovarian cancers based on comparing an individual’s sequence with the company’s BRCA sequences (16). Stoppa-Lyonett claims that the company’s patent is broad because it prohibits alternative techniques from being used to detect mutations. (16). Although alternative, less expensive methods exist to identify breast cancer gene mutations in a patient’s DNA that could identify more mutations; they are not used clinically for genetic testing for breast cancer in the U.S. because of the Myriad patents (17). Since Myriad does not make use of the other methods the researchers used, they are effectively cutting off the public from their use entirely. Dr. Mary-Claire King, a senior author of the 2006 study, maintained in an interview that “a fuller testing process would include more than one technology, and competition would enable that to develop” (14). The ability of a patent holder to prevent health care providers from using a patented genetic sequence denies people crucial medical information. Most drugs only work on a percentage of patients who use them. An asthma inhaler might only work on three of ten people to whom it is prescribed, causing the other seven to suffer symptoms of asthma and pay for an inappropriate drug until the right medication can be found. Genetic testing can help to distinguish those people for whom a drug will work from those people for whom it will not work, but, if the same entity holds the patents on the drugs and the gene sequences, it may prevent use of the gene sequence because the identification of people for whom the drug will not work will limit the market for the drug. In addition to the negative impact that gene patents have on access to and the quality of genetic testing, the possibility of patenting genes has caused some physicians and university researchers to view patients as treasure troves. Genetic research is being undertaken on

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people without their consent as researcher’s prospect for genes. Without their knowledge or consent, the mutations in Dan Greenberg’s and David Green’s Canavan gene mutations were patented (18). This prevents either man from donating their Canavan gene for use by other researchers and allows the patent holder to have a monopoly on (and charge whatever it wants for) assessing whether either man’s children have inherited their father’s mutation. Moreover, the rationales given for the patenting of other health care products (such as drugs) do not support the patenting genes. Genes are inherently different than drugs. The approximately 30,000 genes in our bodies control several hundred-thousand biological proteins (19). Their main function is as encoded information (19). There are fewer downsides to grant a patent on a drug or a medical device than granting a patent on a gene. The nature of genes makes them impossible to invent around (20). In the case of drugs and pharmaceuticals, the disclosure of a new drug in a patent may motivate other researchers to find chemical analogs that may work better or in slightly different ways (21). Patented genetic sequences invite no such innovation. A patent for a particular gene sequence patents the information contained in the sequence – for example the As, Ts, Cs, and Gs of the genetic code – and is therefore impossible to invent around. (20). The discovery of genes does not require the same incentives as drug development. Molecular biologists were attempting to identify genes long before the U.S. Patent and Trademark Office adopted the position that genes could be patented. As opposed to the development of drugs, which is undertaken primarily with private funds (for which investors expect a commercial return), the discovery of genes has been undertaken with vast quantities of public funds. Moreover, there are no expensive clinical trials when a gene is discovered and knowledge about the sequence of the gene is used to identify whether a particular patient has a mutation in that gene. In some cases, testing has begun almost immediately after a disease gene has been identified. Because the U.S. Food and Drug Administration (FDA) does not regulate the clinical services of genetic tests (as opposed to the sale of genetic diagnostic kits or gene therapies), there is no costly FDA approval process. Myriad Genetics, based in Salt Lake City, Utah, along with the University of Utah Research Foundation holds several patents on two breast cancer genes, BRCA1 and BRCA2 and is the sole provider of the full sequencing of BRCA1 and BRCA2 genes in the US on a commercial basis. The Association for Molecular Pathology along with individual patients, medical organisations and others challenging Myriad's gene patents filed a complaint alleging violations of 35 USC S 101, Article I, section 8, clause 8 of the United States constitution. It was contested that the patent claims covered products of nature, law of nature and/or natural phenomena and abstract ideas or basic human knowledge or thought. Other arguments included that: Myriad's patents and its position as the sole provider of BRCA1/2 testing has hindered the ability of patients to receive breast cancer genetic testing; it has impeded the development of improvement to BRCA1/2 genetic testing; and that the human genes are the common heritage of mankind whose use should not be restricted by patent grant. Myriad contested that patenting is a quid pro quo system and gene patents are essential for obtaining capital investment in the development and commercialisation of technology breakthroughs. Myriad disputed the idea that patenting of isolated human DNA conflicts with the advancement of science and asserted that it allowed scientists to conduct research studies on BRCA1/2 freely; further patents on isolated DNA actually promoted research and advanced clinical development to the benefit of patients.

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US court decision Judge Robert Sweet found that the challenged patent claims are directed to (1) isolated DNA containing all or portions of the BRCA1 and BRCA2 gene sequence and (2) methods of comparing or analyzing BRCA1 and BRCA2 gene sequences to identify the presence of mutations correlating with a predisposition to breast or ovarian cancer. He noted that the claims-in-suit directed to isolated DNA containing human BRCA1/2 gene sequences reflect the US Patent and Trade Mark Office's (USPTO) practice of granting patents on DNA sequences so long as those sequences are claimed in the form of isolated DNA. This practice is premised on the view that DNA should be treated no differently from any other chemical compounds and that its purification from the body, using well known techniques render it patentable by transforming it into something distinctly different in character. However, it was held by Judge Sweet that DNA's existence in an isolated form alters neither its fundamental quality nor the information it encodes. In invalidating the patented claims, he concluded that because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 USC S 101. Similarly with regard to the method claim, he held that because the claimed comparisons of DNA sequences are abstract mental processes, they also constitute unpatentable subject matter under S 101. Myriad with others have already filed a notice of appeal with the United States courts of appeal for the federal circuit. Only time will tell what will happen in future and whether the decision of the district court will be overturned at the federal circuit or the case will go up to the US Supreme Court. Many however, believe that the district court's decision, if not in entirety but in part, is likely to be overturned by the federal circuit. At least for now the invalidation of gene patents and the underlying reasoning for doing so has generated concern and curiosity about the patentability of isolated genes not only in the US, but also around the world. It would be interesting to consider the patentability of isolated genes in different parts of the world and how this case when decided ultimately will have an impact on the patenting of isolated gene patents in those geographies.

India's patent law India has emerged as one of the hubs for biotech research and potential commercial market for biological therapeutics and diagnostics for its population of more than one billion people. This and the revised patent law have encouraged patent filings in the biotech field in India. In the US, 35 USC 5 101 defines what inventions are patentable. What is not covered under the meaning of 35 USC 5 101, can be construed to be not an invention and therefore patent ineligible.

Indian Scenario The Indian Patent office guidelines with regard to Biotech related patents can be best described as inconsistent and grossly inadequate. The word gene or DNA does not appear anywhere in the Indian Patent Act nor there is any special directive issued by GOI for according legal protection to Biotechnology related inventions. The only reference for the same can be found in the Examination Manual Chapter 8 which deals with Examination and Grant of Patent applications. The Manual is currently in its third edition and has undergone substantial changes since the time it was introduced. The manual is not a binding document as it is not issued under any provisions of the Patent Act, but serves as an informal written

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guidance for the Examiners at the Patent office. According to the 2005 guidelines a new gene sequence modified or unmodified was considered as novel invention, and providing the function of the gene sequence was sufficient to meet the inventive step and industrial applicability requirement for such inventions. The word genetically modified is not present in the explanation to section 10(5) and grant of patents was not restricted to only those inventions which claimed genetically modified sequences. Though the text of the Patent office Manual is not binding and only serves as a guiding principle for Examiner, it nevertheless leads to major delays in the prosecuting Biotechnology related applications e.g. inventions claiming cDNA sequences. A cDNA sequence is formed from a mRNA sequence using a reverse transcriptase enzyme, a DNA polymerase enzyme and a PCR machine. A cDNA sequence is an identical copy of chromosomal gene sequence minus the introns. Thus they cannot be regarded as truly existing in nature but nevertheless cover the complete functional gene sequence when claimed in a patent. With India being promoted as a hub for clinical research, contract manufacturing and basic R&D in Biotechnology led drug development, there is an immediate need for legislation and concrete guidelines for biotechnology related inventions else delays and road blocks will be a major issues working against the Government efforts of promoting Research & Development in this industry.

Gene Patents: Changing Standards of Indian Patent Office Biotechnology inventions, like inventions in any other field of technology are capable of receiving patent protection provided they fulfil the three basic criteria for obtaining a patent i.e. Novelty, Inventive Step and Industrial applicability. Gene and DNA sequences being neither new, as they have always existed in the bodies of organisms nor inventive since they are discoverable due to their prior existence, posed peculiar legal problems for Patent office's due to their characteristics of being products of nature. However, to advance the cause of Research & Development in the area of Biotechnology, many patent granting jurisdictions have come up with specific guidelines and laws for grant of patents to inventions involving gene sequences. One such example is the ‘DIRECTIVE 98/44/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 July 1998’. The directive, provides that biological material which is isolated from its natural environment … may be the subject of an invention even if it previously occurred in nature. As of January 15, 2007, all of the 27 EU member states have implemented the Directive.

Overcoming objections It is observed that during prosecution, in the examination report for claims directed towards isolated DNA, objection is often raised stating section 3(c). Nonetheless, such objection can be dealt with based on the facts of the individual case by submitting that claimed isolated DNA sequences are recombinant, modified or not identical to those occurring in nature. It is also observed that for waiver of such objection, at times the specification has been amended to incorporate a disclaimer to the effect that the claimed DNA sequence is not available freely in nature. However, it is believed that isolated DNA for which the claims have been granted may not always be substantially different from the naturally occurring

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ones. These patents with claims on isolated DNA or nucleic acid sequences may have been granted based on the earlier precedence of such issued claims. Given such circumstances, if Judge Sweet's decision is upheld in further proceedings asserting that isolated genes are a product of nature and therefore not patentable, it is likely that it may impact Indian patent practice to the extent that it would further affirm the rejections of claims directed towards isolated DNA under section 3(c) of the Indian Patents Act.

Patents and DNA sequences The Controller General of Patents Designs and Trademarks in India is the authority that grants patents. The country has a Patents Act (1970) and Patents Rules (2003) and their amendments also apply to patents. As per the Patent Act, microbiological processes and non-living products from them can be patented. DNA, RNA, amino acid sequences, cell lines, all if artificially produced, can be patented too. Key recent controversies in developing countries have centred on Trade Related Aspects of Intellectual Property Rights (TRIPS), which has caused some level of convergence in patent law, removing the main exceptions to patentable subject matter. It has mandated patents on pharmaceutical products, and precluded discrimination between different sorts of technologies in patent law.

What are the implications? The ruling challenged the constitutionality of patenting all genetic sequences, and therefore could have broad implications for the future of biotechnology and health research. Since the lawsuit challenges the very concept of gene patenting, it is unclear what impact this ruling will have on the remainder of Myriad's patent portfolio. Myriad has stated that it will appeal this decision to a higher court, and "will continue to vigorously defend this litigation". But this ruling has turned around, at least for now, everything that was taken for granted regarding the patenting of DNA sequences and it will have implications worldwide. The appeal process will take time and Myriad's patents may be stayed or suspended. The ruling is non-binding on other federal courts and many other kinds of gene patents that are still held. The higher court may decide to agree with Judge Sweet, but even then it may be further appealed to the US Supreme Court. Although Round One has gone to the ACLU, and Big Biotech is momentarily shaken, the odds are still in favour of the existing patent regime. Let us wait and watch.

Indian Patent Laws on genes India, like other major countries have immensely involved in various biotech and medical research area, being one of the topmost competitor in commercial market in biological therapeutic and diagnostic domains globally. Section 3(c) of Indian Patent Act, states that “mere discovery of scientific principle or the formulation or the discovery of any living/non living substance occurring in nature” is not considered to be an invention. Pertaining to this law, mere isolation of naturally occurring genes from animal or plant body cannot be patentable. Accordingly, section 3 (i) define diagnostic methods is not patentable. Further, it explains that in vivo diagnostic methods practiced on human/animal body cannot be patentable but if diagnosis is performed in vitro i.e. on tissue or fluids that have been removed from body are entitled to be patentable in light of inventive measures. Hence, diagnostic methods employing DNA primers or probes or the like that are different from naturally occurring

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genes/DNA sequences that exhibits modified functions would be considered as patentable inventions. Considering Bilski (30 S.Ct. at 3225), new and useful methods of identifying, isolating, or using genes or genetic information may be patented (prohibiting patenting abstract ideas), that are basically man-made transformation or manipulation of the raw materials of the genome, such as cDNAs. Section 3(j) “plant and animals as whole, seeds and species which involve in its propagation or biological processes are not considered to be patentable”. In addition to this section 3(j) also states that apart from naturally occurring embodies, living entities of artificial origin such as transgenic plants and animals and/or parts thereof are not patentable. Microorganisms are construed to be patentable under section 3 (j). However, section 3(j) and section (c) when combined, states that isolated microorganisms from naturally occurring bodies are not construed to be patentable. Nevertheless, artificially developed genetically engineered microorganisms, vaccines and recombinant DNA are all considered to be patentable. For instance, as seen in the case law of Diamond v Chakrabarty, 447 U.S. 303 (1980), ruled that “anything under the sun that is made by man” is patentable. The Supreme Court established that the man-made products of genetic engineering are eligible for patent protection under 35 U.S.C. § 101. The Patent and Trademark Office responded to Chakrabarty by granting patents on a wide range of engineered DNA molecules and useful genetic methods. The basic fact about genes/gene products being patentable is that when a genetically engineered gene/DNA/amino acid sequence is novel and holds an inventive step thereby ensuring its industrial application, the patents can be claimed as: - Gene sequence/amino acid sequence. - A method of expressing the above sequence. - An antibody against that sequence/protein. - A kit made from the antibody/sequence. In a more brief sense, it should be noted that rDNA, plasmids and process of forming the same are allowed to be patentable under substantive inventive steps employed. Further, unidentified functions of gene/DNA sequences and without any industrial application cannot be construed to be patentable. One such example of gene patents in India, as seen in Indian Patent No. 243373 (279/MUM/2004) assigned to Sichuan Biotechnology Research Center, discloses artificial gene sequence for encoding recombinant super compound interferon with enhanced activity. The independent claim of the patent states: 1. A method for producing a recombinant interferon for inhibiting HBV-DNA replication as well as secretion of HBsAgs and HBeAg comprising steps of; Synthesizing and interferon DNA having a sequence as depicted in Fig.1 or 2 designed according to the codon usage; Placing said interferon DNA in an appropriate host preferably E.Coli and; Expressing said recombinant interferon in said host having an amino acid sequence encoded by interferon DNA. Again looking into Biocon’s story on genes, Using patent information as an integral tool, Biocon determined areas on which the company’s R&D should focus on.One such example is how the company used patent information to gain initial access to the field of human insulin production, where it is now a major player. The product patent on human insulin had long expired, but it was still protected by strong patents on processes of production. In most prosecution cases, it is been observed that the examiner objects claims directed

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towards isolated DNA/gene sequences in context to section 3 (c). Such objections can be dealt stating that the applicant’s/individuals claimed isolated DNA/gene sequence is purely recombinant and in modified form and its functions are not identical to that occurring naturally. But nevertheless, there are certain granted patent claims where isolated DNA/gene sequences are not substantially different from that occurring in nature. Such claims have been granted based on the previous precedence of such issued claims.

India: The high cost of filing a patent on a gene sequences Biotechnology is an extremely fast-moving field in which new products and services are developed from an increasingly complex and cumulative set of underlying technologies. Latesttreatments to diseases come from biotechnology where sequencing genes, identifying individual gene functions and mutations, creating systems to selectively express, regulate or silence genes, predict protein structures and expressions, mapping the influence of genetic make-up on metabolism and / or otherwise analyzing vast amounts of genetic data. These many technologies contribute to the rapid pace of advancement in the life sciences and offer tremendous promise for improving human health and furthering economic development. Organizations investing in research and development (R&D) in the field of biotechnology regularly file patents. In general, biotechnology inventions require description by reference to the sequence of a gene or protein. A gene includes a polynucleotide chain, where each nucleotide is selected from an "A," "G," C," or "T." A protein includes a chain of amino acids. Each amino acid is given a unique one letter code, and there are twenty common and naturally occurring amino acids. A sequence listing will identify the gene or protein by a "SEQ ID NO." (e.g., SEQ ID NO: 1), and provide the entire sequence. One gene or protein may range from several hundred to over a thousand characters. A single gene or protein sequence usually would not be an issue since the entire sequence could be presented in a manageable and affordable number of pages. In rare but not unheard of applications, many sequences-perhaps thousands-are disclosed. In these applications the number of pages becomes very large. In India, the cost of filing a gene sequence patent application is extremely expensive as compared to other jurisdictions. This particular issue may result in the provision being challenged in litigation. It would not be an open and shut case, but it is extremely likely that there are adequate grounds to put a serious dent in the provision. In India applications including sequence listings are allowed. The specific provision is: In case the application for Patent discloses sequence listing of nucleotides and/or amino acids, the same shall be filed in electronic form. However, the fee with respect to the equivalent number of pages shall be payable.

Fee structure adopted by Indian patent office For an entity other than natural person, the fee for each sheet of specification in addition to 30 (sheets) is Rs.400 per sheet. Note that electronic filing is allowed but the fee with respect to equivalent number of pages is required. That is there is no benefit to file electronically. Some countries make the fee affordable or some waive the additional fee altogether. For example, the U.S., the EPO, Japan, Canada, Australia, Brazil, Mexico allow for free or low cost filings of large sequence listings. The forums where the fee is reduced, or where there is no additional fee for filing

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sequences, require electronic filing. In PCT applications, standard practice for writing specifications includes writing important sequences into the text of the application if possible. Such a step guarantees that the sequence is part of the application even if the electronically filed sequence listing is separated from the paper filing in a patent office. But in the case of very large sequence listings, this is not possible since the number of pages would be excessive. In some places, the sequence listing is still filed on paper but is not counted against the page limit. In these forums, printing fees for the sequence listing may apply. India has no provision to reduce the fees associated with large sequence listings. The number of pages of the entire application, including the sequence listing, is taken into consideration when calculating the filing fee. For example, an application with 45 pages of specification, five pages of claims, one abstract page, and 6024 pages of sequence listing would be counted as a 6075 page application. This is unlike the U.S., the EPO, Japan, Mexico, Canada, Brazil, or Australia where the application size would be counted as 51 pages. One recent estimate on an application of roughly this size showed that the filing fees would be over $50,000 (US). In contrast, a U.S. non-provisional application of the same size where the sequence listing was electronically filed would cost $625. China also has higher fees with a large sequence listing, but the fees are capped. The fees for an electronically filed sequence listing are calculated as if the application was filed on paper, but the fees are capped at the amount charged for a 400 page application.

Patenting the genes/gene sequences A close analysis of the history of the U.S. patent laws and their interpretation by the U.S. Supreme Court over the past 150 years indicates that genetic sequences are unpatentable products of nature. Allowing unhindered access to genetic sequences not only contributes to the public good, but could spur innovation. A New York judge rules that trying to patent genetic information cannot be permitted - the first serious setback to the genetic technology industry, which will have implications worldwide. The current as well as the 2008 edition of the Manual regards claims to ‘genetically modified Gene Sequence/ Amino Acid Sequence, a method of expressing the sequence, an antibody against that protein / sequence, a kit containing such antibody / sequence’ as having a single inventive concept and capable of being granted a patent. The above text can be found under the explanation for section 10(5) Unity of Invention. The Patent office indeed does consider claims to genetically modified sequences for grant of Patent. The term ‘Genetically Modified Sequence’ however restricts smooth prosecution of only those inventions which relate to modifying known genes sequences or synthesis of a completely new gene sequence in the lab. To meet the novelty and inventive criteria, the modified gene sequence should not have existed in nature or should differ in at least one aspect from its identical copy in the nature. The difference can be a change of a single base pair which could provide new function, property or configuration to the protein molecule encoded by the gene sequence. Gene patents hamper the development of cures as the researchers were unwilling to undertake the work because of the potential for legal action against them by the holder of the patent. Gene patents also interfere with medical care and increase the cost of the diagnosis and treatment of genetic diseases. The patent holder can charge whatever he

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wants for any test analyzing the patented gene - even if that test uses a technology that was not invented by the patent holder. Myriad, which holds the patent on the BRCA1 and BRCA2 genes, charges $2,900 for its genetic test for breast cancer. Already, one in four laboratories has stopped performing certain genetic tests because of patent restrictions or excessive royalty costs. Gene patents do not seem necessary to encourage technology transfer in the move from gene discovery to the availability of a genetic diagnostic test. As soon as information about the discovery of the hemochromatosis gene was published, laboratories began testing for mutations in the gene. After a patent on the gene was granted seventeen months later, 30% of the 119 U.S. laboratories surveyed reported discontinuing or not developing a genetic test for the disease. The patent holder was asking for an up-front fee of $25,000 from academic laboratories and as much as $250,000 from commercial laboratories, plus a fee of $20 per test (22). The patent interfered with clinical adoption of the test and potentially compromised the quality of testing by limiting the development of higher quality or lower cost alternative testing methods. It would be well within the scope of Congress’s authority to ban patents on nucleotide sequences to undo the mistake made by the patent office in granting them and to protect the public. This is the approach taken under a bill to ban gene patents, H.R. 977, which is currently pending in the U.S. Congress. Gene patents have recently attracted the attention of researchers and the industrial and legal fraternity around the globe. There has been resurgence in deliberation on patenting genes that are isolated from humans. The reason for this is the recent invalidation of gene patents belonging to Myriad Genetics by a federal court in the US. The Indian Patent Law has defined what is an invention under section 2(1) (j) and has also stipulated under section 3 what inventions are not patentable. Section 3 of the Indian Patents Act categorizes what are not inventions within the meaning of the Act. There are specific categories which are pertinent for biotech inventions including those relating to genes and diagnostics. The relevant sections include section 3(c), 3(i) and 3(j). According to section 3(c) of the Patents Act "the mere discovery of a scientific principle or the formulation of or discovery of any living or non-living substance occurring in nature" is not an invention. Thus, merely isolated naturally occurring genes are considered as discovery and not inventions and are therefore deemed to be not patentable as per section 3(c). Further, under section 3(i) of the Patents Act diagnostic methods are not patentable inventions. However, in the Patent Office's Draft Manual of Patent Practice and Procedure 2008, it is stated that while methods of diagnosis practised on the human or animal body are excluded from patentability, methods of diagnosis performed on tissues or fluids, which have been permanently removed from the body are not excluded. Thus, the diagnostic methods employing the DNA primers and probes would be considered as patentable inventions. According to section 3(j) "plants and animals as a whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not patentable." Under section 3(j), animals, plants, or part thereof, not only of the natural origin but such living entities of artificial origin such as transgenic animals and plants or any part thereof are also not patentable. Microorganisms may be construed as being patentable as per section 3(j), however section 3(j) read together with section 3(c) makes it clear that naturally occurring isolated microorganisms are not patentable subject matter in India. Nonetheless, genetically engineered or modified micro-organisms of artificial origin and

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vaccines are considered patentable. It’s interesting to know whether genes are considered as biological or chemical material, whether they would be interpreted as part of plants or animals and if they can be patented or not. The Indian Patent Office's draft manual 2008 does not explicitly elucidate the same, but under the guidelines for the unity of invention, the following example is included: when a genetically modified gene sequence/amino acid sequence is novel, involves an inventive step and has industrial application, the following patents can be claimed: - Gene sequence /amino acid sequence - A method of expressing above sequence - An antibody against that protein/sequence - A kit made from the antibody/sequence. It’s evident that the genetically modified gene sequence is patentable and so is the kit consisting of such a sequence. It can be found in the draft manual of 2005 that biological material such as recombinant DNA, plasmids and the processes of manufacturing thereof are patentable provided that they are produced by substantive human intervention. Further, it is mentioned that gene sequences and DNA sequences with unidentified functions are not patentable due to lack of inventive step and industrial application. Thus as per the Indian patent practice DNA, plasmids are biological material; and DNA or nucleic acid sequences which are modified or made recombinantly by significant human involvement and with identified functions are patentable. The draft manual of 2005 also states that the living entities of natural origin such as animals, plants, in whole or any parts thereof, plant varieties, seeds, species, genes and micro-organism are not patentable and any process of manufacture or production relating to such living entities is also not patentable. Thus mention of genes is found amongst the living entities of natural origin which are not patentable. In this way, section 3(c) and the draft manuals of 2008 and 2005 clarify that the isolated naturally occurring DNA would be considered as discovery and is not patentable in India.

Summary ● For over a decade, there are raising claims that gene patent impedes medical research and diagnosis adversely. ● An important exclusion in Section 3(c) *Section 3 (c) reads as ‘the mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substances occurring in nature’ are not inventions of the Indian Patents Act is that the discovery of an invention is not patentable subject matter. Therefore, the question of whether a DNA sequence is a discovery or an invention must be addressed first. This is based on the assumption that genes are naturally occurring; these are discoveries, and not inventions. We do not have any case laws in India regarding discovery. ● The patenting of genes and/or DNA sequences per se was not allowed in India until January 2005, but processes involving recombinant DNA technology to produce proteins involving a gene or DNA sequence was patentable subject matter. Product patents for DNA, RNA or genetic inventions are patentable subject matter from January 2005. ● In general, once it is established that the claim in a patent is novel, non-obvious and useful, genes and gene products can be patented. Protection of genetic inventions

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will foster development and will augur well for the society because it is the society which will ultimately reap the benefits of genetic inventions.

References 1. See United States Patent & Trademark Office, Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (2001).“An isolated and purified DNA molecule that has the same sequence as a naturally-occurring gene is eligible for a patent because (1) an excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, or (2) synthetic DNA preparations are eligible for patents because their purified state is different from the naturally-occurring compound.” 2. United States Patent & Trademark Office, Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (2001). The guidelines provide “[a]n isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patents because (1) an excised gene is eligible for a patent as a composition of matter or as an article of manufacture because that DNA molecule does not occur in that isolated form in nature, or (2) synthetic DNA preparations are eligible for patents because their purified state is different from the naturally occurring compound.” 3. Doll, John. 1998. “The Patenting of DNA.” Science 280: 689-690. 4. Utility Examination Guidelines, 66 Fed. Reg. 1092 (2001). 5. Aside from the issue of patentable subject matter, current patent law requires that genetic material must also have a beneficial utility to society that is “substantial, specific, and credible” in order to be afforded patent protection. United States Patent & Trademark Office, Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (2001). Clarifications to the USPTO Utility examination guidelines in 2001 state: If a patent application discloses only nucleic acid molecular structure for a newly discovered gene, and no utility for the claimed isolated gene, the claimed invention is not patentable. But when the inventor also discloses how to use the purified gene isolated from its natural state, the application satisfies the “utility” requirement. That is, where the application discloses a specific, substantial, and credible utility for the claimed isolated and purified gene, the isolated and purified gene composition may be patentable. United States Patent & Trademark Office, Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (2001). 6. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1203 (Fed. Cir. 1991). 7. Conley, John M. and Robert Makowski. 2003. “Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (Part II).” Journal of the Patent and Trademark Office Society 85: 371, 382. 8. See 35 U.S.C. P. 112. 9. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1206 (Fed. Cir. 1991). 10. See, e.g., American College of Medical Genetics, “Position Statement on Gene Patents and Accessibility of Gene Testing” (“Genes and their mutations are naturally occurring substances that should not be patented.”), available athttp://www.acmg.net/resournces/policies/pol-015.asp. 11. American Intellectual Property Law Association, 2007. Report of the Economic Survey 2007.

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12. Graham, Stuart J.H., Bronwyn H. Hall, DietmarHarhoff, and David C. Mowery. February 2002. “Post-issue Patent ‘Quality Controls’: A Comparative Study of U.S. Patent Reexaminations and European Patent Oppositions” http://www.nber.org/papers/w8807. 13. Madison, James. 1961. “Federalist No 43.” The Federalist Papers: Alexander Hamilton, James Madison, and John Jay, New York: Mentor, New American Library. 14. Pollack, Andy. March 22, 2006. “Flaw Seen in Genetic Test for Cancer Risk.”The New York Times. 15. Walsh, Tom, Silvia Cassadei, Kethryn Hale Coats, Elizabeth Swisher, Sunday Stray, Jake Higgins, Kevin Roach, Jessica Madell, Ming Lee, SonaCiernikova, LenkaForetoca, PavelSoucek, and Mary –Claire King. 2006. “Spectrum of Mutations in BRCA1, BRCA2, CHEK2, and TP53 in Families at High Risk of Breast Cancer.” JAMA 295: 1379-1388. 16. Benowitz, Steve. 2002. “French Challenge to BRCA1 Patent Underlies European Discontent.” Journal of the National Cancer Institute 9: 80-81. 17. Stockstad, Erik. 2006. “Genetic Screen Misses Mutation in Women at High Risk of Breast Cancer.” Science 311: 1847. 18. U.S. Pat. No. 5,679,635, “Aspartoacylase gene, protein, and methods of screening for mutations associated with Canavan disease.” 19. Greenpeace. 2004 “The True Cost of Gene Patents: The Economic and Social Consequences of Patenting Genes and Living Organisms Patents – A Greenpeace Document.” http://weblog.greenpeace.org/ge/archives/1Study_True_Costs_Gene_Patents.pdf 20. Matthijs, Gert and Dicky Halley. 2002. “European-wide Opposition Against the Breast Cancer Gene Patents.” European Journal of Human Genetics 10: 783-784. 21. Boseley, Sarah. January 2, 2007. “Scientists on a Mission to Bring Cheap Drugs to the World’s Poorest Countries”. The Guardian available at http://www.guardian.co.uk/medicine/story/0,,1981152,00.html. 22. Merz, Jon F., Antigone G. Kriss, Debra G.B. Leonard, and Mildred K. Cho. 2002. “Diagnostic Testing Fails the Test: The Pitfalls of Patents are Illustrated by the Case of Haemochromatosis.” Nature 415: 577-579.

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Drafting Claims for Patent Filing Ramesh Kumar Vijh, ICAR-National Bureau of Animal Genetic Resources, Karnal-132001, Haryana

Drafting a patent application is not easy. A patent application needs to describe the invention completely, and if one is really are entitled to a patent then at least some aspect of his invention is new and non-obvious, which means that heretofore it hasn’t existed. Describing something new that has not previously existed is more of a challenge than most people realize. Many times inventors fail to adequately describe their inventions because the invention is obvious to them, and they think it will be equally obvious to others. The law, however, requires that a patent application explain the invention to someone who is not already familiar with the invention. One of the best way to do this is to explain it like a child explains things when doing a show and tell at school. Children explain everything in excruciating detail, no matter how obvious. Kids do this when they describe things because they have no idea what the person listening knows, and to them it is new and interesting so they explain everything with tremendous detail (whether you want to hear it or not). That is exactly what one need to do in the application. Explain your invention with so much detail that you will bore the knowledgeable reader to death. That is all fine and well, but how do one explain his invention? Here are few things to keep in mind that are critical in order to fully and completely describe your invention.

Application need to be complete and invention must be enabled: This is a legal requirement called the enablement requirement, and the purpose is to insure that every disclosure explains enough so that when the patent expires those skilled in the industry will be able to both make and use the invention. This is a part of the so-called patent bargain. In exchange for a patent, which gives an exclusive right to the owner, it is necessary to describe the invention with specificity so that when the patent expires the invention falls into the public domain and can be used by anyone. Whenever someone drafts a patent application it is important to look at what one has written to see whether someone who is unfamiliar with the invention would be able to appreciate how to make and use the invention after reading the disclosure. It is very important to explain the invention and its various features and nuances with as much detail as possible, paying particular attention to how components are connected, the various process steps one must follow, and/or any preparations that may be necessary prior to beginning. The patent application needs to explain to those skilled in the art how to make and use the invention in a way that does not lead to the need for what is called “undue experimentation”. This means one need to explain the invention so that it could be made and used without individuals having to go through a trial and error process to figure it out for themselves.

Best Mode and Anything that Works too! The best mode requirement means that inventors must disclose any preferences they have in a patent application. The purpose of the best mode requirement is to restrain inventors from applying for patents while at the same time concealing from the public preferred 45

embodiments of their inventions they have in fact conceived. Furthermore, the application one files must disclose the invention in its full detail. If you leave something out of application then it is not considered a part of your invention. Thus, it is not a good idea to leave things out, and particularly not a good idea to leave out something that you believe to be superior. Nevertheless, it is very important for you to describe your invention not only in terms of what works best, but also in terms of what works at all. If your invention becomes a success there will be others who will seek to legally copy your invention, which means they will do what you leave uncovered. For this reason you really need to ask yourself not only what are the required parts of your invention, but if you were trying to copy your own invention without infringing what modifications would you make? This is a critical question because that is the question that copyists will ask themselves. You want to cover not only what you want to do, but also what the copyist would likely want to try to get around your patent.

Written Description It is very important that a patent application completely define your invention because the patent applicant has the obligation to explain the full nature of the invention. If something is left out of the patent application then it cannot be a part of any exclusive right that the Patent Office ultimately grants.

Patent applications must teach the invention The written description requirement states that you need to define your invention so that the reader will be able to appreciate exactly the boundaries of what you have invented. When you say that other, undefined and unexplained variations can be made you are not defining the boundaries in a bright line way. You are leaving it up to the reader to figure it out for themselves - creation of a fatal flaw. When you prepare a patent application you want to explain as much as you can about the invention and all of its various aspects and features. This is critical because you need to make sure this first filing is complete. This is essential because while the format of what you file can be changed, information cannot be added while still keeping the benefit of the original filing date you obtained- one cannot add details without filing a new patent with a new date. For this reason you want to make sure that you not only mention enough to distinguish the prior art you know about, but you need to add multiple levels of specifics and nuance, not only to expand your disclosure, but to make sure that at least one (or hopefully more) of your embodiments will wind up being patentable.

Failure to adequately describe the invention One of the biggest mistakes inventors make is that they simply fall short of the specificity required. One specific problem I see is that many inventors write as if they assume the reader will be already familiar with the invention. It is always best to try and describe the invention so that any interested intelligent person can follow along. First, if any intelligent person can follow along then you certainly have described the invention so that someone with particular knowledge can understand, which satisfies the enablement requirement. Second, by writing so that an interested intelligent reader can

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understand you will provide more than a simple overview. By assuming no previous knowledge on the part of the reader you will describe your invention with greater detail. The message here is very important — describing your invention too broadly and without any specifics will result in patent claims that cannot be issued, or claims that if issued will be very easy to challenge. For this reason you must know what is in the prior art and make sure you accentuate the positive when describing your invention. Focus on what is unique.

Patent Drafting: What is the Patentable Feature? In order for any patent application to be complete the invention must be described with great particularity. Describe the structure and mechanical connections. What is the structure of the components? What is the overall structure of the device? How are things connected? How do they interact? How are the pieces assembled? What are the alternatives for making, connection, interaction? What materials can be used? What optional features are present? What could be present? These and other descriptive questions need to be answered in order to particularly define the invention.

An instruction manual Inventor’s goal is to make sure to describe the invention in a way that specifically describes his invention so that the reader will understand all the various permutations and that you are indeed in possession of all variations. In other words, you need to provide an instruction manual for making and using the invention, paying particular attention to describing modifications, specific embodiments and alternatives.

Filing of patent claims The patent laws require that the applicant particularly point out and distinctly claim the subject matter regarded as the invention. The portion of the application where this is done is not surprisingly called the claims. Patent claims are in many respects the most important part of the application because it is the claims that define the invention for which protection is granted. One can have the most thorough and complete description of an invention imaginable in the issued patent and it won’t matter unless you have been granted patent claims that cover your invention. Sure, such a thorough and complete description is an absolute prerequisite, but without adequate claim coverage no amount of description is enough. The exclusive right is defined by the patent claims. If you don’t have a claim that covers a particular thing then you don’t own the right, it is really that simple. If your patent claims are too narrow, as is always the case when inventors represent themselves, it will be easy for others to get around the patent without infringement. Patent claims are difficult to draft and one of the biggest reasons patent attorneys will always have work. The art of patent claim drafting takes many years to master. The statutes of the claims are embedded in the Patent law. Paragraph (a) relates to what must be disclosed in the specification, with paragraphs (b) through (f) relating specifically to the claims. (a) In General.— The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly

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connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. (b) Conclusion. — The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. (c) Form. — A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form. (d) Reference in Dependent Forms.— Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. (e) Reference in Multiple Dependent Form.— A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered. (f) Element in Claim for a Combination.— An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. It is necessary to include a full and complete description of the invention in the initial filing with the Patent Office. Rearranging of a patent application is always allowed, but addition of new material is never allowed without the filing of a brand new patent application that will receive a new filing date.

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Drafting and filing the patent applications in India P.K. Singh and Lovey Sharma ICAR- National Bureau of Animal Genetic Resources, Karnal- 132 001 (Haryana)

Patent Patent is a Latin word ‘Patere’ means to lay open. A patent is an exclusive right granted by a country to the owner of an invention to make, use, manufacture and market the invention, provided the invention satisfies certain conditions stipulated in the law. Patents must fulfill the following criteria: 1. Novelty: An invention is novel, if it is not disclosed in any type of publication i.e. monographs, articles, journals, books, leaflets, magazine etc. Novelty of any research can be determined through the extensive literature and patent search on various web sites and patent search engines. 2. Usefulness: The invention may be used in the industry means it must have some commercial application. 3. Inventiveness: Only inventions can be patented not the discoveries. In this context, the difference between discovery and invention as interpreted in the Indian Patent Office’s Manual of Patent Practice and Procedure-2005, is that a ‘discovery’ adds to the amount of human knowledge by disclosing something, which has not been seen before whereas, an ‘invention’ adds to the human knowledge by suggesting an act, to be done.

Patent Offices Application for Patent shall be filed with the Patent Office having the appropriate jurisdiction. Territorial jurisdiction of a patent office is decided based on the following: i) Place of residence, domicile or business of the applicant (first mentioned applicant in the case of joint applicants). ii) Place from where the invention actually originated. iii) Address for service in India given by the applicant, when the applicant has no place of business or domicile in India (Foreign applicants).

Patent Territorial Jurisdiction Office Mumbai The States of Gujarat, Maharashtra, Madhya Pradesh, Goa, Chhattisgarh, the Union Territories of Daman & Diu and Dadra & Nagar Haveli. Delhi The States of Haryana, Himachal Pradesh, Jammu and Kashmir, Punjab, Rajasthan, Uttar Pradesh, Uttarakhand, National Capital Territory of Delhi and the Union Territory of Chandigarh. Chennai The States of Andhra Pradesh, Karnataka, Kerala, Tamil Nadu and the Union Territories of Pondicherry and Lakshadweep. Kolkata Rest of India (States of Bihar, Orissa, West Bengal, Sikkim, Assam, Meghalaya, Manipur, Tripura, Nagaland, Arunachal Pradesh and Union Territory of Andaman and Nicobar Islands)

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Types of Patent Applications 1. Ordinary/ Standard Application (Under The Patents Act, 1970) It is the most common type of application filed for obtaining patents without making any reference to another application to claim priority. It may be made with provisional or complete specification. 2. PCT International Application India is a member of the Patent Cooperation Treaty (PCT). Under this treaty, there is an international filing system for patents. It is simple and economical procedure for seeking protection for the inventions in many countries. In this system, the applicant gains an international filing date in all the designated countries, and can confer late entry (up to 31 months) to the national offices without affecting the priority date. Indian patent office is a receiving office for international applications under PCT by nationals or residents of India. The PCT international application can also be filed in the International Bureau of WIPO after taking permission u/s 39 from the Indian Patent Office. 3. PCT- National Phase Application It is not applicable for the PCT international applications filed in India. However, for entering the national phase in other designated countries, separate applications will have to be made within 31 months from the filing of international application to claim the priority date in these countries under their respective patent laws. It is not mandatory for the applicant to submit all the documents while entering the national phase of individual countries as it is obligatory on the part of WIPO to send the published application along with search report, etc. to the designated offices. However, copies of original documents should be submitted for the sake of convenience and faster processing. Services of international patent attorneys and legal translators should be hired as per need. 4. Application For Patent Of Addition When any Institution is in possession of another invention, which is a slight modification on an invention for which patent application is already made or patent is already granted in India, the concerned institution may file an application for patent of addition. There is a benefit of seeking a patent of addition because there is no separate renewal fee for this patent during the term of the main patent. It can be made independent according to the provisions in the patent law during the term of the main patent; otherwise, it will expire along with the main patent. A specific reference to the main patent or the application for the main patent will have to be made in the complete specification of the application for patent of addition. Also, a definite statement must be provided in Form 1 that the invention comprises an improvement in, or a modification of the invention claimed in the specification of the main patent granted or applied for. 5. Divisional Application When it is observed that a patent application made by Institution claims more than one invention, the concerned institution may file divisional application so that separate applications are ultimately filed for separate inventions in the original application. The priority date for all the divisional applications from a single application will be same as that claimed by the original application. This is also called Ante Dating. The complete specification of the divisional application should not include any matter which has not been substantively disclosed in the complete specification of the first application. Also, the reference of parent application should be made in the body of the specification.

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6. Convention Application This is an application claiming priority under the Paris Convention from an application filed in another convention country after obtaining permission under section 39 of the Indian Patents Act. Normally, this type of patent application will not be applicable for ICAR but it is also not ruled out. This can be useful in exceptional cases for non-patentable or difficult to patent subject matter in India, which is patentable in other jurisdiction.

Patent Drafting Patent draft is a type of techno-legal document that need to be prepared so as to disclose all the details about the inventions carried. It is usually with technically and professionally strong in terms of describing all the detail concepts of new invented ideas. Patent drafting includes all the essential details about the invention in respect of why the invention takes place, about target market, how it support to the society and economy as whole etc. It should be precise and logical enough that can describe the concept of invention clearly. The patent drafting procedure governs and regulates the ways of making patent specification and presentation, in close compliance with the rules and regulations of the Patents Act, 1970, and the Patent Rules, 1972 of the Central Government of India. Before drafting the patent application it is advised to go through “Manual of Patent Office Practice and Procedure’ available at website of Indian Patent Office. The patent specification deals with the best and impeccable description of the new invention (using prescribed configuration and size of paper, font, title and sub-titles, drawing sheets, etc.), claims related with invention, abstract of the invention, etc. Details of priority claims, if any, are also furnished in the patent application.

Applicant An Application for a Patent for an invention may be made by any of the following persons either alone or jointly with any other person- True and first inventor /True and first inventor‘s assignee/ Legal representative of deceased true and first inventor or his/her assignee. The term "person" as defined in the Patents Act includes Government. The term person as defined in the General Clauses Act, 1897 includes any company or association or body of individuals, whether incorporated or not. In the case of a limited partnership, the Application may be in the names of all personally responsible partners. Wherever, the inventor(s) is/are not the applicant, a proof of right to apply by way of an endorsement in the Application form (Form 1) or an assignment deed shall be submitted. In case of a convention application, the legal representative or assignee of the applicant in the Convention country can also file a Patent Application in India.

Inventions not Patentable under Indian Patent Act The following are not inventions within the meaning of this Act,— (a) An invention which is frivolous or which claims anything obviously contrary to well established natural laws; (b) An invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment; (c) The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature;

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(d) The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; (e) A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; (f) The mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way; (g) Omitted by the Patents (Amendment) Act, 2002 (h) A method of agriculture or horticulture; (i) Any process for the medicinal, surgical, curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. (j) plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals; (k) A mathematical or business method or a computer programme per se or algorithms; (l) A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions; (m) A mere scheme or rule or method of performing mental act or method of playing game; (n) A presentation of information; (o) Topography of integrated circuits; (p) An invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.

Filing of Patent Applications to Indian Patent Office The patent application can be filed either as provisional application or as complete application on prescribed formats available on the website of Indian Patent Office along with required fee. After the filing of provisional application, the complete application is to be filed within 12 months from the date of filing of provisional application. A patent application to be filed on Form-1 along with Provisional / Complete Specification, with the prescribed fee as given in First Schedule at an appropriate office. However, a provisional specification cannot be filed in case of a Convention Application (either directly or through PCT routes) (For further description of Provisional/Complete Specifications please sees Chapter II of the Patents Rules 2003). Normal fee shall be applicable for applications containing up to thirty pages in specification and up to 10 claims. If the specification exceeds thirty pages or claims are more than ten in number, additional fee as given in First Schedule is payable. To file a patent application, submit form 1, form 2, form 3 and form 5. Subsequent to filing these forms with the appropriate fees, a patent application number may be obtained from

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the patent office. One can choose to file form 9 (optional) and form 18 along with filing a complete application or after filing a complete application. Indian patent application filing forms may be downloaded from the site of Indian Patent Office.

Contents of Patent Application A patent application should contain: 1. Application for grant of patent in Form-1. 2. Applicant has to obtain a proof of right to file the application from the inventor. The Proof of Right is either an endorsement at the end of the Application Form-1 or a separate assignment. 3. Provisional / complete specification in Form-2. 4. Statement and undertaking under Section 8 in Form-3, if applicable. An applicant must file Form 3 either along with the application or within 6 months from the date of application. 5. Declaration as to inventor ship shall be filed in Form 5 for Applications accompanying a Complete Specification or a Convention Application or a PCT Application designating India. However, the Controller may allow Form-5 to be filed within one month from the date of filing of application, if a request is made to the Controller in Form-4. 6. Power of authority in Form-26, if filed through a Patent Agent. In case a general power of authority has already been filed in another application, a self attested copy of the same may be filed by the Agent. In case the original general power of authority has been filed in another jurisdiction, that fact may also be mentioned in the self attested copy. 7. Priority document is required in the following cases: a. Convention Application (under Paris Convention). b. PCT National Phase Application wherein requirements of Rule 17.1(a or b) of regulations made under the PCT have not been fulfilled. The priority document may be filed along with the application or before the expiry of eighteen months from the date of priority, so as to enable publication of the application. In case of a request for early publication, the priority document shall be filed before/along with such request. 8. Every application shall bear the Signature of the applicant or authorized person / Patent Agent along with name and date in the appropriate space provided in the forms. 9. The Specification shall be signed by the agent/applicant with date on the last page of the Specification. The drawing sheets should bear the signature of an applicant or his agent in the right hand bottom corner. 10. If the Application pertains to a biological material obtained from India, the applicant is required to submit the permission from the National Biodiversity Authority any time before the grant of the patent. However, it would be sufficient if the permission from the National Biodiversity Authority is submitted before the grant of the patent. 11. The Application form shall also indicate clearly the source of geographical origin of any biological material used in the Specification, wherever applicable.

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E-Filing 1. The Patent Office provides the facility to file a Patent Application online from the native place of the agent of the applicant or applicant through e-filing. 2. For e-filing, applicant / agent must have a digital signature. For the first time, applicant / agent has to register as a new user and has to create login ID and password on the Patent office portal. (http://www.ipindia.nic.in). 3. A preliminary Software (Client Software) has to be downloaded from the above- mentioned site and has to be installed on the host computer. With the help of said software, an XML file gets generated and all the relevant documents (i.e. Form 1, Form 2, Form 3, etc.) in soft copy have to be uploaded. An Application number and CBR receipt gets generated after successful uploading. In the table below, the list of forms that have to be submitted and their respective fees is provided. Please note that, the fee mentioned is for E-filing only. The patent office charges an additional fee of 10% over the fee for applications filed offline.

Form Title Patent office Fee (INR) 1$ = ~ 60 Comment INR E-Filing only Applica Applicant – nt- other than natural Natural person person Small Entity Others except small entity 1 Application for 1600 4000 8000 Mandatory Grant of Patent 2 Provisional/Co No fee* No fee* No fee* Mandatory mplete Specification 3 Statement and No fee No fee No fee Mandatory Undertaking U/S 8 5 Declaration as No fee No fee No fee Mandatory to Inventorship 9 Request for 2500 6250 12500 Optional Publication 1 Request for 4000 10000 20000 Mandatory 8 Examination of Application for Patent * - A fee of 160/400/800/sheet, based on the type of applicant, is applicable for each sheet exceeding 30 sheets in a patent specification. Further, a fee of INR 320/800/1600/Claim, based on the type of applicant, is applicable for each claim exceeding 10 claims in the patent specification. 54

Language and Paper Size 1. All documents and copies of documents to be furnished shall be written or typewritten or printed either in Hindi or in English language in large and legible characters with deep indelible ink with lines widely spaced upon one side only of strong white paper of a size A4 (29.7cm x 21 cm) with a margin of at least 4 centimeters on the top and left hand part and 3 centimeters on the bottom and right hand part thereof. 2. It is desirable that the documents are prepared with lines spacing of 1.5 or double space in non-script type font (e.g., Arial, Times Roman, or Courier), preferably in a font size of 12. Provided that any document including drawing, if any, may also be filed in electronic form along with a copy of it on a white paper; Provided further that in case of the application for patent discloses sequence listing of nucleotides and/ or amino acids, the same shall be filed in electronic form.

Signature Any signature which is not legible or which is written in a script other than Hindi or English shall be accompanied by a transcription of the name either in Hindi or in English in block letters.

Patents Fees and Validation It includes fee for filing patent application to Indian patent office by an Institution (others alone are with natural persons and / or startup and /or small entity) is Rs.8800 for total 30 sheets and 10 claims. Fees for such application at the time of First Examination request would be RS 22000. Patent rights are granted for a limited period of 20 years. Claims define the scope of invention for which protection is claimed. No patent is granted without claims. The detail of fees for other purpose in context of patent filing is mentioned in The First schedule of Notification of Indian patent office issued on 16-05-2016.

Cost/Fee to Indian Patent Office for grant and maintenance of a patent for 20 years: S. Activity Limit/ Official fee No. condition/ time Individual Legal entity 1. Filing of patent 30 pages and Rs 1750 Rs 8800 application 10 claims maximum For each Rs 180 Rs 880 additional sheet For each Rs 350 Rs 1750 additional claims 2. Request for -- Rs 4400 Rs 22000 examination of patent 3. Requests for early -- Rs 2750 Rs 13750 publication 55

4. Renewal fee 2nd - 6th year Rs 880 Rs 4400 7th - 10th year Rs 2650 Rs 13200 11th – 15th year Rs 5300 Rs 26400 16th – 20th year Rs 8800 Rs 44000 Thus for filing and maintaining a patent for 20 years in Indian patent office is amount of Rs. 4,57,600 by a by a legal entity and Rs 91,650 by an individual provided the patent application is limited to 30 pages and carries 10 claims maximum.

Publication and Examination of Applications Publication of Patent Application  An Application for Patent is not open to public before the expiry of 18 months from the date of filing or date of priority, whichever is earlier.  At the end of 18 months period from the date of filing or from the date of priority whichever is earlier, the Application is published in the Official Journal except in the cases where Secrecy direction u/s 35 is in force.  Application abandoned u/s 9(1) (i.e., complete Specification not filed within twelve months from the date of filing of Provisional Specification).  Withdrawn three months prior to the publication period, i.e., before the end of 15th month from the date of filing or priority, whichever is earlier. This will apply for National Phase entry of PCT Applications as well, if such application has been filed in India before the expiry of 15 months from the date of priority.  The Patent Office publishes the Application in the Official e-Journal ordinarily within one month from the date of expiry of 18 months from the date of filing or priority, whichever is earlier.

Early Publication (a) A request for early publication may be made in Form-9 with the prescribed fee of Rs.2,750/- for natural person(s) or Rs.13,750 for legal entity other than natural person(s).

Particulars of Publication The official Patent Office Journal is published on every Friday with the following particulars: Application number; Date of filing; Title of invention; Publication date; International Patent Classification; Name and address of the applicant; Name of the inventor(s); Priority details like priority document number, date, country etc.; Reference to Patent of Addition / Divisional Application along with filing date of the parent Application; Abstract; No. of claims; Drawings (if any) No patent shall be granted before the expiry of six months from the date of Publication of the Application.

Opposition Proceedings to Grant of Patents It is done where an application for a patent has been published but a patent has not been granted, any person may, in writing, represent by way of opposition to the Controller against the grant of patent on the ground that the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims. The Pre-grant opposition can 56

be filed after the publication of patent and before the grant of patent. The Post-grant opposition can be filed within 1 year of the grant of the patent. An opposition board will be constituted for each of the opposition notifications accepted by the controller for the post grant opposition proceedings. The post-grant opposition can be filed on the grounds as mentioned in Section 25(2), but no other grounds.

Grant of Patents On the grant of patent, the controller shall publish the fact that the patent has been granted and thereupon the application, specification and other documents related thereto shall be open for public inspection. A patent shall be granted for one invention only. On the grant of patent, every patent is allotted a serial number by the electronic system. A Certificate of Patent is generated in the prescribed format and an entry in the e-register is made simultaneously. In the present electronic system, the date of record of Patent in the Register of Patents is the same as the date of grant of Patent by the Controller. The fact that the patent has been granted is published in the official journal of the Patent Office.

Restoration of Patent An application under this section contains a statement, verified in the prescribed manner, fully setting out the circumstances which led to the failure to pay the prescribed fee, and the Controller may require from the applicant such further evidence as he may think necessary. When the patent is restored, the rights of the patentee shall be subject to such provisions as may be prescribed and to such other provisions as the Controller thinks to fit to impose for the protection or the compensation of persons who may have begun to avail themselves of.

Surrender of Patent It is done by a patentee at any time by giving notice in the prescribed manner to the Controller. Any person interested may, within the prescribed period after publication, give notice to the Controller of opposition to the surrender, and where any such notice is given the Controller shall notify the patentee. If the Controller is satisfied after hearing the patentee and any opponent, if desirous of being heard, that the patent may properly be surrendered, he may accept the offer and by order, revoke the patent.

Register of Patents Upon the grant of a patent, the controller shall enter in the register of patents at each appropriate office, the name, address and nationality of the grantee as the patentee, thereof, the title of the invention (including the categories to which the invention relates), the date of the patent and the date of grant thereof together with the address for service of the patentee. The Controller shall also enter in the register of patents particulars regarding proceedings under the Act before the Controller or appellate Board or the court) in respect of every patent.

Compulsory License It is an application for grant may be made under the following provisions: a. Section 84. b. Section 91. c. Section 92. d. Section 92A. At any time after the expiration of 3 yrs from the date of grant of a patent, any person interested may take an application to the Controller

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for grant on any of the following grounds, namely that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or that the patented invention is not available to the public at a reasonably affordable price, or that that the patented invention is not worked in the territory of India.

Revocation It is done where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.

Scientific Advisors He needs to have a degree in science, engineering or technology or equivalent, has at least 15 yrs practical or research experience and he holds or has held a responsible post in a scientific or technical departments of the Central or State Government or in any organization. Scientific advisor is appointed by the court in case of any infringement to assist the court or to inquire and report upon any question of fact or of opinion as it may formulate for the purpose. The remuneration shall be fixed by the court and shall include the costs of making a report and a proper daily fee for any day on which the scientific advisor may be required to attend the court, and such remuneration shall be defrayed out of moneys provided by the Parliament by law for the purpose.

Patent Agents The names, addresses and other relevant particulars are included in the register of patent agents if he is a citizen of India, age of 21 yrs and has a degree in science, engineering or technology from an established university. The qualifying examination for patent agents includes two papers (1) Patents Act and rules and (2) Drafting and interpretation of patent specifications and other documents. A patent agent prepares all documents, transact all business and discharge such other functions as may be prescribed in connection with any proceedings before the Controller under this Act. The names and addresses of patents agents shall from time to time need to be published.

Patent Search It requires hiring a lawyer or professional patent searcher at a cost of $500 or more, sometimes much more. Patent searches were almost always done through patent attorney for determining patentability. Online patent resources include a no. of Internet sites and online databases that provide patent information. They will usually provide information for a limited time span, so be sure that the database we are searching covers the time period that we are researching. If we know the patent number, visit the various URLs for a speedy pdf version of the full text. Offline patent searches includes a great resource for complete patent searching from the first patent ever issued to the latest is a network of special libraries called Patent and Trademark Depository Libraries (PTDLs). Important websites are: (a) http://www.nolo.com/index.cfm (b) http://www.uspto.gov/ (c) http://www.pat2pdf.org/ (d) http://www.patinfo.nic.in/

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(e) http://www.patbase.com (f) http://www.patentmax.com (g) http://www.qpat.com/ (h) http://www.lexis-nexis.com/ (i) www.ipo.go.ip (j) www.ipaustralia.gov.au (k) www.delphion.com (l) www.getthepatent.com

NB: All the information in this article are based on contents of “The Indian Act of 1970”, “The Patent Rules 2003”, “Manual of Patent Office Practice and Procedure” and “ICAR guidelines for Intellectual property management and Technology Transfer/ Commercialization”.

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Annexure Few Patents related to different aspects of animal genetic resources: S.NO. Patent Application Patent Title No. Patents filed by NBAGR, Karnal 1 3773/DEL/2011 A kit for parentage verification in Zebu Cattle (Bos Indicus) 2 3774/DEL/2011 A kit for parentage verification in Camels (Single and Double Hump) 3 3775/DEL/2011 A kit for parentage verification in Buffaloes(Bubalus Bubalis) 4 50/DEL/2013 A kit for parentage verification in Goats 5 298/DEL/2013 A kit for parentage verification in Indian Ruminant Livestock 6 607/DEL/2013 PCR based DNA test for the differentiation of Cattle and Buffalo meat and milk 7 1889/DEL/2013 QTLs for milk yield in buffaloes 8 1890/DEL/2013 QTLs for somatic cell count in buffaloes 9 2426/DEL/2013 QTLs for milk fat percent in buffaloes 10 2427/DEL/2013 QTLs for milk protein percent in buffaloes Some examples of the patents on livestock and poultry filed/granted in USA 1 US 2002/0032530 A1 Integrated genomic services 2 US 2008/0090237 A1 Methods and compositions for comparing chromosomal copy number between genomic samples 3 US 5912147 Rapid means of quantitating genomic instability 4 US 2006/0172329 A1 DNA markers for cattle growth 5 US 2002/0142315 A1 DNA marker for cattle growth 6 US 2010/0009373 A1 Methods and compositions relating to multiplex genomic gain and loss assays 7 US 2009/0263798 A1 Method for identification of novel physical linkage of genomic sequences 8 US 2005/0066377 A1 Arrayed collection of genomic clones 9 US 2003/0096410 A1 Methodology for constructing human/goat chimeras for the production of human cells 10 US 2009/0142755 A1 Assay for detecting genetic abnormalities in genomic nucleic acids 11 US 6580017 B1 Methods of reconstructed goat embryo transfer 12 US 2009/0151640 A1 Poultry selection method to improve the egg production rate 13 US 6440666 B1 Selection for dwarfism in poultry 14 US 2005/0273873 A1 Genomic modification

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Geographical indications and its significance Rajan Sharma and Dhiraj Kumar Nanda ICAR - National Dairy Research Institute, Karnal

Many a times we buy a consumer product because of its geographical origin as we link the product’s quality or its typical characteristics to its place of origin. Over a period of time, a geographical place or region becomes famous for various kinds of consumer goods. As these products have a premium price and acquire high reputation because of their association with a particular geographical area, these products and those associated with them are required to be protected from counterfeiting, misappropriation, forgery etc. Some of such products are listed in Table 1. The protection of such products is at national as well as at international level is highly desirable as customers of these products are liable to be cheated.

Table 1. Some famous examples of geographical indications from India and world Geographical Indications from India Geographical Indications from other parts of world Name of the product Associated place Name of the product Associated place Darjeling tea West Bengal Champagne France Mysore silk Karnataka Havan Cigar Cuba Kullu Shawl Himachal Pradesh Scotch Whisky United Kingdom Coorg Orange Karnataka Tequila Mexico Madhubani Paintings Bihar Swiss knife Switzerland Feni Goa Cognac France TirupathiLaddu Andhra Pradesh Napa Valley wine USA BikaneriBhujia Rajasthan Washington Apple USA Phulkari Punjab, Haryana & Gorgonzola cheese Italy Rajasthan Nashik Valley Wine Maharashtra Irish Cream Ireland Hyderabadi Haleem Andhra Pradesh Roquefort Cheese France

Most of the examples of geographical indication are for agricultural product as the characteristic of such products are influenced by specific local factors, such as climate and soil etc. However, geographical indication may be used for a wide variety of products – natural, agricultural and manufactured. Protection of GI has, over the years, emerged as one of the most contentious IPR (Intellectual Property Rights) issues in the realm of the WTO’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). TRIPS defines GI as any indication that identifies a product as originating from a particular place, where a given quality, reputation or other characteristics of the product are essentially attributable to its geographical origin. Also a geographical indication gives exclusive right to a region (town, province or country) to use a name for a product with certain characteristics that corresponds to their specific location. The Geographical Indications of Goods (Registration and Protection) Act, 1999 protect the geographical indication in India. Registration of geographical indication is not compulsory in India. If registered, it will afford better legal protection to facilitate an action for infringement.

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Geographical indications under TRIPS TRIPS Agreement, which came into force with effect from 1 January 1995 prescribes minimum standard of protection for geographical indications and additional protection for wines and spirits. It requires WTO members to provide legal means to prevent the use of a geographical indication that misleads the public to the geographical origin of the goods or constitutes an act of unfair competition. There are three articles (article 22 to 24) under TRIPS which deal with GI. Article 22 of the TRIPS Agreement says that all governments must provide legal opportunities in their own laws for the owner of a GI registered in that country to prevent the use of marks that mislead the public as to the geographical origin of the good. This includes prevention of use of a geographical name which although literally true "falsely represents" that the product comes from somewhere else. Article 22 of TRIPS also says that governments may refuse to register a trademark or may invalidate an existing trademark (if their legislation permits or at the request of another government) if it misleads the public as to the true origin of a good. Article 22 also says governments may refuse to register or may invalidate a trademark that conflicts with a wine or spirits GI whether the trademark misleads or not. Article 23 of the TRIPS Agreement Article 23 is for the additional protection for GIs for wines and spirits. This article says that GIs for wines and spirits should be protected even if there is no risk of misleading or unfair competition. Article 23 imposes an obligation upon member countries to legislate to prevent the use of geographical indications regarding wines or spirits, which do not originate in the place indicated. An example is the word ‘Champagne’ that is claimed exclusively by the Champagne region of France from which the wine derives its world famous name. No other wine, even if it is made from the same grape variety, by the method, and is identical in taste, aroma and other qualities, can be called ‘Champagne’. Example the usage of the phrase “Champagne made in USA’ is prohibited although it is not deceptive. Further, the registration of a trademark for wines which contains or consists of a geographical indication identifying wines or for spirits shall be refused or invalidated. In the case of homonymous geographical indications for wines, protection shall be accorded to each indication. Each Member shall determine the practical conditions under which the homonymous indications in question will be differentiated from each other, taking into account the need to ensure equitable treatment of the producers concerned and that consumers are not misled.One prominent example, which was much referred to in the negotiation of this provision, is "Rioja", a name identifying wines coming from important wine producing regions in both Spain and Argentina. In this kind of situation, Article 23 provides for coexistence of the homonymous geographical indications, subject to Article 22 (i.e., provided there is no false representation to the public that a wine from a place identified by one of the geographical indications comes from the place identified by the other geographical indication). In providing for such coexistence each Member is required to determine the practical conditions to differentiate the geographical indications from each other, e.g. by way of labelling or the representation of a map showing the country where the region is. Differentiation should be done in a manner that ensures equitable treatment of the producers concerned and that consumers are not misled.

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Article 24 of TRIPS provides a number of exceptions to the protection of geographical indications which are not required to be protected for the protection can be limited. Among the exceptions that the agreement allows are: when a name has become the common (or “generic”) term (for example, “cheddar” now refers to a particular type of cheese not necessarily made in Cheddar, in the UK), and when a term has already been registered as a trademark. Further, this article also indicates that there shall be no obligation under this agreement to protect geographical indications which are not or cease to be protected in their country of origin, or which have fallen into disuse in that country.

Protection of Geographical Indications in India Unless a geographical indication is protected in the country of its origin, there is no obligation under the TRIPS agreement for the other countries to extend reciprocal protection. Consequent upon India joining as a member state of the TRIPS Agreement, a sui –generis legislation for the protection of Geographical Indications was enacted in 1999. The act is known as Geographical Indications of Goods (Registration and Protection) Act, 1999. Subsequently rules were framed and act came into force with effect from 15th September, 2003. The object of the act was three fold, firstly by specific law governing the geographical indications of goods in the country which could adequately protect the interest of producers of such goods, secondly, to exclude unauthorized persons from misusing geographical indications and to protect consumers from deception and thirdly, to promote goods bearing Indian geographical indications in the export market. The Geographical Indications of Goods (Registration & Protection) Act (GI Act), is administered by Registrar of Geographical Indications. The Geographical Indications Registry is located at Chennai in Tamil Nadu having all India jurisdictions. A Register of GI is maintained at the Registry. The Register has 2 parts A & B. Part-A consists of particulars relating to Geographical Indications such as - distinguishing characteristics of the goods and of the registered proprietor; which would be an association of persons, or producers or a body representing interest of such producers such as Tea Board, Coffee Board, and Spices Board. Forinclusion of all producers references may be made in the application. Part- B consists of particulars of the registered authorized users of GI as thoseproducers (traders and dealers) who have not been included in the originalapplication of registration. The basic steps involved are: Filing of the application, Preliminary scrutiny, review by the consultative group committee, issuance of examination report, publication in the Gazette, Opposition proceedings (if any) & grant of GI registration. Any association of person, producers, organization or authority established by or under the law can apply of a geographical indication provided the applicant must represent the interests of the producers. Application fee for registration of geographical indication is Rs. 5000. Once registered, geographical indication is valid for 10 years. It can be renewed from time to time for further period of 10 years each. As per the GI Act, geographical region is defined in the form of longitude and latitude. While applying, the applicant should provide the unique features of the goods, inspection structure, and mechanism to ensure the standards, quality, integrity & consistency. If a particular human skill is involved, the same may be indicated. The goods eligible for GI registration may be, agricultural products, natural, manufacture or man made goods, handicrafts, industrial goods and food items. The Act has classified the goods into 34 classes (fourth schedule – classification of goods – name of the

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classes) and above methods items may belong to one or more classes and this is required to be defined in the application. As per the Act, agricultural good, natural goods and handicraft/industrial goods can be registered as geographical indication. Till date, 272 items have been registered as geographical indication in India. Among the various states, Karnataka has highest registered geographical indications.

Appellations of origins and Lisbon Agreement Appellations of origin are a special kind of geographical indication and phrase is mostly used in Europe. Geographical indications and appellations of origin require a qualitative link between the product to which they refer and its place of origin. Both inform consumers about a product’s geographical origin and a quality or characteristic of the product linked to its place of origin. The basic difference between the two concepts is that the link with the place of origin must be stronger in the case of an appellation of origin. The quality or characteristics of a product protected as an appellation of origin must result exclusively or essentially from its geographical origin. This generally means that the raw materials should be sourced in the place of origin and that the processing of the product should also take place there. In the case of geographical indications, a single criterion attributable to geographical origin is sufficient – be it a quality or other characteristic of the product – or even just its reputation. The Lisbon System for the International Registration of Appellations of Origin offers a means of obtaining protection for an appellation of origin in the contracting parties to the Lisbon Agreement through a single registration. The Lisbon Agreement for the Protection of Appellations of Origin and their International Registration (Lisbon Agreement) was adopted in 1958 and revised at Stockholm in 1967. It entered into force on September 25, 1966, and is administered by the International Bureau of the World Intellectual Property Organization (WIPO), which keeps the International Register of Appellations of Origin and publishes a bulletin entitled Appellations of origin. The Lisbon Agreement is a special Agreement under Article 19 of the Paris Convention for the Protection of Industrial Property. Any country party to the Convention may accede to the Agreement. Countries adhering to the Lisbon Agreement (1967) become members of the Lisbon Union Assembly.As of June 2016, 28 states are party to the convention and 1000 appellations of origin has been registered. The Lisbon Express database (http://www.wipo.int/ipdl/en/search/lisbon/search-struct.jsp) allows for a search on appellations of origin as registered under the Lisbon Agreement, the product to which they apply, their area of production, the holders of the right to use the appellation of origin, any refusals or invalidations notified by member countries, etc.

Geographical indications in agriculture As indicated earlier, geographical indications are typically used for agricultural products, foodstuffs, wine and spirit drinks. As local climate conditions including soil type in a particular region are more likely to influence the characteristics of an agricultural produce, more than one-fourth of the examples for geographical indications in India are from agricultural commodity (Figure 1). Geographical indication tag will help to protect these exclusive special local crops and pave way for better branding and marketing of these products both in domestic and international Market. As India is one of the 17 mega diverse countries of the world, there is tremendous scope for linking an agricultural product having a particular characteristic with a place. Some of the examples under the category of

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agricultural goods granted protection in India as geographical indications are Darjeeling Tea (Assam), Kangra Tea (Himachal Pradesh), Coorg Orange (Karnataka), Nanjanagud Banana (Karnataka), Navara Rice (Kerala), Malabar pepper (Kerala), LaxmanBhog Mango (West Bengal) etc. Following are the potential geographical indication in the area of agriculture but yet to be registered. 1. Chilika curd -Chilika curd is one of uniquefermented dairy product traditionally prepared in a cup shaped bamboo basket by ethnic people of Chilika (Odisha) using milk of Chilika Buffalo, that are found only in and around chilika lake, theyfeed on sea weed on shores of chilika lake. The curd is not only very tasty but can also be stored without refrigeration for days, it is well known for its exceptionally longer shelf life.Lactobacillus isolates from chilika curd have been found to show anti-fungal effect which can be correlated with preservation of curd from fungal spoilage. Dendrocin, an anti-fungal protein isolated from fresh bamboo shoot or the special diet of animal may also help in increasing the shelf-life. 2. KomalChaul – a rice variety of Assam region. This indigenous variety of rice does not require cooking or boiling to make it edible. Soaking the rice in cold water for half an hour makes it ready for serving, hence the name ‘KomalChaul’ or Soft Rice. ‘KomalChaul contains only 4.7% amylose (compared to more than 16% in other rice varieties) making it edible within an hour after soaking.

Significance of geographical indication in livestock sector India possesses one of the largest livestock populations in the world and as per 19th livestock census. The total livestock population consisting of Cattle, Buffalo, Sheep, Goat, pig, Horses & Ponies, Mules, Donkeys, Camels, Mithun and Yak in the country is 512.05 million numbers in 2012. The numbers of milch animals (cows and buffaloes) are about 118.59 million. The distribution of livestock population indicates around 37% cattle, 26.40% goat, 21.23% buffaloes and 12.71% sheep. India is bestowed with rich domestic animal biodiversity with 30 breeds of cattle, 10 breeds of buffalo, 42 breeds of sheep, 30 breeds of goat, 8 breeds of camel, 6 of horse and 18 breeds of poultry in addition to other species. One outstanding example under the livestock sector which has been registered as geographical indication is Kashmir Pashmina. For making Kashmir Pashmina, wool comes from our distinct breeds of the Cashmere goat; namely the Changthangi or Kashmir Pashmina goat from the Changthang plateau in Kashmir region, the Malra from Kargil area in Kashmir region. Although Kashmir Pashmina is under the class handicraft (because of its typical style of making), but for practical purpose above mentioned goat breeds – source of raw material, can be considered as geographical indication. These goat breeds are reared in higher reaches of Jammu and Kashmir. The milk of the many indigenous breeds is thought to be of medicinal value but scientific evidences are lacking. For exampleVechur cow (named after the village Vechoor in Kottayam district of the state of Kerala in India) acknowledged by the Guinness Book of World Records as the smallest in the world (90 cm in height) has been shown to have medicinal properties. SimilarlyDeoni cattle (breeding tract in Bidar district of Karnataka and Parbhani, Nanded, Osmanabad and Latur districts of Maharashtra) is thought to have medicinal value. Milk of many indigenous cows (e.g. Gir cow) has been claimed to cure diabetes. Similarly camel and goat milk also has some medicinal value because of their characteristic composition and presence/absence of bioactive molecules. However, all these needs to be validated; firstly in milk and then their association with a particular geographical area. Further, although act does not prohibit the registration of

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animal breed/plant variety, the registration of breed/variety is difficult unless there is some strong scientific evidences linking the characteristic with place of origin. It may be mentioned here that it may not be possible to register a breed of animal as geographical indication but their produce (milk or meat) can be protected as geographical indication. Such protection will certainly help to alleviate the economic conditions of local community who are the owner of such resources.

Conclusion GIs are a type of industrial property that identifies a good as originating from a particular place, where a given quality, reputation or other characteristics of the good are essentially attributable to its geographical origin. Over 272 Indian products have been recognized as GIs in India and the number of registered geographical indications is increasing every year (Figure 2). In fact, ten foreign products have also been registered as geographical indications in India.Evidently, the potential is immense. It needs to be reiterated that the benefits of the registration of a product as geographical indications is actually realized only when these products are effectively marketed and protected against illegal copying. Effective marketing and protection requires quality assurance, brand creation, post-sale consumer feedback and support, prosecuting unauthorised copiers, etc. Thus, the registration is only the first step in the creation of a market for the geographical indications. Further, this protection first gains significance in the domestic context before international protection becomes relevant. Protection of produce of livestock from geographical indication point has not been taken up and its potential is yet to be realized. Newer scientific evidences will add knowledge in the characteristic of indigenous livestock which may pave the way for their protection under geographical indication.

Figure 1. Types of good registered as geographical indications in India (till June 2016)

Figure 2. Year wise registration of geographical indications in India

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Rights and benefits sharing under Protection of Plant Varieties & Farmers’ Rights act (PPV&FR act) M.R. Meena, Ravinder Kumar, B. Parameswari, Neeraj Kulshershtha ICAR-Sugarcane Breeding Institute Regional Centre, Karnal- 132001.

Registration of a plant variety in India. Rights holders can apply for the registration of a new variety either directly or through their agents. The Office of the Registrar, Protection of Plant Varieties and Farmers' Rights Authority is the appropriate office for filing of the application in India. The different steps that are involved in the registration process in India are as follows:

Completing the application form and filing The Applicant has to file the prescribed form with the requisite fee in the Office of the Registrar. The Applicant can make an application to the Registrar for registration of any variety of such genera and species as specified under sub-section (2) of Section 29 or which is an extant variety or which is a farmer's variety. An agent can complete and sign the application form, provided that the Applicant has issued a signed Power of Attorney appointing them as the agent. The application has to be in respect to a variety and state the denomination assigned to such variety by the Applicant. It has to be accompanied by an affidavit sworn by the Applicant that such variety does not contain any gene or gene sequence involving terminator technology and also a statement containing brief description of the variety bringing out its characteristics of novelty, distinctiveness, uniformity and stability. The application should also contain a complete passport data of the parental lines from which the variety has been derived along with the geographical location in India from where the genetic material has been taken and all such information relating to the contribution, if any, of any farmer, village community, institution, or organization in breeding, evolving, or developing the variety. It should also contain a declaration that the genetic material or parental material acquired for breeding, evolving, or developing the variety has been lawfully acquired. Copies of all the forms are available at Protection of Plant Varieties & Farmers' Rights Authority, India site. The Applicant must, along with the application for registration under this Act, also make available to the Registrar such quality of seeds of a variety for registration of which such application is made so that the Registrar can conduct tests to evaluate whether seeds of such variety along with parental material conform to the standards as may be specified by regulations. The Applicant should also deposit the requisite fees for conducting such tests.

Review by the Registrar After the application has been filed, the Registrar will accept the application absolutely or subject to certain conditions or limitations, after reviewing the application and making such inquiry as he deems fit. If the Registrar is not satisfied with the particulars as mentioned in the application, he can either direct the Applicant to amend the application or in the alternative reject the application.

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Publication and Opposition After the Registrar accepts the application either absolutely or subject to any conditions, it will be advertised in the prescribed manner along with its photographs or drawings. Within three months of the publication of this application, any person may give notice of his opposing the application to the Registrar in the prescribed format. After following the prescribed procedure of serving the Notice of Opposition to the Applicant, perusing the evidence as filed by both the parties and hearing both the parties, the Registrar will either allow or reject the opposition.

Registration When an application for registration of a variety (other than an essentially derived variety) has been accepted and not opposed or opposed but the opposition has been rejected, the Registrar will issue a certificate of registration to the Applicant. A person aggrieved by the decision of the Protection of Plant Varieties and Farmers' Rights Authority or the Registrar can file an appeal before the Plant Varieties Protection Appellate Tribunal.

Term of Registration The certificate of registration issued by the Registrar is valid for eighteen years from the date of registration of the variety in the case of vine and trees, fifteen years from the date of notification of that variety (under Section 5 of the Seeds Act, 1966) by the Central Government in the case of extant varieties and for a period of fifteen years from the date of registration of the variety in other cases. The Registrar may review and renew this registration for the remaining term on payment of the prescribed fee.

PPV and FR Act, 2001 A unique aspect of PPV and FR Act, 2001 is that it confers three concurrent rights to breeders, researchers, farmers and community.

Breeders Rights (u/s 28(1)) The certificate of Registration of a variety issued to under this Act shall confer exclusive rights on the breeder or his successor or his agent or licensee, to produce, sell, market, distribute, import or export of the variety under registration for a period of 15 or 18 years depending on the crop species and subject to payment of renewal fees and fulfilment of other conditions laid under this Act. The following acts are treated as infringement of breeder’s rights u/s 64 of the PPV&FR act. 1. If a person who is not a breeder of a variety registered under this act, sells, exports, imports or produces such variety without the permission of its breeder or within the scope of a registered license or registered agency without their permission of the registered license or registered agent. 2. If a person uses, sells, exports, imports or produces any other variety giving such variety, the denomination identical with or deceptively similar to the denomination of a variety already registered under this act in such a way that it causes confusion in the mind of general people in identifying the registered variety. If any person a) applied false denomination, or b) falsely represents a variety as a registered variety as a registered variety then he shall be punishable u/s 70 or 72 of the Act with imprisonment for a team not less than 6 months which may extend up

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to 2 or 3 years or with a fine not less than 1 or 2 lakh which may be enchanced to 5 lakh, or with both.

Researcher’s Rights (u/s 30) This act allows scientists and researchers to have access to the registered (protected) varieties for experiment or research purposes. The registered variety can also be used by any person as an initial source of a variety for evolving other varieties without the prior approval of the breeder of the registered variety. However, the authorization of the breeder of a registered variety is required where the repeated use of the protected variety as a parental line is required for commercial production of the newly developed variety.

Farmer’s Rights (u/s 30) (FR) The PPV&FR Act define ‘farmers’ as any person who cultivated crops by himself, or cultivates crops by directly supervising the cultivation of land through any other person, or conserves and preserves, severally or jointly, with any person any wild species or traditional varieties, or adds value to such wild species or traditional varieties through selection and identification of their useful properties. Recognizing the role of farmers in conserving genetic diversity, their poor economy condition is to buy seeds for every year and their poor legal literacy the Act confers the following privilege and rights to farmers i) FR on seeds (u/s 39(1iv)): FR on seeds is a traditional right, which includes the right to save their own seeds from one’s crop and to used it for sowing, re-sowing, exchanging, sharing with other farmers, selling his farm produce including seeds of a protected variety in the same manner as he was entitled before the coming into force of this Act. However, farmers are not allowed to sell seeds of protected varieties as branded seeds. Branded seeds mean any seed put in a package or any other container and labeled in manner indicating that such seed is of a variety protected under this Act. ii) FR as breeder of new variety (u/s 39(1i)): the act recognizes the farmers not just as a cultivator, conserver of agricultural gene pool but also a breeder of several successful varieties. Traditional varieties developed or conserved by farmers or by community and new varieties evolved by one or group of farmers are eligible for registration as extant variety or new variety as the case may be. The farmers shall enjoy all the rights as given to the professional breeders of a extant variety or new variety. iii) FR for reward and recognition (u/s 39(1iii)): organized plant breeding which of recent origin. Farmers or tribals or village communities has been engaged in conservation of the genetic resources of land races and wild relatives of economic plants or generation. The improved variety of the modern days are bred from farmers variety or using traditional knowledge of this variety. Therefore, the farmer and tribal communities are entitled for recognition and reward from gene fund constituted under the Act, provided that material so selected and preserved has been used as donor of the genes in varieties registerable under this Act. The PPV&FR authority has instituted “The Plant Genome Savior Community Recognition Award” which carried 10 lakh cash and a citation. During 2008, the recognition was conferred to the Kuruchiya and Karuma tribal communities in Wayanad district (Kerala), in appreciation of their contribution for the conservation and improvement of traditional rice varieties. For the year 2009-10, the Award was conferred to i) ‘Kopatgiri Nandiveerimath Seva Foundation” in recognition of their contribution towards the conservation and documentation of rare and endangered medicinal plant species in

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Kopatgiri hills, Gadag, Karnataka and ii) ‘Panchabati Gramya Unayana Samiti’ for their outstanding contribution in conservation of traditional land races of rice in Koraput Region of Odisha. iv) FR for getting compensation for the loss caused by poor quality seeds (u/s 39(2)): The Act has provision to protect farmers from spurious seeds, unfair marketing practices and exaggerated claims by seed companies. When any propagating material of variety registered under this Act has been sold to farmers, the breeder of such variety is obliged to disclose to farmers on the expected performance of the variety under given conditions. If such the variety fails to provide such performance under such given conditions, the farmer(s) may claim compensation before the authority and the Authority, after hearing the parties, may direct the breeder to pay such compensation as it deems fit, to the farmer(s). v) FR for getting seeds of registered varieties (u/s 47): The Act has an objective of promoting accelerated agricultural growth through assured availability high quality sees and planting materials to farmers. If a PBR title holder does not satisfy the seed requirement of the registered variety and at reasonable price within 3 years after registration, farmers have the rights to take the matter of non-availability of seeds to the Authority, which in turn may initiate remedial measure like compulsory licensing. vi) FR for receiving free services (u/s 44): Considering the poor economic condition of the farmer, the PPV&FR Act exempt farmers from paying fee for registration of farmers varieties, conducting DUS test, renewal of farmer’s variety, fee for opposition and benefit sharing claim. Further, farmer(s) and village community are not liable to pay any fees in any proceeding before the Authority or Registrar or the Tribunal or the High court under this Act or the rules made there under. vii) FR of protection against innocent infringement (u/s 42): The Act provides for protection from innocent infringement i.e. the farmer cannot be prosecuted for infringement of rights specified in the act if he can prove in court that he was unaware of the existence of such rights.

Communities Rights (CR) i) Rights for benefit sharing (u/s 26): when farmer’s variety or its derivative are utilized in the institutional plant breeding programme (by public or private breeder) for the development of new varieties and if the resultant variety is applied for protection, the farmers and traditional communities who have conserved and evolved the germplasm of such varieties are eligible for equitable sharing of the benefit accrued from the commercial use of the variety. The Act mandate the breeders to disclose the passport data of the variety including its parental line and its place of origin and the authority to advertise these information for inviting claims on benefit sharing. More details are given at the end of this section. ii) Authorization of farmer’s variety (u/s 42): breeders wanting to use farmer’s varieties for creating EDVs can’t do so without the permission of the farmer(s) or community involved in the conservation or development of such varieties. Anyone is entitled to register a community’s claim. This intervention enables the registration of farmer varieties even if the farmers themselves cannot do this due to illiteracy or lack of awareness. If the claim on behalf of the community is found to be genuine, a procedure is initiated for benefit sharing and compensation and a share of profits made from the use of a farmer variety in a new variety goes into a National Gene Fund.

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iii ) Rights for claiming compensation for undisclosed use of traditional varieties ( u/s 40- 41) : A breeder who is making an application for registration of any variety under this Act, shall disclose (see u/s 18e) in the application the information regarding the use of genetic material conserved by any tribal or rural families in the breeding or development of such variety. If the breeder wilfully and knowingly fails to disclose the correct identity of parental line or knowledge while registering the variety and the claim by a third party or farmers or community that the people of that village or local community had contributed significantly in the evolution of new varieties registered under the Act is proved, then farmers or community is eligible for compensation from the breeder which would be deposited in the National Gene fund.

Benefit sharing (u/s 26) and Compensation (u/s 41)) (i) Sharing of benefits accruing to a breeder from a variety developed using the farmer’s variety, landrace or any indigenously derived plant genetic resource (PGR) or indigenous knowledge associated with such PGR has been dealt in the Act. (ii) Upon issuance of the Certificate of Registration to a breeder, the Authority may invite claims of benefit sharing of that variety by giving advertisement with details of the variety, its breeder, parental materials used in the development of the variety, its geographical location, details of initial variety if it is an EDV, community knowledge used in the development of the plant variety. (iii) Any person or group of persons or any governmental or NGOs on behalf of any village or local community in India, can make a claim u/s 26, within 6 month from the advertisement, by providing, (a) the contribution made by them to the genetic development of the plant variety, (b) in what capacity the person is making the claim for benefit sharing, (c) in case of “essentially derived varieties”, by giving the terms and conditions in which authorization has been made, and (d) the commercial viability or actual market performance of the variety so registered. The application for claim should accompany fee or Rs. 5000/-. (iv) On receipt of a copy of the claim for benefit sharing, the registered breeder of the plant variety may accept the claim and accordingly intimate the same to the Authority or file his opposition to the claim of benefit sharing within 3 months from the date of such receipt. (v) The Authority determines the amount of benefit sharing to a variety taking in to account. (a) the contribution of the claimant in selecting, conserving, and providing the genetic material, (b) the contribution of such genetic material in providing one or more traits which conferred high commercial value to the variety, and (c) the contribution of such genetic material to impart high combining ability to parents of the hybrid variety relating to benefit sharing. (Vi) Claim for compensation u/s 41: The claim of compensation to the people of any village or local community for their contribution in the development of new variety registered arises if the applicant, knowingly, did not disclose the use of traditional variety of the farmers/community for the development of new variety which was proved by a third party later on or if the breeder did not obtain the consent of the farmers / farming community who have conserved or developed in the genetic materials which was pointed out by someone after the registration. (vii) The Authority, after giving an opportunity of being heard to the parties, dispose of the claim for benefit sharing or compensation or order the breeder to deposit such amount of

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benefit sharing or compensation in the National Gene Fund within 2 or 3 months from the issue of the order. (Vi) The amount of benefit sharing and compensation payable by the breeder is treated as the arrears of land revenue and is recoverable by the breeder is treated as arrears of land revenues and is recoverable by the District Magistrate within whose local limits of jurisdiction the breeder resides.

National Gene Fund (u/s 45): A fund called National Gene Fund is constituted under the Act from the credits received from (a) the benefit sharing from the breeder, (b) the annual fee payable to the authority by way of royalty, (c) compensation provided to the communities, and (d) contribution from any national or international organization and other sources. The fund will be applied for meeting the expenditures (a) to support and reward farmers, community of farmers, particularly the tribal or rural communities engaged in conservation, improvement and preservation of genetic resources of economic plants and their wild relatives, particularly in areas identified as agro-biodiversity hot spots, (b) for capacity building on ex situ conservation at the level of the local body, particularly in regions identified as agro-biodiversity hot spots and for supporting in-situ conservation (A Task Force constituted by the Authority under the chairmanship of Dr M. P. Nayar, Ex. Director, Botanical Survey of India, Kolkata has identified 22 agro hotspot in India during 2009), (c) on benefit sharing and compensation u/s 26(5) and 41 (3), and (d) on transaction cost of administering the gene fund.

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Crops that have been called for registration by the PPV&FR Authority

S. Crop species Botanical name No. 1. Rice Oryza sativa L. 2. Bread wheat Triticum aestivum L. 3. Maize Zea mays L. 4. Sorghum Sorghum bicolor (L.) Moench 5. Pearl Millet Pennisetum glaucum (L.) R. Br. 6 Chickpea Cicer arietinum L. 7. Mungbean Vigna radiata (L.) Wilczek 8. Urdbean Vigna mungo (L.) Hepper 9. Fieldpea Pisum sativum L. 10. Kidney bean Phaseolus vulgaris L. 11. Lentil Lens culinaris Medik 12. Pigeon pea Cajanus cajan (L.) Millsp 13. Indian mustard Brassica juncea L. Czern & Coss 14. Karan rai Brassica carinata A Braun 15. Rapeseed Brassica rapa L. 16. Gobhi sarson Brassica napus L. 17. Groundnut Arachis hypogaea L. 18. Soyabean Glycine max (L.) Merrill 19. Sunflower Helianthus annuus L. 20. Safflower Carthamus tinctorius L. 21. Castor Ricinus communis L. 22. Sesame Sesamum indicum L. 23. Linseed Linum usitatissimum L. 24. Diploid Cotton Gossypium arboreum L. 25. Diploid Cotton Gossypium herbaceum L. 26. Tetraploid Cotton Gossypium hirsutum L. 27. Tetraploid Cotton Gossypium barbadense L. 28. Jute Corchorus olitorieus L. 29. Jute Corchorus capsularis L. 30. Sugarcane Saccharum L. 31. Black pepper Piper nigrum L. 32. Small cardamom Elettaria cardamomum Maton 33. Turmeric Curumma Longa L. 34. Ginger Zingiber officinale Rosc. Lycopersicon lycopersicum (L.) 35. Tomato Karsten ex. Farw.

36. Brinjal Solanum melongena L. Abelmoschus esculentus ( L.) 37. Okra Moench 73

38. Cauliflower Brassica oleracea L. var. botrytis 39. Cabbage Brassica oleracea var. capitata L. 40. Potato Solanum tuberosum L. 41. Onion Allium cepa L. 42. Garlic Allium sativum L. 43. Rose Rosa spp. other than R. damascena

So far the Authority has received 3,491 (as on 31st January, 2012) applications for registration of plant varieties including open pollinated varieties, hybrids, parental lines and transgenic varieties from different stakeholders such as farmers, public and private sector including multinational seed companies.

S. Type of Total number of applications received in different years No. variety 2007 2008 2009 2010 2011 2012 Total (31.01 .2012) 1 New 74 154 179 438 164 04 1013 Variety 2 Extant 355 387 382 97 257 03 1481 variety 3 Farmer’s 2 5 44 4 939 01 995 variety 4 Essentially ------01 01 --- 02 derived varieties Total 431 546 605 540 1361 08 3491

Source: www.plantauthority.gov.in

List of Varieties to which Certificate of Registration have been issued For rice

S. Registration Category Name Applicant Address No No/ Date of of variety of crop . Grant 120 of 2009 Farmers’ Rice President, Swantarta Sainani 1 /21.12.09 Varieties Javik Krishak Samiti, Vill. Prem Nagar, Gadarpur, Udham Singh Nagar, Uttarakhand-263152 2 121 of 2009 Farmers’ Rice Gram Indrapur, Post /21.12.09 Varieties Pratappur, Tehsil Kichha, Udham Singh Nagar District, Uttarakhand-263148

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3 122 of 2009 Farmers’ Rice President, Rishi Parasar Javik /21.12.09 Varieties Krishi Shodh Samiti, Village Chakarpur, Block Bazpur, Udham Singh Nagar, Uttarakhand-262401 4 12 of 2011/ Extant Rice Kanke, Ranchi-834006 24.06.2011 5 17 of 2011/ Extant Rice P.O. Baramunda, P.S. 24.06.2011 Khandagiri, District:Khurda, Orissa- 751003 6 Extant Rice P.O. Baramunda, P.S. 18 of 2011/ Khandagiri, 24.06.2011 District:Khurda, Orissa- 751003 7 32 of 2011/ Extant Rice P.O. Baramunda, P.S. 24.06.2011 Khandagiri, District:Khurda, Orissa- 751003 8 33 of 2011/ Extant Rice P.O. Baramunda, P.S. 24.06.2011 Khandagiri, District:Khurda, Orissa- 751003 9 42 of 2011/ Extant Rice P.O. Baramunda, P.S. 24.06.2011 Khandagiri, District:Khurda, Orissa- 751003 10 47 of 2011/ Extant Rice P.O. Baramunda, P.S. 24.06.2011 Khandagiri, District:Khurda, Orissa- 751003 11 478of 2011/ Extant Rice P.O. Baramunda, P.S. 24.06.2011 Khandagiri, District:Khurda, Orissa- 751003 12 59 of 2011/ Extant Rice Kanke, Ranchi-834006 30.09.2011 13 60 of 2011/ Extant Rice Kanke, Ranchi-834006 30.09.2011 14 61 of 2011/ Extant Rice Kanke, Ranchi-834006 30.09.2011 15 90 of 2011/ Extant Rice P.O. Baramunda, P.S. 21.10.2011 Khandagiri, District:Khurda, Orissa- 751003 16 13 of 2012/ Extant Rice Alfred Nobel 75

07.03.2012 Strasse50. 40789 Monheim, Germany 17 14 of 2012/ Farmer Rice Village+Post:-Nanded, 04.04.2012 Taluka-Nagbid, Dist- Chandrapur-441221 (MH)

Source: www.plantauthority.gov.in For Maize

S. Registration Category Name Applicant Address No. No/ Date of of variety of crop Grant 1 63 of 2011/ Extant Maize Krishi Bhawan, 30.09.2011 Dr. Rajendra Prasad Road, New Delhi-110114 2 64 of 2011/ Extant Maize Krishi Bhawan, 30.09.2011 Dr. Rajendra Prasad Road, New Delhi-110114 3 65 of 2011/ Extant Maize Krishi Bhawan, 30.09.2011 Dr. Rajendra Prasad Road, New Delhi-110114 4 2 of 2012/ Extant Maize Krishi Bhawan, 02.01.2012 Dr. Rajendra Prasad Road, New Delhi-110114 5 3 of 2012/ Extant Maize Krishi Bhawan, 02.01.2012 Dr. Rajendra Prasad Road, New Delhi-110114 6 4 of 2012/ Extant Maize Krishi Bhawan, 02.01.2012 Dr. Rajendra Prasad Road, New Delhi-110114 6 5 of 2012/ Extant Maize Krishi Bhawan, 02.01.2012 Dr. Rajendra Prasad Road, New Delhi-110114 7 6 of 2012/ Extant Maize Krishi Bhawan, 02.01.2012 Dr. Rajendra Prasad Road, New Delhi-110114

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4 74 of 2011/ New Maize 5th Floor, Ahura Centre, 21.10.2011 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093 5 75 of 2011/ New Maize 5th Floor, Ahura Centre, 21.10.2011 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093 6 76 of 2011/ New Maize 5th Floor, Ahura Centre, 21.10.2011 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093 7 107 of 2011/ New Maize 5th Floor, Ahura Centre, 1.11.2011 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093 8 108 of 2011/ New Maize 5th Floor, Ahura Centre, 1.11.2011 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093 9 112 of 2011/ New Maize 5th Floor, Ahura Centre, 7.12.2011 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093 10 114 of 2011/ New Maize 5th Floor, Ahura Centre, 7.12.2011 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093 11 115 of 2011/ New Maize Krishi Bhawan, 7.12.2011 Dr. Rajendra Prasad Road, New Delhi-110114 12 116 of 2011/ New Maize Krishi Bhawan, 7.12.2011 Dr. Rajendra Prasad Road, New Delhi-110114 13 117 of 2011/ New Maize Krishi Bhawan, 27.12.2011 Dr. Rajendra Prasad Road, New Delhi-110114 14 12 of 2012/ New Maize 5th Floor, Ahura Centre, 07.03.2012 96, Mahakali Caves Road, Andheri (East), Mumbai-400 093

Source: www.plantauthority.gov.in

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Feasibility of Animal Breeders rights in India S P Dixit ICAR-National Bureau of Animal Genetic Resources, Karnal 132001, Haryana

Introduction Genetic resources law and policy at the international level, has mostly been focused at plant genetic resources for food and agriculture and on genetic resources and biological diversity in general (CBD, WIPO). A literature review disclosed that Farm Animal Genetic Resources (AnGR) is only very scarcely addressed compared to plant genetic resources (PGR). This does not mean that AnGR are less important for food security and nutrition since, for example, 30% of total nutrition is covered by food from animals. In rural and marginalised areas, livestock contributes 70% of the livelihood (FAO 1999, LID 1999). There is a growing interest among the member countries to the FAO for the need to address AnGR at the international level. When the topic policy and regulatory options for AnGR now comes into attention, there is a danger that experiences from the plant sector may be directly applied to farm animals. Policy and regulatory options should, however, be adapted to the special circumstances for the animal sector and avoid a ‘copy-paste approach’ from the plant sector, if those solutions are not found adequate for the animal sector.

The Subject Matter – Farm Animal Genetic Resources Differences between Plants and Animals A point of departure for a policy and regulator analysis is to develop a clear understanding of the subject matter that is up for discussion. Since the body of policies and regulations mainly have been developed in the plant sector, it is interesting to compare these two sectors to identify similarities and differences relevant for policy making and regulation. At first sight plant breeding does not differ much from animal breeding. Plant and animal breeding are similar in that they need genetic diversity in order to advance, and that the genetics determine adaptation to particular agro-ecological and product qualities to a large extent. However, marked differences do exist. While plant breeder’s aim at development of new varieties to replace old varieties and that may be protected by plant breeders’ rights, farm animal breeding is largely based on selection of individuals within populations based on a continuum of genetic material rather than complete shifts to a new breed. The farm animal breeders are interested in individual animals and populations, while a plant variety is the main focus of plant breeders. Maintaining genetic variation within populations and minimizing inbreeding is much more relevant in farm animals than for plants. Although an individual animal might carry unique gene combinations or new mutations, in contrast to the situation with many plant species, exploiting the unique genetic characteristics of an individual animal is currently extremely difficult due to long generation intervals, low reproduction rates, high cost of evaluating the genetic characteristics of a single animal and the absence of effective use of recombinant gene technology in the animal sector. The unit of diversity in AnGR is, therefore, generally considered to be a population of animals, often referred to as a breed (Gibson and Pullin 2005). The animal breeding sector largely concentrates on the diversity within populations; the costs are often too high to introduce exotic materials into a genetic background required for modern farming due to long generation intervals and small numbers of offspring. This marks a difference, as for plants the introduction of a new gene may be less costly. 78

Biological differences clearly require different approaches to conservation, breeding and use. Compared to plants, fecundity and reproductive capacity is extremely low in farm animals, although there are substantial differences between species.

Analysis of a sui generis system of IP protection for AnGRFA To discover whether there is a need for a sui generis system of IP protection in this field, it is thus essential to know the answers to several questions: - First, what are the elements at play in this analysis?  innovation?biodiversity?conservation?  the competition environment?economic development of agricultural regions? - Second, what is the practical feasibility of a sui generis system; and what are the elements of analysis here? Would it be used at all – taking into account the actual structure of innovation in this field and the specific biological nature of animals? Is there a demand or need in practice (or only in theory)? - Finally, what would the shape of such a system be – taking into account the answers to the above questions?

Reasons for and against Animal Breeders’ Rights Before deciding to call for a sui generis IP system for AnGRFA, it is first necessary to analyse the elements that such a system can influence. Then, one must ask whether the analysis of how these elements operate in the field of AnGR specifically, calls for the implementation of such a system or not, given a consideration of the theoretical design possibilities of the sui generis rights. In general, IPRs are designed to act as incentives to innovation. To do so, they affect the competition environment in a certain field. This in turn, in the field of biological material, can influence biodiversity (the creation of new diversity (‘rearranged’ biodiversity) and the distribution of existing diversity). It can also have ethical implications. If tailored to influence biodiversity or used strategically, IPRs furthermore have an underestimated effect on the conservation of genetic resources. Finally, IPRs have an influence on the level of economic development of a given country – in allowing copying industries or innovative ones. This is no different for sui generis IP rights. However, their (as yet to be determined) shape can take into account the practicalities of each element more specifically and set the balance between them differently from the way other IP systems do.

Animal Breeders’ Rights in Practice In the previous section we have analysed the elements that form the eventual rationale for an Animal Breeders’ Right system. This, however, is only one element to be taken into account in the design of such a system. The second element relates to the obstacles and needs of the practice. Together these elements form the basis for describing how such a system could be designed in concrete terms. Let’s first look at whether: - there are practical difficulties – perhaps of a biological nature – with the application of IP rights of this type to AnGR(FA); and whether - such a system would actually be used in practice? - would the players of the game prefer to (continue to) use other means to protect their innovation? Needless to say that these elements overlap.

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Biological obstacles The literature has addressed the question of sui generis IP systems in this area before – although barely. Most concluded that there are biological obstacles to ‘Animal Breeders’ Rights’. In particular, doubts were expressed as to whether animals are stable enough over the generations. Applicants for IP rights would get an IP right for something they cannot be sure would retain the characteristics based upon which the IP right was granted. Unlike plants, animals may lack the predictability that would be desirable to obtain before covering the subject with an IP monopoly. In comparison, PBR systems on basis of the International Union for the Protection of New Varieties of Plants (UPOV) Convention require ‘stability’ as a condition for the grant of the right. However, that it is not possible to keep an animal breed stable because of the sexual reproduction: herds evolve. This is different for products that are the direct (first-generation) outcome of biotechnological processes, but for those animals stemming from mating and cross-breeding, stable offspring are said out of reach. On this basis, there is no agreement as to the extent to which animal breeds are technically suitable for IP protection at all. To ignore the possibility that animal breeds may be stable, is however to ignore animal breeds as such. After all, breeds such as Holstein cattle and others have been created with ‘traditional’ means. It appears usual for market approval that genetically modified animals show that the engineered feature is stably inherited: that the phenotype and genotype is consistent and predictable. Perhaps it sets the threshold for protection at a high level, but does not point to the practical impossibility of the system as such. Furthermore, PBRs also protect hybrid plants, although they cannot, by themselves, reproduce stably. However, the right holder will know how to produce the hybrids in a stable manner. This will be equally true of animal breeds.

Practical need of IPR? Next to the biological issues comes the question of other practical obstacles and especially that of the practical need. Whereas the theoretical need was addressed above, this does not guarantee that producers and breeders themselves feel a need for such a system or that they would be willing to use the system if put in place. In particular, we come to the question whether control over ‘a breed’ is needed to incentivise progress, or whether control over individual animals is enough. Unlike in plant breeding, the germplasm of superior individual animals will indeed be more important than the breed to which they belong. This would mean that it is enough to physically control the animal to have the ‘monopoly’, and that IPRs may not be used here simply because they are not needed. The commercial value of one single bull can be immense, whereas it is not the breed he stems from that will guarantee consistent production of such highly performing bulls. In this context, the cloning of bulls combined with secrecy methods can be much more attractive than applying for IP protection of the patent type and acquiring the right over perhaps a new animal breed. This argument, however, would only be valid for cattle and fails to recognize that animal individuals and their characteristics do not occur in splendid isolation from the breed they stem from. Furthermore, the arguments exclusively turn on productivity. The proposed system rather aims to stimulate the use and improvement of AnGR diversity and to incentive a change towards exactly the situation described: the use of individual animals (thus the use of one specific genome) to dominate markets.

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Existing systems In the context of both biological and practical objections, it must be mentioned that sui generis IP systems for animal breeds do exist; in Bulgaria, the Czech Republic and Kyrgyzstan. Taking the example of the Czech “Law on the Legal Protection of New Varieties of Plants and Breeds of Animals”, we read that animal breeds shall be granted a “Breeder’s Certificate” provided that the breed at stake is distinct from any other breed commonly known by at least one major trait. Furthermore, the breed must be homogeneous to an “adequate level” and stable in its major traits. It must also be new; however this requirement is in the narrow sense that it may not have been sold or offered for sale in the Czech Republic for longer than one year before the date of application or longer than six years in any other state. Finally, the breed must be sufficiently large in number for reproduction (Article 5). For the purpose of the said law, animal breeds are a population of animals having the same origin and exhibiting characteristic morphological and physiological properties, which is capable of reproducing itself, including hybrids of animals and stocks of poultry. On this basis, the protection granted is a non-transferable, exclusive right to exploit the breed commercially throughout the duration of the breed. Not only is a right to exploit the breed thus being granted, a right to authorize others to perform such commercial exploitation is included. It is unclear; however, to what extent these systems are used in practice, or are operationalised (if at all).

Animal Breeders’ Rights When the theoretical needs and practical obstacles are combined; what concrete shape would an Animal Breeders’ Rights system have to take? We have seen that if one considers the implementation of such a system, it should serve to foster innovation and preferential use of local breeds as well as improving them to ensure them a better market position, and possibly to encourage the economic development of agricultural regions. Practically speaking, the system also has to ensure that it actually can be used or is being used by private players; and that it suits the (biological) specificities of AnGRFA. When deciding on the usual elements that form an IP system of the ‘patent’ type, the following must be considered:  the subject matter; the requirements for eligibility; and  the scope of the rights. Subject matter The question of subject matter forms the basis of the system. One must decide what should be covered in principle by the rights, and how to define it concretely. Should the system:  include biotechnology?  only apply to what is not yet covered by the patent system (and how to define this)?  cover animal breeds?  cover animal breeds ‘for agricultural purposes’?  cover only breeds, only their production methods, or both?  differentiate amongst different ‘types’ of animals? To exclude biotechnology may be to exclude the future. The primary aim of the system, however, would be to cover those areas left out of patent protection. Setting the subject matter on ‘animal breeds’ may – much as with the PBR system – de facto exclude biotechnology anyway since the protection granted would then be inadequate.

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Biotechnological progress occurs at the ‘gene level’, protection of the breed only would be too easily circumvented by third parties, by using the gene in isolation. Furthermore, development at the gene level will usually not be limited to a specific breed, nor necessarily create a new one. A system for animal breeds, therefore, almost automatically protects ‘traditional’ or low-tech progress. Hence one does not need to make a distinction here between breeds that are the outcome of biotechnology and breeds that are not. The definition may be neutral in this respect. The question arises of whether the system should go beyond the PBR analogy (‘plant variety’), to also cover animal gene sequences or production methods. This may then imply dual protection under both sui generis and patent rights in many countries, and no strong proof exists that the patent system is not suited to ‘do the job’ here. As to production methods, these usually consist of classical processes of mating and cross-breeding. Granting IP rights to these would be to grant rights to known methods without clear justification. The rights granted would represent neither an inventive activity, nor an investment of time and money. We thus tend to stick to the subject matter of ‘animal breeds’ only. Then, a decision must be made as to whether only breeds for agricultural purposes should be granted protection, or whether protection should be offered to breeds per se. A priori, a need for ‘a’ use is apparent. A system of this kind is not aimed to trigger investment in creating new colours of existing breeds for instance, as is the case in PBR systems. These cover an endless number of new colour combinations applied to tulips, for instance. Although no internationally agreed principle of animal dignity exists, incentivising such activities does appear to have undesirable ethical implications and furthermore does not ensure progress for the purpose of which the system would be designed. Hence it does seem appropriate to require an agricultural use for a new breed to be granted an Animal Breeders’ Right. Medicinal uses may however be considered as well. The subject of ‘animal breeds’ must also be defined. For the purposes of the Czech law discussed above, animal breeds are a population of animals having the same origin and exhibiting characteristic morphological and physiological properties, which is capable of reproducing itself, including hybrids of animals and stocks of poultry. This definition appears strongly inspired by the PBR system. It is confirmed as a classical definition of animal breeds by the FAO which defines an animal breed as either a sub-specific group of domestic livestock with definable and identifiable external characteristics that enable it to be separated by visual appraisal from other similarly defined groups within the same species or a group for which geographical and/or cultural separation from phenotypically similar groups has led to acceptance of its separate identity. A final question would be whether one should – under the umbrella of AnGRFA – differentiate amongst animal (the taxononomical level above breeds), given the different biological and market realities. This is perhaps one of the biggest differences between the regulation of plants and that of animals. Whereas one can relatively easily establish rules in relation to plants in general, it would not be appropriate to do this for animals. Fish are cultivated almost like plants; cattle are monitored in herd-books; poultry production has its own methods; insects – for instance for the production of honey – are also produced and kept in a distinct manner. Furthermore, only in relation to fish production, is genetic engineering said to have a real potential for use in the (near) future.

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Requirements for eligibility The next question is what the requirements should be for such animal breeds to be eligible for protection. - Should the system include a novelty requirement? And, if so:  How can enough flexibility be ensured to cover also improved local breeds?  Where should the threshold be set between a breed classified as already existing and a new one? Would one consider novelty in the absolute (‘patent’) sense, or novelty on the market at stake only (UPOV-style)?  Should one require an inventive step, or rather protect the investment in time?  Should it embody a criterion of disclosure, and, if so, what should be the subject of the disclosure?  What criteria would assure that a breed has in fact been created?  Should these be the usual PBR criteria of stability, distinctiveness, and uniformity or homogeneity?  What about a criterion to assure that the breed is viable? As in the above discussed Czech law should one require animals to be sufficiently numerous for reproduction?  How does one prove an agricultural use as discussed above: should the animal be tested to ensure that it functions as reported before the right is granted?  Finally, what about the need for exclusions from eligibility; especially in the case that an application is made for protection of animals which would inevitably suffer from the use to which they will be put? The decision on the threshold for novelty seems to be one that must be taken by domestic policy makers. Granting a right for breeds that do not yet exist anywhere in the world appears the most logical from an innovation point of view. However, it may be decided, in order to convince certain players to put their breeds on a given market, to set only a relative novelty criterion: novel = not yet put on the market in that country. A similar reasoning applies to the question of inventiveness. Does one want to reward true innovation, or rather to invest in new breeds? It appears out of question not to include the requirements of stability, distinctiveness, and uniformity. As in the Czech law, one should also impose the existence of a group of animals sufficiently large in number for reproduction. The need for distinctiveness deserves specific attention in this context. This criterion requires breeds to be sufficiently distinct from other known breeds. Linked to what was said above on the necessity for usefulness of the breeds, distinctiveness must go beyond the usual PBR interpretation that also allows new colours. Instead the important characteristics should be disease resistance, increased nutritional value, and general adaptive traits. Against this background, it is also apparent that the function should be tested before the right is granted. The African Model Legislation offers food for thought in this context. It makes a distinction between local varieties and nonlocal varieties for the grant of IPRs. The proposed system imposes additional, ‘multi-locational’ variety trials for at least three seasons to prove that the nonlocal variety being tested does have the characteristics that are claimed (subject to relaxation of the criteria, however, in times of ‘exceptional crises in food production’). Tests as to their local adaptability would avoid instances where high-yield breeds which are imported and eventually crossed with local species then turn out not to be adapted to the specific local circumstances and hence are unproductive. For newly

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developed breeds, there appears no reason to grant an IP right of this type if the function that is claimed cannot be proved to work in practice and to work in the local context. Next, comes the question of disclosure. This is not a common requirement under plant breeders’ rights systems. In view of the necessity of creating germplasm banks with the aim of conservation, the deposit of genetic material may however be considered as a requirement for protection. It might be a useful tool to counter limitations set by private actors to access AnGR in the

Scope of rights The subject matter and the criteria for protection having been discussed, it is now necessary to look at how to design the right itself. What will or should the right allow, and what not? This also touches upon the question of which obligations stand in contrast to the rights which would be granted. - What will the right holder are allowed to exclude others from? Should he or she receive:  The exclusive right to ‘use’?  The exclusive right to ’produce and sell’ only? - Should the right holder be allowed to make any exclusion at all, or should one consider the right as a basis upon which a liability regime is to be implemented? This would mean that the right conferred does not entitle the holder to exclude anyone, yet obliges third parties to compensate the right holder. - Should the right cover eventual progeny and until what point (how many generations)? If progeny are to be covered, is there a need for a so-called farmer’s privilege allowing the use of progeny for one’s own agricultural activity? - What would be the duration of the right? - Depending upon the decisions made, it will then be necessary to tailor the exclusions:  Farmers’ right?  Research exemption? - Furthermore, should there also be a differentiation according to the contribution to the state of the art? - Could one consider favouring small-scale farming; for instance by implementing a market segmentation mechanism decreasing the strength of the rights to favour small-scale farms – e.g. make the scope of the farmers’ privilege dependent on the scale of production? - Finally, should there be differentiation according to whether or not public funding was involved in the creation of the breed (e.g. public– private partnerships)? These are the questions. Although it is clear that many of these questions go beyond a legal analysis, we briefly address them below: The question of the rights that should be covered is a fundamental one. If the right to exclude others from ‘using’ the subject matter is granted, the right becomes very strong. In this constellation, a research exemption enabling the use of the breed for research purposes must be considered, as well as a farmers’ privilege, enabling farmers to use the progeny on their own farms for instance. If however only the right to ‘produce and sell’ is granted, a research exemption, for instance, may already be implied. The idea of a liability regime comes from Jerome Reichman. He suggests that a third party is allowed to access and use the protected subject matter without requiring permission from the owner. However, the third party is then obliged to reasonably compensate the right

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holder for any such use. Animal Breeders’ Rights could be the first field to actually test his theory. The next question – of extending the scope of the rights to include progeny – is in fact existential. It is necessary to enable a return on investment. Without this, the system would be useless, since second generations (or later ones) could be used to produce the protected breed in parallel and nullify the effect of the IP right. Protection would thus have to last as long as the subsequent generations continue to express the (essential) protected characteristics. This right may however be ‘eased’ by the implementation of a farmers’ privilege, as mentioned above. Enabling farmers to use the protected breeds for further breeding – on their own farm for instance – would bring the system (more) in line with classical ownership rules in the AnGR field (where the genetic resources and the possibility of using them are transferred and included in the price). Yet, it would not endanger the recoup of investment in the same way as the exclusion of the next generation from the scope of the IP right would. The question of duration of the right is essentially a non-legal one. It may be linked to the actual contribution that is made to the state of the art. Inventions in the low-tech area (more so than biotechnology) will build upon classical methods, previous endeavours of farmers and natural evolution. Although it will be difficult to define the criteria upon which to base such an assessment, the idea may nonetheless merit further thought. In this context, one could also consider specific means either to reward the original community on whose breeds the improvements have been based, or grant them certain participatory rights. Finally, a number of additional features to improve the access of farmers to the newly developed breeds, and further incentivise investment in innovation can be envisaged. In particular, the above-mentioned market segmentation mechanism decreasing the strength of the rights to favour small-scale farms –e.g. a larger farmers’ privilege depending on the scale of production. In relation to incentivising investment, one must take into account the new structures of many research ventures. Especially in agricultural and medicinal research, many projects are set up in what is called a public–privatePartnership (PPP). Although the degree of collaboration may vary depending on the specific venture, the involvement of public money must be considered when deciding on the strength of the IP rights on the outcome of these projects. While features to attract PPPs in this field may be envisaged, access to the inventions that are the outcome of PPPs must be enhanced, given that consumers will have already paid a part of the cost (through the public money involved).

Conclusions The hypothesis stated at the beginning suggested that the success of an Animal Breeders’ Rights system depends on how it is received and used in practice, yet that its need is intrinsic and the opportunity apparent. The analysis presented here tends to support the hypothesis. However, there are many ‘coulds’, and the right is reserved to be hesitant on the ‘woulds’. The system could be beneficial to innovation in the field, could improve the competition environment, could positively affect the use and conservation of AnGR diversity, and could contribute to the development of agricultural regions. Whether it would, however, has yet to be tested in practice.

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Sui generis systems can fill the ‘IP protection’-gap that is left in relation to promoting low- tech innovation and thus to fostering research on within species diversity in the field of AnGRFA.

References 1. Convention on Biological Diversity (CBD); the World Intellectual Property Rights Organisation (WIPO), in particular the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) and the WTOTRIPS. 2. FAO 1999. The global strategy for the management of farm animal genetic resources. FAO. Rome. 3. LID, 1999. Livestock in poverty-focused development. Livestock in Development. Crewkerne, UK. 4. Gibson, J.P. and Pullin, S.V. 2005. Conservation of Livestock and Fish Genetic Resources. Gibson, J. P. and Pullin, S. V. Science Council Secretariat, FAO. 5. Morten Walløe Tvedt, Sipke Joost Hiemstra, Adam G. Drucker, Niels Louwaars and Kor Oldenbroek. 2007. Legal Aspects of Exchange, Use and Conservation of Farm Animal Genetic Resources.The Fridtjof Nansen Institute 2007. 6. FAO/IPGRI, 2005. Workshop documentation of the International Consultation on Options and Strategies for the Conservation of FAnGR, Montpellier, France, November 7-10, 2005. 7. M. Temmerman, Intellectual Property and Biodiversity: Rights to Animal Genetic Resources, Amsterdam, Kluwer International, forthcoming November 2011; 8. F. Rothschild and S. Newman (Eds.), Intellectual Property Rights in Animal Breeding and Genetics, Oxon and New York, CABI Publishing, 2002; and W. LESSER, Animal Patents: The Legal, Economic and Social Issues, New York, Stockton Press, 1989. 9. Article 53 (a) of the European Patent Convention (Convention on the Grant of European Patents, 10. United Nations Treaty Series 199, available online at: http://www.epo.org/law- practice/legal-texts/epc.html 11. Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex IC to the Agreement Establishing the World Trade Organization, Marrakesh, 15 April 1994, International Legal Material 1197 (1994), available at: http://www.wto.org/english/docs_e/legal_e/27-TRIPS.pdf 12. de Carvalho, N. P. 2005: The TRIPS Regime of Patent Rights, Second Edition, Kluwer Law International.

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Access, Benefit Sharing & intellectual property rights Karan Veer Singh and Jayakumar S ICAR-National Bureau of Animal Genetic Resources, Karnal – 132001, Haryana.

Introduction In the 5th Century B.C. Aristotle presented moral and philosophical arguments to reward inventors for their innovations. With the industrial boom in the 19th century in Europe the need arose to protect inventions from being copied and thus ensure that the investment in innovations would be rewarded. On the other hand, there is a need to disclose innovations to the public to promote/facilitate further development based on existing innovations (Tansey, 1999). To ensure the both aspects of innovation (protection and publication) a legal protection, an Industrial or Intellectual Property Rights (IPRs) system was created. During that time, the legislations on IPRs were designed to protect only industrial products since agricultural innovations did not play such an important role. In the beginning of the 20th agricultural innovation gained importance and consequently its protection but the mechanisms developed by then for this purpose (patents), were not appropriate to protect new plant varieties, basically for three reasons. First, one of the requisites to obtain a patent is, that the invention should really incorporate an inventive step (non-obviousness) what does not apply to new plant varieties created by selection and crossing of already existing varieties. Second, a patent requires an exact description of the innovation and the process to obtain it. This resulted not only difficult but, in most cases impossible. However a pure publication of the description of the material, in contrast to industrial innovations, is of no use for further investigation the protected variety must be physically available. Third, patent protection was considered to be too strong for new varieties and thus hinder a more dynamic development of the agricultural sector since there are traditional and accepted rights and habits of farmers as for instance the saving, reuse and exchange of seeds which are restricted under patent protection. To overcome the above mentioned constraints, a new concept to protect plant varieties, the Plant Breeders Rights (PBRs) system, was designed. When it was formally proposed at the end of the Earth Summit in 1992, the Convention on Biological Diversity (CBD) was seen as the first decisive step taken by the global community to ensure conservation and sustainable use of the world's genetic resources. For the genetic resource rich developing countries, the CBD was particularly important because it recognised that States shall have sovereign rights over the biological and genetic resources within their territories, and can establish laws to regulate access to those resources. Another significant development in the past two decades has been the rapid progress made by the biotechnology industry, raising in its stride the critical issue of extending intellectual property rights (IPRs) to products based on genetic resources, and to the technology used for arriving at such products. The formalisation of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) at the conclusion of the Uruguay Round of GATT negotiations was a direct consequence of the efforts that the commercial interests in this frontier technology had made. This paper aims at raising some of the key issues that arise in the implementation of CBD and the Agreement on TRIPS, particularly for the biodiversity-rich countries where local and indigenous communities have been harnessing the genetic resources using traditional knowledge system over generations.

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CBD Principles The CBD recognizes several broad principles that seek to define the nature of rights of a State over its genetic resources and the legal framework it can establish for regulating access to such resources. CBD’s key principles are as follows: • Every State shall have sovereign rights over the biological and genetic resources within its territory, and can establish laws to regulate access to those resources; • Access to such resources should be on ‘mutually agreed terms’ and should incorporate the principles of ‘prior informed consent’ of the resource provider. Moreover, it recognizes an obligation to ensure ‘fair and equitable’ sharing of benefits arising from access and use of the resources. • Every Contracting Party shall make efforts to develop and carry out scientific research based on genetic resources provided by other Contracting Parties with the full participation of, and to the extent possible, within the countries supplying the genetic material. • Contracting Parties should adopt legislative, administrative and policy measures that could ensure effective participation in biotechnological research activities by those Contracting Parties, especially developing countries, which provide the genetic resources for such research, and where feasible in such Contracting Parties. • Contracting Parties should "take legislative, administrative or policy measures, as appropriate, with the aim that Contracting Parties in particular those that are developing countries, which provide genetic resources are provided access to and transfer of technology which makes use of those resources, on mutually agreed terms, including technology protected by patents and other intellectual property right....". • States should: (i) respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity, (ii) promote their wider application with the approval and involvement of the holders of such knowledge, innovation and practices, and (iii) encourage the equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices.

TRIPS Principles The TRIPS Agreement takes a major step towards harmonisation of the norms and standards of intellectual property protection. It requires members to comply with a defined set of minimum standards for the protection of intellectual property rights covered in it. Its basic principles relevant for the present discussion are as follows: • It mandates countries to provide patents for products and processes in all fields of technology, subject to the tests of novelty, inventiveness and industrial use. • It mandates patenting of ‘micro-organisms’ and non-biological and microbiological processes. • Members are allowed to make limited exclusions from patentability are permitted on the grounds of public order or morality, and in respect of protection extended to human, animal and plant life or health. It also gives states the option for protecting new plant varieties through patents or through any other effective sui generis system. • It recognizes as one of its objective that the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

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Products Based on Biological Resources and Traditional Knowledge: The Basic Issues The concern with inventions based on biological resources is not only about the tangible physical resource alone, but also about the intangible information base associated with that resource, referred to commonly as Traditional Knowledge (TK). The growing importance of biotechnology and the increasing number of patents granted to biotechnology-based inventions highlight the potential value of genetic resources and associated TK. The originators and custodians of much of TK are local and indigenous communities who through years of consistent skill, observation and usage have developed a wealth of a knowledge base regarding the use and properties of various biological resources. The value of TK and its key role in the development of the final product has been the subject of a variety of literature to date. With regard to biological material, it is a settled principle in Europe and North America that while it is not possible to claim as an invention something that occurs in nature, patents can be possible if one extracts it from nature and makes it available for industrial utilization. Such a proposition is explicitly rejected under Indian Patent law for instance, since, discovery of any living thing or non-living substance occurring in nature, are excluded from the purview of patentability. There are various examples regarding the grant of patents in other jurisdictions, commonly in the United States and European countries, over products based on biological resources commonly used in India. Some of these examples are enumerated below:  Use of turmeric in wound healing.  Composition of jamun, bitter-gourd, gur-mar and eggplant for treatment in diabetes.  Various products obtained from the neem tree.  Varieties of basmati which have the characteristics of growing in temperate climate in the absence of sunlight.  Composition of methi as a tonic to bring down blood glucose levels.  Compositions comprising of kala jeera or kalonji for increasing immune functions, and treatment of diabetes, hepatitis, and asthma. Other such examples from South America and Africa include patents granted on quinoa and ayahusca, and on products based on plant material and knowledge developed and used by local communities such as the cases of kava, barbasco and endod. The premise on which this paper is based is that the conflicts that emerge when patents are granted on products of biological resources, are not simply social, political or economic, but rather, strike at the very root and basis of the patent system.

Overview of IPR & TK There are three principal forums where the issues pertaining to protection of TK, access to biological resources and IPRs have figured prominently. These include the Conference of Parties to the CBD, the TRIPS Council of the WTO, and the World Intellectual Property Organization (WIPO). The following section provides an elaboration of the developing country positions advocated through their submissions to the TRIPS Council. These have been elaborated in a recent submission to the TRIPS Council. (i) Why we need Norms of Disclosure Several developing countries have been arguing for effective norms of disclosure revealing source of origin of the resource and TK used in the invention, as well as provide evidence of prior informed consent and benefit sharing. It is believed that disclosure of source of origin and evidence of prior informed consent and fair and equitable benefit sharing in a patent 89

application would play a significant role in preventing biopiracy and misappropriation. It would serve as a critical tool for biodiversity rich countries like India in tracking down applications based on bioresources and related TK, and enable adequate challenges to specious patents. Disclosure of origin of the resource and TK will therefore serve the following purposes. These are: (a) Reducing instances of bad patents; (b) Enabling the patent office to ascertain more effectively the ‘inventive step’ claimed in a particular patent application; (c) Enhancing the ability of countries to track bad patents in the instances where they are granted and challenge the same; (d) Improving compliance with their national laws on prior informed consent and fair and equitable benefit sharing prior to accessing a biological resource/associated traditional knowledge. This would also increase the credibility of the patent system, as well as contribute to achieving the principal objectives of the TRIPS Agreement. (ii) Notions of Equity and Good Faith India and several other countries have also consistently argued for notions of equity and good faith behind the proposal for clarifying the TRIPs Agreement. Equity and Good Faith are principles recognized under most jurisdictions. There are no strict definitions for these terms. They essentially connote a situation of fair play and justice. It has been argued that notions of equity and good faith mandate that the international community create an equitable system for the acquisition, maintenance, and enforcement of intellectual property rights, which does not a priori exclude any section of the society. It has been acknowledged that the principle of equity dictates that a person should not be able to benefit from exploiting IPRs based on genetic resources or associated knowledge acquired in contravention of any legislation governing access to the material. (iii) Role of TK Databases & limitations of relying only on databases Compiling databases of traditional knowledge at the national level is an important aspect being addressed at the national level in several countries, including India, through efforts at compiling a Traditional Knowledge Digital Library. Such databases would play a key role in facilitating a patent examiner’s check against patent requests relating to unauthorised use of the knowledge of traditional communities. It was, however, recognised that given the vast breadth and depth of such knowledge, there was an inherent limitation of such documentation which was that it cannot be completely comprehensive and exhaustive of all the traditional knowledge available in a country. This would be particularly true when traditional knowledge used in a particular invention was undocumented, based on oral traditions or documented in the local languages. In such cases, reliance on the documented source itself may not be sufficient. It has been suggested that the use of databases documenting the knowledge, innovations and practices of traditional communities which can be made widely accessible over the internet, to enable their use by patent examiners, will be an adequate solution to redress the problem of biopiracy. (iv) Limitations of National laws or Contracts It has been suggested that there should be a separate law for governing aspects of biopiracy, and that PIC and benefit sharing can be done through contracts as well. The CBD mandates its member states to enact national laws that would facilitate PIC and benefit sharing in a fair and equitable manner, prior to access and use of biological resources and traditional knowledge. It is acknowledged that these mechanisms can and should be used,

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and several countries have already enacted laws to put in place an Access and Benefit Sharing (ABS) regime. However, this in itself is insufficient to arrest biopiracy and misappropriation of resources. It also does not achieve the central objective of disclosure norms- that is to stall the reward of a patent for knowledge or information misappropriated from another country. For the same reasons, relying on contracts will be insufficient as well. Contracts being voluntary in nature would be ineffective if the parties to the contract are of vastly unequal bargaining strengths, as would be the case involving traditional communities and the commercial interests. National systems by themselves would not be adequate to fully protect and preserve traditional knowledge. For example, the ability of patent offices in national jurisdictions to prevent biopiracy as well as to establish informed consent mechanisms to ensure reward to TK holders, does not ipso facto lead to a similar action on the patent applications in other countries. Similarly, benefit sharing mechanisms established through national legislations would need to be recognized in user countries. The remedies that can be sought under national laws for access and benefit sharing will also inevitably have only territorial application within the country whose laws are violated. It is very clear, that any improvement of the performance of the system of protection of access to genetic resources and protection of IPRs is strongly related to capacity building and improvement of coordination between the stakeholders on national level, as well as on international level (Byerlee and Fischer 2001; Salazar, 2001). These capacity-building programs should be directed to all stakeholders (Farmers, Seed companies, Biotech companies, Governmental Organizations, NGOs, CSOs, Universities and NARS) and should put emphasis on:  Need for the conservation of biodiversity,  Need for the protection of IPRs,  Access to and transfer of genetic resources and technology and  Training of human resources

In addition to capacity building there are other areas where external support is needed. To facilitate the control, databases to register genetic resources and traditional knowledge should be established. Further on, networks for exchange of experiences and information as for instance the Technical Co-operation Network on Plant Biotechnology (REDBIO/FAO) shall be formed and can be an appropriate vehicle to implement the above mentioned capacity building programs. A central element is also to assign clear mandates to the national authority and provide them with the tools necessary to enforce the existent regulations. As a crucial element such an authority should provide space for the participation of all stakeholders in the most important decisions such as the design of the regulations and its interpretation or to establish means of communication (Wendt and Izquierdo, 2000). To achieve this, institutional capacity buildings as well as assignment of sufficient financial and human resources are essential (Salazar, 2001). The solutions of these problems are not only depending on the activities on national level but are strongly dependent on how a better regional cooperation could be achieved. Therefore the support of international organizations such as FAO, WIPO, UPOV, ISNAR and others are indispensable since national governments in developing countries lacking capacities and resources.

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Conservation of livestock genetic resources and its relevance to intellectual property Rajeev A.K Aggarwal ICAR-National Bureau of Animal Genetic Resources Karnal -132001 (Haryana)

The genetic resources of farm animals in India are represented by a broad spectrum of native breeds of cattle, buffaloes, goat, sheep, swine, equines, camels and poultry. The genetic biodiversity among this livestock has developed and stabilized over millions of years of evolution and endowed the indigenous breeds with capabilities to withstand hostile climate, epidemic pests and diseases, and to survive on inadequate quantities of feed, fodder and water. However, over the years due to many reasons the population size of many breeds is declining. As genetic diversity equips farmers and breeders to utilize a wide range of production environments and develop diverse products to meet the needs of local communities, the unavailability of such diversity in future may hamper sustainable development. Hence the need for conservation of animal genetic resources has been accepted in India and it can be strengthened further if the effects of IPRs on animal genetic resources on genetic diversity, genetic improvement and the livelihoods of livestock keepers could be analysed more extensively. Certain guidelines and legal frameworks for exchange of germplasm are in use in India.

Conservation methods Conservation methods can be broadly categorized as in situ and ex situ. In situ conservation means that animals are kept within their production system, in the area where the breed developed its characteristics. Ex situ conservation applies to situation where animals are kept outside their area of origin (herds kept in experimental farms, farm parks, within protected areas or in zoos) or more often, when genetic material is conserved and stored in gene banks in the form of semen, ova, embryo or DNA. Conservation through any of these methods has its own merits and demerits as explained below. 1. Organized flocks/herds: Maintenance of small population at a place away from the main breeding tract of the breed is the ex situ conservation of the live animals. This may be in the form of organized herd maintained in a research institution, bull mother farm, state owned livestock farm, zoo or breed park. This population can be used in regeneration of endangered breed, new breed development and DNA studies. 2. Cryopreservation of embryos: This is ideal for breed improvement, conservation and revival of lost breed. Its main importance is due to its diploid nature and containing all genes. However conserving embryos finds limited use, as its production and transfer require highly skilled manpower and large resources. 3. Somatic cell banking: Somatic cells can be used as genetic material for conservation of endangered animal genetic resources. They are diploid cells and contain full genetic code of an animal. Cost of maintenance of these cells is very low and can be sampled quickly even from remoter area at low cost. They can be used for production of therapeutic proteins also. However somatic cells also find less preference in conservation programmes as the success rate of cloning is still very low. 4. Epididymal sperms banking: Epididymal spermatozoa particularly caudal spermatozoa is mature and have full competence to undergo normal fertilization and cause fetal 92

development. In vitro fertilization (IVF) experiments have revealed that epididymal semen possesses binding sites for important zona pellucida proteins. Collection of cauda epididymal semen from slaughtered animals would be a rapid and cheap alternative of sperms conservation as it would obviate the requirement of time consuming and extensive training of males for semen donation. Hence epididymal spermatozoa cryostorage is promising methodology of conservation especially in small ruminants and further research efforts are needed in this direction. 5. Cryopreservation of embryonic stem cell lines: This can be excellent biological material for producing live animals and producing genetically modified animals. This also find usage in gene and cell therapies, and for producing vital therapeutic proteins. However so far they have limited useage as stable embryonic stem cell lines have not been successfully generated in farm animals except in human and rodents. 6. Cryopreservation of spermatogonial stem cell lines: The Spermatogonial Stem Cells (SSCs) are adult stem cells which transmit genetic information to the next generation and create foundation for spermatogenesis. Transplantation of spermatogonial stem cells from a donor mouse testis into the seminiferous tubules of a recipient mouse testis results in donor-derived spermatogenesis. SSCs transplantation has also been demonstrated in goats, dog, cow, pig, baboon and bovine spermatogonial stem cells shown to be capable of colonizing recipient mouse seminiferous tubules. An in vitro system that supports the proliferation and maintenance of spermatogonial stem cells could be used to preserve and expand spermatogonial stem cell numbers as well as aid in genetic modification. However much needs to be done in farm animals before its potential could be utilized in domestic livestock diversity preservation. 7. Storage of DNA: Cryogenic storage of DNA is another method of preservation of genetic material. It has several advantages over the live germplasm as it is very easy to obtain, store, transport at low cost with no chance of disease transfer. The DNA may find use in gene conservation through their introgression by transgenesis or knock out technology, and can help in recreation of lost breeds by cross checking of different populations or genetic material used. However this has limitations due to the fact that genome maps of different farm species are not yet available and life cannot be created from DNA alone. 8. Frozen Semen: This is ideal for genetic resources utilization activities, providing sample half of the genetic material of preserved breeds in a form that permits convenient introgression into recipient population. However, regeneration of a cryopreserved breed from frozen semen in one generation is possible only if living females of that breed are available, otherwise several generation of up gradation are required to re-establish a conserved breed. In spite of this limitation, availability of established semen freezing technology especially in cattle and buffalo, and presence of semen freezing infrastructure across the country makes it method of choice for conserving indigenous livestock biodiversity. The National Bureau of Animal Genetic Resources (NBAGR) is playing a pivotal role in ex situ conservation through semen cryostorage of indigenous livestock for posterity by establishing a National Semen Bank at Karnal.

Conservation priority High costs of collection and limited use of preserved material restricts development of ex situ collection. Hence it may be appropriate to prioritize breeds for undertaking them in ex situ programme and evaluation of many factors may make basis of such prioritization. To

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implement the conservation programme it is thus essential to have breed wise livestock census along with their population and production trends. However many a times the data is available species wise, there is a need to explore quick population estimates and undertake conservation efforts for threatened breeds. The unique genes possessed by a breed and the likelihood of its extinction may be an important parameter to set the priority of conserving a breed. The quantification of relatedness among breeds can group them in different sets, each set consisting of genetically closer/ related ness breeds which are different than breeds of another set. Such arrangement will drastically reduce the conservation costs as conserving a single breed in a set will represent all breeds of respective set. Such phylogenetic differentiation of breeds is possible by mapping the genes in livestock species using microsatellite markers. The usefulness of these markers for estimation of genetic distances among closely related population in different species of livestock has been documented by numerous studies (Bowcock et al., 1994, Buchanan et al., 1994, Cianpolini et al., 1995, Bradley et al., 1996, Mac Hugh et al., 1997). Food and Agricultural Organization (1996) has well laid detailed technical programme for large scale international conservation project using microsatellite markers under MODAD project. Based upon abovementioned considerations some breeds of different species have been undertaken for ex situ conservation programme and for keeping their frozen semen in National Semen Bank at NBAGR (Table 1). Simultaneously ex situ conservation in form of DNA and Somatic cells has also been taken at NBAGR.

Breed population trends The population trend of a breed is an important parameter to suggest, whether a breed should be undertaken for its conservation. However generally breed wise census are not available. The endangered status of an animal breed can be determined by the size of breeding stock, expressed through number of breeding females and sex ratio, which may differ among different species. The endangered status of an animal breed depending upon minimum population size in different species has been suggested by different workers (Table 2). The population size, which may be applicable to Indian conditions, has also been suggested (Table 3).

Sample size in preservation programme Sample size in preservation programs are influenced by both genetic considerations and cost. For a dominant gene, semen to produce 20 viable offspring (100 units; a unit of semen is the amount appropriate for one insemination) should suffice, but somewhat more semen (possibly 200 units) may be desirable in preserving a recessive gene. The preservation of quantitative variation within a population or breed would require about 100 units of semen from each of 10 to 20 unrelated males (CAST, 1984). As per Smith 1984, conserving collection of frozen semen from 25 sires would be adequate for all species. However it is appropriate to have frozen stores, which are large enough to provide a good representation of the conserved stock and to prevent much genetic drift or inbreeding.

Exchange of animal genetic resources Exchange of animal germplasm between India and other countries is regulated by various Acts, Rules and regulations formulated by the Government of India, time to time.

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 Access to any biological material including Animal Genetic Resources of the country is regulated under Biological Diversity Act (BDA, 2002).  Under Section 3 to 5 of the BDA Act “No person shall without previous approval of the National Biodiversity Authority, obtain any biological resource occurring in India. However, Sections 3 and 4 shall not apply to collaborative research projects involving transfer or exchange of biological resources between institutions, including Government sponsored institutions of India, and such institutions in other countries, however, such collaborative research projects should satisfy the certain conditions as specified by BDA in sub-section (3) of Section 5”.

Guidelines regarding the Exchange of Genetic Resources for Research Guidelines regarding the Exchange of Genetic Resources for Research have been prepared by the ICAR, which also covers the Exchange of animal genetic resources. Material Transfer Agreement (MTA) ICAR has adopted the protocol/procedure for germplasm exchange and MTA to be followed in ICAR system (circular no. 4-18/2010-IC.II dated 24.01.2011). Following procedure must be adopted for exchange of any type of germplasm under collaborative and other than collaborative categories.

Guidelines for exchange of animal germplasm other than research  Guidelines for export and import of the any type of germplasm (live animals, semen, ova, embryo and gonads) of livestock species have been laid down by Department of Animal Husbandry, Dairying & Fisheries (DAHDF), Ministry of Agriculture, which may be followed for exchange of animal germplasm, the purpose of other than research. Details of guideline in general as well as sanitary may be obtained at website of DAHDF (www.dahd.nic.in).  All the exchange of AnGR/germplasm will require prior permission from BDA as per the provisions made under Biological Diversity Act and Rules and Regulations framed by MOEF under this Act.  Exchange of animal germplasm is regulated as per provisions made under The Livestock Importation Act, 1898 and various amendments made time to time. General and sanitary guidelines for exchange of germplasm including live animals have been developed and modified time to time by the DAHDF, Ministry of Agriculture, GOI. Important features of Guidelines laid by the DAHDF are described below, which are subjected to change made by the department, time to time. These changes may be available from Website of the department (www.dahd.nic.in).  DAHDF, Govt. of India is the nodal agency for making/modifying the regulations exchange of germplasm, through notification. DAHDF may restrict import of any other product through notification from time to time and may also remove or continue the restriction on various germplasm already under restricted list in Exim policy of Ministry of Commerce, GOI.

Conclusion India is a repository of a large segment of biodiversity in livestock germplasm, with nearly 39 breeds of cattle, 13 of buffaloes, 40 of sheep, 24 of goats, 9 of camel, 6 of horses and ponies, 16 of poultry, 3 of pig, 1 of donkey and many populations of other livestock like Yak, 95

Mithun etc. Having so large animal diversity and spread over large territory of country, it becomes a gigantic task to conserve even those breeds where populations is decreasing. Further the divergence in methods for undertaking ex situ conservation programme also complicates it. This situation necessitates the selection of a cost effective ex situ conservation method and involvement of many agencies in undertaking ex situ conservation programme working in a network at national level for preserving the indigenous farm resources. There is also need for protection of the customary right of livestock keepers to breed their animals and other IPR issues in this regard so as to protect the real driver of livestock biodiversity conservation.

Table 1. Germplasm (Frozen semen) stored in National GeneBank of NBAGR, Karnal Cattle Buffalo Goat Sheep Equine Yak Camel

Amritmahal Assamese Black Bengal Garole Marwari Arunacha Jaiselmeri Swamp li

Dangi Banni Chegu Zanskari

Gangatiri Bhadawari Osmanabadi Poitou

Gir Jaffarabadi Assam Hill

Hallikar Murrah

Hariana Nilli-Ravi

Kangayam Pandharpuri

Kankrej Surti

Kherigarh Tarai

Khillar Mehsana

Krishan Valley Toda

Ongole Nagpuri

Ponwar

Punganur

Rathi

Red Kandhari

Red Sindhi

Sahiwal

Tharparkar Species=7 96

Vechur Breeds=44 Frieswal Males=311 Gaolao Semen Doses=1,29,174

Table 2. Population estimates for endangered status of breed Country Cattle Sheep Goat Pig Horse Reference England 750 1,500 500 150 1,000 Alderson (1981) West Germany 7,500 15,000 5,000 - 5,000 Simak (1991) Europe 1,000 500 200 200 - Maijala (1982) General 10,000 10,000 10,000 10,000 10,000 FAO

Table 3. Population size of indigenous breeds for their status of endangerment ( ,000) Species Normal Insecure Vulnerable Endangered Critical Reference Cattle 25 15-25 5-15 2-5 <2 Nivsarkar et al., Buffaloes 30 20-30 10-20 5-10 <5 1994 Sheep 50 30-50 15-30 8-15 <8 Goats 30 20-30 10-20 5-10 <5 Camels 20 15-20 5-15 205 <2 Horses 20 15-20 5-15 2-5 <2 Pigs 10 5-10 1-5 0.5-1.0 <0.5 Cattle >30 20-30 10-20 5-10 <5 Nivsarkar et al., Buffaloes >35 25-35 15-25 10-15 <10 2000

References 1. Alderson L. 1981. The conservation of Animal Genetic Resources in United Kingdom. FAO Animal Production and Health Paper No. 24, pp 53-76. FAO, Rome. 2. Bowcock A.M., Ruiz-Lineares A., Tonfohrde J., Minch E., Kidd J.R. and Cavalli-Sforza L.L. (1994). High resolution of human evolutionary trees with polymorphic microsatellite. Nature 368, 455-457. 3. Bradley D.G., MacHugh D.E., Cunning-ham P. and Loftus R.T. (1996). Mitochondrial diversity and the origins of African and European cattle. Proceedings of the NationalAcademy of Sciences of the USA 93, 5131-5135. 4. Buchanan F.C., Adams L.J., Littlejohn R.P. et at (1994) Determination of evolutionary relationships among sheep breeds using microsatellites. Genomics 22, 397-403. 5. CAST (1984). Animal germplasm preservation and utilization in agriculture. Published by Council for Agricultural Science and Technology. Report No. 101, 30-31. 6. Cinapolini R., Moazani-Goudarzi K., Vaiman D. et al. (1995). Individual Multilocus genotypes using microsatellite polymorphisms to permit the analysis of the genetic variability with in and between Italian beef cattle breeds. Journal of Animal Science 73, 3259-68. 7. Food and Agricultural Organisation of the United Nations FAO (1996)Global projects for the maintainance of Domestic Animal Genetic Diversity (MoDAD). 97

8. Mac Hugh, D.E., Shriver, M.D., Laftus, R.T., Cunningham, P., Bradley, D.G. (1997). Microsatellite DNA variation and the evolution, domestication and phlogeography of taurine and zebu cattle (Bostaurus and Bosindicus ). Genetics 146, 1071-86. 9. Maijala K., 1982. Preliminary report of the working party on animal genetic resources in Europe. In Conservation of Animal Genetic Resources. Session 1. Commission of Animal Genetics, EAPP, G.I.@Leningrad. 10. Nivsarkar, A.E., Gupta, S.C., Vij, P.K. and Sahai R. 1994. Identification and conservation of endangered breeds of livestock- strategies and approach. Proceedings of the National Symposium on Livestock Production and Management held at GujaratAgriculturalUniversity, Anand, 21 to 23 February 1994. 11. Nivsarkar A E, Vij P K, Tantia M S (2000). Strategies for conservation. In Animal Genetic Resources of India Cattle and Buffalo. pp 318-333, ICAR, India 12. Simak E. 1991. The conservation of rare breeds in West Germany. In Genetic Conservation of Domestic Livestock. (Ed.) Lawrence Alderson. Pp. 65-69. CAB International, London. 13. Smith, C. 1984. Economic benefits of conserving animal genetic resources. Animal Genetic Resources Information. 3: 10-14.

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Commercialization and Technology Transfer Issues faced by R & D Organization Y.S. Rajput Emeritus Scientist, National Dairy Research Institute, Karnal

Most of R & D Organizations in India are funded by Government of India. Culture of commercialization of technology in Govt. R & D organization is new to the system. Whenever transition from occurs from existing system to new system, issues are bound to be there or generated. These issues must be fully understood to arrive at meaningful solution. Most of issues might be common to all technologies while some issues could be technology specific. Technology transfer on commercial lines in ICAR is new to the system and issues cropped up during technology transfer are discussed here.

Exclusive or Non-exclusive terms in technology transfer- This clause is essential to understand because it will have far reaching consequences. Exclusive means that technology will not be sold to other than licensee who has been given this right by licensor. If this licensee does not bring the technology to market, technology will be killed. It is not in interest of neither ICAR nor inventor that technology generated from public fund is killed. The way out could be to agree for conditional exclusiveness. For example, exclusiveness can be considered for limited period say for two to five years and this will allow sale of technology after expiry of exclusive period. A further safe guard can also be introduced by incorporating clause which states that in case technology does not come to market within defined period, exclusiveness will be converted into non-exclusiveness. To elaborative it further, if purchaser demands exclusiveness for five years, a clause can be added to bring it to market within two years of transfer of knowhow document and technology failing which remaining exclusive period will be converted into non-exclusive period. ICAR advises to promote technology transfer on non-exclusiveness. Exclusiveness is to be considered only when purchaser insists for it and is prepared to pay reasonable and attractive license fees which can be negotiated from case to case basis.

Royalty Clause- It is a fact that realization of royalty is not easy. In most of situation, royalty is partly realized. It does not mean that royalty can never be fully realised. Technology management committee at Institute level must apply their mind and wisdom to go for royalty or not. If technology has firm market potential and inventors feel that generated technology will last long and will not become obsolete, royalty clause must be insisted. Royalty must be calculated on sale price of product, not on net profit because such clause is prone to different interpretation and royalty value can be reduced or denied. Royalty clause also puts pressure on inventor to fully cooperative and helps the purchaser in removing technical hurdles in scaling up technology. Royalty value is usually defined in percent terms of sale price. Royalty realization also helps in knowing that technology has really reached to market.

Ownership Issues- Ownership issues may also crop up at times. One can sale technology if it is owned. The best way to establish ownership is by filing patent which covers technology generated. After grant of patent, it must be maintained too. Inventors must record and maintain data record of invention to enable its use in case of dispute of ownership. In case 99

of invention carried out from supports from ICAR, ownership rests with ICAR. In ICAR institute, inventors assigns the technology to ICAR and by virtue of it, ownership of technology including patents rests with ICAR. Thus, all earnings from technology transfer belong to ICAR. However, ICAR has made internal arrangement to distribute benefit money to all stakeholders including inventors. One should be careful in signing agreement with other organization for technology transfer. All clauses of such agreement must be understood for all possible interpretation including ownership and patent rights. Ownership of microorganisms isolated in ICAR system is with ICAR and these must be deposited at approved facilities. Ownership of small improvement in technology by purchaser of technology must rest with ICAR and it should be clearly mentioned in agreement failing which licensor can be robbed of royalty.

Technology Performance Issue- Issues related to performance or non-performance of technology could be very serious. Even, discussion on it brings bad name to organization. Thus, technology claims should never be over-claimed. Technology claims should be precisely worded and communicated. It is advisable to communicate complete details under which technology performs. There may be list of do’s and do-not’s. Transfer of complete details of experimental conditions and material specificity required for technology may done at the time of know how transfer. If technology has been tested only in lab scale, it should be stated. Licensee may be advised if inventors foresee additional standardization or modification in scaling of technology. If technology uses micro-organisms, experimental conditions under which these micro-organisms are to maintained for retaining biological properties must be defined. Deferred Payment- It is not desirable to accept demand for deferred payment of license fees. If it is at all to be accepted, it must be against bank guarantee. Biodiversity Issues- If technology uses biological material covered in biodiversity act, it should be stated in agreement. Dispute Redressal- technology transfer agreement must contain dispute redressal system acceptable to both party to amicably resolve all disputes.

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Golden rice and lessons learnt Jayakumar S, Karan Veer Singh and Dr Reena Arora ICAR-National Bureau of Animal Genetic Resources Karnal -132001 (Haryana)

The widespread vitamin A deficiency in Africa and South-East Asia provided a motive to develop a rice variety which would contain high levels of beta-carotene, or pro-vitamin A. Swiss researchers Ingo Portrykus and Peter Beyer managed to develop such a rice variety with the help of transgenic technology, transforming the plant with genes from daffodil and a soil bacterium Erwinia uredovora (Ye et al. 2000). The production of beta-carotene resulted in yellow-orange rice grains, hence the name ‘Golden Rice’. However, much of the technology they needed to develop this beta-carotene producing rice was owned by universities and biotechnology companies. In fact, some 70 intellectual property rights from 32 different institutes and companies applied, although the extent to which these patents are actually blocking the development and commercialization differs depending on the country of release (Kryder et al. 2000). The access to all these proprietary elements seemed like a daunting and near impossible task, and for that reason the ownership of the project was transferred to the multinational seed and biotechnology company Syngenta. This company was able to negotiate humanitarian licences to all crucial elements of the technology. Six key-patent holders were approached, and an agreement was reached that allowed Potrykus to grant licences, free of charge, to developing countries, with the right to sub-license (Verbeure et al. 2006). Because of this result, the Golden Rice case is widely mentioned as an example of a successful way of dealing with ‘patent thickets’ (the combination of a large number of patents that apply on a technology). At the same time, the expected positive publicity of this model project is expected to have played a role in the willingness of patent holders to grant humanitarian licences. As a result of the increasing complexity of the intellectual property (IP) framework under which the international agricultural development community operates, the Rockefeller Foundation funded an ISAAA project to conduct a selective Freedom-To-Operate (FTO) analysis of Golden Rice with the objectives of a. reviewing the IP and Technical Property (TP; or tangible property) components associated with Golden Rice. b. providing institutions interested in distributing Golden Rice™ with the information needed to develop strategic options for handling the proprietary science embedded in the product; and c. developing possible alternative strategies on how the IP/TP constraints could be managed effectively. Any FTO opinion is a risk management opinion and its results vary on a country-by country basis. It is a dynamic opinion; never a definitive answer. FTO analysis contains information on ownership and statutory protection issues; it is not intended to be a final legal opinion. It also provides the relevant information to make sound policy and strategy decisions.

Technical Property At least fifteen TP components went into the three different genetic constructs; many of which were acquired by ETH-Zürich under Material Transfer Agreements or by use licenses.

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Some of this complexity stems from the product being a multi-transformant, in which three genes/enzymes (phytoene synthase, phytoene desaturase, and lycopene cyclase) were introduced in the carotenoid biosynthetic pathway.

Intellectual Property Depending on the country where the current form of GoldenRice would be used, it has been identified between zero and 44 patents which applied to the product. In the USA and most countries of the European Union, around 40 patents apply. In the 10 top rice producing countries, many fewer patents apply, namely: China (11), India (5), Indonesia (6), Bangladesh (0), Vietnam (9), Thailand (0), Myanmar (0), Japan (21), the Philippines (1) and Brazil (10). Similarly, in the top ten rice importing countries, relatively few patents apply: Iran (0), Brazil (10), Nigeria (0), the Philippines (1), Iraq (0), Saudi Arabia (0), Malaysia (0), South Africa (5), Japan (21) and Côte d’Ivoire (10). A total of 26 of the approximately 70 patents Identified, it contain primarily process claims thus reducing somewhat the number of applicable patents which could inhibit FTO in a given country. A detailed analysis on a country-by-country basis may reduce the complexity of the IP landscape. Transfer and use of Golden Rice, depending on the country in which it is to be deployed, would, at a minimum, require agreements from a dozen or so entities (public and private) for the TP transfer and use. In addition, again depending on the country of use, between zero and 40 licenses for IP rights would be required, from a dozen or so entities. In total, negotiations with 12 to 20 entities might be required, again depending on the country of release. If a regional or international organization, such as the International Rice Research Institute (IRRI), wishes to obtain FTO, say for national use in all developing countries in Asia, licenses for around 30-40 patents would need to be obtained (in addition to the resolution of TP). There are a series of tasks that should be completed in order to adequately manage the IP/TP. These are: 1. Complete and regularly update the present FTO analysis, preferably on a country-bycountry basis. 2. Develop a scientific strategic plan (who manages, what is to be done, which biotech and germplasm components are to be used, where is the research to be done, who is to do the research, what are the timelines for completion) for finalizing the current scientific initiative. 3. Draft and negotiate a strategic plan for distribution (who manages, what must be licensed, list of licensors/licensees, acceptable terms, timelines) of the finished product(s). Complete a cost/benefit analysis for the preferred options. It will be for the developing countries, which wish to benefit from Golden Rice and for the organizations whose mandate is to assist these countries to make choices on the best options to follow. The dominating consideration must be the impact of Golden Rice on the health and well-being of rice producing and consuming populations. These and related factors will condition the speed and configuration of the eventual broad release of Golden Rice. National Agricultural Research Services, once they obtain access to Golden Rice, may still wish to conduct their own FTO review in order to confirm which IP issues and TP issues are covered in their country. This is particularly true if the recipient country foresees an export market for its Golden Rice. Additionally, any country to which they export their Golden Rice will likely present a different IP/ TP landscape. It is essential that a strategic plan be developed by any entity wishing to develop and disseminate the product in light of an extensive cost/benefit analysis and list of alternative strategies. Resolving the IP and TP issues still provides a formidable challenge to the

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ultimate release of Golden Rice. Sound planning and resolution of the IP/TT issues will contribute to a timely release of Golden rice and future essential products for the benefit of all people.

Lessons learnt from golden rice The rapid resolution of the IP constraints surrounding Golden Rice demonstrated, first of all, how effective IP management, coupled with strong collaborations between the public and private sectors, can help achieve global access to new technologies and products for humanitarian goals. More specifically, three specific lessons have been learned: 1. Intellectual property and patents did not delay the development and introduction of Golden Rice by a single day. Notwithstanding this, the resolution of the potential IP constraints could not be ignored. 2. Other constraints are much more critical to the introduction of Golden Rice, in particular, and to potentially life-saving food biotechnology applications, in general. These constraints are, in decreasing order of importance: the necessity of governments to establish a sustained and positive policy priority for the adoption of all relevant, including novel, technologies in agriculture the importance of the establishment of affordable, workable, and science-based regulatory systems designed to comply with international obligations and to address local needs and concerns (The unnecessarily burdensome, overly politicized regulatory requirements for genetically modified organisms [GMOs] and the absence of consideration of benefit has led to years of delay in the introduction of Golden Rice technology. Yet there is no evidence to justify such a burdensome regulatory system.) The need for the capacity and funding of national agricultural rice research institutions to keep segregated different versions of genetically modified crops, including conducting field trials with them the anticipated need to develop effective seed distribution systems for reaching farmers in remote areas, including the presence of private sector entities willing to invest in seed distribution systems (However, a major aim is also to have farmers pass the seed on to neighboring farmers to reach “infrastructure remote” areas often associated with VAD.) 3. Recognizing that universities are not set up to develop products, Syngenta was instrumental in converting the proof-of-concept results generated at ETH Zurich and University of Freiburg into deliverable products. Although Syngenta retained commercial exclusivity for the technology, the company decided not to develop a commercial product of Golden Rice for markets in developed countries. Syngenta’s continued support of the project with advice and scientific know-how has proven absolutely essential for the success of the product-development partnership. From a broader perspective, the FTO review of Golden Rice, in particular before “commercial analysis,” served as a wake-up call to the public sector to pay more attention to IP management as a powerful tool for meeting public sector goals. Concern about potential constraints on public sector research and innovation in agriculture spurred the public sector’s interest in intellectual property. One important response was work that led to the formation of the Public Intellectual Property Resource for Agriculture (PIPRA). PIPRA is a public sector initiative that recognizes that continuing and enhancing relationships with the private sector, and between the public sector institutions, are critical components of the utilization of intellectual property to meet public sector goals. As part of its initial work, PIPRA began a study of the structure of IP ownership in agricultural biotechnology. This

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study found that roughly one-fourth of the patented inventions were made by public-sector researchers, which is substantially larger than the IP portfolio held by any single agricultural biotechnology company. It is, however, highly fragmented across institutions and across technology categories. And much of this IP has been licensed, often under terms that are confidential but which have likely resulted in greatly restricted access to the underlying technologies. The study suggested that, apart from a few important exceptions, public- sector scientists have invented many of the types of technologies that are necessary to conduct basic biological research and develop new transgenic plant varieties. For instance, they have developed technologies to transfer genes into plant cells; have characterized specific DNA elements that drive unique patterns of gene expression; and have identified many genes that confer important plant traits. Such discoveries underscore the fact that public-sector research institutions have been significant sources of technological innovation.

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