Ipr

Ipr in agriculture

1. K.SAI SANTHOSH RAM/13-50 SEED SCIENCE & TECHNOLOGY welcome

2. 2 property Land and building Gold and cash Intellectual Trade

3. IPR

4. It is property that you can’t see. It is not real property (land) or personal property (things). It is property that can only be perceived by the intellect. Like Real Property: It can be bought, sold, licensed, exchanged, given away. The owner can prevent unauthorized use. Not simply knowledge or discovery. A range of property rights accorded to “ creations of the mind”. Intellectual activity resulting from the industrial, scientific, literary or artistic fields. 4 What is intellectual property?

5. Intellectual Property Rights IPRs refers to “the legal ownership of by a person or business of an invention/ discovery attached to a particular product/ process which protects the owner against unauthorized copying or limitation.” 5 Introduction

6. Basic objectives of balanced IP Protection- To Acknowledge & appreciate the creative expression. Empower creative persons. Promote innovation through exclusive rights . Public disclosure to expand knowledge stock. Support for markets in technology. Support diffusion and incremental innovation. Technology specialists can induce the larger firms to license as well. 6 The Role of IPRs

7. Copyright Patents Plant breeder’s rights(PBR) Trade secrets Other IPs Geographical Indications Trade marks Industrial Designs Integrated Circuits Plant Varieties protection 7 Protection forms of Intellectual Property

8. Nature of IP. Pace of Technology D evelopment. Associated Costs. Security Considerations. Need to show Inventions Duration of Protection. The Type of Protection S ought. Choice of IPR protection

9. Definition: The bundle of exclusive rights granted to the authors/creators of original works of expression that are fixed into a tangible medium Exclusive Rights: Right to reproduce Right to make derivative works Right to distribute Right to publicly display and perform Right to perform sound recordings publicly by means of digital audio transmissions 9 Copyright Basics

10. EXAMPLES: 1.Authored and edited books. 2.Audio and Video Cassettes. 3.In Biotechnology the Copyright may cover DNA sequence data that may be published Computer software has been included under the (Information T echnology A ct 2000)

11. The copy right is limited both in time and extent. Does not prevent another person from using either idea or the information contained in a copyright material. Disadvantages of copyright

12. Any word, symbol or device (or combination) that differentiates a company or individual’s products and services from competitors. Symbol helps the consumer to identify products of a particular company. Mark must be used in connection with public distribution of goods or services to secure legal rights. Marks is the symbol is directly related to the company. 12 Trademark definition

13. The possibilities are almost limitless. Trademarks may be one or a combination of words, letters, and numbers. They may consist of drawings, symbols, three-dimensional signs such as the shape and packaging of goods, audible signs or colors used as distinguishing features. 14 What kinds of trademarks can be registered ?

14. An exclusive right given to an inventor by the government to exclude others from imitating, manufacturing, using or selling the invention in question for commercial use for specified time. There are three kinds of patents: A utility patent on the functional aspects of products and processes ; A design patent on the ornamental design of useful objects ; A plant patent on a new variety of a living plant. Patents do not protect idea, structures and methods that apply technological concepts. 15 Patent

15. 1856 Act for protection of inventions on the basis of British law of 1852 1859 Patent monopolies called exclusive privileges (14 year) 1872 Patents and Designs Act 1883 Protection of Inventions Act 1888 Inventions and Designs Act 1911-1947 Modern patent era by Patents and Designs Act. First time an authority call Controller General of Patents appointed 1959 Justice Ayyangar’s report 1967 Patent Act bill introduced in the Parliament 1970 The Patents Act passed by the parliament 1972 The Patents Act-1970 came into force on April 20, 1972 1994 Amendment by ordinance to include Exclusive Marketing Rights (EMR’s) 1999 Amendment passed by the parliament. New patent amendment bill referred to select committee 2003 Patents Act 1970 with second amendment comes into force 2005 Patent Act 1970 (2005 Amendment) comes in to force from 1-1-2005 HISTORY OF PATENT ACTS IN INDIA 16

16. Novelty. Inventiveness. Industrial application and usefulness. Patentability. Disclosure. Patent requirements

17. Exclude others from making, using or selling the patented invention for up to 20 years. may be licensed or sold. does not prohibit non-commercial research. In return for full public disclosure of invention (when filed) and contribution to public domain at expiry of patent term. 18 Rights of Patent Owners

18. Rewards time, money & effort associated with research. Stimulates further research as competitors invent alternatives. Encourages innovation and research by permitting companies to recover R&D costs during period of exclusive rights. Limited term encourages quick commercialization. Patents allow early exchange of information between research groups. Avoiding duplicate efforts. Increasing general pool of public information. 19 Benefits of Patent System

19. Limitation of time Limitation of space. Limits of A Patent

20. Usually the biotechnology applications comprise the claims relating to the following subject matters: ( a ) Polynucleotides or gene sequences (product and/or process), (b) Polypeptides or protein sequences (product and/or process), (c) Vectors (e.g., plasmids) (product and/or process), (d) Gene constructs or cassettes and gene libraries, (e) Host cells, microorganisms and stem cells (product and/or process), transgenic cells, (f) Plants and animals tissue culture (product and/or process) CLAIMS OF BIOTECHNOLOGICAL INVENTIONS 21

21. (g) Pharmaceutical or vaccine compositions comprising microorganisms, proteins, polynucleotides (product and/or process), (h) Antibodies or antigen binding fragments thereof (monoclonal or polyclonal), ( i ) Diagnostic kits and tests, and (j) Diagnostic tests (products/process) such as a test for the detection of a mutation in a gene/protein which might be associated with a particular condition such as protein expression or a disease.

22. Patenting Biotechnological Inventions Are biotechnological inventions patentable ? New / novel Inventive step Industrial application Law of the land (non patentable inventions - Morality) Written Disclosure + Special disclosure requirement Deposit of Biological Materials 23

23. Biological material isolated from its natural environment or human body or produced by a technical process The industrial application / function of a genetic material ( eg : sequence or a partial sequence of a gene) must be disclosed in the patent application 24 Patentable biotechnological invent ions

24. 25 Patents in Biotechnology

25. In US, there are three forms of protections for plant related inventions. These are Utility patents, Plant patent act(PPA), Plant variety protection act(PVPA) Patenting of plant related inventions

26. But under section 3(j) of Indian patents act 1970 plants are not considered patentable subject matter under section3(h) of the act, and method of agriculture and horticulture are not patentable. Similarly, essentially biological processes for the production or propagation of plants or not patentable under section 3(j) Plant varieties may be protected in India under PPVFRA which has recently came into force.

27. S.No PATENT NUMBER TITLE 1 US5,024,944 Transformation, somatic embryogenesis and whole plant regeneration method for glycine species 2 US5,986,181 Transformation and regeneration of fertile cotton plants 3 EP910239 Transformation of cotton explant with Agrobacterium 4 WO0042207 Transformation of a soybean germline with Agrobacterium Patents related to transformation of dicot plants

28. S.No PATENT NUMBER TITLE 1 US6,720,488 Transgenic maize seed and method for controlling insect pests 2 WO05096806 Edible vaccine in the form of rice 3 AU3402897 Transformation of wheat with Agrobacterium 4 AU7134298 Transformation of sorghum with agrobacterium /pioneer hi-bred Patents related to transformation of monocot plants

29. PATENT AWARDED TO SUBJECT OF PATENT W.R. Grace and Co. All transgenic cotton DNA plant Technology All transgenic pepper Enzo Biochem , Inc. Antisense RNA Technology Mycogen Corp. Any method of modifying the cry gene of B. thuringiensis

30. r –DNA technology Micro organisms Vaccines Polymerase chain reaction (PCR) DNA/RNA and protein sequences DNA sequencing methods Hybridoma technology Stem cell technology Plant tissue culture Genetically modified plants and animals Cloning of animals, such as dolly and many more Patenting areas in Biotechnology :

31. Method of transforming cells or complete biological entity such as microbes, plants are animals. Methods of cloning and expression of desired genes in the same or different cells. Method of optimizing gene expression to produce useful therapeutic proteins. Method of producing transgenic plants or animals. Method of screening and detection of specific DNA sequnces. Method of designing probes, primers, recombinant vectors.   Patentable processes involving in r-DNA technology:

32. Different cloning vehicles (vectors) such as plasmids, cosmids, phagemids, etc. Probes, primers and oligonucleotides. Vaccines and other useful proteins. Transgenic / genetically modified organisms. Patentable products involving r-DNA technology

33. A gene is a structural unit of inheritance in living organisms. For patenting of DNA/RNA sequences the following steps should be undertaken: 1.I dentify novel genetic sequences. 2. Specify the resulting product from the sequence. 3. Specify how product functions in nature( use ). 4. Enable one skilled in the field to use the sequence for its stated purpose.   Patenting of DNA/RNA sequences:

34. DNA sequence cDNA sequence Expressed sequence tag (EST) Single nucleotide polymorphism. (note: meet the above mentioned criteria of patentability) The patenting of genes and/or DNA sequences is popular in the US and EU. In india , no product patent protection of DNA/RNA or genes per se was allowed till January 2005. Patentable things:

35. This is an important area of research in plants. Patentable things under this category are Transformation techniques Regeneration protocols Explants Transformation vectors Selectable marker genes Reporter genes Promoters and enhancers Genetically modified plants Tissue culture techniques and genetic transformation of plants:

36. Patents in the area of biotechnology have beciome very important in recent years. The basic criteria for patentability are three fold: Novelty Inventiveness Industrial appilication. Patents of microorganisms , genes, genetically modified plants and animal have generated a lot of debate in many countries. The latest amendment has mandated india to grant product patents for genes, drugs, and microorganisms, and most of the other biotechnological inventions. Regarding protection of plant varieties, I ndia choose to opt for the sui generis system for protection of plants and plant varieties by enacting the protection of plant varieties and farmers right act 2001(PPVFRA). Conclusion:

37. PPVFRA may be granted for plant varieties which have N ovelty and exhibit the characteristics of distinctiveness , uniformity , stability . ( DUS ) This PPVFRA act recognizes farmers as Innovators Conservers Breeders Preservers cultivators of plants and plant varieties.

38. Headquarters : Geneva UPOV : 54 Member countries Conventions : 1961,1972,1978,1991 The concept of breeders rights, researchers exemption and farmers privileges Successive changes in UPOV made it more in favour of breeders/ companies Technical guidelines developed for 200 species International Union for the Protection of New Varieties of Plants (UPOV)

39. Passed by Lok Sabha on 9 th August, 2001 Passed by Rajya Sabha on 28 th October, 2001 Assented by the President of India on 30 th October, 2001 Act no. 53 of 2001 The Protection of Plant PPV&FR Varieties and Farmers’ Rights Rules, 2003 The Protection of Plant Varieties and Farmers’ Rights Act 2001

40. Major spheres of activity of PPV&FR Act, 2001

41. To provide for the establishment of an effective system for the protection of plant varieties, the rights of farmers and plant breeders and to encourage the development of new varieties of plants; Protection of farmers rights : With respect of their contribution made at any time in conserving, improving and making available plant genetic resources for the development of new plant varieties; Protection of Plant Breeders rights : To stimulate investment for research and development both in public and private sector for the development of new plant varieties for accelerated agricultural development. PPV&FR Act 2001

42. Registration Voluntary & to be allowed for: Plant Breeder’s Variety Extant Variety Farmer’s Variety Plant Breeder’s Variety to satisfy the NDUS conditions Extant Variety & Farmer’s Variety to satisfy only DUS conditions Allows Researchers exemptions and Breeders rights Essentially Derived Varieties registration requires specific approval Allows elaborate farmers’ rights Period of protection : 15 years for annuals, 18 years for trees & vines Registration of Plant Varieties

43. Regulatory framework PPV&FR Authority www.plantauthority.gov.in Gazette notification on 11 th Nov. 2005 Mandate Registration of plant varieties Characterization and documentation of registered varieties Documentation, indexing and cataloguing of farmer’s varieties Providing compulsory cataloguing facility for all plant varieties Ensuring that seeds of all registered varieties are made available to farmers Collection of comprehensive statistics on plant varieties, Maintenance of National register of Plant variety.

44. Breeders rights Act shall confer an exclusive right on the breeder or his successor, his agent or licensee to produce, sell, market, distribute, import or export the variety. Researchers exemptions Any variety registered under this act will be allowed for conducting experiments or research and using it as an initial source for creating other varieties. Breeders and Researchers Rights

45. Plant breeders rights are the rights granted by the government to a plant breeder, originator of a variety to exclude others from producing or commercializing the propagating material of that variety for a minimum period of 15-20 years. PBR

46. 1.The opportunity to breeders of obtaining profits from varieties developed by them will act as an incentive in promoting plant breeder research. 2. It encourages private companies to invest in plant breeding activities. 3.It will enable access to varieties developed in other countries and protected by IPR laws. 4.Inceased competition among various organizations engaged in plant breeding is likely to be beneficial to both the farmers and the nation. Benefits from PBR

47. PBR will encourage monopolies in genetic material for specific traits. It suppresses free exchange of genetic material and may encourage unhealthy practices. The holder of PBR may produce less seed than the demand in order to increase prices for achieving more profit. Farmers privilege to resow the seed produced by him may become diluted/eliminated. PBR may increase cost of seed which will burden to the poor farmers of India and would limit the benefits from new varieties. Disadvantages from PBR

48. 1.Right to register traditional varieties. 2.Right to sell seed. 3.Right to reward and recognition. 4.Protection against innocent infringement . 5.Right to information. 6.Benefit sharing for use of biodiversity conserved by farming community. Farmers Rights

49. Trade secret is any information that gives a company a competitive edge over competitors and which the company maintains a secrete and away from public knowledge EXAMPLES: 1.Coco Cola company brand syrup formula. 2.polaroid company instant film chemical formula . 3.KFC. TRADE SECRET

50. They are for unlimited duration . It is not necessary to satisfy the rather stringent requirements for protection under patents. The cost of filling, contesting and enforcing patents is saved. The risk of someone improving upon the product, process, etc. is minimised . Advantages

51. Indications which could be used to recognize that a good has originated in a particular locality where the given quality reputation of the good are essentially attribute to its geographical origin. EXAMPLES: 1.Scotch whisky, 2.California wines, 3.Tuscany Olive oil, 4. C hampagne. GEOGRAPHICAL INDICATIONS

52. The term “Geographical indications” signifies that a product originates in a country or specific locality where it has been traditionally produced GIs are defined as “a good originating in the territory of a member or a region or locality in that territory where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin” Most GIs relate to agricultural products or those derived from them. Handicraft products specific to a region are also registered under GI Act, 1999.

53. AGRICULTURE RELATED REGISTERED GIs S.no Name of the product State 1. Basmati Rice India 2. Darjeeling Tea (word and Logo) West Bengal 3. Kangra Tea Himachal Pradesh 4. Malabar Pepper Kerala 5. Alleppey Green cardamom Kerala 6. Pokkali Rice Kerala 7. Mango Malihabadi Dussheri Uttar Pradesh 8. Guntur Sannam Chilli Andhra Pradesh 9. Mahabaleshwar Strawberry Maharashtra 10. Madurai Malli Tamil Nadu 11. Udupi Mattu Gulla Brinjal Karnataka

54. S.No Name of the product State 1. Tirupathi Laddoo Andhra Pradesh 2. Bikaneri Bhujia Rajasthan 3. Pochampalli sarees Andhra Pradesh 4. Gadwal sarees Andhra Pradesh 5. Mysore sandal soap and oil Karnataka 6. Phulkari handicraft Punjab, Rajasthan and Haryana 7. Champagne France

55. Basmati Rice Muga silk - Assam Kolhapuri Chappals - Maharashtra Thanjavur Veena – Tamil Nadu Chambal Rumal – HP and Jammu

56. Armagh Apples - Ireland Kampot Pepper - Cambodia

57. Prior to 1999, there was no specific legislation to regulate geographic indication. In 1999, India in compliance with TRIPS (Trade related aspects of Intellectual Property Rights) enacted the GI Act Geographical Indication of Goods (Registration and Protection) Act, 1999.

58. Registration of GIs is for a period of 10 years or for a period till the date on which the registration of geographical indication of authorized users expires, whichever is earlier.

59. Provides for registration and better protection for GIs relating to goods. Provides for registration and better protection for GIs relating to goods. Provides for registration and better protection for GIs relating to goods .

60. In September 1997 a USA company RiceTec Inc. was granted U.S. on "basmati rice lines and grains." The company entered international basmati market with brands like “ Kasmati and Texmati ”. RiceTec Inc., owned by Prince Hans-Adam of Liechtenstein, faced international outrage over allegations of  biopiracy . BASMATI RICE – A CASE STUDY

61. Two Indian Non Governmental Oragnisations (Centre for Food Safety and Research Foundation for Science, Technology and Ecology with support from Centre for Scientific and Industrial Research (CSIR) filed a legal petition in the United States. The Indian Govt. challenged the patent officially in June 2000.

62. The United States Patent and Trademark Office reviewed the situation. RiceTec Inc. lost the case and withdrew most of the claims of the patent, including, most importantly, the right to call their rice lines "basmati. A more limited varietal patent was granted to RiceTec in 2001 on claims dealing with three strains of the company’s rice lines.

63. Turmeric: The CSIR (Council of Scientific and Industrial Research , India) asked for a re- examination of the US Patent no. 5 401 504 which was granted for the wound healing properties of turmeric. In a landmark decision, the United States Patent and Trademark Office (USPTO) revoked this patent after ascertaining that there was no novelty, the innovation had been used in India for centuries 64 INTERNATIONAL DEVELOPMENTS IN IP : EXAMPLES FROM INDIA

64. 1.IPR has encouraged monopolies; many take overs have been motivated by access to an IPR. 2.The IPR situations in many cases is quite complicated. 3.It is perceived by many as a threat to food security. 4.It may be detrimental to the livelihood of the poor in developing countries. PROBLEMS FROM IPR

65. Present Scenario: Current IP regime in India IP protection form Product Legislation Patent Agrochemicals, machinery, PHT ,novel gene, processes IPA,1970;1999;2002;2005 New variety/extant variety/farmers variety distinct, uniform, stable plant grouping PPVP&FR Act 2001 GI Products of specific territorial origin GI Act 1999 TD/TM/TS/copyright Agrochemicals, machinery, PHT, software All Acts in place Community rights Genetic resources, TK Biodiversity Act, 2002 66

66. Biotechnology in India 67

67. THANK YOU