Analysis of indian patent regime in the present biotechnology boom

... making, using, offering for sale, selling or importing for these purposes the patented product This is in conformity with Article 28(1)(a) of the TRIPS Agreement In the case of the grant of a patent. .. from being destroyed by fungal infections The Indian government filed a complaint in the USPTO accusing W.R Grace of copying an Indian invention A complaint was also made to European Patent Office73... the drug controller, and in case the medicine is to be administered orally, the food department 16 The “exclusive privileges” included the rights of making, selling, licensing and using the invention

TABLE OF CONTENTS

TABLE OF CONTENTS 1

SUMMARY 3

TABLE OF CASES 4

CHAPTER I: AN OVERVIEW OF TRADITIONAL KNOWLEDGE AND INTELLECTUAL PROPERTY RIGHTS 6

1.1 I NTRODUCTION 6

1.3 B IOPIRACY 24

1.3.1 Case Study: Turmeric 27

1.3.2 Case Study: Neem 28

1.3.3 Case Study: Basmati 31

1.4 A PPLICATION OF C ONVENTIONAL IPR S ON TRADITIONAL KNOWLEDGE 36

1.4.1 Patents, TRIPS and traditional knowledge 37

1.4.2 Other forms of IPRs and traditional knowledge 46

1.5 S OCIAL IMPACT OF PATENTING TRADITIONAL KNOWLEDGE 49

1.6 P ROTECTION 52

1.6.1 Methods of Protection 57

CHAPTER II: DEFENSIVE PROTECTION OF TRADITIONAL KNOWLEDGE 60

2.1 I NTRODUCTION 60

2.2 P RIOR A RT 61

2.2.1 The legal position 62

2.2.2 Recommendations and Conclusion 68

2.3 D ATABASES 73

2.3.1 Legal Protection of Databases 76

2.3.2 Endeavours in India 89

2.3.3 Advantages of traditional knowledge databases 93

2.3.4 Criticism of the traditional knowledge databases 93

2.3.5 Recommendations 97

2.3.6 Conclusion 100

2.4 C OMPULSORY D ISCLOSURE OF O RIGIN 103

2.4.1 Challenges in Disclosure of Origin 113

2.4.2 Conclusion 116

2.5 P RIOR I NFORMED C ONSENT 117

2.5.1 Challenges in obtaining PIC 124

2.5.2 Case Study: The Jeevani experience 125

2.5.3 Recommendations and conclusion 127

2.6 C ONCLUSION 129

CHAPTER III: POSITIVE PROTECTION OF TRADITIONAL KNOWLEDGE 131

3.1 I NTRODUCTION 131

3.2 S UI GENERIS RIGHTS 131

3.2.1 Sui Generis protection systems-legal sanctions 137

3.2.2 Geographical Indications (GI) 144

3.2.3 Other sui generis Indian Acts 149

3.2.4 Recommendations and Conclusion 160

3.3 A CCESS AND B ENEFIT S HARING (ABS) 163

3.3.1 The Bonn Guidelines 164

3.3.2 Relevant provisions in other Indian Legislation 167

3.3.3 Indian benefit sharing instance 169

3.3.4 Suggestions and conclusion 170

3.4 G LOBAL B IOCOLLECTING S OCIETY (GBS) 172

3.4.1 GBS in India 177

3.4.2 Conclusion 180

3.5 C ONCLUSION 181

CHAPTER IV: PATENTABILITY OF MODERN BIOTECHNOLOGY INVENTIONS IN INDIA 183

4.1 I NTRODUCTION 183

4.1.1 Classification of modern biotechnology 185

4.2 D IAMOND V C HAKRABARTY 188

4.3 R ELAXIN 193

4.4 O NCOMOUSE 196

4.5 E THICAL ISSUES OF BIOTECHNOLOGY PATENTING IN I NDIA 202

4.5.1 India and Article 27(3)(b) 203

4.6 I NDIA ’ S PATENT POLICY PRIOR TO TRIPS AND SUBSEQUENT DRIVERS FOR CHANGE 210

4.7 P ATENT (A MENDMENT ) A CT 2005 218

CHAPTER V: CONCLUDING OBSERVATIONS 224

BIBLIOGRAPHY 232

Summary

The Truman declaration divided the world into the “developed” and

“underdeveloped” Save those living in USA, Europe, Japan and few other countries, most human beings became citizens of the Underdeveloped World as the wholesale march towards development, Western style, became the mantra for progress that was almost entirely indifferent to nature The ensuing large-scale environmental disorders have brought this Baconian model of growth and development to the brink It has also provided a fresh opportunity for traditional knowledge, culture and wisdom to come

to the forefront of decision-making by consumer sectors India, with its rich repertoire

of such a traditional knowledge base, has a definite edge while preparing its own roadmap for sustainable development and poverty alleviation Wizening from biopiracy episodes and for promoting investment in biotechnology, the Indian government has spruced up the patent legislation The instant thesis highlights the efficacy of the methods of protecting traditional knowledge and analyses the new provisions introduced in Indian statute laws for preservation and promotion of traditional technology and encouragement for investment in modern biotechnology It

is seen that while there has been movement in enactment of legislation, there are latches and ambiguities which need to be clarified The problems of unclear definitions, overlapping and sometimes contradictory provisions in the new laws, when rectified, would lead to stronger protection for traditional knowledge and genetic resources, and a generally more robust patent regime in India

TABLE OF CASES

Bellsouth Advertising & Publishing Corp v Donnelly Information

Publishing Inc and another 999 F2d 1436 (11th Cir 1993) 1445

Burlington Home Shopping v Rajnish Chibber 1995 PTC (15) 278 84

Catnic Components Ltd and Another v Hill & Smith Ltd [1982] RPC

183

70

CCH Canadian Ltd v Law Society of Upper Canada [2004] S.C.C 13 85

Commissioner of Patents v President and Fellows of Harvard College

and Ors 2002 SCC 76

187,196

Dimminaco AG v Controller of Patents and Designs & Others,(Aid

No.1 of 2002)

191,205

Eastern Book Company v Navin J Desai A.I.R 2001 Delhi 185 85,102

Feist Publications v Rural Telephone Service 499 US 340, 113 L Ed 2d

Himalaya Drug Company v Sumit Suit No.S-1719 of 2000 88,102

Improver Corporation v Remington Consumer Products Ltd [1990] FSR

Lallubhai Chakubhai v Chimanlal & Co (1935) A.I.R 1936 Bombay 99 65

Matthew Binder & Co v West Publishing Co (158 F.3d 674, 48

U.S.P.Q 2d (BNA) 1560 (2d Cir 1998); 158 F 3d 693, 48 U.S.P.Q 2d

(BNA) 1545 (Cir.1998)

77

Merck & Co Inc v Pharmaforte Singapore Pte Ltd, [2000] 3 SLR 717 70

Merrell Dow Pharmaceuticals Inc.v H N Norton & Co [1996] R.P.C

Moore v Regents of the University of California 793 P.2d 479 204

Mother's Restaurant v Mother's Other Kitchen, Inc., 218 U.S.P.Q 1046

(TTAB 1983)

33

Plant Genetic Systems/Glutamine Synthetase Inhibitors (T356/93) [1995]

E.P.O.R 357

203

P.L.G Research Ltd v Ardon International Ltd [1993] F.S.R 197 64

Scotch Whiskey Association v Pravara Sakhar Shakar Karkhana Ltd

University of London Press v University Tutorial Press [1916] 2 Ch 601 81

Warren Publishing Inc v Microdos Data Corp and others (522 US 963

(1997))

77

V.Govindan v E.M.Gopalakrishna and Anr AIR 1955 Madras 391 84

CHAPTER I: AN OVERVIEW OF TRADITIONAL KNOWLEDGE AND INTELLECTUAL PROPERTY RIGHTS

1.1 INTRODUCTION

The Egyptian rulers, during their imperial expeditions were known to bring back exotic foliage from different nations with them One of the earliest recorded plant hunting expeditions took place 5000 years ago when Pharaoh Sankhkara sent ships to Gulf of Aden to collect cinnamon and cassia used for embalming the dead.1 The recent years witnessed a different form of trade in foliage and genetic material Farnsworth, the distinguished pharmacognosist, indicated that in 1980 a quarter of the prescriptions dispensed from community pharmacies in the United States2 contained active principles from the higher plants.3 Rapid growth of new technologies in genetic engineering and biotechnology has led to an increased commercial interest in the wealth of biological resources and the traditional knowledge of developing nations

India has been one of the world’s biologically and culturally diverse countries.4 India

is also one of the most advanced developing countries in terms of scientific capabilities, including the life sciences.5 She is the only developing country to appear

1 JUMA CALESTOUS, THE GENE HUNTERS: BIOTECHNOLOGY AND THE SCRAMBLE FOR

SEED, (1989) 38

2 Hereinafter referred to as US

3 N.R FARNSWORTH, Pharmaceutical Technology, (August 1995) 14

4 India is one of the 12-mega diverse countries of the world With only 2.5% of the land area, India already accounts for 7.8% of the global recorded species India is also rich in traditional and indigenous knowledge, both coded and informal See, National Biodiversity Authority website at

< http://www.nbaindia.org> (last accessed on 5 July 2005)

5 According to Lall, India had 869,000 tertiary-level students of natural sciences in 1990 S LALL,

Technological Change and Industrialization in the Asian Newly Industrializing Economies:

EXPERIENCES OF NEWLY INDUSTRIALIZING ECONOMIES: ACHIEVEMENTS AND CHALLENGES (L Kim & R Nelson eds., 1990) 13-68 at 44

in a survey of top ten countries for industrial literature citations.6 Although India has developed research capabilities in a broad range of biotechnologies and biotechnology applications,7 awareness about intellectual property rights has historically been poor

in India

The developed countries have complained that intellectual property rights8 protection

is weak in India, thereby deterring them from investing in research there.9 However, the last decade has been the era of activity in the field of intellectual property rights in the country After the ratification of the Agreement on Trade Related Aspects of Intellectual Property Rights,10 there have been three amendments to the Indian Patent Act of 1970 In a bid to protect the vast traditional knowledge and related genetic resources, provisions have been introduced in the Indian Patent Act, and further Acts

8 Hereinafter also referred to as IPR / IPRs

9 The Indian press had highlighted the findings of the recent World Bank Development Report, which claims that "at least 25 per cent of global chemical and pharmaceutical companies are unwilling to invest in India as the protection offered to intellectual property rights (IPR) by New Delhi is too inadequate to allow them to transfer the latest and effective technologies."

Source: The Hindu Business Line, Mumbai, October 5, 1998, 9

10 Agreement on Trade Related Aspects of Intellectual Property Rights (hereinafter referred to as TRIPS ): The final round of the multilateral trade negotiations which had commenced at Uruguay culminated

at the Marrakesh Ministerial held at Marrakesh, Morocco in December 1993 with the establishment of the World Trade Organization (WTO) To standardize the IPR regimes, the members of the WTO signed the multilateral agreement Trade-Related Aspects of Intellectual Property Rights (TRIPS) in the same ministerial The TRIPS aimed to achieve a global intellectual property rights regime through the following methods: -the broadening of existing rights; -the creation of new (sui generis) rights;-the progressive standardization of the basic features of IPR TRIPS efforts toward harmonizing the IP regimes in the member states are evident through its various articles By Article 3, the members accepted the principle of ‘National Treatment’ whereby each member state is required to provide similar IP protection to the right holders irrespective of their nationality Article 4 lays down the ‘Most Favoured Nation’ principle whereby any favour or concession granted by a state to any other state should be extended to all the other member states of the WTO It is presently the most relevant treaty

on global IPR regimes A detailed discussion is available inter alias at Chapter IV

have been legislated The present thesis is a study of the current patent scenario in India

The major concern India has shared with some of the biodiverse developing nations is the protection of traditional knowledge Not only are these issues of concerns within hard intellectual property law, but also raise important development and social issues

as Convention on Biological Diversity demonstrates In Chapter I of the thesis, definitions and classifications of traditional knowledge have been stated Subsequently instances of disputes regarding unauthorized exploitation of genetic resources and associated traditional knowledge have been discussed This is followed

by a comprehensive study of the impact of patenting traditional knowledge; the suitability of standard intellectual property11 laws to protect traditional knowledge and positive and defensive methods of protecting traditional knowledge

Chapter II begins with an analysis of the problems of having a non uniform definition

of “prior art” for assessing the novelty of an invention This is followed by discussions on traditional knowledge databases and India’s efforts to establish such databases; and; compulsory disclosure of origin and prior informed consent as two defensive methods for protecting traditional knowledge and India’s initiatives in these regards

Chapter III discusses positive protections to traditional knowledge: developing sui

generis rights for traditional knowledge, access and benefit sharing provisions

between the traditional knowledge holders and the bio prospectors with an Indian

11 Hereinafter also referred to as IP

example of benefit sharing with Kani tribe and finally the efficacy of establishment of Global Bio-collecting Society, suggested by Peter Drahos, in the Indian context

Aside from protecting traditional knowledge and taking into account interests of indigenious people, India aspires to participate in modern day biotechnology of food and medicines Chapter IV deals with some issues relating to the modern biotechnological inventions and India’s probable position in case of patenting of third generation biotechnology inventions It concludes with a brief overview of the relevant changes in the Patent (Amendment) Act 2005

Evolution of Patent Act in India

According to W.R.Cornish, “Patents are rights granted in respect of inventions, i.e technological improvements, great and small, which contain at least some scintilla of inventiveness over what is known”.12 It has a prohibitive tenor as well.13 Patent precludes anybody but the inventor or his authorized person to use the patented invention without the inventor’s permission or without paying royalty to the inventor.14 Like other proprietary rights, a patent allows the patent-holder to exercise

12 WILLIAM CORNISH & DAVID LLEWELEYN, INTELLECTUAL PROPERTY: PATENTS, COPYRIGHTS, TRADEMARKS AND ALLIED RIGHTS, (5th ed 2003) ¶ 1-05

13 A literal translation of the Latin litterae patents, letters patent referred to open letters or official

documents by which certain privileges, rights, ranks or titles were conferred by sovereign rulers Letters patent were first issued in the sixth century in Europe for discovery and conquest of foreign lands on their behalf This has prompted them to be called instruments of “colonization” by Vandana

Shiva, a noted scholar and environmentalist in India See, Nic Paget-Clarke, An Interview with Dr

Shiva, at < http://www.inmotionmagazine.com/shiva.html > (last accessed 3 August 2004)

14 Patent is “The right which they accord is to prevent all others—not just imitators, but even independent devisers of the same idea—from using the invention for the duration of the patent” See,

supra note 12

monopoly over his property, the invention, for a stipulated period subject to the restrictions imposed by the other laws of the land.15

The first legislative enactment on patents in India granting “exclusive privileges”16 to inventors for a period of 14 years was Act VI of 1856 The Indian Patents and Designs Act of 1911 repealed all the previous pieces of legislation regarding patents

in India During 1911 and 1970, in bids to improvise patent legislation, various amendments were introduced In 1957, Government of India set up the Ayyangar Committee under Justice Rajagopala Ayyangar for suggestions regarding revision of patent law Justice Ayyangar submitted his report in 1959, which, overcoming various impediments developed into the Patents Act, 1970, the present statute on patents in India The Act, along with Patent Rules came into force on 20th April 1972

India joined World Trade Organization17 in 1994 and TRIPS Agreement was promulgated in 1995 In July 1996, US initiated WTO dispute settlement procedures over India's failure to implement its TRIPS obligations, namely setting up of mailbox facilities and granting Exclusive Marketing Rights.18 The European Union19 made a

15 For instance, the owner of a patent of a new medicine can not market the medicine without appropriate permissions from other authorities, namely, the drug controller, and in case the medicine is

to be administered orally, the food department

16 The “exclusive privileges” included the rights of making, selling, licensing and using the invention in India for a period of 14 years The Act of 1856 was modified and re-enacted as Act XV of 1859 This Act was followed by the Patterns and Designs Protection Act, 1872 and Protection of Inventions Act in

1883 These two Acts were further modified by the Inventions and Designs Act of 1888

17 World Trade Organization (also and hereinafter referred to as WTO): The World Trade Organization

is an international body overseeing trade agreements among its 148 member states Established in

1995, after a series of trade negotiations, the WTO functions as a forum for discussing existing and new trade rules and as a dispute settlement body among the member states More about WTO can be

found in the official home page at < http://www.wto.int > (last accessed 3 October 2005)

18

TRIPS Article 70.8 (mailbox provision) requires a country such as India, which did not provide product patent protection to pharmaceutical products on January 1, 1995, to establish, starting on that date, a system that will permit innovators to file patent applications for such products In addition, once the conditions of Article 70.9 are met, the product that is the subject of the patent application that was registered in the mailbox will be granted "exclusive marketing rights" if it was not yet patentable Exclusive marketing rights are also, and hereinafter in the thesis referred to as EMRs

similar complaint on 1st April 1997 The final panel report on this case was issued in August 1997 wherein it was held that India had failed to meet her obligations under the TRIPS In 1998, India joined the Patent Co-operation Treaty20, and a chapter was added to Patent Rules 1972 providing for filing of international patent applications in India under the PCT To comply with the WTO ruling, The Patent (Amendment) Act

1999 was passed in March 1999, including Exclusive Marketing Rights21 and establishing a mailbox to receive foreign patent applications.22 Subsequently the Patent Act was amended in 200223 and 2004.24 The Patents Amendment Act 2005,

Article 70.8, TRIPS: Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall: (a) notwithstanding the provisions of Part VI, provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed; (b) apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application; and (c) provide patent protection in accordance with this Agreement as from the grant of the patent and for the remainder of the patent term, counted from the filing date in accordance with Article 33 of this Agreement, for those of these applications that meet the criteria for protection referred to in sub paragraph (b).

19 Hereinafter also referred to as EU

20 Patent Cooperation Treaty (hereinafter referred to as PCT): The Patent Cooperation Treaty is a multilateral agreement that provides for filing of an international application when protection is sought for an invention in several countries The Treaty was concluded in 1970, amended in 1979, and modified in 1984 and 2001 The membership to the Treaty is open to the Paris Convention member countries As per Article 3, patent aspirants of contracting states of PCT can simultaneously obtain priority for their inventions without having to file separate application in their countries of interest In addition the system provides much longer time for filing patent application in member countries The time available under Paris Convention for securing priority in other countries is 12 months from the date of initial filing Under the PCT, the time available could be as per Article 22(1), maximum 30 months Further, an inventor is also benefited by the search report prepared under the PCT system to be sure that the claimed invention is novel As per Article 31, the inventor can also opt for preliminary examination before filing in other countries to be doubly sure about the patentability of the invention

The text of the Treaty is at < http://www.wipo.int/pct/en/texts/pdf/pct.pdf > (last accessed 1 September

2005)

21 Also known as EMRs

22 The Patent (Amendment) Ordinance was passed in January 1999, which became an Act in March

1999 Chapter IVA Sections 24A-D of the Patents Amendment Act 1999 provided for EMRs

23 As per Section 48(a) of the Indian Patents Act, 1970 as amended in 2002 a patent confers on the owner the exclusive right by himself, his agents, assignees or licensees to prevent any third party,

without explicit authorization, from making, using, offering for sale, selling or importing for these

purposes the patented product This is in conformity with Article 28(1)(a) of the TRIPS Agreement In the case of the grant of a patent for a method or process of manufacture, this right extends to the

‘product obtained directly by the patented process See, Section 48(b), the Patents act, 1970 as amended in 2002 This is in conformity with Article 28(1)(b) of TRIPS

24 Sources: P.NARAYANAN, INTELLECTUAL PROPERTY LAW, (3 rd ed., 1998), 9-15;

RAJIV JAIN & RAKHEE BISWAS, LAW OF PATENTS, (2d ed 1999), 1.1 - 1.10

amending the Patent Act of 1970, has been passed by the Upper House of the Indian Parliament and is now the Act in force for patents in India.25

First, it is estimated that over one-third of the world’s population lacks regular access

to affordable essential drugs Traditional medicine is widely available, accessible and affordable to most people It is still a widely practiced way of medical treatment in various parts of the world

Second, the high possibility of future drugs being based on traditional plant remedies

is in large part rooted in the fact that precedents exist in the discovery of aspirin, antibiotics and quinine.26 There have been various attempts subsequently to

25 Patent Amendment Ordinance 2004 was passed by the Indian Parliament on 26 December 2004 The

Ordinance was ratified into an Act by the Parliament on 24 March 2005 See, Patent Legislation

Passed, March 2005, at < http://www.cptech.org/ip/health/c/india/patents-act-amendments.html > (last

accessed on 19 September 2005)

26 Lord Hoffman summarises the procedure behind the discovery from drugs from natural ingredients

In the judgement in the case of Merrell Dow v Norton, his Lordship wrote, “The Amazonian Indians

have known for centuries that cinchona bark can be used to treat malaria and other fevers They used it

in a form of powdered bark In 1820, French scientists discovered that the active ingredient, an alkaloid called quinine, could be extracted and could be used more effectively in the form of sulphate of quinine In 1944, the structure of alkaloid molecule (C 20 H 24 N 2 O 2 ) was discovered This meant that the substance could be synthesized Imagine a scientist telling an Amazonian Indian about the discoveries

of 1820 and 1944 He says: “We have found the reason why the bark is good for fevers is that it contains an alkaloid with a rather complicated chemical structure which reacts with the red corpuscles

in the bloodstream It is called quinine.” The Indian replies: “That is very interesting In my tribe, we

manufacture drugs from natural ingredients on the basis of information based on traditional knowledge

The following two tables illustrate some relevant figures.27

Global Sales for Products Derived from Genetic Resources, 1997 (USD in billion) 28

Ornamental horticultural produce 16-19

The following table shows the total global gross sales in these industries and the component of product sales that are of natural origin

Estimated Global sales in the Pharmaceutical, Personal Care and Cosmetics, And Crop Protection Industries, and Component of Products derived from Genetic Resources, 1997 (USD bn)

Product USD bn Sales of natural origin

call it the magic spirit of the bark.” ” He held that if a particular usage of a substance was known, identification of the active ingredient causing the particular usage would not prevent it from forming

non-part of prior art Merrell Dow v H N Norton & Co [1996] R.P.C 76, HL

27 The tables have been cited from: KERRY TEN KATE & SARAH A LAIRD, THE COMMERCIAL

USE OF BIODIVERSITY: ACCESS TO GENETIC RESOURCES AND BENEFIT SHARING,

(Repr ed., 2000) 315

28 The aforesaid figures relate to certain products which are solely derived from genetic resources There are some products which could have been produced using various components not involving genetic resources Only a proportion of these products are derived from genetic resources

like folklore and trade secrets For protecting traditional knowledge, it is necessary to devise a definition of the knowledge that would be protected under this category Some endeavours regarding defining traditional knowledge are being enumerated in the following discussion.29

Blakeney30 has said that the intellectual creations of the traditional communities were initially classified as “folklore” Subsequently World Intellectual Property Organization,31 and United Nations Educational, Scientific and Cultural Organization,32 convened a ‘Group of Experts on the Protection of Expressions of Folklore by Intellectual Property’ who discussed the appropriate terminologies in this context In the meeting held in Paris in December, 1984, objection to the use of the

29 Singapore, for instance, noted that the fact that there was no clear consensus as to the specific scope

of traditional knowledge hindered discussions regarding commitments is this area Singapore position

on TRIPs: Non-Paper by Singapore, Council for Trade-Related Aspects of Intellectual Property Rights,

JOB(00)/7853, 11 December 2000 Also see The CIPR (Commission of Intellectual Property Rights) Report of September, 2002 The CIPR has held that there is no widely accepted definition of traditional

knowledge It is a combination of a wide range of concerns and objectives CIPR, Integrating

Intellectual Property Rights and Development Policy, Report of the Commission of Intellectual Property Rights, September 2002, 75, 78

30 Michael Blakeney; The Protection of Traditional Knowledge under Intellectual Property Law,

[2000] E.I.P.R., 251

31 World Intellectual Property Organization (commonly known as and hereinafter referred to as WIPO

in the instant thesis) is one of the 16 specialized agencies of the United Nations system of organizations dealing with the promotion and protection of intellectual property Based in Geneva it was established under a treaty, “ The Convention Establishing the World Intellectual Property Organization of July 14, 1967” It operates under United Nations Education, Scientific and Cultural Organization (UNESCO) and entered into force in 1970 The treaty was subsequently amended in 1979 and 2000 At present it has 183 signatories See, G.GREGORY LETTERMAN, BASICS OF INTERNATIONAL

INTELLECTUAL PROPERTY LAW, (2001) 26-27 Also see, About WIPO, at http://www.wipo.int/about-wipo/en/overview.html ( last accessed on 22 July 2005) and Member States,

at http://www.wipo.int/members/en/ ( last accessed on 25 April 2006)

32 United Nations Educational, Scientific and Cultural Organization (commonly known as and hereinafter referred to as UNESCO in the instant thesis) is an agency under the United Nations It was estbalished in 1946 and is headquartered in Paris, France, with over 50 field offices and several institutes and centres throughout the world The Organization’s main objective is to contribute to peace and security by promoting collaboration among the nations through education, science and culture in order to further universal respect for justice, for the rule of law and for the human rights and fundamental freedoms (Article 1 of UNESCO’s Constitution) 191 nations belong to UNESCO UNESCO pursues its action through five major programmes: education, natural sciences, social & human sciences, culture and communication & information Projects sponsored by UNESCO include literacy, technical, and teacher-training programmes; international science programmes; regional and cultural history projects, the promotion of cultural diversity; international cooperation agreements to secure the world’s cultural and natural heritage and to preserve human rights More about the

organization can be found at the UNESCO website at www.unesco.org (last accessed on 3 July 2005)

term “folklore” was raised on the ground that the term implied “a negative connotation of being associated with the creations of lower or superseded civilizations”.33 However, the objections being superseded, the 1985 meeting provided an inclusive definition for “Expressions of Folklore” which read as follows:

“(…) “expressions of folklore” mean productions consisting of characteristic elements

of the traditional artistic heritage developed and maintained by a community, or by individuals reflecting the traditional artistic heritage developed and maintained by a community, in particular:

(i) verbal expressions, such as folk tales, folk poetry and riddles;

(ii) musical expressions, such as folk songs and instrumental music;

(iii) expressions by action, such as folk dances, plays and artistic forms or rituals, whether or not reduced to a material form; and

(iv) tangible expressions, such as

(a) production of folk art, in particular, drawings, paintings, carvings, sculptures, pottery, terracotta, mosaic, woodwork, metalware, jewellery, basket weaving, needlework, textiles, carpets, costumes; (b) musical instruments;

(c) architectural forms.”34

This terminological approach was the subject of an in-depth discussion at the World Forum on the Protection of Folklore, convened by WIPO and UNESCO in Phuket, Thailand in April 1997.35 The aforesaid definitions had remained functional till

objections to the use of the term “folklore” for referring to all indigenous knowledge were raised at the above conference It was pointed out that the definition failed to include all aspects of life of the indigenous people, including their scientific knowledge.36 The term “traditional knowledge” was coined to address the lapses of the term “folklore” A major distinction was that, folklore, chiefly dealing with artistic expressions, is discussed in terms of copyright protection, while traditional knowledge, involving scientific knowledge including inventions, is considered in terms of other form of intellectual property protection, particularly patents.37

Attempts to define traditional knowledge have been made by various international conventions The various conventions have used the terms ‘traditional knowledge’ and ‘indigenous knowledge’ in different contexts Significant work has been done on this subject by WIPO in response to the need for greater clarity in respect of terminology and the subject matter covered under it.38 The WIPO Secretariat made

explore “issues concerning the preservation and protection of expressions of folklore, intellectual property aspects of folklore and the harmonization of different regional interests”

36 Unesco-WIPO World Forum on the Protection of Folklore, UNESCO/WIPO/FOLK/PKT/97/1,March

17, 1997 at < http://www.ompi.int/meetings/en/details.jsp?meeting_id=3074 > (last accessed on 3 June

2004)

37 Blakeney, supra note 30 at 252

38 Discussions regarding selecting suitable terminologies were held by the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional knowledge and Folklore in their preliminary meetings WIPO established the Intergovernmental Committee (IGC) on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore in October 2000 to discuss and debate issues relating to traditional knowledge, genetic resources and folklore Along with the WIPO members, independent bodies and non-governmental organizations can also participate in the IGC proceedings as observers The functions of the IGC include policy debate, reports on national experiences, empirical surveys, exchange of experience of indigenous and local communities, analysis

of legal and policy options for enhanced protection of traditional knowledge, crafting specific practical tools, development of recommendations for revision of the international patent system to take account

of traditional knowledge, and capacity building and awareness initiatives The IGC has met 8 times since inception, the last meeting being in Geneva in June 2005 More about the IGC can be found at the WIPO website, at < http://www.wipo.int/tk/en/igc > (last accessed on 24 June 2005) Also see,

< WIPO/GRTKF/IC/3/9, at http://wipo.int/traditionalknowledge/report > last accessed on 24 June

2005)

use of the following working concept of ‘traditional knowledge’ for the purposes of the fact-finding missions in 1998-1999:39

“Traditional Knowledge’ … refer[s] to tradition-based literary, artistic or scientific works; performances; inventions; scientific discoveries; designs; marks, names and symbols; undisclosed information; and all other tradition-based innovations and creations resulting from intellectual activity in the industrial, scientific, literary or artistic fields”

This definition further explains that “tradition-based” refers to “knowledge systems, creations, innovations and cultural expressions which have generally been transmitted from generation to generation; are generally regarded as pertaining to a particular people or its territory; and, are constantly evolving in response to a changing environment.”

The Convention on Biological Diversity40 has provided an alternative description of traditional knowledge in its provisions Article 8(j) of the CBD provides for each

39

Inter-Governmental Committee on Intellectual Property and Genetic Resources, Traditional

knowledge and Folklore, at

< http://www.wipo.int/documents/en/meetings/2002/igc/doc/grtraditionalknowledgefic3_9.doc> (last accessed on 13 December 2004)

40 The Convention on Biological Diversity (commonly known as and hereinafter referred to as CBD in the instant thesis) entered into force on 29 December 1993 It is the outcome of the Earth Summit in Rio de Janeiro, Brazil in 1992 It contains three national level obligations: to conserve, to sustainably use, and to share the benefits of biological diversity Other aspects of biodiversity such as in situ and ex situ conservation of wild and domesticated species; access to genetic resources and technology, including biotechnology; new and additional financial resources, and safety of release or experimentation on genetically-modified organisms, also known as bio-safety were included in the convention Parties to the Biodiversity Treaty “affirm sovereign rights over the biological resources found within their countries, while accepting responsibility for conserving biological diversity and using biological resources in a sustainable manner,” according to an International Union for the Conservation of Nature (IUCN) assessment of the treaty The treaty, in its article on objectives, commits Parties to “fair and equitable sharing of the benefits arising out of the utilization of genetic resources.” Other Articles of the Convention discuss Access to Genetic Resources, Access to and Transfer of Technology, and Handling of Biotechnology and Distribution of its Benefits India has

been a member of the treaty since 1994 For full text see CBD website, at

<http://www.biodiv.org/convention/articles.asp> (last accessed on 4 September 2005)

contracting party to incorporate in its domestic legislation, the following definition of traditional knowledge: “(…) knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles (…)”.41 CBD explains that traditional knowledge has “[d]eveloped form experience and gained over the centuries and adapted to the local culture and environment, traditional knowledge is transmitted orally form generation to generation.”42 Characterizing traditional knowledge, CBD states, “it [traditional knowledge] tends to be collectively owned and takes the form of stories, songs, folklore, proverbs, cultural values, beliefs, rituals, community laws, local language, and agricultural practices, including the development of plant species and animal breeds.”

CBD, in a separate document, has qualified “traditional knowledge” to be a “term used to describe a body of knowledge built by a group of people through generations living in close contact with nature It includes a system of classification, a set of empirical observations about the local environment, and a system of self-management that governs resource use (…) In the context of knowledge, innovation is a feature of indigenous and local communities whereby tradition acts as a filter through which innovation occurs In this context, it is traditional methods of research and application and not always particular pieces of knowledge that persist Practices should therefore be seen as the manifestations of knowledge and innovation”.43

41 Convention of Biological Diversity, Article 8(j): Traditional Knowledge, Innovations and Practices:

Introduction, at < http://www.biodiv.org/programmes/socio-eco/traditional/default.asp > (last accessed

on 4 September, 2005)

42 id

43 Convention of Biological Diversity, Traditional Knowledge And Biological Diversity: Note by the

Executive Secretary, UNEP/CBD/TKBD/1/2, Hague, 18 October 1997, ¶¶ 84, 86.

It should be kept in mind that WIPO and CBD have different accents While the former strives to promote “simpler, cheaper and more secure” intellectual property protection throughout the world,44 the later aims to achieve conservation and sustainable development of world biodiversity.45 The definition of WIPO has a comparatively wider scope as it explicitly recognizes that traditional knowledge is

“constantly evolving”46

The UNESCO and the WTO have offered other significant definitions of traditional knowledge These are:

• “The traditional knowledge and expressions of indigenous cultures are defined

as the ways in which indigenous cultures are expressed and which are manifestations

of worldviews of the indigenous peoples of the Pacific Traditional knowledge and cultural expressions are any knowledge or any expressions created, acquired and inspired (applied, inherent or abstract) for the physical and spiritual well-being of the indigenous peoples of the Pacific The nature and use of such knowledge and expressions are transmitted from one generation to the next to enhance, safeguard and perpetuate the identity, well-being and rights of the indigenous peoples of the Pacific”.47

44 World Intellectual Property Organization, WIPO’s Vision, at <

http://www.wipo.int/about-wipo/en/dgo/pub487.htm > (last accessed on 3 September 2004)

45 Convention of Biological Diversity, Sustaining Life on Earth: How the Convention on Biological

Diversity promotes nature and human well-being , at

< http://www.biodiv.org/doc/publications/guide.asp > (last accessed on 3 September 2004)

46 World Intellectual Property Organisation, Inter-Governmental Committee on Intellectual Property

and Genetic Resources, Traditional knowledge and Folklore, at

< http://www.wipo.int/documents/en/meetings/2002/igc/doc/grtraditional knowledgefic3_9.doc > (last accessed on 15 August 2004)

47 UNESCO Symposium on the Protection of Traditional knowledge and Expressions of Indigenous

Cultures in the Pacific Islands, Noumea, 15-17 February 1999: Final Declaration, at

<www.unesco.org/culture/copyright/folklore/html_eng/declaration.shtml> (last accessed on 3 September 2004)

• “Traditional knowledge consists largely of innovations, creations and cultural expressions generated or preserved by its present possessors, who may be defined and identified as individuals or whole communities, natural or legal persons, who are holders of rights The economic, commercial and cultural value of this traditional knowledge for its possessors warrants and justifies a legitimate interest that this knowledge be recognized as a subject matter of intellectual property”.48

“Indigenous knowledge” is either used to describe knowledge held and used by communities, peoples and nations that are indigenous, or to denote knowledge which

is itself indigenous, in the sense of specifically originating in a certain region or country, that is, “indigenous means belonging to, or specific to, a particular place”.49 Whichever sense of ‘indigenous knowledge’ is used, the general usage seems to suggest that all indigenous knowledge is traditional knowledge, although it is likely that some traditional knowledge may not have the specific characteristic of being

“indigenous”.50 There are again several definitions for the term “indigenous people”, but essentially the term refers to people who characteristically exist under “conditions

of severe disadvantage relative to others within the states constructed around them.”51

A distinction between traditional knowledge and indigenous knowledge may be drawn from the example of the codified forms of one of the traditional knowledge

48 World Trade Organization, Proposal on Protection of the Intellectual Property Rights Relating to

the Traditional knowledge of Local and Indigenous Communities: Communication from Bolivia, Colombia, Ecuador, Nicaragua, and Peru, WT/GC/W/362, WTO, Geneva, 12 October 1999

49 Graham Dutfield , Comment on the Draft WIPO Report on Fact-finding Missions on Intellectual

Property and Traditional Knowledge: Intellectual Property Needs and Expectations of Traditional Knowledge Holders (1998-1999) dated December 12, 2000 at < http://www.wipo.int/tk/en/tk/ffm/ffm-

report-comments/msg00016.html > (last accessed on 3 September 2004)

50 J Mugabe, “Intellectual Property Protection and Traditional Knowledge,” Intellectual Property and

Human Rights (WIPO, 1999), 97 at 98-99

51 See, S JAMES ANAYA, INDIGENOUS PEOPLES IN INTERNATIONAL LAW, (1996) 3

systems in India, the Ayurveda52 The word is a combination of the two Sanskrit words “Ayu” and “Veda” The word “Ayu” would mean “life”, (in the sense of living span) while “Veda” refers to the knowledge Crudely translated, the word would mean

“the knowledge for long life” This is a classical codified medical system and is not folk or developed by indigenous people Thus traditional medical knowledge system would not be synonymous to an indigenous knowledge or folk knowledge Hence while all indigenous knowledge is traditional, not all traditional knowledge is indigenous Dutfield, in his comments on the Draft Report says that “‘Indigenous’ means belonging to, or specific to, a particular place.”53 It is in this sense that the term

‘indigenous knowledge” is used in the instant thesis

Some have objected to the use of the word ‘traditional’ and have preferred the word

‘customary’ while referring to such knowledge It has been apprehended that usage of the word ‘traditional’ would preclude the modern innovations made in the areas Further, for establishing antiquity of a particular knowledge, documentary proof might be sought The term ‘customary knowledge’ would not involve such issues.54 In the instant thesis the term “traditional knowledge” is used to comprehend customary knowledge The definitions are only a generic description of forms of traditional knowledge and do not achieve the distinct classification of traditional knowledge WIPO has held that the term ‘traditional knowledge’ is a working term only and it

“acknowledges the right of indigenous groups, local communities and other TK

52 R.A Mashelkar, Protecting intellectual property,at <

http://www.india-seminar.com/2005/547/547%20r.a.%20mashelkar.htm > (last accessed on 22 June 2005)

53Dutfield , supra note 49.

54 World Intellectual Property Organization, Traditional Knowledge – Operational Terms and

Definitions, WIPO/GRTKF/IC/3/9,May 20, 2002, ¶ 19, at

< http://www.wipo.int/documents/en/meetings/2002/igc/pdf/grtkfic3_9.pdf > (last accessed on 3 July

2005)

holders to decide what constitutes their own knowledge, innovations, cultures and practices, and the ways in which they should be defined.”55

To conclude on the subject of overlapping and inadequate definitions of traditional knowledge, WIPO has observed that different terms may therefore be used for overlapping subject matter and the same term may be used in contrasting ways, so it may only be possible or desirable to settle on a particular definition in the context of a specific legal instrument and with a defined policy goal.56

A more pragmatic approach to treating traditional knowledge is explaining what kinds

of knowledge should be protected If any protection system is to be established, it is essential that the subject matter of the protection is clearly identified, as all such knowledge will need to be documented in some way Categories of traditional knowledge could include: agricultural knowledge; scientific knowledge; technical knowledge; ecological knowledge; medicinal knowledge, including related medicines and remedies; biodiversity-related knowledge; “expressions of folklore” in the form of music, dance, song, handicrafts, designs, stories and artwork; elements of languages, such as names, geographical indications and symbols; and movable cultural properties.57 Excluded from this description of traditional knowledge would

55 World Intellectual Property Organization, WIPO Report on Fact-finding Missions on Intellectual

Property and Traditional Knowledge: Intellectual Property Needs and Expectations of Traditional Knowledge Holders (1998-1999), 25 ‘TK’ and ‘tk’ are frequently used acronyms of traditional

knowledge

56 WIPO/GRTKF/IC/3/9, supra note 54 ¶ 15 See also, CIPR, supra note 29

57 UNESCO, in its thesaurus, puts forward the following classifications of traditional knowledge:

1 Ethno-botany: this field includes cultural environmental resources and indigenous people’s ancestral remains, human genetic materials 2 Traditional architecture: this field includes all sites of cultural significance and immovable cultural property and their associated knowledge 3 Traditional technology: this field includes traditional resource management techniques including traditional conservation measures and scientific, agricultural, technical and ecological knowledge, and the skills required to implement this knowledge (including that pertaining to resource use practices and systems

of classification) 4 Traditional medicine: this field includes all forms of traditional medicine that is based on knowledge of diseases and curative methods and therapeutic substances 5 Traditional agriculture: this field includes methods and implements used in traditional forms of agriculture and growing crops 6 Traditional folklore: this field includes cultural dances, ceremonies and ritual

be items not resulting from intellectual activity in the industrial, scientific, literary or artistic fields, such as human remains, languages in general and other similar elements

of “heritage in the broad sense”.58

Further, given the diversity of traditional knowledge, it is not possible to regard the whole genre for the same IP protection.59 For instance, while traditional fables may

be considered for copyright protection, traditional medicines would be discussed under patent protection Hence a classification is often useful But the boundaries of the above classifications are flexible and in many cases overlap and require evaluation for more than one intellectual property protection For instance most indigenous medicine would be involving genetic resources and perhaps accompanying rituals

One instance of traditional medical knowledge using genetic resources is the Indian medical treatise of Ayurveda This codified medical system, in the form of written literary work, will be a subject matter to be discussed for copyright protection which protects original literary works However the medicines prepared will involve herbal resources and the protection of such medicine will be a patent law issue The consensus among the scholars around the world has been to identify ‘medicine, food

performances and practices, games and sports, music, language, names, stories, traditions, songs in oral

narratives UNESCO Thesaurus, available at <http://www.ulcc.ac.uk/unesco/terms/list158.htm> (last

accessed on 24 July 2004)

58 World Intellectual Property Organization, Traditional Knowledge: Glossary of Terms, at

<http://www.wipo.int/tk/en/glossary/index.html> (last accessed on 24 July 2004)

59 According to CIPR, there is also confusion about what is meant by “protection” and its purpose since

protection should not be used in the IP sense See supra note 29 While in the IP sense, protection,

would crudely refer to maintenance of the monopoly rights of the IP holder, for traditional knowledge

it would encompass a wide range of concerns from the prevention of loss and erosion of traditional knowledge to acknowledgment of the knowledge holders and preservation and proper dissemination with sharing of benefits with the knowledge holders

and agriculture’60 as the thrust areas and introduce specific protections to this priority zone.61

For the purpose of this thesis, “traditional knowledge” would refer to knowledge with the following attributes:

i Knowledge which has evolved over time and has been transmitted through generations

ii Knowledge which is traceable to particular groups of people either having common residence area, or common religion, language or culture

iii The knowledge which has developed for the physical and/or spiritual upliftment of the people

iv The knowledge involves nature, by way of genetic resources

v The knowledge may be held or created by the community or by an individual in the community

vi The knowledge has economic or cultural value

1.3 BIOPIRACY

In many cases relating to exploitation of traditional knowledge, the southern bloc of less developed nations have often alleged underhand dealings of ‘biopiracy’ in the hands of the north bloc, more developed nations Biopiracy is not defined in any of the conventions relating to traditional knowledge It relates to “the appropriation of the knowledge and genetic resources of farming and indigenous communities by

60 See generally, World Intellectual Property Organization, Inventory of Existing Online Databases

Containing Traditional knowledge Documentation Data, WIPO/GRTKF/IC/3/, available at

<http://www.wipo.int/documents/en/meetings/2002/igc/doc/grtkfic3_5.doc5> (last accessed on 12

September 2004) and see, also, the website of the Indigenous Knowledge and Development Monitor, at

<http://www.nuffic.nl/ciran/ikdm> ( last accessed on 12 September 2004)

61 In the instant thesis, unless expressly mentioned, traditional knowledge would refer to medicinal, food and agricultural knowledge only

individuals or institutions seeking exclusive monopoly control (usually patents or plant breeders' rights) over these resources and knowledge”.62

The alleged appropriation of resources and knowledge include patenting of existing forms of knowledge or practices that are absent from the popular public databases, and the commercial monopolisation of such practices, or knowledge, in manners which deleteriously affect the interests of the knowledge holder communities Researching genetic material on the basis of the available prior knowledge and developing new drugs, with longer shelf life, which are administered effortlessly, per se is not contrary to the interests of indigenous peoples or threat to biodiversity The indigenous communities allege that the pharmaceutical industry has,

pre-in many pre-instances not taken their consent, as facilitators, before gopre-ing ahead with the commercial exploitation of the traditional knowledge While bio-prospecting helps in identifying traditional knowledge with commercial potential, biopiracy appropriates these resources and knowledge by way of privatizing them for commercial gain without obtaining prior informed consent from or awarding compensation to the knowledge holder group The prevalent types of biopiracy are as follows:

a) The granting of invalid patents

These are patents granted for inventions which are either not novel or are not inventive having regard to the traditional knowledge already in the public domain Such patents may be granted either due to oversight of the patent examiner or because the examiner did not have access to the knowledge It might also be granted due to disparity of definition followed by the different IP regimes since the national patent

62 Admitting the dearth of definition of biopiracy, CIPR has incorporated the quoted definition

propounded by The Action Group on Erosion, Technology and Concentration (ETC Group) See, supra

note 29 at 74

regime (for example, as in US) may not recognize some forms of public disclosure of traditional knowledge as prior art

b) The granting of valid but bad patents

Patents may correctly be granted under national law on inventions derived from a community’s traditional knowledge or genetic resources It could be argued this might still constitute biopiracy for the reasons mentioned below:

• Patenting standards are too low Patents are allowed, for instance, for inventions which amount to little more than discoveries, or involve minor tinkering of the naturally occurring organisms

• Even if the patent represents a genuine invention, however defined, no arrangement had been made to obtain prior informed consent from the communities holding the knowledge or resource which was the origin to the invention, and for sharing the benefits of commercialization of the invention with the knowledge holder community.63

A number of cases involving patenting of traditional knowledge have attracted international attention As a result, the issue of traditional knowledge has been brought to the fore of the general debate surrounding intellectual property The examples of turmeric, neem and basmati illustrate the issues that can arise when patent protection is granted to inventions relating to traditional knowledge already in the public domain

63 Article 15(4), (5), Convention on Biological Diversity, available at

<http://www.biodiv.org/convention/articles.asp?a=cbd-23> (last accessed on 19 October 2005)

1.3.1 Case Study: Turmeric

Background

Turmeric64 has been used in India from ancient times for a variety of purposes It is used in Indian cuisine as a seasoning; the cloth industry uses turmeric as a natural dye while its skin lightening and antiseptic qualities makes it a frequently use home remedy as well as an important component of traditional Indian medicines

Patent

In March 1995, two expatriate Indians at the University of Mississippi Medical Centre, Jackson were granted a US patent65 for turmeric to be used to heal wounds

Challenge

The Indian Council for Scientific and Industrial Research (CSIR) filed a case with the

US Patent Office challenging the patent on the grounds of “prior art”, i.e existing public knowledge CSIR explained that turmeric has been used for thousands of years for healing wounds and rashes and therefore its use as a medicine was not a new invention CSIR’s claim had to be backed by written documentation claiming traditional wisdom CSIR went so far as to present an ancient Sanskrit text and a paper published in 1953 in the Journal of the Indian Medical Association The US Patent Office upheld the objection and cancelled the patent on 14 August 1997 for lack of novelty

successful in pushing the instant patent in other countries including India, commercialization of turmeric for would healing in India would have become illegal.66

Observation

Turmeric is perhaps the first case which was successfully challenged for the appropriation of traditional medical knowledge Furthermore, the patent description contained the following information:

“Turmeric, a yellow powder developed from the plant Curcurma longa, is commonly used as a food colorant in many Indian dishes and imparts a bitter taste Although it

is primarily a dietary agent, turmeric has long been used in India as a traditional medicine for the treatment of various sprains and inflammatory conditions…turmeric

is a natural product that is readily available in the food store” 67

Even after such admission in the patent application, the patent was granted by the United States Patent and Trademarks Office.68 Dutfield has observed: “This case seems to indicate unwillingness on the part of patent examiners in the United States to accept the evidence of traditional knowledge as prior art unless it has been validated

by scientists and published in learned - preferably North American or European - journals”.69

1.3.2 Case Study: Neem

Background

66 Another example of alleged biopiracy is the Enola bean patent case described in note 321 here after

67 The text of the patent no 5,401,504 is available at < http://patent.womplex.ibm.com> (last accessed

on 12 June 2004)

68 United States Patent and Trademarks Office is hereinafter referred to as USPTO

69 Graham Dutfield, Is novelty still required for patents in the United States? the case of turmeric, at

<http://users.ox.ac.uk/~wgtrr/turmeric4.htm> (last accessed on 12 June 2004)

Neem70 is a tropical tree with wide adaptability and is especially suited to semi-arid conditions Though it is now grown in many Asian countries and in the tropical regions of the western hemisphere, neem is considered to be part of India's genetic bio-diversity because of its wide use

Patent

Two patents for inventions based on neem were granted to W.R Grace in 1990 and

1994 The earlier patent is “for improving the storage stability of neem seed extracts containing azadirachtin,” a chemical that is an active agent in neem.71 The second patent is “for storage of stable insecticidal composition comprising neem seed extract" which permitted "increasing the shelf-life stability of azadirachtin solution” 72 The fungicidal effect of hydrophobic extracts of neem seeds was known and used for centuries on a broad scale in India, both in Ayurvedic medicine to cure dermatological diseases, and in traditional Indian agricultural practices to protect crops from being destroyed by fungal infections The Indian government filed a complaint in the USPTO accusing W.R Grace of copying an Indian invention A complaint was also made to European Patent Office73 to revoke the European patent The patent has been struck down by the EPO after it was proved that neem had been used as insecticide through similar methods for a very long time by the Indian farmers.74

While Europe follows a world-wide novelty system, US recognizes only written foreign knowledge as prior art Since the neem formulations were traditionally used

70 Scientific name: Azadirachta Indica

71 Patent No 4,946,681

72 Patent No 5,124,349

73 Hereinafter referred to as EPO

74 On 8 March 2005, European Patent Office dismissed the appeal made against their 2000 order to

revoke the neem patent See, India wins Landmark Patent Battle, at

<http://news.bbc.co.uk/1/hi/sci/tech/4333627.stm> (last accessed on 10 March 2005)

by farmers in Indian, no written literature could be produced to support this age-old agricultural practice, and hence neem is still a valid patent in United States

Implications

Traditionally, the Indian farmers would make a water-soluble extract from the neem seeds and administer to the crops In 1992, W.R Grace secured its rights to the formula that used the emulsion from the Neem tree's seeds to make a powerful pesticide They asserted that this process was a discovery because they said that this entailed manipulation yielding greater and better results The divergent view is that the product marketed by the patentee is a mere manipulation of the solution used in India and is thus obvious Since the use of neem as a pesticide is renowned, the patent lacked novelty Moreover due to the prior art base and the available technology, the patented product was obvious.75

A consequence of the patent is that W R Grace started importing neem seeds from India for its production The diversion of neem seeds from being almost a free resource to the current exorbitantly high price has resulted in making the neem seeds unaffordable for the poor local farmers.76 As the processing and exporting of the seeds and neem oil is no longer available to them, the farmers are at the receiving end.77

PROPERTY RIGHTS, (2001) 61

76 Indian Rupee is hereinafter referred to as INR United States Dollar is hereinafter referred to as USD

As a result of the export, the price of neem sky-rocketed from a mere INR 300 (USD 7 approx.) to the

current levels of INR 3000 (USD 68.9 approx.)-6000 (USD 137.7 approx.) a ton See, All India Level

Price, at <http://agmarknet.nic.in/rep1.asp> (last accessed on 23 August 2004)

77 Since the patents under attack were concerned with purer forms and more stable forms of the active ingredient, it may be argued that these purer and more stable forms are not found in prior art While it

has been discussed in Chapter II section 2.2.2 herein that prior art should be construed broadly, it can

be disputed whether the prior art was actually novelty defeating Following such a view, the claims may be considered new However, there still would remain the question of inventiveness, i.e., whether purification and stabilization would have been obvious in regard to the prior art It could also be argued that whether mere purification would not lead to a very low standard of inventiveness To avoid such controversies regarding evaluation of prior art, the Indian Patent Amendment Act 2005, under Section 3(p) excludes inventions based on traditional knowledge from patentability See note 316 hereinafter

1.3.3 Case Study: Basmati

Background

Basmati is the long grained aromatic rice grown in the Himalaya foothills in the northwestern parts of India and in Pakistan and is a major export crop for both countries.78

Patent

In 1997, Rice Tec, a Texas company, acquired a patent in a novel method of breeding a long grain of aromatic rice, in a novel method of preparing and cooking the rice, and in the grains themselves.79 Rice Tec's claims are for a a specific rice plant (Claims 1-11,

78 The word “basmati” in, Hindi, the official language of India, means fragrant The Basmati rice is so named because of its distinctive aroma

79 Patent number 5663484 The full 20 claims of the patent are as follows:

(1) A rice plant, which plant when cultivated in North, Central or South America, or Caribbean Islands a) has a mature height of about 80 cm to about 140 cm; b) is substantially photoperiod insensitive; and c) produces rice grains having i) an average starch index of about 27 to about 35, ii) an average 2- acetyl-1-pyrroline content of about 150 ppb to about 2,000 ppb, iii) an average length of about 6.2 mm

to about 8.0 mm, an average width of about 1.6 mm to about 1.9 mm, and an average length to width ratio of about 3.5 to about 4.5, iv) an average of about 41% to about 67% whole grains, and v) an average lengthwise increase of about 75% to about 150% when cooked (2) The rice plant of claim 1, wherein said starch index of i) consists of the sum of percent amylose of about 24 to about 29 and of alkali spreading value of about 2.9 to about 7 (3) The rice plant of claim 2, wherein said rice grains additionally have an average burst index of about 4 to about 1 (4) The rice plant of claim 2, wherein said rice grains consist of less than about 20% chalky, white belly or white center grains (5) The rice plant of claim 1, wherein said plant produces about 3,000 lbs

to about 10,000 lbs of seed per acre (6) The rice plant of claim 1, which plant a) has a mature height

of about 119 cm; and b) produces rice grains having i) an average starch index of about 29, an average percent amylose of about 24.5, and an average alkali spreading value of about 4.5, ii) an average 2- acetyl-1-pyrroline content of about 400 ppb, iii) an average length of about 6.75 mm, an average width

of about 1.85 mm, and an average length to width ratio of about 3.65, iv) an average of about 50% whole grains, and v) an average lengthwise increase of about 90% when cooked (7) The rice plant of claim 1, which plant a) has a mature height of about 115 cm; and b) produces rice grains having i) an average starch index of about 29, an average percent amylose of about 26.2, and an average alkali spreading value of about 2.9, ii) an average 2-acetyl-1-pyrroline content of about 150 ppb, iii) an average length of about 7.26 mm, an average width of about 1.85 mm, and an average length to width ratio of about 3.92, iv) an average of about 45% whole grains, and v) an average lengthwise increase of about 75% when cooked (8) A rice plant produced from Bas 867 seed having the accession number ATCC 75941 (9) A rice plant produced from RT1117 seed having the accession number ATCC

75939 (10) The rice plant of claim 1, which plant a) has a mature height of about 115 cm; and b) produces rice grains having i) an average starch index of about 28.9, and average percent amylose of about 25.8, and an average alkali spreading value of about 3.1, ii) an average 2-acetyl-1-pyrroline content of about 400 to about 450 ppb, iii) an average length of about 6.49 mm, an average width of about 1.77 mm, and an average length to width ratio of about 3.87, iv) an average of about 41% whole grains, and v) an average lengthwise increase of about 90% when cooked (11) A rice plant produced from RT1121 seed having the accession number ATCC 75940 (12) A seed produced by the rice plant

of any of claims 1 to 11 (13) A rice grain derived from the seed of claim 12 (14) A progeny plant of the rice plant of any of claims 1 to 11 (15) A rice grain, which has i) a starch index of about 27 to

14), for seeds that germinate the patented rice plant(Claim 12), for the grain that is produced by the rice plant (Claims 13, 15-17), and for the method of selecting plants for breeding and propagating particular grains of rice (Claims 18-20)

The patent led to a series of protests by the farmers and the citizens of India and Pakistan since Basmati has been a chief export item from these countries The government of Indian applied for re-examination of the patent at the USPTO The attorneys for the Indian government stated: "Rice Tec has got a patent for three things: growing rice plants with certain characteristics identical to Basmati, the grain produced by such plants, and the method of selecting rice based on a starch index (SI) test devised by Rice Tec, Inc.”.80 The challenge was based on the fact that the plant

about 35, ii) a 2-acetyl-1-pyrroline content of about 150 ppb to about 2,000 ppb, iii) a length of about 6.2 mm to about 8.0 mm, a width of about 1.6 mm to about 1.9 mm, and a length to width ratio of about 3.5 to about 4.5, iv) a whole grain index of about 41 to about 63, v) a lengthwise increase of about 75% to about 150% when cooked, and v) a chalk index of less than about 20 (16) The rice grain

of claim 15, which has a 2-acetyl-1-pyrroline content of about 350 ppb to about 600 ppb (17) The rice grain of claim 15, which has a burst index of about 4 to about 1 (18) A method of selecting a rice plant for breeding or propagation, comprising the steps of: a) preparing rice grains from rice seeds; b) determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) identifying a rice plant which produces grains having an average PA of about 22 to about 29, an average ASV of about 2.9 to about 7, and an average SI of about 27 to about 35; e) selecting a seed from said plant; and f) growing said seed into a plant (19) A method of selecting a rice plant for breeding or propagation, comprising the steps of: a) preparing rice grains from rice seeds; b) determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) cooking a sample of said grains and determining the percent elongation of cooked grains; e) identifying a rice plant which produces grains having an average PA of about 22 to about 29, an average ASV of about 2.9 to about 7, an average SI of about 27

to about 35, and an average cooked grain elongation of about 75% to about 150%; f) selecting a seed from said plant; and g) growing said seed into a plant (20) A method of selecting a rice plant for breeding or propagation, comprising the steps of: a) preparing rice grains from rice seeds; b) determining i) the percent amylose (PA), and ii) the alkali spreading value (ASV) of samples of said grains; c) summing said PA and said ASV to obtain the starch index (SI) of said grains; d) determining the burst index of a sample of said grains; e) identifying a rice plant which produces grains having an average PA of about 22 to about 29, an average ASV of about 2.9 to about 7, an average SI of about 27

to about 35, and an average burst index of about 4 to about 1; f) selecting a seed from said plant; and g) growing said seed into a plant

80 Basmati Case Study available at <http://www.american.edu/TED/basmati.htm> (last accessed on 3

July 2005)

varieties and grains already exist as a staple in India.81 The patent was not novel and was an obvious invention, being based on rice that is already being imported in theUS India's attorneys also seeked to challenge the use of the term "basmati" in conjunction with the patent and in marketing of the rice.82 Such use of the term

created confusion as to geographic origin83 and usurped the goodwill and recognition established with basmati rice grown and sold from India.84

As a result of the re-examination application filed by the Indian government through

an NGO named APEDA85, Rice Tec agreed to withdraw the claims On 29 January,

2002, the USPTO issued a Reexamination Certificate and cancelled claims 1-7, 10,

81 See Vandana Shiva, Basmati Biopiracy: Rice Tec Must Withdraw All Patent Claims For Basmati

Seeds And Plants, The Hindustan Times (November 20, 2000), available at

<http://www.vshiva.net/Articles/Basmati%20Biopiracy.htm> ( last accessed on 3 July 2004)

82 Id

83 Basmati might not be protected as a geographical indication since the word ‘Basmati’ does not indicate the geographical origin of that particular rice but describes an attribute Moreover, neither India nor Pakistan had a relevant enactment protecting geographical indictaions at the time of the issuance of the patent in 1997 Under Article 24.9, TRIPS does not require a member to protect geographical indications unless they are protected in their country of origin India legislated The Geographical Indications of Goods (Registration and Protection) Act in 1999 is discussed in Chapter II sections 3.2.2 of the thesis

84 Trademark law could have also been a basis for challenging the use of Basmati Rice Tec could be prevented from marketing Basmati rice in a way that creates confusion with the Indian product But, in order to be successful for such a claim, the Indian government would have to show likelihood of confusion among consumers since 15 USC (Chapter 22 dealing with trademarks) § 1114(a)-(b) specifies likelihood of confusion as an element of trademark infringement claim Rice Tec did not trademark the term "Basmati" and it has been careful in marketing its product so as not to use the term Basmati as an indication of source In UK, Rice Tec markets the product as Texmati rice, since British law protects the use of the term Basmati to refer to rice coming from India and Pakistan Rice Tec also uses Texmati in its US sales, but uses the term Basmati on its packaging The Indian government could argue that this use of the term Basmati is what creates confusion among consumers The term Basmati need not be federally registered as a trademark for India to raise the claim since under 15 USC § 1125(a) confusing or deceptive marks are recognized even if the marks are not registered However, Rice Tec would have a strong argument that India cannot bring an infringement action because

"Basmati" could not be protected as a trademark Rice Tec's strongest argument is that Basmati is really

a descriptive mark; the word means fragrant and hence describes a major attribute of the product Under 15 USC § 1052(f), descriptive marks are protected only if they have secondary meaning, that is, the term makes the ordinary consumer recognize the source of the product as opposed to the product itself In this vein, Rice Tec could also argue that under 15 USC § 1064(3), which permits cancellation

of trademarks that are generic, the term Basmati has become a generic term for a particular category of rice and hence cannot be protected Finally, even if the Indian government could win on the point of the strength of the mark, Rice Tec still has a good argument that its use of the term Basmati does not cause confusion among consumers, who can see that rice comes from Texas, not India This is because in the

case of Mother's Restaurant v Mother's Other Kitchen, Inc., 218 U.S.P.Q 1046 (TTAB 1983), the

Court rejected opposition claim by Canadian company alleging likelihood of confusion between Canadian company's registered Mother's mark and US company's Mother's mark because “prior use and advertising of a mark in connection with goods or services marketed in a foreign country creates

no priority rights in said marks in the United States”

85 Agricultural and Processed Food Products Export Development Authority

and 14-20 (the broad claims covering the rice plant) and entered amendments to claims 12-13 on the definition of chalkiness of the rice grains Claims 8, 9, and 11 covering the specific samples of the plant from the genetically modified seed itself still stand

Implications

Rice Tec has lost its claims that provide a specific written description of the plants that the company claims ownership in Rice Tec must rely on the seeds deposited at the ATCC86 since under claims 8, 9 and 11 it still has valid claims in the plants that are

germinated from the seed The title of the patent now reads: “Bas 867, TR1117 and

RT 1121” based on the rice lines developed by Rice Tec.87

Other cases like the Hoodia Cactus patent88 and the Hessian Jute patent89 have also fueled the biopiracy outcries from the third world countries.90

86 American Type Culture Collection

87 The abstract reads: “the invention relates to novel rice lines and to plants and grains of these lines The invention also relates to a novel means for determining the cooking and starch properties of rice grains and its use in identifying desirable rice lines Specifically, one aspect of the invention relates to novel rice lines whose plants are semi-dwarf in stature, substantially photoperiod insensitive and high yielding, and produce rice grains having characteristics similar or superior to those of good quality Basmati rice Another aspect of the invention relates to novel rice lines produced from novel rice lines The invention provides a method for breeding these novel lines A third aspect relates to the finding that the starch index (SI) of a rice grain can predict the grain's cooking and starch properties, to a method based thereon for identifying grains that can be cooked to the firmness of traditional Basmati rice preparations, and to the use of this method in selecting desirable segregants in rice breeding

programs” See supra note 79

88 Hoodia Cactus: The San, who live around the Kalahari Desert in southern Africa, have traditionally eaten the Hoodia cactus to stave off hunger and thirst on long hunting trips In 1995 South African Council for Scientific and Industrial Research (CSIR) patented Hoodia’s appetite-suppressing element

In 1997 they licensed the patent to the UK biotech company, Phytopharm In 1998, the pharmaceutical company Pfizer acquired the rights to develop and market P57, a potential slimming drug and cure for obesity (a market worth more than £6 billion), from Phytopharm for up to $32 million in royalty and milestone payments On hearing of possible exploitation of their traditional knowledge, the San People threatened legal action against the CSIR on grounds of “biopiracy” They claimed that their traditional knowledge had been stolen, and CSIR had failed to comply with the rules of the Convention on

Biodiversity, which requires the prior informed consent of all stakeholders, including the original discoverers and users An understanding now has been reached between the CSIR and the San whereby the San, recognised as the custodians of traditional knowledge associated with the Hoodia plant, will

The aforesaid cases are illustrative of the fact that industries are looking towards the vast bio-resources and the traditional knowledge of their use in field of medicine When patent protection is granted to products based on traditional knowledge already

in the public domain, they can be challenged on the grounds of novelty and inventive step, as seen above While some jurisdictions, for instance the EPO, subject the patent applications through strict scrutiny before the patents are granted, other patent systems follow the rules of ‘first to file’ and ‘issue first – revoke later’ What this

receive a share of any future royalties See, The SAN and the CSIR to formulate benefit-sharing model

for anti-obesity patent , 22 March, 2002 available at

<http://www.csir.co.za/plsql/ptl0002/PTL0002_PGE013_MEDIA_REL?MEDIA_RELEASE_NO=180

0500> (last accessed on 5 July 2004) Joint media release by the South African San Council and the

CSIR, Scientists and South African San join forces in research project on San use of indigenous

plants: Bioprospecting agreement between the CSIR and the South African San Council signed in Upington, 28 October 2004, available at

<http://www.csir.co.za/plsql/ptl0002/PTL0002_PGE013_MEDIA_REL?MEDIA_RELEASE_NO=723 3055> (last accessed on 12 December 2004)

89 Jute ‘Hessian’ Patent: Jute is a principal agricultural produce of India It is a natural fiber and has qualities of being cheap, its fabrics being used for various purposes including garments and covers Geo-Hess, a UK based company, in view of present day global concerns on non-biodegradability of plastics and anticipating the huge market demands of bio-degradable covers, sometime in 1994 filed an application for European Patent claiming the use of Hessian (a jute variety) sheet as a bio-degradable cover for waste The European Patent (no 728048) was given to Geo-Hess, for the use of ‘Hessian’ cloth on landfill sites, to cover rubbish Geo-Hess then claimed that anyone covering rubbish with

‘Hessian’ cloth would have to pay a royalty of 65 per cent of the cost of ‘Hessian’ in the UK, where the company was registered The company also sent claim notices to a number of firms that were using Hessian for covering land-fills, prior to the patent grant The patent application was contested by the Jute Manufacturers Development Council (JMDC), in India, on the grounds that the invention lacked both novelty and inventive merit The argument made by the JMDC was that when canvas, a jute variety, was well known as waste cover there can be no invention in suggesting use of Hessian, another jute variety, for same purpose EPO opposition division based its decisions on the documentation and arguments of the JMDC and revoked the GEOHESS patent citing non-inventiveness It is submitted that the EPO decision does not give merit to the argument against novelty in use of Hessian, as covering cloth This is because the traditional use of jute in India was not documented adequately See,

JMDC website at http://www.jute.com (accessed on 12 October 2004)

90 While this is not a biopiratical invention, an example of controversies relating to multi national corporations and developing countries is the issue of cultivation of Monsanto’s genetically modified Bt.Cotton in India Though some claim that Bt.cotton, with its enhanced capacity to ward off bollworm pests, is a success; others condemn the Government of India decision to allow the cultivation of the transgenic cotton, and, refer to instances of failure of the genetically modified seeds to deliver results,

or of instances where farmers have been defrauded with fake seeds For a supporting view, see, Bt

Cotton Creates Three Times the Earnings for Indian Farmer at Council of Biotechnology Information

website at http://www.whybiotech.com/index.asp?id=4515 (accessed on 4 October 2005) ; R.B Barwale, V.R Gadwal, Usha Zehr, & Brent Zehr, Prospects for Bt Cotton Technology in India, at

<http://www.agbioforum.org/v7n12/v7n12a04-zehr.htm> (last accessed on 4 October 2005) For a

dissenting view see, amongst others, Rhea Gala, India’s Bt cotton Fraud, at

<http://www.i-sis.org.uk/IBTCF.php> (last accessed on 4 October 2005).; Dr Suman Sahai’s views in Sheela Bhatt,

Expert demands inquiry into Bt cotton cultivation, at <http://in.rediff.com/news/2005/sep/29bt.htm>

(last accessed on 4 October 2005)

implies is that the person who files the patent application first, and has the earliest priority date, is awarded the patent, whether or not he is the inventor or the owner Also in the patent systems in most countries, biotechnology patents are granted without much initial challenge or search, with the good faith belief that in case of an illegality, the actual inventor will initiate revocation proceedings This system of fairness does not work where the true owners, are far distanced from the modern world of patents and industry like in many cases of traditional knowledge

In the cases discussed above, invalid patents were issued because the patent examiners were not aware of the relevant traditional knowledge Traditional knowledge collections do not form part of the prior art databases available to many patent examiners To be fair to the present system, a patent examiner can only examine an application against all ‘known’ inventions In the case of traditional knowledge, the policy of secrecy by traditional knowledge holders makes it difficult for a thorough search to be fruitful

1.4 APPLICATION OF CONVENTIONAL IPRS ON TRADITIONAL KNOWLEDGE

According to WIPO, intellectual property refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, and designs used in commerce.91 Cornish has stated that “Intellectual property protects applications of ideas and information that are of commercial value.”92 The whole range of intellectual property includes patents protecting technological inventions; copyright protecting literary, artistic or musical creations; trade mark laws protecting trademarks against

91 See, World Intellectual Property Organization, About Intellectual Property, at

<http://www.wipo.int/about-ip/en/ > (last accessed on 5 November 2004)

92 See supra note 12, at 4

imitation The list is not exhaustive since new kinds of intellectual creations are emerging These inventions deserve protection but are often not very easily protected through standard IP protection laws.93

1.4.1 Patents, TRIPS and traditional knowledge

The different categories of traditional knowledge may fall within different intellectual property rights protection94 such as: patents, copyrights95, trademarks,96 geographical indications.97 Protection for biological resources through intellectual property rights legislation, such as patents, have traditionally been excluded on grounds of public morality because of the need to encourage everyone from the smallest farmer to multinational companies to foster innovations and to prevent commercialisation of critical sectors like food and healthcare However pharmaceutical companies have

93 An example is computer programs Due to word limit limitations and limited relevance to the central theme of the thesis, the issue of copyright protection of software is not being discussed It is only mentioned that Under Section 7A of Singapore Copyright Act, Chapter 63, enforce from 1 January

2005, literary work includes computer programs While this is consistent with the position taken by the international for a, since TRIPS, under Article 10, provides for protection of computer programs as literary works, whether patents are more suitable rights for protecting computer programs is still a much debated issue

94 The interface of some of these rights and traditional knowledge is discussed in Chapter III, section

3.2 of the thesis

95 Copyright: Copyright is a right given for a limited period against the copying of defined types of cultural, informational; and entertainment productions These works include literary, dramatic, musical and artistic works, cinematography film and sound recordings Copyright mostly relates to the right to copy or reproduce the work in which copyright subsists The right is to reward “that distinctness which results from the creator’s myriad choices made in the course of constructing the work in the chosen medium.” According to Cornish, the basis of copyright lies in the personal character in the subject matter of the copyright work It is the expression of the work which is protected rather than the idea behind it Hence copyrights are not concerned with the originality of ideas but that of the thought or expression While the parameters for evaluation of originality of ideas or aesthetic value are subjective, copyright aims to protect the more tangible skill, judgment, labour and economic investments made in

the work Hence lists like timetable index in Blacklock v Pearson [1915] 2 Ch 376; or street directories in Kelly v Morris (1866) L.R 1 Eq 697 have been recognized as copyrightable subject matters See, supra note 12 at ¶ 1-06

96 Trademark: A trademark is a formally registered symbol identifying the manufacturer or distributor

of a product A person selling his goods under a trademark acquires a limited exclusive right for use of the mark in relation to the goods Such right is recognized as a property in the trade mark and is protected under the common law till such mark is used

See, supra note 12 at ¶ 15-04 to 15-07

97 See, Chapter III section 3.2.2

attempted to protect traditional antidotes to modern diseases98 by patents though requirements of patentability often do not match the attributes of folk medicines

Some conflicts stem from the fact that folk medicines include knowledge of traditional cures involving herbs, leaves, and other treatments often unknown to the rest of the world.99 These cures are tailor-made to suit the genetic makeup of people who are immune from certain diseases thus far considered incurable in other parts of the world but vulnerable to some other diseases unique to their genetic make World Health Organization100 defines traditional medicine as “the sum total of all the knowledge and practices, whether explicable or not, used in diagnosis, prevention and elimination of physical, mental or social imbalance and relying exclusively on practical experience and observations handed down from generation to generation, whether verbally or in writing”.101 Indigenous knowledge, being part of the public domain and being trans-generational and communally shared, is therefore not protectable

Evaluation of the suitability of patents for protection of traditional knowledge and related genetic resources reveals that the subject has not been effectively dealt with in

98 For example, the rosy periwinkle, unique to the Madagascar region, contains properties that can cure certain forms of cancer See, http://www.herbs2000.com/herbs/herbs_periwinkle.htm (accessed on 5

June 2005) The anti-cancer drugs ‘vincristine’ and ‘vinblastine’, developed from this plant, resulted in

annual sales of around USD 100 million for Bristol-Myers Squibb See, NAOMI ROHT-ARRIAZA,

Of Seeds and Shamans: The Appropriation of the Scientific and Technical Knowledge of Indigenous and Local Communities, in, BORROWED POWER: ESSAYS ON CULTURAL APPROPRIATION

(Bruce Ziff & Pratima V Rao, eds., 1997) 255 at 256

99 Traditional medicines, catering to local ailments and comprising of locally available resources including foliage, are difficult to replicate in other geographical locations

100 World Health Organisation, also referred to as WHO is a United Nation’s organisation established

to supervise health care around the world It was established in 1948 and is headquartered in Geneva Presently it has 192 member states, including all UN Member States except Liechtenstein More about

WHO can be found at http://www.who.int/ (last accessed on 5 October 2005)

101 See, World Health Organisation, Traditional Medicine Programme., at

<http://www.who.int/medicines/organization/trm/orgtrmdef.shtml> (last accessed on 4 September 2004)

international IPR laws The most significant IPR treaties in the context of biodiversity and international trade regime are CBD and TRIPS While CBD incorporates measures for protection of traditional knowledge, the more far-reaching TRIPS, is silent about the subject Patents are covered under Article 27 of the TRIPS

‘Patentable Subject Matter’, enumerated in Article 27, reads:

“Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced”

Article 27(2)102 goes on to list grounds for exclusion from patentability It allows Member States to bar the patenting of inventions when the commercial exploitation

conflicts with ordre public or morality This includes protection of human, animal or

plant life or health or to avoid serious prejudice to the environment.103 Article 27(3)(a) further permits member states to exclude diagnostic, therapeutic and surgical methods for the treatment of humans and animals Article 27(3)(b)104 extends the list of

102 Article 27(2) TRIPS Agreement: Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect

ordre public or morality, including to protect human, animal or plant life or health or to avoid serious

prejudice to the environment, provided that such exclusion is not made merely because the exploitation

is prohibited by their law

103 However as per Article 27(3)(b), members shall provide for the protection of plant varieties either

by patents or by an effective sui generis system or by any combination thereof The provisions of this

subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement

104 Article 27(3)(b), TRIPS Agreement: Members may also exclude from patentability: …(b)plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes However, Members shall provide for

the protection of plant varieties either by patents or by an effective sui generis system or by any

permissible exclusions to include plants, animals, other than microorganisms, and essentially biological processes for the production of plants and animals other than non-biological and micro-biological processes Whilst Articles 27(2) and (3) do set out important permissible exclusions, it must be stressed that Article 27(3)(b) requires

members to protect plant varieties either by patents or by an effective sui generis

system Further, Article 27(3)(b) does not allow exclusion for microorganisms and non-biological and micro-biological processes Given the importance of Article 27(3)(b), its provisions are made expressedly subject to review four years after date of entry into force of the WTO Agreement

This option intensifies the debate concerning IPRs for biological and genetic resources between the technology-rich North and the gene-rich South Article 27(3)(b) has been used by some member nations to ban patenting of life forms especially those falling under biotechnology domain There has been continuous pressure from countries like the US to review the ban on patenting of life forms These countries have argued that biotechnology inventions involve extraction or isolation of genes found in plants and animals, and since the results of the bio-technological processes are essentially microbiological, the resultant products should

be granted patent protection just like other organic chemicals The divergent view is that, since Article 27(3) (b) sanctions excluding ‘essentially biological processes’,105

or controlling the result it is desired to achieve, the process would not be excluded.”

See, GRAHAM DUTFIELD, INTELLECTUAL PROPERTY, BIOGENETIC RESOURCES AND TRADITIONAL KNOWLEDGE, (2004) 29