PROTECTION OF TRADITIONAL KNOWLEDGE : INDIA’s EFFORTS

Professor (Dr.) S.K. Verma University of Delhi Team Leader EU-India TIDP – IPR Component Seminar on Industrial Property (IPR) Cochin University of Science & Technology 25 January 2007 1

THE CONTEXT

       Significance of TK Protection TK valuable in global economy, Important for biotechnology based industries industry and agriculture, Traditional societies depend on it for their food and healthcare needs, Important for conservation and sustainable development of environment and management of biodiversity, Food security of the country is linked to protection of TK Need to enable tribsl communities to harness TK for their economic uplift and growth Fast mobility of tribal societies 2

THE CONTEXT

   Large array of reported cases on misappropriation/biopiracy of TK Patents on natural products – neem, turmeric, Basmati rice, Hoodia cactus, African potato, ayahuasca, may apple Infringement of many artistic works of indigenous people of Africa, Australia 3

THE CONTEXT

International Initiatives for Protection of TK  CBD – Art. 8(j); Bonn Guidelines on Access and Benefit Sharing related to GRs   WIPO – IGC (working since 2000); Efforts of PCT, IPC Revised Draft Provisions for the Protection of TK, two sets of Draft provisions – TCEs & TK WTO/TRIPS – Art. 27(3)(b) Art. 70(3) Art. 71(1) Doha Declaration-paras 19 and 32 4

•Other Bodies     FAO – ITPGRFA UNCTAD ILO Convention - No. 169 of 1989 UN Sub-Committee on the Protection and Promotion of Human Rights – Working Group on Indigenous   Populations UN Convention to Combat Desertification IGC Draft provisions list the issues to be considered by policy makers while considering the form and means of protection at national, regional and international level 5

IGC – Draft (TK Protection)

  Policy Objectives (16) Respect. Recognition - TK Conservation & Preservation, TK holder - PIC & ABS - TK &TCE linkages Core Principles (9) - Need & Expectations - Recognition - Customary laws - Specificity of TK 6

IGC – Draft (TK Protection)

 Substantive Principles (14) Misappropriation - Scope of subject matter, Eligibility for protection - Beneficiary, PIC & ABS - Acquisition of Rights and Formalities - Duration of Protection - International and Regional Protection 7

SUMMARY OF INTERNATIONAL INITIATIVES

     Predominant View for devising a Sui Generis regime for TK Protection Emphasis mainly on the IP protection which promotes the marketable technology/product only, holistic character of TK difficult to protect Demands of Developing Countries now mainly centered on the following Two Issues: Patent applicant must disclose the country and source of origin of biological material and TK; Patent applicant must provide evidence on compliance with the country of origin’s laws on PIC and benefit sharing India has moved for an amendment of Art. 29 of TRIPS along with other countries in this respect.

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Developed Countries’ prefer  Bilateral contracts; and  Databases and Registers on TK – non-accrual of economic benefits are not addressed by databases; only TK in the public domain is listed; part of defensive protection, little role in positive protection of TK; static and rigid - not conducive for dynamic character of TK; may fuel further piracy.

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National/Regional Initiatives

    So far 24 National and 7 Regional initiatives have been taken for TK protection Most of them have the CBD approach EU approach on indication of source (Recital 27 of Biotechnology Directive) There is a wide variation in the scope and extent of protection- covering community and farmers’ rights in some cases, e.g. Model law for Africa 10

PROTECTION OF TK TO SAARC REGION

     SAARC countries are: Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka.

SAARC Region is rich in TK and had been subjected to misappropriation and bio-piracy of its TK in the past Rich in biodiversity, much of it is used in traditional manner Region has a predominantly common cultural traditions and share tremendous commonality, requiring a joint approach on TK protection Joint efforts necessary for defensive as well as positive protection of TK 11

SAARC-WIPO SUB-REGIONAL FORUM AND AGENDA FOR TK PROTECTION

   Four meetings of the Forum: Colombo (1998), Kathmandu (1999), Dhaka (2001) and Thimpu (2002), and an Expert workshop in New Delhi (2003) Preservation and promotion of TK was identified as one of the areas of cooperation in 1998 The Third SAARC-WIPO Forum (2001)outlined the strategy on TK protection with particular emphasis on: 12

 Collective ownership of TK  Documentation of TK, establishing systems for access and benefit sharing in relation to GRs, creation of a community knowledge fund for these purposes, and human resource development  Proposed model legislation on TK, mechanisms, contractual terms and practices, regulating access to and benefit sharing in GRs, protection and conservation - a model relevant for international protection of TK 13

 Documentation of TK ,including folklore  Common stand at the IGC meetings  Use of information technology for effective and coordinated enforcement of IPRs (including TK); and to designate focal points for coordination and follow-up  Agreed to build synergies on collective action for the enforcement IPRs on a sub-regional basis Coordinated program for Regional Action

Fourth Meeting of the Forum

Reiterated the decisions of the Third Forum with the addition of preparing an inventory on TK, particularly on known medicinal plants/their knowledge 14

i.

ii.

iii.

iv.

v.

vi.

FOLLOW UP ACTION AND AREAS OF COOPERATION

Ist Expert Workshop on TK held in November 2003 in Delhi Emphasized the coordinated program for SAARC Regional Action Discussed the basic elements for a Generis regime and principles of TK protection Scope of protected subject matter Mechanisms of Access to TK Requirements of protection of TK Sui 15

The Workshop did not discuss: a. Scope of the rights b. Right holders c. Procedure for Acquisition & Maintenance of Rights The Workshop was concerned with the TK and GRs and not with the Folklores It also did not discuss the access conditions to TK Documentation and Databases 16

AREAS OF COOPERATION

3 rd and 4 th SAARC-WIPO Forums identified wide agenda Emphasized cooperation at International/ Regional levels

International Cooperation

 Prevention of Bio-piracy a) A common stand in the IGC meetings on the issue b) Under WTO/TRIPS insistence on disclosure, PIC and benefit sharing requirements c) Exclusion of life-forms from patentability 17

d) Amendment of Article 29 of TRIPS e) Uniform national legislation to this extent

Regional Measures

• Adoption of a Model Law on the lines of African Union, Andean Community or on ASEAN Nations (yet to be adopted) • Mutual and reciprocal recognition of TK amongst them • Preparing mutually recognized databases on TK • Led to the adoption of Legal Instrument for SAARC Countries on Protection of TK (Draft SAARC Framework) 18

Draft SAARC Legal Framework

    Registration and setting up of Licensing mechanism (registration optional, conceive SAARC TKDL for defensive and positive protection, registers, databases etc.) Protection for open domain TK databases Defensive Protection and faster invalidation of wrong patent Customary laws- (to be respected in the protection of TK) 19

Draft SAARC Legal Framework

     Defines TK in line with the IGC’ draft provisions and includes the know-how, skills, innovations, practices and learning that form part of TK systems, knowledge embodied in traditional life style of a community or people, or contained in codified knowledge systems. Scope of protected subject matter is wide and includes the compiled TK in registries, digital libraries or databases against misappropriation and misuse beyond the traditional context Provides a broad framework of eligibility for protection which TK should meet (Art. 4, draft) Procedure for enforcement nationally and regionally Form of positive protection 20

Draft SAARC Legal Framework

  i.

ii.

Prohibits acquisition of TK or exercising control over it in violation of PIC requirements and defines such acquisition as an act of misappropriation.

Exceptions and limitations to TK acquisition: use, exchange and transmission for customary practice by TK holders; Use of traditional medicines for household purposes, government hospitals, non commercial public health purposes 21

Draft SAARC Legal Framework

   Benefit sharing: Commercial or industrial use of TK requires just and appropriate compensation; - equitable compensation to recognized TK holder; - equitable compensation to Competent authority if TK holder not identifiable No compensation for non-commercial use, but suitable benefit sharing be encouraged – access to research outcomes and involvement of source community in research and educational activities 22

Draft SAARC Legal Framework

  PIC: Acquisition of TK in violation of PIC, use of TK in violation of mutually agreed terms on access to TK amounts to acts of misappropriation. TK readily available to the general public excluded from this requirement, but if commercially used to provide equitable compensation (to whom?) 23

Draft SAARC Legal Framework

   Enforcement: important for TK’s maintainability to achieve the objectives of protection. For this a Competent Authority/authorities visualized, having range of functions.

Measures to be fair and equitable, not burdensome for holders and be accessible.

Provide safeguards for legitimate third party interests and of the general public.

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Draft SAARC Legal Framework

 1.

2.

3.

Duration of protection: For it, three aspects mentioned Protection against misappropriation – last indefinitely so long TK fulfils the criteria of eligibility; Protection against commercial uses without equitable compensation – fixed term from the filing date of declaration (not specified) Against other acts under national laws – national laws to specify the duration 25

Objectives of the protection

- prevent the misappropriation of TK - ensure PIC and benefit sharing - ensuring the distribution of benefits - conservation of biodiversity - rewarding innovations based on TK The draft highlights:   Role of Governments in positive protection Access Mechanism for TK 26

Main premise of Protection:  Bonn Guidelines  Capacity building of indigenous/ local people  Access for non-commercial and educational purposes •Modes of protection of TK :

sui generis

regime, customary law, contractual terms, common law principles, land laws etc.

•Identifying the national measures to preserve TK and traditional ways of life , values and legal structure – recognition of customary laws and protocols 27

DATABASES ON TK

Databases require in-puts on the following:  Policy directions on the purpose of databases  Involvement of the indigenous communities   Consultation with the stakeholders Choice of mechanism of documentation  Necessary Measures during documentation and after documentation for continuous updating India and Pakistan provide provisions under their laws.

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National Attempts to Protect TK – Bangladesh

Biodiversity and Community Knowledge Protection Act, 1998 (draft)  Communities are the common owners or sole custodians of the biological and genetic resources      Community rights held by people in perpetuity Establishes an access regime and includes a reciprocity clause Not less than 50% of the net monetary gains from commercialization of biological and genetic resources to be shared with the concerned community/group as community Provides for National Biodiversity Information System and makes registration compulsory, with responsibility of NBIS Access and collection with the approval of NBA, a fixed fee for prospecting 29

National Attempts to Protect TK – Pakistan

        Access to Biological Resources and Community Rights, 2004 (draft) Applies to biological resources and related knowledge, technologies- in-situ and ex-situ Access on mutually agreed terms & PIC, and competent authority (national) National authority to decide about the terms and conditions of access State to recognize and protect the community rights, who are lawful custodians in perpetuity, their involvement perceived in conservation of TK At least 10% of benefits to be paid to concerned community from commercial use of bio-resources A national inter-sectoral coordination committee for implementation and enforcement of the legislation Establishment of National Information System (concerned with R&D activities) 30

National Attempts to Protect TK India

  India: 3 Acts relevant on the issue Patents (Amendment) Act, 2005   Protection of Plant varieties and Farmers’ Rights Act, 2001 Biological Diversity Act, 2002- contains elaborate provisions on benefit sharing but weak in prior informed consent and involvement of communities in decision-making Recently to protect the rights of tribals, the Government has introduced a bill – Scheduled Tribes (Recognition of Forest Rights) Bill, 2005; cleared by the Cabinet 31

Patents (Amendment) Act

    Makes including biological processes biochemical, microbiological processes (sec. 5).

as patentable, biotechnological and Microorganisms are patentable (sec. 3(j)).

For patent on biological material, specifications must disclose the source and geographical origin of the biological material used in the invention (sec. 10(d)).

Non-disclosure a ground for opposition of the patent (sec. 25) 32

   A patent is refused or revoked for giving wrong information about the source of geographical origin of biological material (sec. 64(p)(q)).

Plant varieties or essentially biological processes are non-patentable (sec.3).

An invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component/s is also non-patentable (sec.3

(p)).

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Protection of Plant Varieties and Farmers’ Rights Act, 2001

 Makes provisions for benefit-sharing and compensation for traditional, rural and tribal communities.

  Creates a nodal body – Plant Varieties and Farmers’ Rights Protection Authority at the national level.

Provides for a National Gene Fund.

 Authority is empowered to determine the benefit sharing for individuals or groups when a protected variety is developed, using their genetic material.

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Protection of Plant Varieties and Farmers’ Rights Act, 2001

  Amount of compensation dependent upon the extent and use of their genetic material and the commercial utility of the variety.

Amount from the benefit sharing will be credited in the Gene Fund, village community be paid out of it conservation and sustainable use of GRs for 35

Biological Diversity Act, 2002

   Gives effect to the mandate of CBD and to some extent PGRFA Treaty.

Addresses generally issues of biodiversity management, and PGR management in particular.

Main focus is to address the issue of bio piracy and to protect, respect and conserve TK related to PGRs of local people.

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Biological Diversity Act, 2002

   Nodal Agency – National Biodiversity Authority; State Biodiversity Boards, Biodiversity Management committees are also created  Biodiversity Funds at central, state and local levels.

To check bio-piracy, access to PGRs is regulated.

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Main Provisions of the Act

Act provides for the prior approval of the NBA: • • • by foreign individuals, companies or associations to obtain any biological resources occurring in India or knowledge thereto for research, commercial utilization, bio-survey or bio-utilization.

Transfer of research result relating to these resources, publication are followed.

of research papers etc.

is exempted; collaborative research projects also exempted; if guidelines Prior permission is also required if inventor seeking any kind of IPR in or outside India of an invention based on biological research or information on a biological resource obtained from India.

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• • • For patent, prior permission of the NBA required after the acceptance of the patent but before the sealing of the patent by the patent authority concerned.

The NBA may take steps to oppose the grant of IPRs outside India.

NBA may impose benefit sharing fee or royalty or both on the commercial utilization of such IPR related product.

  The NBA, while granting approval, will ensure equitable sharing of benefits on mutually agreed terms – between persons seeking approval, local bodies concerned and the benefit claimers.

NBA to frame guidelines on access and benefit sharing – Benefit Sharing may be in monetary or non-monetary terms, including joint ownership of IPRs with the NBA or identified claimers (sec. 21).

National Bio-diversity Fund to channel benefits

to the claimers.

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Documentation of bio diversity TKDL

    the Bio-diversity Management Committees (at local level) are entrusted with the documentation of bio diversity – in order to monitor and protect bio resources to curb bio-piracy and effectively challenge the IPRs granted in foreign jurisdictions.

Varied private experiments in documentations are already underway – open registers and close registers modes exist Other successful peoples’ biodiversity registers are Shristi and Honey bee.

Case of Arogyapacha 40

TKDL     The Government of India has prepared a Traditional Knowledge Digital Library (TKDL) on TK about medicinal plants, to ward off incidence of piracy, containing 36,000 formulations used in

Unani , Siddha

ancient books.

Ayurveda - Indian system of medicine, from 14 , 1,60,000 have been further transcribed Access to examination TKDL regulated through “Access Agreement”, confidentiality to be maintained, TKDL information use is limited to patent search and Registers have limited utility.

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     

Grey Areas

Guidelines and framework on benefit sharing are yet to be framed.

Clearly establishes that creators and holders of TK do not have property rights over their knowledge – but IPRs for community fraught with some difficulties, both in enforcement and grant.

Biological Diversity Rules, 2004 framed. Act in force.

Not clear whether the reward will be monetary or non-monetary or both; whether monetary reward will be one-time payment etc.

No machinery provided for disputes resolution on ABS.

Mode of benefit sharing and the identification of probable stake-holders and distribution of benefit are fraught with many problems.

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  No definition of TK is attempted.

The Act outlines the framework of benefit-sharing when the foreign party is involved   The Government’s approach in India towards IPRs and biological resources is CBD – centric  Actual operation of these legislations is yet to be seen   Fine-tuning on benefit sharing is yet to be done Main efforts presently confined to check bio-piracy  Mandatory disclosure of source pertaining to biological resources and knowledge thereto in patent application has put in place

On ABS, an international framework is necessary to facilitate the flow of PGRs.

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Conclusion

      The three legislations provided ample scope to check the misappropriation of TK- part of defensive protection Action is required for positive protection The effect of the Acts is yet to be seen, number of bodies may not be working in unison A holistic approach to protect TK is required, for the capacity building of thesel societies At regional/international level mutual recognition and reciprocity in enforcement of TK important, which is yet to be devised TKDL/documentation important but not the solution for TK protection 44

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