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PROTECTION OF TRADITIONAL KNOWLEDGE : INDIA

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PROTECTION OF TRADITIONAL KNOWLEDGE : INDIA s EFFORTS Professor (Dr.) S.K. Verma University of Delhi Team Leader EU-India TIDP IPR Component – PowerPoint PPT presentation

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Title: PROTECTION OF TRADITIONAL KNOWLEDGE : INDIA


1
PROTECTION OF TRADITIONAL KNOWLEDGE INDIAs
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
2
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

3
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

4
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

5
  • 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

6
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

7
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

8
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 origins laws on
    PIC and benefit sharing
  • India has moved for an amendment of Art. 29 of
    TRIPS along with other countries in this respect.

9
  • .
  • 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.

10
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

11
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

12
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

13
  • 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

14
  • 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

15
FOLLOW UP ACTION AND AREAS OF COOPERATION
  1. Ist Expert Workshop on TK held in November 2003
    in Delhi
  2. Emphasized the coordinated program for SAARC
    Regional Action
  3. Discussed the basic elements for a Sui Generis
    regime and principles of TK protection
  4. Scope of protected subject matter
  5. Mechanisms of Access to TK
  6. Requirements of protection of TK

16
  • The Workshop did not discuss
  • Scope of the rights
  • Right holders
  • 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

17
  • AREAS OF COOPERATION
  • 3rd and 4th SAARC-WIPO Forums identified wide
    agenda
  • Emphasized cooperation at International/ Regional
    levels
  • International Cooperation
  • Prevention of Bio-piracy
  • A common stand in the IGC meetings on the issue
  • Under WTO/TRIPS insistence on disclosure, PIC and
    benefit sharing requirements
  • c) Exclusion of life-forms from patentability

18
  • 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)

19
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)

20
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

21
Draft SAARC Legal Framework
  • 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

22
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

23
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?)

24
Draft SAARC Legal Framework
  • Enforcement important for TKs 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.

25
Draft SAARC Legal Framework
  • 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

26
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

27
  • 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

28
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.

29
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

30
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 RD activities)

31
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

32
Patents (Amendment) Act
  • Makes biological processes as patentable,
    including biochemical, biotechnological and
    microbiological processes (sec. 5).
  • 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)

33
  • 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)).

34
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.

35
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 for conservation and sustainable use of GRs

36
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.

37
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.

38
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 of research papers etc. is
    exempted collaborative research projects also
    exempted if guidelines are followed.
  • 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.

39
  • 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.

40
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

41
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
    Ayurveda, Unani, Siddha - Indian system of
    medicine, from 14 ancient books.
  • 1,60,000 have been further transcribed
  • Access to TKDL regulated through Access
    Agreement, confidentiality to be maintained,
    TKDL information use is limited to patent search
    and examination
  • Registers have limited utility.

42
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.

43
  • No definition of TK is attempted.
  • The Act outlines the framework of benefit-sharing
    when the foreign party is involved
  • The Governments 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.

44
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

45
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