PROTECTION OF TRADITIONAL KNOWLEDGE : INDIA

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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
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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

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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

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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

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• 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

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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

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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

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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.

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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

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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

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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

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• 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

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• 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

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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

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• 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

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• 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

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• 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)

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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)

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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

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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

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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

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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?)

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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.

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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

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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

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• 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

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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

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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)

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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

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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)

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• 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 for conservation and sustainable use of GRs

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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 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.

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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

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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.

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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 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.

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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

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Thank You