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
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

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.

.
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.

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
11
positive protection of TK

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
14
known medicinal plants/their knowledge

FOLLOW UP ACTION AND AREAS OF

COOPERATION
i.

ii.
iii.

iv.

v.
vi.

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 Sui
Generis regime and principles of TK
protection
Scope of protected subject matter
Mechanisms of Access to TK
Requirements of protection of TK

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

3rd and 4th 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, noncommercial 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 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.
24

Draft SAARC Legal Framework

1.

2.

3.

Duration of protection: For it, three

aspects mentionedProtection 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.
28

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 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)
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)).
33

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.
34

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

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 biopiracy and to protect, respect and conserve
TK related to PGRs of local people.
36

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.

37

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.
38

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

39

Documentation of biodiversity TKDL

the Bio-diversity Management Committees (at local

level) are entrusted with the documentation of biodiversity in order to monitor and protect bioresources 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 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.
41

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.
42

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.
43

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
44
solution for TK protection

45