2. Traditional Knowledge
(TK)
TK associated with the biological
resources is the knowledge about a
country‟s biodiversity; the applied uses
and applications of biological resources
and the prevalent practices.
It is an intangible component of the
resource itself. TK has the potential of
being transformed into commercial
opportunity, providing useful leads for
development of products and processes.
Hence, a share of benefits must accrue to
creators and holders of Traditional
Knowledge (TK).
2
3. What is Biodiversity?
Biological diversity comprises all
species of plants, animals and
microorganisms and the variation
between them, and the ecosystems
of which they form a part.
3
4. Biopiracy
Misappropriation of TK
for the purpose of
seeking exclusive patent
ownership over that
knowledge.
The process through
which the rights to
genetic resources and
knowledge are “erased
and assumed by those
who have exploited
indigenous knowledge
and biodiversity.
4
5. Key Issues Surrounding
Biopiracy
Understanding the precise legal status
of genetic resources and traditional
knowledge,
Understanding the exact boundaries of
biopiracy in order to ensure more
effective measures to confront this
phenomenon,
At
present, bioinformatics, proteomics, ge
netic engineering and synthetic
biology, among others, promote more
subtle ways of misappropriation and
illegal access to and use of genetic 5
6. Some Examples of Biopiracy of
Traditional Knowledge
Colgate Case
Colgate, the world‟s largest producer of toothpaste, patented a tooth
cleaning powder.
American household goods giant was granted the patent in the U.S.
in June for what it claimed was a groundbreaking “red herbal
dentifrice.”
Indian activists claim that the patent is bogus because the
ingredients - including clove oil, camphor, black pepper and
spearmint - have been used for the same purpose for hundreds, “if
not thousands,” of years on the subcontinent.
However, its patent filing argues that the use of red iron oxide, which
is less abrasive than ingredients in traditional toothpaste, is new.
According to Colgate the old recipe has become new, and through
this “legal contraption”, the American company intends not to pay
royalties.
India is in the process of creating 34 million web pages to help
prevent the “biopiracy” of its ancient folk remedies that document
the techniques and claim them as Indian property.
The matter is pending before the USPTO.
6
7. Turmeric Case
In 1995, two Indian nationals at the University of
Mississippi Medical Centre were granted US patent no.
5,401,504 on "use of turmeric in wound healing".
The Indian Council of Scientific and Industrial
Research (CSIR) requested the US Patent and
Trademark Office (USPTO) to re-examine the patent.
CSIR argued that turmeric has been used for
thousands of years for healing wounds and rashes
and therefore its medicinal use was not novel.
Their claim was supported by documentary evidence
of traditional knowledge, including an ancient Sanskrit
text and a paper published in 1953 in the Journal of
the Indian Medical Association.
Despite arguments by the patentees, the USPTO
upheld the CSIR objections and revoked the patent.
7
8. Basmati Rice Case
In late 1997, an American company RiceTec
Inc, was granted a patent by the US patent
office to call the aromatic rice grown outside
India „Basmati‟. RiceTec Inc, had been trying to
enter the International Basmati market with
brands like „Kasmati‟ and „Texmati‟ described
as Basmati-type rice with minimal success.
CSIR challenged the rice patent.
After reexamination, the USPTO disallowed all
the physical characteristic claims.
The Indian Government, a strong advocate of
geographical indications for food
products, claimed victory when the USPTO
limited the number of claims granted to
RiceTec.
RiceTec still has a patent and can still call its
rice Basmati. 8
9. Examples of Biopiracy of TK:
An International Perspective
Hoodia Cactus Case
Hoodia, a succulent plant, originates from the Kalahari Desert of South
Africa. For generations it has been known to the traditionally-living San
people as an appetite suppressant.
In 1995 CSIR patented Hoodia‟s appetite-suppressing element (P57).
In 1997 they licensed P57 to the UK biotech company, Phytopharm.
In 1998, Pfizer acquired the rights to develop & market P57 as a potential
slimming drug & cure for obesity from Phytopharm for upto $32 million.
The San people eventually learned of this exploitation of their traditional
knowledge, and in June 2001, launched legal action against South
African CSIR and the pharmaceutical industry on grounds of bio-piracy.
The CSIR claimed they had planned to inform the San of the research
and share the benefits, but first wanted to make sure the drug proved
successful.
In March 2002, an understanding was reached between the CSIR and the
San whereby the San, recognised as the custodians of traditional
knowledge associated with the Hoodia plant, will receive a share of any
future royalties.
Thus San are likely to end up with only a very small percentage of
eventual sales. 9
10. Ayahuasca (Banisteriopsis caapi Mort.) Case
For generations, Shamans of indigenous tribes throughout the Amazon
basin have processed the bark of B. caapi Mort. to produce a ceremonial
drink known as “Ayahuasca”. The Shamans use Ayahuasca (which
means “wine of the soul”) in religious and healing ceremonies to
diagnose and treat illness, meet with spirits, and divine the future.
An American, Loren Miller obtained US Plant Patent 5,751 in June 1986,
granting him rights over an alleged variety of B. caapi Mort. which he
had collected from a domestic garden in Amazon and had called “Da
Vine”. The patent claimed that Da Vine represented a new and distinct
variety of B. caapi Mort., primarily because of the flower colour.
The Coordinating Body of Indigenous Organisations of the Amazon
Basin (COICA), which represents more than 400 indigenous tribes in the
Amazon region, along with others, protested about a wrong patent that
was given on a plant species.
They protested that Ayahuasca had been known to natives of the
Amazon rainforest and it is used in traditional medicine and cultivated
for that purpose for generations, so Miller could not have discovered it,
and should not have been granted such rights, which in effect,
appropriated indigenous traditional knowledge.
On reexamination, USPTO revoked this patent on 3rd November 1999.
However, the inventor was able to convince the USPTO on 17th April
2001, the original claims were reconfirmed and the patent rights
restored to the innovator.
10
11. Convention on Biodiversity
(CBD)
Signed by 150 government leaders at
the 1992 Rio Earth Summit.
Came into force on 29 December 1993.
India is also a party to the CBD.
Secured rights to control access to
genetic resources for the countries in
which those resources are located.
Article 8(j) of the CBD deals with issues
relating to traditional knowledge
associated with biological resources.
11
12. Main Objectives of CBD
conservation of biological diversity
sustainable use of the components
of biological diversity
fair and equitable sharing of the
benefits arising out of the
utilization of genetic resources
12
13. National Attempts to
Protect TK- India
National Biological Diversity
Act, 2002
Patents Act, 1970 through its
amendments in 2005
Protection of Plant Varieties and
Farmers‟ Rights Act, 2001
Geographical Indications Act, 2003
13
14. Biological Diversity Act,
2002
Gives effect to the mandate of CBD and to some
extent the Treaty of Plant Genetic Resources for
Food and Agriculture (PGRFA), 2001.
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.
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.
14
15. 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.
• 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.
15
16. 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.
16
17. Patents (Amendment) Act,
2005
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)
17
18. 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)).
18
19. 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.
19
20. 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
20
21. Geographical Indications Act,
2003
GIs are collective rights owned by the
concerned communities. In India 'The
Geographical Indications of Goods
(Registration and Protection) Act (GI Act) was
enacted in 2003 in compliance with India's
obligations under TRIPS at the WTO.
GI acts as a signaling device that helps
producers differentiate their products from
competing products in the market and
enables them to build a reputation and
goodwill around their products, which often
fetch a premium price. 21
22. Interface Between Geographical
Indication & Traditional Knowledge
Geographical Indications can be applied to the
tangible manifestations of traditional knowledge
that can be identified with a geographical region.
GI Law can be used to make a policy that facilitates
growth based on TK across geographical regions
of the country.
The law of GI‟s is a law facilitating holistic
economic development and public policy to that
effect.
It gives rights to community organization and
association of manufacturers of goods to exploit
GI leading to more equitable and distributed
growth potential.
Marries social justice and sustainable growth with
Intellectual Property Law. 22
23. What is TKDL??
Traditional Knowledge Digital Library (TKDL), an
electronic database which provides information on
traditional knowledge existing in the country.
TKDL acts a bridge between the traditional knowledge
information existing in local languages and the patent
examiners at IPOs.
It is a collaborative project between CSIR, Ministry of
Science & Technology and Department of AYUSH
(Ayurveda, Yoga & Naturopathy, Unani, Siddha and
Homeopathy), Ministry of Health & Family Welfare and
is being implemented at CSIR.
This database enables the Patent Offices all over the
world to search and examine any prevalent prior art,
and thereby prevent incorrect grant of patent on
products/processes based on knowledge in public
domain. 23
24. 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.
24
25. New TKDL Disclosures by
Indian Patent Office
The official Indian Patent Office Website
has put up a list of all the applications that
are pending and belong, as per the
judgment exercised by the Patent Office, to
the category of Traditional Knowledge.
The list contains, in its present form, the
application number, date of filing, the
publication date, the title of the invention
and the name and address of the
applicant.
In case of any discrepancy, one has been
asked to contact delhi-patent@nic.in
25
26. APPLICATION DATE OF APPLICANT APPLICANT PUBLICATION
Sr.No TITLE OF INVENTION
NUMBER FILING NAME ADDRESS DATE
"AYURVEDIC CHOCOLATE
COMPOSITION AS
D-38,
DELIVERY SYSTEM FOR
INDUSTRIAL
NUTRIENTS AND
17-Feb- ARVIND AREA,
1 348/DEL/2010 MEDICATIONS WITH 27-Jul-2012
2010 KUMAR HARIDWAR,
ACTIVE AMOUNT OF HERBS
UTTRAKHA
INCLUDING SHILAJEET
ND, INDIA
AND COW URINE
CONTENTS."
45, PLACE
PIERRE ABEL
COSMETIC COMPOSITION FABRE GANCE, F-
5212/DELNP/20
2 06-Jul-2011 CONTAINING A LOCUST DERMO- 92100 27-Jul-2012
11
BEAN GUM HYDROLYSATE COSMETIQU BOULOGNE-
E BILLANCOU
RT, FRANCE,
MAMPUZHA
CKAL(HOUS
A COMBINATION OF PARTS MAMPUZHA
E),
OF FIVE PLANTS CKAL
15-Dec- CHEMPERI
3 3851/CHE/2010 PROCESSED IN COCONUT THOMAS 20-Jul-2012
2010 (P.O),
MILK THAT REDUCE PAIN GEORGE
KANNURE
CAUSE BY MIGRAINE VAIDYAR
(DT.) - 670
632. 26
27. Contd.
ENTOMOLOGY
RESEARCH
SAVARIMU
INSTIUTE,
2371/CHE/20 14-Jun- A HERBAL FORMULATION FOR THU 13-Jul-
4 LOYOLA
12 2012 CONTROLLING VECTOR MOSQUITOES IGNACIMU 2012
COLLEGE,
THU
CHENNAI - 600
034
ENTOMOLOGY
RESEARCH
A PROCESS FOR PREPARATION OF 3- INSTITUTE,
SAVARIMU
HYDROXY-2-METHOXY SODIUM LOYOLA
2382/CHE/20 14-Jun- THU 13-Jul-
5 BUTANOATE, A NOVEL CYTOKINE COLLEGE,
12 2012 IGNACIMU 2012
MODULATOR FROM THE LEAVES OF NUNGAMBAK
THU
CLERODENDRUM PHLOMIDIS L.F. KAM,
CHENNAI-600
034
5-11-509, OPP.
ALL INDIA
RADIO,
Y.
2450/CHE/20 20-Jun- HERBAL CREAM FOR THE TREATMENT UNIVERSITY 13-Jul-
6 MADHUSU
12 2012 OF LEUCODERMA ROAD, 2012
DAN RAO
VIDYARANYA
PURI,
WARANGAL
27
28. TKDL and Access Agreements
At the end of the day the TKDL is increasing the
quality of the patents that are granted in their
foreign jurisdictions. Thus even these foreign
countries are gaining from access to the TKDL.
It‟s a win-win situation for both India and other
countries.
TKDL Access Agreement has in-built
safeguards on non-disclosure to protect India‟s
interest against any possible misuse. Under the
agreement, the patent examiners at
International Patent Offices can utilize TKDL for
patent search and examination purpose only
and cannot reveal the content to any third party
unless it is necessary for citation purpose.
28
30. Access and Benefit sharing
for export of neem leaf
(Azhadirachta indica)
Bio India Biologicals (Indian
firm) exported neem leaf
accessed from Andhra
Pradesh.
Royalty of 0.053 Million
received by NBA
In 2010, NBA has
transferred an amount of
Rs.20,000/- to Amarchinta
BMC in Andhra Pradesh
towards benefit sharing.
The amount utilized for
awareness programme;
planting saplings and
fencing. 30
31. Access to Sea Weed
(Kappaphycusalvarezii) from
coastal districts of Tamil Nadu
Ms. Pepsico India Holdings Pvt. Ltd
(MNC) and M/s. Ganesan and Sons
(Indian firm) submitted applications for
exporting the dry sea weed.
The sea weed was collected from the
Self Help Groups (SHGs) of Coastal
Tamil Nadu having the knowledge and
skills of sea weed cultivation and
exported for commercial purpose.
The agreements were signed with NBA
and the royalty amount was paid. 31
32. TKDL Outcome Against
Biopiracy
GINGER CASE:
British Pharma firm filed for
patent in 2006 for
pharmaceutical composition
using ginger, claiming it
discovered use of ginger and
kutki plant in treatment of
cold.
India cited medicinal texts
dating back to the 18th
century on use of ginger to
treat cough, asthma & lung
diseases using TKDL
database.
British patent office accepts
Indian evidence, rejects
application 5 years later.
32
33. TKDL REMEDIES THROUGH
GI’s
GI Law can be used to make a policy that
facilitates growth based on traditional
knowledge across geographical regions of
the country.
GI law facilitates holistic economic
development and public policy to that
effect. It gives rights to community
organisation and association of
manufacturers of goods to exploit GI
leading to more equitable and distributed
growth potential.
33
34. GI-TKDL MERGER
Under Articles 1 (2) and 10 of the Paris Convention for
the Protection of Industrial Property, geographical
indications are covered as an element of IPRs. They are
also covered under Articles 22 to 24 of the Trade Related
Aspects of Intellectual Property Rights
(TRIPS) Agreement, which was part of the Agreements
concluding the Uruguay Round of GATT negotiations.
India, as a member of the World Trade Organization
(WTO), enacted the Geographical Indications of Goods
(Registration & Protection)Act, 1999 has come into force
with effect from 15th September 2003. Examples of GI in
Tamilnadu: Madurai Jasmine, Tanjore Veena, Bhavani
Jamukkalam, Salem Mango, Kanjeepuram Silk, Bodi
Cardamom etc.
Further, there was a ground-breaking deal between
UNCLE CHIPS and potato growers in Punjab wherein it
was agreed that GI indications would be accorded to in
order to protect interests of the potato growing farm
communities in Punjab.
34
35. Some More Examples of GI
Multani Mitti:
It was one of the earliest substances to ever be
used as a beauty mask.
It consists of a lime-rich clay from the far
northwestern region of India to which is added
rice bran and milk. Although it is an effective
clay for improving the facial complexion, it is
also used to draw toxins from the skin of the
entire body.
Scientifically, it has been shown to be
bacteriostatic against gram positive bacteria; it
can even be administered internally in cases of
poisoning to decrease the absorption of the
harmful substance.
Because of its high mineral content and
moisturizing effect, it helps nourish the skin,
nails, and hair. It is reputed to help reduce
arthritic pain caused by inflammation.
Generally speaking, mud reduces the pain
associated with burns, insect, and bee stings
(bears roll in the mud when they‟re stung) and
will draw out heat through the skin. 35
36. GOOD LOOK Wayco Wipes:
GOOD LOOK Wet Wipes, a product of Wayco Research (UK) Ltd.,
London, gives perfect remedy from the humanity and wipe out
the fear factor of perspiration & odour which results after rain
and makes life miserable.
Also brings freshness as it leaves behind a pleasing fragrance of
lemon or jasmine and soothing coolness when applied to face or
any other part of the body which precipitates the most.
One of their major ingredients is ALOE VERA- Aloe vera, also
known as the true or medicinal aloe, is a species of succulent
plant in the genus Aloe that is believed to have originated in the
Sudan.
Aloe vera grows in arid climates and is widely distributed in
Africa, India, and other arid areas.
The species is frequently cited as being used in herbal medicines
and cosmetics.
Many scientific studies of the use of aloe vera suggest that Aloe
vera extracts are useful in the treatment of wound and burn
healing, minor skin infections, sebaceous cyst, diabetes, and
elevated blood lipids in humans.
These positive effects are thought to be due to the presence of
compounds such as polysaccharides, mannans, anthraquinones,
and lectins.
36
37. Calamine Lotion:
Kaolinite is one of the
most common minerals
used in calamine lotions;
it is mined, as kaolin, in
Brazil, India, Australia, K
orea, the People's
Republic of China.
There is always a
Predominance of kaolin
in tropical soils. Kaolinite
clay occurs in
abundance in soils that
have formed from the
chemical weathering of
rocks in hot, moist
climates- for example in
tropical rainforest areas.
37
38. Veet
Veet, is a current trademark of chemical
depilatory internationally-sold products
manufactured by Reckitt Benckiser Hair
removal creams, mousses and gels, and
waxes are produced under this brand.
Nelumbo nucifera is one of the
ingredients of Veet, which is known by
number of names including Indian
Lotus, Sacred Lotus, Bean of India, or
simply Lotus, is a plant in the
monogeneric family Nelumbonaceae.
This plant is an aquatic perennial. Native
to Tropical Asia and
Queensland, Australia, it is commonly
cultivated in water gardens.
The pink lotus is the national flowers of
India. Nelumbo nucifera flower extract is
the INCI (International Nomenclature of
Cosmetic Ingredients) term for lotus
blossom extract from Indian lotus
flowers. It has excellent astringent
properties, for example, thus refining the
skin.
38
39. 3 Phases of TK Management
Before documentation
During documentation
After documentation
39
40. Before Documentation- 5 Steps
Planning the documentation process
Broadly understanding indigenous
peoples and community interests and
needs
Defining the objectives: what is sought ?
Participation and prior informed consent
Assessing legal issues: IP
considerations
40
41. IP Issues
Conducting an IP Assessment
Assessing the subject matter to be
documented
Assessing applicable IP laws
Assessing other applicable legal
regimes
Developing an IP Management Strategy
to implement the IP Objectives
41
42. During Documentation- 2 Steps
Obtaining, organizing, systematizing,
maintaining and transmitting TK
Continuously informing indigenous
peoples and communities about
progress in documentation process
42
43. During Documentation-
Check List
Ensure appropriate PIC documentation (or evidence) has been
obtained (or is obtained during this phase of the process)
Document TK in a precise and standardized manner (including
through indigenous and local nomenclature or classifications or
local management systems)
Do not disclose non disclosed or confidential TK
Follow agreed guidelines or conducts, obligations and legislation
and regulations (including ABS) in place
Regularly inform stakeholders, especially indigenous people and
communities, about advances and progress in the documentation
process
Verify whether technological safeties for processing and
managing data are operational (safety of the database or
registration devices)
Adapt technology to local needs (if documentation involves
interaction directly with indigenous peoples and communities)
Ensure appropriate disclaimers are developed and made visible 43
44. During Documentation- IP
Issues
Recording TK and Associated GR
Managing Disclosure
Managing Confidentiality
Key IP clauses for confidentiality
contracts among documentation
partners
Sample confidentiality contracts which
have been used in documentation
initiatives
44
45. After Documentation- 3 Steps
Promoting the TK documentation
database or register
Monitoring uses and users of
documented TK
Verifying whether initial planning
objectives and milestones have been
met
45
46. After Documentation-
Check List
Verify that TK documentation planning objectives have
been met
Verify that comments and inputs made by stakeholders
(especially indigenous peoples and communities) have
been appropriately addressed
Check who is accessing and using TK (if this was the
case)
Check whether and how national IP offices are using
the documented TK
Inform indigenous peoples and communities about the
progress and results of the TK documentation process
Ensure management of the database or register is in
hands of competent and technologically savvy
professionals (or a well trained community member(s)
if they are to ultimately create and manage the
database).
46
47. After Documentation-
IP Issues
Positive Protection: Acquisition of
IP Rights
Defensive Protection: Public
Disclosure
Establishment and Use of
Databases
Enforcement of IP Rights
47
49. For further information, please feel free to write on:
unitedpatent_ipr@sify.com
Neha Sharma (Associate)
M/s United Overseas Trade Mark Company
M/s United Overseas Patent Firm
49