Case studies on Neem,
Turmeric and Basmati
(Traditional Knowledge)

Indian Patents Act,
Section 10(4)(d)(ii)(D)
if the applicant mentions a biological material in
the specification………………………………… such
material is not available to the public, the application
shall be completed by depositing the material to an international
depository authority under the Budapest Treaty and by fulfilling the
following conditions, ………………. disclose the source and geographical
origin of the biological material in the specification, when used in an
invention.

Section 3: Inventions not patentable
p. Invention which is traditional knowledge which is an
aggregation or duplication of known properties of
traditionally known component or components.

FORM 1
Point 9(iii) of form 1 has a declaration from the applicant
which reads as;
• The invention as disclosed in the specification uses
the biological material from India and the necessary
permission from the competent authority shall be
submitted by me/us before the grant of patent to
me/us.

Pre/Post Grant Opposition
Sections 25 (1) and (2).
• a……
• b…..
• j. that the complete specification does not disclose or wrongly
mentions the source and geographical origin of the biological
material used for the invention

Revocation
Section 64(1)(p).
• a……
• b…..
• p. that the complete specification does not disclose or wrongly
mentions the source and geographical origin of the biological
material used for the invention

Convention on Biological Diversity (1993)
• The CBD has three primary objectives:
– The conservation of biological diversity
– The sustainable use of its components; and
– The equitable sharing of benefits arising from the use of genetic
resources.
• The CBD provides that States have sovereign rights over their natural
biological resources including genetic resources. Genetic resources are no
longer considered ‘the common heritage of mankind’.
• Key Principles
– Prior Informed Consent
– Mutually Agreed Terms

• Negotiations under the CBD to establish an
international regime on access and benefit-sharing
2010.
• Form of the treaty not agreed but could include:
– Standards for national legislation
– Standard material transfer agreements
– Model clauses for benefit-sharing agreements
– Monitoring and enforcement capability
• Impacts regulates genetic resources as such, trade in
genetic resources and development of products
derived from them

Biodiversity Act 2002
6. No person shall apply for any intellectual property right, by
whatever name called, in or outside India for any invention based
on any research or information on a biological resource obtained
from India without obtaining the previous approval of the
National Biodiversity Authority before making such application.
• Provided that if a person applies for a patent, permission of the
National Biodiversity Authority may be obtained after the
acceptance of the patent but before the sealing of the patent by
the patent authority concerned:
• Provided further that the National Biodiversity Authority shall
dispose of the application for permission made to it within a
period of ninety days from the date of receipt thereof.

Biodiversity Act 2002
Permission from NBA needed before making IP application for an
invention
Atleast before sealing/grant of the patent
Request disposed within 90 days
NBA may impose such terms and conditions/benefit sharing fee/
royalty or both
• Not applicable to Protection of plant varieties but intimation of such grant to NBA

Procedure for obtaining the permission
• Filing Form III with prescribed fees of (Rs.500)
• Approval will be in the form of a written agreement executed
by both the parties.
• If rejection- an opportunity of being heard to the applicant.

Where permission needed?
• when the results of any research which has
made use of the country's biodiversity is
sought to be commercialized
• when the results of research are shared with
a foreigner or foreign institution.
• when a foreign institution/individual wants
access to the country's biodiversity for
undertaking research.

Agreement
If the biological material is of Indian origin then an
agreement has to be executed by the applicant with
the NBA
Annexure
• Details of the Biological Resources
• Details of the Invention
• Details of the territories where intellectual property
rights over the Invention is sought to be taken.

PENALTIES
• Violation of S.6
• Imprisonment may extend to 5 yrs, or fine up
to Rs.10 lakhs or damages with fine

TRADITIONAL KNOWLEDGE RELATING
TO BIOLOGICAL DIVERSITY RULES, 2009
(DRAFT)

Definition of Traditional Knowledge
(TK)
• No agreed definition
• Working definition:
“The knowledge, innovations and practices of
indigenous and local communities embodying
traditional lifestyles” as well as “indigenous
and local technologies”
(CBD, Articles 8(j) and 18.4)

TK-definition
The collective knowledge of a traditional community including of a
group of families, on a particular subject or a skill and passed
down from generation to generation, either orally or in a written
form, relating to properties, uses and characteristics of a plant
and animal genetic resources; agricultural and healthcare
practices, food preservation and processing techniques and
devices developed from traditional materials; cultural
expressions, products and practices such as weaving patterns,
colors, dyes, pottery, painting, poetry, folklore, dance, and music;
and all other products or processes discovered through a
community process including by a member of the community
individually but for the common use of the community

Biodiversity Act
• S.36(5) and S.62 empowers the Central
Government to make rules

TK
• Traditional medicines
• Folklore
• Songs
• Dances
• Rituals
• Designs
• Handicraft … ….

Characteristics of Traditional
Knowledge (TK)
• TK is usually
• held collectively
• transmitted orally or otherwise from
generation to generation
• dynamic, evolving over time
• Access and use of TK in communities is
generally governed by a wide variety of
unwritten customary laws

Role of TK
 Pharmaceuticals and botanical medicines
 Personal care and cosmetics
 Agricultural and horticultural products-
like insecticides
 Biotechnologies in fields other than
healthcare and agriculture

Issues
More than 6000 patents in USA are obtained based on
plant traditional knowledge
• Should each patent be monitored?
• Solution?
• Should ex-cheq be spent on challenging patents?
• How can TK be preserved ?

TK
• Problems:
– not documented
– origin difficult to trace
– knowledge source: often “a person”
– difficult to particularise
– Does not easily fit into known forms of IP
– Awareness low

TK
• Traditional medicines:
– It has been used: no novelty
– not documented
– who is the inventor?
• Folk music
– author?
– Various versions? How many copyrights?

Objectives of protecting TK
 Preserve TK
 Increase awareness of its value
 Commercialize it, where appropriate, with
equitable benefit sharing
 Prevent its unauthorized use
 Conserve biodiversity

Systems for protecting TK
• Special regime: International Understanding
• Documentation
• Access and benefit-sharing mechanisms
• Sui generis systems to protect TK

Documentation & registries
Important tool to preserve TK
Can help to establish the existence of prior
art
Registries: Access to registries : improper use
?????

Criteria for Benefit sharing
The Authorities will notify in the official gazette, guidelines for
the formula for benefit sharing, which includes applying for
patent and IPRs.
Authority shall ensure conservation and sustainable use of
biodiversity
The benefit sharing is based on case to case basis to the third
parties

Criteria for Benefit
sharing-2 contd

Access
&
benefit
sharing
(ABS)
Prior Informed Consent
• standard modus operandi of many
companies
• bargaining power disparity problem
Contractual arrangements
• Over fifty countries are currently in
the process of writing ABS legislation
• In many cases such legislation refers
explicitly to the protection of TK
ABS legislation

DRAFT GUIDELINES ON ABS
• Point of concern
• “Knowledge associated thereto” not
defined
• Unreasonable benefit sharing principles:
1. Participation of atleast one researcher
from research institute designated
by NBA
2. Sharing of IP rights with the designated
institute

POINTS OF CONCERN (Contd)
Complicated procedure to obtain access to TK
1. Involvement of a chain of offices
2. No prescribed time limit
Too much of discretion in hands of NBA
Treatment of confidential information
No proper adjudication mechanism
Appeal to Supreme court not justified

Kani tribe
• Tropical Botanical Garden and Research Institute
(TBGRI) in Kerala on an expedition
• Tribe did not get tired
• “aarogya pacha” (Trichopus zeylanicus) -
• Analysed-prepared-“Jeevani” a TK based
restoractive, bio/immno-enhancing, anti-
stress/fatigue agent.
• Jeevani manufactured by Arya Vaidya Sala
• benefit shared with Kani tribe with the help of a
trust fund.

MISUSE OF TK

Turmeric Patent
 U.S. Patent No. 5,401,504 was
granted to Das et al.
 Related to wound healing
property of turmeric
 Is commonly known in India :
grant of patent outraged Indians
 This patent was challenged by
way of re-examination at USPTO
by CSIR
 All claims eventually cancelled

Patent on wound healing
property of Turmeric
Traditional Knowledge :
• traditionally used for centuries to heal
wounds and rashes.
• effective ingredient in medicines,
cosmetics and dyes.
• used as a spice for flavoring Indian
cooking.
Patent case: In 1995, a US patent was granted
on use of turmeric in wound healing.

Challenge to turmeric patent
• Prior Art - Ancient Sanskrit text and a paper published in
1953 in the Journal of the Indian Medical Association.
• The Council of Scientific & Industrial Research (CSIR), India,
filed a re-examination case with the USPTO.
• The USPTO revoked this patent in 1997; no novelty; known
in India for centuries.
• A landmark judgment - a patent based on traditional
knowledge was successfully challenged.

Prior art for turmeric in Urdu

K & S Patent Experience
…Revocation of “turmeric” patent...
• 32 prior art citations finally cited
• Patent and all its claims revoked by USPTO

Prior art - English Translation

Prior art English Translation

Prior art for Turmeric

Prior art for Turmeric

Revocation of Turmeric Patent

Revocation of Turmeric Patent

ENOLA BEAN PATENT
(Mexican Bean Bio-Piracy)
• Yellow bean
• commonly grown by Mexican farmers
• US Company Pod-Ners patented it in 1999 Patent
No:584079
• Filed cases against Mexican farmers selling yellow
bean in US
• Patent challenged at USPTO
– 29 April 2008 board of patent appeals (BPA)
affirms rejection of the case
• Federal court affirms ( October 2009)
affirms BPA’s rejection

KILTA case

Dhanpath Seth & Others
Vs
M/S Nil Kamal Plastic Crates Ltd
OSA No.8 of 2006
‘A device for manually hauling
agricultural products’
Patent No 195917 granted on
11.07.2005

Court Held
Patentee went for DB.
• DB intern held that the “device developed by
the plaintiff is in fact the result of the
traditional knowledge and
aggregation/duplication of known products
such as polymers and, therefore, cannot be
said to be an invention”.
• Therefore the plaintiff’s are not entitled for
injunction

BASMATI CASE

TITLE: BASMATI RICE LINES AND GRAINS
Filed : Jul. 8, 1994
Appl.No.: 272,353
Patent Number : 5,663,484
Date of Grant : Sep. 2, 1997
Inventors : Eugenio S. Sarreal, John A. Mann, James
Edward Stroike, Robin D. Andrews
Assignee : Rice Tec, Inc.

Basmati Patent

Ricetec’s Patent
ABOUT THE PATENT...
• Novel rice lines- cross of Basmati rice of Pakistani origin and
semi-dwarf variety of American origin;
• Claims to replicate self-defined “traditional Basmati”
characteristics when grown in the Territory
• Claims to overcome inherent deficiencies of “traditional
Basmati” including
– photoperiod sensitive - long maturity period
– low-yielding
– disease - susceptible
– tall plant prone to lodging

Basmati Patent

Basmati Claims

Basmati claims -contd.

Ricetec’s Patent
CRUX OF THE INVENTION
“Invention” of a rice plant which can grow in
North, South, Central America and Caribbean
Islands (The Territory) and produces grains with
‘Basmati’ characteristics

• Request for Re-examination filed on April 28,
2000
• May 22, 2000: Examiner finds new question
of patentability is raised by the Request;
orders re-examination of all the claims
• RiceTec surrendered claims 1-7, 12 to 20

NEEM CASE

EP 90250319
Claim 1 as originally filed (1990)
An insecticide and foliar fungicide comprising neem oil
which is substantially free of azadirachtin and salannin,
said neem oil prepared by:
a) extracting dried, coarsely ground neem seeds with a
non-polar, hydrophobic solvent to obtain a neem oil
extract,
b) removing the solvent to obtain the neem oil product

Objections by Examining Division
• Claim 1 to be construed as directed to neem oil as
such
• Neem seed extracts with hexane known, as well as
their insecticidal properties
• Antifungal effects of neem seed also known
However:
• Antifungal effects of azadirachtin-free extract of
neem seed neither known nor suggested from any
document retrieved during search

Neem Case – Claim 1 as granted (1994)
A method of controlling fungi on plants
comprising contacting the fungi with a neem oil
formulation containing 0.1 to 10 % of a
hydrophobic extracted neem oil which is
substantially free of azadirachtin, 0.005 to 5.0%
of emulsifying surfactant and 0 to 99% water.

Neem Case – Grounds for opposition
Exceptions to Patentability
• Art. 53(a) EPC: exploitation of invention contrary
to morality:
– Neem tree has been used in India for millenia,
– patent would threaten livelyhood of gatherers of
neem tree
• Art. 53(b) EPC: Patent claims plant variety:
– By using seed from one plant variety, the patent
indirectly claims the variety as such

Neem Case – Grounds for Opposition
Novelty and Prior Use
• Art. 54 EPC: Novelty
– Antifungal effects of neem oil and neem leaves
known for centuries
• Affidavit Mr. Phadke (India):
– Public field trials took place in 1985/1986
involving treatment of plants with hexane extracts
of neem seed,antifungal effect observed

Neem Case – Oral Proceedings (2000)
Morality – Plant variety
Decisions by Opposition Division:
• Morality:
– No direct link between endangering of livelihood of people in India
and claimed method of controlling fungi,
– European Patent gives no rights in India
– Traditional uses known for centuries are related to novelty/prior use
issues and have to be documented
• Plant variety:
– Azadirachta Indica is not a variety, but species, a higher taxonomic unit
– Claim to method of controlling fungi cannot be construed as relating
to the plant as such

Neem Case – Oral Proceedings
Novelty criteria Art. 54 EPC
(1) An invention shall be considered to be new if it does
not form part of the state of the art.
(2) The state of the art shall be held to comprise
everything made available to the public by means of
– a written or oral description,
– by use,
– or in any other way,
before the date of filing of the European patent
application.

Neem Case – Oral Proceedings
Novelty – Witness Hearing- Decision
• Oral testimony of Mr. Phadke credible to Opposition
Division
• Established that hexane neem seed extract
containing a surfactant used in public to treat plants
against fungi
Decision
• Main request lacks novelty and (restricted) auxiliary
request inventive step
• Patent revoked

Neem Case – Appeal (2005)
T 416/01
• The Technical Board of Appeal dismissed
• the appeal of the Patent Proprietor against the
decision of the Opposition Division.

Wapishana tribes
• A tribe in amazon jungles divided between Brazil and
Guyana
• Betrayal of British Scientist-Prof. Conrad Gorinsky.
• Cunani (Clibadium Sylvestre)
– US pat 5786385 titled Polyactylenes for reversible heart
blocking agent / neuro - muscular active or for use as a
mycobactericide
• Tipir, the nut of greenheart tree
– US pat 6048867 titled Biologically active Rupunines”
*Source: Journal of Intellectual property rights. Vol 15, March 2010,PP146-150

Medicine from Kadambh tree
• Kadambh tree (Mitragyna parvifolia)
• A composition- cadambine and dihydroconchonine –
granted patent in India
• Cure for Type II diabetes
• Kadambh is considered as a sacred tree
• “ The tree is widespread and there would not be any
dearth of the raw materials for the medicine”
• Filed a petition in Rajasthan high court against
cutting of kadambh trees

Thoughts to share
• Should not be a barrier for research,
development of products and trade
• To avoid conflict between established IPs and
the non conventional rights.
• Regulated by International treaty.
• Change of mind sets
• Trust and confidence should be built between
the stake holders.

More examples of TK as subject of patent application
• Kava (Piper methysticum Forster) TK in the Pacific,
Fiji and Vanuatu, North America and Europe
• Ayahuasca (Banisteriopsis caapi Mort.) TK of
Shamans of indigenous tribes throughout the Amazon
basin
• Quinoa (Chenopodium quinoa Willd.) TK of millions in
the Andes, especially Quechua and Aymara people
• Hoodia (Hoodia gordonii (Masson) Sweet ex
Decne) TK of African tribesmen

Traditional Knowledge Digital Library
(TKDL)
• A digital documentation, created by the Government of India.
• Covers Indian traditional knowledge related to Ayurveda,
Unani, Siddha and Yoga. (0.29 million medicinal formulations)
• Available in five international languages (English, German,
French, Japanese and Spanish)
• Created 200 sub-groups under A61K 36/00 in International
Patent Classification
• Searchable with Boolean operators using Keywords, IPC and
disease names

TKDL - access available
• European Patent Office.
• United States Patent & Trademark Office.
• Japan Patent Office.
• United Kingdom Patent Office.
• Canadian Intellectual Property Office.
• German Patent Office.
• Intellectual Property Australia.
• Indian Patent Office
• Chile Patent Office.

Proposal to include TKDL as part of the
PCT Minimum Documentation
• In the 22nd MIA held in 2015, the Indian Patent Office
presented a proposal for inclusion of TKDL in the PCT
Minimum Documentation.
• A draft Access Agreement was also proposed.

Concerns
Some Authorities expressed concerns about certain provisions
contained in the draft access agreement of TKDL, notably in
relation to :
• the confidentiality and non-disclosure requirements,
• the necessity to monitor and report statistics on the use of
citations from the TKDL
• the implications for an ISA losing access to the full PCT
minimum documentation if the access agreement to the
TKDL was terminated under the termination provisions of the
draft agreement.
• the importance for Authorities to be able to load the data
from the TKDL into its own IT systems.
• if added to the PCT minimum documentation, the TKDL
should have the same level of access as other collections in
the PCT minimum documentation and should be equally
available to the applicant.

Progress during the 23rd session of MIA
held in January 2016
The Indian Patent Office was invited to present a Revised
Access Agreement along with a working document setting
out its proposals with regard to the inclusion of the Indian
TKDL in the PCT Minimum Documentation, taking into
account the discussions in the MIA, the PCT Minimum
Documentation Task Force and the Intergovernmental
Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore (IGC of WIPO).

Revised TKDL Access Agreement -
Major changes
“The User shall, whenever required, deliver only that information
from TKDL contents which is relevant for the purposes of citation in
patent grant procedure in all phases including opposition
proceedings, to the patent applicant(s) or any other person who is
party to such proceedings. The User may, whenever required,
deliver only, such relevant information from TKDL contents to other
patent offices under any agreement between the User and such
offices to share the cited documents of a patent application. Except
as mentioned above, the User undertakes to preserve
confidentiality of the entire contents of TKDL”
• Modified to clarify that TKDL citations could be communicated to
opponents and other patent offices also apart from the applicant.

Revised TKDL Access Agreement -
Major changes
The User shall on a quarterly basis send the
number of times content of TKDL was cited by the
User’s examiners during the search process
relating to published patent applications.
The need for submitting quarterly reports on
citations taken from TKDL by the User has been
eliminated as the Users stated that the necessity
to monitor and report statistics on the use of
citations from the TKDL is inconvenient.

Revised TKDL Access Agreement -
Major changes
“This Agreement shall be renewed further
automatically for periods of 5 years each, on
completion of the Agreement period, provided the
Agreement is not terminated under clause 11 of this
agreement.”
• Period of Agreement increased from 3-5 years with
facility for auto-renewal

Revised TKDL Access Agreement - Major changes
• This Agreement can be terminated by either of the
signatories by giving three months notice to the other
signatory.
This clause has been removed as it was a concern for
other offices.
(the implications for an International Searching
Authority losing access to the full PCT minimum
documentation if the access agreement to the TKDL
was terminated under the termination provisions of
the draft agreement)

Revised TKDL Access Agreement -
Major changes
“Either party may terminate this Agreement if the
other party materially breaches its obligations under
this Agreement and fails to cure such material
breach, provided that the non-breaching party shall
give written notice of its intention to terminate and
shall allow the breaching party 15 days after receipt
of such notice to remedy the breach”

Revised TKDL Access Agreement -
Major changes
“Failure of either party to discharge any obligation or
perform as per the terms or conditions of this
Agreement as a result of conditions beyond its control
such as but not limited to, war, strikes, fires, floods,
government restrictions, acts of terrorism, public
health emergencies, power failure or damages to or
destruction of any network facilities or servers, shall
not be deemed a breach of the Agreement”

The importance for Authorities to be able to load the
data from the TKDL into its own IT systems.
• The significance of the technical content was the main
consideration
• No such criterion was considered for inclusion of existing items of
non-patent literature part of PCT Minimum Documentation. (The
Indian Patent Office has experienced the difficulty of negotiating
with different Publishers as there is no uniform format for data,
subscription rates and conditions for transfer of raw data)
• All International Authorities not desirous of loading the non-patent
literature data on to their internal servers.

TKDL is currently offered for subscription only to patent offices
and that it should be equally available to the applicant to make
an informed decision while applying for a patent.
• The TKDL is offered for subscription only to Patent Offices for the purpose
of defensive protection. This is to protect traditional medicinal knowledge
from misappropriation, on which livelihood and healthcare needs of
millions of people in India are dependent.
• TKDL is based on published books of Indian Systems of Medicine, which
are available in open domain and can be sourced by any
individual/organization at national/international level.
• Special nature of Traditional Knowledge database is accepted by MIA .
• There needs to be different criteria for inclusion of TK databases. The
Inter-Governmental Committee on Genetic Resources, Traditional
Knowledge and Folklore (IGC) was set up by WIPO acknowledging the
special protection required for Traditional Knowledge. Traditional
knowledge periodicals were first added to the PCT Minimum
Documentation, based on a suggestion by the IGC.

Online prior art search
• Online prior art search services on TKDL for applicants before filing
a patent application.
• The Indian Patent Office could offer such services directly to the
applicants or to any other Authority
• Other Authorities may also offer such services to their applicants