IP Guidelines and Agreements

for Access and Use of Genetic

and Natural Resources

A presentation
By

D.CALAB GABRIEL
of K&S Partners
06th April 2010
 SYNOPSIS

• Patents Act 1970

• Convention on Biological diversity
• Biodiversity Act 2002
• TK related to biodiversity rules 2009
(draft)
• Draft guidelines for accounts benefit
sharing
• Case studies
 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

The monitory benefits will be deposited in

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