PEOPLE, PLANTS AND PATENTS : A BALANCE BETWEEN IPR

PROTECTION AND BENEFIT SHARING

Mahak Chandak and Rumana Gauran*

Introduction
The relationship between genetic resources, Traditional Knowledge (TK), and
Intellectual Property Rights (IPR) is among the most controversial agenda items in the
negotiations of several international organizations. The growing use and vast potential of
TK related to genetic resources has led to an increase in the patenting of inventions based
on genetic resources or information pertaining to them. Certain initial problems surround
the patenting of TK, however, as in many cases TK has been passed down through
several generations and at first sight might not meet the criteria of novelty and inventive
step. This view misconstrues the true nature of TK, however, which should not be
regarded simply as ―old‖ knowledge1and although much of TK originates in the past, it is
not static. There is usually no single act of discovery when creating TK2 but each new
generation or individual which develops such knowledge contributes and adds to that
knowledge base. Continued illegal access and unsustainable use threatens to promote
‗erosion‘ of genetic resources and TK, reduce governmental funds available for
conservation activities, create social inequity by failing to compensate traditional
communities for use of their knowledge, and increase mistrust between the business
community and biodiversity rich countries over the potential commercial use of genetic
resources and TK.

With the world community already aware of the current debate and conflict between
CBD, TRIPs, IPR, TK and bio-diversity, because of varied considerations and factors-
political, economic, social; this paper proposes certain appropriate solutions both at
international and domestic level to harmonize the laws such that the ultimate objective of
first, protecting TK and bio-diversity within and outside the IPR regime is achieved and
second, the conflict of interests between the developed and developing countries is
leveled considerably.

The first part of the paper gives a cursory glance of conflict between international
agreements regarding IPR, particularly the TRIPs and CBD and the problems faced by
indigenous community to enforce their rights. The second part provides for solutions to
the issue, both at national and international regime.

*students of VIII Semester, Gujarat National Law University

1
World Intellectual Property Organization, Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore, Review of Existing Intellectual Property
Protection of Traditional Knowledge (2002), WIPO/GRTKF/IC/3/7, at para. 33.
2
Dutfield, G., ‗Protecting Traditional Knowledge and Folklore‘, in Grosheide, F.W., Brinkhof, J.J.
(eds.), Intellectual Property Law: Articles on The Legal Protection of Cultural Expressions and
Indigenous Knowledge (2002), pp. 63-86, at p. 79.

1
 Part I

TRIPs v. CBD:-

There has been much debate surrounding the issue as to whether there is any conflict
between the provisions of the TRIPs and CBD. Countries like the U.S. argue that
implementation of TRIPs is supportive of measures that would implement the obligations
of the CBD most effectively. They also consider that the TRIPs and the CBD have
different non-conflicting objectives and purposes and deal with different subject-matter.

The proponents of the view that there is an inherent conflict between the two, argue that
TRIPs primarily intends to recognize that intellectual property interests and do not
consider national sovereignty over plant genetic resources. The Agreement does not
provide for benefit-sharing or disclosure of the country of origin. The expanding patent
protection covering claims to indigenous knowledge like the protection on Neem,
Turmeric, Ayahuasca is also against the principles of the CBD. The Agreement does not
address issues like access to bio-diversity, benefit-sharing and the interests of the
traditional community.3

Countries like Brazil, Peru, Pakistan argue that an international action should be taken so
that patent applications should be required to disclose the source and country of origin of
any bio-resources or TK used in inventions and also to demonstrate that they had
obtained prior informed consent from the competent authority in the country of origin
and entered into fair and equitable benefit-sharing arrangement or that they followed
national legal requirement.4 Ultimately the TRIPs and CBD should be implemented in a
mutually supportive and consistent manner.

Problems faced by indigenous communities:-

Indigenous communities also face practical obstacles when patenting TK. Often they do
not possess the requisite technical know-how needed to complete an application. There is
a need to raise the technical competence of indigenous communities and providing them
with technical, scientific and legal support. This long term capacity-building within
indigenous communities is central in empowering them, enabling them to retain control
over their resources. 5 The achievement of this capacity building will undoubtedly will
require time, hence, this side of developing TK for wider use outside indigenous

3
Law of Plant Varieties Protection, Elizabeth Verkey, Eastern Book Company, Lucknow, First Ed., 2007,
pg. 204-205.
4
WTO,IP/C/W/368/Rev. 1
5
Marko Berglund, The Protection of Traditional Knowledge Related to Genetic Resources: The Case of a
Modified Patent Application Procedure, (2005) 2:2 SCRIPT-ed, pg. 208-209.

2
communities often lies with private companies or public institutions such as universities.
This brings with it issues regarding joint-inventorship, which can be granted only if both
parties contribute directly to the inventive concept. 6 When genetic resources form the
basis of a patent application, the input of indigenous communities can be limited to plant
identification while product developers or public institutions identify, isolate and purify
the active chemical compounds.

In cases where the indigenous communities are aware of violation they often struggle to
meet the financial burden of applying for or challenging patents. Transaction costs for
enforcement need to be reduced since at present they are prohibitively costly and
complicated7 Insight may be gained from the TRIPs regime applicable to designs which
stipulates that:- requirements for securing protection for textile designs, in particular in
regard to any cost, examination or publication, do not unreasonably impair the
opportunity to seek and obtain such protection.8 Besides financial aid, the need to build
the technical and legal capacity of indigenous communities is again apparent as is the
need for access to information and good legal advice.9

Problems with existing contract-based approach:-

Regarding access to genetic resources and ensuing benefit-sharing, contracts have

become ‗the most common way of recording mutually agreed terms.‘ 10 Examining the
provisions of access contracts can provide insight into effective benefit-sharing regimes.
Private entities such as pharmaceutical or cosmetic companies and public bodies such as
universities have entered into contractual agreements with indigenous communities.
These are collectively termed Material Transfer Agreements (MTA) or Information
Transfer Agreements (ITA) and often set out mutually agreed terms. 11 As this contractual
regime remains on a voluntary basis in many countries, the point of establishing

6
Blakeney, M., ‗Ethnobiological Knowledge and the Intellectual Property Rights of Indigenous
Peoples in Australia‘, in Blakeney, M. (ed.), Perspectives on Intellectual Property: Intellectual
Property Aspects of Ethnobiology (1999), pp. 83-99, at p. 93.
7
World Intellectual Property Organization, Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore, Matters Concerning Intellectual Property
and Genetic Resources, Traditional Knowledge and Folklore – An Overview (2001),
WIPO/GRTKF/IC/1/3, at para. 82
8
Article 25.2, Agreement on Trade-Related Intellectual Property Rights (hereinafter TRIPs
Agreement).

9
Posey, D.A., Dutfield, G., Beyond Intellectual Property: Toward Traditional Resource Rights for
Indigenous Peoples and Local Communities (1996), at p. 76.

10
Convention on Biological Diversity, Conference of the Parties, Addressing the Fair and Equitable
Sharing of the Benefits Arising Out of Genetic Resources: Options for Assistance to Developing
Country Parties to the Convention on Biological Diversity (1998), UNEP/CBD/COP/4/22, at para. 32.
11
Article 15(4) of the Convention on Biological Diversity stipulates that access to genetic resources
shall be on mutually agreed terms.

3
minimum standards for access agreements has been raised.12 WIPO has gone some way
to this end by drafting IP guidelines for access and benefit-sharing.13

The positive publicity surrounding equitable dealing with source communities can be
used to boost consumer image and subsequent sales, as shown by the effect of the Merck-
INBio agreement, for example. 14 This oft-cited agreement raises an interesting issue
relating to the parties to access contracts, however. Indigenous communities were
excluded from the negotiations between Merck and the Costa Rican national biological
sample collecting agency and were not made direct beneficiaries of the ensuing benefits.
As Article 3 of CBD safeguards national sovereignty over biological resources, national
government are under no obligation to redistribute benefits to their own indigenous
populations. Parallel to the issue of improved protection for TK, indigenous communities
may face a broader struggle for respect of their other rights. Here the idea of an
ombudsman with a wider mandate becomes even more attractive. Within IP law, any
system of protection must work to protect the rights of the indigenous communities
concerned. As noted by the African Group at the 7th Session of WIPO‘s
Intergovernmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore (IGC), a central problem with the use of contracts is
the unequal bargaining power of the parties.15

Countries like the U.S. believe that a more appropriate solution for any kind of
misappropriation would be to strengthen national regimes outside the patent systems in
order to address all instances of commercialization of misappropriated resources and/or
traditional knowledge that need to be addressed regardless of whether these instances
involve patenting or not and do not support the proposed new disclosure requirement.16
The U.S. disagrees with the disclosure requirement because it believes that this
mechanism will not prevent the grant of mistakenly granted patents 17 and cites the

12
Convention on Biological Diversity, Panel of Experts on Access and Benefit-sharing, Options for
Access and Benefit-Sharing Arrangements (1998), UNEP/CBD/EP-ABS/2, at para. 39.
13
World Intellectual Property Organization, Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore, Genetic Resources: Draft Intellectual
Property Guidelines for Access and Equitable Benefit-Sharing (2004), WIPO/GRTKF/IC/7/9.
14
Asebey, E.J., Kempenaar, J.D., ‗Biodiversity Prospecting: Fulfilling the Mandate of the Biodiversity
Convention‘, 28 Vanderbilt Journal of Transnational Law 703, at p. 728. Asebey and Kempenaar
provide a detailed account of the Merck-INBio Agreement at pp. 725-730.

15
World Intellectual Property Organization, Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore, Draft Report of the Seventh Session (2004),
WIPO/GRTKF/IC/7/15 Prov. 2, at para. 187.
16
IP/C/W/469, para 9
17
e.g., IP/C/W/434, paragraph 13, information indicating country of origin, ex situ collection sites, etc.,
will do little to ensure ascertainment of inventorship, novelty or inventive step because such information
does not address the considerations underlying these requirements, such as acts of invention or the state of
the relevant art.

4
example of Turmeric Case wherein the country of origin was identified but this
information had little relevance to the maters of patentability at hand.18

With respect to genetic resources the U.S. opines that if all biological resources
automatically contain such an economic or intellectual contribution, then the most
appropriate system of protection, regardless of any eventual patenting or
commercialization, should be a national contract-based Access and Benefit Sharing
System (ABS) that permits monitoring of the biological resource upon access. Yet,
instead, the proponents argue in favour of new patent disclosure requirements that would
have little, if any, effect in actually protecting this purported economic and intellectual
contribution of the biological resource. The options proposed by the United States,
includes, use of organized databases of prior art and a more general disclosure of
information material to patentability requirement are consistent with ‗systematizing‘
information and would more directly provide the required information to patent
examiners rather than providing ‗hints‘ which would bear little, if any, relation to the
issues under consideration.19 Finally it concludes by stating that the proposed disclosure
requirement is not an appreciable solution.

With little experience in negotiating or defending access agreements and few

administrative or legal resources, indigenous communities often find themselves at the
losing end of such bargains. Here again the importance of capacity-building is
highlighted and should form part of any benefit-sharing system. Access contracts have
inherent weaknesses, however, and problems include implementing and enforcing them.
Moreover, there are often no guarantees that such contracts will be entered into in the
first place. Indeed, the use of contracts has been heavily criticized as countries have
argued that contracts do not provide the necessary guarantees to sufficiently protect TK.
At the 7th IGC India emphatically stated that ‗[h]owever carefully any model contract is
drafted, however ardently such contracts try to correct the huge imbalance between the
provider and the user, such an approach simply cannot lead to anything even remotely
resembling a fair and equitable regime.‘20 This view was also supported by Brazil and
stated that disclosure of origin requirement should not be dependent on a contract which
too is voluntary. A system of safeguards in a universally binding instrument is therefore
needed, which guarantees that TK which forms the basis of an invention or innovation
has been legitimately obtained. Introducing sui generis elements into the patent
application procedure is a possible solution.

Under the aegis of the Biodiversity Convention, the Bonn Guidelines were adopted to
specifically deal with issues relating to access and benefit-sharing relating to genetic
resources. State Parties are invited to designate a national focal point21 to provide external

18
IP/C/M/49, paragraph 102
19
IP/C/W/469, para 26
20
WIPO/GRTKF/IC/7/15 Prov. 2, at para. 175. See also para. 183 for Ecuador‘s contribution on this point.
21
Article 13, Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the
Benefits Arising out of their Utilization (hereinafter Bonn Guidelines).

5
actors with the possibility to easily identify the relevant parties to be consulted. The
Guidelines also address issues such as increasing indigenous community participation
and capacity to participate,22 prior informed consent,23 and mutually agreed terms.24 The
Bonn Guidelines also call for benefit-sharing to be instituted for derivatives of genetic
products. 25 Although detailed in the issues relating to genetic resources, the Bonn
Guidelines also remain voluntary. The WIPO IGC has also developed guidelines in the
form of the draft IP guidelines for access and benefit-sharing. 26 As with any other
guidelines, strict adherence cannot be guaranteed, and none of the above measures may
ultimately prove to guarantee sufficient protection of TK.

Part II

1. Proposed solutions within the Patent regime:-

1.1 A modified patent application procedure:-

Patent law can be modified and by adding sui generis elements sufficient protection of
indigenous communities‘ rights can be achieved. A system introducing sui generis
elements into existing conventional IPRs will also prove conceptually easier to adopt in
many countries than other, such as rights-based, approaches. Using the well-established
patent paradigm will enable effective interpretation and application by patent offices
which deal with applications. To minimize alienating critical industry acceptance of this
proposal, these safeguards are of a procedural nature and limit the additional burden
placed on applicants. The introduction of three procedural safeguards within patents is
proposed.

A new patent application procedure:-

1) Disclosure of origin:- When applying for a patent for an invention which is based on
TK related to genetic resources or information pertaining to these resources, an applicant

22
Article 16(a)(vi)-(vii), Bonn Guidelines.

23
Article 16(d) and Articles 24-40, Bonn Guidelines.
24
Article 16(b) and Articles 41-50, Bonn Guidelines.
25
Article 44(i), Bonn Guidelines.
26
World Intellectual Property Organization, Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore, Genetic Resources: Draft Intellectual
Property Guidelines for Access and Benefit-Sharing Contracts (2004), WIPO/GRTKF/IC/6/5;
WIPO/GRTKF/IC/7/9.

6
should be under an obligation to disclose the origin of the material used. This could come
under the form of a certificate of origin indicating where the resource or information was
obtained from. Besides the legal support this would give indigenous communities in their
own countries, on an international level this would provide patent examiners from third
countries with a starting point for prior art searches and would give them the possibility
of liaising more effectively with the focal points in the country of origin of the TK.
Identifying these focal points will facilitate third country patent examiners in confirming
that the requirements of local access regulations had been met. It should be noted that an
attempt to introduce the disclosure of origin requirement for plant and animal genetic
resources has been made at the European level. 27 The requirement itself is largely
ineffective as the origin of the material need only be provided if it is known. Applicants
are under no obligation to ascertain what the origin is, a problem which is magnified as
much bio-prospecting is outsourced and carried out by intermediaries. 28 It has been
argued that introducing the disclosure requirement into the patent application procedure
would not reflect the features and conditions of the Biodiversity Convention and would
not take into effect the practical impact of the measures. 29 Introducing a disclosure
requirement into the patent application procedure would bring with it additional costs but
these should not prove to be inhibitive. India is of the opinion that the CBD and TRIPs
are in conflict with each other and the inclusion of provisions in TRIPS to protect genetic
resources and associated traditional knowledge from misappropriation would, in practice
not only support fulfillment of the objectives of the CBD, but would also be in line with
the fundamental objectives of TRIPS.30
India proposes three types of disclosure requirement:- (a) disclosure of source and
country of origin of the genetic materials and associated traditional knowledge used in
developing the invention claimed in the patent application; (b) disclosure of the evidence
of prior informed consent; and (c) disclosure of the evidence of a benefit-sharing
agreement. As is evident, these disclosure requirements are intended to achieve different
yet interrelated objectives of the CBD. India believes that the solution to the problem
regarding misappropriation and bad patents should be solved within the patent regime
and this could be achieved only by amending the TRIPs Agreement, since TRIPs is the

27
http://europa.eu.int/eur-lex/pri/en/oj/dat/1998/l_213/l_21319980730en00130021.pdf,
Sterckx, S., ‗Some Ethically Problematic Aspects of the Proposal for a Directive on the Legal
Protection of Biotechnological Inventions‘, [1998] EIPR 123. Recital 27 of the Biotech
Directive reads that- ―Whereas if an invention is based on biological material of plant or animal
origin or if it uses such material, the patent application should, where appropriate, include information
on the geographical origin of such material, if known; whereas this is without prejudice to the
processing of patent applications or the validity of rights arising from granted patents.‖

28
ten Kate, K., Laird, S.A., The Commercial Use of Biodiversity: Access to Genetic Resources and
Benefit-Sharing (1999), at p. 302.
29
World Intellectual Property Organization, Intergovernmental Committee on Intellectual Property and
Genetic Resources, Traditional Knowledge and Folklore, Draft Report of the Seventh Session (2004),
WIPO/GRTKF/IC/7/15 Prov. 2, at para. 187.
30
IP/C/W/459, para 1

7
only international document regarding IPRs. The benefits of the disclosure requirement
cited by India are as follows31:-
 Disclosure of source or country of origin would prevent the grant of bad patents
that do not fulfill the patentability criteria of novelty and/or inventive step. The
procedure for revocation of patents is more expensive and burdensome than
merely requiring patent applicants to disclose the source and country of origin of
the genetic resources and associated traditional knowledge. . The disclosure of
origin obligation, on the other hand, would only require reasonable efforts on the
part of patent applicants to obtain the relevant information.
 It would act as a crucial factor in the determination of the patentability of
biotechnological inventions.
 Disclosure of origin will be relevant in helping patent examiners to determine
whether the claimed invention constitutes an invention that is excluded from
patentability under Article 27, paragraphs 2 and 3 of TRIPS; would serve as part
of a process to systematize available information of biological resources and
traditional knowledge that will continuously build the prior art information
available to patent examiners and the general public; and will be useful in cases
relating to challenges to patent grants or disputes on inventorship or entitlement to
a claimed invention as well as infringement cases.
 Disclosure of origin will respect the rights and obligations of holders of the
traditional knowledge on the basis of which the patent is issued, as well as the
rights of the countries of origin of the genetic resources. A contract-based system,
howsoever perfect it may be, cannot ensure the effectiveness and mandatory
enforcement at the international level.
 Given the different nature of the prior art and inventive step involved in cases of
genetic resources and traditional knowledge associated with them, disclosure of
source and country of origin can surely help the patent office to request more
information from the patent applicant during examination of the application to
ensure that bad patents are not issued. This can surely prevent bio piracy and
misappropriation of traditional knowledge by the patent applicant. This is clearly
one of the objectives of the CBD and this can be achieved only if changes are
introduced in the global regime governing the patent law and not through national
access legislation alone. This also adds to the certainty and legitimacy of the
patent system. The disclosure requirement is also not as costly as the contract-
based system envisaged by the United States.
 Disclosure of source and country of origin also facilitates realization of the CBD
objectives of PIC and benefit sharing. Production of the evidence of PIC and
benefit sharing along with the patent application are proposed specifically to
achieve this. It is in this context that the proposal from India and Brazil
emphasized the need for national systems to support the international obligation
in this regard. Thus, it is incorrect to state that the object of the new disclosure
requirement of source and country of origin is of "little or no utility" if national
regimes on PIC and benefit sharing are not in place. Even in the absence of a

31
IP/C/W/459, para 6,7, 10, 11,12, 15, 16.

8
 national ABS regime, disclosure of source and country of origin could surely help
prevent bio piracy and misappropriation of traditional knowledge associated with
genetic resources by preventing the issue of bad patents. Additionally, in the
cases where national ABS regimes have been established, disclosure ensures that
the requirements of these national regimes are met by bio-prospectors.
 What is attempted through mandatory disclosure requirement is to ensure that the
implementation of the TRIPS Agreement and of the obligations under the CBD
should take place in a mutually supportive manner. As explained, this requires
internationally binding legal obligations rather than national regulatory measures
alone. The US contract-based solution sidelines this issue.

2) Prior Informed Consent:- Having identified the origin of the material through
certification provided with a patent application, it is easier for a patent examiner to
confirm whether an applicant has complied with the requirement of prior informed
consent (PIC). Enabling indigenous communities to retain control over their animal or
plant resources will be facilitated by introducing the requirement of PIC at the patent
application stage. To enable PIC to be obtained as easily and as quickly as possible, a
system of clearly established legislative, administrative and policy measures needs to be
put into place in countries with indigenous communities.32 Legislative efforts regarding
PIC have been made in Europe. Recital 26 of the Biotech Directive calls for consent to be
obtained where the patent application is based on biological material of human origin or
if it uses such material. This provision should be further developed, however, and free
and informed consent should be obtained from the owners or holders of plant or animal
genetic resources as well. Moreover, the provision should be made legally-binding.

3) Benefit-sharing with a focus on capacity-building:- When applying for a patent,

applicants should be under a procedural obligation to enter into benefit-sharing
negotiations with TK source communities. At the least these would include negotiations
relating to monetary benefits including access fees, up-front, milestone and royalty
payments, licence fees, and research funding. Negotiations relating to non-monetary
benefits should cover the sharing of research results, collaboration, co-operation and
contribution in the provider country or community, participation in product development
and education and training. 33 Including the negotiation of capacity-building measures,
such as technology transfer, as a procedural obligation of a patent application would shift
the onus of technology transfer from States, as provided for in the CBD and TRIPs, onto
the private businesses and public institutions which in fact own this technology.

32
Convention on Biological Diversity, Panel of Experts on Access and Benefit-sharing, Options for
Access and Benefit-Sharing Arrangements (1998), UNEP/CBD/EP-ABS/2, at para. 39.
33
For a more complete list of monetary and non-monetary benefits to be addressed, see for example
Appendix II of the Bonn Guidelines or Appendix I of the Annex to WIPO/GRTKF/IC/6/5.

9
1.2 Proposals for the review of Article 27.3(b) of the TRIPs:-

Proposal on the life patenting Proposals on the sui generis

provisions provision

India  Harmonize CBD and TRIPs  To decide effective sui generis

through disclosure of origin. system may be left to each
 Exclude patent on all life forms Member to evolve in its legal
or atleast patents based on system and practice.
traditional/indigenous  It is essential to ensure that the
knowledge. preservation of farmers‘ rights
 National policy to decide what is not considered a dilution of
are patentable microorganisms, effectiveness of the system.
including in light of Art. 27.2.
 Developing countries cannot
accept any further strengthening
of the protection presently
provided to life forms.
U.S.A.  Eliminate the exclusion for  Incorporate UPOV 91 into
plants and animals so that they TRIPs.
must be patentable in all
countries.

African  Review should be extended to 5  Review should be extended to

Group years and clarify that plants, 5 years.
animals, micro-organisms, their  Sui generis laws should allow
parts and natural processes protection of community
cannot be patented. rights, the continuation of
 TRIPS should contain provisions farmers‘ practices and the
to promote the conservation and prevention of anti-competitive
sustainable use of genetic practices.
material and prevent bio-piracy.  Farmer‘s rights must be
protected retained and
construed in consistency with
the CBD, the FAO
International Undertaking on
Plant Genetic Resources and
the OAU Model Law on
Farmers‘, Breeders‘ and
Community Rights.

10
1.3 Recommendations For Action Relating to International Regime:-

WTO esp. TRIPs:- CBD:- Other processes:-

 Review and  Develop a protocol  Development of the

amendment of on the protection of FAO Undertaking
Article 27.3(b). indigenous and local on Plant Genetic
 Full consideration of community Resources, either in
relevant provisions knowledge and itself or as a
of CBD, and other resource rights. protocol under the
relevant  Assess the CBD.
international treaties relationship of IPRs  Cooperation at the
and processes. to access and SAARC level to
 Review of Article benefit-sharing jointly conserve
7,8,31 of TRIPs and provisions, biodiversity, achieve
Article 16 of CBD. including in the sustainable use, and
 Expansion or development of promote equitable
maintenance of the guidelines or best benefit-sharing.
exceptions in Article practices for  At all international
27.3(b) of TRIPS. achieving equitable forums, setting up of
 Expansion or benefit-sharing from ―intercultural
maintenance of sui use of genetic panels‖ to evaluate
generis clause resources. the terms of ―cross-
relating to plant  Providing inputs in cultural
variety protection. the ongoing WIPO transactions‖.
 Bring TRIPs in processes on ―new
conformity with beneficiaries‖.
CBD.  Develop code of
 Enhancing scope of conduct on access
Article 22, 23, 29 of and benefit-sharing.
TRIPs.
 Implementation of
TRIPs should be
such so as to achieve
its objective.

11
1.4 Recommendations at Regional Level:-

Patent Legislation:- Plant Varieties Biodiversity Other Processes:-

Protection Legislation:-
 Exclusion Legislation:-  Database of TK to
from  Article 8(j) of be compiled.
patentability  Modified CBD to be  Capacity of
all life forms application implemented indigenous
and existing for plant at the regional community to
TK. variety level. protect their TK
 Modified protection.  Define should be
patent  Farmer‘s ‗community‘ enhanced.
application rights should  Legislation to  Strengthen local
disclosing get full include bio- system of
the origin. treatment. chemicals. Government
 Impose  Farmer‘s  In-depth  Establishment of
penalties rights to securitization proper
when the include right by national authorities.
modified to sue bio-diversity
patent breeders if agencies.
application the latter‘s‘  Creation of
procedure is claims are additional
not adhered not realized. institutions.
with.  Creation of
national and
local gene
funds.

2. Proposed solutions outside the Patent regime:-

1.1 Alternatives that Countries could exploit to protect TK of indigenous and local
peoples other than the new patent application procedure regionally:-

1) Trade secret. Traditional peoples have used—and possibly continue to use—

trade secrets to protect their knowledge. However, this form of protection of
traditional knowledge is generally not institutionalized: institutions to safeguard
trade secrets of indigenous and local peoples are either weak or absent in most
countries. It is therefore crucial that national legislation be enlarged to contain
specific measures that would enable indigenous and local peoples to apply trade
secrets to protect their knowledge and innovations. Such measures may include
explicit articulation of traditional knowledge as subject matter for protection
through trade secrets.

12
 2) Creation of sui generis legislation suitable to their cultural and political
conditions. They should explore the development of systems that will first and
foremost protect traditional knowledge as intellectual property of indigenous and
local peoples. Such systems should also encourage (or even require) the flow of
benefits from bioprospecting to indigenous and local peoples. According to
Dutfield, ―legislation could be drafted in such a way as to allow a community to
become the successor in title of . . . discovery and development process. As a
right holder, they would have exclusive rights to withhold from third parties their
consent to make, use, an offer for sale, or import the plant variety that they
developed.‖34

3) It is crucial that new research be conducted on traditional forms of intellectual

property and how traditional knowledge was/is protected by indigenous and local
peoples in different parts of the world. Case studies illuminating how indigenous
and local peoples perceive intellect and whether they treat it as property worth
protecting would be useful. This work would form the basis for national and
international processes to establish property protection regimes suitable for
traditional knowledge and innovations.

4) Documentation of TK:- Several developed and developing countries have agreed

on the importance of documenting TK. TK documentation data constitute an
important form of non-patent literature with specific characteristic making it a
category of non-original databases. If the development of such measures takes
into account the needs and priorities of all stakeholders, they might: (i) avoid the
grant by IP offices of patents for TK-based inventions which are not novel and
non-obvious; (ii) avoid the costs of challenging such patents for TK holders and
other interested third parties; (iii) facilitate recognition of the technological value
of TK by all users of non-patent literature. There is a need to create more easily
accessible non-patent literature databases that deal with TK. With the help of
developing countries, TK can be documented, captured electronically and placed
in the appropriate classification within the International Patent Classification so
that it can be more easily searched and retrieved. A TK digital library (TKDL)
would help to prevent patenting pf products based on TK. India has taken an
initiative to create TKDL. Department of Indian Systems of Medicine &
Homeopathy (ISMH) has spearheaded a classification system named TK
Resource Classification (TKRC) for the purpose of systematic arrangement,
dissemination and retrieval of TK resources. TKRC relating to more than 2000
medicinal plants, information on processes for the preparation of the drugs and its
users, details of plants used, therapeutic compound formulations, compositions,
doses and diseases, in which they are used, along with the list of documents
wherein such information is available, has already been completed by Indian
experts. For documenting TK, it is necessary that TKRC gets accepted globally.
However, an immediate drawback of placing information in the public domain is

34
Dutfield, G., Can the TRIPS Agreement Protect Biological and Cultural Diversity? (Biopolicy
International No. 19, ACTS Press, Nairobi, 1997).pp. 39-40.

13
 that it becomes very difficult to control.35 By voluntarily placing information in
community registers indigenous communities also forgo the possibility of
receiving compensation for that knowledge. Open-access databases should only
be used for TK which is already in the public domain or for which prior informed
consent has been obtained. 36 To avoid this issue of non-compensation,
confidential registers have been proposed. The aim of these registers and
databases is not only to document TK but also to encourage technology transfer
and equitable business relationships between indigenous communities and non-
indigenous users of TK.37 As envisaged by CBD clearing-house mechanism, such
registers place interested parties in contact with each other. Indigenous
communities can place information on confidential registers outlining the content
and use of their TK without revealing commercially valuable details. Interested
companies are then able to approach these communities through the appropriate
body and establish proper commercial links. The creation of a global bio-
collecting society (GBS) has been proposed to deal with these issues on a global
scale.38 Any information provided by indigenous communities would be strictly
confidential and the GBS – while also serving to assist in contractual negotiations
and monitoring the use of TK – would serve as a point of contact for interested
parties. As information on these registers is not in the public domain, complete
confidentiality within the GBS, but also within the indigenous communities in
question, must be guaranteed. Any such strategy will otherwise fail as information
obtained in ignorance as to the real source of information, or by less scrupulous
means, can lead to the granting of a patent and undermining of the system. To
ensure this confidentiality the coupling of digital rights management with TK has
been proposed.39

35
Posey, D.A., Traditional Resource Rights: International Instruments for Protection and
Compensation for Indigenous Peoples and Local Communities (1996), at p. 46.
36
World Trade Organization, Council for Trade-Related Aspects of Intellectual Property Rights, The
Protection of Traditional Knowledge and Folklore: Summary of Issues Raised and Points Made
(2002), WTO/IP/C/W/370, at para. 16.
37
Examples include the People‘s Biodiversity Register and the local innovation databases of the
Society for Research and Initiatives for Sustainable Technologies and Institutions, both in India. See
Dutfield, G., ‗Protecting and Revitalising Traditional Ecological Knowledge: Intellectual Property
Rights and Community Knowledge Databases in India‘, in Blakeney, M. (ed.), Perspectives on
Intellectual Property, supra note 5, pp. 101-122, at pp. 117-121.
38
Drahos, P., ‗Indigenous Knowledge, Intellectual Property and Biopiracy: Is a Global Bio-
Collecting Society the Answer?‘, [2000] EIPR 245.
39
Owens, R., ‗Digital Rights Management and Documentation of Traditional Knowledge: Strange
Bedfellows?‘, in Grosheide, F.W., Brinkhof, J.J. (eds.)

14
 Conclusion

The paper has primarily focused on improving the current position regarding protection
of TK, bio-diversity. As is evident the present contract-based approach shortcomings and
the indigenous communities do not possess the requisite know-how needed to complete
an application and often struggle to meet the financial burden of applying or challenging
patents. This problem is added by the fact that the TRIPs and CBD are in conflict with
each other.

The proposed solutions set out in Part II of the paper, are the various alternatives that are
available to the Countries for harmonization of the conflicting interests. Inspite of all the
alternatives available, a concerted, global approach incorporating internationally
enforceable minimum standards is needed. Non-customary users of TK would also
benefit from an international regime. Internationally enforceable minimum standards
would guarantee global protection for TK and the safeguards introduced would go some
way in guaranteeing that the indigenous communities in question are dealt with equitably.

The TRIPs offers opportunities but reform is needed which will bridge the gap between
those parties calling for introduction of sui generis systems of protecting TK and those
parties content with the current system of protecting TK through conventional IPRs. A
compromise solution of inserting sui generis elements into conventional IPRs may prove
acceptable to both sides of the debate.

15
 References

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16
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International Instruments:

1. Convention on Biological Diversity, 1992.

2. The Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994.
3. The International Convention for the Protection of New Varieties of Plants, 1978
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4. Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the
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Property a
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17
 Property Guidelines for Access and Equitable Benefit-Sharing (2004),
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16.

18