ACCESS, BENEFIT SHARING & INTELLECTUAL PROPERTY RIGHTS

Introduction
In the 5th Century B.C. Aristotle presented moral and philosophical arguments to reward
inventors for their innovations. With the industrial boom in the 19th century in Europe the need
arose to protect inventions from being copied and thus ensure that the investment in innovations
would be rewarded. On the other hand, there is a need to disclose innovations to the public to
promote/facilitate further development based on existing innovations (Tansey, 1999). To ensure the
both aspects of innovation (protection and publication) a legal protection, an Industrial or
Intellectual Property Rights (IPRs) system was created. During that time, the legislations on IPRs
were designed to protect only industrial products since agricultural innovations did not play such an
important role.

In the beginning of the 20th agricultural innovation gained importance and consequently its
protection but the mechanisms developed by then for this purpose (patents), were not appropriate to
protect new plant varieties, basically for three reasons. First, one of the requisites to obtain a patent
is, that the invention should really incorporate an inventive step (non-obviousness) what does not
apply to new plant varieties created by selection and crossing of already existing varieties. Second,
a patent requires an exact description of the innovation and the process to obtain it. This resulted
not only difficult but, in most cases impossible. However a pure publication of the description of
the material, in contrast to industrial innovations, is of no use for further investigation the protected
variety must be physically available. Third, patent protection was considered to be too strong for
new varieties and thus hinder a more dynamic development of the agricultural sector since there are
traditional and accepted rights and habits of farmers as for instance the saving, reuse and exchange
of seeds which are restricted under patent protection. To overcome the above mentioned
constraints, a new concept to protect plant varieties, the Plant Breeders Rights (PBRs) system, was
designed.
When it was formally proposed at the end of the Earth Summit in 1992, the Convention on
Biological Diversity (CBD) was seen as the first decisive step taken by the global community to
ensure conservation and sustainable use of the world's genetic resources. For the genetic resource
rich developing countries, the CBD was particularly important because it recognised that States
shall have sovereign rights over the biological and genetic resources within their territories, and can
establish laws to regulate access to those resources. Another significant development in the past
two decades has been the rapid progress made by the biotechnology industry, raising in its stride

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the critical issue of extending intellectual property rights (IPRs) to products based on genetic
resources, and to the technology used for arriving at such products. The formalisation of the
Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) at the conclusion of
the Uruguay Round of GATT negotiations was a direct consequence of the efforts that the
commercial interests in this frontier technology had made.

This paper aims at raising some of the key issues that arise in the implementation of CBD
and the Agreement on TRIPS, particularly for the biodiversity-rich countries where local and
indigenous communities have been harnessing the genetic resources using traditional knowledge
system over generations.

CBD Principles
The CBD recognizes several broad principles that seek to define the nature of rights of a State over
its genetic resources and the legal framework it can establish for regulating access to such
resources. CBD’s key principles are as follows:
• Every State shall have sovereign rights over the biological and genetic resources within its
territory, and can establish laws to regulate access to those resources;
• Access to such resources should be on ‘mutually agreed terms’ and should incorporate the
principles of ‘prior informed consent’ of the resource provider. Moreover, it recognizes an
obligation to ensure ‘fair and equitable’ sharing of benefits arising from access and use of the
resources.
• Every Contracting Party shall make efforts to develop and carry out scientific research based on
genetic resources provided by other Contracting Parties with the full participation of, and to the
extent possible, within the countries supplying the genetic material.
• Contracting Parties should adopt legislative, administrative and policy measures that could ensure
effective participation in biotechnological research activities by those Contracting Parties,
especially developing countries, which provide the genetic resources for such research, and where
feasible in such Contracting Parties.
• Contracting Parties should "take legislative, administrative or policy measures, as appropriate,
with the aim that Contracting Parties in particular those that are developing countries, which
provide genetic resources are provided access to and transfer of technology which makes use of
those resources, on mutually agreed terms, including technology protected by patents and other
intellectual property right....".
• States should: (i) respect, preserve and maintain knowledge, innovations and practices of
indigenous and local communities embodying traditional lifestyles relevant for the conservation

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and sustainable use of biological diversity, (ii) promote their wider application with the approval
and involvement of the holders of such knowledge, innovation and practices, and (iii) encourage the
equitable sharing of benefits arising from the utilization of such knowledge, innovations and
practices.
TRIPS Principles
The TRIPS Agreement takes a major step towards harmonisation of the norms and
standards of intellectual property protection. It requires members to comply with a defined set of
minimum standards for the protection of intellectual property rights covered in it. Its basic
principles relevant for the present discussion are as follows:
• It mandates countries to provide patents for products and processes in all fields of technology,
subject to the tests of novelty, inventiveness and industrial use.

• It mandates patenting of ‘micro-organisms’ and non-biological and microbiological processes.

• Members are allowed to make limited exclusions from patentability are permitted on the grounds
of public order or morality, and in respect of protection extended to human, animal and plant life or
health. It also gives states the option for protecting new plant varieties through patents or through
any other effective sui generis system.

• It recognizes as one of its objective that the protection and enforcement of intellectual property
rights should contribute to the promotion of technological innovation to the mutual advantage of
producers and users of technological knowledge and in a manner conducive to social and economic
welfare, and to a balance of rights and obligations.

Products Based on Biological Resources and Traditional Knowledge: The Basic Issues
The concern with inventions based on biological resources is not only about the tangible
physical resource alone, but also about the intangible information base associated with that
resource, referred to commonly as Traditional Knowledge (TK). The growing importance of
biotechnology and the increasing number of patents granted to biotechnology-based inventions
highlight the potential value of genetic resources and associated TK.
The originators and custodians of much of TK are local and indigenous communities who
through years of consistent skill, observation and usage have developed a wealth of a knowledge
base regarding the use and properties of various biological resources. The value of TK and its key
role in the development of the final product has been the subject of a variety of literature to date.
With regard to biological material, it is a settled principle in Europe and North America that while
it is not possible to claim as an invention something that occurs in nature, patents can be possible if

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one extracts it from nature and makes it available for industrial utilization. Such a proposition is
explicitly rejected under Indian Patent law for instance, since, discovery of any living thing or non-
living substance occurring in nature, are excluded from the purview of patentability. There are
various examples regarding the grant of patents in other jurisdictions, commonly in the United
States and European countries, over products based on biological resources commonly used in
India. Some of these examples are enumerated below:
 Use of turmeric in wound healing.
 Composition of jamun, bitter-gourd, gur-mar and eggplant for treatment in diabetes.
 Various products obtained from the neem tree.
 Varieties of basmati which have the characteristics of growing in temperate climate in the
absence of sunlight.
 Composition of methi as a tonic to bring down blood glucose levels.
 Compositions comprising of kala jeera or kalonji for increasing immune functions, and
treatment of diabetes, hepatitis, and asthma.
Other such examples from South America and Africa include patents granted on quinoa and
ayahusca, and on products based on plant material and knowledge developed and used by local
communities such as the cases of kava, barbasco and endod. The premise on which this paper is
based is that the conflicts that emerge when patents are granted on products of biological resources,
are not simply social, political or economic, but rather, strike at the very root and basis of the patent
system.

Overview of IPR & TK

There are three principal forums where the issues pertaining to protection of TK, access to
biological resources and IPRs have figured prominently. These include the Conference of Parties to
the CBD, the TRIPS Council of the WTO, and the World Intellectual Property Organization
(WIPO). The following section provides an elaboration of the developing country positions
advocated through their submissions to the TRIPS Council. These have been elaborated in a recent
submission to the TRIPS Council.

(i) Why we need Norms of Disclosure

Several developing countries have been arguing for effective norms of disclosure revealing
source of origin of the resource and TK used in the invention, as well as provide evidence of prior
informed consent and benefit sharing. It is believed that disclosure of source of origin and evidence
of prior informed consent and fair and equitable benefit sharing in a patent application would play a

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significant role in preventing biopiracy and misappropriation. It would serve as a critical tool for
biodiversity rich countries like India in tracking down applications based on bioresources and
related TK, and enable adequate challenges to specious patents. Disclosure of origin of the
resource and TK will therefore serve the following purposes. These are:
(a) Reducing instances of bad patents;
(b) Enabling the patent office to ascertain more effectively the ‘inventive step’ claimed in a
particular patent application;
(c) Enhancing the ability of countries to track bad patents in the instances where they are granted
and challenge the same;
(d) Improving compliance with their national laws on prior informed consent and fair and equitable
benefit sharing prior to accessing a biological resource/associated traditional knowledge. This
would also increase the credibility of the patent system, as well as contribute to achieving the
principal objectives of the TRIPS Agreement.

(ii) Notions of Equity and Good Faith

India and several other countries have also consistently argued for notions of equity and
good faith behind the proposal for clarifying the TRIPs Agreement. Equity and Good Faith are
principles recognized under most jurisdictions. There are no strict definitions for these terms. They
essentially connote a situation of fair play and justice. It has been argued that notions of equity and
good faith mandate that the international community create an equitable system for the acquisition,
maintenance, and enforcement of intellectual property rights, which does not a priori exclude any
section of the society. It has been acknowledged that the principle of equity dictates that a person
should not be able to benefit from exploiting IPRs based on genetic resources or associated
knowledge acquired in contravention of any legislation governing access to the material.

(iii) Role of TK Databases & limitations of relying only on databases

Compiling databases of traditional knowledge at the national level is an important aspect
being addressed at the national level in several countries, including India, through efforts at
compiling a Traditional Knowledge Digital Library. Such databases would play a key role in
facilitating a patent examiner’s check against patent requests relating to unauthorised use of the
knowledge of traditional communities. It was, however, recognised that given the vast breadth and
depth of such knowledge, there was an inherent limitation of such documentation which was that it
cannot be completely comprehensive and exhaustive of all the traditional knowledge available in a
country. This would be particularly true when traditional knowledge used in a particular invention

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was undocumented, based on oral traditions or documented in the local languages. In such cases,
reliance on the documented source itself may not be sufficient. It has been suggested that the use of
databases documenting the knowledge, innovations and practices of traditional communities which
can be made widely accessible over the internet, to enable their use by patent examiners, will be an
adequate solution to redress the problem of biopiracy.

(iv) Limitations of National laws or Contracts

It has been suggested that there should be a separate law for governing aspects of biopiracy,
and that PIC and benefit sharing can be done through contracts as well. The CBD mandates its
member states to enact national laws that would facilitate PIC and benefit sharing in a fair and
equitable manner, prior to access and use of biological resources and traditional knowledge. It is
acknowledged that these mechanisms can and should be used, and several countries have already
enacted laws to put in place an Access and Benefit Sharing (ABS) regime. However, this in itself is
insufficient to arrest biopiracy and misappropriation of resources. It also does not achieve the
central objective of disclosure norms- that is to stall the reward of a patent for knowledge or
information misappropriated from another country. For the same reasons, relying on contracts will
be insufficient as well. Contracts being voluntary in nature would be ineffective if the parties to the
contract are of vastly unequal bargaining strengths, as would be the case involving traditional
communities and the commercial interests. National systems by themselves would not be adequate
to fully protect and preserve traditional knowledge. For example, the ability of patent offices in
national jurisdictions to prevent biopiracy as well as to establish informed consent mechanisms to
ensure reward to TK holders, does not ipso facto lead to a similar action on the patent applications
in other countries. Similarly, benefit sharing mechanisms established through national legislations
would need to be recognized in user countries. The remedies that can be sought under national laws
for access and benefit sharing will also inevitably have only territorial application within the
country whose laws are violated.

It is very clear, that any improvement of the performance of the system of protection of
access to genetic resources and protection of IPRs is strongly related to capacity building and
improvement of coordination between the stakeholders on national level, as well as on international
level (Byerlee and Fischer 2001; Salazar, 2001). These capacity-building programs should be
directed to all stakeholders (Farmers, Seed companies, Biotech companies, Governmental
Organizations, NGOs, CSOs, Universities and NARS) and should put emphasis on:

 Need for the conservation of biodiversity,

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  Need for the protection of IPRs,
 Access to and transfer of genetic resources and technology and
 Training of human resources

In addition to capacity building there are other areas where external support is needed. To
facilitate the control, databases to register genetic resources and traditional knowledge should be
established. Further on, networks for exchange of experiences and information as for instance
the Technical Co-operation Network on Plant Biotechnology (REDBIO/FAO) shall be formed and
can be an appropriate vehicle to implement the above mentioned capacity building programs. A
central element is also to assign clear mandates to the national authority and provide them with the
tools necessary to enforce the existent regulations. As a crucial element such an authority should
provide space for the participation of all stakeholders in the most important decisions such as the
design of the regulations and its interpretation or to establish means of communication (Wendt and
Izquierdo, 2000).

To achieve this, institutional capacity buildings as well as assignment of sufficient financial

and human resources are essential (Salazar, 2001). The solutions of these problems are not only
depending on the activities on national level but are strongly dependent on how a better regional
cooperation could be achieved. Therefore the support of international organizations such
as FAO, WIPO, UPOV, ISNAR and others are indispensable since national governments in
developing countries lacking capacities and resources.