2b.biopiracy Selera-GU 2019 PDF

Faculteit Rechtsgeleerdheid
Universiteit Gent
Academiejaar 2012-13
Biopiracy
Masterproef van de opleiding

‘Master in de rechten’
Ingediend door
Saskia Lemeire
(studentennr. 00803054)
Promotor: Professor Frank Maes

Commissaris: Hendrik Schoukens
!
Acknowledgment
I would like to express my sincere gratitude to some people, without whose help, support and patience
it would not have been possible to complete the process of writing this master thesis.
First and foremost, I want to thank my kind parents, my mother for her patience and presence and
my father for always posing critical questions. They have not only given me the freedom and trust to
make my own choices in life and in my education, but have supported me every step of the way.
Secondly, a special thanks is preserved for François Grossmann who has calmly endured every
moment of despair. Without his support and help this thesis would not look the same.
Thirdly, I would like to thank Sigrid Heirbrant for always believing in me, Toby De Backer for
giving me a push when I need it and both of them for their friendship that I value very high.
And last but not least, a special acknowledgement is preserved for Professor Frank Maes, for his
enthusiasm on the subject I chose for this thesis, and to Hendrik Schoukens, for giving me the freedom
to develop this dissertation in my own way.
Contents
Introduction 1
I Situating the Problem, Pirates or Heroes? 3
1 Defining the Concept, What is Biopiracy? 5

1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.2 Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3 Putting it in the Right Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.4 Why is it a Problem? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 History 12
3 Case Law 16
3.1 The Neem Tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
3.2 Enola Bean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.3 European Patent Office versus US Patent and Trademark Office . . . . . . . . . . . . . . 19
4 Preliminary Conclusion 20
II Analysis of the Existing Legal Framework 21
5 Patent Law and Patentable Subject Matter 23

5.1 World Intellectual Property Organization . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.2 TRIPS Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
5.2.1 Minimum Standard of Patentability . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.2.2 Exceptions to Patentability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.3 EU Directive on the Legal Protection of Biotechnological Inventions . . . . . . . . . . . 30
6 Convention on Biological Diversity 33

6.1 Protecting the Knowledge and Innovations of Indigenous Communities . . . . . . . . . 38
6.2 Access and Benefit Sharing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
6.3 Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
7 The Interface between the TRIPS Agreement and the Convention on Biological Diver-
sity 41
7.1 Current Status of Plant Genetic Resources . . . . . . . . . . . . . . . . . . . . . . . . . 42
7.2 Adapting the TRIPS Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
8 Nagoya Protocol 45
8.1 The Text . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
8.2 Assessment of the Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
II
III Towards a Solution 53
10 Rhetoric 56
11 European Union Initiatives 59
12 Using Patent Law to Protect Traditional Knowledge 63

12.1 A Mandatory Disclosure Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
12.1.1 National Legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
12.1.2 Disclosure outside Patent Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
12.1.3 Disclosure as a TRIPS Obligation . . . . . . . . . . . . . . . . . . . . . . . . . . 66
12.1.4 Disclosure through the WIPO . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
12.2 Prior Art and Digital Databases of Traditional Knowledge . . . . . . . . . . . . . . . . . 70
13 Alternatives 71
Conclusion 75
Bibliography 78
Annex I: Summary Table of Membership of the Treaties Administered

by WIPO 86
Annex II : Nederlandstalige Samenvatting 91
III
List of Abbreviations
ABS Access and Benefit Sharing

CBD Convention on Biological Diversity
CGIAR Consultative Group on International Agricultural Research
CGRFA Commission on Genetic Resources for Food and Agriculture
COP Conference of the Parties (Convention on Biological Diversity)
EPO European Patent Office
FAO Food and Agriculture Organization of the United Nations
IGC Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore (WIPO)
IPR Intellectual Property Rights
LDC Least Developed Country
MTA Material Transfer Agreement
NGO Non-governmental Organization
PBR’s Plant Breeders’ Rights
PCT Patent Cooperation Treaty
PVP Plant Variety Protection
SPTL Substantive Patent Law Treaty
TRIPS Trade Related Aspects of Intellectual Property Rights (in GATT)
UPOV International Union for the Protection of New Varieties of Plants
USPTO United States Patent and Trademark Office
WHO World Health Organization
WIPO World Intellectual Property Organization
WTO World Trade Organization
IV
Introduction
“ Knowledge is power ” 1
Sir F. Bacon
The end of the twentieth century has been the dawn of a new age, the age of knowledge. The
rapid advances made in science and technology have made knowledge a valuable commodity. For ex-
ample, internet has brought a revolutionary change. Similarly, genetic sequencing is mind-bending in
its implications for bioscience.2 The increased importance of knowledge explains why the economy
of intellectual property is much more of a political concern now than it was two decades ago. The
WTO Agreement on Trade-Related Aspects of Intellectual Property Rights has created a globalized
system of broad patentability. These technological changes and their legal protection have produced a
widespread concern about biodiversity. This concern has been expressed through campaigns against
the ‘plunder of nature’.3 Biopiracy is one of the detrimental side effects generated by the expanding
value and protection of intellectual property.
Biopiracy is the unauthorized or uncompensated use of biological resources and traditional knowl-
edge adhering to other (often developing) countries and their local and indigenous communities. It
feels morally unjust that farmers from developing countries should pay for seeds that are developed
from varieties which originally came from their territories. Neither does it feel fair to appropriate the
traditional knowledge of an indigenous community about the uses of a plant to develop a product and
make profit of it without that community receiving any compensation in return. One example is the
raging public opinion on Monsanto cases. Monsanto is a biotech giant that regularly appears in the
media with protests against its ‘seed oligarchy’ and its unfair treatment of small farmers.4 This is only
one company. In the pursuit of profit, morality is often forgotten.
This unjust phenomenon started out as a story of dominant developed countries that imposed their
demands on weaker developing countries. However, that story has gotten a lot more complicated.
Biopiracy is generated by a complex regime of legislation. Activists often use a one-sided discourse
of ruthless multinationals exploiting the poor population of developing countries. This dissertation
strives to put biopiracy in the right context, give an insight to the key issues and take on the search
for a remedy. The following paragraphs will set out the structure of this dissertation by briefly taking
a peak into each of its three parts.
1
“Sciencia potentia est”, Sir Francis Bacon, Religious Meditations, Of Heresies, 1597.
2
D. E. SCHMIDT, “Postcard from the Reality-Based Universe: Wish You Were All Here! A Meditation on the Relationship
Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources”, Environ-
mental Law, 2008, Vol. 38, 363.
3
C. MAY, World Intellectual Property Organization (WIPO): Resurgence and the Development Agenda, Abingdon, Taylor &
Francis, 2006, 1-2.
4
RT, “Monsanto protests scheduled in 36 countries”, 9 May 2013, http://rt.com/usa/monsanto-march-protests-world-069/.
RT, “Monsanto takes home $23mln from small farmers, seeks to maintain ‘seed oligarchy”’, 13 February 2013,
http://rt.com/usa/monsanto-seeds-trial-bowman-123/.
The Guardian, “Monsanto-the black stain on the biotech industry”, 11 August 2011,
http://www.guardian.co.uk/commentisfree/2011/aug/11/monsanto-biotech-industry-monoculture.
1
Firstly, the phenomenon of biopiracy will be situated in its context. Since the problem is not
widely known, the first part of this dissertation will explain what biopiracy exactly is and why it is a
problem. For a full understanding of the current international negotiations and more specifically its
difficulties, it is important to know the history leading to the emergence of biopiracy. That is why the
author provides an overview of the evolution of intellectual property law and biodiversity protection.
Additionally, two cases concerning biopiracy will be discussed to assess how the EU and US patent
authorities handle claims of biopiracy.
Secondly, an analysis of the current legal framework concerning biopiracy is made. The two inter-
national agreements with the biggest impact in this respect are the WTO Agreement on Trade-Related
Aspects of Intellectual Property Rights and the UN Convention on Biological Diversity. To a certain
extent these regimes are incompatible and in reality this gap condones biopiracy. Part two of this
dissertation will highlight the controversial provisions in both of these agreements and the conflict in
the interface between them. In 2010 the Nagoya Protocol was adopted to adjust some of the existing
implementation problems of the Convention on Biological Diversity. The author will look at the ob-
jectives of the protocol and assess whether it is likely to realize those.
Lastly, the third part of this dissertation considers the possible options to remedy the negative ef-
fects of biopiracy. On the international level there are many discussions taking place, covering a wide
array of possible measures. To remain within the scope of this dissertation, the author has limited this
part to the most realistic and effective measures discussed for a remedy.
Throughout the pages of this dissertation the international discussion on biopiracy will be studied
in all its aspects, but also suggestions will be made for a workable remedy that is realistic in light of
the current status of discussion. Biopiracy is only one of the various topics of conflict that cause the
impasse in WTO negotiations. It is a very clear example of how difficult a solution can be reached
when there is a substantial conflict between the claims of different states. Biopiracy tends to stir up
emotions and heavy moral judgement, but this dissertation offers a legal view on the topic taking into
account the perspectives from the different stakeholders. It is the author’s aspiration that the extensive
legal inquiry of this dissertation can offer the reader a new understanding of the problems surrounding
biopiracy.
2
Part I
Situating the Problem, Pirates or

Heroes?
The first part of this dissertation strives to offer an elaborate overview on the controversy sur-
rounding biopiracy, before conducting an analysis of the legal framework in the second part and sug-
gesting a remedy in the third part. Although biopiracy is a highly debated issue, it is not widely known.
Therefore an introductory chapter will start by providing the reader with a definition of the concept.
As there is no harmonized understanding of what biopiracy exactly is, it is important to discuss the
key elements of the definition and the points under debate. This chapter will further put the problem
in its context by giving voice to counter arguments and explain why biopiracy is a problem that is in
need of a solution.
The second chapter will look at the historical evolution of the biopiracy controversy. During the
last decades, science and industry have changed quite a lot. A thorough knowledge of the international
legal actions those changes triggered will make for a better understanding of the current legal situa-
tion. This knowledge will be a sound base to assess the current regulation that applies to biopiracy in
part two of this dissertation.
Throughout the third chapter the judicial assessment of biopiracy will be illustrated through a ren-
dition of two ‘textbook’ biopiracy cases. By looking at the approach of the European Patent Office in
one case and the reasoning of the United States court in another, the most important differences be-
tween these two influential patent regulators will become clear. Looking at two concrete examples of
biopiracy will further clarify the impact of biopiracy. The differentiating views of the European Patent
Office and the US Patent and Trademark Office are an important element to consider when presenting
a workable solution for the problem in part three.
4
Chapter 1
Defining the Concept, What is

Biopiracy?
1.1 Introduction
Throughout the ages, humans have been hunting and collecting plants, seeds and other natural ele-
ments. Recorded explorations of foreign natural elements trace back to Ancient Egypt, when Queen
Hatshepsut sent her army out on a search for a specific tree.5 One of the first influential ethnob-
otanical works was written in AD 77 by the Greek physician Dioscorides. His De Materia Medica de-
scribes nearly 600 plants and their medicinal uses.6 During colonial times many explorers and colonists
brought back plants, minerals and observations of the practices of local communities to the metropoli-
tan state. In 1474 the Republic of Venice enacted the first known general patent statute as an incentive
to create or import new technologies.7 Whether for food, science, economic profit or medicinal use, a
broad range of players have been and are making use of biological resources.8
Up to the present day, genetic resources9 and traditional knowledge associated with those resources
play a significant role in different sectors of industry (in plant and animal breeding, biocontrol, food
and beverage, horticulture, industrial biotechnology10 , pharmaceutical industry and cosmetics). Many
of these industries use biological resources for research and development. For example, over the last
30 years 26% of all new approved drugs are natural products or have been developed from a natural
element.11 In the agricultural industry a lot of research is dedicated to enhance the resistance of plants
through research on different types of seeds and genetic manipulation. This process of research and
development is encouraged through patent protection.
5
D. F. ROBINSON, Confronting Biopiracy: Challenges, Cases and International Debates, Abingdon, Earthscan, 2010, 1.
(further referred to as ‘D. F. ROBINSON, Confronting Biopiracy’)
6
Encyclopædia Britannica, Pedanius Dioscorides (retrieved 28 March 2013),
http://www.britannica.com/EBchecked/topic/164412/Pedanius-Dioscorides.
7
D. F. ROBINSON, Confronting Biopiracy, supra 5, 3.
C. A. NARD and A. P. MORRISS, “Constitutionalizing Patents: From Venice to Philadelphia”, Review of Law and Economics,
2006, 234.
8
Throughout this dissertation the term ‘biological resources’ is used as defined in the UN Convention on Biological
Diversity meaning “including genetic resources, organisms or parts thereof, or any other biotic component of ecosystems
with actual or potential use or value for humanity”. (UN CBD Art. 2)
9
Throughout this dissertation the term ‘genetic resources’ is used as defined in the UN Convention on Biological Diversity
meaning ‘genetic material of actual or potential value’. (UN CBD Art. 2)
10
Throughout this dissertation the term ‘biotechnology’ is used as defined in the UN Convention on Biological Diversity
meaning ‘any technological application that uses biological systems, living organisms, or derivates thereof, to make or modify
products or processes for specific use’. (UN CBD Art. 2)
11
Proposal for a Regulation, COM/2012/0576 final, 4 October 2012, Proposal for a regulation of the European Parliament
and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utiliza-
tion in the Union, 2, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.
5
The UN Convention on Biological Diversity declares that in accordance with principles of inter-
national law, states have the sovereign right over the resources within their national jurisdiction and
the authority to determine access to those resources. Furthermore the Convention obliges the con-
tracting parties to share in a fair and equitable way the results and benefits arising from research
and development based upon genetic resources with the party providing these resources.12 However,
some countries claim a violation of their sovereign rights by companies which don’t comply with these
obligations. This is called biopiracy.
1.2 Definition
Biopiracy is a phenomenon that only recently started getting international attention. An official defi-
nition of the concept does not exist. The term itself is relatively new, being only used for the first time
in the early 1990s. It is closely related to the term bioprospecting which also stems from the 1990s.
Bioprospecting or bio(diversity) prospecting is defined in the Oxford Dictionary as “the search for plant
and animal species from which medicinal drugs and other commercially valuable compounds can be ob-
tained”.13 The term is widely used for “any program that endeavours to collect genetic material and/or
the knowledge of its uses, usually from areas with high concentrations of biodiversity”.14
The term ’bioprospecting’ originates from the 1993 book Biodiversity Prospecting: Using Genetic
Resources for Sustainable Development by Reid et al. from the World Resources Institute. In the book
bioprospecting is defined as “the exploration of biodiversity for commercially valuable genetic and bio-
chemical resources”.15 The authors aimed to promote the preservation of biodiversity and the sharing
of its benefits by stressing its economic potential. Although the terminology might be new, the practice
of collecting biological material is not. Multiple examples from history, not in the least from colonial
history, show that this is an old practice. Anthropology Professor Cori Hayden states that bioprospect-
ing is a new name for an old practice. Its novelty lies in ethical considerations which have established
that the taking of biological resources now comes with a mandate to give back.16
The first use of the term biopiracy is usually attributed to activist Pat Mooney, Executive Director
of the Canada-based NGO Action Group on Erosion, Technology and Concentration (ETC Group).17 It
was used as a way to raise questions about the practice of bioprospecting due to growing frustrations
about the appropriation and monopolization of resources and traditional knowledge.18
12
Articles 3, 15 and 19, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.
13
“bioprospecting”, Oxford Dictionaries, Oxford University Press,
http://oxforddictionaries.com/definition/english/bioprospecting.
14
C. HAMILTON, “Biodiversity, biopiracy and benefits: what allegations of biopiracy tell us about intellectual property.”
Developing world bioethics, 2006, Vol. 6(3), 159. (further referred to as ‘C. HAMILTON, “Biodiversity, biopiracy and benefits”’)
15
The authors cite the previous use of the term ’chemical prospecting’ by Thomas Eisner between 1989 and 1992.
W. V. REID et al., Biodiversity Prospecting: Using Genetic Resources for Sustainable Development, Baltimore, World Resources
Institute Publications, 1993, 2-3.
16
C. HAYDEN, When Nature goes Public : The Making and Unmaking of Bioprospecting in Mexico, Princeton, Princeton
University Press, 2003, 2.
17
Before 2001 the ETC Group was named the Rural Advancement Foundation International (RAFI).
18
“The terms ‘traditional knowledge’ and ‘indigenous knowledge’ refer to knowledge that is held collectively (at the com-
munity or national level), has been used for generations by local communities and has contributed to the development of
crop varieties, food security and medicines, as well as the emergence and continuation of artistic work in the form of music,
handicrafts and artisanship.”
L. R. HELFER, “Regime Shifting”, infra 48, 29.
6
As mentioned earlier, biopiracy is not a term with an accepted legal meaning, nor is there a consen-
sus on what the term exactly comprises. Scholars, activists and politicians each give a slightly different
definition. However, before looking in depth at the issue, it is important to understand its meaning and
the debate surrounding it. By analysing the definitions given by a number of sources, I will attempt to
offer a clear description of biopiracy.
Only in recent years included, the Oxford Dictionary defines it as:
“the practice of commercially exploiting naturally occurring biochemical or genetic material,

especially by obtaining patents that restrict its future use, while failing to pay fair compensa-
tion to the community from which it originates”.19
This definition limits the object of biopiracy to ‘biochemical and genetic material’, while giving a broad
description of the practice as ‘commercially exploiting, especially by obtaining patents’. It explicitly
mentions the lack of fair compensation.
The ETC Group, which originally coined the term, gives the following definition:
“Biopiracy [...] refers to the appropriation of the knowledge and genetic resources of farm-
ing and indigenous communities by individuals or institutions that seek exclusive monopoly
control (patents or intellectual property) over these resources and knowledge.” 20
Here the object is more extensive and includes both genetic resources and associated knowledge. Sec-
ondly, a focus is placed on ‘farming and indigenous communities’. Thirdly, compared to the Oxford
Dictionary definition the scope is somewhat more limited to cases where patents or intellectual prop-
erty are used to seek control.21
One of the most known activists against biopiracy is the Indian scientist Vandana Shiva. She
interprets the term the following way:
“Biopiracy refers to the use of intellectual property systems to legitimize the exclusive own-
ership and control over biological resources and biological products and processes that have
been used over centuries in non-industrialized cultures.” 22
With regard to the object of biopiracy, there is no reference to associated knowledge. However, com-
pared to the previous definition, she broadens the victimized group from ‘farming and indigenous
communities’ to ‘non-industrialized cultures’. Just like most authors, Vandana Shiva targets intellec-
tual property systems.
While most descriptions of biopiracy only include intellectual property systems of control, some
scholars say this is not fully complete. The unauthorized collection and use of biological resources
and associated knowledge, not implicating intellectual property, is also labelled biopiracy by them.
This practice is often referred to as the misappropriation of biological resources and/or traditional
knowledge.23 This is reflected in professor Graham Dutfield’s definition of the term:
“[...] it normally refers either to the unauthorized extraction of biological resources and/or
associated traditional knowledge from developing countries, or to the patenting of spurious
‘inventions’ based on such knowledge or resources without compensation.” 24
19
“biopiracy”, Oxford Dictionaries, Oxford University Press, http://oxforddictionaries.com/definition/english/biopiracy.
20
Action Group on Erosion, Technology and Concentration (ETC Group), http://www.etcgroup.org/issues/patents-biopiracy.
21
D. F. ROBINSON, Confronting Biopiracy, supra 5, 18.
22
V. SHIVA, Protect or Plunder? Understanding Intellectual Property Rights, London, Zed Books, 2001, 49.
23
D. F. ROBINSON, Confronting Biopiracy, supra 5, 20-21.
24
G. DUTFIELD, Intellectual Property, Biogenetic Resources, and Traditional Knowledge, Earthscan, 2004, 52.
7
Quite some definitions narrow the scope of biopiracy to patenting. However, various authors also
note the impact of other intellectual property systems. More specifically plant breeders’ rights (PBRs)
established through plant variety protection are known to constitute biopiracy as well.25 Plant variety
protection is a patent-like system. It allows a plant breeder to prohibit specific unauthorized uses of a
new plant variety.26
Based on the aforementioned descriptions by actors and authors of importance, I have developed a
definition of biopiracy that adequately summarizes the problem. Biopiracy refers to the appropriation
of biological resources and/or associated traditional knowledge and to the use of intellectual prop-
erty systems to legitimize the exclusive ownership and control over these resources and/or associated
traditional knowledge, without adequate authorization and benefit-sharing from other (usually devel-
oping) countries, indigenous or local communities. This broad definition emphasizes the problem and
its larger questions of equity.27
In order to respect the scope of this dissertation, I will refrain from going into detail on this mis-
appropriation of knowledge. This dissertation will rather treat biopiracy from a legal perspective. The
emphasize will be on intellectual property protection as the legal aspect of biopiracy is a story of con-
flicting rights over intellectual property and conservation of biological resources. Within intellectual
property protection there are different regimes to protect intellectual property. Because patent protec-
tion is the most used of those to claim exclusivity over biological resources and thus poses the biggest
problem for biopiracy, the focus will be on patent regulation. More specifically, I will focus on how
the current patent legislation makes biopiracy possible and what should be altered to prevent biopiracy.
As the issue of biopiracy is highly controversial, it is no surprise that the terminology is equally
contested. Being a derogatory term, biopiracy is often replaced by terms as ‘unauthorized access’ and
‘misappropriation’.28 That is how definitions of these terms are increasingly entangled, yet defined dif-
ferently by every actor. The result of this confusing rhetoric is the existing vague terminology. Many
actors involved avoid even using the word. One does not even have to be an attentive reader to notice
that the word ‘biopiracy’ is nowhere to be found in the Nagoya Protocol, which essence is to tackle
biopiracy by providing a transparent legal framework for the fair and equitable sharing of benefits
arising out of genetic resources (infra Part II, Chapter 8). Even in a recent proposal for a regulation
concerning biopiracy by the Greens in the European Parliament, the term biopiracy is used very cau-
tiously.
1.3 Putting it in the Right Perspective

Many critics say that there is no such thing as biopiracy. They argue that most corporations simply
act in accordance with existing international property law. Legal scholar Jim Chen points to local gov-
ernments, instead of foreign bioprospectors, as being primarily responsible for environmental damage
caused by the collection of biological specimens. This criticism points out correctly that “the idea of
sovereignty over natural resources and biodiversity not only provides nations with rights but also imposes
25
26
W. H. LESSER, “Plant Breeders’ Rights: An Introduction” in A. KRATTIGER, R. T. MAHONEY, L. NELSEN, et al (eds.),
Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices, Oxford, MIHR and
Davis, PIPRA, 2007, 381, www.ipHandbook.org.
27
T. J. KIM, “Expanding the Arsenal Against Biopiracy: Application of the Concession Agreement Framework to Prevent
Misappropriation of Biodiversity”, SMU Science and Technology Law Review, 2010-2011, Vol. XIV, 79.
28
Report prepared for IUCN-Canada and distributed at the Fourth Meeting of the ABS Working Group,
T. YOUNG, “An Analysis of Claims of Unauthorized Access and Misappropriation of Genetic Resources
and Associated Traditional Knowledge”, Granada, 2006, document UNEP/CBD/WG-ABS/4/INF/6, SCBD,
http://data.iucn.org/dbtw-wpd/html/EPLP-067-5/section17.html.
8
some important obligations, which countries sometimes forget”. As a consequence, governments should
blame themselves for the failure to protect their biodiversity and for not putting limits on the research
on and appropriation of biological resources. These arguments are very harsh towards developing
countries, but they do present some rational points. Therefore they deserve some consideration.29
Taking the United States as an example, one can understand the point of these critics. Various laws
have been enacted to protect biodiversity, such as the Endangered Species Act or the Marine Mammal
Protection Act, and are being effectively enforced. The United States has an effective conservation
program in force. However, a large part of the world’s biodiversity is found in developing countries
and many of these countries do not have the financial means needed to implement a qualitative biodi-
versity protection.
Bioprospecting and biopiracy seem to be two sides of the same coin. As unfair and negative as
the practice of biopiracy may sound, critics are right to say that bioprospecting is of essential impor-
tance to some sectors of industry, not in the least to the pharmaceutical and agricultural industry. It
needs to be noted that bioprospecting has made important contributions to science, for example ele-
ments of rosy periwinkle have produced anti-cancer medication.30 Research into indigenous peoples’
knowledge of biological resources and their use is a since long recognized drug discovery strategy.
Globalization and biotechnology have led to the identification and development of drugs in every po-
tential environment.31
World agriculture depends on the crossbreeding of plants in hope of uniting the best features of a
plant and creating a new variety that is stronger and more resistant.32 By improving the resistance of
plants and growing stronger varieties, farmers and companies raise the probability of having a good
harvest. Scientists working with genetically modified plants argue that these nutritionally enhanced
crops could help alleviate Third World hunger.33 It is a fact that the world population is growing and
climate is changing, possibly making fertile grounds unusable in a couple of decades. Modification
of plant varieties could soon prove to be essential in securing the world’s food supply. Because plant
breeding is expensive and demands a high level of technology, it is mainly conducted by large compa-
nies in developed countries.
The goal of the intellectual property rights system is to give incentive to create and to encourage
technological advancement. Research and development is very money and time consuming. In order to
make this profitable for companies, they are awarded the exclusive rights over their creation for a cer-
tain amount of time. However, by the time a product is released on the market usually a company only
has left a couple of years (or sometimes months) of exclusivity to make profit out of their development.
The average cost to research and develop each successful drug was estimated to be e1,059 billion in
2005 (including the cost of the thousands of failures). It takes 10 to 15 years to bring a new medicine
on the market.34 The complete process of crossbreeding plants from germplasm to a commercially vi-
29
M. V. GUBAREV, “Misappropriation and patenting of traditional ethnobotanical knowledge and genetic resources”, Jour-
nal of Food Law and Policy, 2012, 72.
30
V. TEJERA, “Tripping over Property Rights: Is it Possible to reconcile the Convention on Biological Diversity with article
27 of the TRIPS Agreement?”, New England Law Review, 1999, Vol. 33, 971.
31
B. A. LIANG, “Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,
Journal of Commercial Biotechnology, 2011, Vol. 17(3), 249.
32
H. J. BORDWIN, “The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”,
Ecology Law Quarterly, 1985, Vol. 12(4), 1055.
33
M. WOODS, “Food for Thought: The Biopiracy of Jasmine and Basmati Rice”, Albany Law Journal of Science and Tech-
nology, 2002, Vol. 13, 126.
34
Innovation.org, “Drug Discovery and Development: Understanding the R&D Process”, Pharmaceutical Research and
Manufacturers of America, 2007, http://www.innovation.org/drug_discovery/objects/pdf/RD_Brochure.pdf. European Fed-
eration of Pharmaceutical Industries and Associations, “The Pharmaceutical Industry in Figures: Key Data 2012”, 6,
http://www.efpia.eu/sites/www.efpia.eu/files/EFPIA_Figures_2012_Final-20120622-003-EN-v1.pdf.
9
able plant variety takes ten to fifteen years.35 Knowing that most patent regulations award exclusivity
rights for a period of 20 years, not so much time is left to generate sufficient revenues to cover the costs.
Many activists deliberately simplify the scientific process and the intellectual property rights sys-
tem in their protest. Biopiracy is not simply a claim of theft or misallocation of benefits, it is rather a
concept that raises broader questions about the intellectual property rights system itself.
1.4 Why is it a Problem?

Biopiracy is mainly a problem of lesser developed countries. They are often rich in biodiversity and
genetic resources, but have a lack of technology. In what are now developed countries many plant va-
rieties were destroyed during the ice ages due to glaciation, therefore countries with a tropical climate
have the biggest biological diversity.36 Developed countries house the companies that have the knowl-
edge and capital needed for technological advancement. These companies then go to the biologically
rich developing countries for a prospection of useful elements. The TRIPS-Agreement that is supposed
to provide protection of intellectual property is the legal basis which makes biopiracy possible.
The companies that face claims of biopiracy are mainly pharmaceutical and agricultural compa-
nies. Modern agriculture depends on plant breeding to improve the quality of plants. When a company
develops a new plant variety, it takes a patent on it and sells the seed to farmers. However, the seed
produced by a hybrid plant (the offspring of crossbreeding) is not suitable for planting. A hybrid is
produced by crossing two compatible plants in such a way that the result combines the best of both
‘parents’. To get the seed for this hybrid, the ‘parent plants’ (known as in-bred lines) have to be com-
bined in the same way again. The seed of the hybrid itself will result in a different plant than the
hybrid. Only if farmers would have access to the in-bred lines, they would be able to produce the
hybrid seed on their own. However, most companies protect this knowledge as a trade secret.37 Hav-
ing to buy seed from a company year after year often means a swift economical death for little local
farmers.
Nowadays, there are almost 1000 patents issued for genetically modified versions of five big crops:
rice, wheat, maize, soybeans and sorghum. Almost 70% of these patents belong to only six companies:
Sanofi (previously called Aventis), Dow, DuPont, Mitsui, Monsanto and Syngenta. All these companies
are based in the EU, the US or Japan and together they are in control of 30% of the global seed market.38
A second threat caused by modern agriculture is genetic erosion. The widespread cultivation of
improved plant varieties has led to more genetically uniform plants. Due to this increasing uniformity
multiple plant varieties have gone extinct. This loss of plant genetic diversity is called genetic erosion.
This increases the vulnerability of agriculture. The more similar the genetics of crops are, the more
similar they will react to environmental forces and the larger the impact of a natural disaster can be.39
Biological diversity is not only important for research and development, it also provides a higher re-
35
36
Ecology Law Quarterly, 1985, Vol. 12(4), 1054-1058.
37
H. J. BORDWIN, ‘The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”,
38
nology, 2002, Vol. 13, 136.
39
Ecology Law Quarterly, 1985, Vol. 12(4), 1056-1057.
10
sistance to climatological changes and natural disasters.
The pharmaceutical industry is involved because a substantial part of drug development is based on
natural elements and their derivatives. In 2011 the world pharmaceutical market was worth e614,583
billion, 41,8% of it belonging to the US and Canada, 26,8% to Europe and 12% to Japan. In that same year
the US pharmaceutical industry spent $ 38,5 billion (approximately e29,5 billion) on R&D followed by
the European expense of e27,5 billion on R&D.40 The world commercial seed market is estimated to
be worth $ 45 billion (approximately e34,5 billion). The US seed market was worth $ 12 billion in
2011 (approximately e9,2 billion).41 The size of these markets and their budgets for R&D clearly show
the importance of these industries. That is why this dissertation will focus on the agricultural and
pharmaceutical industry in examining the phenomenon of biopiracy.
Companies are not the only ones responsible. National governments are to blame too. The in-
digenous communities have not always been protected by their own governments. In some instances,
national authorities have taken unilateral actions that leave indigenous peoples and their resources
outside benefits sharing arrangements. In developing countries the lifestyle of a lot of indigenous or
local communities is dependent on their biological environment. Therefore an effective biodiversity
management is essential for their livelihood. The economic pressures of the 1990s forced developing
countries to ‘sell’ and deplete their resources.42 Nowadays too, economic profit often prevails over
conservation of biological diversity for developing countries.
40
European Federation of Pharmaceutical Industries and Associations, “The Pharmaceutical Industry in Figures: Key Data
2012”, 5 and 14, http://www.efpia.eu/sites/www.efpia.eu/files/EFPIA_Figures_2012_Final
-20120622-003-EN-v1.pdf.
41
International Seed Federation, “Estimated Value of the Domestic Seed Market in Selected Countries for the year 2011”.
http://www.worldseed.org/isf/seed_statistics.html.
42
11
Chapter 2
History
For a thorough understanding of the controversy surrounding biopiracy, it is essential to take a closer
look at the historical evolutions leading up to the emergence of the problem. In order to understand the
biopiracy discourse, two historical developments are important. Firstly, the current intellectual prop-
erty system is a result of the globalization of Euro-American intellectual property regimes, particularly
through the World Trade Organisation’s (WTO) Agreement on Trade Related Aspects of Intellectual
Property. Secondly, through the Convention on Biological Diversity biodiversity has been recognized
as a category of resources and biological resources have become a commodity.43 This chapter offers
an overview of the historical events and international instruments that have led to the adoption of the
WTO Agreement on Trade Related Aspects of Intellectual Property and the Convention of Biological
Diversity.
Until the 1930s patent protection did not extend to biological life forms. Plant varieties were not
considered inventions and were consequently excluded from intellectual property protection. In the
1930s the method of crossbreeding plants to produce a ‘hybrid’ that is stronger became a widespread
practice in industrialized countries. Seed companies then used their growing influence to obtain plant
breeders’ rights legislation.44 In the US the Plant Patent Act was enacted in 1930, allowing to patent
the phenotype (entire plant) for asexually reproduced plants. The 1970 Plant Variety Protection Act
provides intellectual property protection for varieties that are new, distinct, uniform and stable.45 This
greatly expanded patentability and had as a consequence that even seeds could be patented under some
conditions.46
Before modern methods of plant breeding existed, patent protection was not considered an effective
system for the protection of newly developed plant varieties. Crossbreeding plants was a rather obvi-
ous method to any farmer and consequently didn’t meet the non-obviousness requirement of patent
protection. Neither comprised the breeding an inventive step. Modern biotechnology brought plant
breeding to laboratories. The extension of patent protection to modern plant breeding methods and
the resulting products increases the significance of patents in plant variety protection. A patent has the
advantage of offering a broader protection. Plant variety protection only relates to the specific variety
concerned and the scope of the protection is limited by reference to the physical material itself.47
43
C. HAMILTON, “Biodiversity, biopiracy and benefits”, supra 14, 160.
44
J. R. KLOPPENBURG, “Seeds, Sovereignty, and the Vía Campesina: Plants, Property, and the Promise of Open Source
Biology”, Paper prepared for the Workshop on Food Sovereignty University of Saskatchewan, 2008, 4.
45
K. AOKI, “Food Forethought: Intergenerational Equity and Global Food Supply ? Past, Present and Future”, Wisconsin
Law Review, 2011, 425.
46
E.K., “North and South: The WTO, TRIPS, and the Scourge of Biopiracy”, Tulsa Journal of Comparative and International
Law, 2003-2004, 288.
47
M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E.
EVENSON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 41.
12
Mid-twentieth century a number of international research gene-banks was established to conserve
plant genetic resources in the form of raw germplasm and to provide samples of these materials for
agriculture, plant breeding and research. These gene-banks became part of the International Agricul-
tural Research Centres and the Consultative Group on International Agricultural Research (CGIAR).48
The research of the Consultative Group is dedicated to food security and poverty eradication in devel-
oping countries. These evolutions heralded a new era of plant ownership. Coming from a period of
free exchange of plant germplasm and limited exclusive ownership rights over plants, research became
increasingly globalized in the form of gene-banks and companies pushed for legal protection of the
results of their research.
The first international attribution of intellectual property rights for plant genetic resources was
the 1961 International Convention for the Protection of New Varieties of Plants (UPOV Convention).
The convention provides a framework for intellectual property protection of plant varieties. These
plant variety rights are often referred to as ‘plant breeders’ rights’ (PBRs). PBRs are property rights
for intentionally bred new plant varieties. PBRs are a weak form of IPR protection compared to the
protection a patent offers, but they are easier to obtain. The UPOV Convention was primarily to the
advantage of industrialized countries where plant breeders were concentrated. Although it was possi-
ble to claim the possession of modified plant genetic resources as of then, raw plant genetic resources
were still seen as common heritage.49
In 1983 the UN Food and Agriculture Organization (FAO) adopted the International Undertaking
on Plant Genetic Resources (the Undertaking), a non-binding agreement dealing with the conservation
and exchange of plant genetic resources for food and agriculture. This agreement stirred up discus-
sion on whether plant germplasm should be considered as a ‘common heritage of mankind’ and thus
available to anyone without restriction.50 This was part of the so called ‘seed wars’ of the 1980s, an
international controversy over the access to, control over and preservation of plant genetic resources.
This discussion was fought over at various international meetings during the 1970s and 1980s, the
principal arena for the conflict being the FAO. Like so many debates within the United Nations, in the
controversy surrounding plant germplasm developed and developing countries were and are still on
opposite sides.
The International Undertaking established the Commission on Genetic Resources for Food and
Agriculture. The Commission is the only permanent forum that deals with issues related to plant ge-
netic resources. It offers a place for government discussions and negotiations concerning biological
diversity that are relevant for food and agriculture.51 With regard to the International Undertaking on
Plant Genetic Resources, the primary concern was exactly this ‘common heritage’ principle. In prac-
tice plant genetic resources were freely collected in developing countries, but when sold back by seed
companies the seed varieties developed from those resources were IPR protected. The Undertaking
labelled all plant genetic resources ‘common heritage’, including special genetic stocks (elite breeding
lines and hybrid parents). This label barred intellectual property protection of natural materials.52
48
D. F. ROBINSON, Confronting biopiracy, supra 5, 24.
L. R. HELFER, “Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual Property Lawmak-
ing”, The Yale Journal of International Law, 2004, Vol. 29(1), 38. (further referred to as ‘L. R. HELFER, “Regime Shifting”’)
49
K. RAUSTIALA and D. G. VICTOR, “The Regime Complex for Plant Genetic Resources”, International Organization, 2004,
Vol. 58(2), 286.
50
D. F. ROBINSON, Confronting biopiracy, supra 5, 25.
51
Food and Agriculture Organization of the United Nations, Commission on Genetic Resources for Food and Agriculture,
History, http://www.fao.org/nr/cgrfa/cgrfa-about/cgrfa-history/en/.
52
H. J. BORDWIN, “The Legal and Political Implications of the International Undertaking on Plant Genetic Resources”, Ecology
Law Quarterly, 1985, Vol. 12(4), 1063-1064.
J. R. KLOPPENBURG, Seeds and Sovereignty: The Use and control of Plant Genetic Resources, Duke University Press, 1988, 8.
13
Freely sharing those broadly defined plant genetic resources would radically undermine the prop-
erty rights breeding companies possess. Therefore the Undertaking was opposed by the US and differ-
ent European countries. Industrialized states argued that the application of the International Under-
taking on cultivated plant varieties conflicted with the UPOV Convention. After some negotiations and
lobbying the Undertaking was revised and the Agreed Interpretation of the International Undertaking
was issued in 1989. This interpretation recognised that plant breeders’ rights (as protected under the
UPOV Convention) were not incompatible with the International Undertaking. The Commission on
Plant Genetic Resources for Food and Agriculture simultaneously adopted Resolution 5/89 on farm-
ers’ rights. Traditional farmers make important contributions to the conservation and improvement
of plant materials, farmers’ rights are attributed as an acknowledgement for these contributions. The
adoption of the interpretation and the resolution was an attempt of the Commission to achieve a
balance between the rights of breeders (formal innovators) and the rights of farmers (informal innova-
tors).53
After seven years of negotiation in the Commission, the International Undertaking has been re-
viewed and in 2001 replaced by the International Treaty on Plant Genetic Resources for Food and
Agriculture, popularly known as the International Seed Treaty. Unlike the International Undertaking,
the treaty is a binding legal instrument. The soft law provisions developed in the Commission were
now put into ‘hard law’ rules. The treaty recognizes farmer’s rights and establishes a multilateral sys-
tem to facilitate access and equitable benefit sharing.54
The growing antagonism between developed and developing countries has led to the enactment of
two treaties that are of crucial importance for this dissertation: the 1992 UN Convention on Biological
Diversity and the 1994 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS
Agreement). The Convention on Biological Diversity has been referred to as ‘the grand bargain’ be-
cause it tries to find a balance between facilitated access to genetic resources and benefit-sharing. The
Convention is especially important because it deals with biodiversity as genetic resources over which
nations have sovereign rights. In doing so, the convention concluded the ‘seed wars’ discussion and as
a consequence genetic resources could no longer be seen as common heritage.
The Uruguay Round constituted the first multilateral negotiations on intellectual property rights
and concluded in the TRIPS Agreement and the establishment of the World Trade Organisation (WTO).
The TRIPS Agreement is the most comprehensive international instrument on intellectual property
rights (IPRs). The Agreement created an obligation for all WTO members to implement a minimum
level of protection for 7 categories of intellectual property. Of these categories one is crucial for the
topic of biopiracy: the regulation on patents.. It increased the standards of protection for IPRs consid-
erably. Although developing countries were reluctant in the negotiations to reform their intellectual
property legislation, they made important concessions without receiving any concession back from
developed countries.
As technology became more and more important for international competition, industrialized
countries wanted to protect their technological advancement through IPRs. Especially the US supremacy
in technology had been eroded by counterfeiting by Japan and some other Asian industrializing coun-
tries. Apart from protection for new technology, multinational companies lobbied for the elimination
or reduction of trade barriers in developing countries to get unrestricted access to those markets. The
establishment of the TRIPS Agreement shows the importance and influence of the industry and mainly
of the pharmaceutical, agricultural biotechnology and software industry. Industrialized countries have
53
L. R. HELFER, “Regime Shifting”, supra 48, 36-37.
Food and Agriculture Organization of the United Nations, Commission on Genetic Resources for Food and Agriculture,
History, http://www.fao.org/nr/cgrfa/cgrfa-about/cgrfa-history/en/.
54
14
defended the TRIPS Agreement as part of a WTO deal of intellectual property rights for developed
countries and free market-access for developing countries.55 However, this globalization of the Euro-
American notions of patentability only aggravated the already existing problems concerning IPRs.56
One of the most controversial points of the TRIPS Agreement was and still is the high minimum
standard of patentability included in article 27. This article is crucial for the issue of biopiracy be-
cause it protects the biopirates. The general international approach to recognise the possibility to
patent a living organism is a consequence of US case law. 57 In the landmark decision of Diamond v.
Chakrabarty the US Supreme Court decided:
“[...] the patentee has produced a new bacterium with markedly different characteristics from
any found in nature and one having the potential for significant utility. His discovery is not
nature’s handiwork, but his own; accordingly it is patentable subject matter under §101.” 58
Five years later the US Patent Court upheld a patent granted for an entire corn plant, including the
seed, in the Ex parte Hibberd case. Due to this jurisprudence companies can legally oblige farmers to
buy new seed every year instead of replanting seed generated by their own plants. Now this view
is adopted by many developed countries, it is generally conceived possible to patent manmade living
organisms under certain circumstances.59
At this period in history (early 1990s) the discourse of biopiracy emerged. Activists from all over
the world raised their voices against the TRIPS Agreement as it was so heavily influenced by industri-
alized countries. As Walden Bello puts it, “TRIPS has paved the way for the private ownership of products
developed from the traditional knowledge of communities in the South”.60 Especially in developing coun-
tries, NGO’s started to campaign against biopiracy. For example in India farmers started the ‘Neem
campaign’ (infra Chapter 3). In the 1990s the first biopiracy cases were tried in court as activists chal-
lenged patents of multinational companies.
55
L. R. HELFER,“Regime Shifting”, supra 48, 3.
56
C. M. CORREA, Intellectual Property Rights, the WTO and Developing Countries: The TRIPS Agreement and Policy Options,
Zed Books, 2000, 2-5.
57
58
U.S. Supreme Court 1980, 447 U.S. 303, Diamond v. Chakrabarty, 310.
59
E.K. BENDER, “North and South: The WTO, TRIPS, and the Scourge of Biopiracy”, Tulsa Journal of Comparative and
International Law, 2003-2004, 289 and 297.
60
W. BELLO, “Building an Iron Cage: The Bretton Woods Institutions, the WTO and the South” in S. ANDERSON (ed.),
Views from the South: The Effects of Globalization and the WTO on Third World Countries, Food First Books and the Interna-
tional Forum on Globalization, 2000, 77.
15
Chapter 3
Case Law
This chapter will look at two ’textbook’ biopiracy cases. Both the Neem Tree case and the Enola Bean
case have generated a lot of protest and media attention as there was in both cases a clear abuse of
multinational companies towards local communities or farmers. These cases provide concrete exam-
ples of biopiracy and show that in some cases judicial authorities can provide a solution. However,
these cases are expensive and lengthy. In both cases discussed, the proceedings took up to ten years
after which the patent is anyway almost outdated. Therefore it is still essential to amend the existing
legal structure allowing biopiracy to occur.
I have chosen to take a closer look at these two cases because they both provide a clear example
of what biopiracy is and what its effects are. Complementary, as the Neem Tree case was tried by
the European Patent Office and the Enola bean case was judged before the US Patent and Trademark
Office, the cases touch upon some important differences between European and US Patent Law. The
European Union and the United States together form the biggest block of industrialized countries and
thus have had a lot of influence on the current legal framework for patents.
3.1 The Neem Tree

The neem tree is native to India and Burma, but has been exported to Africa in the 20th century and
now also flourishes in several West-African countries. In its native environment the tree is well known
for its medicinal qualities and has been used widely for a whole range of purposes, from a teeth cleaner
to a fungicide.61 In the early 1990s research of pesticides turned to nature for finding solutions. Due
to its exportation to Africa and subsequently to other regions in the world, the tree captured interna-
tional attention. Enthusiasm was great because of the few side effects. Neem products are unique in
the sense that they do not kill, but rather repel insects.62
In 1990 W. R. Grace and Co., a multinational chemicals and materials company based in the US,
and the United States Department of Agriculture filed a European Patent Application. After a long ex-
amination procedure the European Patent Office granted the requested patent on a fungicide derived
from a neem seed extract in 1994. In 1996 the patent was transferred to Thermo Trilogy, a former
affiliate of W. R. Grace. The patent was challenged by a team of three people: Vandana Shiva, direc-
tor of the New Delhi based Research Foundation for Science, Technology and Ecology; Linda Bullard,
then vice-president of the International Foundation of Organic Agriculture Movements (IFOAM); and
Magda Aelvoet, then president of the Green Group in the European Parliament. The patent chal-
61
A fungicide is a chemical used to destroy fungus or inhibit the growth of it. Fungus can cause serious damage in
agriculture.
62
Report of an Ad Hoc Panel of the Board on Science and Technology for International Development National Research
Council, “Neem: A Tree for Solving Global Problems”, Washington National Academy Press, 1992, 3-5.
16
lenge was part of the larger Neem Campaign of India, a campaign launched in 1993 by Indian farmers
who feared the patent protection of the increasing foreign control over their recourses and traditional
knowledge.63
The patent was opposed on the grounds of lack of novelty, lack of inventive step, insufficiency of
disclosure and for being contrary to morality. In 2000 the European Patent Office (EPO) decided to
revoke in its entirety the patent on a fungicide based on neem seed. The patent was judged to lack
novelty and an inventive step.64 One of the main arguments on which the EPO based its decision was
the article ’Effect of Volatiles of Some Plant Extracts and their Oils on Conidia of Erysiphe Polygoni
DC’ published in 1981 by H. B. Singh and U. P. Singh. With this article it is obvious for a skilled person
to come to the same result as the patentee, as states the decision. Therefore the patent was not novel,
not inventive. In March 2005 the Technical Board of Appeals upheld this decision. In its judgement
the Board of Appeal stated that the invention was novel (contrary to the decision of 2000), but lacked
an inventive step.65
The case has been called a landmark victory in the world’s first case against biopiracy. However,
once again the term ‘biopiracy’ was only uttered outside of the proceedings. The opponents did claim
the invalidity (among others) on the ground of article 53(a) of the European Patent Convention. Para-
graph (a) dictates an exception to patentability when an invention is contrary to morality and ordre
public. In the oral proceedings the opponents explained that the patent would threaten the livelihood of
millions of gatherers of the neem tree as large quantities of neem seed are exported for the production
of the fungicide, leading to a reduction in the natural resources. When a company starts developing a
natural product, supply becomes more restricted. Secondly, upholding this patent would have deprived
the Indian people of their cultural heritage and natural resources. The denial of the existence of prior
art would violate the rights of these people as the community to which the resource and knowledge
belonged would be denied its use. In its decision the EPO did not address these objections, but instead
considered it as a question of prior public use. Relying heavily on the testimony of Mr. Abhay D.
Phadke and the previously published scientific article by Mr. Singh and Singh, the EPO decided there
was in fact prior use and consequently revoked the patent.66
The Neem Tree case was the first case of biopiracy in which the European Patent Office revoked a
patent. It was heralded by many activists as an importance legal precedent. Since then other biopiracy
cases have been concluded with the revocation of the patent, for example the Maca case and the
Pelargonium case both concluded in 2010.
The neem patent concerned in this case is only one of many patents granted on inventions derived
from the neem tree. The European Patent Office and the United States Patent and Trademark Office
have granted multiple neem patents. Unlike the EPO, the United States Patent and Trademark Office
has not revoked any of its neem-based patents due to a lack of written proof. Under US Patent law,
63
C. HAMILTON, “Biodiversity, biopiracy and benefits”, supra 14, 165-166.
L. BULLARD, “Freeing the Free Tree: A Briefing Paper on the First Legal Defeat of a Biopiracy Patent: The Neem Case”, Inter-
national Federation of Organic Agriculture Movements, 2005, 1-3, http://www.ifoam.org/press/press/pdfs/Briefing_Neem.pdf.
64
European Patent Office, Opposition Division 13 February 2001, Application No. 90 250 319.2, Method for control-
ling fungi on plants by the aid of a hydrophobic extracted neem oil, Grounds for the Decision, EPO online register.
https://register.epo.org/espacenet/application?documentId=EFIVPD4GMNBAK03&number=EP90250319&lng
=en&npl=false.
65
Article 53, European Patent Convention, 5 October 1973. European Patent Office, Technical Board of Appeal 4 May 2005,
Application No. 90 250 319.2, Method for controlling fungi on plants by the aid of a hydrophobic extracted neem oil, Decision
of 8 March 2005, EPO online register.
66
European Patent Office, Opposition Division 13 February 2001, Application No. 90 250 319.2, Method for controlling
fungi on plants by the aid of a hydrophobic extracted neem oil, Minutes of the Oral Proceedings and Hearing of Witness Mr.
Abhay D. Phadke, EPO online register.
17
prior art outside of the US has to be proven by written or published documents.67
3.2 Enola Bean

Another ’textbook’ biopiracy case is the case before the United States Patent and Trademark Office
(USPTO) concerning the yellow enola bean. In 1999 Larry Proctor was granted Patent no. 5,894,079 for
a yellow bean originally from Mexico, which he called the ‘Enola bean’ after his wife. Larry Proctor, a
US citizen, had bought a package of beans in Mexico, planted those beans several years and detected
a new strain of the bean that was yellow the whole year round. In addition to the patent, he was
also granted a Plant Variety Protection (PVP) certificate for the new variety of the bean.68 That gave
Proctor and his company, Pod-Ners, the exclusive right to commercialize the Enola bean.
Proctor used the patent and PVP certificate to block the import of all similar beans from Mexico
through the US Customs Service. In order to import similar beans to the US, Mexican farmers and
traders were required to obtain a license from Pod-Ners and pay royalties of six cents per pound of
beans sold. Knowing that the average price in Los-Angeles was twenty-seven cents per pound, it is
clear that Mexican import was heavily disadvantaged on the market. As a consequence the yellow
bean production in Mexico fell from 250 000 tons to 96 000 tons in the 2000-2001 season.69
The International Center for Tropical Agriculture (CIAT), a Columbia-based research and devel-
opment organization, filed a petition for re-examination of the Enola bean patent with the USPTO
in 2000 with support of the FAO. Not only had Mexican farmers been cultivating the Enola bean for
centuries, there was even written evidence that US farmers had grown similar yellow beans since the
1930s. Moreover, CIAT had a gene bank containing 260 varieties of yellow beans of which six showed
striking similarities with the Enola bean described in the patent. Therefore its novelty was challenged.
However, Proctor claimed that the Enola bean was never cultivated in the US before and that its dis-
tinct colour made it novel.70
The USPTO Board of Appeals re-examined the patent and after an appeal of the patent owner fi-
nally rejected the patent in 2008. Firstly, Proctor’s invention was obvious as every person of ordinary
skill in the art would have done the same as him. Secondly, the board found the evidence to prove there
was prior art (the invention was known before). The Enola bean was found to have an identical genetic
fingerprint compared to the well known Azufrado Peruano bean. Therefore the burden of proof was
shifted and Proctor was required to show the difference between the prior art and his product, what
he failed to do. That is why the USPTO rejected the patent for obviousness and lack of novelty.71 In
a last attempt to overturn the ruling rejecting the Enola bean patent, Larry Proctor turned to the US
Court of Appeals for the Federal Circuit. The court affirmed the decision of the USPTO with a short
67
mental Law, 2008, Vol. 38, 332.
68
M. V. GUBAREV, “Misappropriation and Patenting of Traditional Ethnobotanical Knowledge and Genetic Resources”,
Journal of Food Law and Policy, 2012, Vol. 8, 86-89.
69
E. DONOVAN, “Beans, Beans, the Patented Fruit: the Growing International Conflict over the Ownership of Life”, Loyola
of Los Angeles International and Comparative Law Review, 2002, 121-122.
70
E. DONOVAN, “Beans, Beans, the Patented Fruit: the Growing International Conflict over the Ownership of Life”, Loyola
of Los Angeles International and Comparative Law Review, 2002, 125-126.
G. N. RATTRAY, “Patents & Technology: Recent Article: The Enola Bean Patent Controversy: Biopiracy, Novelty and Fish-
and-Chips”, Duke Law & Technology Review, 2002, Vol. 1(1), 5.
71
United States Patent and Trademark Office, Board of Patent Appeals and Interferences 29 April 2008, Appeal 2007-3938,
Ex Parte POD-NERS, L.L.C., 30-31.
18
and clear judgement and an appeal to ‘common sense’.72
This case proves the importance of written evidence of prior art to challenge a patent under US
law. The Board of Patent Appeals based its decision on published articles and written evidence of prior
art.
3.3 European Patent Office versus US Patent and Trademark Office

The European Patent Convention contains an exception for ordre public or morality in article 53(a).
Inventions that are contrary to ordre public or morality are excluded from patentability. The EPO is
stringent on this requirement and assesses every invention before granting a patent. The US has never
had a similar exception in its patent law, but in case law a doctrine of morality was developed. The
USPTO has used morality as a ground for refusing patents on gambling machines and later to assess
controversial biotechnology inventions. However, few examples of its application are available.73
One of the main requirements for a patent is novelty. In a patent application process patent offices
always search for prior art, “the entire body of knowledge which was available to the public before the
filing or, if priority is claimed, before the priority date, of a patent application”.74 The European Patent
Convention works with a standard of absolute novelty. An invention cannot form part of the prior art
and prior art is defined broadly as “[...] everything made available to the public by means of a written or
oral description [...]”.75 Similarly, the Japanese Patent Act includes oral testimonies in prior art without
geographical limitations.76 Unlike the European Patent Convention and the Japanese Patent Act, the
US Patent Act upholds a lower standard of relative novelty. All written materials documenting prior
knowledge or use of the invention will be an obstacle for granting a patent. As for the invention being
known or used by others without written documentation of it, only the knowledge and use that has
taken place in the US will be taken into account.77
The previously considered cases offer an illustration. We can clearly see that in the Enola Bean
case where the USPTO relied only on published evidence that this specific variety of bean was already
known in Mexico. The neem patents are a good example of this different approach adopted by the EPO
and the USPTO. A change is desirable. This requirement in US Patent Law is becoming anachronistic
in our increasingly globalized world.78
72
ETC Group, “Enola Patent Ruled Invalid: Haven’t we Bean here before? (Yes, yes, yes, yes and yes.)”, News Release, 14
July 2009.
http://www.etcgroup.org/sites/www.etcgroup.org/files/publication/pdf_file/etcnr_enola_14july09.pdf.
United States Court of Appeals, Federal Circuit, 10 July 2009, 2008-1492, In Re Pod-Ners, L.L.C.
73
K. CHOUDHARY, “Ordre Public and Morality Exclusions from Patentability”, Indian Legal Impetus, 2012, Vol. V (IX),
22-24. http://singhassociates.in/UploadImg/NewsImages/Vo%20V%20Issue%20IX.pdf.
74
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”, 16
March 2001, WIPO/GRTKF/IC/1/3, para 78.
European Patent Office, “What is prior art?”, http://www.epo.org/learning-events/materials/inventors-handbook/
novelty/prior-art.html.
75
Article 54, European Patent Convention, 5 October 1973.
76
nal of Food Law and Policy, 2012, 83.
77
US Patent Act, 35 U.S.C. §102.
P. DRAHOS, The Global Governance of Knowledge: Patent Offices and their Clients, Cambridge University Press, 2010, 146.
78
mental Law, 2008, Vol. 38, 332.
19
Chapter 4
Preliminary Conclusion
It is important to realize that biopiracy is not a legal concept. It is a term often used by activists, tending
to build the symbolic image of rich multinationals abusing poor farmers and indigenous communities.
It is dangerous to get carried away by this rhetoric and strand in a one-sided discourse oversimplifying
the complex issue of biopiracy. To avoid this, I have given an overview of different understandings of
the concept and the main counterarguments.
For a better understanding of the legal framework and a possible remedy, this part has anchored
the legal issue posed by biopiracy in its problematic reality. Although many still deny it, biopiracy
does exist and it poses a real problem. Biopiracy threatens the livelihood of local communities and
constitutes an imminent danger to biodiversity. The biggest obstacle to realizing a solution will be
exactly what caused all the controversy: the contraposition of developed and developing countries.
Money must flow in today’s economy and biological resources happen to be extremely valuable.
20
Part II
Analysis of the Existing Legal

Framework
This dissertation aims to develop a realistic and workable legal solution for the problem posed by
biopiracy. Before a solution can be developed, one has to know where exactly the problem lies. That
is why this part will answer the question of which legal regimes affect the issue of biopiracy and how
they interact. Most importantly, this section will determine the deficiencies of the current legal frame-
work.
The first chapter will handle the legal regime of patentability. The most authoritative instrument
on the international level is without doubt the TRIPS Agreement. Especially its article 27 has stirred
up quite some controversy. First of all, it obliges the WTO members to adopt a very broad interpre-
tation of patentable subject matter. Secondly, it contains a (limited) obligation to adopt intellectual
property protection for life forms. Although the TRIPS Agreement is later of date than the Convention
on Biological Diversity, we will first look at the intellectual property regime it establishes. These two
agreements are interrelated to a certain extent because the negotiations leading to their adoption oc-
curred in the same time. For a good understanding it will be easier to first assess the TRIPS Agreement
and only then look at the Convention on Biological Diversity.
After looking at the legal framework for intellectual property, the second chapter will take a better
look at the Convention on Biological Diversity. This convention was established out of concerns for
the diminishing biodiversity. We will look at how the rules of the Convention on Biological Diversity
affect biopiracy. What are the objectives of the convention? Even more importantly, does the conven-
tion succeed in realizing her objectives? The convention has faced quite some criticism for not aiming
high enough and for its lack of an effective enforcement. Where are the weak spots in the convention?
Intellectual property protection and environmental protection are widely seen as promoting pro-
foundly conflicting visions. The two key international conventions in these matters, the TRIPS Agree-
ment and the UN Convention on Biological Diversity, appear to be incompatible to many scholars.
While the TRIPS Agreement stimulates international economic development by strengthening intellec-
tual property protection, The Convention on Biological Diversity is designed to preserve biodiversity
and traditional agrarian knowledge and promotes sustainable development.79 The third chapter strives
to clarify the entangled discourses of intellectual property and biological diversity and see where they
clash.
The most recent international instrument concerning biopiracy is the Nagoya Protocol. It is a pro-
tocol supplementary to the Convention on Biological Diversity. The protocol offers a more effective
legal framework for access and benefit sharing. However, it has not entered into force yet and will not
do so until it has sufficient ratifications. Since it has no real legal power yet, it is hard to assess the
effects the protocol will have. Nevertheless, chapter four will take on a critical review of its text and
see if there are any loopholes.
79
C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversity
and Biotechnology”, Washington University Law Quarterly, 1998, Vol. 76(1), 255.
22
Chapter 5
Patent Law and Patentable Subject

Matter
In order to fully understand the phenomenon of biopiracy and its origin, this chapter will examine the
essence of the problem: the patent. More specifically it will look into the patentability of biological
resources and traditional knowledge. As intellectual property law (among which patent law) is the tool
used to abuse of these resources and knowledge it is important to determine what exactly is patentable
before finding legal mechanisms of protection.
The purpose of the patent system is to stimulate technological innovation. To reach this goal, an
inventor is attributed the exclusive right over his invention for a limited period of time. The patent
system separates knowledge that can be appropriated and patented from public knowledge that is not
viable for patenting. Genetic resources present a challenge in this divide as it is not always clear
whether a biotechnological invention is merely a discovery in nature or a patentable innovation. The
condition of an inventive step can already be fulfilled by the simple isolation, purification or applica-
tion of a biological recourse. The current intellectual property regime permits and even promotes the
patenting of inventions derived from genetic resources.
The customary legal systems of indigenous communities are incompatible with the western in-
tellectual property regime. The clash of these two incompatible legal frameworks lies at the heart of
biopiracy. It is the origin of the problematic inequality in benefit distribution and ownership of patents
derived from genetic resources or traditional knowledge. Their incompatibility makes it difficult to
find a suitable compromise. The intellectual property regime allows ’biopirates’ to monopolize genetic
resources without sharing the benefits with the local community. To address the injustice of biopiracy,
the rights of indigenous communities need to be effectively recognized.80
At present, no such thing as a supranational patent office exists that can grant a globally applicable
patent. Neither are there internationally harmonised standards that determine which inventions can
be subject for patent protection. Up to today, there is no international treaty nor an international body
that has set out a binding standard for patentability. As there is no international law on patentability,
this matter is left to the discretion of national states. Many scholars agree that novelty, inventive step
and industrial applicability are common international standards on patentability, but in reality there is
little consensus among the different national approaches. This substantive amount of national discre-
tion is why biopiracy is not such an easy issue to resolve. Not only is there a clash between developed
80
T. J. KIM, “Expanding the Arsenal Against Biopiracy: Application of the Concession Agreement Framework to Prevent
Misappropriation of Biodiversity”, SMU Science and Technology Law Review, 2010-2011, Vol. XIV, 80-82.
23
and developing countries, regulation is subject to domestic politics and interests.81
5.1 World Intellectual Property Organization

The World Intellectual Property Organisation (WIPO) is one of the specialized agencies of the UN. As
their site states, it is their mission is to “promote innovation and creativity for the economic, social and
cultural development of all countries, through a balanced and effective international intellectual property
system.” 82 The WIPO was created in 1967, but its origins trace back to the late 19th century. The
organization has 185 members (over 90% of the countries of the world). WIPO administers 25 treaties
and provides dispute settlement services. It provides information and training to its member states,
especially to developing countries.83 The WIPO General Assembly has created standing, expert and
intergovernmental committees to conduct studies on specific intellectual property topics. These com-
mittees develop soft law guidelines and recommendations.84 The WIPO presents itself as a merely
technical agency, but in reality its agenda is highly politicized. Due to its external perception of tech-
nical agency, the importance of the organization is often underestimated. 85
The WIPO used to be the principal intergovernmental organization in the intellectual property
field, but the enactment of the TRIPS Agreement has cost the WIPO quite some of its power. Al-
though the WIPO is often overlooked in the shadow of the WTO, the organization should not be
underestimated. Even though the TRIPS Agreement was established at the expense of WIPO’s policy
dominance, the organization has re-established its role and is again an important actor in the global
governance of intellectual property. The WTO focusses on enforcement and dispute settlement. WIPO
provides assistance to developing countries and is a forum for studies and soft law creation. Whereas
the activities of the WTO have been dominated by developed countries, WIPO has not clearly chosen
the side of either industrialized or developing countries. Therefore WIPO is an important forum for
intellectual property policy setting in the post-TRIPS environment.86
Under the auspices of the WIPO, the Patent Cooperation Treaty was concluded in 1970. Nowadays
the treaty has 146 members, including all the highly influential industrialized countries. The most
notable absent countries include Saudi-Arabia, Argentina and Iran. The Patent Cooperation Treaty
(PCT) has created an international patent application system with uniform formal requirements. Al-
though the application procedure is internationally harmonized under this treaty, this doesn’t result in
an international patent. The international patent application merely offers a preliminary examination
by one of the international authorities, which issues a non-binding opinion on whether the invention
appears to meet the patentability criteria. Article 33 PCT stipulates that an invention has “to be novel,
to involve an inventive step (to be non-obvious) and to be industrially applicable”. However, a definition
of these terms is largely left to the discretion of national states. Moreover, paragraph 5 of article 33 and
article 27 clarify that contracting states are free to apply additional or different criteria for obtaining
a national patent.87 After this international procedure, the inventor needs to apply to every national
patent authority of the countries where he wishes to pursue a patent.
81
Journal of Food Law and Policy, 2012 (8), 73-74.
82
World Intellectual Property Organization, “What is WIPO?”, http://www.wipo.int/about-wipo/en/.
83
L. R. HELFER, “Regime Shifting”, supra 48, 12.
84
85
C. MAY, World Intellectual Property Organization (WIPO): Resurgence and the Development Agenda, Abingdon, Taylor &
Francis, 2006, 3.
86
87
Article 27 and 33, Patent Cooperation Treaty, 19 June 1970 (last amended 1 April 2002).
24
Why then go through the international procedure? The PCT procedure has great advantages, the
biggest advantage certainly being the internationally recognized filing date and its consequences for
prior art searches. In the patent application, the inventor can designate a number of member states.
Once a patent application is filed under the PCT, that filing date will be regarded as the national filing
date in every of the designated states. This means that any prior art that becomes known in one of the
designated countries, can’t be used against the application from the filing date before the PCT forth.88
In 2000 the harmonization process driven by the WIPO was taken a step further with the adoption
of the Patent Law Treaty. This treaty aims to harmonize the formal aspects of national and regional
patent procedures to make them more user-friendly. Unlike the Patent Cooperation Treaty, the Patent
Law Treaty only has a small amount of parties with its 32 member states. However, 38 countries (or
regional organizations) have signed, but not yet ratified the treaty. Among those are the United States
and the European Patent Organization (EPO).89
Developing states proposed the adoption of a disclosure requirement for patents derived from ge-
netic resources in the Patent Law Treaty. That would oblige a patent applicant to prove he has obtained
permission from the country of origin to access genetic resources. Developed countries argued that the
procedural Patent Law Treaty was no place for such a substantive law matter. The WIPO Secretariat
did create an intergovernmental committee for further discussion. That is how the Intergovernmental
Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC)
was established in 2000. The committee was instructed to address the intellectual property aspects of
genetic resources and traditional knowledge.90
In its first sessions, the IGC has set out a wide-ranging work program. The committee is working
on model contractual clauses for access and benefit sharing, the creation of a database for traditional
knowledge, the prior art status of traditional knowledge, legal protection of traditional knowledge,[...]
In 2003 the WIPO General Assembly extended the Committee’s mandate and allowed it to develop new
international instruments.91 However, decisions of the Committee are not binding, they serve only as
recommendations to the WIPO members.92 While the ICG continues to develop soft law, these topics
are also discussed in hard law negotiations over the Substantive Patent Law Treaty.
Logically, the next step in internationally harmonizing patent law is going beyond formalities. In
2001 WIPO’s Standing Committee on the Law of Patents discussed a first draft of the Substantive
Patent Law Treaty. In 2004 the United States, Japan and the EPO filed a joint proposal to make the
definition of prior art, grace period, novelty and inventive step a priority discussion point. During
informal consultations the subjects sufficiency of disclosure and genetic resources have been put for-
ward as priority issues as well. The negotiations on the Substantive Patent Law Treaty were put on
hold in 2006 because the Standing Committee deemed it premature to reach an agreement between the
different parties. However, the committee is continuing its efforts to harmonize patent law.93
88
World Intellectual Property Organization, “Patent Cooperation Treaty (PCT) (1970)”,
http://www.wipo.int/pct/en/treaty/about.html.
Patent Lens, “There is no such Thing as an International Patent”, http://www.patentlens.net/daisy/RiceGenome/g2/3544.html.
89
World Intellectual Property Organization, “Patent Law Treaty (2000)”, http://www.wipo.int/treaties/en/ip/plt/summary_plt.html
and http://www.wipo.int/treaties/en/statistics/details.jsp?treaty_id=4.
90
91
L. R. HELFER, “Human Rights and Intellectual Property: Conflict or Coexistence?”, Minnesota Intellectual Property Re-
view, 2003, Vol. 5(1), 60.
92
93
World Intellectual Property Organization, “Draft Substantive Patent Law Treaty”,
http://www.wipo.int/patent-law/en/harmonization.htm.
25
5.2 TRIPS Agreement
The TRIPS Agreement was the first comprehensive international instrument dealing with intellectual
property rights (IPRs). There have been other intellectual property agreements before, but the TRIPS
Agreement is the first that has teeth. Infringements of the agreement can be brought before the dis-
pute settlement body. Non-compliance with the rulings of the WTO panels can be punished with trade
sanctions.94 The agreement obliges each member to provide a relatively high minimum standard of
intellectual property protection.
The negotiations leading to the adoption of the agreement have been heavily influenced by de-
veloped countries that wanted to see their technology protected against counterfeiting activities. The
result is a strong intellectual property protection that disadvantages the countries of the South which
are rather agriculture-based. India is one of the countries with the loudest voice against the inequali-
ties created by the TRIPS Agreement. In 1993 the Neem campaign was launched as protest against the
increasing patent protection (supra Part I, Chapter 3). In many developing countries there have been
protests against the coming into force of the TRIPS Agreement.95
The goal of the TRIPS Agreement is to reduce barriers to international trade and to promote effec-
tive and adequate protection of intellectual property rights. Article 7 of the Agreement formulates the
objective in the following terms:
“The protection and enforcement of intellectual property rights should contribute to the pro-
motion of technological innovation and to the transfer and dissemination of technology, 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.” 96
The article vaguely requires a balancing of interests, which in itself can be interpreted both in
favour and against biopiracy. 97 The relationship between the TRIPS Agreement and the human rights
to health and food has also been questioned.98
A number of developing countries have expressed their concern on the difficulties faced by de-
veloping countries to gain access to foreign technology. Therefore, a five-year transition period was
granted to developing countries to comply with TRIPS obligations (until 2000). Least-developed coun-
tries (LDCs) were given time until end 2005, but this period has already been extended to 2013. In a
WTO meeting in March 2013 the members accepted the possibility to extend this deadline even fur-
ther.99
Now the transition period to adopt the necessary legislation has ended, developing countries feel
the consequences of the TRIPS Agreement. For many developing countries the adjustment (or even
creation) of their laws and institutions in order to comply with TRIPS obligations has been a costly
94
view, 2003, Vol. 5(1), 54.
95
96
Preamble and article 7, Agreement on Trade-Related Aspects of Intellectual Property Rights, 15 April 1994, Marrakech
Agreement Establishing the World Trade Organization, Annex 1C.
97
Journal of Food Law and Policy, 2012 (8), 74.
98
99
WTO, “Poorest Countries’ Extended Intellectual Property Transition: Time−Limited or Indefinite?”,
http://www.wto.org/english/news_e/news13_e/trip_05mar13_e.htm.
The WTO members are still undecided on whether to set a new deadline or grant each country the time it needs. However,
this transition period does not mean that LDCs are entirely exempted from compliance with the TRIPS Agreement. For
more detail, see the link to the WTO website cited above.
26
project. The United Nations Development Programme has criticized the agreement for not taking into
account the different level of development of developing countries, nor their economic circumstances.
Equally contested are the bilateral ‘TRIPS-plus’ agreements. ‘TRIPS-plus’ is a reference to bilateral
treaties concluded between a developed and a developing state which contain rules on intellectual
property protection that are stricter than the TRIPS obligations. These TRIPS-plus agreements often
ensure an earlier deadline for implementation of the TRIPS obligations then agreed in the WTO agree-
ment and include the obligation to implement the 1991 UPOV Convention.100 In general, the criticism
against the TRIPS Agreement has focussed on its effects on public health, human rights, biodiversity
and plant genetic resources.101
The article that is most important to the issue of biopiracy is article 27 concerning patentable
subject matter. Article 27 has generated the greatest controversy between developed and developing
countries. This article has proved so controversial because it contains a limited obligation to grant
intellectual property protection for life forms.102
“Article 27: Patentable Subject Matter
1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any in-
ventions, whether products or processes, in all fields of technology, provided that they
are new, involve an inventive step and are capable of industrial application. Subject to
paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article,
patents shall be available and patent rights enjoyable without discrimination as to the
place of invention, the field of technology and whether products are imported or locally
produced.
2. Members may exclude from patentability inventions, the prevention within their ter-
ritory of the commercial exploitation of which is necessary to protect ordre public or
morality, including to protect human, animal or plant life or health or to avoid serious
prejudice to the environment, provided that such exclusion is not made merely because
the exploitation is prohibited by their law.
3. Members may also exclude from patentability:
(a) diagnostic, therapeutic and surgical methods for the treatment of humans or ani-
mals;
(b) plants and animals other than micro-organisms, and essentially biological processes
for the production of plants or animals other than non-biological processes. How-
ever, Members shall provide for the protection of plant varieties either by patents or
by an effective sui generis system or by any combination thereof. The provisions of
this subparagraph shall be reviewed four years after the date of entry into force of
the WTO Agreement.” 103
5.2.1 Minimum Standard of Patentability

The first paragraph of article 27 establishes a minimum standard of patentability. It determines that
patents shall be available for any invention in all fields of technology, which is a very broad conception
of patentability. In paragraph 3 it is explicitly clarified that micro-organisms and non-biological and
microbiological processes for producing plants and animals are not to be excluded from patentability.
100
G. K. ROSENDAL, “The Convention on Biological Diversity: Tensions with the WTO TRIPS Agreement over Access to
Genetic Resources and the Sharing of Benefits” in S. OBERTH´’UR and T. GEHRING (eds.), Institutional Interaction in Global
Environmental Governance, Cambridge and London, MIT Press, 2006, 91.
101
United Nations Development Programme, Making Global Trade Work for People, Earthscan, 2003, 220-221 and 226.
102
103
Article 27, Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C to the Marrakech Agreement
Establishing the World Trade Organization, 15 April 1994 (further referred to as TRIPS Agreement).
27
The TRIPS Agreement has managed to set a harmonized minimum standard. However, countries are
free to instate stronger protection and commonly accepted understandings of the terms ‘new’, ‘inven-
tive step’, ‘micro-organisms’ or ‘plant variety’ are nowhere to be found. Ultimately, patent protection
is to a substantial extent dependent on national implementation.
Intellectual property courts try to make a distinction between patentable inventions and the dis-
covery of non-patentable material in nature. Since the case of Diamond vs. Chakrabarty it has been
established in US case law that it is possible to patent “anything under the sun that is made by man”
104 (supra Part I, Chapter 2). This means that genetically modified organisms, processes to create and
products derived from plant genetic resources can be patented, in short: all manmade living organisms
except for human beings.105 Since the 1980s it is possible to patent genes and gene sequences in the US,
the EU, Japan and many other countries.106 Even the possibility to patent human genes already exists
for over 30 years, proving the high standard of patentability upheld in industrialized countries. The
general approach is that gene sequences are inventions when they have been isolated and purified.107
Hence, patenting plant genetic resources has become a piece of cake in the liberal patent regimes of
developed countries.
Countries are free to decide that genes and gene sequences are a mere discovery and thus not
patentable. The TRIPS Agreement doesn’t include an obligation to make genetic materials patentable.
For example Mexico has excluded the patentability of genetic materials. There is no commonly ac-
cepted definition of micro-organisms either in science or in patent practice. However, a restrictive
interpretation of the term would not help developing countries to shield their genetic resources from
patentability. A company still can collect a plant sample and take it to a country where patenting it is
possible. 108
Why do developing countries abide by these rigorous standards implemented by developed coun-
tries? Developed countries can exercise a lot of pressure on developing countries. For example the
US and the EU have a lot of leverage because their consumer markets are the largest in the world.109
Developing countries economically as well as politically can’t afford cutting ties.
5.2.2 Exceptions to Patentability

Paragraphs 2 and 3 comprise three exceptions to the general rule on patentability. Only in these three
situations an exclusion of certain inventions from patent law is allowed. Firstly an exception can be
made when necessary to protect ordre public or morality, including to protect human, animal or plant
life or health. The interpretation of the concepts ‘ordre public’ and ‘morality’ can vary significantly,
resulting in very different national outcomes.110 The second exception provided in paragraph 3(a) is
104
U.S. Supreme Court 1980, 447 U.S. 303, Diamond v. Chakrabarty, 309.
105
V. TEJERA, “Tripping over Property Rights: Is it Possible to reconcile the Convention on Biological Diversity with article
27 of the TRIPS Agreement?”, New England Law Review, 1999, Vol. 33, 980.
106
E. J. ROGERS, “Can You Patent Genes? Yes and No”, Journal of the Patent and Trademark Office Society, 2011, Vol. 93(1),
19-20.
Although patent on human genes have been granted for over 30 years by now, the matter is still surrounded
by controversy. See BBC News, “Human Genome: US Supreme Court hears Patents Case”, 15 April 2013,
http://www.bbc.co.uk/news/world-us-canada-22157410.
107
108
International Law, 2003-2004, 310-311.
M. BLAKENEY, “International Proposals to Regulate Intellectual Property Rights in Plant Genetic Resources” in R. E. EVEN-
SON and V. SANTANIELLO (eds.), The Regulation of Agricultural Biotechnology, Oxfordshire, CABI, 2004, 39-40.
109
110
28
of no importance to the subject of this dissertation. However, the third exception is highly relevant to
biopiracy.
Article 27.3(b) allows an exemption from patentability for plants and animals and the biological
processes for their production. At first glance this seems to give developing countries some leeway.
However, paragraph 3 states that micro-organisms, non-biological and microbiological processes and
plants can’t be excluded from patentability. Any country excluding plant varieties from patent pro-
tection is obliged to provide an effective sui generis system of protection. In the end, WTO members
are obliged to create patent protection for micro-organisms, for non-biological and microbiological
processes for the production of plants or animals and patent and/or sui generis protection for plant
varieties.
In order to establish a sui generis system, it is essential to know what a plant variety is. As men-
tioned earlier, there is no internationally accepted definition of what constitutes a plant variety. The
only relevant debate attempted to distinguish between a patentable plant and a non-patentable plant
variety. This has resulted in an agreement among European patent offices that what is protectable by
a plant variety right under the UPOV Convention is not patentable and everything outside the scope
of the UPOV Convention is patentable. In the UPOV there have been many discussions on the concept
of plant variety. In the end it comes down to the national legislator to determine a legal understanding
of the term.111
The TRIPS Agreement doesn’t provide a definition of an effective sui generis system. The flexi-
bility of this sui generis option could be used to create a protection system that limits the possibility
of biopiracy.112 However, the WTO pushes to adopt the already existing UPOV Convention when
choosing for the sui generis option of protection. The UPOV Convention has 2 negative effects. The
convention protects plant varieties by granting rights to plant breeders. This ownership of plants by
breeders puts legal and economic restrictions on farmers. Originally, farmers are the main source of
seed supply in developing countries. Certain new technologies prevent the reuse of seed, thus putting a
heavy burden on farmers. Secondly, the UPOV framework favours industrialization of plant breeding.
The highly marketed plant varieties tend to replace nature’s less predictable varieties. These increas-
ingly uniform plants diminish biodiversity.113 The African Group has proposed to add a footnote to
paragraph 3(b) defining sui generis as to incorporate farmers’ and indigenous peoples’ rights.114 Be-
cause of the controversy surrounding subparagraph 3(b), a review was planned.
Article 27.3(b) contains a clause that demands a review of the provisions contained therein four
years after its entry into force. This review began at the WTO Conference in Seattle in 1999. During
this review, developing countries started their efforts to harmonize the TRIPS Agreement with other
international instruments (for example the Convention on Biological Diversity). In 2001 the WTO
members adopted the Doha Declaration. Paragraph 19 of that declaration instructs the TRIPS Council
to examine the relationship between the TRIPS Agreement and the CBD and the protection of tradi-
tional knowledge and folklore.115
111
112
113
Genetic Resources Action International (GRAIN), “TRIPS versus Biodiversity: What to do with the 1999 Review of Article
27.3(b)”, 1999, 2, http://www.grain.org/article/entries/11-trips-versus-biodiversity-what-to-do-with-the-1999-review-of-article-27-3-b.
114
International Law, 2003-2004, 317.
115
Journal of Food Law and Policy, 2012, Vol. 8, 75.
L. R. HELFER, “Regime Shifting”, supra 48, 63-65 and 67.
29
Although the TRIPS Agreement has resulted in a fairly high standard of intellectual property pro-
tection, there are definitely some gaps in the regulatory framework it has set up. The TRIPS Agreement
does not provide intellectual property protection for the traditional knowledge of indigenous commu-
nities. Nor does it include a requirement to consider unwritten traditional knowledge as a form of
prior art. Thus it is actually possible to patent traditional knowledge in its original form (see supra
Part I, Chapter 3, 3.3). The agreement doesn’t require the disclosure of the origin of genetic resources,
neither does it require any sharing of benefits. The way intellectual property protection is organized
by the WTO is to the detriment of developing countries. 116
5.3 EU Directive on the Legal Protection of Biotechnological Inven-

tions
In 1998 the EU Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (the Biotech
Patent Directive) was adopted after 10 years of negotiation. During the negotiation process there was
an intense conflict between the provisions of the TRIPS Agreement and those of the Convention on
Biological Diversity. Several EU member states, environmental and farmer’s groups and the European
Parliament tried to include the obligations of the Convention on Biological Diversity in the Patent
Directive. However, the final text of the Patent Directive is more inspired by TRIPS obligations. The
Directive gave patent protection to plant varieties and pharmaceutical products and didn’t include any
mechanism of benefit-sharing for genetic resources.117
The Biotech Patent Directive was adopted to clarify what is patentable and what is not and to
harmonize the EU member states’ regulation on biotechnological patents. Most of the EU member
states were given until 2000 to transpose the directive into domestic legislation. Article 27 of the
TRIPS Agreement was of big influence on the final text of the directive. Article 3.2 of the directive
recognizes the general patentability of biological material: “biological material which is isolated from
its natural environment or produced by means of a technical process may be the subject of an invention
even if it previously occurred in nature”.118 The exception to patentability of article 27.2 was already
incorporated in the European Patent Convention’s exception for ordre public and morality in article
53(a). The controversial article 27.3(b) resulted in article 4 of the directive:
“Article 4
1. The following shall not be patentable:

a) Plant and animal varieties
b) Essentially biological processes for the production of plants or animals.
2. Inventions which concern plants or animals shall be patentable if the technical feasibility
of the invention is not confined to a particular plant or animal variety.
3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which con-
cern a microbiological or other technical process or a product obtained by means of such
a process.” 119
116
117
Genetic Resources and the Sharing of Benefits” in S. OBERTHÜR and T. GEHRING (eds.), Institutional Interaction in Global
118
Article 3.2, Directive 98/44/EC of the European Parliament and Council on the Legal Protection of Biotechnological
Inventions (6 July 1998), OJ. L, 30 July 1998, No 213, 13.
119
Article 4, Directive 98/44/EC of the European Parliament and Council on the Legal Protection of Biotechnological Inven-
tions (6 July 1998), OJ. L, 30 July 1998, No 213, 13.
30
Thus, the EU legislation concerning patentability of biological material is an almost literal copy of ar-
ticle 27 TRIPS with its possible exceptions implemented.
Proposals to include a provision on prior informed consent and a disclosure of origin requirement
were not successful. Although these two issues did not make it into the legal provisions of the directive,
they were both included in as formal statements in the preliminary considerations of the directive.
They were mentioned as following:
“(26) Whereas if an invention is based on biological material of human origin or if it uses such
material, where a patent application is filed, the person from whose body the material is taken
must have had an opportunity of expressing free and informed consent thereto, in accordance
with national law;
(27) 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;” 120
Of course these recitals are not binding. They are just a reflection of the discussion regarding the text
of the directive. The fact that the considerations of the directive do make reference of prior informed
consent and a disclosure of origin requirement proves that these issues have been seriously considered
and discussed. Questions were raised on whether the directive was compliant with the Convention on
Biological Diversity. All the EU member states and the European Union are members of the conven-
tion. Nevertheless, the European Court of Justice ruled that the Biotech Patent Directive is compliant
with the obligations under the Convention on Biological Diversity.121
EU members Belgium and Denmark have made amendments to their national patent legislation
to incorporate the objectives of the Convention on Biological Diversity and the Bonn Guidelines (see
infra Part II, Chapter 6). Denmark was the first to do so. Danish patent law requires that a patent
application includes information on the geographical origin of the genetic material. In case of non-
compliance the penal code applies. Norway has adopted similar legislation. Switzerland has also made
disclosure of the source of genetic material or traditional knowledge mandatory, punishable with a
penalty of CHF 100 000 (approximately 81 000 euro). However, it is doubtful whether this punishment
is severe enough to discourage misappropriation, especially for large companies. Belgium has taken
a different approach by proposing an amendment to its domestic patent legislation. According to the
proposal an invention developed in breach of the Convention on Biological Diversity is contrary to
ordre public and morality and would be banned from patentability, consequently a patent for this in-
vention could be revoked.122
120
Recitals 26 and 27, Directive 98/44/EC of the European Parliament and Council on the Legal Protection of Biotechnolog-
ical Inventions (6 July 1998), OJ. L, 30 July 1998, No 213, 13.
121
J. CURCI, The Protection of Biodiversity and Traditional Knowledge in International Law of Intellectual Property, Cambridge
122
J. CURCI, The Protection of Biodiversity and Traditional Knowledge in International Law of Intellectual Property, Cambridge
31
The proposed amendment to Belgian patent legislation inserted the non-binding recitals 26 and 27
of the EU Directive as full legal provisions, thus giving the EU Directive a maximalist transposition
into national law. The draft text proposed to add 6) to the existing article 15 §1 of the Belgian patent
law.
“Art. 15. - §1. De octrooiaanvraag moet bevatten:
1. een tot de Minister gericht verzoek tot verlening van een octrooi;
2. een beschrijving van de uitvinding;
3. één of meer conclusies;
4. de tekeningen waarnaar de beschrijving of de conclusies verwijzen;
5. een uittreksel;
6. een vermelding van de geografische oorsprong van het biologisch materiaal van plan-
taardige of dierlijke oorsprong op basis waarvan de uitvinding ontwikkeld werd, indien
deze bekend is. De Koning kan de toepasselijke voorwaarden en uitvoeringsmaatregelen
vastleggen.” 123
This new point 6 requires the disclosure of origin in a patent application of the biological material
of plants or animals of which the invention is developed. The proposal also envisioned to introduce the
informed consent requirement of recital 26 of the EU Directive into the Belgian patent law. However,
the Council of State (Belgium’s supreme administrative court) was of the opinion that the adoption of
this new provision would lead to inconsistencies between the EU member states. Therefore the Coun-
cil of State rejected the informed consent provision and only a requirement of origin disclosure was
adopted.124
The final amendment did introduce the requirement of origin disclosure in Belgian legislation as
proposed, but rejected the harsh sanction for non-compliance of the proposal. Instead of revoking the
patent, a more moderate sanction would be sought in the spirit of the Swiss, Norwegian and Danish
approach.125 However, this provision won’t have much effects since the Belgian patent office is not a
search authority and does not check compliance.126 So the Belgian disclosure of origin requirement is
not very effectively enforced.
123
Wetsontwerp tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de octrooibaarheid van
biotechnologische uitvindingen, Parl.St. Kamer, 2004-51, nr. 1348/001, 51.
124
Wetsontwerp tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de octrooibaarheid van
biotechnologische uitvindingen, Parl.St. Kamer, 2004-51, nr. 1348/001, 13-14.
Wetsontwerp en Wetsvoorstel tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de oc-
trooibaarheid van biotechnologische uitvindingen, Verslag namens the Commissie voor het bedrijfsleven, het wetenschaps-
beleid, het onderwijs, de nationale wetenschappelijke en culturele instellingen, de middenstand en de landbouw, Parl.St.
Kamer, 2005-51, nr. 1348/006, 24.
125
Artikel 15 §1(6), Wet van 28 maart 1984 op de uitvindingsoctrooien, BS 9 maart 1985.
Wetsontwerp en Wetsvoorstel tot wijziging van de wet van 28 maart 1984 op de uitvindingsoctrooien wat betreft de oc-
trooibaarheid van biotechnologische uitvindingen, Verslag, Parl.St. Kamer, 2005-51, nr. 1348/006, 25.
126
KAMAU, E. C., “Disclosure Requirement Ð A Critical Appraisal” in KAMAU, E. C. and WINTER, G., (eds.), Genetic
Resources, Traditional Knowledge and the Law: Solutions for Access and Benefit Sharing, Earthscan, 2009, 408.
32
Chapter 6
Convention on Biological Diversity
The growing international awareness of the disappearance of biodiversity resulted in the adoption of
the Convention on Biological Diversity (CBD) in 1992. Due to economic pressure, developing countries
were forced to make money out of their biological resources. This led to a depletion of their resources
and diminishing biodiversity.127 The CBD is the biodiversity regime’s foundational agreement. It
is a compromise to the competing claims of developed and developing countries. On the one hand,
biodiversity-rich but biotechnology-poor developing countries wanted financial benefits and technol-
ogy transfers to promote conservation rather than exploitation of the genetic resources within their
territory. On the other hand, biodiversity-poor but biotechnology-rich industrialized states lobbied to
minimize benefits and transfers while maximizing access to those resources.128 By recognizing intel-
lectual property rights, a compromise was sought between the claims of industrialized and developing
countries.
The parties of the CBD have not been able to reach a compromise on the use of the broader term
‘biological’ resources, or to use the narrower term, ‘genetic’ resources. Generally, developing and
least-developed countries have preferred ‘biological’ and developed countries have preferred ‘genetic’
resources.129 Therefore both terms are used in an almost interchangeable way in the convention and
in the coming pages of this dissertation.
The CBD uses economic incentives to encourage a high valuation of biological resources. With
market-based strategies the convention makes the conservation of biodiversity economically more
interesting. The main goal of the Convention on Biological Diversity is to protect biodiversity in
developing nations.130 The means used to reach that goal are economic. The CBD is the first inter-
national agreement that addresses “the endangered partnership between indigenous communities with
special knowledge of their environment and conservation of the natural resources which these populations
rely on to maintain their traditional lifestyles”.131 Through promoting benefit-sharing and technology
transfers the Convention tries to make the conservation of biodiversity more economically beneficial
than its exploitation.
The Convention has three objectives: the conservation of biological diversity, the sustainable use
of the components of biological diversity and access to genetic resources and fair and equitable sharing
127
B. A. LIANG, “ Global governance: Promoting Biodiversity and Protecting Indigenous Communities against Biopiracy”,
128
129
D. F. ROBINSON, Confronting Biopiracy, supra 5, note 1, 140.
130
mental Law, 2008, Vol. 38, 349.
131
nology 2002, Vol. 13, 133.
33
of benefits arising from their utilisation.132 Articles 6 through 14 includes measures to realize the first
and second objective of the convention, promoting the conservation and sustainable use of biodiver-
sity. Articles 15 through 21 address the third objective, the fair and equitable sharing of benefits.133
Article 8(j) is one of the key provisions related to intellectual property in the CBD. It requires state
parties to:
“[. . . ] respect, preserve and maintain knowledge, innovations and practices of indigenous and
local communities embodying traditional lifestyles relevant for the conservation and sustain-
able use of biological diversity and promote their wider application with the approval and
involvement of the holders of such knowledge, innovations and practices and encourage the
equitable sharing of the benefits arising from the utilization of such knowledge, innovations
and practices.” 134
The combination of the term ‘traditional’ with the terms ‘knowledge’, ‘innovation’ and ‘practice’ is
significant. This article recognizes that traditional knowledge is not static, but that it, to the contrary,
can bring innovation. The formulation ‘holders of such knowledge’ implies ownership, or at the least
the existence of legal entitlements. This article seems to say that indigenous and local communities
have rights over their knowledge, innovations and practices, even though they are not protected by
IPRs under the TRIPS Agreement.135
While everyone agrees that biodiversity needs to be preserved, the ‘fair and equitable sharing of
the benefits’ arising from the use of biological resources is a more controversial objective. Articles 15
through 21 of the CBD contain the necessary elements for system of fair and equitable benefit sharing.
Among these articles, article 15 and 16 are the most controversial. Article 15 recognizes the sovereign
right of a state over its genetic resources and requires prior informed consent. Article 16 creates an
obligation to provide and facilitate transfer of technologies. These two articles together are at the heart
of the controversy between developed and developing countries and therefore deserve a closer look.136
In order to protect biodiversity, article 15 of the CBD makes countries the gatekeeper of their own
resources. It specifies that states have the sovereign rights over and a responsibility to conserve natural
resources located within their boundaries. National governments can determine the conditions to gain
access to genetic resources. These conditions for access and benefit-sharing as well as restrictions
on the use of genetic resource need to be defined in national laws or in Material Transfer Agreements
(MTAs).137 In any way, this access shall be on mutually agreed terms and subject to the CBD provisions.
Paragraph 5 of article 15 requires that this access to genetic resources shall also be subject to prior
informed consent (PIC) of the state providing such resources, unless otherwise determined by that
state.138 Thus, the CBD emphasizes in situ preservation (the preservation on the original location)
132
Article 1, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.
133
134
Art 8(j), UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.
135
G. DUTFIELD, Intellectual Property Rights, Trade and Biodiversity: Seeds and Plant Varieties, Earthscan, 2000, 35.
136
G. K. VENBRUX, “When Two Worlds Collide: Ownership of Genetic Resources Under the Convention on Biological
Diversity and the Agreement on Trade-Related Aspects of Intellectual Property Rights”, University of Pittsburgh Journal of
Technology Law and Policy, 2005, Vol. 6, 10.
137
Material Transfer Agreements (MTAs) “sometimes referred to as biodiversity prospecting contracts, are agreements between, on
the one hand, national governments or indigenous peoples that own or control access to biodiversity resources and, on the other,
the commercial entity that seeks access to those resources”.
L. R. HELFER, “Intellectual Property Rights in Plant Varieties: An Overview with Options for National Governments”, FAO
Legal Papers Online, 2002 (31), 10.
138
34
of both biodiversity and the traditional knowledge systems and cultures associated with developing
countries. 139
“Article 15. Access to Genetic Resources
1. Recognizing the sovereign rights of States over their natural resources, the authority to
determine access to genetic resources rests with the national governments and is subject
to national legislation.
2. Each Contracting Party shall endeavour to create conditions to facilitate access to genetic
resources for environmentally sound uses by other Contracting Parties and not to impose
restrictions that run counter to the objectives of this Convention.
3. For the purpose of this Convention, the genetic resources being provided by a Contracting
Party, as referred to in this Article and Articles 16 and 19, are only those that are provided
by Contracting Parties that are countries of origin of such resources or by the Parties that
have acquired the genetic resources in accordance with this Convention.
4. Access, where granted, shall be on mutually agreed terms and subject to the provisions
of this Article.
5. Access to genetic resources shall be subject to prior informed consent of the Contractiong
Party providing such resources, unless otherwise determined by that Party.
6. Each Contracting Party shall endeavour to develop and carry out scientific research
based on genetic resources provided by other Contracting Parties with the full partic-
ipation of, and where possible in, such Contracting Parties.
7. Each Contracting Party shall take legislative, administrative or policy measures, as ap-
propriate, and in accordance with Articles 16 and 19 and, where necessary, through the
financial mechanism established by Articles 20 and 21 with the aim of sharing in a fair
and equitable way the results of research and development and the benefits arising from
the commercial and other utilization of genetic resources with the Contracting Party
prociding such resources. Such sharing shall be upon mutually agreed terms.” 140
Article 15 determines that genetic resources and traditional knowledge are national resources, but
governments have not always protected the indigenous and local communities from who that knowl-
edge originates. Sometimes communities that are rich in the knowledge of biodiversity have a tenuous
relationship with the government of the state in which they live.141 There are cases known where
the state closed a deal without considering the indigenous people and their knowledge.142 Because
of these concerns about the benefits of biodiversity reaching the right beneficiaries, the CBD contains
some provisions on how states should treat their indigenous communities. The Convention encourages
cooperation, equitable benefit-sharing and respect for indigenous lifestyles that promote the sustain-
able use of biological resources.143 Article 16 is the article most related with the interface between
intellectual property and biodiversity. It explains what constitutes appropriate access to and transfer
of technology.144
139
mental Law, 2008, Vol. 38, 349.
140
141
142
143
Article 8 and 10, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992.
144
and Biotechnology”, Washington University Law Quarterly, 1998, Vol. 76(1), 261-264.
35
“Article 16. Access to and Transfer of Technology
1. Each Contracting Party, recognizing that technology includes biotechnology, and that
both access to and transfer of technology among Contracting Parties are essential ele-
ments for the attainment of the objectives of this Convention, undertakes subject to the
provisions of this Article to provide and/or facilitate access
for and transfer to other Contracting Parties of technologies that are relevant
to the conservation and sustainable use of biological diversity or make use of
genetic resources and do not cause significant damage to the environment.
2. Access to and transfer of technology referred to in paragraph 1 above to developing coun-
tries shall be provided and/or facilitated under fair and most favourable terms, including
on concessional and preferential terms where mutually agreed, and, where necessary, in
accordance with the financial mechanism established by Articles 20 and 21. In the case
of technology subject to patents and other intel-
lectual property rights, such access and transfer shall be provided on terms which
recognise and are consistent with the adequate and effective protection of intel-
lectual property rights. The application of this paragraph shall be consistent with para-
graphs 3, 4 and 5 below.
propriate, 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
rights, where necessary, through the provisions of Articles 20 and 21 and in accordance
with international law and consistent with paragraphs 4 and 5 below.
propriate, with the aim that the private sector facilitates access to, joint development
and transfer of technology referred to in paragraph 1 above for the benefit of both gov-
ernmental institutions and the private sector of developing countries and in this regard
shall abide by the obligations included in paragraphs 1, 2 and 3 above.
5. The Contracting Parties, recognizing that patents and other intellectual property
rights may have an influence on the implementation of the Convention, shall cooperate
in the regard subject to national legislation and international law in order to ensure
that such rights are supportive of and do not run counter to its objectives.145
To promote equitable benefit-sharing, paragraph 3 of article 16 requires those who develop a tech-
nology based on genetic resources to provide access to and transfer of that technology to the develop-
ing country which has provided these resources. Of course biotechnology companies are reluctant to
simply give developing countries access to their technologies. That would help create their competi-
tion. The governments of developed countries are equally reluctant to weaken their control over IPRs
and institute such legislation that is detrimental to the companies based within their territory.146
Paragraph 5 of the article specifies that the contracting states must “ensure that such rights [in-
tellectual property rights] are supportive of and do not run counter to the Convention’s objectives”.
The meeting documents of the negotiations show that this paragraph was a compromise between the
perspective of intellectual property rights essential for technology on the one hand, and the primacy
of environmental protection over IPRs on the other hand.147 It doesn’t give a clear indication of the
145
Article 16, UN Convention on Biological Diversity, Rio de Janeiro, 5 June 1992, (emphasis added by the author of this
dissertation).
146
147
Article 15, para 4, Second Revised Draft Convention on Biological Diversity, UNEP/Bio.Div/N4-INC.2/2, 1991.
Report of the Intergovernmental Negotiating Committee for a Convention on Biological Diversity on the Work of its Fourth
36
relationship between the provisions of the convention and intellectual property rights. This is an ex-
ample of the compromised and often ambiguous language of the Convention on Biological Diversity.
The competing claims of developed and developing countries have resulted in various concessions and
as a consequence the convention doesn’t meet the expectation of either negotiating block.148
One example of the result article 16 aims at is the agreement between Costa Rica’s Instituto Na-
cional de Biodiversidad (INBio) and the US based pharmaceutical company Merck & Company, Ltd.
(Merck). INBio is a private, non-profit organization closely linked to the Costa Rican government. In
1991 INBio agreed to collect and prepare samples from Costa Rican plants, insects and micro-organisms
for Merck in exchange for $ 1 135 000 (approximately 869 000 euro) and royalties on any commercial
product derived from those samples. INBio decided to give 10% of the initial benefits and 50% of the
royalties to the Costa Rican authorities in charge of managing the country’s national parks. This biodi-
versity prospecting cooperation is a good example of the constructive approach the CBD envisions.149
Every two years there is a Conference of the Parties (COP), a meeting of all the CBD members, to
determine how the Convention should be applied and implemented. Through the COP the approach
to intellectual property has evolved over the years. The harmonization of the intellectual property
rights in the TRIPS Agreement and the CBD’s objectives has become increasingly important. With
regard to intellectual property, the COP has focused on two issues. Firstly, the COP is trying to protect
the traditional knowledge of indigenous communities. Secondly, they advocate a disclosure of origin
requirement for intellectual property rights applications. That means that a patent applicant should
disclose information on where the genetic resources or traditional knowledge which form the basis
of the application come from. Both of these issues are seen as injustices of the TRIPS Agreement by
developing countries and NGOs.150
Negotiating Session, UNEP/Bio.Div/N4-INC.2/5, 1991, 16, para 102.

Article 15, para 4, Third Revised Draft Convention on Biological Diversity, UNEP/Bio.Div/N5-INC.3/2, 1991.
Report of the Intergovernmental Negotiating Committee for a Convention on Biological Diversity on the Work of its Sixth
Negotiating Session, UNEP/Bio.Div/N6-INC.4/4, 1992, 15, para 10.
C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversity and
Biotechnology”, Washington University Law Quarterly, 1998, Vol. 76(1), 264.
148
L. GLOWKA, et al., A Guide to the Convention on Biological Diversity, IUCN, Gland and Cambridge, 1994, 84.
G. K. VENBRUX, “When Two Worlds Collide: Ownership of Genetic Resources Under the Convention on Biological Diversity
and the Agreement on Trade-Related Aspects of Intellectual Property Rights”, University of Pittsburgh Journal of Technology
Law and Policy, 2005, Vol. 6, 13.
149
H. SVARSTAD, “Analysing Conservation ? Development Discourses: The Story of a Biopiracy Narrative”, Forum for
Development Studies, 2002, Vol. 29(1), 77-79.
C. R. MCMANIS, “The Interface between International Intellectual Property and Environmental Protection: Biodiversity and
Biotechnology”, Washington University Law Quarterly, 1998, Vol. 76(1), 270-271.
150
37
6.1 Protecting the Knowledge and Innovations of Indigenous Com-
munities
The Convention on Biological Diversity recognizes the importance of traditional knowledge of indige-
nous communities. Therefore the contracting parties take up the commitment to respect, preserve and
maintain the knowledge, innovations and practices of indigenous communities in article 8(j). In 1998
the COP established the Working Group on Article 8(j) to “implement the commitments of article 8(j)
of the Convention and to enhance the role and involvement of indigenous and local communities in the
achievement of the objectives of the Convention”.151 One of its tasks is to provide advice on the legal
protection of the knowledge and innovations of indigenous and local communities.152
The ad hoc working group monitors the implementation of article 8(j) by the member nations and
has recommended various measures to protect traditional knowledge. On the topic of access to genetic
resources and the equitable sharing of benefits arising from their utilization the ad hoc working group
has contributed to the adoption of the Nagoya Protocol (see infra Part II, Chapter 8). The working
group has further recommended the use of sui generis systems, the use of contractual agreements, the
establishment of registers of traditional knowledge and the development of guidelines and codes of
conduct for researchers.153 By promoting and monitoring this wide range of measures, the working
group tries to protect traditional knowledge.
6.2 Access and Benefit Sharing

Out of the Convention on Biological Diversity a Working Group on Access and Benefit Sharing was
established in 2000. Its mission was to develop guidelines for the implementation of the access and
benefit sharing-provisions of the convention.154 The ad hoc working group was equally asked to de-
velop guidelines addressing the relationship between intellectual property rights and the CBD’s access
and benefit sharing rules. In 2001 de working group presented draft guidelines which were adopted by
the COP in 2002: the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing
of the Benefits Arising out of their Utilization (Bonn Guidelines).155
The most important feature of the Bonn Guidelines is that it encourages countries to use disclosure
requirements to monitor whether applicants comply with the CBD provisions. The guidelines stress
the importance of prior informed consent, the prior consent of a state and/or indigenous community
from which genetic resources are sought. Through an obligation to disclose certain information in
a patent application, countries could control whether prior informed consent was obtained, which is
the country of origin of the genetic resources or traditional knowledge used, whether the condition of
151
Convention on Biological Diversity, “Working Group on Article 8(j)”, http://www.cbd.int/convention/wg8j.shtml.
152
153
Executive Secretary of the Ad Hoc Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of
the Convention on Biological Diversity, “Legal and Other Appropriate Forms of Protection for the Knowledge, Innovations
and Practices of Indigenous and Local Communities Embodying Traditional Lifestyles Relevant for the Conservation and
Sustainable Use of Biological Diversity”, UNEP/CBD/WG8J/1/2, 2000.
Report of the Ad How Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of the Convention
on Biological Diversity on the Work of Its Second Meeting, Conference of the Parties to the Convention on Biological
Diversity, Sixth Meeting, UNEP/CBD/COP/6/7, 2002, 21.
Executive Secretary of the Ad Hoc Open-Ended Inter-Sessional Working Group on Article 8(j) and Related Provisions of the
Convention on Biological Diversity, “Progress in the Implementation of Article 8(j) and Related Provisions and Its Integration
Into the Various Areas of Work Under the Convention and Through the National Reports”, UNEP/CBD/WG8J/7/2, 2011, 2.
154
Convention on Biological Diversity, “Working Group on Access and Benefit Sharing”, http://www.cbd.int/abs/wgabs/.
155
38
access to the resources have been respected,...156
In 2004 the working group was given a new mandate to negotiate an international instrument in
cooperation with the Ad Hoc Working Group on Article 8(j) and related provisions. The goal was
to create an “international regime on access to genetic resources and benefit-sharing with the aim of
adopting an instrument/instruments to effectively implement the provisions in Article 15 and Article 8(j)
of the Convention and the three objectives of the Convention”.157 After several years of negotiation, a
protocol on ’Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from
their Utilization to the Convention on Biological Diversity’ was adopted in Nagoya, Japan, in 2010 (see
infra Part II, Chapter 8).
6.3 Implementation
The Convention on Biological Diversity is a binding international treaty, but it has no enforcement
mechanisms other than public opinion. Whereas the TRIPS Agreement has a very effective enforce-
ment mechanism, the CBD is a convention without teeth. Therefore it relies heavily on its implemen-
tation by national governments. Not only relies the convention to a great extent on the willingness of
its member states, its language is compromised and often ambiguous.158 As a result of the many com-
promises made between the different wishes of developed and developing countries, the convention is
formulated in a way that is open for different interpretations.
The language of the CBD doesn’t assure a strong willingness to fight for biodiversity. In the Con-
vention itself we find provisions that leave space for escaping from a strong protection regime. Article
20 prioritizes economic and social development as well as eradication of poverty for developing coun-
tries. It specifies that these objectives override the objectives of the convention. This means that
biological diversity in theory can be put aside if economic or social goals require to do so.159 Neither
does the convention take a firm stand against intellectual property rights threatening biodiversity. Due
to its ambiguous language and lack of enforcement mechanism, the convention has failed to meet the
expectations of both developed and developing countries.
Although the main goal of the Convention on Biological Diversity is to protect biodiversity, the
convention doesn’t contain a substantive obligation to do so. Instead of explicitly adopting an obli-
gation to protect, the convention determines that sovereign states have the sovereign right to exploit
their own resources. Neither does the CBD recognise that biodiversity is the natural heritage of hu-
mankind. A label of natural heritage of humankind would imply an obligation to protect and preserve
such a heritage. However, the Convention only mentions that biodiversity is a common ‘concern’ of
humankind.160 This use of soft language is exactly why the convention disappoints.
A big blow for the value of the Convention on Biological Diversity is the absence of the United
States. Already during the negotiations leading to the adoption of the CBD, the US announced that
it would not sign the CBD. Signing the convention would impair the American intellectual property
156
Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Aris-
ing out of their Utilization, Secretariat of the Convention on Biological Diversity, 2002, para?s 16 and 53,
http://www.cbd.int/doc/publications/cbd-bonn-gdls-en.pdf.
157
Convention on Biological Diversity, “Working Group on Access and Benefit Sharing”, http://www.cbd.int/abs/wgabs/.
158
mental Law, 2008, Vol. 38, 349.
159
L. D. GURUSWAMY, “The Convention on Biological Diversity: Exposing the Flawed Foundations”, Environmental Conserva-
tion, 1999, Vol. 26(2), 79-80.
160
L. D. GURUSWAMY, “The Convention on Biological Diversity: Exposing the Flawed Foundations”, Environmental Con-
servation, 1999, Vol. 26(2), 81.
39
protection system. In June 1993 the Clinton administration eventually did sign the CBD. It only did so
because a number of pharmaceutical and biotechnology companies that previously were against the
convention changed their opinion. These companies feared to miss out on lucrative bioprospecting
opportunities if they stayed away from the CBD completely. Although the US signed the CBD, it never
ratified the convention and is thus not a party.161
Activist groups against biopiracy heavily criticized the CBD. An alliance of different action groups,
among which the ETC Group (NGO that coined the term ‘biopiracy’, see supra Part I, Chapter 1), has
baptized itself into the ‘Coalition Against Biopiracy’. Between 2002 and 2008 this coalition has held an
award ceremony every two years. The ‘Captain Hook Awards’ were given to companies or institutions
that had commited biopiracy. There were also ‘Cog Awards’ for opposing biopiracy (a ‘cog’ is a ship
designed to repel pirate attacks). These award ceremonies were each time held simultaneously with
the Conferences of the Parties to the Convention on Biological Diversity.162 This display of symbolism
shows how much displeasure the CBD stirred up among activists.
161
162
H. SVARSTAD, “Analysing Conservation & Development Discourses: The Story of a Biopiracy Narrative”, Forum for
Development Studies, 2002, Vol. 29(1), 73.
Captain Hook Awards and Cog Awards, http://www.captainhookawards.org/.
40
Chapter 7
The Interface between the TRIPS

Agreement and the Convention on
Biological Diversity
The TRIPS Agreement and the Convention on Biological Diversity appear to be incompatible to a cer-
tain extent. The TRIPS Agreement promotes intellectual property protection to stimulate international
trade. The goal of the CBD is to protect biodiversity and foster sustainable development. How can in-
tellectual property protection and environmental protection merge? Can the TRIPS Agreement and
the Convention on Biological Diversity coexist without conflicting? Is there any conflict at all between
the TRIPS Agreement and the CBD? Looking at the reaction of various states on this question there
are mainly three different opinions.
A first group of states is of the opinion that the TRIPS Agreement and the Convention on Biological
Diversity can be implemented in a mutually supportive way and consequently that there is no conflict
at all. A second group of countries reaches the conclusion that there is no inherent conflict, but that
the international community has to monitor and if needed intervene to ensure the two agreements
are mutually supportive. The third and most debated view is that the TRIPS Agreement and the CBD
are not supportive. This last group thinks that there are a number of conflicting issues on substan-
tive provisions. The proposed amendments to the TRIPS Agreement generally require that in a patent
application information has to be disclosed about the source and country of origin of any biological
material or traditional knowledge used in the invention. Another demand is the obligation for patent
applicants to obtain prior informed consent from the community or country where they access biolog-
ical material and a benefit-sharing agreement with this community or country.163
Intellectual property protection and environmental protection are widely seen as promoting pro-
foundly conflicting visions. On the one hand, the TRIPS Agreement stimulates international economic
development by strengthening intellectual property protection. On the other hand, the Convention
on Biological Diversity is designed to preserve biodiversity and promote sustainable development.164
The goals these agreements pursue are miles apart from each other. Protecting biodiversity may put
barriers to intellectual property protection and thus to the economic development the TRIPS Agree-
ment pursues. But then again, patenting could indirectly reduce biological diversity.165 As the seed
industry is dominated by only a handful of multinational companies that have the means to promote
163
J. CARR, “Agreements That Divide: TRIPS vs. CBD and Proposals for Mandatory Disclosure of Source and Origin of
Genetic Resources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 139.
164
165
41
their products, developing countries don’t have so much incentive to preserve their biological diversity.
Article 27 of the TRIPS Agreement mentions the main criteria of patentability (novelty, inventive
step and industrial application). Any disclosure requirement concerning access to genetic resources,
prior informed consent or benefit-sharing as the CBD promotes, would be an extra requirement on
top of the TRIPS criteria. It is not clear if this would be compatible with the TRIPS Agreement. Some
states argue that disclosure requirements for patent applications would be an obstacle to technological
advancement based on genetic materials. That would be contrary to the TRIPS Agreement.166 The
TRIPS agreement doesn’t include any disclosure requirement regarding the country of origin of any
biological materials. It awards full protection to the patentee for his invention and does not consider
or provide benefit-sharing for any origin of the invention. According to activists, the way the TRIPS
agreement is construed condones and facilitates biopiracy.167
Traditional knowledge is treated fundamentally different under the CBD and the TRIPS Agreement.
Article 8(j) of the CBD explicitly recognizes the importance of traditional knowledge of indigenous
communities. It is one of the central elements of the CBD. On the contrary, traditional knowledge
is expressly not protected under the TRIPS provisions that only protect ‘new’ inventions. There is
a gap between the attitudes of both instruments. Intellectual property protection gives incentive to
and rewards individual authorship and technological research. Such a culture inevitably clashes with
more traditional lifestyles protected by the CBD. Some cultures consider it immoral to privatize living
organisms and commonly useful human knowledge.168
7.1 Current Status of Plant Genetic Resources

Throughout history the international rules governing plant genetic resources have evolved and split
those resources into three different categories subject to different rules (see Part I, Chapter 2). The
first category of raw plan genetic resource is nowadays under the sovereignty of the state in which
territory they are located. The second category is made up of plant genetic resources ‘worked’ by man.
These are eligible for intellectual property protection. Plant materials in international seed banks, the
third category, are seen as common heritage and thus available to anyone.169
7.2 Adapting the TRIPS Agreement

The 1999 review of article 27.3(b) of the TRIPS Agreement was the first step on a long road of debate.
The initial debate focused on the morality of patenting life forms. Over years of discussion, the focus
has shifted to patentability requirements. Developing countries want to instate disclosure of origin
as evidence of prior informed consent and benefit sharing as a patent requirement. Proposals of de-
veloping countries to amend the TRIPS Agreement have mainly requested to (1) harmonize IPRs with
the rules of the CBD, (2) deny patent protection to inventions inconsistent with the CBD, (3) protect
traditional knowledge and (4) ensure the TRIPS-compatibility of national farmers’ rights.170 Where
166
167
Genetic Resources Action International (GRAIN), “TRIPS versus Biodiversity: What to do with the 1999 Review of Article
27.3(b)”, 1999, 2,
http://www.grain.org/article/entries/11-trips-versus-biodiversity-what-to-do-with-the-1999-review-of-article-27-3-b.
168
mental Law, 2008, Vol. 38, 351.
169
170
42
WTO Conferences were originally occupied with moral issues, they currently address technical topics.
In recent years, the WTO has adopted a couple of non-binding declarations that emphasize the
need to compromise the TRIPS Agreement with other international treaties. These interpretive state-
ments were answering the criticism against the TRIPS Agreement.171 Various UN human rights bodies
have stated that the intellectual property rules of the TRIPS Agreement are a threat to economic, social
and cultural rights. Different NGOs, developing countries and the World Health Organization (WHO)
expressed their concern over intellectual property rights on pharmaceuticals. The organization made
a distinction between essential drugs and other drugs that are commodities. The WHO has questioned
whether intellectual property incentives are adequate to ensure investment in medication needed by
the poor.172
In November 2001 the Fourth WTO Ministerial Conference was held in Doha to launch the Doha
Round, a round of WTO negotiations to reform the international trading system. An important objec-
tive of the Doha Round was to improve the trading conditions for developing countries. At the Doha
Conference, on the agenda was the effect of the international intellectual property policy on developed
and developing countries. That would have been a good opportunity to discuss the issue of biopiracy,
but the debate over third world access to patented medicines overshadowed the discussion.173 The
conference resulted in the adoption of the Declaration on the TRIPS Agreement and Public Health
(Public Health Declaration) and the Doha Ministerial Declaration.174
The Public Health Declaration adopted at the Doha Conference is an answer to the protests of
developing nations, human rights NGO’s and officials of intergovernmental organizations concerning
the issue of access to patented medicines. Some developing states were combatting a HIV/AIDS crisis,
but the much needed patented pharmaceuticals were too expensive. The Public Health Declaration
reaffirms the principle of balanced IPRs. With regard to effective measures, the declaration extends the
transition period for least-developed countries until 1 January 2016 to implement TRIPS obligations
concerning patents and undisclosed information relating to pharmaceutical products.175
The second result of the Doha Conference was the Doha Ministerial Declaration. Paragraph 19 of
the declaration instructed the TRIPS Council to “examine, inter alia, the relationship between the TRIPS
Agreement and the Convention on Biological Diversity, the protection of traditional knowledge and folklore
and other relevant new developments raised by members [...] and shall take fully into account the develop-
ment dimension”.176 This approach shows the growing concern over the negative effects of the TRIPS
Agreement for developing countries. However, up until today the US has blocked the request of the
CBD’s Executive Secretary to obtain observer status in the Council. The (already renewed) application
171
172
173
WTO, “The Doha Round”, http://www.wto.org/english/tratop_e/dda_e/dda_e.htm.
M. WOODS, “Food for Thought: The Biopiracy of Jasmine and Basmati Rice”, Albany Law Journal of Science and Technology,
2002, Vol. 13, 134.
174
L. R. HELFER, “Human Rights and Intellectual Property: Conflict or Coexistence?”, Minnesota Intellectual Property
Review, 2003, Vol. 5(1), 60-61.
175
The search for an answer to the growing global HIV/AIDS crisis continued in further negotiations, which led to the
adoption of an interpretive statement. The decision “allows developing countries that lack sufficient domestic manufacturing
capacity to meet their public health needs by importing generic drugs from other WTO members without restriction as to type of
disease or type of emergency”.
L. R. HELFER, “Regime Shifting”, supra 48, 5 and 67.
Declaration on the TRIPS Agreement and Public Health, World Trade Organization, 14 November 2001, para 7.
176
WTO, Doha Ministerial Declaration, WT/MIN(01)/DEC/1, 14 November 2001, para 19.
Convention on Biological Diversity, “Cooperation with WTO”, http://www.cbd.int/incentives/coop-wto.shtml.
43
submitted by the Secretariat is still pending.177
Invoking the Bonn Guidelines and paragraph 19 of the Doha Declaration, a group of developing
countries proposed the creation of additional patent disclosure rules. In order to obtain a patent related
to plant materials or traditional knowledge, the applicant would have to provide certain information.
These proposed rules are stricter in comparison with the current regulation as disclosure of origin
is not mandatory yet, it is left to the discretion of national governments. Initially, developed coun-
tries opposed the proposal, but the EU and Switzerland countered the proposition with a compromise.
However, developing countries rejected this compromise and continued to advocate a strong protec-
tion of genetic resources and traditional knowledge. Whether these talks will result in a breakthrough
is doubtful now trade negotiations have collapsed at the WTO Cancún Conference.178
At the 2003 WTO Conference in Cancún, developing countries sought to limit patent protection
for biotechnology, while industrialized countries lobbied for the WTO to adopt the UPOV Convention.
The UPOV Convention offers plant variety protection, but hardly considers third world farmers.179 On
the contrary, plant variety protection comes with a potential danger of concentrating technology own-
ership and restricting the free exchange of seed between farmers.180 In Cancún developing countries
were far better organized than at previous WTO conferences. A new negotiating block saw the light.
The G-20 was formed by developing states to strengthen their position in WTO negotiations.181 The
breakdown of talks in Cancún shows that developed and developing countries are still on opposite
positions. Finding a compromise will be hard.182
177
Convention on Biological Diversity, “Cooperation with WTO”, http://www.cbd.int/incentives/coop-wto.shtml.
L. R. HELFER, “Human Rights and Intellectual Property: Conflict or Coexistence?”, Minnesota Intellectual Property Review,
2003, Vol. 5(1), 60-61.
178
179
nology, 2002, Vol. 13, 134.
180
R. TRIPP, N. LOUWAARS and D. EATON, “Plant Variety Protection in Developing Countries. A Report from the Field”,
Food Policy, 2007, Vol. 32, 355.
181
The G-20 quickly included more than 20 countries, but its name refers to its date of creation. Originally the members of
the G-20 were: Argentina, Bolivia, Brazil, Chile, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, El Salvador, Guatemala,
India, Mexico, Pakistan, Paraguay, Peru, Philippines, South Africa, Thailand and Venezuela. Since the creation of the group,
it has had quite some changes of members.
N. BULLARD, “G20: Their Power is Not Ours”, Focus on Trade, 2004 (98), 7-10.
P. M. VEIGA, “Brazil and the G-20 Group of Developing Countries”, WTO,
http://www.wto.org/english/res_e/booksp_e/casestudies_e/case7_e.htm.
182
view, 2003, Vol. 5(1), 60-61.
44
Chapter 8
Nagoya Protocol
In 2010 the United Nations adopted the Nagoya Protocol on Access to Genetic Resources and the Fair
and Equitable Sharing of Benefits Arising from their Utilization. The Protocol was supplementary to
the Convention on Biological Diversity and intended to correct the flaws of the CBD. In 2004 the Work-
ing Group on Access and Benefit Sharing and the Working Group on Article 8(j) and Related Provisions
were instructed to create an international regime for access and benefit-sharing (ABS). After several
years of negotiation the Nagoya Protocol was adopted. To become effective it needs to be ratified by
50 countries. The protocol will enter into force 90 days after the deposit of the fiftieth instrument of
ratification. In May 2013 the protocol had 92 signatories and was ratified by 16 countries.183
The CBD Secretariat expects the Nagoya Protocol will enter into force by 2015. India and South
Africa have already ratified the treaty and Brazil has signed and showed its satisfaction with the pro-
tocol. The United States has not made any move towards signing yet and probably will not do so,
regarding its absence from the CBD. The European Union and most of its member states have signed,
but not yet ratified the protocol. France has already made a lot of requests for changes. Some NGOs
have expressed discontent about the protocol. In short, there are mixed reactions towards the proto-
col.184
In Nagoya three instruments were adopted. The 173 present states did not only create the Nagoya
Protocol, but also a strategic action plan with 20 objectives to 2020 and a financial mechanism for
the implementation of the convention.185 This strategic plan is supposed to help realize the first two
objectives of the CBD: conservation and sustainable use of biodiversity. However, the action plan is
non-binding and not precise.
Despite the CBD and the Bonn Guidelines, there are almost no efficiently functioning regimes for
access and benefit sharing (ABS). Only a few countries have created an ABS system in their national
legislation. Most of those are states providing genetic resources and not the ones using the resources.186
The most relevant framework already in place for ABS is offered by the Bonn Guidelines. However,
those guidelines are non-binding and thus only have effect if a country converts its provisions in na-
183
The countries that have already ratified the treaty are: Albania, Botswana, Ethiopia, Fiji, Gabon, India, Jordan, Lao
People’s Democratic Republic, Mauritius, Mexico, Micronesia, Panama, Rwanda, Seychelles, South Africa and the Syrian
Arab Republic.
Nagoya Protocol, “Status of Signature and Ratification, Acceptance, Approval or Accession”,
http://www.cbd.int/abs/nagoya-protocol/signatories/default.shtml.
184
C. AUBERTIN and G. FILOCHE, “The Nagoya Protocol on the Use of Genetic Resources: One Embodiment of an Endless
Discussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 61.
185
Discussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 52 and 62.
186
E. C. KAMAU, B. FEDDER and G. WINTER, “The Nagoya Protocol on Access to Genetic Resources and Benefit Shar-
ing: What is New and What are the Implications for Provider and User Countries and the Scientific Community?”, Law,
Environment and Development Journal, 2010, Vol. 6(3), 248.
45
tional laws. A protocol, on the contrary, is a stronger, binding commitment for nations. All the actors
involved had a strong desire to reach a solution on the ABS issue and one that would lead to the ac-
tual establishment of ABS. Indigenous communities and developing nations wanted a solution for the
abuse of biopiracy. Companies, researchers and developed nations could use a clear legal framework
to protect themselves from the claims of biopiracy.187 For all the stakeholders, the adoption of the
binding Nagoya Protocol on ABS was a victory.
The conflict over some issues made the final adoption of the protocol uncertain until the last mo-
ment. The countries didn’t easily find an agreement on the scope of the protocol, compliance mea-
sures and the balance of rights and obligations of provider- and user-countries.188 The majority of
the present states could not reach an agreement. Therefore, Japan brought together a small group of
influential nations (the EU, Brazil, Norway and the African Group) in a secret meeting which could
create a consensus-based text.189 A result had to be reached. After years of troubled negotiations and
continuing erosion of biodiversity, no one wanted this effort to fail. Moreover, the countries that were
both users and suppliers of biological material also had interests in other international negotiations
(for example in the WTO and WIPO). Those countries didn’t want the CBD to interfere with these
other talks, so they had an interest to clarify some of the CBD issues through the Nagoya Protocol.190
A lot of effort was done to finally reach a result, failure was not an option.
8.1 The Text

The preamble of the protocol refers to articles 15 and 8(j) of the CBD and states the third objective
of the CBD to be its goal: the fair and equitable sharing of benefits. It affirms the link between this
objective and the other two CBD objectives, the conservation and sustainable use of biodiversity. The
preamble further refers to some of the difficulties in the implementation of the CBD. Article 6 of the
protocol repeats that access to genetic resources shall be on mutually agreed terms and subject to the
prior informed consent of the providing party. The protocol is very elaborate on the procedure of ac-
cess and does a lot of effort to facilitate this access procedure.191 The compliance with these rules shall
be monitored by national checkpoints that every member state has to create and the ABS Clearing
House Mechanism. This Clearing House Mechanism will monitor and share information related to ac-
cess and benefit-sharing.192 The Nagoya Protocol offers an elaborate set of rules on access procedure,
mutually agreed terms and prior informed consent.
In articles 6 and 7, a distinction is made between access to genetic resources dealt with by the
former article and access to traditional knowledge associated with genetic resources dealt with in the
latter. Article 7 requires states to ensure that traditional knowledge associated with genetic resources
held by indigenous and local communities has been accessed with the prior informed consent of these
187
188
K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Benefit-Sharing for Indigenous
and Local Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 525.
189
International Institute for Sustainable Development, “Summary of the Tenth Conference of the Parties to the Convention
on Biological Diversity: 18-29 October 2010”, Earth Negotiations Bulletin, 2010, Vol. 9(544), 26.
190
191
K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Benefit-Sharing for Indigenous
and Local Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 524-526.
192
Environment and Development Journal, 2010, Vol. 6(3), 252.
46
communities.193 The application field of the protocol doesn’t include human genetic resources and
genetic resources that are not subject to the sovereign rights of states (for example in international
waters). Genetic resources dealt with by other ABS instruments such as the FAO instruments are also
not included in the scope of the Nagoya Protocol. Raw genetic resources (meaning not adapted or used
for research) used for food or farming are not either subject to the protocol.194 A lot of institutions and
international instruments deal with genetic resources. The negotiations towards the Nagoya Protocol
have brought a degree of order to this overlap by trying to define the field of application of the protocol.
Benefit-sharing is required for every utilization of genetic resources. Then defining what a utiliza-
tion is, is crucial to know when benefit-sharing is due. Article 2 defines it as following:
“Utilization of genetic resources means to conduct research and development on the genetic
and/or biochemical composition of genetic resources, including through the application of
biotechnology as defined in Article 2 of the Convention” 195
During the negotiations a list of kinds of research and development was made. This list was not
included in the protocol, but can still be used as an indication. It is important that R&D on the bio-
chemical composition of genetic resources is explicitly mentioned. Drugs based on the extraction of
chemicals from biological resources clearly fall within the scope of the protocol. The lack of clarity has
always been a big problem in the instruments adopted concerning genetic resources and this definition
brings a bit more clarity.196
The compliance measures set out by the Nagoya Protocol are rather complicated. Articles 15 and
16 of the protocol instruct each member state to take measures to ensure that genetic resources and
traditional knowledge used within its jurisdiction have been accessed with prior informed consent and
on mutually agreed terms. The divide between genetic resources and traditional knowledge is upheld
in these provisions. Article 15 deals with compliance with legislation for genetic resources and article
16 with compliance for traditional knowledge. This obligation is meant for user states: the state in
which the resources or knowledge is utilized is made responsible for controlling whether their nation-
als have respected the domestic law and the law of the state providing the resources. A system of dual
control is created. Not only the provider state, but also the user state watches over compliance with
the treaty. In practical terms, this is quite complicated. States will have to cooperate to establish a
double control system.197
Article 17 obliges parties to enhance transparency and monitor the utilization of genetic resources.
Where articles 15 and 16 leave it primarily to the discretion of national authorities to decide which
measures should be taken to realize compliance, article 17 provides clear guidelines for establishing
a monitoring mechanism. Monitoring would happen through checkpoints which submit information
to the ABS Clearing-House Mechanism. One important formulation of article 17 needs mentioning.
The protocol draws a clear distinction between genetic resources and traditional knowledge, as seen
in the previous articles. It is peculiar that article 17 only mentions “monitoring the utilization of ge-
netic resources”. Any similar monitoring mechanism explicitly designed for traditional knowledge is
193
Articles 6 and 7, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.
194
195
Article 2(c), Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from
their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.
196
Environment and Development Journal, 2010, Vol. 6(3), 251-252.
197
Articles 15 and 16, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.
Discussion”, Sustentabilidade em Debate, 2011, Vol. 2(1), 57-58.
47
not spoken of. Considering the clear distinction of the protocol in many other articles, this lack of
mentioning traditional knowledge could have far-reaching consequences.198
Article 18 aims at achieving compliance with mutually agreed terms by ensuring contract en-
forcement. Each member state must encourage providers and users of genetic resources to include
provisions regarding dispute resolution in their mutually agreed terms. This article makes clear that
benefit-sharing is a contractual issue and its enforcement is thus an issue of contract enforcement.
Consequently, the Nagoya protocol entails no obligation for user states to ensure benefit-sharing.
They only have to make sure that benefit-sharing can be enforced through the justice system. The
enforcement of benefit-sharing is a contractual issue and this come with difficulties of forum, liti-
gation costs,. . . Many provider states were disappointed that the protocol didn’t provide a stronger
enforcement of benefit-sharing. Paragraph 4 explicitly foresees a review of the effectiveness of article
18.199
Already during the negotiations on the Nagoya Protocol, states realized the challenges of the new
compliance system enshrined in the protocol. Therefore they considered a pioneering option in inter-
national environmental law: the establishment of an international ombudsperson to “support develop-
ing countries and indigenous and local communities to identify breaches of rights and to provide technical
and legal support in ensuring effective redress of such breaches”.200 This would have resulted in a cross
level compliance mechanism operating on the local and national level while connecting to the interna-
tional level. Eventually this was not included in the protocol, but of course the member countries can
still establish an ombudsman in the future through the Conference of the Parties.201
8.2 Assessment of the Protocol

Compromise, the word used to describe all the aforementioned international efforts for preserving
biodiversity in this dissertation, applies again for the Nagoya Protocol. On the one hand the protocol
broadens the field of application of the Convention on Biological Diversity. On the other hand the
disputed issues of retroactivity and derivatives have been sidestepped. States managed to agree on
balancing the responsibilities in exchange of avoiding controversial concepts.
Article 3 regarding the scope of the protocol was one of the most disputed articles during the ne-
gotiations. The article determines that the protocol shall apply to genetic resources and traditional
knowledge within the scope of Article 15 of the Convention and to the benefits arising from the uti-
lization of such resources and knowledge. The African Group wanted the protocol to apply to genetic
resources accessed prior to the adoption of the Nagoya Protocol and prior to the adoption of the
Convention on Biological Diversity. That would mean that the protocol applies to already existing col-
lections of genetic resources and that benefit-sharing is required for new and continuing uses of these
already accessed materials. However, industrialized countries opposed this proposal. They argued that
198
Article 17, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from
E. C. KAMAU, B. FEDDER and G. WINTER, “The Nagoya Protocol on Access to Genetic Resources and Benefit Sharing: What
is New and What are the Implications for Provider and User Countries and the Scientific Community?”, Law, Environment
and Development Journal, 2010, Vol. 6(3), 253.
199
K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Benefit-Sharing for Indigenous and
Local Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 531.
200
Article 14bis, Draft Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from
their Utilization to the Convention on Biological Diversity, Annex I, UNEP/CBD/COP/10/5/Add. 5, 2010.
201
E. MORGERA, “Bilateralism at the Service of Community Interests? Non-Judicial Enforcement of Global Public Goods
in the Context of Global Environmental Law”, European Journal of International Law, 2012, Vol. 23, 761.
48
it would go against legal clarity and legal certainty. Eventually, the Nagoya Protocol doesn’t include
any reference to its temporal scope or to retroactivity.202
Another controversial question during the negotiations was whether the protocol would cover
derivatives of genetic resources. A derivative is a biochemical compound derived from a genetic re-
source, in other words, a small natural element extracted from genetic material. Often it is a derivative
of plant material that constitutes a useful, commercially viable, product for a company either in its
pure form or developed. Obviously industrialized countries wanted to limit the protocol’s application
field as much as possible. Thus, they opposed the mentioning of derivatives. Article 2 of the protocol
offers a rather broad definition of the term, but the term ‘derivatives’ does not appear anywhere else
in the protocol.203 The parties have kept the definition in the protocol, but in reality the reference to
derivatives has little effect. Developed countries are satisfied that the scope of the Nagoya protocol in
reality doesn’t include derivatives.204
A reform of patent legislation hasn’t been addressed in the negotiations leading to the adoption of
the Nagoya Protocol. Many developing countries want to include mandatory disclosure requirements
in patent applications for a biotechnological invention. Then the applicant would have to provide
proof that the biological material at the origin of the innovation has been required with prior in-
formed consent and sharing of the benefits. The certificate referred to in article 17 of the protocol
is not a certificate of origin to comply with a disclosure requirement. It is only a certificate contain-
ing information. It is not mandatory and will only be used for informational purposes in the ABS
Clearing-House Mechanism. Negotiations on a reform of patent legislation can probably only be held
in the WIPO forum discussing the Substantive Patent Law Treaty (see supra Part II, Chapter 5).205
The protocol doesn’t provide much improvement for the rights of indigenous and local communi-
ties to their resources and knowledge. The protocol does recognize that these communities have rights
both to the traditional knowledge they hold and the genetic resources located in their territory.206
The Nagoya protocol also enacts the principle of dual prior informed consent. That mean that both
the national authorities and (when necessary) the local community need the give their prior informed
consent before access to genetic resources or traditional knowledge can be granted. However, the
protocol recognizes that indigenous communities have rights, but doesn’t define these rights. What
this protocol will really mean to local and indigenous communities depends on the implementation by
states.
The Nagoya Protocol is again weak on some crucial points. The Protocol avoids specifics on drug
access and equitable compensation for indigenous peoples. Neither does it deal with biodiversity
management planning nor with the implementation. The Nagoya Protocol still heavily relies on im-
202
K. KOUTOUKI and K. R. BIEBERSTEIN, “The Nagoya Protocol: Sustainable Access and Benefit-Sharing for Indigenous and
Local Communities”, Vermont Journal of Environmental Law, 2012, Vol. 13, 527-528.
203
“Derivative means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of
biological or genetic resources, even if it does not contain functional units of heredity.”
Article 2(e), Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from
204
on Biological Diversity: 18-29 October 2010”, Earth Negotiations Bulletin, 2010, Vol. 9(544), 4 and 26.
205
206
Articles 6 and 7, Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010.
49
plementation by the state itself, but that can be a problem in poor countries.207 Article 25 simply
refers to article 20 of the Convention on Biological Resources with regard to financial resources for
the implementation of the protocol. That article determines that “the developed country Parties shall
provide new and additional financial resources to enable developing country Parties to meet the agreed
full incremental costs to them of implementing measures which fulfil the obligations of this Convention
[. . . ]”. In a further paragraph the drafting states have recognized that the extent to which developing
parties will effectively implement their commitments under the convention will depend on the effec-
tive implementation by developed countries of their commitment to financial resources and transfer of
technology.208 Thus, the Nagoya Protocol doesn’t bring more financial support for developing coun-
tries.
The Nagoya Protocol is a compromise text. User states were made responsible for their nationals
and a monitoring mechanism was created. In exchange the notions of derivatives and temporal scope
were not mentioned. Many deemed the final draft of the Nagoya protocol a masterpiece in creative
ambiguity. The compromise text didn’t manage to resolve all the outstanding issues. Instead, the dis-
puted issues were either removed from the text or replaced by a more general formulation open for
interpretation.209 However, this flexibility in interpretation might prove to be too flexible for an effec-
tive implementation of the protocol.
At the Conference of the Parties in Nagoya the present states had to recognize that they had failed
to meet the 2010 biodiversity target.210 However, it was not this failure, the continuing erosion of
biodiversity despite 18 years of international negotiations, that the 10th Conference of the Parties is
remembered for, but the success of the Nagoya Protocol. The protocol was received as a victory for
biodiversity, although it is not sure if it will result in a substantial improvement. The protocol clarifies
some of the issues that were left unclear by the CBD, but will probably only provide minor changes in
reality. It was more important to the negotiating parties not to fail, than to really succeed. The negoti-
ations have ended with a concrete result and the framework for negotiations has been preserved. That
is the real victory of the 10th COP, not the changes the Nagoya Protocol envisions.211
The success or failure of the Nagoya Protocol depends on the adoption of strong national legisla-
tion by the member states. The protocol is created to provide more legal certainty and transparency
for the providers and users of genetic resources. On the one hand it tries to make conditions for access
more predictable and on the other hand the protocol ensures benefit-sharing even when the genetic
materials are taken outside of the provider state. At least in theory, this protocol is a great effort to
prevent biopiracy. Contractual ABS agreements could deliver the economic resources needed for the
conservation of biodiversity and a compensation for traditional knowledge. An ABS regime would
adjust the lack of protection of indigenous communities and developing countries under intellectual
property law. However, the Nagoya Protocol will only know success if its parties make benefit-sharing
a reality.212
207
208
their Utilization to the Convention on Biological Diversity, Nagoya, 29 October 2010. Article 20, UN Convention on Biological
Diversity, Rio de Janeiro, 5 June 1992.
209
210
211
212
V. DANLEY, “Biopiracy in the Brazilian Amazon: Learning from International and Comparative Law Successes and
Shortcomings to Help Promote Biodiversity Conservation in Brazil”, Florida A&M University Review, 2012, Vol. 7, 305-306.
50
Chapter 9
“ The contemporary law of intellectual property routinely falls short of its stated ideal of
advancing the progress of science and the useful arts. ” 213
J. Chen
Developing countries have two main complaints about the efforts of industrialized countries to
strengthen international intellectual property protection. Firstly, raw genetic resources and traditional
knowledge originating from developing countries can freely be transferred to industrialized countries,
while the commercial products and technology derived from these resources are very expensive be-
cause of the intellectual property protection. Secondly, developing nations feel that intellectual prop-
erty protection is constructed in favor of the technological innovation of industrialized nations.
Through the WIPO and the WTO the minimum standards of patent law have been globally harmo-
nized. The TRIPS Agreement is constructed in the disadvantage of farmers and indigenous communi-
ties of developing countries. Farmers who have preserved and improved plant varieties for generations
do not get any recognition under the WTO regime. Traditional agricultural innovation and traditional
knowledge of indigenous communities do not fit into the TRIPS Agreement and are consequently de-
prived of protection although this knowledge is a form of intellectual property.214 The establishment
of such a strong intellectual property protection worldwide has been realized under dominance of in-
dustrialized countries.
The rapid disappearance of biodiversity has spurred the international community to take action
and that has resulted in the Convention on Biological Diversity. The Convention essentially makes the
national government of biodiversity-rich states their own gatekeeper. Each state has sovereignty over
the genetic resources located within its territory and determines the conditions of access to them. This
access shall be on mutually agreed terms and subject to prior informed consent and benefit-sharing.
These conditions for access and benefit-sharing as well as restrictions on the use of genetic resource
need to be defined in national laws.215 The Convention has very good intentions, but no teeth. Its
effects in reality are thus a lot more insignificant than those of the TRIPS Agreement.
213
J. CHEN, “Parable of the Seeds: Interpreting the Plant Variety Protection Act in Furtherance of Innovation Policy”, Notre
Dame Law Review, 2005, Vol. 81, 115.
214
and Biotechnology”, Washington University Law Quarterly, 1998, Vol. 76(1), 268-269.
215
L. R. HELFER, “Intellectual Property Rights in Plant Varieties: An Overview with Options for National Governments”, FAO
Legal Papers Online, 2002 (31), 10.
51
Although some countries assert that the TRIPS Agreement and the CBD are mutually supportive,
there is definitely a field of tension between these agreements. This field of tension is where the opin-
ions of developed and developing countries clash. During the last two decades the WTO members
have tried in several WTO conferences to reach consensus on amending the TRIPS Agreement so it
takes the development conditions of less developed states more into account. Small amendments have
been made, but no consensus has been found on major controversial issues such as biopiracy.
In 2010 the Conference of the Parties adopted the Nagoya Protocol as part of the realization of
the CBD objectives. The protocol aims to create an effective access and benefit-sharing system but
hasn’t entered into force yet. There is a market for genetic resources. The Nagoya protocol aims to
regulate this economy based on knowledge and biotechnology. The incomes it generates would have to
promote the preservation of biodiversity.216 The protocol is a promising commitment of its signatories,
but lacks clarity. Whether it will really create a more effective ABS regime and thus limit biopiracy
will have to be assessed in the future.
216
52
Part III
Towards a Solution
“ So what went out free, would return with a price tag. ” 217
D. E. Schmidt
Morally, it doesn’t feel right that farmers from developing countries should pay seed that is devel-
oped from plant varieties which originally came from their territories and which they have cultivated
for over centuries. Morally, it doesn’t feel right either to appropriate the traditional knowledge of an in-
digenous community to develop a product and make profit of it without that community receiving any
compensation in return. On those moral principles the whole international community agrees. Those
principles are even enshrined as objectives, goals and considerations, but the international community
doesn’t manage to agree on hard law rules that are enforceable and will provide a solution to biopiracy.
During the last decade a real biodiplomacy has emerged. Some developing countries have gotten a
lot of political weight. Where industrialized countries still managed to dominate the WTO during the
negotiation of the TRIPS Agreement, these new political actors put a lot of pressure to realize their own
demands now. On the 10th COP Brazil demanded one billion dollars annually to protect its biodiversity
until 2020.218 This is just one example. Developing countries have much more political leverage now
than they had 20 years ago. As the demands of developed and developing countries conflict on many
of the substantive issues, negotiations are to a large extent blocked. How can a solution be reached?
What would a good solution look like?
A first step towards finding a solution would be to adopt a new rhetoric. Until now activists and
even developing countries have used a rhetoric with a negative connotation that accuses industrialized
countries. That is not a good basis for constructive discussion. Chapter ten will look at the rhetoric
currently used and assess why it is detrimental to the ongoing negotiations. It will look at the changes
necessary for a better rhetoric. An essential first step towards result is creating a more constructive
environment for discussion.
Recently, a proposal was submitted to the European Parliament to implement the Nagoya Protocol
in the European Union. In this post-TRIPS lawmaking environment, the big division between North
and South that was present during the Uruguay Round is slowly disappearing. Developing countries
don’t all agree on intellectual property issues anymore and some developed countries start to support
reform proposals. Other powerful countries such as the US continue to oppose a reform of intellectual
property law, but that becomes more difficult now these new alliances emerge.219 Especially the Euro-
pean Union and its member states seem determined to bring the TRIPS Agreement more in line with
the CBD. What is the EU’s position towards biopiracy today? Chapter eleven will look at the steps the
EU is currently taking to adapt their patent regime. What approach does the EU take to work towards
a solution and are its commitments sincere?
The most obvious way to bring about change is using patent law to protect genetic resources and
traditional knowledge. The high minimum standards of patent law allow a broad interpretation of
patentability and omit to protect developing countries and indigenous communities. It is only logical
to search for a solution at the origin of the problem. Most WTO and WIPO members are of the opinion
that the solution has to be found in changing the patent law. However, there is a lot of disagreement
on which venue is appropriate to accomplish a change and how that change should look like. Chapter
twelve strives to offer an overview of the view of different countries and the most realistic solutions
217
mental Law, 2008, Vol. 38, 334-335.
218
219
54
discussed. Of course changing patent law is not the only solution possible. There are alternatives.
Chapter thirteen will discuss other possibilities that are suggested and applied.
55
Chapter 10
Rhetoric
Activist groups often bring the simplified story of the rich multinational company that steals the
knowledge or resources of a local community and makes big profit out of it. In this story the multi-
national companies are called biopirates, often along with the developed countries where these com-
panies are located. There is a lot of symbolic language used. This rhetoric of ‘piracy’ is probably
unhelpful and maybe even counterproductive. This chapter will look into the rhetoric used by advo-
cates for indigenous rights and will assess whether it is in need of a change. Specifically two scholars
will be discussed, Paul Heald and Cynthia Ho, who have made some interesting remarks on the rhetoric
used for biopiracy.
At this point of the dissertation it has become crystal clear that biopiracy is a controversial issue
that is subject of an intense political debate. Everyone would like to see social justice for indigenous
people and protection for biodiversity. Just like everyone wants to see medical progress and treatments
for diseases. Similarly every farmer wants a good harvest and every consumer wants good vegetables
in the supermarkets. There is wide agreement that these are desirable end-goals, but the means to
reach those are in dispute.220 In politics, diplomacy and negotiations, how something is said is almost
just as important as what is said. Calling someone a pirate is maybe not the best strategy to get what
you want.
The vocabulary used against biopiracy is primarily framed in terms of moral obligation, unjust en-
richment and free-riding. Scholar Paul Heald judges this rhetoric to be ineffective. He calls the call for
protection by the advocates of indigenous communities a rhetorical disaster. There is a wide consensus
among intellectuals that current intellectual property rights are too broad.221 Arguments based on jus-
tice will better serve the protection of bio-prospectors than that of indigenous communities. Advocates
for indigenous communities essentially want the same as bio-prospecting companies (conservation of
biodiversity and the traditional knowledge of local communities about plants) and thus should avoid
making them into opponents by calling them pirates.222
During the last two decades, large multinational companies of the pharmaceutical, agribusiness
and biotechnological industry have managed to expand intellectual property protection. Nowadays a
wide variety of inventions qualify for protection, sometimes even through sui generis protection. On
the one hand, these companies aren’t interested in more rights or better protection for indigenous
220
mental Law, 2008, Vol. 38, 351.
221
P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11,
521-522.
222
mental Law, 2008, Vol. 38, 352.
56
communities as having to compensate them would raise their research costs. On the other hand, there
is a lot of corporate interest in the vast potential of biodiversity. Genetic resources are an important
source for drug development and new agricultural products, so the ‘biopirates’ lose potential income as
biodiversity disappears and it is disappearing at an alarming rate. It has even been suggested that, un-
der certain circumstances, “the bioprospecting value of certain genetic resources could be large enough to
support market-based conservation of biodiversity”. Therefore, indigenous communities would be much
more effective in their fight against the destruction of their territory and resources with the biopirates
on their side.223
If one side possesses the financial and political resources and the other side possesses knowledge
and resources, then why haven’t they cooperated yet to protect biodiversity? Heald has identified a
number of factors that have driven these two groups apart: high transaction costs, a lack of information
for indigenous communities, corrupt governments, a lack of trust, a threat to the cultural integrity of
indigenous communities and the economic interest for poor countries in selling biodiversity.224 Thus,
it is important to build a new bridge between indigenous communities and companies in need of re-
sources. The first step towards cooperation is adopting a new rhetoric.
There is a need to align the interests of developing nations, their indigenous communities and bio-
prospecting companies. Cynthia Ho, a legal scholar, agrees with Heald that the claims of biopiracy
haven’t had much effect in protecting the rights of indigenous communities. The WTO is dominated
by developed countries. Claims of piracy and theft made by developing nations that have much less
bargaining power in the WTO don’t have positive effect. Developed countries don’t want to come
across as immoral thieves and consequently won’t engage in a discussion based on claims of piracy.
These developed countries have always argued that the TRIPS Agreement is sufficiently flexible. How-
ever, they close numerous TRIPS-plus agreements with developing countries which are economically
pressured into cooperation.225
Industrialized countries might be more inclined to listen to a discourse of national sovereignty

than to accusations of piracy. State sovereignty is an widely recognized principle of international law.
As all states recognize each other’s right to sovereignty, it is a rhetoric that is easily understood by
both authorities and a state’s population. This strategy has proven to be successful in the interna-
tional controversy surrounding HIV/AIDS drugs. The US has reconsidered the enforcement of patent
on HIV/AIDS drugs for example in Brazil and South Africa through claims of national sovereignty
backed up with a negative public opinion.226 As for companies, a lot of multinational pharmaceutical
companies and recently more and more agricultural companies have serious image problems. Their
business often goes at the cost of the poor and thus, they have an image of being greedy. Engaging in
environmental preservation could lift their image to a better level.227
Ho proposes to introduce an internet-based commentary system hyperlinked to patents. That way

everyone who wants can comment on a specific patent and the patent holder can enter in discussion.
It’s a system to enhance communication and transparency. She says that a different rhetoric is only a
start. Complementary to that, communication between the opposite sides should be improved. Sec-
223
530-534.
224
P. J . HEALD, “The Rhetoric of Biopiracy”, Cardozo Journal of International and Comparative Law, 2003-2004, Vol. 11, 535.
225
C. M. HO, “Biopiracy and Beyond: A Consideration of Socio-Cultural Conflicts with Global Patent Policies”, University
of Michigan Journal of Law Reform, 2006, Vol. 39, 504 and 511.
mental Law, 2008, Vol. 38, 353.
226
of Michigan Journal of Law Reform, 2006, Vol. 39, 507-509.
227
57
ondly, the trend to patent everything that comes out of a laboratory should be put to a halt. Patenting
every result of research could limit research instead of promoting it. Thirdly, the biopiracy campaign-
ers can definitely find allies in developed countries in the debate on whether living organisms should
be patentable. There is much variation among industrialized countries on this topic as it is still highly
controversial.228
228
of Michigan Journal of Law Reform, 2006, Vol. 39, 517-520 and 532-534.
mental Law, 2008, Vol. 38, 352-354.
58
Chapter 11
European Union Initiatives
As mentioned before, the North-South divide (developed countries vs. developing countries) is slowly
eroding. Among industrialized countries especially the European Union is doing efforts to reform its
law and bring it more in line with the CBD. The European Union is not only member of the CBD, it also
signed the Nagoya Protocol on 23 June 2011. Currently the EU is working on the legislative process
to implement the protocol. The EU implementation of the protocol is planned to be completed in late
2014/early 2015.229
In 2011 and 2012 a consultation was held, an impact study conducted and then finally a draft
proposal released. End 2011, after signing the protocol, a public consultation was held among EU
stakeholders to explore the possible effects of the protocol.230 Then the Institute for European Envi-
ronmental Policy conducted a study to analyse legal and economic aspects of implementing the Nagoya
Protocol in the EU. The final report of the study was presented on 10 August 2012.231 On 4 October
2012 a ‘Proposal for a Regulation of the European Parliament and of the Council on Access to Genetic
Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union’
was submitted to the European Commission.
In July 2012 Catherine Grèze, responsible of the Development Committee, submitted a report on
the development aspects of intellectual property rights on genetic resources and more specifically the
impact IPRs have on poverty reduction in developing countries. After a discussion and voting pro-
cedure in the committee and in the European Parliament, the parliament adopted the report in the
form of a resolution on 15 January 2013.232 Although a resolution is merely a non-binding political
statement, the adopted resolution was welcomed as a strong signal of the EU’s commitment to tackle
biopiracy.
The resolution recalls the link between the protection of biodiversity and the realization of the
Millennium Development Goals, specifically the goal focused on the eradication of extreme poverty
and hunger. The resolution further “stresses the challenges that intellectual property rights over genetic
resources and traditional knowledge raise in developing countries in terms of access to medicine, produc-
tion of generic drugs and farmers’ access to seeds”. The EU and its member states are urged to ratify the
Nagoya Protocol as a first step in addressing the problem of biopiracy. The resolution acknowledges
229
European Commission, “Communication on the EU Strategy for Implementation of the Interna-
tional Regime on Access to Genetic Resources and Benefit-Sharing (Nagoya Protocol)”, July 2011,
http://ec.europa.eu/governance/impact/planned_ia/docs/2012_env_002_communication_abs_en.pdf.
230
European Commission, Environment, “Consultation”, http://ec.europa.eu/environment/consultations/abs_en.htm.
231
Institute for European Environmental Policy, Ecologic and GHK, “Executive Summary of the Final report for the Euro-
pean Commission, DG Environment”, Study to analyse legal and economic aspects of implementing the Nagoya Protocol on ABS
in the European Union, Brussels and London, Institute for European Environmental Policy, 2012, 1-2.
232
European Parliament Legislative Observatory, 2012/2135(INI), Development aspects of intellectual property rights on
genetic resources: the impact on poverty reduction in developing countries.
59
that there is no generally acceptable definition of the term ’biopiracy’, but refers to misappropriating
and/or illicitly benefiting commercially from the use of traditional knowledge and genetic resources.
To conclude the resolution suggests two measures necessary to tackle biopiracy: improving disclosure
requirements related to genetic resources and traditional knowledge and working towards a coherent
global governance system.233
The legislative proposal concerning implementation of the Nagoya Protocol is still awaiting its first
reading in the parliament. The proposal is now referred to the Economic and Social Committee and
the Committee of the Regions. On 10 July 2013 there is a vote scheduled in the committees and 22
October 2013 is set as an indicative plenary sitting date.234 The proposal aims to protect the rights of
indigenous communities and (mostly developing) countries that provide genetic resources and tradi-
tional knowledge, while giving European researchers and companies improved access to resources at
low cost with more legal certainty.235
The legislative proposal strives for an effective implementation of the Nagoya Protocol through a
set of rules for the users of genetic resources and associated traditional knowledge. Article 4 sets out
the main obligation for users.
“Article 4. Obligations of users.
1. They shall exercise due diligence to ascertain that genetic resources and traditional knowl-
edge associated with genetic resources used were accessed in accordance with applicable access
and benefit-sharing legislation or regulatory requirements and that, where relevant, benefits
are fairly and equitably shared upon mutually agreed terms. Users shall seek, keep, and
transfer to subsequent users information relevant for access and benefit-sharing.” 236
Given the diversity of users within the EU, the proposal doesn’t oblige all users to take the same
measures for exercising due diligence. Minimum features of due diligence measures are set out and
more specific measures are guided through the recognition of best practices.
The proposal further wants to establish an internet-based register of Union trusted collections.
Collections of genetic resources are major suppliers of genetic resources and traditional knowledge.
This register of collections would only include collections that supply samples which are legally ac-
quired with the establishment of mutually agreed terms. The system of Union trusted collections
should lower the risk that illegally acquired genetic resources are used in the EU and give the users of
resources more legal certainty.237
The success or failure of legal instruments is dependent on its enforcement. Article 7 of the pro-
posal sets out a system for monitoring compliance.
“Article 7. Monitoring user compliance.
1. Member States and the Commission shall request all recipients of public research funding
233
European Parliament resolution, 2012/2135(INI), 15 January 2013, Resolution on development aspects of intellectual
property rights on genetic resources: the impact on poverty reduction in developing countries.
234
European Parliament Legislative Observatory, 2012/0278(COD), Access to Genetic Resources and the Fair and Equitable
Sharing of Benefits Arising from their Utilization (Nagoya Protocol): Union Implementation and Ratification.
235
European Commission Press Release, “Environment: Commission Proposes Measures to Tackle ’Biopiracy’ and Facilitate
Nature-Based Research”, 4 October 2012, http://europa.eu/rapid/press-release_IP-12-1063_en.htm.
236
Article 4 and recital 14, Proposal for a Regulation, COM/2012/0576 final, 4 October 2012, Pro-
posal for a regulation of the European Parliament and of the Council on Access to Genetic Re-
sources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union, 2,
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.
237
Article 5 and recital 19, Proposal for a Regulation, COM/2012/0576 final, 4 October 2012, Pro-
60
involving uses of genetic resources and traditional knowledge associated with genetic resources
to declare that they will exercise due diligence in accordance with Article 4.
2. Users shall declare to the competent authorities established under Article 6(1) that they
exercised due diligence in accordance with Article 4 on the occasion of requesting market
approval for a product developed on the basis of genetic resources or traditional knowledge
associated with such resources, or at the time of commercialisation where a market approval
is not required. [. . . ]” 238
Article 9 states that competent authorities will carry out checks to verify if users comply with the
requirements set out in articles 4 and 7. Member states must provide rules on the penalties applicable
to breaches of articles 4 and 7 of the proposal, but have the discretion to determine what penalties
will apply. Article 11 proposes fines, immediate suspension of specific use activities or confiscation of
illegally acquired genetic resources. Any punishment must be effective, proportionate and dissuasive.
Article 15 confers the power to implement this proposal to the Commission.239
Prior informed consent is not mentioned very often. Users need to comply with the applicable
access and benefit-sharing legislation, which will often include prior informed consent, but it doesn’t
make a strong case for prior informed consent. The proposal follows the spirit of the Nagoya pro-
tocol in leaving the member states the discretion to decide on whether they wish to regulate access
and require prior informed consent and benefit-sharing to get access to genetic resources or not. The
proposal clarifies that it only applies to resources accessed after the entering into force of the Nagoya
Protocol. As the protocol is silent on its temporal scope, the EU proposal makes an explicit choice to
limit its temporal scope.240 The use of the term Ôdue diligenceÕ is slightly alarming. It only refers
to the intention of a user instead of imposing a strong obligation, but then again the proposal lists
requirements and compliance measures that nonetheless can make the regime a valuable ABS-regime.
On 20 March 2013 the Economic and Social Committee has given its opinion on the draft proposal
and on the 6th of May Committee on the Environment, Public Health and Food Safety has submit-
ted its report on the proposal. The Economic and Social Committee has noted that the proposal only
applies to genetic resources and traditional knowledge required after the entering into force of the
Nagoya Protocol. The committee regrets the failure to develop rules that apply to current use of ge-
netic resources and traditional knowledge which have already reached the EU without ABS treaties.
The Committee on the Environment, Public Health and Food Safety has proposed many amendments
to the proposal. It has stressed the importance of mentioning prior informed consent in the articles of
the regulation and to specifically prohibit biopiracy in its considerations. The report even suggests to
adapt the Directive to protect the environment through criminal law to include biopiracy as a criminal
offence, if committed intentionally or with serious negligence.241
238
Article 7, Proposal for a Regulation, COM/2012/0576 final, 4 October 2012, Proposal for a regulation of the European
Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from
their Utilization in the Union, 2, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.
239
Articles 9, 11 and 15, Proposal for a Regulation, COM/2012/0576 final, 4 October 2012, Proposal for a regulation of the Eu-
ropean Parliament and of the Council on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization in the Union, 2, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0576:FIN:EN:PDF.
240
Explanatory memorandum, Proposal for a Regulation, COM/2012/0576 final, 4 October 2012, Pro-
241
Opinion of the European Economic and Social Committee, CES2314/2012, 20 March 2013, Opinion of the European
Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council on Access
to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union.
Draft Report of the Committee on the Environment, Public Health and Food Safety, PE508.195, 6 May 2013, Draft Report on
the proposal for a regulation of the European Parliament and of the Council on Access to Genetic Resources and the Fair and
Equitable Sharing of Benefits Arising from their Utilization in the Union, 11, 28 and 34.
61
The real consequences this legislative proposal will have, will only become clear further down the
road. There are already quite some amendments proposed to the draft text and the proposal still needs
to make it through the parliament and council. Will lobby groups manage to impede the realization
of a law as happened so many times before on the international level? Will the increasingly negative
public opinion, spurred by examples as the practices of Monsanto, will be convincing enough to get
this proposal through the legislative proposal? It seems like the EU is committed to take serious action
against biopiracy. The proposal is a very promising step forward. However, it is necessary to remain
cautious. Time will tell if the EU is in it for real this time.
62
Chapter 12
Using Patent Law to Protect Traditional

Knowledge
This chapter will look at an approach to resolve the problem of biopiracy from within the international
patent system. A limited group believes that biopiracy will eventually be prohibited under interna-
tional customary law as a form of regular piracy. However, that view is not supported by international
practice, nor is biopiracy recognized as a crime by international law.242 At the international level a
much better approach would be to work within the international patent system. This chapter will
examine how the language and concepts of the international patent regime could be used to achieve
the goals of the CBD.243 International intellectual property law is an important tool of political econ-
omy. The existence of multiple institutions dealing with it is an advantage to achieve changes. The
possibility to work in different forums exists, so one just has to find the most effective way to reach a
result.244
Currently major industrialized states (and regions) such as the US and EU apply a low threshold
for protection on intellectual property. That means that their patent offices easily grant patents and
courts are becoming the arbiters of patentability. In the last two decades there have been many cases
such as the ones concerning the neem tree and the enola bean (see supra Part I, Chapter 3). Putting the
threshold for intellectual property protection higher can be justified on the ground of more certainty
for the biotechnology sector.245
The resources of indigenous communities are usually existing plant material or traditional knowl-
edge about plants, but the current intellectual property regime only protects new inventions. That is
why the IPR system offers little help for biopiracy. Some IPR tools could potentially protect the rights
of indigenous communities. Copyright protection applies to writing and artwork so it could protect
traditional cultural elements, but a copyright is attributed to an individual (not to groups) and is limited
in time. Trade secret law is a good option to protect the cultural heritage and traditional knowledge of
indigenous communities if the community is able to conceal its knowledge. If knowledge is communal,
and thus not secret anymore, it is not protectable as a trade secret. The IPR regime offers no protection
for most of the existing knowledge and resources of indigenous communities.246
242
nal of Food Law and Policy 2012, 85.
243
I. MGBEOJI, “Patents and Traditional Knowledge of the Uses of Plants: Is a Communal Patent Regime Part of the Solution
to the Scourge of Bio Piracy?”, Indiana Journal of Global Legal Studies, 2001-2002, Vol. 9, 165.
244
245
246
63
Working from within the intellectual property regime, two categories of protection can be awarded.
A first category, defensive protection, creates new intellectual property rights for the holders of tradi-
tional knowledge and genetic resources. Indigenous communities can then enforce these intellectual
property rights against others trying to use their knowledge or resources. However, as some scholars
have remarked, imposing western notions of property on indigenous communities might not serve
their best interests.247 Indigenous communities might have a different notion of property. Moreover,
many of them won’t have the means to enforce their intellectual property rights, nor the knowledge
on how to fight a breach of their IPRs. A second, more appropriate, form of protection is positive pro-
tection. Positive protection awards holders of traditional knowledge and genetic resources the benefits
from the commercialization of their knowledge. The following pages of this chapter will explore the
possibilities to award indigenous communities the benefits of their resources and knowledge.248
12.1 A Mandatory Disclosure Requirement

Introducing a mandatory disclosure requirement to protect the rights of indigenous communities is one
of the most controversial intellectual property-related measures against biopiracy. This requirement
would make the disclosure of certain information a condition to obtain a patent. A patent applicant
would then be obliged to give this information. The establishment of a mandatory disclosure require-
ment would provide a mechanism to ensure compliance with the provisions of the Convention on
Biological Diversity, specifically with the national sovereignty principle, prior informed consent re-
quirement and the sharing of benefits.249
Not all the proposals of a mandatory disclosure requirement envision the same goal. In general, a
disclosure requirement is suggested with one of these three different functions:
! A first disclosure requirement that has been proposed obliges to disclose any genetic resource or
traditional knowledge used in the development of an invention. This way the requirement has a
descriptive or transparency function.
! A more comprehensive obligation demands disclosure of prior informed consent, access on

mutually agreed terms or benefit-sharing agreements. These more extensive disclosure re-
quirements are seen as a possibility to monitor compliance with the Convention on Biological
Diversity. Understood like this, the requirement has a compliance function. It can be used to
oblige patent applicants to give evidence that they complied with the governing rules.
! The most commonly discussed requirement entails the disclosure of the geographical origin of
the genetic resources or traditional knowledge. This can be aimed at the country, but also at a
more specific location. This ensures that genetic resources can be accessed to reproduce the in-
vention, but also reveals the source of knowledge or resources for benefit-sharing or determining
the jurisdiction which applies to the resources.250
Developing countries have since long advocated for disclosure requirement to realize the goals of
the Convention on Biological Diversity. The Bonn Guidelines adopted by the CBD’s Conference of the
Parties in 2002 recommended to use patent applications to monitor compliance with the access and
mental Law, 2008, Vol. 38, 339-340.
247
248
249
B. LU, "Disclosure Requirements for Patent Application: Article 29 of the TRIPS Agreement and a Dimensional Explo-
ration", European Intellectual Property Review, 2012, Vol. 34(5), 341-342.
250
WIPO, “Technical Study on Disclosure Requirements Related to Genetic Resources and Traditional Knowledge”,
UNEP/CBD/COP/1/INF/17, 2003, 4.
64
prior informed consent rules of the CBD.251 However, until now industrialized countries have always
opposed the introduction of a mandatory disclosure requirement. Various proposals have been submit-
ted, mainly to the WTO and the WIPO, and the discussion is ongoing in multiple international forums.
Until now the negotiating countries haven’t managed to reach a consensus.
There are four ways through which a disclosure requirement can be introduced. A first possibility
is to leave it to the discretion of national authorities. A second possibility is to introduce a disclosure
requirement, but realize its enforcement outside the scope of patent law. The third and fourth path
both seek to introduce a disclosure requirement in international patent law. The current international
regime concerning intellectual property protection already has some provisions that ask for the disclo-
sure of origin. However, these have limited effects or are not mandatory. On the regional and national
level there are some disclosure provisions as well, but they vary greatly. Some are mandatory, some are
just an encouragement and nothing more.252 Some countries seek to establish a disclosure requirement
through the WTO, others address the WIPO.
12.1.1 National Legislation

Industrialized countries generally prefer the use of national legislation to determine patent applica-
tion requirements. This is far from surprising. These countries are not in favour of introducing new
requirements and in domestic law they are free to do as they please. Rather than disclosure require-
ments, they propose contracts to enter into benefit-sharing agreements and realize the goals of the
CBD. The US has argued that the best approach to realize the CBD’s objectives is through national
laws and contracts which include a commitment on disclosure.253
To ensure the enforcement of a disclosure requirement, grave consequences need to be linked to

violations. The most effective measures are the rejection or revocation of a patent in case of non-
compliance. Currently, the Andean Pact, Costa Rica, Brazil and India refuse to grant a patent if the
geographical origin and/or prior informed consent are not disclosed.254 However, other regimes con-
nect less discouraging consequences to disclosure requirements or merely encourage disclosure (the
current European regime). In short, there is much variety among national laws concerning disclosure
requirements.
The difference among the applicable laws on genetic resources is big and this creates a complex
regime. Often resources are used transboundary. Then the country providing the resources has to rely
on the country in which the resources are used to take measures to ensure that its laws are followed.
As a national law is only applicable on the territory of the country, transnational actions are com-
plicated and companies and researchers face a complex labyrinth of requirements.255 The complexity
of enforcement of disclosure requirements defined differently in every country is a major obstacle.
Therefore national law is not an effective tool to establish a mandatory disclosure requirement.
251
252
H. BAUMŰLLER and D. VIVAS-EUGUI, “Towards Effective Disclosure of Origin Ð The Role of the International ABS
Regime”, ICTSD Bridges, 2004, No. 4, 21.
253
World Trade Organization, “TRIPS Reviews, Article 27.3(b) and Related Issues: Background and the Current Situation:
The Debate”, http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.
254
E. C. KAMAU, “Disclosure Requirement Ð A Critical Appraisal” in E. C. KAMAU and G. WINTER (eds.), Genetic Re-
sources, Traditional Knowledge and the Law: Solutions for Access and Benefit Sharing, Earthscan, 2009, 408-409.
255
H. BAUMŰLLER and D. VIVAS-EUGUI, “Towards Effective Disclosure of Origin — The Role of the International ABS
Regime”, ICTSD Bridges, 2004, No. 4, 21.
65
12.1.2 Disclosure outside Patent Law
Currently, the EU regime dealing with patent on biotechnological inventions merely encourages the
disclosure of origin. The proposal to implement the Nagoya Protocol will establish a mandatory disclo-
sure requirement. A user of genetic resources or traditional knowledge will be obliged to disclose the
origin of the resources and to declare that due diligence was exercised to access the resources and that
where relevant benefits were shared. The legal consequences of non-compliance with this disclosure
requirement are outside the scope of patent law. The proposal leaves discretion to national authorities
to determine the applicable penalty, but proposes fines, suspension of activity or confiscation of the
illegally acquired resources. None of the measures relates to the patent procedure.256
The problem is that consequences outside the scope of patent law will have much less effect. If
obtaining and keeping a patent is made conditional of fulfilling a disclosure requirement the incentive
for compliance is big. Penalties not relating to the patent will oblige patent applicants way less to com-
ply. If a fine is less expensive than acquiring legal access and prior informed consent to resources and
entering into a benefit-sharing agreement, there is even an economic incentive to continue committing
biopiracy. In a resolution adopted in January 2013 the European Parliament has stated it “considers it
crucial to establish mandatory requirements on disclosing the origin of genetic resources during patent
proceedings”. The parliament encourages an amendment of the TRIPS Agreement or a WIPO treaty
to establish an international mandatory disclosure requirement. When such a requirement will be
introduced, its effectiveness will depend on its compliance measures. The most effective compliance
measures are the ones relating to the granting of a patent.257
12.1.3 Disclosure as a TRIPS Obligation

Incorporation of a disclosure requirement in the TRIPS Agreement would ensure compliance with the
provisions of the Convention on Biological Diversity. The big advantage of the TRIPS Agreement is
that it is a binding agreement with a very effective enforcement mechanism (its dispute settlement sys-
tem that can issue trade sanctions). However, the WTO also comes with a substantive obstacle. In the
WTO industrialized countries have an important influence and these countries generally don’t want
the establishment of extra patent requirements. This makes an amendment of the TRIPS Agreement
the most interesting option to establish a change, but also the most difficult to realize.
The negotiation of a disclosure requirement for genetic resources in patent applications is one of
the main issues in international intellectual property law and in the WTO negotiations. Since the
Doha Round the WTO negotiations have been blocked to a large extent due to the conflicting demands
of developed and developing countries. Although there are serious obstacles, the unresolved issues
such as a disclosure requirement for genetic resources are still on the WTO agenda. The members in
favour of a disclosure requirement have proposed the disclosure of the origin of biological resources
and knowledge used, evidence of prior informed consent and evidence of benefit-sharing. Other mem-
bers such as the US, Canada and Japan oppose the use of a disclosure requirement to realize the goals
of the Convention on Biological Diversity.258
In 2005 a group of developing countries has showed its desire to include a mandatory disclosure
requirement in the TRIPS Agreement. The group was represented by Brazil and India and included Bo-
livia, Colombia, Cuba, Dominican Republic, Ecuador, Peru, Thailand and had the support of the African
groups and some other developing countries. They wanted a patent application to disclose three things:
256
257
258
66
the origin of the genetic resources or traditional knowledge used, evidence of prior informed consent
and evidence of fair and equitable benefit-sharing.259 The disclosure of origin requirement discloses
information relevant to prior art and is used this way to combat biopiracy. Requiring evidence of prior
informed consent and benefit-sharing is meant to ensure compliance with the Convention on Biologi-
cal Diversity.260 In July 2008 a group of WTO members submitted a proposal to discuss the disclosure
requirement together with two geographical indications issues.261 So the issue is still on the WTO
agenda, but the member states have not managed to reach a consensus on it yet.
Three options have been proposed to amend the TRIPS Agreement. The first suggestion is to add
an exception to the existing exceptions of patentability under article 27. The new exception would
come under paragraph 3:
3. “Members may also exclude from patentability:
c) products or processes which directly or indirectly include genetic resources or traditional

knowledge obtained in the absence of compliance with international and national leg-
islation on the subject, including failure to obtain the prior informed consent of the
country of origin or the community concerned and failure to reach agreement on condi-
tions for the fair and equitable sharing of benefits arising from their use. Nothing in the
TRIPS shall prevent Members from adopting enforcement measures in their domestic leg-
islation, in accordance with the principles and obligations enshrined in the Convention
on Biological Diversity.” 262
According to some scholars article 29 of the TRIPS Agreement would be the most appropriate article
to introduce a disclosure of origin requirement.
“Article 29: Conditions on Patent Applicants
1. Members shall require that an applicant for a patent shall disclose the invention in a
manner sufficiently clear and complete for the invention to be carried out by a person
skilled in the art and may require the applicant to indicate the best mode for carrying
out the invention known to the inventor at the filing date or, where priority is claimed,
at the priority date of the application.
2. Members may require an applicant for a patent to provide information concerning the
applicant’s corresponding foreign applications and grants.” 263
Developing countries have proposed to insert a new article 29bis for the disclosure of origin. The
European Parliament has expressed its support for this request in the resolution adopted in January
259
Council for Trade-Related Aspects of Intellectual Property Rights, Submission from Bolivia et al., “The Relationship Be-
tween the TRIPS Agreement and the Convention on Biological Diversity (CBD) and the Protection of Traditional Knowledge,
Elements of the Obligation to Disclose Evidence of Benefit-Sharing under the Relevant National Regime”, IP/C/W/442, 18
March 2005.
World Trade Organization, “TRIPS Reviews, Article 27.3(b) and Related Issues: Background and the Current Situation: The
Debate”,
http://www.wto.org/english/tratop_e/trips_e/art27_3b_background_e.htm.
260
261
262
Council for Trade-Related Aspects of Intellectual Property Rights, Communication from Peru, “Article 27.3(b), Relation-
ship Between the TRIPS Agreement and the CBD and the Protection of Traditional Knowledge and Folklore”, IP/C/W/447, 8
June 2005.
J. CARR, “Agreements That Divide: TRIPS vs. CBD and Proposals for Mandatory Disclosure of Source and Origin of Genetic
Resources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 140-141.
263
Article 29, Agreement on Trade-Related Aspects of Intellectual Property Rights, Annex 1C to the Marrakech Agreement
Establishing the World Trade Organization, 15 April 1994.
67
2013.264 Another option proposed is to issue an authoritative interpretation of article 29 TRIPS.265 Var-
ious options are possible, but it is clear that articles 27 and 29 are the articles best suited to introduce
a disclosure requirement.
The introduction of a disclosure requirement in the TRIPS Agreement is a controversial issue both
among scholars and states. Some even argue that the TRIPS Agreement sets out minimum standards
and thus, no additional requirements are allowed. The US has stated that an additional substantive re-
quirement of patentability would be incompatible with the TRIPS Agreement. Industrialized countries
have also argued that a the proposed disclosure requirement is not sufficiently linked to the inven-
tion to be of importance for patentability. The obligation to disclose information on all the genetic
resources simply used at a certain point in the development would create an unproportional admin-
istrative burden on patent offices. Some countries such as the US advocate the use of contracts for
benefit-sharing. However, developing countries judge this to be an incomplete solution.266 It doesn’t
look like a consensus is soon to be reached.
12.1.4 Disclosure through the WIPO

Another often suggested way to introduce a disclosure requirement is through the World Intellec-
tual Property Organization. Even within the WIPO different places for discussion have been proposed.
Some see WIPO’s Patent Cooperation Treaty (PCT) fit for the introduction of a disclosure requirement.
Others prefer the discussion to be held in the Intergovernmental Committee on Intellectual Property
and Genetic Resources, Traditional Knowledge and Folklore (IGC). Again others think the negotiations
on the Substantive Patent Law Treaty (SPTL) are the most appropriate venue for a disclosure require-
ment.
Cuba is strongly in favour of an amendment to WIPO’s Patent Cooperation Treaty (PCT). The
disclosure requirement proposed would be similar to the proposed change in the TRIPS Agreement.
Switzerland has proposed that the amendment would allow optional participation so national authori-
ties can decide to slowly incorporate the obligation in domestic law for. Switzerland has also asked the
disclosure to be a formal requirement for the patent application, but not a substantive one. A granted
patent would then only be revoked if a failure to disclose was based on fraudulent intent. The proposal
for a disclosure requirement in the PCT would only apply to inventions directly based on a specific ge-
netic resource. Thus, disclosure for every biological resource used somewhere along the development
procedure would not be required.267
264
265
266
267
Resources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 142.
68
Some countries think the IGC is a more appropriate venue to discuss the establishment of a disclo-
sure requirement. The proposal submitted in the IGC is essentially the same as the one submitted to
amend the PCT. Since 2001 a new international legal instrument is being negotiated in the WIPO, the
Substantive Patent Law Treaty (SPTL). This could prove a good opportunity to establish a mandatory
disclosure requirement. In the draft text of the SPTL a disclosure requirement for patents is allowed,
but it is not mandatory for countries to ensure disclosure. However, the last SPTL negotiations have
failed in 2006 and since then the creation and even further negotiations of the SPTL have been put on
hold until further notice.268
In June 2009 the African group submitted a proposal to WIPO’s IGC to give a new incentive for
discussion and break the stagnant situation. The proposal was submitted to the 14th session of the IGC.
The African group first gave a summary of the general views of the WIPO members and mentioned
the unresolved issues such as a definition of traditional knowledge, who should be the beneficiary
of protection and whether an international instrument is really needed. The African group further
proposed to work toward a legally binding international instrument for the protection of traditional
knowledge.269
The issue of a disclosure requirement is still being discussed in the IGC. In 2002 the Conference
of the Parties of the Convention on Biological Diversity asked the IGC to conduct a study on methods
within the patent system for requiring disclosure.270 Many countries have already submitted propos-
als and remarks. From a recent document it is clear that the IGC is still working on draft articles for
introducing a disclosure requirement.271 However, so far no real progress has been made.
The proposals to introduce a mandatory disclosure requirement are quite popular taken into ac-
count all the CBD, WTO and WIPO members. However, caution is necessary. The goal of the disclosure
requirement is to introduce an ABS regime into patent law, while the essence of ABS lies outside the
scope of a patent. If a disclosure requirement would be introduced, it will be of crucial importance
that the requirement is very clear and has a clearly defined scope of application. If not, it could create
uncertainties in the patent system, reduce the value of patents and ultimately discourage research and
development. The proposals to introduce a disclosure requirement need to be studied from a tech-
nical perspective outside of the political debate. A disclosure requirement would only truly create a
better ABS regime and prevent biopiracy if it is complemented by effective national systems and the
use of contractual benefit-sharing agreements.272 A mandatory disclosure requirement would mean an
important step forward, but only if done in a correct way.
268
Resources in Patent Applications”, Journal of Transnational Law and Policy, 2008, Vol. 18(1), 143.
269
J. J. OSEITUTU, “A Sui Generis Regime for Traditional Knowledge: The Cultural Divide in Intellectual Property Law”,
Marquette Intellectual Property Law Review, 2011, Vol. 15, 173.
270
World Intellectual Property Organization, “WIPO Process Regarding an Invitation by the Convention on Bi-
ological Diversity on Access to Genetic Resources and Disclosure Requirements in IP Rights Applications”,
http://www.wipo.int/tk/en/genetic/proposals/.
271
WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folk-
lore, “Consolidated Document Relating to Intellectual Property and Genetic Resources, Rev. 2”, 8 February 2013,
http://www.wipo.int/edocs/mdocs/tk/en/wipo_grtkf_ic_23/wipo_grtkf_ic_23_www_230222.pdf.
272
D. KEATING, “Access to Genetic Resources and Equitable Benefit Sharing Through a New Disclosure Requirement in
the Patent System: an Issue in Search of a Forum”, Journal of the Patent and Trademark Office Society, 2005, Vol. 87, 530-531.
69
12.2 Prior Art and Digital Databases of Traditional Knowledge
Traditional knowledge of indigenous communities is very dispersed. Often it is difficult to identify
the owner of specific knowledge and to assign the rights over specific knowledge within or between
groups.273 Sometimes there is intangible, but real cultural harm in patenting traditional knowledge
without consent. Patent law is a system based on private ownership of knowledge. However, some
cultures forbid private ownership of knowledge that is of importance for the community.274 A database
of traditional knowledge would facilitate access and benefit-sharing considerably and prevent the er-
roneous granting of patents.
In order to be viable for a patent, an invention must be novel and non-obvious. That is why patent
offices do a prior art search. If prior art exists, then almost automatically a lack of novelty and obvi-
ousness are presumed. There is a tight correlation between those three concepts.275 The existence of a
database would facilitate the search for prior art and thus prevent that patents are granted erroneously.
The only international database for traditional knowledge is the Indigenous Knowledge Database com-
piled by the World Bank.276 Both India and the Republic of Korea have a national digital database of
traditional knowledge. The WIPO has a portal of online databases and registries of traditional knowl-
edge and genetic resources.277 National patent offices can easily search for the existence of prior art
this way.
On this matter, the interpretation of prior art used by the US needs to be mentioned. The US
doesn’t consider prior art from outside the US if it is not proven by written documentation (supra Part
I, Chapter 3). Considering the world is more and more globalized, this is an anachronistic interpre-
tation. Out of fairness a broader interpretation should be adopted. Of course the establishment of
databases provides more written documentation and will also help to resolve this unfair element in the
US patent application process.
For genetic resources there is an extensive digital database compiled by the Consultative Group on
International Agricultural Research (CGIAR). The database gives all the available information on the
genetic resources stored in the gene banks of the CGIAR. This is especially helpful for research and
development.278 In March 2013 Canada, Japan, the Republic of Korea and the US submitted a recom-
mendation to the IGC of the WIPO on the use of databases. The recommendation requests that every
WIPO member would possess a searchable database of genetic resources and traditional knowledge.
The requesting countries state that this would facilitate prior art searches and consequently address
the erroneous granting of patents.279
273
274
mental Law, 2008, Vol. 38, 333.
275
276
World Bank, Database of Indigenous Knowledge and Practices, http://www.worldbank.org/afr/ik/datab.htm.
277
World Intellectual Property Organization, “Portal of Online Databases and Registries of Traditional Knowledge and Ge-
netic Resources, http://www.wipo.int/tk/en/databases/tkportal/.
Council of Scientific and Industrial Research, Traditional Knowledge Digital Library (TKDL) of Ayurveda,
http://www.csir.res.in/External/Utilities/Frames/career/main_page1.asp?a=tkdl_topframe.htm&b=tkdl_left
.htm&c=../../../Heads/TKDL/main.htm.
Korean Traditional Knowledge Portal, http://www.koreantk.com/en/JZ0100.jsp.
278
Consultative Group on International Agricultural Research (CGIAR), System-wide Informational Network for Genetic
Resources (SINGER), http://www.genesys-pgr.org/.
279
WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folk-
lore, Submission of Canada, Japan, the Republic of Korea and the United States of America, “Joint Recommendation on the
Use of Databases for the Defensive Protection of Genetic Resources and Traditional Knowledge Associated with Genetic
Resources”, WIPO/GRTKF/IC/24/7, 28 March 2013.
70
Chapter 13
Alternatives
Of course patent law is not the only option to search for a solution to biopiracy, there are alternatives.
In reality companies don’t start to search nature randomly to find useful resources. They work with
research leads that significantly reduce the amount of time and money for searching. Those research
leads are often provided by local or indigenous communities.280 Maybe a solution for the fair and eq-
uitable sharing of benefits can be found by bringing these two actors together, not necessarily through
patent law obligations.
Public-private partnerships could provide a solution for the problems arising from bioprospecting
and biopiracy. If corporations act ethically and provide compensation for the traditional knowledge or
natural resources used as part of a partnership with an indigenous community, these indigenous com-
munities will benefit economically. If their economic position improves, they can be a possible market
for the company to sell their manufactured products. Hence the investment can pay off. Corporations
can provide education and infrastructure to local communities which can result in closer relationships.
To assure that this all happens fairly, it is important that there is a third partner involved from the
civil society or academic world.281 A very good example is the partnership between Merck and INBio
(supra Part II, Chapter 6).
However, it seems that private corporations will need stronger incentives to start a more ethical
way of gathering their resources. More transparency can possibly provide incentives for good be-
haviour and voluntary cooperation. Transparency alone won’t do the trick, an effective system of
accountability is needed too. Punishment for non-compliance to the rules is exactly what the existing
conventions and protocols lack.282
Academic Peter Drahos has proposed a creative non-intellectual property solution, the creation of
a global bio-collecting society. It would be a private organization outside the context of any treaty
negotiation. He argues that an international organization will most likely serve the interests of indige-
nous groups better than state organizations. The global biocollecting society would be funded by the
World Bank. The society would act as a repository for community registers of indigenous knowledge
and provide assistance in contractual negotiations between indigenous communities and a third party.
The society would also have a monitoring service for the use of indigenous knowledge and a dispute
resolution system. This would give companies legal certainty over the use of genetic resources and it
280
533-534.
281
Journal of Commercial Biotechnology, 2011, Vol. 17(3), 250-251.
282
T. A. KURSAR, “What are the Implications of the Nagoya Protocol for Research on Biodiversity?”, BioScience, 2011, Vol.
61(4), 257.
71
would help resolve the free-riding behavior that now causes biopiracy.283
The question is: what will companies be willing to pay to receive knowledge from this institution?
Drahos has designed a complex mechanism of compensation for those who contribute knowledge to
the global bio-collecting society.284 It is a quite complicated construction and probably companies
will be more inclined to enter in a public-private partnership than to cooperate with this society.
Nevertheless it is an interesting thinking exercise.
283
DRAHOS, P., “Indigenous Kowledge, Intellectual Property and Biopiracy: Is a Global Biocollecting Society the Answer?”,
EIPR 2000, Vol. 22 (6), 248-250.
284
539-540.
72
Chapter 14
The objective of this part of the dissertation has been to seek a way out of the current impasse in inter-
national negotiations towards a better protection of the genetic resources and traditional knowledge
of developing countries and indigenous communities. International negotiations are taking place at
various venues and those discussions are not focused on finding a remedy for biopiracy, but address
a wide array of issues. Therefore it was necessary to limit this section to the discussions the author
of this dissertation believes to be key elements on the road to a remedy. This section has strived to
offer an overview of the current status of discussion on these key issues and the way they should move
forward. To address the problem of biopiracy in an adequate manner certain measures should be taken.
First of all, a more constructive rhetoric should be adopted. Even the name of the phenomenon,
biopiracy, is a very negative term. Although what is happening doesn’t feel morally correct, there
are always two sides to a story. The issue of biopiracy is more complex than what some activists are
describing. On a politically sensitive matter it is not a good idea to turn the other party into an ad-
versary from the start. The blaming of industrialized countries’ government should stop and a more
constructive discussion should be started. That can be done by focusing on the importance of preserv-
ing biodiversity and the cooperation that is possible. A different vocabulary sure won’t be a magic
solution for the problems, but it could ease the negotiations.
Secondly, the implementation of the Nagoya Protocol is an important step forward. The European
Union is currently debating a legislative proposal to do so. Not only is it important to implement
the protocol in domestic law, the way it is done is even more important. Just like all the previous
international instruments, the Nagoya Protocol heavily relies on strong implementation by national
(or regional in the case of the EU) authorities. The EU’s implementation is a very interesting exam-
ple since it consists of developed countries and only relatively recent started to support a reform of
its patent law. The EU seems to have taken up a strong commitment, but there are already some
improvements suggested for the legislative proposal. Imposing strong obligations is key, as history
has shown that soft law guidelines and recommendation haven’t realized much. As for the EU, it will
be interesting to see the final text of the legislation and see how the result of implementation turns out.
Thirdly, certain changes to patent law could provide a substantial change. The European proposal
establishes a mandatory disclosure requirement. Many states agree that this is the way to proceed. A
disclosure requirement can be used to monitor if access legislation and prior informed consent were re-
spected and if benefits are shared in a fair and equitable way. The EU has connected a failure to disclose
to consequences outside patent law (fines, confiscation of resources). The most effective enforcement
would be to make disclosure a condition for obtaining a patent. However, many states disagree on
which consequences to connect to failure to disclose and on where to negotiate such an obligation.
73
Although a mandatory disclosure requirement is indeed a very good approach to monitor compli-
ance and remedy biopiracy, not just any disclosure requirement will do that. It is essential to study the
possible implications for research and development and to develop a regulation that would not impede
science or only in the most limited form possible. A disclosure requirement could have negative effects
on technological advancement and that should be prevented. True progress on this issue should come
from a combination of an effective mandatory disclosure requirement and public-private partnerships
supported with databases on genetic resources and traditional knowledge. Public-private partnerships
provide an mutually beneficial cooperation between indigenous communities and companies when ef-
fected good. Biopiracy is a very complex problem, so its remedy won’t be easy. It is mainly a question
of effective international legislation so national governments will be obliged to implement effective
obligations and provide incentives for technological companies to cooperate with developing nations
and their local communities. A combination of disclosure requirements and mutually beneficial con-
tractual agreements will bring a remedy much closer.
74
Conclusion
This dissertation has strived to provide the reader with a nuanced context for the problem of biopiracy,
a full legal analysis of its legal framework and suggestions for a remedy. Currently the legal instru-
ments protecting the holders of genetic resources and traditional knowledge are not efficiently imple-
mented and as a consequence have little effect. That is why biopiracy continues to happen.
In the first and introductory part of this dissertation, the concept of biopiracy was explained and
put into a nuanced context by giving voice to the different perspectives on the issue. Not only is there
controversy on how to address the problem of biopiracy, there is not even a consensus on the exis-
tence of the problem and on a definition for the term. Within the scope of this thesis biopiracy can be
defined as the use of intellectual property systems (mostly through patents) to legitimize the exclusive
ownership and control over biological resources and/or associated traditional knowledge appropriated
without adequate authorization and/or benefit-sharing from other (usually developing) countries and
indigenous or local communities.
History shows that the growing expansion of technology was pushed by developed countries to
protect their technological knowledge and culminated in the adoption of minimum standards for patent
law in the WTO TRIPS Agreement. Efforts of the much weaker developing nations to address the neg-
ative effects of IPRs on developing countries and their biodiversity have been much less effective.
However, the tide is turning. The neem tree case provided the first victory in a biopiracy case before
the European Patent Office in 2005. Although the European Union seems to have taken up the commit-
ment to adjust the negative side effects of international patent law, this attitude can’t be generalized
for all industrialized countries. For example the US continues to oppose reforms of international intel-
lectual property law strongly. The difference of mentality of the European and the American patent
authorities can clearly be spotted in case law.
The first part being an introductory section, the focal point of this dissertation resides in its second
and third part. The second part has offered an extensive inquiry on the international legal agreements
that affect biopiracy, the two main instruments being the TRIPS Agreement and the Convention on Bi-
ological Diversity. The third part then builds upon the second part by providing suggestions to remedy
the current impasse in international negotiations and address the problem of biopiracy by effectively
protecting the holders of genetic resources and traditional knowledge.
The two most influential international institutions in the field of patent law are the WIPO and
the WTO. WIPO has done a great deal of work in harmonizing the formal procedure of patent appli-
cations. However, its efforts to harmonize substantive issue by developing a Substantive Patent Law
Treaty have been put on hold since 2006 due to a lack of consensus. The WTO has managed to im-
plement minimum standards of intellectual property protection through the TRIPS Agreement. Non-
compliance can result in trade sanctions so countries prefer to abide by its provisions. Especially its
article 27 is very controversial because it establishes a very broad interpretation of what is patentable
that extends to living organisms and obliges countries to provide intellectual property protection for
micro-organisms, non-biological processes and plant varieties.
75
The growing concern for the disappearance of biodiversity has resulted in the adoption of the
Convention on Biological Diversity. The convention aims to promote the conservation of biological
diversity, the sustainable use of the components of biological diversity and access to genetic resources
and fair and equitable sharing of benefits arising from their utilisation. Its text truly proves that the
establishment of the CBD was a compromise to the competing claims of developed and developing
countries. As a result the convention has no teeth. It is plagued by vague concepts and soft law rec-
ommendations. It is not surprising that the convention has not brought about big changes in reality.
Nonetheless, it has marked a shift in mentality and provides a base for developing countries to back
up their demands.
The TRIPS Agreement and CBD promote objectives that are on opposite sides of a spectrum. In
many WTO Conferences and Conferences of the Parties to the CBD, states have tried to align their
interests and change the existing agreements to make them more mutually supportive. However, apart
from some small accomplishments and a lot of good intentions, no real changes have been realized.
The TRIPS Agreement has teeth and the CBD lacks compliance mechanisms so intellectual property
has primacy over biodiversity and biopiracy concerns. In 2010 the Nagoya Protocol was adopted to
establish a more effective access and benefit-sharing regime. The protocol has not entered into force
yet, so only time can tell what its real consequences will be. However, the protocol relies heavily on
implementation of national authorities just like the CBD. It is questionable whether a lot of states will
commit themselves to effectively enforce the Nagoya Protocol.
In the third and final part, suggestions have been made to remedy the negative effects of biopiracy.
From a diplomatic point of view, the current rhetoric used to negotiate a solution for biopiracy is not
such a good strategy. The practice of blaming should be abandoned and common grounds should
be sought to create a constructive atmosphere for further negotiations. For an effective remedy to
biopiracy, the last part of this dissertation suggests three measures that would bring about progress:
a mandatory disclosure requirement, more extensive databases of genetic resources and traditional
knowledge and public-private agreements.
A mandatory disclosure requirement could be used to monitor compliance with the CBD and rem-
edy biopiracy. However, it is important to study its effects on technological research and development
and consider thoroughly the scope of the disclosure requirement. The best way to enforce a disclosure
requirement effectively is to make it a condition for obtaining a patent. The possible revocation of a
patent is sufficiently discouraging for patent applicants to comply with the requirement. The second
tool for a remedy, databases of genetic resources and traditional knowledge, would make a prior art
search much easier for patent offices. The better prior art searches can be conducted, the less patents
will be granted erroneously. The third measure suggested is promoting public-private agreements be-
tween companies and developing nations or indigenous communities. Whereas a mandatory disclosure
requirement prevents abuse and databases prevent the erroneous granting of patents, benefit-sharing
agreements offer the solution for the core of the problem. Through mutually beneficial contracts be-
tween companies and indigenous communities, these communities would finally get the compensation
they deserve and implicitly give their authorization to a company. The combination of these three mea-
sures could provide real progress.
In conclusion, this dissertation has aimed to provide a legal perspective on the issue of biopiracy
and suggest measures to remedy the problem. Biopiracy is a complex issue and it is the author’s
belief that a consensus in the international community is still far away. This thesis has undertaken an
attempt to provide the reader with a better understanding of the clash between intellectual property
on the one hand and biodiversity and local communities on the other hand. It is the author’s hope that
this dissertation has shed a new light on the topic of biopiracy and has given the reader some food for
thought.
76
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Summary Table of Membership of the World Intellectual Property Organization (WIPO) and the
Treaties Administered by WIPO, plus UPOV, WTO and UN
STATES W P B PCT PLT MI MM MP H GH N LI RO LO IPC PH VC BP S NOS TLT W CT W PPT WAS SG BEIJING UN U W TO
Afghanistan X 1 X
Albania X X X X X X X X X X X X X X X X 16 X X X
Algeria X X X X X X X X X X 10 X
Andorra X X X X 4 X
Angola X X X 3 X X
Antigua and X X X X X 5 X X
Barbuda
Argentina X X X X X X X X X X X 11 X X X
Armenia X X X X X X X X X X X X X X X X X X 18 X X
Australia X X X X X X X X X X X X X X X X 16 X X X
Austria X X X X X X X X X X X X X X X X 16 X X X
Azerbaijan X X X X X X X X X X X X X X X X X 17 X X
Bahamas X X X 3 X
Bahrain X X X X X X X X X X X X X 13 X X
Bangladesh X X X 3 X X
Barbados X X X X X X X X 8 X X
Belarus X X X X X X X X X X X X X X X 15 X X
Belgium X X X X X X X X X X X X X X X 15 X X X
Belize X X X X X 5 X X
Benin X X X X X X X X X 9 X X
Bhutan X X X X X 5 X
Bolivia X X X X X 5 X X X
(Plurinational
State of)
Bosnia and X X X X X X X X X X X X X X X X X X X X X X X 23 X
Herzegovina
Botswana X X X X X X X X X 9 X X
Brazil X X X X X X X X X 9 X X X
Brunei X X X X X 5 X X
Darussalam
Bulgaria X X X X X X X X X X X X X X X X X X X X X 21 X X X
Burkina Faso X X X X X X X X X X 10 X X
Burundi X X 2 X X
Cambodia X X 2 X X
Cameroon X X X X 4 X X
Canada X X X X X X X 7 X X X
Cape Verde X X X 3 X X
Central X X X X 4 X X
African
Republic
Chad X X X X 4 X X
Chile X X X X X X X X X X X X 12 X X X
China X X X X X X X X X X X X X 13 X X X
Colombia X X X X X X X X X X 10 X X X
Comoros X X X X 4 X
Congo X X X X X X X 7 X X
Costa Rica X X X X X X X X X X X X 12 X X X
Croatia X X X X X X X X X X X X X X X X X X X X X X 22 X X X
Cuba X X X X X X X X X X X X X X 14 X X
Cyprus X X X X X X X X X X X X 12 X X
Czech X X X X X X X X X X X X X X X X X 17 X X X
Republic
Côte d'Ivoire X X X X X 5 X X
Democratic X X X X X X X X X X X X 12 X
People's
Republic of
Korea
Democratic X X X X 4 X X
Republic of
the Congo
Denmark X X X X X X X X X X X X X X X X X X 18 X X X
Djibouti X X X 3 X X
Dominica X X X X X X 6 X X
Dominican X X X X X X X X X X 10 X X X
Republic
Ecuador X X X X X X X X 8 X X X
Egypt X X X X X X X X X X X X X X X 15 X X
El Salvador X X X X X X X X X X X X 12 X X
Equatorial X X X X X 5 X
Guinea
Eritrea X 1 X
Estonia X X X X X X X X X X X X X X X X X X X 19 X X X
Ethiopia X X 2 X
Fiji X X X X 4 X X
Finland X X X X X X X X X X X X X X X X 16 X X X
France X X X X X X X X X X X X X X X X X X X X X X 22 X X X
Gabon X X X X X X X X 8 X X
Gambia X X X X 4 X X
Georgia X X X X X X X X X X X X X 13 X X X
Germany X X X X X X X X X X X X X X X X X X X 19 X X X
Ghana X X X X X X X X X 9 X X
Greece X X X X X X X X X X X X X X X X 16 X X
Grenada X X X X 4 X X
Guatemala X X X X X X X X X X 10 X X
Guinea X X X X X X X X X X X 11 X X
Guinea- X X X X 4 X X
Bissau
Guyana X X X 3 X X
Haiti X X X X 4 X X
Holy See X X X X 4
Honduras X X X X X X X X X X X 11 X X
Hungary X X X X X X X X X X X X X X X X X X X X 20 X X X
Iceland X X X X X X X X X X X X 12 X X X
India X X X X X X X 7 X X
Indonesia X X X X X X X 7 X X
Iran (Islamic X X X X X X 6 X
Republic of)
Iraq X X 2 X
Ireland X X X X X X X X X X X X X X X 15 X X X
Israel X X X X X X X X X X X X 12 X X X
Italy X X X X X X X X X X X X X X X X X X X X X 21 X X X
Jamaica X X X X X X X X X X X 11 X X
Japan X X X X X X X X X X X X X X 14 X X X
Jordan X X X X X X X X 8 X X X
Kazakhstan X X X X X X X X X X X X X X X X X 17 X
Kenya X X X X X X X X X 9 X X X
Kiribati 0 X
Kuwait X 1 X X
Kyrgyzstan X X X X X X X X X X X X X X X X X X X X X 21 X X X
Lao People's X X X X 4 X X
Democratic
Republic
Latvia X X X X X X X X X X X X X X X X X X 18 X X X
Lebanon X X X X X X 6 X
Lesotho X X X X X X X 7 X X
Liberia X X X X X X X X 8 X
Libya X X X X 4 X
Liechtenstein X X X X X X X X X X X X X X X X X X 18 X X
Lithuania X X X X X X X X X X X X X X X 15 X X X
Luxembourg X X X X X X X X X X X X X X X X 16 X X
Madagascar X X X X X 5 X X
Malawi X X X X X X X 7 X X
Malaysia X X X X X X X X 8 X X
Maldives X 1 X X
Mali X X X X X X X X 8 X X
Malta X X X X X X 6 X X
Marshall 0 X
Islands
Mauritania X X X X 4 X X
Mauritius X X X 3 X X
Mexico X X X X X X X X X X X X X X X X X 17 X X X
Micronesia X 1 X
(Federated
States of)
Monaco X X X X X X X X X X X X X X X 15 X
Mongolia X X X X X X X X X X X X X X X 15 X X
Montenegro X X X X X X X X X X X X X X X X X X X X X X X 23 X X
Morocco X X X X X X X X X X X X X X X 15 X X X
Mozambique X X X X X X 6 X X
Myanmar X 1 X X
Namibia X X X X X X X X 8 X X
Nauru 0 X
Nepal X X X 3 X X
Netherlands X X X X X X X X X X X X X X X X X X X 19 X X X
New Zealand X X X X X X X X 8 X X X
Nicaragua X X X X X X X X X X X X 12 X X X
Niger X X X X X X 6 X X
Nigeria X X X X X X 6 X X
Norway X X X X X X X X X X X X X 13 X X X
Oman X X X X X X X X X X X X X X 14 X X X
Pakistan X X X 3 X X
Palau 0 X
Panama X X X X X X X X X X X 11 X X X
Papua New X X X 3 X X
Guinea
Paraguay X X X X X X X 7 X X X
Peru X X X X X X X X X X X X 12 X X X
Philippines X X X X X X X X X 9 X X
Poland X X X X X X X X X X X X X X X X X X 18 X X X
Portugal X X X X X X X X X X X X X X X 15 X X X
Qatar X X X X X X X 7 X X
Republic of X X X X X X X X X X X X X X X 15 X X X
Korea
Republic of X X X X X X X X X X X X X X X X X X X X X X X X 24 X X X
Moldova
Romania X X X X X X X X X X X X X X X X X X X X X 21 X X X
Russian X X X X X X X X X X X X X X X X X X X 19 X X X
Federation
Rwanda X X X X X X X 7 X X
Saint Kitts X X X X X 5 X X
and Nevis
Saint Lucia X X X X X X X X X X X 11 X X
Saint Vincent X X X X X 5 X X
and the
Grenadines
Samoa X X 2 X X
San Marino X X X X X X X 7 X
Sao Tome X X X X X X 6 X
and Principe
Saudi Arabia X X X 3 X X
Senegal X X X X X X X X 8 X X
Serbia X X X X X X X X X X X X X X X X X X X X X X X X 24 X X
Seychelles X X X 3 X
Sierra Leone X X X X X 5 X X
Singapore X X X X X X X X X X X X X 13 X X X
Slovakia X X X X X X X X X X X X X X X X X X X 19 X X X
Slovenia X X X X X X X X X X X X X X X X X X X X X 21 X X X
Solomon 0 X X
Islands
Somalia X 1 X
South Africa X X X X X 5 X X X
South Sudan 0 X
Spain X X X X X X X X X X X X X X X X X X X 19 X X X
Sri Lanka X X X X X X X 7 X X
Sudan X X X X X X 6 X
Suriname X X X X X X 6 X X
Swaziland X X X X X X 6 X X
Sweden X X X X X X X X X X X X X X X X X 17 X X X
Switzerland X X X X X X X X X X X X X X X X X X X X X 21 X X X
Syrian Arab X X X X X X X X X X X X X 13 X
Republic
Tajikistan X X X X X X X X X X X X X X X X X 17 X X
Thailand X X X X 4 X X
Timor-Leste 0 X
Togo X X X X X X X X X X X 11 X X
Tonga X X X 3 X X
Trinidad and X X X X X X X X X X X X X X 14 X X X
Tobago
Tunisia X X X X X X X X X X X X 12 X X X
Turkey X X X X X X X X X X X X X X X X X 17 X X X
Turkmenistan X X X X X X X X 8 X
Tuvalu 0 X
Uganda X X X X 4 X X
Ukraine X X X X X X X X X X X X X X X X X X X X X 21 X X X
United Arab X X X X X X X 7 X X
Emirates
United X X X X X X X X X X X X X X X X X 17 X X X
Kingdom
United X X X X X 5 X X
Republic of
Tanzania
United States X X X X X X X X X X X X X X 14 X X X
of America
Uruguay X X X X X X X X X X X X 12 X X X
Uzbekistan X X X X X X X X X X X 11 X X
Vanuatu X X 2 X X
Venezuela X X X X X 5 X X
(Bolivarian
Republic of)
Viet Nam X X X X X X X X X 9 X X X
Yemen X X X 3 X
Zambia X X X X X 5 X X
Zimbabwe X X X X 4 X X
the former X X X X X X X X X X X X X X X X X X X X X 21 X X X
Yugoslav
Republic of
Macedonia
OTHER W P B PCT PLT MI MM MP H GH N LI RO LO IPC PH VC BP S NOS TLT W CT W PPT WAS SG BEIJING UN U W TO
ENTITIES
African X X 2
Intellectual
Property
Organization
(OAPI)
European X X X X X 5 X X
Union (EU)
Hong Kong, 0 X
China
Macao, 0 X
China
Taiwan, 0 X
Province of
China
TOTAL 185 174 166 146 32 36 56 88 60 45 83 27 91 52 62 78 31 78 35 50 55 90 91 3 31 1 193 71 159
W WIPO Convention P Paris Convention B Berne Convention PCT Patent Cooperation Treaty
PLT Patent Law Treaty MI Madrid Agreement (Indications of MM Madrid Agreement (Marks) MP Madrid Protocol
Source)
H Hague Agreement GH Geneva Act of Hague N Nice Agreement LI Lisbon Agreement
RO Rome Convention LO Locarno Agreement IPC Strasbourg Agreement PH Phonograms Convention
VC Vienna Agreement BP Budapest Treaty S Brussels Convention NOS Nairobi Treaty
TLT Trademark Law Treaty WCT WIPO Copyright Treaty WPPT WIPO Performances and WAS Washington Treaty
Phonograms Treaty
SG Singapore Treaty BEIJING Beijing Treaty on Audiovisual UN United Nations (UN) U UPOV Convention
Performances
WTO Agreement establishing the World
Trade Organization (WTO)
Annex II: Nederlandstalige
Samenvatting
De masterproef ‘Biopiracy’ biedt een juridische analyse van het internationale rechtskader waarin
biopiracy ontstaan is en onderzoekt maatregelen die een oplossing kunnen bieden. Deze masterproef
is onderverdeeld in drie delen: een inleidend deel waarin het fenomeen biopiracy gekaderd wordt en
twee uitgebreidere delen die de hoofdzaak van deze thesis uitmaken.
In het eerste onderdeel wordt biopiracy in zijn context geplaatst. Niet alleen is biopiracy een politiek
controversieel onderwerp, er bestaat zelfs geen eensgezindheid over een definitie voor de term. In het
licht van deze masterproef kan biopiracy gedefinieerd worden als het gebruik van intellectuele eigen-
domsbescherming (meestal octrooien) om het exclusieve bezit te legitimeren van biologische grond-
stoffen en/of daarmee geassocieerde traditionele kennis die verworven zijn zonder toestemming of
compensatie van andere (meestal ontwikkelings-) landen en lokale of inheemse gemeenschappen. Het
eerste onderdeel geeft verder een overzicht van de historische evoluties en bespreekt via twee recht-
szaken het verschil in mentaliteit tussen de Europese en Amerikaanse octrooi verlenende autoriteiten.
In het tweede onderdeel wordt een juridische analyse gemaakt van de internationale akkoorden die
een effect hebben op biopiracy. De twee belangrijkste instrumenten zijn in dit opzicht het TRIPS akko-
ord van de Wereldhandelsorganisatie en het VN Biodiversiteitsverdrag. Deze twee akkoorden hebben
elk een zeer verschillend doel voor ogen. Niet nakoming wordt door het TRIPS akkoord zwaar be-
straft via handelssancties, vandaar is er effectief een wereldwijde minimum standaard aan intellectuele
eigendomsbescherming. Het biodiversiteitsverdrag is echter heel wat minder krachtig. Daardoor kan
biopiracy blijven voortbestaan. Er zijn verschillende (grotendeels) vruchteloze pogingen ondernomen
om het TRIPS akkoord aan te passen. In 2010 is het Nagoya Protocol aangenomen dat tracht een ef-
fectiever regime tot stand te brengen om voordelen van biologische middelen en traditionele kennis te
verdelen. Of dit protocol werkelijk iets zal veranderen, zal pas duidelijk worden na zijn inwerkingtred-
ing.
Het derde en laatste onderdeel tracht enkele suggesties te geven om tot een oplossing te komen
voor het probleem van biopiracy. Eerst en vooral zou een meer diplomatische retoriek aangenomen
moeten worden om een betere atmosfeer tot stand te brengen voor verdere onderhandelingen. Er volgt
een pleidooi voor het aannemen van drie maatregelen die tot een oplossing zouden kunnen leiden: een
informatieverplichting in een octrooiaanvraag, databanken voor biologische middelen en traditionele
kennis en publiek-private akkoorden. De huidige impasse in internationale gesprekken met betrekking
tot biopiracy geven echter niet veel hoop op een spoedige oplossing.
Samenvattend bevat deze masterproef een analyse van de zwakke punten in het huidige interna-
tionale rechtskader rond biopiracy en suggesties om deze aan te pakken.
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Faculteit Rechtsgeleerdheid

Masterproef van de opleiding

Promotor: Professor Frank Maes

I Situating the Problem, Pirates or Heroes? 3

1 Defining the Concept, What is Biopiracy? 5

II Analysis of the Existing Legal Framework 21

5 Patent Law and Patentable Subject Matter 23

6 Convention on Biological Diversity 33

III Towards a Solution 53

11 European Union Initiatives 59

12 Using Patent Law to Protect Traditional Knowledge 63

Annex I: Summary Table of Membership of the Treaties Administered

Annex II : Nederlandstalige Samenvatting 91

ABS Access and Benefit Sharing

Situating the Problem, Pirates or

Defining the Concept, What is

Only in recent years included, the Oxford Dictionary defines it as:

“the practice of commercially exploiting naturally occurring biochemical or genetic material,

1.3 Putting it in the Right Perspective

1.4 Why is it a Problem?

3.1 The Neem Tree

3.2 Enola Bean

3.3 European Patent Office versus US Patent and Trademark Office

Analysis of the Existing Legal

Patent Law and Patentable Subject

5.1 World Intellectual Property Organization

5.2.1 Minimum Standard of Patentability

5.2.2 Exceptions to Patentability

5.3 EU Directive on the Legal Protection of Biotechnological Inven-

1. The following shall not be patentable:

“Art. 15. - §1. De octrooiaanvraag moet bevatten:

Convention on Biological Diversity

“Article 15. Access to Genetic Resources

Negotiating Session, UNEP/Bio.Div/N4-INC.2/5, 1991, 16, para 102.

6.2 Access and Benefit Sharing

The Interface between the TRIPS

7.1 Current Status of Plant Genetic Resources

7.2 Adapting the TRIPS Agreement

8.1 The Text

8.2 Assessment of the Protocol

Industrialized countries might be more inclined to listen to a discourse of national sovereignty

Ho proposes to introduce an internet-based commentary system hyperlinked to patents. That way

European Union Initiatives

Using Patent Law to Protect Traditional

12.1 A Mandatory Disclosure Requirement

! A more comprehensive obligation demands disclosure of prior informed consent, access on

12.1.1 National Legislation

To ensure the enforcement of a disclosure requirement, grave consequences need to be linked to

12.1.3 Disclosure as a TRIPS Obligation

3. “Members may also exclude from patentability:

c) products or processes which directly or indirectly include genetic resources or traditional

“Article 29: Conditions on Patent Applicants

12.1.4 Disclosure through the WIPO

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