Biopiracy and Intellectual Property Rights – to What Extent Biopiracy Represents a Threat to Traditional Knowledge and How the International Legal System Allows it

Faculty of Law

Aleksandar Zahariev

Student number: 11003847

International Trade and Investment Law Master's Track

Biopiracy and Intellectual Property Rights – to What Extent Biopiracy

Represents a Threat to Traditional Knowledge and How the International

Legal System Allows it

Master’s Thesis

Supervisor: J. Mathis

Abstract:

The purpose of this study is to investigate the effects of Biopiracy on Traditional Knowledge and Biodiversity. In its four chapters, the paper addresses the problem by systematically analyzing the crucial points surrounding the issue. The first chapter follows the development of the notion biopiracy. The second one deals with the existing international legal system. The third analyzes the case law on Biopiracy. Finally, the fourth chapter checks the current developments and the work of the International organizations that are trying to resolve the problems arising from Biopiracy.

Nowadays, the protection of traditional knowledge under intellectual property law is a widely debated topic due to the disputes it has provoked between the developing and the developed states of the WTO. The developing countries blamed the developed states for not granting sufficient protection to the traditional knowledge and customs of the indigenous peoples within the established legal frameworks. Such deficiency of security has serious ramifications as those documents are being implemented constantly worldwide.

The results of the research indicate that there is an urgent need for rapid changes which can solve the issue of Biopiracy. As suggested in the paper, methods of resolution exist; however, governments should be ready to sacrifice certain interests and seek cooperation.

Keywords: Biopiracy, Bioprospecting, TRIPS, WTO, IPRs, CBD, Traditional Knowledge,

Table of Contents

Chapter 1

1. Introduction

1.1 What exactly is Biopiracy?

1.2 Development of Biopiracy

1.3 Regulation of Biopiracy

Chapter 2

2.

Agreement on Trade Related Aspects of Intellectual Property Rights

2.1

Article 27 from the Agreement on Trade Related Aspects of Intellectual Property

Rights

2.2

CBD or the Convention on Biological Diversity

2.3

Clash between TRIPS and CBD?

Chapter 3

3. The legal practice on Biopiracy – another way to prove that the current legal

framework needs urgent changes.

Chapter 4

4.WIPO – World Intellectual Property Organization

4.1 A step forwards or a step backwards – Nagoya Protocol?

4.2 Possible solutions to Biopiracy within and outside the existing legal framework

4.3 Conclusion

Abbreviations

ETC Group-Action Group on Erosion, Technology and Concentration CBD – Convention on Biological Diversity

TRIPS – the Agreement on Trade-Related Aspects of Intellectual Property Rights WTO – World Trade Organization

IPRS – Intellectual Property Rights

GATS – General Agreement on Trade in Services DSU – The Dispute Settlement Understanding LDC – least developed countries

TDK – Traditional Knowledge

VCLT – Vienna Convention on the Law of Treaties UK – United Kingdom

NGO – Non-governmental organization US/USA – United States of America

CIAT – International Center for Tropical Agriculture WIPO – World Intellectual Property Organization PLT – Patent Law Treaty

IGC-GRTKF – the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore

Chapter 1

1. Introduction

The humankind has been polluting the Earth for ages, which resulted in the ongoing climate change and the extinction of many biological species. Thus, currently, the conservation of the plants and animals on our planet is a major issue. It is a well-known fact that plants are a crucial resource for the creation of medicines, as they are rich in bio materials. However, in the developed countries, most of the flora is dying out due to constant pollution (by factories, automobiles etc.), as well as owing to incessant analyses and experiments. In other words, industries (such as pharmaceutical companies and cosmetic companies) are constantly looking for new biological resources to be analyzed and eventually become the basis for the synthesis of new products. This is the reason why researchers are interested in plants which were never examined. Unfortunately, most of the pure and unanalyzed biological resources are to be found in the developing countries. It can be said that the flora in most of the developing countries has not been scientifically tested yet, but the indigenous people living in these regions are familiar with the benefits of certain herbs. Such information (possessed by native people) is useful for industries because big companies invest millions in the creation of new machines which would facilitate the determination and extraction of the chemical compounds from the plants. So, if pharmaceutical or other companies cooperate with the indigenous people, who already use plants to treat wounds or cure infections, this will reduce the expenses for research and will bring higher profits for those companies. The complication comes from the fact that the knowledge gained from native people is often inherited from previous generations; it is also rarely written down, which means that it is almost always not formulated or safeguarded. Furthermore, such information or "know-how" on the use of plants and other bio material is often gained from tribes or communities situated in developing states which do not have the influence to protect them. The interesting thing about the knowledge of native peoples is that there is not a single individual who possesses the property rights over this information; hence, it is impossible to discover who actually identified the compounds and invented the methods to use a certain plant as a medicine.1

The lack of property rights attached to the knowledge of the indigenous people, as well as the fact that these communities are mainly located in countries not able to take the legal and political steps

1 _{John Reid, 'Biopiracy: The Struggle For Traditional Knowledge rights' [2009-2010] 34(1) American Indian Law} Review 77.

to safeguard the information, makes it possible for pharmaceutical companies, scientists and others to make huge amounts of money. Not only is the "stolen" traditional knowledge helpful in the conduction of a single piece of research, but it can also become the basis for further breakthroughs, in science which makes its value even higher. Frequently, however, such knowledge is taken by a company, being represented as a new creation, and later on granted a patent. Native communities believe that such an act is a fraud because they are the ones who discovered and invented it (if it is a plant or a method) but did not have the opportunity (resources, influence, power) to apply for a patent on their own. This issue is difficult to solve because if traditional knowledge has a strong legal protection, this can discourage industries to invest; therefore, future breakthroughs in medicine, cosmetics and other fields would not be seen that often. The knowledge of native people helps in the identification of beneficial ingredients in plants, animals and insects, which reduces the money spent on research. Nonetheless, if the information of the indigenous peoples is not highly protected, companies would not reimburse the natives for their knowledge. In other words, if the indigenous peoples are given even a small part of the profits, this can change their lives a lot. So an equilibrium should be found, in order for both businesses and native peoples to benefit.2

Normally, a patent is granted for something completely new (a certain product or process) because it is against the objectives of patent law to grant property rights for something that is already known. Many suggest that the easiest way to solve the occurring problem is through documenting all the existing methods and discoveries because this would allow the copyright agents to check whether the creation could be given a patent or not. The obstacle with such an approach is that in order for a discovery to be registered, it must be awarded a patent. Unfortunately, traditional knowledge needs more examination to satisfy the conditions for a patent. Native peoples do not have the resources or the technology to test their methods, thus, a plausible solution for them is to come to legal terms with the companies which will ensure the well-being of both parties. As many scholars argue, such a contractual relation is easier to come up with as an idea rather than to actually utilize it in practice.3

Traditional knowledge can be described as the information possessed by the indigenous societies globally, which comprises various processes and data passed from one generation to another. Despite the various cultural traditions inherited within the indigenous communities, researchers are mainly interested in the information concerning medical treatments. Such cultural practices in the sphere of medicine involve the use of various herbs, insects etc. Pharmaceutical companies are

2 _{Ibid 78.}

3 _{Katie Bates, 'A Penny for Your Thoughts: Private and Collective Contracting for Traditional Medicinal Knowledge} Modeled on Bioprospecting Contracts in Costa Rica' [2007] 41(3) Georgia Law Review 970.

constantly trying to get access to such traditional treatments on the basis of which they can develop a new drug or medical therapy. While the number of new diseases is rapidly growing and at the same time the pharmaceutical industry is trying to provide a cure or treatment for the sick, stealing information from indigenous communities is a common practice. Taking data from native societies around the world (without consent), patenting and selling the new product without reimbursing the ones who actually invented it is often called Biopiracy. Billions of dollars are made through data obtained by indigenous peoples but without the legal obligation for compensation; the companies which profited are reluctant to reimburse the actual discoverer. 4

As it can be established from the above mentioned information, Biopiracy is a serious problem which ignores the culture and tradition of the indigenous peoples and ensures high profits for greedy owners of companies within various types of industries. Therefore, the purpose of this paper is to expand on why Biopiracy is a threat to the Traditional Knowledge, which is closely connected with the culture and well-being of the indigenous peoples within the developing countries and subsequently to answer how and why such an act is possible under the international legal system that is supposed to promote justice. To tackle the problem, the thesis would consider several crucial points such as the evolution of the term Biopiracy, how it is regulated, the efficiency of the available remedies and the ongoing steps taken by the international authorities. Firstly, with the aim to exhaustively analyze the issue, the next two sections of the paper will focus on the definition of Biopiracy and its development in the recent history, which will further familiarize the reader with the topic. Then, the text will address how Biopiracy is regulated domestically as well as under the international legal system in order to check for existing differences or similarities and find where the problem lies. In the third chapter, the text will examine some cases dealing with Biopiracy, which plays the role of showing the costly and ineffective remedies available. In the end, the last chapter provides the current developments on the issue and suggestions on how the problem can be resolved. In the conclusion, it becomes clear that Biopiracy can be resolved in various ways; however, the conflict of political interests in the relationship between developed and developing states prevails.

1.1 What exactly is Biopiracy?

4 _{Bryan Bachner, 'Facing the Music: Traditional Knowledge and Copyrigh' [2005] 12(3) Human Rights Brief 9; Cynthia}

M. 'Biopiracy and Beyond: A Consideration of Socio-Cultural Conflicts with Global Patent Policies' [2006] 39(1) University of Michigan Journal of Law Reform 436.

Traditional knowledge and genetic material are crucial elements in businesses such as biotechnology, cosmetics etc and a high percentage of the products on the markets have been created on the basis of ingredients found in nature. Presumably, all of these products are protected by patents. Despite the legal actions taken, which led to the adoption of international conventions – for instance, the United Nations Convention on Biological Diversity – many companies are still trying to avoid certain requirements such as sharing the profits with native peoples / developing countries, which actually contributed the information or the bio material. These actions taken by the undertakings are often referred to as Biopiracy.5

The term biopiracy became better known in recent years; however, there is still no concrete description of it. The word biopiracy was introduced in the late twentieth century, approximately at the same time as the establishment of the term bioprospecting. Both terms are interlinked. Bioprospecting means seeking to find and examine unknown flora and fauna with the aim to discover bio resources that would help in the invention of new medications, while biopiracy is the action of using certain generic resources or traditional knowledge by industries with the goal to make large amounts of profit, often by attaining patents that limit the use of these resources for others and without reimbursing the society or the state from which it is derived.6 _{Many scholars}

believe that the term biopiracy formed as a result of the resentment of various states and societies in connection with the action of bioprospecting. Some even consider that the word biopiracy was made up by people working in a Non-Governmental Organization situated in Canada, called the ‘ETC’ Group.7

At the current moment, there are several definitions of Biopiracy as there is no general agreement on what precisely the phrase encompasses. Some of these interpretations of Biopiracy focus on the absence of reimbursement for the indigenous peoples or states where the resource was obtained, as well as on the fraudulent way of using the resource by acquiring patents with the desire for high profits (various industries) (Oxford Dictionary).8 _{Other explanations of the term address more}

specifically the position of the native peoples and their protection such as the one introduced by the

5_{Daniel Robinson, Collecting-Prospecting-Piracy , Confronting Biopiracy (Routledge 2011) 4.}

6_{Chris Hamilton, 'Biodiversity, Biopiracy and Benefits: What Allegations of Biopiracy Tell us About Intellectual}

Property' [2006] 6(3) Developing world bioethics 158-159.

7_{Etc group, 'Bioprospecting/Biopiracy and Indigenous Peoples' (ETC Group- monitoring power, tracking technology,}

strengthening diversity, 1995) <http://www.etcgroup.org/content/bioprospectingbiopiracy-and-indigenous-peoples> accessed

8 April 2016.

8 _{'biopiracy, n.' (OED Online, OUP December 2015) <http://www.oed.com.proxy.uba.uva.nl:2048/view/Entry/251067?} redirectedFrom=Biopiracy#eid> accessed 8 April 2016. - Biopiracy- 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 compensation to the community from which it originates.

above mentioned ETC Group.9 _{Most of the advocates (many scholars from developing countries),}

trying to stop Biopiracy, define the term in such a way that it can bring doubt to the legality of existing intellectual property frameworks, which allow the use of Biopiracy.10 _{After seeing that}

Biopiracy has various definitions, it is not shocking that this term – and practice – raises many questions which are still to be answered and deliberated upon by various parties and states. It is often witnessed that in many disputes related to Biopiracy, parties are even hesitant to use the phrase in order to avoid further complications.11 _{This thesis will look mainly at the issue of}

Biopiracy in a legal context, which will examine how intellectual property rights make the presence of Biopiracy possible and what disputes arise in connection with the preservation of traditional knowledge and generic resources.

Of course, there are also academics who do not regard Biopiracy as something unacceptable or erroneous. This group of people claims that Biopiracy does not exist because companies accused of Biopiracy are actually following the established international intellectual property legal framework. It is even argued that national states must take more adequate actions to protect their generic resources if they want to prevent future disputes on the topic. To a certain extent, this stand on the issue can be understood; however, most of the countries which are supposed to increase the protection of their bio resources are developing countries. In other words, undeveloped states do not have the financial capacity to push such national agendas and invest in the preservation of their flora and fauna.12 _{But Biopiracy cannot be seen only as something that states should totally}

eradicate, as – in its own way – it encourages various companies to spend millions with the aim to create something new. Biopiracy stimulates improvement not only in the sphere of cosmetics or pharmaceutical sciences but also in the field of crop production.13 _{According to the numbers which}

the United Nations presented at the beginning of 2016, there are more than seven billion people on the Earth.14 _{Therefore, through Biopiracy, companies which are trying to create new, stronger types}

9_{Etc group, 'Patents & Biopiracy' (ETC Group- monitoring power, tracking technology, strengthening diversity, 1995)<}

http://www.etcgroup.org/issues/patents-biopiracy> accessed 8 April 2016.- Biopiracy- the appropriation of the knowledge and genetic resources of farming and indigenous communities by individuals or institutions that seek exclusive monopoly control (patents or intellectual property) over these resources and knowledge. ETC Group believes that intellectual property is predatory on the rights and knowledge of farming communities and indigenous peoples. 10_{Vandana Shiva, Patents: Myths & Reality (1 edn, Penguin Books India 2001) 47-49.}

11_{Florian Rabitz, 'Biopiracy after the Nagoya Protocol: Problem Structure, Regime Design and Implementation}

Challenges' [2015] 9(2) A Journal of the Brazilian Political Science Association 40.

12_{Maxim Gubarev, 'Misappropriation and patenting of traditional ethnobotanical knowledge and genetic}

resources' (HeinOnline, Spring 2012) <http://heinonline.org/HOL/LandingPage? handle=hein.journals/jfool8&div=5&id=&page=> accessed 8 April 2016.

13_{Christoph Then, 'Biopiracy and Seeds' (No Patents on Seeds, 2014) <http://www.alt.no-patents-on-seeds.org/index.php?}

option=com_content&task=view&id=39&Itemid=42> accessed 8 April 2016.

14_{Christoph Then, 'UN projects world population to reach 85 billion by 2030, driven by growth in developing}

countries' (United Nations- Sustainable Development

Goals , 2015)

of crops by experimenting on various plants (not examined up to the current moment), using crossbreeding techniques, can reduce the costs for research and spend more on actual testing. So if Biopiracy helps resolve the issue of world hunger, should it be considered something bad? The expenses for creating a new product, especially in the pharmaceutical industry, are extremely high. Conducting research and experimenting with various compounds can take an average of ten to fifteen years before a product is actually released on the market and profit is made, while in accordance with patent law, companies able to receive property rights, have only twenty years before their discovery is made public. Biopiracy is a controversial topic which should be analyzed from various angles.15

Before the paper can go into detail and discuss the legal issues of Biopiracy and after the term was briefly explained in the previous paragraphs, a short history of its development must be presented. This will make the reader even more acquainted with the topic and would clarify why Biopiracy is an issue which must be resolved and taken seriously by the world leaders.

1.2 Development of Biopiracy

One should not go much further back in time in order to analyze how Biopiracy arose as a problem. Since the start of the first round of multilateral trade negotiations in 1947 until the current moment, the disagreements between the developed countries, on the one hand, and the developing countries on the other, have been increasing and deepening.16 _{This tension led to the creation of various}

treaties addressing specific topics with the aim to facilitate the desires and needs of all contracting parties. The international documents which are instrumental to the issue of Biopiracy are the TRIPS Agreement and the Convention on Biological Diversity. The CBD Convention is of crucial value not only because it attempts to provide the possibility of developed states to use biological resources, ensuring at the same time that the indigenous peoples / developing states receive a fair share from the potential profits, but also because it establishes that countries have autonomous rights over their national biodiversity. 17

15_{CBRA , 'Fact Sheet New Drug Development Process' (California Biomedical Research Association, 2015)}

<http://www.ca-biomed.org/pdf/media-kit/fact-sheets/CBRADrugDevelop.pdf> accessed 8 April 2016.

16 _{Jasper Womach, 'Agriculture: A Glossary of Terms, Programs, and Laws, 2005 Edition' (University of North}

Texas Digital Library, 16 June 2005) <http://digital.library.unt.edu/ark:/67531/metacrs7246/> accessed 10 April

2016; Ondina Leal and others, 'Global Ruling Intellectual Property and Development in the United Nations Knowledge Economy' [2014] 11(2) Vibrant: Virtual Brazilian Anthropology 117.

17 _{Bryan Liang, 'Global governance: Promoting biodiversity and protecting indigenous communities against} biopiracy ' [2011] 17(3) Journal of Commercial Biotechnology 249.

The eighth round of multinational trade negotiations, also called the Uruguay Round (1986-1994), achieved the agreements on establishing the WTO and the TRIPS (as well as GATS, DSU etc.). The Uruguay Round brought new subject matters for deliberations, namely intellectual property, trade in services and others. 18_{With the adoption of the Agreement on Trade-Related Aspects of Intellectual}

Property Rights (considered the most exhaustive international mechanism on IPRS) the parties of the World Trade Organization were required to ensure that the various types of intellectual property rights are implemented and respected. 19_{The issue of Biopiracy is closely connected to the}

governance of patents (which is a form of intellectual property). Despite the fact that during the considerations of the TRIPS agreement, the least developed countries were unwilling to bring change to their existing IPRs legal frameworks, they eventually decided to compromise on certain aspects, in order to conclude a deal. However, the developed countries were not prone to sacrifice any of their goals or legal systems (and because they had much more bargain power), so they did not. There were not many conflicts in the first years after the conclusion of the TRIPS; nevertheless, with the advancement of technology, the member states of the WTO started applying more and more the intellectual property rights, safeguarding their innovations. Unfortunately, this development in technology, as well as the search for new places to sell goods, led to the increase of pressure on an international level. This pressure, utilized by financially dominant states and corporations, was intended to reduce the trading obstacles and obtain easier entrance to the markets of developing countries. In other words, developed countries wanted and lobbied for the TRIPS Agreement because it safeguards intellectual property rights (really important for states which are advanced in the industrial sector) and because it provides the developing states with the opportunity to trade in various new markets without difficulties.20 _{This argument might seem fair but the reasons}

why the developed countries defended the TRIPS agreement is because they are the ones gaining more benefits (they become both monopolists with the created patent protection on their products and have wide access to markets in the developing countries). So the already existing tension between developed and developing countries, plus the problems which the TRIPS agreement introduced (especially with article 27 (requirements for issuing a patent), which actually allows Biopiracy) attracted more attention, which encouraged activists from all over the globe to speak their minds and force their governments to answer the pending questions.21 _{Biopiracy was one of}

those unanswered questions. The problem of Biopiracy was illuminated in the twentieth century (by those activists groups) and is still a relevant topic today.

18 _{Michael Finger and Julio Nogués, ' "The Unbalanced Uruguay Round Outcome: The New Areas in Future WTO} Negotiations' [2002] 25(3) The World Economy 322-324.

19 _{World health organization, 'Essential medicines and health products-WTO and The TRIPS agreement' (World}

Health Organization, 2016) <http://www.who.int/medicines/areas/policy/wto_trips/en/> accessed 10 April 2016.

20 _{Laurence Helfer, 'Regime Shifting: The TRIPs Agreement and New Dynamics of International Intellectual} Property Lawmaking' [2004] 29(1) Yale Journal of International Law 37.

After the paper introduced, defined and hinted why Biopiracy is a topic of analysis, it is time to go further and examine in detail how the matter is regulated internationally, as well as nationally. Before addressing the existing legal frameworks, however, it must be noted once again that Biopiracy is not a concrete legal notion, and for this reason, various definitions were provided above. In other words, Biopiracy is a complicated issue requiring more attention, and therefore this master thesis discusses the notion in various contexts.

1.3 Regulation of Biopiracy

As it was mentioned above, in this part of the paper the legal frameworks concerning Biopiracy will be discussed; however, prior to checking the legal instruments, the core aspect of the dispute in relation to Biopiracy must be made clear, i.e. patenting. The most controversial disputes surrounding Biopiracy are connected with questions in regard to copyrights (patents), conferred to inventions based on traditional knowledge or generic resources. In other words, since the law on patenting is part of the intellectual property law, it is crucial to see and discover what patent law is and how its misuse raises the question of biopiracy, provoking legal scholars to analyze it.

The patent law legal framework was created with the intent to boost the development of science and technology. Thus, through patents, the innovator of a new process or product (which has never been created previously) is granted absolute right over this new creation for a certain period of time. The patent law mechanisms can distinguish whether something can be awarded a patent because it is ingenious and nobody else has managed to discover it, or not be granted an exclusive right because it is part of the general knowledge. But the patent system differentiating competence is often questioned when it comes to patenting various creations discovered using biological materials or information from indigenous peoples. The dilemma comes from the fact that the current legal system allows the granting of a patent if there is a new innovative process or compound, for example, a group of researches finding a new plant that is used by a tribe (which boils it in water and drinks the substance). So if the group of researchers brings the plant to a laboratory and extracts the essential herb, creating a pill which has a stronger effect, the patent law system will most of the times award a patent in cases similar to this one because it is a new way of using the biological material. In other words, the existing intellectual property legal framework advocates new methodologies, products obtained from bio resources, or the traditional knowledge of peoples.22

22 _{Tak Jong Kim, 'Expanding the Arsenal Against Biopiracy: Application of the Concession Agreement} Framework to Prevent Misappropriation of Biodiversity' [2010] 14 SMU Science and Technology Law Review 82.

Currently, the intellectual property system permits Biopiracy by granting various researchers or companies exclusive rights without obliging them to share the newly discovered information or the profits with the states where the bio material was found, or with the indigenous peoples who disclosed their wisdom.

Unfortunately, there is no commonly accepted standard to specifically explain what can be and what cannot be safeguarded under patent law, as this is left to be determined under national law. Therefore, now the issue of Biopiracy is not only a result of the relation between developing and developed countries but also a matter of national concern, which involves many political views and corruption.23

Chapter 2

2. Agreement on Trade Related Aspects of Intellectual Property Rights

It was stated earlier that there are two legal documents that are of crucial importance to the problem of Biopiracy – the TRIPS agreement and the Convention on Biopiracy. Due to the fact that the TRIPS agreement is considered the most comprehensive international document on intellectual property rights, and because patent law is a category of IPRs – introduced in the previous section – the thesis will first examine this document.24 _{The TRIPS was ratified during the negotiations of the}

Uruguay Round in 1994.25_{It is the first intellectual property agreement to provide the possibility for}

dispute resolution in case of violation of its rules. Additionally, all member states of the World Trade organization were bound to implement the TRIPS in their national systems, which included the establishment of a certain level of intellectual property rights protection.26

During the discussions between the states regarding the TRIPS agreement, and while mediating the terms, objectives and the regulatory measures, in many developing countries there were demonstrations against the adoption of the agreement.27 _{This type of civil unrest was provoked by}

the fact that due to the stronger bargaining power possessed by the developed countries, their goals

23_{Gubarev (n 12).}

24 _{Laurance Hlefer, 'Human Rights and Intellectual Property: Conflict or Coexistence?' [2003] 5(1) Minesota} Intellectual Property Review 54-55.

25 _{World trade organization, Anatomy of the Negotiations. in Jayashree wata and Antony Taubman (eds), The}

Making of the TRIPS Agreement Personal Insights From The Uruguay Round Negotiations (World Trade

Organization 2015) 56.

26 _{M. Nair, 'TRIPS,WTO and IPR- How Effective is the Dispute Settlement Process? ' [2009] 14(1) Journal of} Intellectual Property Rights 346.

were attained by introducing strict IPR safeguards which protect new technology. However, the developing countries, which are more focused on crop production as they have rich biodiversity, were badly affected by the new rules.28

What is interesting about the Agreement on Trade Related Aspects of Intellectual Property Rights is the fact that if one reads article seven (incorporating the objectives), it becomes obvious that the document ambiguously tries to ensure harmony which will satisfy both developed and developing countries. Nevertheless, because of the broad way in which the article is written down, it can be read in a manner that defends biopiracy as well as against it.29 _{It is true that TRIPS left the}

possibility for the national authorities to issue laws that can diminish harmful effects from the agreement as seen in article eight, paragraph one, where countries are allowed to formulate or amend laws in order to conserve the public interests (of course, this new or amended rules must be in conformity with the rules of the agreement, which again can be seen as contradictory). 30 _Article

27, paragraph 2 TRIPS also supports article 8 (1) to some extent by permitting the exclusion from a patent of some creations which might threaten the public interest or the wildlife.31 _{Of course, the}

question of how supportive the article is will be addressed in more detail further below, as article 27 TRIPS is probably the most controversial one with respect to biopiracy and the relationship between developing and developed states. Except for the existing loops in article 8 (1) and 27 (2), when the Agreement on Trade Related Aspects of Intellectual Property Rights was agreed upon, the least developed countries and the developing countries were given the so-called transitional periods (a period of time during which they have to make changes in order to implement the laws of the TRIPS). The least developed states were granted a period of almost eleven years (until 2005), while the developing countries had to comply with the rules of TRIPS until 2000. Unfortunately, the LDC and the developing states faced many obstacles during those transitional periods so their deadline to comply was prolonged until 2013.32_{In 2013, it was evaluated that at the time of negotiation of the}

TRIPS agreement, the financial and political status of the LDC and the developing countries was not well considered, which left those states struggling. A fascinating fact is that there are still several states which are trying to adjust and utilize TRIPS within their systems in the scope of medical products and drugs. Not only was it hard for the developing countries to think of plans to

27 _{Charles Mcmanis, 'The Interface between International Intellectual Property and Environmental Protection:} Biodiversity and Biotechnology' [1998] 76(1) Washington University Law Review 256-258.

28 _{Ibid 257.}

29_{Gubarev (n 12) ; The Agreement on Trade-Related Aspects of Intellectual Property Rights(15 April 1994)} LT/UR/A-1C/IP/1 art 7<http://docsonline.wto.org> accessed 20 April 2016.

30 _{Peter Yu, 'The Objectives and Principles of the TRIPs Agreement' [2009] 46(1) Houston Law Review 811.} 31 _Ibid.

32 _{World trade organization, 'Responding to least developed countries’ special needs in intellectual} property' (World Trade Organization, May

change their legal and bureaucratic systems, but some scholars also argue they had to face the reality that the traditional knowledge of the native peoples and their biodiversity will not be safeguarded. To put it another way, developing countries spent their time and resources to change their legal and administrative frameworks in the hope of accessing technology, but at the same time, they lost the control of the TDK and biodiversity. Is then the goal of the Agreement on Trade Related Aspects of Intellectual Property Rights to actually bring balance and social welfare to all members?33 _{This question the thesis will try to answer by first analyzing article 27 of the TRIPS}

agreement, and later on by discussing the position of the Convention on Biological Diversity and its relation with the TRIPS.

The text will now dedicate several paragraphs to article 27 of the TRIPS, and will illuminate why it is so contentious for Biopiracy and the relation between developed and developing countries.

2.1 Article 27 of the Agreement on Trade Related Aspects of Intellectual

Property Rights

Article twenty-seven of the Agreement on Trade Related Aspects of Intellectual Property Rights is situated in Section five of the document, which deals with Patents. The whole text of the article is presented below in order for the reader to follow the analysis of the paper more easily.

Article 27

Patentable Subject Matter

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, 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.

33_{Oran Young, The Convention on Biological Diversity : Tensions with the WTO TRIPS Agreement over Access}

to Genetic Resources and the Sharing of Benefits. in Sebastian Oberthür and Thomas Gehring (eds), Institutional

2. Members may exclude from patentability inventions, the prevention within their territory 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 animals;

(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, 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.34

To begin with, the first section of the article provides the basic requirements which need to be fulfilled in order for a patent to be granted. The problem with this part of article 27 is that it is considered too general because it includes all new creations in the sphere of technology. Through the first paragraph, the agreement intends and is almost successful in creating a unified prerequisite for a patent to be awarded. Nonetheless, as it was noticed earlier, countries can introduce harsher conditions. Thus, patentability is closely connected to how the national authorities apply the rules of the TRIPS and whether they are eager to create a stable safeguarding system.35 _{The patent system is}

constantly struggling with what can be patented and what not. In most of the developed countries, granting a patent to various genetic materials is something normal; however, under the rules of the Agreement on Trade Related Aspects of Intellectual Property Rights, there is no requirement for the states to allow genetic resources to be awarded patents. Despite the fact that such lack of obligation seems to be beneficial for developing countries, because this might make it possible for them to protect their biological resources, there is no restriction that stops businesses from gathering samples and bringing them to a legal regime under which no restraint addressing the patentability of the bio material exists. 36_{Therefore, it seems that developing countries are highly disadvantaged by}

the TRIPS agreement, without being able to fight against it, as they might lose access to large markets or ruin their political relations with economically stable and influential states, which they are not in the position to do.37

34 _{The Agreement on Trade-Related Aspects of Intellectual Property Rights(15 April 1994) LT/UR/A-1C/IP/1 art} 27<http://docsonline.wto.org> accessed 20 April 2016.

35 _{Helfer(n 20) 63.}

36 _{Erin Bender, 'North and South: The WTO, Trips, and the Scourge of Biopiracy' [2003] 11(1) Tulsa Journal of} Comparative and International Law 311.

The next two sections of the article go on to explain in what cases it is approved to preclude something from being patented. Under paragraph two and three only three possibilities are given. Under paragraph 2 an exclusion from patenting is allowed in situations where the "orde public" or morality (the understanding of these two terms vary, thus they can be different in the various domestic legislative systems) has to be preserved, plus circumstances where the life and the physical wellness of a person or the flora and fauna must be conserved.38 _{Paragraph 3 (a) of article}

27 deals with the exclusion from patentability of the "diagnostic, therapeutic and surgical methods for the treatment of humans or animals" – this exemption is not really connected with Biopiracy. However, paragraph 3 (b) (article 27 TRIPS) is of utmost importance to the issue of Biopiracy because it permits the possibility of exclusion from granting a patent to plants and animals and the bio methods for their manufacturing. When one reads this paragraph, it is a little bit confusing, since on the one hand plants and animals can be excluded (so in a way developing countries would be able to have control over their bio diversity), but after a closer look into the paragraph, TRIPS does not allow micro-organisms, non-biological and microbiological processes to be precluded from patenting. Therefore, developing countries have some margin for

maneuver although it is extremely limited.39 _{In the second part of paragraph 3(b) it is}

established that Member States have two options: they should either provide protection of plant varieties by patents, or by sui generis mechanism (a type of system which provides protection externally – not within the existing legal instruments). 40_{Unfortunately, sui generis is not specifically characterized in the articles of the TRIPS,} but this type of option under article 27 (3) (b) is a possible solution against Biopiracy. The World Trade Organization, of course, pushes its own agenda, trying to implement the Convention created by The International Union for the Protection of New Varieties of Plants, which safeguards plant varieties by giving more powers to the one breeding, not to the people who actually produce the crops. This occurs to be a problem because, in less developed states, farmers provide seed, thus, if you give exclusive rights over certain seed to the person breeding it, this person would have too much control, which will allow him to put financial pressure. Furthermore, this document – favored by the WTO – attempts to industrialize the market, which can lead to developing only products (seeds) which are easy to sell at a profit, thus affecting the bio variety seriously. At the end of article 27, paragraph 3(b), the possibility of review is granted. Because of the controversy surrounding this article, many developing countries urged for certain changes in 2001, mainly focusing on adjusting the TRIPS in

38_{Gubarev (n 12) 75.}

39 _{Michael Blakeney, International proposals to regulate intellectual property rights in plant genetic resources. in R} Evenson and V santaniello (eds), The regulation of agricultural biotechnology (CABI Publishing 2004) 41. 40_{Robinson (n 5) 30.}

accordance with the Convention on Biodiversity and other international documents.41 Despite the discontent of developing countries, no significant change was effected. The states in the World Trade Organization, when adopting the Doha Declaration on the TRIPS agreement and Public Health, asked for an in-depth analysis of the connection between the CBD and the TRIPS, as well as for more clarification on the traditional knowledge safeguard instruments.

It might seem that the TRIPS agreement is an exhaustive document, providing a good level of IPRs protection; however, it has many problematic points such as the lack of safeguard mechanisms for the native communities’ knowledge. What is more, the Agreement on Trade Related Aspects of Intellectual Property Rights does not recognize the traditions or data possessed by the indigenous peoples as something that must be protected, so patenting certain traditions or methods by companies, is a common activity. TRIPS barely puts any obligations on the companies to reveal from where the biological resources were obtained (with what products they are produced) or to share the profits. Nowadays, the intellectual property legal framework is working mainly to support the aims of the developed countries while the developing countries are

disadvantaged, their positions and preferences not being respected.42

2.2 CBD or the Convention on Biological Diversity

This international document was developed due to the rapid extinction of a vast number of plants and animals around the world. The fast exhaustion of bio resources was mainly caused by technological innovations, as the economically powerful states (which are also technologically developed) sought ways to access and explore the bio materials situated in the developing countries while, at the same time, those less developed states wanted to acquire technology.43 _Many

researchers see the Convention as an agreement which satisfies the needs of its parties on a give-and-take basis.

The approach of the CBD is rather innovative as it basically tries to help developing countries to have control over their biological resources and make the preservation of those resources more compelling from a financial standpoint. Moreover, the Convention on Biological Diversity advocates equal technology and benefit distribution, hoping to establish a situation where saving the flora and fauna is more cost-effective and practical, rather than destroying it in order to gain profits.

41_{Gubarev (n 12) 75.} 42_{Helfer(n 20) 30.} 43_{Liang (n 17) 249-250.}

First of all, it is important to address the main goals of the Convention on Biodiversity as this will help with the explanation of the general framework of the document, making it easier for the reader to understand the more specific analysis.44 _{From article six to article fourteen, one can find the first}

two of the three aims of the CBD, i.e. the preservation and the proper exploitation of biological resources. 45_{The third objective can be found under articles fifteen to twenty – it deals with the issue}

of reasonable and proportionate allocation of benefits.46 _{This third goal of the Convention on}

Biological Diversity is a very disputable topic. As it was mentioned, the various elements of the third objective are located within article fifteen to twenty-one; however, the ones that are always surrounded by questions are articles fifteen and sixteen. These two provisions are often disputed because they touch upon the main interests of the developed and the developing countries. On the one hand, article fifteen provides states with the absolute right over their bio material, obliging other countries to ask for consent before exploring certain plants or animals. On the other hand, article sixteen ensures and assists the process of relocation of technology.47 _{Through article 15,}

states are given control over their genetic resources within their territories, which allows them to choose what requirements need to be fulfilled in order for someone (a company) to be given the right to use the biological material. In other words, national authorities have to adopt legislation which describes the limitations and requirements for the exploitation of biological resources within their borders (and of course all the limitations and conditions must be in accordance with the rest of the articles in the Convention). The conservation of the biodiversity and the traditional knowledge is not only covered by articles six to fourteen, but there is also an emphasis on it in article fifteen, paragraph five. In this paragraph, one can find the so-called prior informed consent, which is crucial to the protection of the knowledge of native peoples and the existing biodiversity, since it prevents companies from gathering data or collecting samples and then bringing them to the territory of another state, where they can analyze it and apply for patenting. All in all, article 15 of the CBD recognizes bio resources and the knowledge of the native peoples as part of the state's resources.48

Sadly, that has not always been the case – in the past, governments were not involved or interested in protecting the rights of their indigenous people. In order to prevent this from happening again, the Convention on Biodiversity also included certain measures outlining how the governments should behave towards native societies. 49

44 _{Helfer (n 20) 28.} 45 _{Mcmanis (n 27) 260.} 46 _Ibid.

47 _{Greg Venbrux, 'When Two Worlds Collide: Ownership of Genetic Resources unde rthe Convention on} Biological Diversity and the Agreement on Trade-Related Aspects of Intellectual Property

Rights' [2005] 6(1) Pittsburgh Journal of Technology Law and Policy 10. 48_{Liang (n 17) 249.}

Now turning to article 16, which clarifies how the proper transfer of technology should be conducted. As clarified above, article 16 together with article 15 are controversial provisions. In paragraph three of article sixteen, it is stated that the country who uses a resource from another state (often a developing state) should share the benefits and transfer the technology to it. Nonetheless, private companies refuse to follow this article because they do not want to lose their advantage on the market, which naturally leads to the fact that developing countries are unwilling to make the access to their resources easier. 50 _{It can be said that the Convention on Biological Diversity tries to}

be a buffer between the interests of the developed and developing countries, since most of its articles are vague and do not provide specific answers on how IPRS and the CBD interact. The CBD was supposed to be a compromise; however, after reading its provisions, it seems to raise even more questions rather than provide answers to the already existing ones. An interesting thing about the CBD is that periodically the signatories of the document meet with the goal to improve and go forward. In connection with this paper, the meetings in recent years are mainly directed at fixing the issues surrounding the protection of TDK as well as aiming to make it obligatory for patent applicants to reveal from where the genetic resources were obtained and whether they were collected with or without the consent of the state in which there were found. These two problems are a matter of constant deliberation because they are the major unfair bits within the TRIPS agreement with regard to the less developed countries.51

After discussing the more controversial, and from my perspective – more general provision, now it is time to focus on another essential article of the Convention on Biological Diversity, closely connected to IPRS. The provision which I deem to be of great importance is namely article 8 paragraph j in the CBD. This exact paragraph acknowledges the fact that TDK can be a basis for development and modernization. It also hints that indigenous peoples hold the exclusive rights over their traditions and information despite the fact that this is not ensured under the "most exhaustive agreement "on intellectual property rights, i.e. the Agreement on Trade Related Aspects of Intellectual Property Rights. The very existence of the provision within the CBD is evidence that traditional knowledge is acknowledged as an essential issue, which should be respected and protected by the states parties to the document.52

The observation of the Convention on Biodiversity exposed its weak points and more specifically the fact that its wording is too vague, as well as the fact that it relies on the implementation of national authorities in order to be effective (since it lacks enforcement mechanisms). To put it

50 _{Helfer(n 20) 32.} 51 _{Ibid 28.}

another way, instead of bringing solutions, the Convention is considered a disappointment by non-governmental organizations and activists, as it is capable of coping neither with the existing issues needing clarification nor with more open questions.

2.3 A Clash between TRIPS and CBD?

Having analyzed the two important documents regarding Biopiracy in the previous two sections (TRIPS and CBD), the thesis is about to explore how they overlap, whether they collide and if there is an actual conflict between these two regimes.

There are many different opinions on this topic, but it is crucial for the paper to confront the provisions of both documents, as they play a major role in the problem of Biopiracy. Thus, a comparison between these two international legal frameworks might provide some resolution or at least give clues on how the issue should be approached, as well as what can be done in the future.53

In the previous two sections, it was clearly explained that the TRIPS agreement's goals are to first establish a harmonized level of patentability, which is to be respected by all the parties within the World Trade Organization. The second general objective is to provide better access for exclusive right owners to proceedings, making it possible for them to actually apply their IPRs. The third aim is to create a dispute resolution measures in case parties of the agreement do not take seriously certain commitments they have made. The Convention on Biological Diversity has a different purpose, i.e. to safeguard the existing biodiversity and promote sharing of benefits and technology.54

The major drawbacks of the CBD, compared to the TRIPS, which can be recognized immediately are that it cannot be enforced, lacking provisions on how conflicts could be resolved.55

Nevertheless, let's make an even more general comparison of the two frameworks. The Convention on Biological Diversity entered into force on 29 December 1993. The Agreement on Trade Related Aspects of Intellectual Property Rights became effective two years after that – on 1st January 1995.

56_{Interestingly enough, neither document contains any measures suggesting dependability between}

53 _{Carr Jonathan , 'Agreements That Divide: TRIPS vs CBD and Proposals for Mandatory Disclosure of Source} and Origin of Genetic Resources in Patent Applications' [2008] 18(1) Journal of Transnational Law and Policy 140.

54_{Helfer (n 20) 29, 32; Dutfield, Graham; muraguri, lois and leverve, florian, 'Exploring the flexibilities of TRIPS to} promote biotechnology capacity building and appropriate technology transfer' (International Centre for Trade and Sustainable Development , 2006) <http://ictsd.net/i/ip/3555/> accessed 28 April 2016 11-12.

55 _{Smith, Mitchell, 'The Relationship between TRIPs and the CBD: A Way Forward?' (Social Science Research} Network , 2009) <http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1403000> accessed 29 April 2016 5. 56 _{Cbd.int, 'History of the Convention' (Convention on Biological}

Diversity, 2005) <https://www.cbd.int/history/> accessed 29 April 2016; World trade organization, Anatomy of

the Negotiations. in Jayashree wata and Antony Taubman (eds), The Making of the TRIPS Agreement Personal

the two legal frameworks. What is more, under the Convention on Biological Diversity, it is clearly stated – under article 22 – that the application of the document must not contradict commitments the state parties have under other international documents. Of course, when this article entered into force, the TRIPS agreement was not present yet.57 _{This, however, should not be a problem because}

of the existent laws under Public International law, more specifically the Vienna Convention on the Law of Treaties. The VCLT has the answers in case the international documents deal with the same subject matter; however, this is a big question surrounding TRIPS and the CBD, which is still not resolved (whether TRIPS and CBD share the same subject matter). The TRIPS agreement would have a slight advantage in case the VCLT is used to check which treaty should prevail, because it entered into force later, and the way it is structured and written down is more specific.58_{Nonetheless, the reason why such international agreements are put in place is not to check}

which one would prevail, but to ensure the well-being and the prosperity of the people around the world. Thus, it is true that articles under the CBD, such as article 16 paragraph 5 and paragraph 3, are advocating something like a mutual respect, given the fact that they want to ensure sharing of technology and benefits, but still follow the rules of international law. In other words, article 16 CBD considers the rights of intellectual property rights holders, thereby promoting mutual recognition. Under the TRIPS, there is no mechanism to connect the intellectual property rights with the requirements under the Biological Diversity Convention, but that does not mean that they do not overlap.59

Article 27 of the TRIPS is the perfect and probably the most significant example of how the two regimes interact. According to this provision of TRIPS, countries' governments must acknowledge the inventions or processes without acting in a discriminative manner. Paragraph 2 of the same provision provides the possible methods to avoid patentability (protect orde public etc). Therefore, if states want to fight against the problem of Biopiracy, they can easily address article 8 of the TRIPS, which obliges Members to adopt laws which are in accordance with the agreement and then refer to article 27(2) by stating that Biopiracy can be seen as a threat or violation of orde public/morality. Moreover, as it was already mentioned (in the analysis of article 27(3)(b) TRIPS in the previous sections) states parties to the World Trade Organization have the power to decide what is to be patented and what not, with the limitation that if they determine not to provide certain species/processes with patent protection, they must create special regimes safeguarding those plants

57 _{Consultants (Wye) Ltd Centre for European Agricultural Studies, Geoff Tansey, Queen Mary Intellectual Property} Research Institute, Study on the Relationship between the Agreement on TRIPS and Biodiversity Related Issues( Final Report for DG TRADE European Commission, CEAS 1843/CIEC, 200) p.55

58 _{Mark Villiger, Commentary on the 1969 Vienna Convention on the law of the Treaties (1 edn, Martinus Nijhoff} Publishers 2009) 403.

or animals. Developing countries have been advocating the amendment of article 27(3)(b) TRIPS (to include prior informed consent) while the developed countries wish its removal because of the compulsory patenting on micro-organisms, bio and non-bio processes. If those restrictions did not exist, biopiracy would be a constant practice.60

While the CBD suggests mutual existence and balance between the rules of the two frameworks, and the TRIPS does not at the same time contain provisions directly or indirectly referring to the rules of the Biodiversity Convention, it is difficult to argue about an existing clash. Neither the TRIPS nor the CBD contains measures that can hamper a country's commitments under either of the two regimes. There are no provisions contradicting directly, yet there are still situations where implementing the requirements from one of the agreements could somehow affect the application of the rules of the other. A case in point is article 16, paragraph 5 of the CBD, which identifies a possibility of intellectual property rights having unfavorable effects on the utilization of the Convention's laws. Article 8, paragraph (j) of the Convention on Biological Diversity shows the significance of traditional knowledge and the need to protect the native peoples’ culture, while under the TRIPS, TDK is not safeguarded as its measures are only dealing with recent innovations. Nonetheless, such indirect overlaps or conflicts can easily be fixed with understanding from the parties, and interpretation. To put it another way, problems such as Biopiracy or clashes between international legal documents can be resolved only with the recognition of the problem, cooperation, and mutual understanding, because most of the times the issue is not about the legal texts but the parties trying to push their agendas instead of thinking for the common good.61

Chapter 3

3. The legal practice on Biopiracy – another way to prove that the current legal

framework needs urgent changes.

60_{Helfer (n 20) 64; D Schmidt , 'Postcard from the Reality-Based Universe: Wish YouWere All Here! A} Meditation on the Relationship Between Science, Intellectual Property Law, and the Rights of Indigenous Populations in Plant Genetic Resources' [2008] 38(1) Environmental Law 351.

Up to now, the text dealt with the legal framework surrounding the issue of Biopiracy.

In this chapter, the case law on the topic will be analyzed because it depicts the negative effects of Biopiracy on indigenous peoples (as it is in a way "stealing" their traditional knowledge without compensation), as well as the bad impact on developing countries. Only a few of these cases resulted in mutually beneficial outcomes for the parties, providing some sort of solutions to the problem. Thus, the text will examine exactly those few cases which provided a solution. Nevertheless, the time frame within which the disputes were decided, as well as the amount of money which had to be paid for the services, prove that there is an urgent necessity for a change in the legal system as it permits (and to a certain extent encourages) the existence of Biopiracy. In other words, the thesis wants to show that situations where the outcomes were positive (creating precedence, fighting against Biopiracy), actually play the role of an argument that there is still need for change in the current legal framework.

The first case which the thesis will summarize is the Hoodia Cactus case (the Hoodia plant can be found in the southern parts of Africa). This case is important because of the fact that this type of cactus has been used by the native African tribes to overcome starvation and thirst. A company, situated in the United Kingdom, learned about the effects of the plant and decided to apply for a patent over the P57 agent which suppresses hunger (potential cure for obesity). The estimated profits were huge; however, no compensation was intended for the indigenous people who actually discovered the beneficial properties of Hoodia.62 _{The native people using this cactus are called San}

people. A couple of years after the UK company applied for a patent, several non-governmental organizations received the information about the case, deciding to help the San people to start legal proceedings for a benefit-sharing agreement. The negotiations were conducted through the South African Council for Scientific and Industrial Research, which administered the research on whether the San people had the right to claim benefit-sharing. Within the legal system of South Africa, the traditional knowledge and the generic resources were not well safeguarded. Nonetheless, with the help of the NGOs and the provisions of the Convention on Biological Diversity (article 8 (j) CBD), it was argued and established that indigenous peoples should have been asked for permission before the company could apply for a patent, thus leading to the outcome that the profits from selling the product based on the agent within the plant must be equally distributed between the native peoples (knowledge owners) and the enterprise. This is considered the first case where a benefit-sharing agreement was negotiated, the negotiations ending positively for the indigenous people. Unfortunately, it is still to be decided how the San people will be compensated. The lesson that should be learned from the Hoodia Cactus case is that national states must implement better

protection over the traditional knowledge and their biodiversity, as well as the need for amendment of the international legal framework, as indigenous people are unable to defend their rights alone without the help of non-governmental organizations willing to support them.63

The next two cases are crucial because they showcase rare circumstances where patents that were already granted are being invalidated in order to protect traditional knowledge, prevent the extinction of biodiversity and safeguard the interests of farmers in certain developing countries. The first of those two cases dealt with a patent granted in Europe. The patent was granted based on an agent found in an excerpt from a seed of a Neem tree (a tree which grows in India, famous for the fact that it can be used in toothpaste, detergents for pesticides or even in repellents).64_The

company, situated in the United States, together with the US Department of Agriculture, applied for a patent in Europe. After several years of analysis, the patent was awarded for the agent within the seed, which is used to fight pesticides. However, renowned activists disputed the awarded patent; they acted in order to help the Indian Government in the fight to safeguard its farmers, the existing biodiversity and the traditional knowledge which was being stolen and used by private foreign company.65 _{The challenge of the patent was built on arguments questioning the uniqueness of the}

product and the deficiency of information provided to the authorities. After the steps taken by the activists, and the close examination carried out by the European Patent Office, the patent was annulled as the findings of the company were not unique and lacked innovative processes. The decision of the European Patent Office was appealed but the Board of Appeals reached the same conclusion; the only difference was that it believed that the creation was unique. This so-called Neem Tree case is crucial to the topic of Biopiracy. Despite the fact that nowhere in the case the word "Biopiracy" was used (which is only mentioned outside proceedings), it still matters because the European Patent Office invalidated an awarded patent for the first time. Unfortunately, this is one of many patents based on bio agents found in the Neem Tree, and this single invalidated patent was not annulled in the United States but only in Europe.66 _{So, after ten years of expensive court}

proceedings, the patent was abolished in Europe but not in the USA. In other words, the European Patent Office created a precedence that might bring solutions to the issue of Biopiracy; however, the fact that it may take up to ten years to resolve such a dispute (which is half the amount of time for

63 _{Tonye Marcelin , 'Biodiversity Regulatory Options: Involvement of Rural Communities in DecisionMaking} Processes in South Africa' [2006] 8(6) The Journal of World Intellectual Property 810-824; Rachel Wynberg, ' Rethoric, Realism and Benefit-Sharing: Use of Traditional Knowledge of Hoodia Species in the development of an Appetite Suppressant' [2004] 4(4) The Journal of World Intellectual Property 851-870.

64 _{Report of an ad hoc panel of the board of science and technology for international development and}

others, Neem: A Tree for Solving Global Problems (1 edn, The National Academy Press Washington DC 1992) 4. 65 _{Hamilton (n 6) 165-166.}

66 _{Linda Bullard , 'Freeing the Free Tree A Briefing Paper on the Neem Biopiracy Case' (Northwest Resistance}

against Genetic Engineering , 2005)

which a patent is granted – 20 years), as well as the fact that it is extremely expensive, makes it impossible for local farmers or indigenous peoples to bring claims on their own. 67

The second case of importance concerning the problem of Biopiracy is often referred to as the Enola Bean case. The proceedings of this dispute were held in front of the United States Patent and Trademark Office. The Enola bean was brought from Mexico to the US in 1999 by an American citizen who decided to grow and later cultivate the seed after he discovered the unique yellow color of the bean. The American citizen's name was L. Proctor who applied for a patent before the American Patent authorities and eventually was granted one. Proctor received not only a patent but also a certificate confirming the discovery of a new sort of beans.68 _{Therefore, Larry Proctor had the}

autonomous right to sell the bean, being also entitled to stop any imports of analogous beans from Mexico. Mexican farmers were forced to pay a certain amount of money in order to be able to export their products, which put them in a detrimental position on the US market.69 _{Luckily for the}

Mexican farmer, the International Center for Tropical Agriculture disputed the novelty of the Enola bean and asked for a revision of the granted patent. The CIAT argued that Mexican and American farmers had grown identical beans years before the Enola bean was patented.70 _{After close}

examination of the filed complaint, the US Patent and Trademark Office annulled the patent in 2008. It took the American authorities approximately nine years to reach a decision, which is rather slow when it comes to earning your livelihood (a problem which Mexican farmers faced).

Summarizing the three cases, showing the positive outcomes (which is not seen very often) but proving that the existing systems are not adequate enough (due to the high costs and lengthy procedures) confirms the argument that there is a crucial need for changes within the current legal framework. The current legal system, as shown previously in the text, allows Biopiracy in a way. It even makes it useless – or sometimes even impossible – to challenge awarded autonomous rights because of the amount of money and time that have to be invested (where an adequate resolution to the dilemma is not guaranteed). Therefore, after the thesis analyzed the existing legal framework and the case law on the topic, it is time to see what can be transformed and who has the authority to do it. To put it another way, the text will continue with some examination of the World Intellectual Property Organization and its work, which might have answers to the question of how Biopiracy can be stopped and whether the authorities do enough to solve the problem.

67 _{Schmidt (n 60) 332.} 68_{Gubarev (n 12) 86-89.}

69 _{E Donovan, 'Beans, Beans, the Patented Fruit: the Growing International Conflict over the Ownership of} Life' [2002] Loyola of Los Angeles International and Comparative Law Review 122.