Vol. 7.5 December 2003


BIOTECHNOLOGY, PATENT LAW AND PIRACY:
Mirroring the Interests in Resources of Life and Culture

Jerzy Koopman(1) (Utrecht University)



Readers are reminded that this work is protected by copyright. While they are free to use the ideas expressed in it, they may not copy, distribute or publish the work or part of it, in any form, printed, electronic or otherwise, except for reasonable quoting, clearly indicating the source. Readers are permitted to make copies, electronically or printed, for personal and classroom use.

Cite as: Jerzy Koopman, Biotechnology, Patent Law and Piracy: Mirroring the Interests in Resources of Life and Culture, vol 7.5 ELECTRONIC JOURNAL OF COMPARATIVE LAW, (December 2003), <http://www.ejcl.org/ejcl/75/art75-7.html>


Contents
1. Introduction
2. Biotechnology and the hunt for biopharmaceuticals
3. The resources of biotechnology
4. Patent law and genetic inventions
5. Piracy?
5.1 Traditional knowledge and genetic resources
5.2 Globalization of intellectual property
6. National legislation to prevent piracy
7. The Convention on Biodiversity: Connecting innovation with conservation?
8. Initiatives to reconcile TRIPS and the CBD
9. Where to go from here?
Notes

1. Introduction

In the last decade, the application of modern biotechnology for agricultural, ecological and medical purposes has sparked great hopes for the extent to which man can explore and exploit biological resources for his well-being. Simultaneously, the commercial use thereof has led to intense international and multicultural conflicts and debates. These conflicts and debates hinge on the conflicting claims concerning two of the most important 'resources of biotechnology' - genetic material and knowledge. These claims may have a proprietary character, but too often also relate to spiritual, ecological and ethical considerations. The proponents of one or the other claim may be driven primarily by commercial motives, but may equally well be inspired by cultural opinions. The way in which these claims are awarded or rejected determines, to a large extent, the overall freedom of access to and use of genetic material, whether modified or not. Also, it greatly affects the attribution of the benefits that result from its commercial exploitation. Intellectual property law, and particularly patent law, has a profound influence on the manner in which said claims may be awarded. Patents on genetic inventions principally add to the information available for innovation through the disclosure of the invention in the patent application. At the same time, though, they grant exclusionary rights to the patentee in regard to the commercial use of the invention and the genetic material it consists of. Of course, also the benefits deriving from such use are exclusively for the patentee. The manner in which genetic inventions can be patented may be called the internal patent law perspective. It is determined by positive law and has a technically legal character. The consequences of the manner in which patents for genetic inventions are granted may be called the external perspective. The external perspective deals with broader social outlooks, such as the freedom of access and the use of knowledge related to genetic material and the material itself. These perspectives are interconnected and interactive. This is exemplified by the manner in which they are dealt with in the Convention on Biodiversity (CBD) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).(2) The implementation of these treaties determines to a large extent the manner in which the 'global commodity' genetic material, and the knowledge pertaining thereto, can be exploited commercially. Also, it directs the role of the global public domain in innovation, traditional usages of genetic material and sustainable development. This paper briefly highlights some of the mirroring interests in genetic material and related knowledge - 'the resources of life and culture' - and the impact patent law has on the manner in which they could be safeguarded. Furthermore, national and international initiatives that are taken for this purpose are briefly analysed. To conclude, some suggestion are presented on how the seemingly conflicting interests in this field can be reconciled. Also, issues that would need further research and discussion are formulated, in an attempt to identify the steps ahead in this highly dynamic field.


2. Biotechnology and the hunt for biopharmaceuticals

For thousands of years, human beings have exploited biological resources for medical, agricultural and other purposes.(3) Modern biotechnology is only the latest fashion by which man is able to use his natural environment to feed, cure and house himself. Nevertheless, it is a special fashion in its 'potential . . . to construct artificial conditions in which specific variables can be known in such a way that they can be manipulated'.(4) Modern biotechnology allows for the direct and tailored modification of the genetic building blocks of organisms, their isolation from their uncultivated environments (the genomes) and their application for new means - i.e. therapies of genetic predispositions of organisms, regardless of whether they are humans or crops, and the development of new medicines with advanced curative properties.(5)

The promises of modern biotechnology are reflected in the commercial valuation of the products that it delivers. In 2002, the European Commission estimated that in 2004 the world market for biopharmaceutical products would amount to EUR 506 billion.(6) It is expected that plant biotechnological products, particularly in the pharmaceutical field, will contribute most to the success of biotechnology. The proceeds generated through the sale of these biopharmaceuticals can be gigantic. For example, the pharmaceutical company Merck & Co. generated over 4 billion US dollars through the sale of Simvastatin in 1998, while in the same year Bristol-Myers Squibb sold over 1,5 billion US dollars worth of Pravastatin.(7)


3. The resources of biotechnology

Whilst profitable, the research and development (R&D) of these products is generally expensive and risky. The successful development of a biopharmaceutical product may cost as much as 800 million US dollars.(8) Equally burdensome are the technical and legal risks involved. The company making the financial investments always faces the risk that its efforts will not lead to a concrete product after all. And if it does, it still has to overcome a variety of regulatory hurdles before it can commence to market and distribute the product.(9)

Of course, money is not the only resource of biotechnology, albeit the only one that is provided entirely by the developed world - countries such as the US, the UK, France and Japan. These countries have a huge economic and technological advantage over other countries, particularly in the cost-intensive field of biotechnology. They are commonly referred to as 'the North'.(10) The other resources used in bioindustry are, of course, labour, knowledge and genetic resources and they have a global and diverse origin.(11)

Genetic resources are primarily found in developing countries with a tropical climate, such as Brazil, Peru and Costa Rica. They are commonly referred to as 'the South'. Biodiversity is largest in these countries - the variety of genes, organisms and ecosystems. Presently, most of it is neither publicly known nor easily accessible. The promises of biotechnology make it worthwhile to intensely prospect this material, screen it for beneficial properties and, if there is a 'hit' (a promising compound or activity), modify it in a variety of ways to develop a concrete product.(12)

As indicated above, the genetic resources currently available were shaped in thousands of years of evolution and human cultivation.(13) For prolonged periods of time, indigenous communities have shaped their environment and its organisms, and thus the genetic resources embodied therein. Hence, they delivered part of the labour that ultimately contributes to the development of biopharmaceuticals. The character and focus of the labour of these communities, and its relevancy for the eventual biopharmaceuticals developed, differ to a large degree from the labour that is conducted within the bioindustry, universities and botanical gardens. Nevertheless, the manner in which indigenous communities have lived in and worked with the organisms in their traditional environment has endowed them with extensive knowledge. Because the non-technological nature of that knowledge, it is commonly referred to as 'traditional knowledge'. Unlike 'modern knowledge', pertaining, e.g., to biotechnology and the way it is applied in bioindustry, traditional knowledge is not applied according to humanistic principles. It stems from holistic principles and is applied according to notions of biocentricism, co-evolution and equality. Its methodology and approach differ from 'modern science' in the sense that it is very practical, does not rely on empirical verification and connects the physiological characteristics of organisms with their spiritual ones. For the physiological characteristics, the holders of traditional knowledge, such as shamans and other types of healers, focus on the visible (phenotypic) properties. In contrast, biotechnology directly addresses the biochemical (genotypic) properties.(14) For these reasons, traditional knowledge usually does not contribute directly to the development of a biopharmaceutical, which ultimately originates from biotechnologies and other 'modern' means. However, it is helpful anyhow and is often indirectly involved in the R&D process of bioindustry. Traditional knowledge holders regularly put Western scientists, such as botanists and pharmacologists, on track, indicating to them particular organisms whose medical properties are known to them. Also, and during later stages of the R&D process, they may assist in finding beneficial use for the organisms or their compounds, and act as a source for practical verification.(15)

Clearly, the R&D process for a new biopharmaceutical product involves many participants from many disciplines, cultural backgrounds, countries and stages. Briefly stated, it could commence by means of bioprospection in a biodiversity-rich country, with the help of an indigenous community. It would further entail extensive screenings of the material thus collected, modifications and, in the end, clinical trials. After repetitive successful trials, the company involved may apply for approval by the national authorities and, eventually, the biopharmaceutical may be registered and reach the market. In view of the promises of these products, societies would clearly want to stimulate their development. At the same time, the complexity and costliness thereof may scare off potential investors and inventors. What company would be willing to devote its resources to such a project, without being able to earn back the investment after a successful product has been developed? Here patent law comes in.


4. Patent law and genetic inventions

A patent grants the patentee the right to exclude others from commercially using the patented invention for a period of twenty years.(16) The underlying assumption is that, through exclusivity, potential inventors are incited to devote their resources to R&D of new products and inventions, because of the prospect of acquiring patents and, therefore, exclusivity in the exploitation for a limited period of time.(17) In view of the immensely high investments needed for the development of biotechnological products, this presumption would particularly apply to bioindustry.(18)

Historically, an ambivalent patent practice existed in regard to inventions involving biological materials.(19) In view of the emergence of modern biotechnology, the past decade has led to a firm practice in this regard. Presently, thousands of patents are granted for all sorts of biological inventions every year in the US and Europe.(20)

This development has sparked heated debates. The broadest debate concerns the ethical and societal aspects of patenting genetic materials.(21) Some of the concerns expressed in that debate are not only related to the consequences of particular inventions - traditionally, not the primary focus during the examination of a patent application - but also to the manner in which the criteria for patentability are applied. It mostly concerns the novelty and non-obviousness requirements, and, additionally, the manner in which patent applicants are required to disclose information to enable others to repeat the process.(22) Also, the manner in which the exclusion of patentability of discoveries is applied is intensely debated in the field of biotechnology.(23) Despite the existing practice of patenting biotechnological inventions, it shows that several primary questions continue to be posed, and the controversy has not quieted down.(24)

A debate which is held separately, but is more or less intertwined with both the ethical and the technical controversy surrounding the patenting of genetic inventions, addresses the manner in which claims to some of the resources of biotechnology can be recognized by means of patent law. At the heart of this debate is the question whether the manner in which today's bioindustry prospects biological resources and commercializes the products deriving from them through patent law amounts to the 'theft' of knowledge of indigenous communities and genetic material from the provider countries. Some hold the opinion that these commercial activities amount to cultural piracy and biopiracy.(25)


5. Piracy?

Two circumstances are supposed to enable the North to conduct its piracy. First, current patent law does not readily allow the recognition of different types of knowledge used in arriving at an invention. Also, the origin of the biological material and the manner in which it was acquired are irrelevant to the patentability of an invention or the rights related to a patent granted. Second, TRIPS has rendered the Northern patent regimes into a global regime, also where biotechnological inventions are concerned.

5.1 Traditional knowledge and genetic resources

The claim of cultural piracy is established on the following basis. For a variety of reasons, traditional knowledge can hardly be recognized, let alone rewarded, in present patent procedures. Recognition of traditional knowledge in a patent procedure is hampered by the fact that it is usually not codified, categorized and structured in manners that are common in the Western world. Languages and methodology are completely different from the languages and methods of 'modern science' with which scientists creating biotechnological inventions work. Hence, it is almost impossible for patent examiners to 'translate' traditional knowledge concepts into those of Western science - and subsequently recognize them in a patent application. Although some traditional knowledge has been described, both by indigenous communities themselves and by Western scientists, it is not yet done in a coherent and structured fashion. The same applies to most databases that contain traditional knowledge.(26) Hence, the information patent examiners would want to investigate is fragmentized and often not reliable. However, even if such information would be more readily accessible, it may just as well not bear any light on the patentability of an invention. There may be a causal relation between the use of traditional knowledge and the invention for which a patent application is filed, but it is likely not to show from the invention. Not only the translation of concepts 'hides' traditional knowledge, but also the fact that highly technical products, such as biopharmaceuticals, are the sum of the parts, and traditional knowledge may be the most indirect one of them. Therefore, even if traditional knowledge contributed directly to the development of a biopharmaceutical product, it is likely that it would not be recognized as such during the patent procedure. It is likely that the patent office will grant a patent for the invention involved, while it should not, or restrictively, do so because part of it lacks novelty and/or is obvious.(27)

The so-called appropriation of traditional knowledge by means of patenting certain products that partially derive from that knowledge is one side of this problem. Clearly, indigenous communities and representative organizations seem to have possibilities to fight outright unjustified patents.(28) They may act defensively. The other side of the problem may be that they cannot adequately protect their knowledge and the tangible manifestations thereof. They lack offensive measures to protect their interests, as their knowledge and the products deriving therefrom are either not suited for patenting or are considered to have fallen into the public domain. The public/private domain paradigm and the manner in which certain information or goods are considered to be public or private is, at least in the field of intellectual property, determined mostly by the notion of 'communication'. This can be exemplified by the definition of 'novelty' in Article 54(1) and (2) of the EPC, according to which publicly communicated information belongs to the state of the art and cannot be patented. This implies that Northern bioindustry generally keeps its knowledge, and certain inventions, secret until it applies for a patent. It is very conscious of the danger of losing its claims, and pursues to make effective use of the law of trade secrets and, ultimately, patent law to safeguard its interests.(29) Traditionally, indigenous communities have treated their knowledge differently. Although traditional knowledge is often held exclusively as well, that exclusivity does not hinge on the Western concept of communication or secrecy, but rather on attributes of the keeper of the knowledge. For example, shamans and traditional healers may hold and apply particular knowledge exclusively, though not because they themselves developed it or held it secret from other community members, but because they fulfil certain spiritual or cultural requirements. Therefore, much of the traditional knowledge relevant for the development of biopharmaceuticals has fallen into the public domain. However, even if it has been kept secret and is first communicated publicly upon filing a patent application, it would still not be eligible for patent protection. Traditional knowledge has been developed over generations and in communities over prolonged periods of time. Therefore, it is impossible to identify the individual inventor - which is necessary for patent protection. Often, the communities concerned do not even wish to appoint a representative as such since they feel that the knowledge involved belongs to all and cannot be attributed to an individual. A community patent does not exist, however. Also, other patent requirements prevent traditional knowledge, and certain products deriving therefrom, from being patented. For example, most of the time the innovations concerned are not immediately industrially applicable.(30) It is important, however, that some indigenous communities do not only endeavour to prevent others from appropriating their traditional knowledge through patent law, but do not want to make use of that exclusive proprietary right themselves either. Many indigenous communities do not recognize the concepts of individual ownership, exclusion and competition that underlie Western property law regimes.(31)

The diverse origin of traditional knowledge makes the protection thereof even harder. Cultures and their manifestations - whether they are scientific, spiritual or artistic - are generally accessible, open and dynamic. Like human beings from all cultures, indigenous communities have exchanged much knowledge and many customs over time. Therefore, it is difficult to identify the communities to which the knowledge should predominantly be attributed. The fact that many communities, sharing similar knowledge, reside in different countries further complicates the matter.(32)

A similar situation exists in regard to genetic resources and reflects upon the claim of biopiracy. As stated above, most genetic resources are found in the South - in developing countries with a tropical climate. Presently, the origin of the material used in the development of an invention or the manner in which the inventor acquired it is irrelevant for patentability.(33) Indication of the origin of the material used is only required if it concerns a rare material, which the patent examiner needs to acquire himself to check whether the invention can be repeated (enablement).(34) Consideration 27 of the European Biotechnology Directive states that the geographical origin of biological material must be disclosed in the patent application if the invention deals with such material.(35) However, this consideration has not been repeated and included in the Directive itself, and can therefore not be applied. Also, Consideration 27 explicitly states that the obligation to disclose the origin of biological materials used in the development of the invention does not affect the examination of patent applications or the validity of the rights related to patents granted. The origin of the tangible materials used in the development of an invention is irrelevant for the patentability of the invention since the latter focuses on the novel intellectual effort, contributing to technological progress. The societal aspects of a particular technological step forward, for example the behaviour of the patent applicant when acquiring the material used in the invention or the danger of application of a certain invention, are deemed irrelevant and are to be regulated by other regimes.(36) However, even if one is inclined to include considerations about the origin of the material and the manner in which a patent applicant has acquired such in the examination procedure, the legal ramifications thereof would be hard to determine. Should the provider of such material benefit from the invention? If so, how should this be accomplished? One may doubt the basis therefore as the provider did not actually contribute intellectually to the invention. Also, his exclusive claim to the tangible material concerned may be controversial. The same genetic material is present in many countries. Giving preference to a benefit-sharing claim from one or the other country may lack a legitimate basis.(37)

5.2 Globalization of intellectual property

The second circumstance supposedly enabling the North to conduct its cultural piracy and biopiracy is related to the implementation of the TRIPS. The TRIPS was concluded in 1994, in the course of the establishment of the World Trade Organization (WTO). Ratification of TRIPS is a prerequisite for membership of the WTO. Of course, developing countries practically had no choice but to adhere to TRIPS. Their economic development made it absolutely necessary to join the WTO, which allows them to freely trade their products around the world. Hence, they were forced to implement TRIPS in their national legislations.(38) The North insisted on the connection between TRIPS and the WTO as it would enable it to effectively enforce the intellectual property rights pertaining to some of its most important export products, i.e. technology and artistic creations such as medicines and films.(39) At the same time, it is clear that developing countries do not have the means to participate in the 'race to innovation'. The state of their technological and economic development does not allow them to compete with equal arms.(40) Therefore, the South feels that it is not only confronted with cultural piracy and biopiracy, but that it is even forced to collaborate. It not only finds that its genetic and knowledge resources are appropriated, but that it must even legitimize the 'theft' through granting and enforcing intellectual property rights. In view of this, some of these countries have made national legislation providing measures against the appropriation of those resources through intellectual property law.


6. National legislation to prevent piracy

In the past few years, many developing countries have implemented sui generis regimes for both the offensive and the defensive protection of their genetic resources and the traditional knowledge of their indigenous communities. For example, Costa Rica, Brazil, Peru and India have implemented legislation for that purpose.(41) These statutes have in common that they condition access to genetic resources and traditional knowledge upon the fulfilment of certain requirements, such as prior informed consent of a national office governing the country's biological resources and the indigenous communities involved. Furthermore, biological samples and knowledge can only validly be transferred if proper benefit-sharing agreements are concluded, allowing the source country and the indigenous communities involved to share in the proceeds deriving from the commercial exploitation of the material or knowledge concerned. The statutes presuppose the existence of intellectual property rights in the materials and knowledge concerned, and often negate the existing public/private domain paradigm. Even the transfer of biological samples or of traditional knowledge does not exhaust the proprietary rights pertaining thereto - the provider usually remains entitled to exploit the object of transfer regardless of any subsequent intellectual property rights of the acquirer. Most importantly, these statutes generally indicate that within the countries concerned no intellectual property rights can be obtained if the aforementioned requirements, such as benefit sharing, are not fulfilled. Sometimes, violating the requirements of these statutes amounts to a criminal offence and may be prosecuted accordingly.(42)

Obviously, these statutes violate TRIPS in various manners, most importantly by negating the distinction between the public and the private domain, adding additional requirements to the patentability of inventions and apparently providing for continuous licenses to the transferors by operation of law. However, these statutes seem to correspond more or less with another treaty which existed before the conclusion of TRIPS - the Convention on Biodiversity.


7. The Convention on Biodiversity: Connecting innovation with conservation?

The Convention on Biodiversity was concluded in 1993, one year before the conclusion of TRIPS.(43) Its main goals comprise the conservation of biodiversity, sustainable exploitation of its components and the equitable and fair sharing of the benefits deriving therefrom. Referenced national sui generis regimes are mostly based on a few provisions in the CBD. Most importantly, Article 3 of the CBD states that states have sovereign rights over their biological resources. Article 8(j) of the CBD obliges states to:

Subject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable 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.

Article 8(j) is related to Articles 15 and 16 of the CBD, which are generally considered to be the 'heart' of the convention.(44) Article 15(1) and (2) repeat that states have sovereign rights over their biological resources insofar as they are the country of origin or have acquired them in compliance with the CBD. Pursuant to Articles 15(4) and (5), access to biological resources is conditioned upon prior informed consent of the source country. Furthermore, Article 15(7) states that the countries involved should provide for a mechanism that allows fair and equitable sharing of the benefits arising from the commercial and other utilization of genetic resources. Article 16 of the CBD concerns access to and transfer of technology. Article 16(2) states that developing countries are to have access to technology under 'fair and most favourable terms', albeit consistent with the 'adequate and effective protection of intellectual property rights'.

Clearly, both bioprospecting activities and the commercialization of the products resulting therefrom - among other things by means of intellectual property law protection - are subjected to both TRIPS and the CBD. It is the interface between these treaties that determines the manner in which various commercial and other interests in genetic resources and various types of knowledge can be safeguarded. Nevertheless, it is clear that the CBD and TRIPS are not easily implemented fully at the same time. Some of their provisions do not seem to correspond or are even outright in conflict with each other. For example, in principle, the exclusive rights of the patentee (Article 28 of TRIPS) would not allow 'fair and equitable' benefit-sharing (Articles 15 and 16 CBD).(45)

Nevertheless, and on a general level, both the CBD and TRIPS allow the consideration of interests that, strictly speaking, fall outside their scope. Hence, Article 16 of the CBD explicitly states that intellectual property rights should be recognized and respected. Similarly, Article 7 of TRIPS emphasizes one of the underlying aims of the global intellectual property law regime:

The protection and enforcement of intellectual property rights should contribute to the promotion 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.

Moreover, Article 31 of TRIPS provides for granting compulsory licenses if the potential licensor has unsuccessfully made reasonable efforts to acquire such a license from the patentee, or a situation of national emergency exists.(46) In my opinion, it is from these ambivalent and unclear interfaces that a fully integrated international bioprospecting regime should be developed.


8. Initiatives to reconcile TRIPS and the CBD

Several international governmental organizations ('IGOs') have taken initiatives to that extent; however, to discuss them falls outside the scope of this paper. Briefly, the characteristics and aims of the most relevant initiatives - those taken by the World Intellectual Property Organization (WIPO) and the Secretariat of the CBD - will be considered.(47) WIPO and the Secretariat of the CBD - through its working groups and expert panels - work closely together in pursuing to integrate the two instruments and to reconcile some of the interests involved.

WIPO has conducted an extensive fact-finding mission, to inquire into possible means for the protection of the interests of traditional knowledge holders.(48) Clearly, most manifestations of traditional knowledge cannot be protected pursuant to current intellectual property law. Therefore, WIPO suggests to develop of a sui generis regime. Its most important requirements would be that it concerns documented and concrete knowledge with which the applying community has a cultural association. Rightholders would have the right to prevent the reproduction and fixation of literary and artistic expressions, and the exploitation of technical elements.(49) Although sui generis protection for traditional knowledge may solve some of the conflicts, many problems remain, and further study is required. It would be good to clarify the relation of such a regime with existing intellectual property law, delineate the subject matter, develop methods to identify the proper communities, monitor infringements and mechanisms for enforcement and provide sufficient legal certainty given the dynamic nature of the knowledge protected.(50) Also, the proposed sui generis regime would not address non-economic interests in the subject matter, which, as was noted above, is of great importance to the communities involved.

Another part of the WIPO initiative is aimed at allowing patent examiners to consider traditional knowledge when they inquire into the novelty and non-obviousness of inventions.(51) For this purpose, WIPO has started an experiment with the Traditional Knowledge Digital Library, which in the future could be integrated in its Intellectual Property Digital Libraries.(52) The Traditional Knowledge Digital Library is to provide concise, categorized and standardized information on prior traditional knowledge and to allow patent examiners to apply the novelty and non-obviousness requirements accurately. Whilst increasing the chance that appropriation of traditional knowledge will be noticed during patent procedures, this initiative has one important downside. It puts the traditional knowledge concerned in the public domain, disabling the communities concerned even more in their attempt to obtain protection offensively.

Also the working groups and expert panels of the CBD, pursuing to pave the road for implementation, have made considerable efforts. A major achievement is the conclusion of the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization in 2002.(53) The Bonn Guidelines may give providers of genetic material and/or knowledge and the acquirers and users thereof directions in the drafting of agreements that comply with both the CBD and TRIPS. These so-called Material Transfer Agreements are to safeguard ethical and users' interests of indigenous communities, to regulate the acquisition and enforcement of intellectual property rights in common consent, yo provide accurate descriptions of the genetic material and related traditional knowledge concerned and to specify the ways in which such may be exploited commercially (Articles 42-44 A). Pursuant to Articles 44-50 A, Material Transfer Agreements are also to provide specified ways of benefit-sharing. However, the Bonn Guidelines go further than providing suggestions for the contents of Material Transfer Agreements only. They also propose to link directly the patentability of an invention consisting of or made by using of genetic material and/or traditional knowledge, to prior informed consent of provider countries and/or indigenous communities and fair and equitable benefit-sharing (Articles 1 and 2 C). Clearly, several of the referenced sui generis regimes in the South already provide for these additional requirements for patentability.(54)

Despite the steps made by the promulgation of the Bonn Guidelines, several key problems remain. The competence of indigenous communities and provider countries with respect to the traditional knowledge and genetic material subjected to the Material Transfer Agreements remains uncertain. As indicated above, this uncertainty derives from the diverse origin of both genetic material and traditional knowledge. This will directly affect the validity of the agreements and raises the question whether courts of law will be inclined to uphold and enforce them. Also, the manner in which the ethical interests of communities should be aligned with the enforcement of intellectual property law pursuant to TRIPS remains unclear. Furthermore, although the rights and obligations in regard to the initial knowledge and material may be specified in the agreements, the legal ramifications thereof for derived inventions and products are not articulated. In regard of the purported additional requirements for patentability - prior informed consent and benefit sharing - questions remain as well. What would be the extent of these requirements in view of the indirect relation between initial material and knowledge, and the eventual invention (end product)? When are the rights of the provider countries and communities exhausted? And what is the legal status of these requirements? Are they formal or substantive ones, i.e. affecting the validity of patents?

Nevertheless, several botanical gardens, controlling a lot of the ex situ genetic material originating in developing countries, adhere to the Common Policy Guidelines for Participating Botanical Gardens that correspond with important elements of the Bonn Guidelines.(55)

Also, collaborations between public and private participants in bioprospecting activities have led to grassroots initiatives through which some of the interests concerned may be reconciled. For example, the projects of the International Cooperative Biodiversity Group (ICBG) aim to conduct bioprospecting activities in a variety of developing countries, among which Peru and Surinam, in compliance with Articles 8(j), 15 and 16 of the CBD. The ICBG consists of universities, companies, indigenous communities' representative organizations and national governmental institutes, both from the North and the South. By means of a combination of contractual instruments, such as prospecting, transfer of know-how, and trade secret agreements, and the sharing of intellectual property rights eventually obtained, the ICBG pursues to integrate both the CBD and TRIPS.(56) Nevertheless, the ICBG projects are severely criticized, mostly because they do not address the non-economic importance of traditional knowledge. Also, from a commercial perspective the relatively low royalty rates and other financial benefits awarded to developing countries and indigenous communities have led to complaints.(57)


9. Where to go from here?

The manner in which present-day biopharmaceuticals are developed shows that the classical concept of centre and periphery is no longer applicable, neither economically nor culturally. Local, regional and global interests are inherently connected. The globalization of patent law pursuant to TRIPS greatly adds to this interconnection.(58) In my opinion, one should, however, not ignore the monoculturally determined precept of intellectual property law. Patent law is supposed to stimulate certain types of innovation. It is one of the means by which societies, with a certain level of technological development, can strive to arrange economic growth. Conversely, patent law is the 'product' of a cultural arrangement as well. It seems to me that the application of a monocultural legal concept, such as patent law, to a multicultural world, where different countries have different policy aims and economic needs, is problematic. One may doubt whether the rigid application of TRIPS leads to justified outcomes. This doubt may even increase given the particular features of biotechnological inventions. Other than many other types of inventions, such as mechanical or electronic ones, they seem to build on a combination of substantial intellectual and practical contributions. Many of these go unnoticed when the innovator is awarded for his beneficial efforts through the grant of a patent. Hence, indigenous communities have modified biological materials in their environment for thousands of years, but are mostly left empty-handed. The efforts made, for example by WIPO and the Secretariat of the CBD, to provide them with a share in the benefits of exploitation may be inappropriate. They may not correspond with the needs and expectations of these communities, especially because of their differing cultural perspectives on how one could appropriately exploit natural resources. Another complicated matter relates to the claims of biodiversity-rich countries to the genetic resources present in their territories. These claims have been honoured in the CBD, and countries now have sovereign rights over their genetic resources. The actual basis for this sovereignty is, in my opinion, extremely ambiguous. Increasingly, calls are made to treat genetic resources as the common heritage of mankind.(59) Even more so, the legal ramifications of national sovereignty over genetic resources are unclear and may lead to equivocal rights and obligations. It is my opinion that both the CBD and the Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization wrongly mix rights and obligations pertaining to tangible objects and intangible ones - intellectual innovations. This conceptual confusion will not facilitate a further integration of the CBD and TRIPS and may diminish the chance that present conflicts will be resolved in the future.

Probably, the reconciliation of the various interests in genetic resources and knowledge, used in the development of biopharmaceuticals, can only occur through a change of conduct of all participants. Patent examiners should pursue to enhance their means of accurately examining the novelty and non-obviousness of inventions. Bioindustry should recognize the contributions of others to the inventions they develop and patent. The North - the developed world - should seek to stimulate its industries in doing so and may find ways of approaching the TRIPS obligations of developing countries with some leniency. The South - the developing world - may want to benefit from its genetic resources, while simultaneously recognizing the difference between 'raw' tangible material and the eventual invention deriving therefrom. Indigenous communities should pursue to protect their interests proactively, either through sui generis regimes or by other means, but should also allow others to continue their activities and recognize that legal uncertainty may have detrimental effects on the interests of bioindustry. Hence, if they participate in global commercial activities, they should also attempt to play by the rules and, for example, organize them in such a manner as to allow others to have legal certainty.

Obviously, it is the rules that complicate the endeavoured change of conduct; and it is the rules, which, in my opinion, do not suit the present situation of bioprospection and commercialization of the products deriving therefrom. Where to go from here? I would suggest the following.

First, attempts to protect the interests of developing countries in reaping some of the benefits obtained through exploitation of their genetic resources should be distinguished from initiatives to protect the interests of indigenous communities. The former may have control over tangible resources, whereas the latter have intellectually contributed to the development thereof. In my opinion, only the claims of indigenous communities may affect the patentability of inventions, because they influence the novelty or non-obviousness thereof. The claims of developing countries are hard to recognize in the realm of patent law - it would open the door to a variety of claims of the 'owners' of tangible objects used in the making of an invention and may therefore blur the distinction between the intangible (intellectual creation) and the tangible (the manifestation of such a creation). The former is subject to intellectual property law, whereas other legal instruments may apply to the latter.

Second, if one concludes that indigenous communities have indeed significantly contributed to the formation of particular genetic resources, one may want to reward these communities. If this cannot be done according to present-day patent law, one should consider changing that regime or develop an alternative instrument. Before initiating this, it is recommended that the actual contributions of the communities concerned be clarified. The same applies to the relevancy of their traditional knowledge for the development of biopharmaceuticals. When becomes the assistant a co-inventor? Subsequently, the standards for patentability - and perhaps the 'technical focus' of that law - may need alteration in order to allow the protection of more types of innovations. A sui generis system may be developed instead. However, given the manner in which the contributions to the actual biotechnological invention may be blurred, one may consider developing such a system for the inventions at hand, instead of for one of its resources, i.e. traditional knowledge; a sui generis regime tailored to, for example, plant biotechnological inventions. The present initiatives to develop a sui generis regime particularly for traditional knowledge may show to be unworkable. How is it to be integrated into the present patent law regime? How should the non-economic cultural considerations be dealt with?

The claim of cultural piracy and biopiracy needs to be analysed. According to Black's Law Dictionary (8th edition), piracy consists in 'the unauthorized and illegal reproduction or distribution of materials protected by copyright, patent or trademark law'. Also, and related to tangible objects, it could mean: 'robbery, kidnapping or other criminal offence committed at sea' or 'the crime of using force or threat to seize control of an aircraft, especially one in flight'. Clearly, these definitions, neither under present general property law nor under intellectual property law, directly apply to genetic resources and traditional knowledge. A clear understanding of the question whether developing countries and indigenous communities have a justified 'proprietary' claim to the resources concerned is necessary - and if so, whether the conduct of certain bioprospectors amounts to piracy.

Extensive analysis of the application of the novelty and non-obvious requirements to the inventions concerned is required. Moreover, a full-blown analysis of the differing concepts and methodologies of 'traditional' and 'modern' science is needed. Also, in the approach suggested cultural perspectives on the exploitation of natural resources, innovation and proprietary concepts would have to be compared. Do the principles underlying patent law necessarily differ from the principles underlying the concepts of guardianship or custodianship, applied in other cultures? Legal-philosophical analysis would offer the insight required, and possibly show that these perspectives, and therefore the claims deriving from them, are not so much in conflict as may seem at the outset.

I would recommend focusing on the potential consequences of any possible change in the manner in which inventions may be protected by patent law. These changes may drastically influence the speed of innovation in the highly promising field of biotechnology. While seeking to shape new concepts, embodying new approaches to innovation and the exploitation of knowledge and genetic resources, one should not ignore the presupposed positive effects of present-day patent law.

To conclude, I recommend that the North and its bioindustry participate actively in the debate and contribute constructively thereto. One reason may be that the bioindustry would not want to be confronted with opposition procedures in which the validity of its patents is disputed. It needs legal certainty to be able to conduct its activities successfully. Another reason may be more fundamental. Decency may require a positive approach to the claims of developing countries and indigenous communities. The North has initiated both the global prospecting of genetic resources and the global application and enforcement of intellectual property law. As the famous Dutch Admiral Piet Heyn once observed, referring to the original inhabitants of the areas under Dutch colonial rule: 'De vriendschap moet van onse zijde beginnen: Want wij soecken haer ende niet zij ons.'(60)



Notes

1. Centre for Intellectual Property Law, Molengraaff Institute for Private Law, Utrecht University, the Netherlands. This paper is based on a presentation held at the Ius Commune Research School workshop on Intellectual Property at Edinburgh University School of Law, 19-20 June 2003. Reactions are most welcome.

2. Convention on Biodiversity, 1993, available at <http://www.biodiv.org>. The Agreement on Trade-Related Aspects of Intellectual Property Rights, 1994; Marrakesh Agreement Establishing the World Trade Organization, Annex 1 C, Legal Instruments - Results of the Uruguay Round, available at <http://www.wto.org/english/docs_e/legal_e/final_e.htm>.

3. M. Weatherall, In Search of a Cure: A History of Pharmaceutical Discovery, Oxford University Press, 1990, p. 3. Aboriginals seem to have had modified organisms for at least 100,000 years. See D. Posey, 'Commodification of the Sacred through Intellectual Property Rights', Journal of Ethnopharmacology (83), 2000, p. 6.

4. P. Rabinow, Making PCR: A Story of Biotechnology, Chicago University Press, 1998, p. 20.

5. For the workings of biotechnology and its potential for a variety of goals, see P.J. Russel, I-Genetics, San Francisco: Benjamin Cummings, 2002, pp. 375 ff. In the remainder of this article, for illustrative reasons references are made to medical biotechnological products, particularly pharmaceuticals. Biotechnological pharmaceutical products are generally referred to as 'biopharmaceuticals'.

6. Commission of the European Communities, Life Sciences and Biotechnology - A Strategy for Europe, COM(2002) 27 final, p. 7, available at <http://europa.eu.int/eur-lex/en/com/cnc/2002/com2002_0027en01.pdf>.

7. S. Laird (ed.), Biodiversity and Traditional Knowledge, London [etc.]: Earthscan, 2002, pp. 250 ff. See also the newsletters 'Leading Biotechnology Drugs on the Market' of the e-journal Med Ad News, available at <http://www.medadnews.com/index.asp>. Apart from the end products, also components of the genetically modified organisms concerned could be commercially promising. For example, the biopharmaceutical Vinblastine, used in the treatment of Hodgkin's disease, is one of Eli Lilly & Co's best-selling products. The medicine is derived from the plant 'Cantharanthus Rosus', and the seeds of that plant became highly priced commodities as well. In 1993, the market price for a kilogram of seeds of this plant was worth 5 million US Dollars. See A. Sasson, Biotechnologies in Developing Countries: Present and Future. Volume 2: International Cooperation, Paris: UNESCO, 1998, pp. 228-232.

8. Nuffield Council on Bioethics, The Ethics of Patenting DNA, 2002, p. 14. Please note that these figures are contested from time to time; available at <http://www.nuffieldbioethics.org>.

9. See, e.g., M.H.M. Schellekens and J.E.J. Prins, 'Regulatory Aspects of Genomics, Genetics and Biotechnology: An Orientation on the Positions of Germany, the United Kingdom and the United States', vol. 7.1 EJCL 2003, available at <http://www.ejcl.org/71/art71-2.html>. On other risks involved, see A. Streltzer, 'U.S. Biotechnology Intellectual Property Rights as an Obstacle to the UNCED Convention on Biological Diversity: It Just Doesn't Matter', TRNATLAW (6) 1993, p. 293.

10. See OECD, Biotechnology Statistics in OECD Member Countries: Compendium of Existing and National Statistics, Paris: OECD, 2001, available through <http://www.oecd.org>.

11. See, on the resources of biotechnology, J. Janssen, 'Property Rights on Genetic Resources: Economic Issues', Global Environmental Change (9), 1999, pp. 313-321.

12. WEHAB Working Group, A Framework for Action on Biodiversity and Ecosystem Management, World Summit on Sustainable Development, 2002, pp. 1-17, available at <http://www.johannesburgsummit.org/html/documents/summit_docs/wehab_papers/ wehab_biodiversity.pdf>. See further P. Ehrlich and E. Wilson, 'Biodiversity Studies: Science and Policy', Science (253) 1991, pp. 785-762. It is noted that the progress in biomatics, enabling the selection of recombination of countless genes and their purported functions, seems to diminish the need to work on the 'natural material' itself.

13. See N.A. Campbell and J.B. Reece, Biology, San Francisco: Benjamin Cummings, 2002, pp. 426-709. Genetic change occurs without and by means of human intervention. The former is called natural genetic drift.

14. See Posey, 'Commodification of the Sacred through Intellectual Property Rights', supra note 3, and R. Barsh, 'Taking Indigenous Science Seriously', in: S. Bocking (ed.), Biodiversity in Canada: Ecology, Ideas and Action, Toronto Broadview Press, 1999, pp. 154-166.

15. See, e.g., G.A. Cordell, 'Biodiversity and Drug Discovery: A Symbiotic Relationship', Phytochemistry (55) 2000, pp. 463-480; C. Weiss and T. Eisner, 'Partnerships for Value Added through Bioprospecting', Technology in Society (20) 1998, pp. 483-484.

16. Article 63(2) of the Convention on the Grant of European Patents (European Patent Convention - EPC), 1973, 1065 U.N.T.S. 199.

17. See, generally, P. Drahos, A Philosophy of Intellectual Property, Aldershot: Dartmouth, 1996.

18. See the economic analysis provided in S.J.R. Bostyn, Enabling Biotechnological Inventions in Europe and the United States, Munich, EPOscript, 2001, chapter I, and K.W. McCabe, 'The January 1999 Review of Article 27 of the TRIPS Agreement: Diverging Views of the Developed and Developing Countries Towards the Patentability of Biotechnology', JIPL (6) 1998, pp. 47-49.

19. In 1873, Louis Pasteur was granted a patent on '. . . improvements in the manufacture and in the treatment of yeast and wort, together with apparatus for doing the same . . .', US patent 141, 072 (1873), whilst others were denied patents for inventions working on or consisting of biological materials. See, e.g., D.J. Kevles, A History of Patenting Life in the United States with Comparative Attention to Europe and Canada, European Group on Ethics of Science and New Technologies, 2002, pp. 3-4, available at <http://europa.eu.int/comm/european_group_ethics/docs/study_kevles.pdf>.

20. See, e.g., OECD, Genetic Inventions, Intellectual Property Rights and Licensing Practices: Evidence and Policies, 2002, available at <http://www.oecd.org/dataoecd/42/21/2491084.pdf>. For the application of the requirements of patentability, see, among others, Bostyn, Enabling Biotechnological Inventions in Europe and the United States, supra note 18 (genes and related compounds); G. Van Overwalle, Octrooieerbaarheid van Plantbiotechnologische Uitvindingen [The patentability of plant biotechnological inventions], Brussel: Bruylant, 1996; J. Koopman, 'The Patentability of Transgenic Animals: A Proposal for Harmonization', FIPMELJ (XIII/1) 2002, pp. 103-204 (animals).

21. These debates usually focus on the exclusion of patentability for violation of the ordre public and morality, as incorporated in Art. 53(a) EPC. See, e.g., P. Drahos, 'Biotechnology, Patents and Morality', EIPR 1999, p. 441; Nuffield Council on Bioethics, The Ethics of Patenting DNA, supra note 8. A recent report of the European Commission emphasizes that these issues have not been solved yet; European Commission, Life Sciences and Biotechnology, supra note 6, and the efforts of the European Group on Ethics in Science and New Technologies, see <http://europa.eu.int./comm/european_group_ethics/avis_en.htm>.

22. Articles 52(1) and 83 EPC.

23. Article 52(2)(a) EPC. See, e.g., J. Conley and R. Makowski, 'Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents', J. Pat. & Trademark Off. Soc'y (85) 2003, pp. 301 ff.

24. It seems to concern all types of biotechnological inventions, albeit one category, such as ESTs and SNPs more than any other, for example transgenic plants. See, e.g., WIPO/BIOT/WG/99/1. See also, on different types of biotechnological inventions, Nuffield Council on Bioethics, The Ethics of Patenting DNA, supra note 8; L. Demaine and A. Fellmeth, 'Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent', Stan. L. Rev. (55) 2002, pp. 303-462; D.M. Gritter, 'International Conflicts over Patenting Human DNA Sequences in the United States and the European Union: An Argument for Compulsory Licensing and a Fair Use Exemption', NYU L.R. (76) 2001, pp. 1623-1691, and supra note 18.

25. The term 'biopiracy' was introduced in 1994 by the FAO's Assistant Director-General Obaidullah Khana. 'FAO Official Blasts Western Biopiracy', Reuter, 6 June 1994.

26. See, e.g., <http://web.worldbank.org/WBSITE/EXTERNAL/EXTSITETOOLS/0,,contentMDK: 20062759~menuPK:98409~pagePK:98400~piPK:98424~theSitePK:95474,00.html>, <http://www.colorado.edu/Research/HARC/tradknow.html> and <http://www.nuffic.nl/ciran.ik>.

27. This happened with the notorious neem tree patents of W.R. Grace Inc. It concerned the Indian plant Azadirachta indica, locally known as the Sarva-roga nivarini. This plant has been used by Indian farmers and traditional healers for thousands of years, and seems to have characteristics that are useful both agriculturally and medically. W.R. Grace received several patents on the plant and certain of its compounds and derivative products, and enforced its patent proactively. Several groups of 'traditional users' in India were threatened with infringement suits and ordered to halt the commercial exploitation of the plant. Only after prolonged battles in the media and before the EPO, one of W.R. Grace's European patents (no. EP 436 257 B1) was revoked because of lack of novelty. The corresponding US patent, no. 512,4349, however, was sustained. See hereon G. Dutfield, Intellectual Property Rights, Trade and Biodiversity, London: Earthscan, 2000, pp. 65-67.

28. In Europe, for example through Article 99 EPC, opposition to the patent, among other things for lack of novelty.

29. P. Drahos and J. Braithwaite, 'Intellectual Property, Corporate Strategy, Globalisation: TRIPS in Context', Wis. Int'l L.J. (20) 2002, p. 451. Drahos and Braithwaite analyse the manner in which large Western corporations have become dependent on intellectual property law and tailor their commercial activities and conduct accordingly.

30. On the difficulties of offensively protecting traditional knowledge and related products through patent law, see generally N. Roht-Arriaza, 'Of Seeds and Shamans: The Appropriation of the Scientific and Technical Knowledge of Indigenous and Local Communities', Mich. J. Int'l L. (17), 1996, pp. 919-965 and F.W. Grosheide and J.J. Brinkhof (eds.), Intellectual Property Law: Articles on the Legal Protection of Cultural Expressions and Indigenous Knowledge, Antwerp [etc.]: Intersentia, 2002 (Molengrafica Series, 13).

31. See The Crucible Group II, Seeding Solutions: Options for National Laws governing Access to and Control of Genetic Resources, vol. 2, Rome: IPRC-IPGRI, 2001; J. Boyle, Of Shamans, Software and Spleens ,Cambridge, Mass.: Harvard University Press, 1996; D. Posey and G. Dutfield, Beyond Intellectual Property, Ottawa: International Development Research Centre, 1996. This is also expressed in various statements made by indigenous communities and their representatives. See the Statement from the International Workshop on Indigenous Peoples and Development, 1997; the Sabah Statement on the Protection and Conservation of Indigenous Knowledge, 1995; the Suva Statement on Indigenous Peoples' Knowledge and Intellectual Property Rights, 1995; the Statement from the COICA/UNDP Regional Meeting on Intellectual Property Rights and Biodiversity, 1994; the Julayinbul Statement on Indigenous Intellectual Property Rights, 1993; Kari-Oca Declaration and Indigenous Peoples Earth Charter, 1992; Mataatua Declaration on Cultural and Intellectual Property Rights of Indigenous Peoples, 1992; the Declaration of Principles of the World Council of Indigenous Peoples, 1984; availabe at <http://users.ox.ac.uk/~wgtrr/decin.htm>. These declarations have in common that they consider knowledge, land and natural resources, such as genetic material, to be inseparable. Indigenous communities have responsibilities for their natural environment which relate to 'guardianship' or 'custodianship' and are not considered to be rights that could be alienated or otherwise exploited for one's individual benefit, like a property right.

32. On the natural exchange between cultures, see R.J. Coombe, 'The Properties of Culture and the Possession of Identity: Postcolonial Struggle and the Legal Imagination' in: B. Ziff and P.V. Rao (eds.), Borrowed Power: Essays on Cultural Appropriation, New Brunswick: Rutgers University Press, pp. 74 ff. Attempts to solve these problems have been made, for example by the establishment of representative organizations, which would be entitled to decide upon transfer and the future commercial use of the knowledge and would divide the proceeds thereof to the communities they represent; supra note 31.

33. See, e.g., Article 27 TRIPS. Patents can be granted for inventions in all areas of technology, and regardless of the location of invention and whether components thereof are imported or not.

34. WIPO/GRTKF/IC/4/11, p. 27; WIPO/BIOT/99/1; WIPO/SCP/3/11, §208.

35. European Council Directive 98/44/EC, 1998 OJ L 213, pp. 13-21.

36. See, e.g., the Convention on the International Trade in Endangered Species of Wild Fauna and Flora, 1973 (CITES). CITES regulates the import and export of endangered species; available at <http://www.cites.org>. On the stance that patent law is not the appropriate instrument to deal with all sorts of societal aspects of inventions, see e.g. R. Crespi, 'Patenting and Ethics: A Dubious Connection', J. Pat. & Trademark Off. Soc'y (85) 2003, p. 47; U. Schatz, 'Patentability of Genetic Engineering Inventions in EPO Practice', Int'l Rev. Indus. Prop. & Copyright L. (1) 1998, p. 2. But see, e.g., Roht-Arriaza, 'Of Seeds and Shamans', supra note 30, pp. 942-944.

37. Cf. J. Vogel, 'The Successful Use of Economic Instruments to Foster Sustainable Use of Biodiversity: Six Case Studies from Latin America and the Caribbean', Biopolicy Journal (2) 1997, pp. 5-7. Vogel analyses among other things the relation between the lack of scarcity of genetic resources and the economic valuation thereof in benefit-sharing agreements.

38. The grace periods that were granted to certain developing countries pursuant to Articles 65 to 67 TRIPS are expired now, or about to expire, or are, for most countries, not applicable given the exclusion of pharmaceuticals in Article 70(8) and (9). The Declaration on the TRIPS Agreement and Public Health ('Doha declaration'), allowing further postponement to 2016, is only applicable to the least developed countries. WT/MIN(01)/DEC/2, 20 November 2001.

39. For an extensive overview of the circumstances leading to the conclusion of TRIPS, see, among others, Drahos and Braithwaite, 'Intellectual Property', supra note 29, and S. Sell, 'Post-TRIPS Developments: The Tension between the Commercial and Social Agendas in the Context of Intellectual Property', Fla. J. Int'l L. (14) 2002, pp. 193 ff.

40. Machlup already concluded that developing countries should not implement intellectual property law regimes. See F. Machlup, An Economic Review of the Patent System, Washington: US Government Printing Office, 1958. See also C. Juma, 'Intellectual Property Rights and Globalisation: Implications for Developing Countries', Center for International Development, Harvard University, 1999 (Science, Technology and Innovation Discussion Paper No. 4), and J. Lerner, 'Patent Policy Innovations: A Clinical Examination, 53 VNLR (53) 200, pp. 1841 ff.

41. Costa Rica implemented the Ley de Biodiversidad, A.L. No. 7788 (1998), available at <http://www.grain.org/brl/costarica-leybiodiversidad-1998.cfm>; Brazil implemented its Ley PM 2.186-16, 2001, available at <http://www.planalto.gov.br>; Peru implemented the Ley sobre la conservación y approvechamiento sotenible de la diversidad biológica, C. no. 26839, 2002, available at <http://www.indecopi.gob.pe>; India implemented the Biological Diversity Act, B. 93/2000, 2002, available at <http://www.nifindia.org>.

42. The Brazilian statute illustrates this. Recently, a German national was suspected of committing biopiracy, and was arrested in Brazil. M. Astor, 'German Man Arrested in Brazil Accused of Biopiracy', Associated Press, 4 September 2003.

43. Supra note 2.

44. Given the scope of this paper, only brief references are made to these Articles.

45. See, generally, on the interface between the CBD and TRIPS S.R. King et al., 'Biological Diversity, Indigenous Knowledge, Drug Discovery and Intellectual Property Rights: Creating Reciprocity and Maintaining Relationships', Journal of Ethnopharmacology (51) 1996; Ch. McManis, 'The Interface between International Intellectual Property and Environmental Protection: Biodiversity and Biotechnology', WAULQ (76) 1998, pp. 255-279.

46. Also, the Preamble and Article 8 of TRIPS emphasize the importance of social and public interests and show that this instrument is not narrowly tailored to trade issues only. It is noted, however, that these provisions may factually not offer developing countries means to redress certain effects of TRIPS. Past conflicts about the implementation of TRIPS caused the US to consider the imposition of severe trade sanctions on the developing countries that allegedly were not fulfilling their international obligations, e.g. Argentina, Brazil, Thailand and South Africa. See, e.g., K. Maskus, Intellectual Property Rights in the Global Economy, Institute for International Economics, 2002, p. 178, available at <http://www.iie.com> and E. 't Hoen, 'TRIPS, Pharmaceutical Patents, and Access to Essential Medicines: A Long Way from Seattle to Doha', Chi. J. Int'l L. (3) 2002, p. 2. The North thus has an effective tool enabling it to force developing countries to comply with its wishes, perhaps sometimes even when the latter do not have to comply strictly pursuant to TRIPS or other international instruments.

47. Other IGOs addressing the issues related to the interface between CBD and TRIPS are (with reports and keywords): WTO (IP/C/W/195; IP/C/W/228; WT/GC/W/233; IP/C/M/32 (§128); IP/C/M/33 (§121); IP/C/W/347/Add.1; IP/C/W/370; trade, medicines); UNCTAD (TD/B/COM.1/EM.13.3 (§17); trade, development); FAO (CPGR/91/12' CPGR-6-95/8; CGRFA-Ex3/96/LIM/2; CGRFA-Ex5/98/inf.1Annex; CGRFA-Ex8/99/8'CPGR-BSP1,2,4 and 8; food, agriculture, genetic resources); UNESCO (CLT-2002/CONF.203/5; CLT-2002/CONF.203/3 (and Rev.); CLT-2002/CONF.205/5; CLT-2003/CONF.205/5; culture, natural sciences, traditional knowledge); WHO (EB111.R12/2003; WHO/EDM/TRM/2002; EB87.R24/1991; WHA41.19/1988; traditional medicine).

48. See WIPO, Report on Fact-Finding Missions on Intellectual Property and Traditional Knowledge (1998-1999), Intellectual Property Needs and Expectations of Traditional Knowledge Holders, Geneva, April 2001. See also UNEP/CBD/WG-ABS/1/4, p. 8.

49. WIPO, Report on Fact-Finding Missions, p. 226.

50. WIPO/GRTKF/IC/4/8, pp. 22-31.

51. WIPO, Report on Fact-Finding Missions, p. 217.

52. WIPO/GRTKF/IC/2/6, p. 26. The database is available at <http://www.wipo.int/globalissues/databases/tk/index>.

53. See UNEP/CBD/COP/6/20 and COP Decision VI/24, available at <http://www.biodiv.org/decisions/default.asp?m=cop-06&d=24>.

54. For a national initiative to reconcile both treaties in the user country Belgium, see G. Van Overwalle, 'Belgium Goes Its Own Way on Biodiversity and Patents', EIPR 2002, p. 233.

55. Available at <http://www.kew.org/conservation/principles.html>. Botanical gardens from around the world followed these guidelines. Thus far, however, no Dutch botanical garden participates.

56. See <http://www.nih.gov/fic/programs/icbg.html> and J.P. Rosenthal, The International Cooperative Biodiversity Program: A Benefit-Sharing Case Study for the Conference of the Parties to the Convention on Biological Diversity, available at <http://www.biodiv.org./doc/case-studies/default.aspx>.

57. See, e.g., interview with J. Martínez Alier, Deuda ecológico y biopiratería, 2002, available at <http://www.grain.org/sp/publications/biodiv32-5-entrevista.cfm>.

58. See, on the concept of economic and cultural centres and peripheries, F. Lionnet, 'Logiques métisses: Cultural Appropriation and Post-Colonial Representations', College Literature, (10) 1992, p. 116.

59. See, e.g., The International Undertaking on Plant Genetic Resources for Food and Agriculture (FAO, 1983), available at <http://www.fao.org/ag/cgrfa/IU.htm>; the Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997), available at <http://www.unesco.org/shs/human_rights/hrbc.htm>. See also D.A. Cleveland and S.C. Murray, 'The World's Genetic Resources and the Rights of Indigenous Farmers', Current Anthropology (38/4) 1997, p. 481; The Council for Responsible Genetics, The Blue Mountain Declaration, available at <http://www.gene-watch.org>. See also <http://hornacek.coa.edu/dave/Reading/patents.html>.

60. Freely translated: 'Friendship should be initiated by us, because we are looking for them, whereas they are not looking for us'; quoted in C.R. Boxer, Zeevarend Nederland en zijn wereldrijk 1600-1800, Amsterdam: Maarten Muntinga, 2002 (Rainbow pockets), p. 322 (original title: The Dutch Seaborne Empire 1600-1800, London: Hutchinson, 1977).


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