Instituto Alexander von Humboldt Ana María Hernández Salgar Primera edición Santafé de Bogotá, octubre de 1999 Instituto Alexander von Humboldt www.humboldt.org.co Primera versión Revisada por Rafael H. Aramendis R. y Santiago Rojas Arroyo Versión final revisada por Paola Ferreira Miani Edición Jorge Escobar Guzmán Acknowledgements
This publication would not have been possible without the guid-
ance, knowledge, patience and dedication of Dr. Paola Ferreira Miani,Coordinator of the Policy and Legislation Program of the InstitutoAlexander von Humboldt.
Rafael Aramendis, Santiago Rojas and other experts deserve special
mention. With their mastery of the theme, they greatly contributed to theenrichment of the content of this book. They not only collaborated in thereview of the document, but they also contributed with relevant ideas.
Our special acknowledgement to Cristián Samper, María del Pilar Pardo
and Glenda García Royero for their collaboration and observations onthe different themes of the book.
Finally, Instituto Alexander Von Humboldt would like to express its
gratitude to all those who participated, directly or indirectly, in provid-ing the information which enabled this work to be written.
The relationship between intellectual property rights (IPR) and
biodiversity may be the most controversial issue in the internationalenvironmental debate. The debate covers issues of great importance suchas whether living matter should be patented, the relationship between IPRand the protection of traditional knowledge, innovations and practices, andwith technology transfer. All of these topics are closely related with theConvention on Biological Diversity (CBD). The revision of the agreementon Trade Related Intellectual Property Rights (TRIPS) within the WorldTrade Organization (WTO), in the Millenium Round has increased the de-bate, because it may strongly affect the relation between IPR andbiodiversity. These issues are also been discussed in other internationalforums. Such is the case of the meetings on traditional knowledge within theCBD, and the revision of Andean Decision 344 on a common industrialproperty regime within the Community of Andean Nations (CAN).
IPR where created and designed to promote technological development,
mainly in industrial activities. Nowadays, with the evolution of newtechnologies, and particularly of modern biotechnology, IPR are been usedfor purposes that go far beyond their initial scope. New needs for protectionof creations of the human mind, have required in the past adjustments of theIPR system. Likewise, nowadays an analysis to identify the positive andnegative aspects of the application of IPR in this context is required, to beable to propose reforms to the IPR system or viable alternatives.
Discussions about issues such as whether living matter as existing in
nature should be patented, are generally very emotive, due to their relationwith ethical, sovereignty and property issues. Likewise, debates onprotection of traditional knowledge directly affect the cultural integrity ofethnic minorities. On the other hand, there are important economic interests
that will be directly or indirectly affected by the decisions taken on these topics.
With the publication of this study, the Instituto de Investigación en
Recursos Biológicos “Alexander Von Humboldt”, wants to contributeconstructively to this debateI . The main purpose of this document is tobring closer conflicting positions regarding biodiversity and IPR, byoffering an objective analysis of the different points of view. In thiscontext, the document aims at bringing closer two internationalagreements that are very related thematically but very apart in theireffective interactions.
Our interest is not to provide the formula to solve the debate, but to
promote a constructive reflection about fundamental issues affecting theconservation and sustainable use of biodiversity. We hope that thispublication contributes to a better understanding of the topics beendiscussed in these forums, to promote reflection and inspire possiblesolutions to negotiators and decision makers in these issues. Likewise,we wish that non specialists interested in the relation between intellectualproperty rights and biodiversity benefit from it.
Finally, we would like to emphasize the great dedication and
rigorousness of the author of this publication Ana María HernándezSalgar, researcher of the Instituto Alexander von Humboldt.
Research in Policy andLegislation Program
Intellectual property rights (“IPR”) are the rights given to persons
over the creation of their minds.II They are of two types: a) Copyrightsand rights related to Copyrights, and b) industrial property rights. Theformer refer to the creations that result in works, such as literary, musicalor artistic creations. Industrial property rights refer to trademarksIII ,geographical indications IV , drawings or industrial modelsV , patents VI ,andindustrial secrets or information that has not been revealedVII , amongstother things. Furthermore, there are also the plant breeder’s rights, whichare subject to legislation different from that governing industrial prop-erty. The former has been regulated, for the purposes of the AndeanCommunity, by the International Union for the Protection of New Variet-ies of Plants - UPOV - and Decision 345 of the Cartagena Agreement,regarding a Common Régime of Protection of the Plant Breeder’s Rights. This document will focus on the rights regarding industrial property thatdeal with the issue of biodiversity, because the protection which theycan offer opens the possibility of protecting all spheres of life, whetherflora or fauna. The protection of the new plant varieties will be discussedbiefly, as it demands an analysis different from that of the patents regime.VIII
Intellectual property rights were formally introduced by an international
treaty in 1883, when the Paris Convention on Industrial Property was signed,and the Union for the Protection of Industrial Property was created. Yet, theintellectual property rights which were directly related to the trade of goodsand services, were structured on the postulates of the Paris Convention bythe GATT Uruguay Round which led to the signature of the MarrakeshConvention, allowing for the creation of the World Trade Organization(WTO). The creation of the WTO gave origin to the development andreadjustment of agreements in areas that dealt with the trade of goods andservices among the Member Countries.IX One such agreement refers toTrade-Related Intellectual Property (TRIPS), which has today become oneof the principal legal instruments in the area of intellectual property rights. The provisions of TRIPS will not come into force in developing countriesuntil January 1st 2000, however, and Article 27.3.b will be subject to review. It is therefore important to discuss certain provisions of the agreement andrestructure those that might be contrary to national interests or legislation.
In early 2000, the WTO will initiate the review of its Agreements, in what
will be known as the Millennium Round. During this review, there will bediscussions regarding the application of TRIPS Article 27.3.b., which hasa close relationship to the protection of the components of biological diver-sity, such as plants, animals and microorganisms. It has been proposed that,within the scope of that Article, it would be convenient to discuss whethercurrent intellectual rights might or might not be extended to the knowledge,innovations and practices of traditional communities. Another biodiversityrelated issue that will be discussed during the Millennium Round is biotech-nology, which as this document will show, is relevant both to the issue ofintellectual property, and to the conservation and sustainable use ofbiodiversity. The Member-Countries of the Andean Community have al-ready started the review of Decision 344 regarding the Common Regime ofIndustrial Property, in order to present a unified position on different IPRissues, including those relating IPR to biodiversity.
The Convention on Biological Diversity is the framework convention
on biodiversity issues. It’s objetives are the conservation, sustainable useand the fair and equitable sharing of benefits araising out of the utilization ofbiodiversity. According to Article 2 of the Convention, biodiversity isconceived, at all its levels (gene, species, population, ecosystem and land-scape) as the “variability among living organisms from all sourcesincluding,inter alia, terrestrial, marine and other aquatic ecosystems andthe ecological complexes of which they are part; this includes diversitywithin species, between species and of ecosystems.”
Although at first sight the close relationship between the components
of biodiversity and the law of intellectual property is not evident, this issuehas recently become highly controversial. Basically, the discussion is cen-tered on whether only biotechnological developments in plants, animals ormicroorganisms that fulfill the requirements of novelty, inventive status andindustrial application are subject of protection, or whether it also embracesthe possibility of patenting biological material in its natural state. This de-bate has intensified in recent years because with the application of newtechnologies to living organisms, and with the widespread uses found forbiological and genetic resources, there has been an increase in the numbersof applications for “privatization” (i.e. exclusive exploitation), and the sub-sequent commercialization of the components of biodiversity through intel-lectual property titles.
On the other hand, attention will be given to a topic of tremendous
importance for a country such as Colombia. The issue is whether it is con-venient or not to protect knowledge, innovations and traditional practicesby means of current IPR, or by means of sui generis systems. This paperwill not deal with some topics of major ethical importance, such as theHuman Genome Project. Biodiversity will be exclusively analyzed from thepoint of view of the Convention on Biological Diversity.
This study will center on current concerns regarding the incidence of
IPR on biological, genetic and microbiological resources. Thus, the analysiswill not only discuss the TRIPS now in force, but also those which arecurrently under review, and will focus on those that have connections withthe objects that are subject to be patented. We do not propose to answer allthe questions raised, but to offer an overview, as complete as we can, of thestate of the art on this topic, to generate questions for future debates, and totry to put together all the different points of view and positions in order tofacilitate the decision-making process.
This study will develop the following points in order to clarify the
principal topics that bear a relation between IPR and biodiversity:
1. Biodiversity Conservation. This chapter includes a short analysisof generalities on conservation and the sustainable use of theConvention´s view of biodiversity. The most salient general aspectsof TRIPS are also presented, with the existing relationship betweenintellectual property and living matter, particularly in connection withthe topic of plants, animals, essentially-biological procedures, micro-organisms, and obtention of plant varieties. The relationship betweenIPR and traditional knowledge will also be analyzed, as well as theissue of the ex situ conservation and intellectual property.
2. The sustainable use of biodiversity and its relation with the appli-cability of intellectual property rights. This chapter introduces thedifferent meanings of use that the components of biodiversity re-ceive when they are patented or when they are protected by otherIPR rights.
3. Access to biodiversity components, safety in their use, and distri-bution of benefits. First, the issue of access to genetic resources andthe ongoing debates regarding the possibility of protecting them bymeans of intellectual property rights will be discussed. Biotechnol-ogy and biosafety topics will follow. Finally, the distribution of ben-efits and the relation with IPR will be analyzed.
4. Cooperation Mechanisms. Governmental cooperation, scientificand technical cooperation, research and education, and the follow-up and exchange of information will be analyzed. Instituto Alexander Von Humboldt hopes that this work will be use-
ful to anyone interested in obtaining information regarding the mostrelevant current and future discussions on intellectual property rightswith respect to trade and biological diversity. I. The Conservation of Biodiversity.
A. General aspects of conservation and sustainable use ofbiodiversity-.B.TRIPS General Aspects-. C. Intellectual Prop-erty Rights and Living Matter-.D. Intellectual Property Rightsand Traditional Knowledge-. E. Intellectual Property Rightsand Ex Situ Conservation.A. General aspects of conservation and the sustainable use of biodiversity
Since the 1972 Stockholm Conference, and even before that, the
international community has expressed its concern for the improperuse of the environment. Twenty years later, in 1992, the United NationsSummit on Environment and Development took place. This summit gaveorigin to the principles of conservation and sustainable use now in place,as contemplated in “Agenda 21”. One result of this summit was alsothe Convention on Biological Diversity, which is part of Colombianlegislation (Law 165/94), and which is the world action framework onbiodiversity.
One of the foundations or central axes of the Convention on Bio-
logical Diversity is the conservation of biodiversity. Alongside theconservation generalities and the use of sustainable components in-cluded in the Convention, we find the regulations, decisions, programsand projects that must be established or developed within nationalboundaries in order to conserve biodiversity and make sustainable useof its components. These provisions should, where possible, be inte-grated into plans, programs and to sectoral and cross-sectoral policy.
Furthermore, there are basic provisions of the Convention to pre-
vent a negative impact on biodiversity; these are precautionary mea-sures. The preamble addresses the issue as follows: “Noting that it isvital to anticipate, prevent and attack the causes of significant re-duction or loss of biological diversity at source”, and “Noting alsothat were there is a threat of significant reduction or loss of biologi-cal diversity, lack of full scientific certainty should not be used as areason for postponing measures to avoid or minimize such a threat”
Other measures which are the responsibility of States in order to achieve
the conservation and sustainable use of biodiversity, relate to sovereigntyand the exploitation of their biological resources. This is especially relevantwhen referring to access to genetic resources, in terms which must bemutually agreed, and with the consent of the country of origin or collection.
In addition, recognizing the importance of the work of the traditional
communities in the conservation and sustainable use of the biodiversity,the Convention has established an obligation to protect their knowledge,innovations and practices.
The Convention articles on sustainable use refers to the measures de-
signed to ensure that the exploitation of biodiversity will not result in itslong term decline. These terms are central to the Convention, and aredirectly associated with the benefits that may result, and that must be sharedin a fair and equitable maner among all concerned.
One way of facilitating the implementation of this provisions, is pro-
vided through access and transfer of technology to developing countries,on fair and equitable conditions. The Convention stipulates that accessand transfer must respect all existing legislation on intellectual property,associated to technologies and biotechnologies.
Finally, the initiation of these basic measures of conservation, sustain-
able use, and distribution of benefits must be implemented by effectiveaccess to genetic and biological resources, the transfer of adequate tech-nologies, and funding. These must be the main goal of the Convention onBiological Diversity. B. TRIPS - General Aspects. 1. National Treatment-. 2. Most-Favored-Nation Treatment. 3. Industrial property.
In the terms of TRIPS, this study has interpreted the “generalities” as
the terms which the Parties must adopt within their territory so that theywill level in their international responsibilities in trade and in intellectualproperty rights, and that are of interest for this analysis. 1. National Treatment
One of the interesting points of commerce which also affects IPR is that
of “national treatment”.1 This is one of the most decisive but indirect issueswhich relates to intellectual property. Basically, “national treatment” meansgiving treatment to foreigners no less favorable than that afforded to citi-zens of another State with respect to the protection of intellectual property. We highlight this point because “national treatment” can be considered asa national measure for the promotion of trade and of IPR development, andin this respect, it would be applicable to patent applications based on,amongst other things, components of biodiversity. The acceptance of spe-cial treatment in matters as complex as IPR, and the offer of equal conditionsto nationals and foreigners might lead to different interpretations. In ex-treme cases, one might think that developing countries are taking the risk ofhanding their cultural or national heritage to countries with more technol-ogy, or financial capacity.
Nevertheless, from a different perspective, “national treatment” also
benefits less developed countries, since they win the advantage of beingable to compete under equal conditions, in the acquisition of IPR. In thiscontext, one might say that IPR were established to guarantee certain rightsto inventors, and to promote research and results. This, in turn, encouragesprocesses of technological development linked to new inventions and tothe transfer of technology. In this respect, “national treatment” also pro-vides an incentive to inventors so they develop their products and proce-dures, and promote the exchange of technological developments, inherentto the inventions that IPR applicants transfer to the State where they wishto protect their invention. 2. Most-Favoured-Nation Treatment
In addition to national treatment, there is Most-Favoured-Nation Treat-
ment.2 This means that if a Member of the WTO grants privileges to an-other Member, it must also extend them to all the other Members. AlthoughMFN is not as controversial as “national treatment”, it does imply thatthough certain countries will obtain privileges, the development of all fieldsof creation of the human mind will be favored in countries where technologi-
cal and financial facilities are better. On the other hand, the MFN clauseallows for a balance in the possibilities of acquiring IPR in countrieswith different degrees of development. 3. Industrial Property
The main interest for biodiversity in the analysis of intellectual
property rights is that of industrial property. In this context, the mostrelevant topic is patents; geographical indications and the protectionof unrevealed information come second. These are the IPR that areclosely related within current and future discussions in biodiversityand IPR related issues. The analysis will focus on the theme of pat-ents, because at this moment, there is the possibility of modifyingTRIPS Article 27.3.b3 which refers precisely to the possibility of de-nying excluding from patentability certain elements closely related tobiodiversity. An explanation of the content of each of the issues onindustrial property follows.
Patents are rights that are conceded to a private individual or legal
entity for any inventions, whether of products or processes, in all fieldsof technology, provided that they are new, involve an inventive stepand are capable of industrial application (TRIPS Article 27). This will bethe most relevant point of our analysis, because it is the only one thatmakes explicit mention of the use of biological and microbiological re-sources in the acquisition of patents. Furthermore, it is the only intellec-tual property right that protects the content of biotechnological cre-ations,4 that is, the modifications made to a product or procedure, andnot to the visible form in which the creations are presented.
Geographical indications refer to the intellectual property rights
that identify a good as originating in the territory of a Member, or a regionor locality in that territory, where a given quality, reputation or other char-acteristic of the good is essentially attributable to its geographical origin(TRIPS Article 22). This provision is important because it provides sup-port for defining the benefits to be earned from industrial property rightsin relation to the products extracted from a given country. Yet it is worth
noting that this mode of protection does not cover the content of theinvention, but only the country(ies) or place(s) of origin of the base livingmatter and of the final result, provided that the good comply with thecharacteristics given above, and that the biological material is characteristicof that place or country. These indications can signal, for example, that abasket woven with a special bark or liana which is typical of a given place,comes from a specific region or country. Another classic example is that ofwines, which are generally known by their geographical indications, suchas “Bordeaux”. This wine has earned a reputation because of the particularvines that grow in the region of France around Bordeaux, and that give thewine its characteristic flavor etc.
The protection of undisclosed information is given to information that
is secret, has a commercial value because it is secret, and has been subjectto reasonable steps under the circumstances to keep it secret. This provi-sion is designed to prevent information legitimately classified secret frombeing disclosed to, acquired by, or used by others without the consent ofthe owner of the secret, in a manner contrary to honest commercial prac-tices. (TRIPS Article 39). It is relevant here since it could provide ideas onhow to protect the traditional knowledge of indigenous, Afro-Americanand local communities. Nevertheless, as will be shown later, the protectionof industrial secrets, as currently provided for in TRIPS, is not an appropri-ate tool for protecting traditional knowledge. Furthermore, in the context ofIPR, WTO Members have admitted that the rights regarding the protectionof information refer to private rights and not to collective ones, thus deny-ing protection for collective rights, such as those over traditional knowl-edge.5 This is the starting point of a discussion as to whether the scope ofcurrent IPR régimes is sufficient to offer protection in several areas coveredby the Convention on Biological Diversity.
Finally, it should be mentioned that TRIPS gives Member-States the
opportunity to create and strengthen their internal laws by introducingnational or regional rules for protection which are wider than TRIPS itselfsuggests, providing that they do not violate the terms of the Agreement. Therefore, a legally binding instrument, such as Decision 344 of the CartagenaAgreement, is stricter than TRIPS, but is compatible with the Agreement. This point will be further analyzed in due course. C. Intellectual property rights and living matter. 1. Plants and animals-. 2. Essentially biological procedures-. 3.Microorganisms-. 4. The New Plant Varieties.
Article 27 of TRIPS establishes that Parties may exclude from pat-
entability, among others, plants and animals other than microorgan-isms, and essential biological processes for the production of plantsand animals, other than non-biological and microbiological processes. The use of the word “may”, gives countries the freedom to choosewhether they exclude them or not. At a regional level, Decision 344 ofthe Cartagena Agreement does not consider living matter present innature6 as an invention; and if there is an invention produced with prod-ucts or products thereof of biodiversity, the species or breeds and theessentially biological procedures used in their acquisition are not con-sidered patentable. Plants are not mentioned because in the AndeanCommunity, inventions in plants are protected by the grant of breeder’sright and not by patents, as regulated by Decision 345.
The Article thus identifies what may be admitted for patent protec-
tion, in accordance with the WTO guidelines and the three requirementsgiven above, but its application is a matter entirely for the States todecide on, depending on their internal policies and legislation.
In the same Article, TRIPS explains that intellectual property may
be protected by patents for inventions in all fields of technology, pro-vided that the inventions comply with three requirements: novelty, in-ventive status and industrial application. In terms of intellectual prop-erty, the relationship with living matter is basically a question of pro-tection that may be granted to the new developments in biotechnology;its scope may be extended depending on the future changes to IPR regu-lations. The Convention on Biological Diversity is quite open: it al-lows the international treaties on IPR to regulate this area. Therefore,for the purposes of TRIPS, there must be more profound studies on thegranting of patents and on other intellectual property rights related totechnologies based on biodiversity.
Finally, in this chapter on intellectual property and living matter, it
should be noted that TRIPS Members may exclude from patentabilityinventions, the prevention within their territory of the commercial exploi-tation of which is necessary to protect ordre public or morality, includ-ing to protect human, animal or plant life or health or to avoid seriousprejudice to the environment. There are evident problems regarding theserestrictions: how does one define a “danger to morality” ?
Might these exceptions not become hidden obstacles to trade of
certain products or technologies? Should we perhaps question the grant-ing of patents and the commercial exploitation of certain biotechnologi-cal products which might be harmful (such as certain living modifiedorganisms) ? If so, would this not be an attempt to regulate an area thatcorresponds in the first instance to the Convention on Biological Diver-sity ? As we can see, the Agreement is very ambiguous and must there-fore be understood in its broadest sense. The broad sense of the applica-tion of TRIPS is given in Article 1.1 of the Agreement, that allows thelegislation of Member-States to be even stricter in their national regula-tions, provided that they stay within TRIPS parameters. 1. Plants and animals.
The scope of patent protection is addressed to both the procedures
and the products of plants and animals and of essentially biologicalprocedures. Initially, within this scope, there is no possibility of grantingpatents to any component of biodiversity in its natural state becausethere is no novelty and no inventive step involved. Yet, the doors areopen to the protection of new biotechnological developments (both inproducts and procedures), including living modified organisms by man.
In general, this could be taken to mean that no living matter existing in
nature should be patentable, because human beings have not intervenedin its creation, and thus, two of the requirements for granting a patent -novelty and inventive status - can not be satisfied. This covers bothbiological and microbiological organisms. Nevertheless, there are con-flicting positions on the point. We will consider first the case of plants
and animals. On the one hand, it could be held that the mere discovery ofany unknown taxa, whether vegetal, animal or microbiological, is not aninvention, and is therefore not admissible for patent protection. Like-wise, if a new type of biotechnological treatment is applied to a variety inorder to obtain a different variety or to improve the existing one, patentprotection should be available because man has taken part in the im-provement of the organism, or in the creation of a new organism whichdid not exist as such in nature. This is our interpretation of the regula-tions of Andean Community, as stated in Decision 344 on IndustrialProperty.
On the other hand, in countries such as the United States, national
patents have been granted to discoveries, and in Europe biological orgenetic material isolated from its environment may be considered patent-able. Despite this, it cannot be said that these countries are infringingTRIPS, because they agree on the fact that such material is patentable ifit meets the requirements of inventive status, novelty and industrial ap-plicability. The difference in the positions lies in the interpretation ofapplication given to these three requirements in national legislation.
Following the same line of argument as for the example for plants and
animals, differences in the interpretation and interests regarding the pat-enting of genes or sections of genes have arisen. A gene from a plant oranimal and/or its properties should not be patentable because it exists assuch in nature. It can thus be classified as a discovery but not as aninvention, and it does not change just because it has been isolated. Likewise, a gene that has been isolated by biotechnological means couldbe patentable because it complies with the requirements needed to pro-tect inventions. Nevertheless, the States which permit genetic patentsclaim that the mere isolation of a gene is in itself novel, because genes donot exist in isolation in nature. Other States say that genes may not bepatented unless they contain a biotechnological modification that allowssome innovation and inventive status to be shown, because isolationper se does not change a gene.
We can thus see that the arguments regarding patent protection for
genetic and biological material in plants and animals turn on the differ-
ence in interpretation that States have made of the meanings and
limits of the requirements for granting patents. The implications forbiodiversity and way in which the Convention applies to these differ-ences are a matter of great controversy, not only from an ethical point ofview, but also from a practical one, as will be seen later. 2. Essentially biological procedures.
With regard to the topic of essentially biological procedures for the
production of plants and animals, it should be said that in general, thesebiological procedures are those that have not been designed, and that donot depend on human intervention for their functioning,7 (e.g. photo-synthesis). According to TRIPS, they could be excluded from a possiblepatent regime. The protection by means of IPR could be given in terms ofinnovative level when applied to the knowledge associated with theprocedure, or even to conditions artificially adapted for the process totake place. The issue of the essentially biological procedures is not ascontroversial as that of plants and animals, because “essential” proce-dures have been differentiated from those which are not, thus providinggreater clarity as to whether they qualify for patent protection. 3. Microorganisms.
The issue of microorganisms is much more complex because pro-
tection has already been determined at international level as part ofindustrial property rights. TRIPS Article 27.3.b. does not consider mi-croorganisms and non-biological and microbiological procedures aspossible exceptions from protection. In this same regard, one finds theregulations for the deposit of biological material in Rule 13(bis) of thePatents Cooperation Treaty (PCT) and in the regulations for the de-posit of microorganisms for patents in the Budapest Treaty.
Although in general terms it has been acknowledged that microor-
ganisms can be patented, the issue is also controversial. There are thosewho think that patenting microorganisms in their natural state should notbe allowed because discoveries do not hold an inventive status and thesole fact of identifying them can not be interpreted as the result of
human invention nor of novelty. Nevertheless, this is not explicitly stated ininternational law, and its interpretation is even more confusing in certainregional legislation.8
One way to facilitate understanding of the application of IPR to microor-
ganisms and/or to microbiological procedures would be to establish a dif-ference between isolated microorganisms, modified microorganisms, andmicroorganisms in their natural state. In this way, patent procedures couldbe applied in a less controversial way. Article 27, mentioned above, statesthat microorganisms can be patented, since the exclusion applies to “.plantsand animals except microorganisms.”. According to the TRIPS rules, pat-ented material must be inventive, novel, and industrially applicable. It is inthe application of both these sections of TRIPS that the controversy origi-nates, because the same rule can be interpreted in different ways.
Consequently, claims for patents that make use of microorganisms must
indicate the degree of invention or of novelty that they contain, whether intheir products or in their procedures. In this case, the reference would be tomanIPRulated microorganisms and not to original ones. This is the positiontraditionally adopted by developing countries. Nevertheless, other entirelyopposed positions can be found in the European General Directive 98/44Article 3.29 which states that the protection covers the biological materialisolated from its natural environment. As we can see, some States acceptthat the simple isolation of a material can be classified as novel or inventive,and thus may be patented. In synthesis, the argument turns on whetherpatents can be applied only to microorganisms which have been manipu-lated and to those in which man has intervened with the use of techniques,such as biotechnology, or also to those that are found in their natural andfree form in their own environment. From the above discussion, it can beinferred that the procedures that have been used in laboratories to producea protein synthesis, or other such procedures, can be patented, but thedebate still continues for microbiological procedures and for non- inter-vened microorganisms. At all events, it is quite difficult to check whether amicroorganism has been intervened or not, especially if it is rememberedthat the inventories in this group are still very incomplete. 4. The New Plant Varieties
Another component of great importance in Article 27 of TRIPS refers
to the granting of protection for plant breeder’s through patents, aneffective sui generis system or a combination of both. Colombia, is asignatory to both TRIPS and UPOV (1978), and is a party to Decision 345of the Cartagena Agreement on the Common Regime for Protection ofPlant Breeder’s Rights (1993). In this way, Colombia has acquired a toolthat could be used to protect the new varieties produced by biotechno-logical or other processes, despite the controversies that its applicationgenerates.10
The negotiations for the verification of Article 27, which includes the
review of the protection for plant breeder’s rights, will take place in early2000. Colombia must work out a clear position on this matter. D. Intellectual Property Rights and Traditional Knowledge
The protection of knowledge, innovations and traditional practices
is a key issue. The rights of the traditional communities seek protec-tion since they are a cultural asset which takes account of the valuesand services of the ecosystems which would otherwise have to be in-vestigated by western techniques - a complex, expensive and time-con-suming process. Cultures other than western culture must be respected,and a means to protect them must be found but only where protectionis framed in the context of history, its cosmovision and culture. Also,their traditions are collective and they are generally transmitted orallyfrom generation to generation. However, even though such traditionsmaintain the cultural identity of these people, and are therefore knownand respected by everybody in these communities, there is certain spe-cialized knowledge which may be in the hands of only a few (or onlyone) individuals.
This is the case of the mamas, shamans, and jaibanás, the “witch-
doctors” who have the wisdom to cure physical, mental or spiritual ill-ness and the authority to manage social conflict in the community. Inwestern societies and individual,1 1 and therefore do not cover tradi-
tional knowledge held by the entire community, which would be a
“collective” right even though it is stilll private to the community. Incase of specialized knowledge, such as the examples mentioned above,it can be considered “individual” because only one person possesses itand according to the culture, only this person can transmit it. But theknowledge as a whole continues to be “collective” to the communitybecause it has been obtained through years of experience. In this re-spect, an initial conflict in the application of IPR to traditional knowl-edge because at present the collective status of traditional knowladgeis not taken into account, and the protection of inventions is on indi-vidual basis.
In general, it has been said that this knowledge does not have enoughprotection, and that the framework of IPR does not offer the kind ofsecurity required. Current norms on industrial secrets have elementsthat can be helpful in protecting that knowledge. However, the protec-tion of non-revealed information is directly related to industrial activ-ity. Because of this, it would not be proper in the first instance to saythat this type of protection is suitable to safeguard traditional knowl-edge, innovations and practices. There would not necessarily be theindustrial ingredient that would allow them to be covered by TRIPSand, furthermore, they could not be considered as private and individual. Nevertheless those traditional knowledge that are going to be com-mercially exploited can be protected as an industrial secret if held inthe name of a legal person.
On the other hand, in the field of protection of this kind of knowledgeby patent, it is necessary to study the extent to which it can be consid-ered as novel.12 This knowledge, due to its traditional character, hasnecessarily been known and transmitted for generations. In Colombiathe concept implies “absolute novelty”, that is, that an invention is con-sidered novel when it has not been known before in any way. Conse-quently, traditional knowledge could not be covered by a patent as such,because it is generally known by one or several persons (even if onlywithin a given community). Other countries like the United States, how-ever, use the concept of “relative novelty”: an invention is novel if it isnot known through publications or other media for a determinate time
in advance of the submission of the patent application. This could beinterpreted to mean that the knowledge of traditional communities is“novel”, provided that it has not been made public before the applica-tion for the patent is submitted, even though it existed before. Such asituation could be common since most of the communities which pos-sess such knowledge are culturally-isolated minority groups. In addi-tion, it could be very difficult to prove that an application for patentprotection has its roots in traditional knowledge since the knowledgeis generally not recorded or is only known or used by small communi-ties in very small geographical areas. Therefore patent applications re-lated to biodiversity must include clear indications regarding the sourceof the basis of the invention, and its geographical origin.
Decision 391 of the Cartagena Agreement, on access to genetic
resources, states (Temporary Provision 8) that mechanisms to protecttraditional knowledge, including sui generis mechanisms, must be ex-plored. So far, however, there has not been any concrete proposal by theState, nor by the Andean Community nor its Secretariat, that develops thisProvision. There is therefore no practical mechanism of practical appli-cation in the region.
As can be seen, there is a debate concerning the feasibility of covering
traditional knowledge within the terms of current intellectual propertyregimes. Some countries, such as the United States, believe that the issueof traditional knowledge should not be discussed at TRIPS, because Ar-ticle 27.3 .b. specifically mentions sui generis systems for the protec-tion of plant varieties, and leaves no room for further study of the protec-tion of traditional knowledge. Other countries, such as Colombia, India,Brazil and Canada, however, are ready to study the issue within the contextof the WTO, to analyze if it is feasible for TRIPS to regulate this matter,even though it is not explicit in the mandate of TRIPS. What is importanthere is that this knowledge is vital for the conservation and sustainabledevelopment of biodiversity. There are different ways of understandingthe way that nature works, and in this sense, traditional knolwedge is a newproposal on how to use and manage the environment. On the other hand,traditional knowledge contains a rich understanding of products and pro-cedures that could have value in medicinal products, food, etc.
In this way, the first question that needs to be asked is whether it isnecessary to establish a western system of protection for knowledgethat has been and is still preserved by communities through ancestralpractices and customs. If the answer is that it is necessary, then weshould ask in what way it would be convenient to establish a new sys-tem to protect community knowledge through national or regional pro-cess of study and research.
If a western regulatory framework were to be created for the pro-
tection of this knowledge, we could say that what is being protected isthe rights of the traditional communities acquired by them for havingdeveloped their knowledge, in the same way that IPR have been estab-lished to protect an inventor’s rights over its knowledge. The next ques-tion might be, what sort of protection could there be? A database isbeing set up in India, where the most deeply rooted knowledge and tra-ditions are to be found, and the knowledge recorded in it will be ex-cluded from patent protection. It is interesting that in this case the wayto protect information is to make it public. However, this solution hasits shortcomings: traditional knowledge could lose its commercialvalue, since it can not be patented because it would loose its novelty. The communities interested in its exclusive use would thus be inhibitedfrom any industrial exploitation of the inventions that use that traditionalknowledge. Also, third parties could exploit it commercially even withoutpatent protection. Also, there is no pattern in which one could place thedifferent concepts that the communities have regarding the way to treattheir knowledge, and national laws differ in their treatment of such com-munities. Although the Convention on Biological Diversity calls for theconservation of traditional knowledge related to the conservation and sus-tainable use of biodiversity, the truth is that any study of ways to protectthis knowledge would be on a case-by-case basis, depending on each com-munity and country.
Consequently, it is not clear how the issue of traditional knowledge
could be introduced into the context of existing regimes of intellectualproperty rights. Up to now, no legal instrument has been defined or iden-tified which could comprehend the concept of traditional knowledge it-self and the intangible components of which it is made. It could be saidthat, applying the earlier remarks with reference to the collective
character of community knowledge, the legal status of the communitycould somehow be established in a way in which better protection isoffered for the needs and possibilities of the communities. Efforts havebeen made in this direction. For example, the World Intellectual Prop-erty Organization (WIPO) has organized consultative workshops withtraditional communities, at the international level, as an exercise todiscover concerns regarding IPR. In this respect, it would be conve-nient to promote studies and research at regional and national levels toidentify alternatives for a new or sui generis regulatory framework. Or, in certain cases, to make the present regulations on patent and in-dustrial secrets more specific, so that they could specifically cover theprotection of this type of knowledge. It would be useful to make apresentation of the various modes of protection now available, andthose that can be created or modified, in order to study the most viableones, including the alternative of not applying protection of any kind. E. Intellectual Property Rights and Ex Situ13 Conservation
Here, the CBD calls for the adoption of national measures for the
conservation and sustainable use of biological resources which areoutside their habitat, or in ex situ conditions, preferably in their coun-try of origin. Consequently, facilities to investigate plants, animals andmicroorganisms should be established.
For example, gene banks or banks of live material related to IPR,
are incorporated into international patent norms, not so much for theirrole in the conservation of ex situ collections but because they arerequired to act as depositories for patents of invention based onbiodiversity components. There are, however, negotiations and actionsclosely related to intellectual property and biological material that ex-press strong concern for the conservation of ex situ collections. Forexample, the negotiations of the FAO Commission on Genetic Re-sources for Food and Agriculture is reviewing food resources listed inex situ collections. Likewise, the Patents Cooperation Treaty, PCT, hasregulated the deposit of biological material (including microorgan-isms) made in order to obtain the international registration of a patent14. Other international groups are also working on the IPR issue in con-nection with the conservation of biodiversity, in or ex situ.
When an application for a patent that uses biological or microbiological
material is being studied, the samples of the material must be deposited in aninstitution, with the purpose of corroborating the content of the descriptionof the invention made in accordance with the Patent Cooperation TreatyPCT, and the Treaty of Budapest on the Deposit of Microorganisms (1977). TRIPS, when permitting patents on procedures and products obtained from livematerial, should provide its Member-States with appropriate guidelines of insti-tutions that might be able to handle the samples of living material, or refer themto the relevant international treaties.
A research center acting as a depositary institution must comply withthe following requirements, among others15:-
The research center must be internationally reputed.
The sample must be given to the center under a Material TransferAgreement.
The center must issue a certificate as evidence of the deposit.
The depositor must give a copy of that certificate to the nationalauthority to which the patent application is made.
This certificate should specify the country of origin or collectionof the sample, and a prior informed consent from that country shouldbe legally required.
The certificate must include tangible evidence of the consent givenby the traditional communities from which the sample was taken. This applies to the case in which access to traditional knowledgeof the intangible component is associated with the genetic re-sources and its products thereof.
According to the above, TRIPS must be more specific in the formula-
tion of recommendations for the establishment of research centers thatmight operate as depositaries of live material samples for patents. Theintention is to guarantee security, t national and international levels, in thehandling and maintenance of the samples, and to assure compliance withother related norms. This control function should be carried out at thenational level, with patent offices and deposit centers acting in concert. Naturally, the overall guidelines contained in the CBD should be takeninto account when establishing mechanisms for the conservation and useof live material deposited for the purpose of obtaining a patent. II. The Sustainable Use of Boidiversity and its Relation to the Application of Intellectual Property Rights
The analysis of the relationship between the sustainable use of thebiodiversity and its application to IPR, has been focused on the use ofintellectual property rights, stressing the importance of patents,greographical indications, and their relation to trade.
Article 10 of the Convention on Biological Diversity (CBD) deals withthe subject of sustainable use of the components of boidiversity. It statesthat conservation and sustainable use tests should be integrated to de-cision-making national processes. CBD also points out that the Partiesshould adopt measures related to the use of biological resources toavoid, or reduce to the minimum, adverse effects. On the other hand,the Preamble of the Marrakesh Agreement that establishes the WorldTrade Organization, states that commercial and economic activitiesshould take into account an optimum use of the world’s resources, ac-cording to the objective of sustainable development. Moreover, theyshould also try to protect and preserve the environment. It is worthremembering that TRIPS is an agreement that depends from the previ-ously mentioned one and therefore, the Preamble of the MarrakeshAgreement will also apply to it. In this sense, TRIPS states that if theParties want to formulate or modify their laws, they can adopt mea-sures which will protect health and encourage socioeconomic and tech-nological development. It is also possible to prevent the commercial-ization of a patent if it turns out to be harmful for the environment, orfor human health, among others.
Article 27, Number 2 of the same Agreement states that Members mayexclude from patentability inventions, the prevention within their terri-tory of the commercial exploitation of which is necessary to protectordre public or morality, including to protect human, animal or plantlife or health or to avoid serious prejudice to the environment. As canbe observed, although TRIPS by itself does not point out clear mecha-nisms to reduce harmful uses to biodiversity, nor is its function, it isindeed coherent with CBD’s spirit. It establishes measures to prevent
illicit commerce and abuse of IPR which will adversely affect both
commerce and the environment. It should, nevertheless, be mentionedthat these measures are of national nature and therefore, at the time ofdeciding upon the granting of a patent, it is the State’s responsibility tolook after its compliance.
It is worth noting that use, in the context of intellectual property, is
related to the exclusive exploitation rights the owner has over the in-vention. It is necessary to mention therefore, that the rights the holderof an IPR title has, especially over patents, are the following accordingto TRIPS Article 28:
“(a) where the subject matter of a patent is a product, to prevent
third parties not having the owner’s consent from the acts of: making,using, offering for sale, selling, or importing for these purposes thatproduct; (b) where the subject matter of a patent is a process, to pre-vent third parties not having the owner’s consent from the act of usingthe process, and from the acts of: using, offering for sale, selling, orimporting for these purposes at least the product obtained directly bythat process”.
The controversy about the use of patents granted for biotechnological
substances, basically is about , firstly, the danger that the handling, ma-nipulation, transport and release of LMOs could represent, and secondly,to the private ownership which is given to patented objects. In relation tothe latter, there have been several widely criticized cases. For example,there have been attempts to patent seeds from plants that do not repro-duce. For this plants, a new stock would have to be bought for each newharvest16 . This has proveked farmers to claim rights, and has also madepeople understand that a possible space to privatize new products has beenopened, thus affecting food security, but at the same time favoring themonopoly of agrarian trade. Nevertheless, benefits from these develop-ment can also be found since genetic transfer risks from these plants towild parentals could be avoided. Intellectual property rights are a mecha-nism to encourage technological development that, although in some casescould be arguable because of its effects, can generally show beneficialeffects for people, including farmers, as is the case of the protection ofthe obtention of new plant varieties.
Nevertheless, the privatization given to patents is not absolute
and is limited in time. For example, if a product is protected for acertain use, and after being commercially exploited somebody elserealices that this same product can have a second use, differentfrom the original one, that person can present a new patent applica-tion for that second use. In the same way, any person can modifythe primary protected product in oreder to obtain a new one whichwill therefore have a new use.
To promote a sustainable use of the biological material employedin patenting applications, and in general to promote its conserva-tion, it should be considered that in the patenting application cer-tain parameters could be added so that they could help clarify thepurpose for the use of the biological elemnt, as well as its place oforigin. In this way, the inclusion of the requirement could be pro-posed as 17 :
a certificate of the country of origin of the biological samplethat includes a geographical indication of either the country,region, or specific place where the sample was obtained, orthe specific geographical area from which it comes.
tangible evidence that the biological material was taken outfrom the country of origin with a previous informed consent.
In this way, the information obtained about origin and use of
that biological material would be of great help when consideringthe applicability of fair and equitable distribution criteria for thebenefits obtained through the marketing and use of patented prod-ucts which include biological components. III. Access to biodiversity components, safety in their use and sharing of benefits A. Access to genetic resources and its relation to IPR - B. Biotechnol-ogy and Biosafety, its development with respect to IPR and benefitsobtained.A. Access to genetic resources and its relation to IPR.
The TRIPS agreement does not specifically mention the topic of ac-
cess to genetic resources as such. However, it does discuss patenting ofliving matter in general, and both of these topics are closely related. Inorder to investigate the active components that can be extracted fromplants, animals or micro organisms, with the object of producing, forexample, a certain medicine, it becomes necessary to access a geneticresource or a by-product18 from it. In other words, in order to patentliving matter modified by man through modern biotechnology or any de-rived process, for commercial use, access to genetic resources of thatmaterial is necessary. In that context, and although TRIPS does not regu-late access, there is a national and regional legislation regarding this is-sue, such as Decision 391 of the Cartagena Agreement concerning Ac-cess to Genetic Resources, Biodiversity Law 7788/98 in Costa Rica, andAdministrative Order (ADO) No. 96-20 in the Philippines.
There is currently a general concern regarding the possibilities of pat-
enting genetic resources, as reflected in the European Directive on Bio-technology. Again, we find ourselves in the discussion mentioned at thebeginning of this analysis, of whether or not it is possible to patent thegenetic resource in its natural state, and whether an isolated genetic re-source has any inventive level that would deserve protection.
As noted previously, in order to be able to register a patent, any inven-
tion, and in this case those that use a genetic resource, it must have suf-fered some kind of human induced modification, so that it acquires a levelof innovation and inventiveness, and that has an industrial application.
This is what has to be proved when attempting to obtain protection, ac-cording to Article 27, TRIPS. In other words, those scientific and techni-cal procedures, and products derived from these procedures that are basedon information extracted from genetic resources and have been modifiedor altered, may be patented if novelty, inventiveness and industrial appli-cation can be demonstrated. However, as mentioned previously, this opin-ion is not shared by those who sustain that mere isolation of the gene issufficient for patenting.
With regard to this issue certain doubts arise. For instance, what are
the existing controls over the applications of patents of living matter,considering that these must be a product of biotechnological processesand not mere discoveries? It is worth noting that it can become verydifficult, if not impossible, to prove that a genetic resource which hasbeen modified does not exist naturally, and furthermore taking into ac-count that sequencing is different for each individual. IPR becomes auseful tool in reducing these difficulties because in the application forpatents of biological material or micro organisms the applicant mustpresent lists of DNA, RNA, proteins, nucleotides or amino acid se-quences - specifying the modifications made to the material- thus jus-tifying that there is an invention within the natural product.
The traffic of biological material for commercial use has become a
main concern in environmental legislation, especially in countries oforigin or collection, which generally do not have adequate infrastruc-ture or internal legislation to react to the problem. Generally, illegalsample extraction becomes an easy method of access to genetic re-sources, which can then be used for creating products and processes forindustrial applications. In this case, the activity is not only a crime, but italso closes all possibilities of obtaining equal and fair shering of benefitsderived from access to this genetic resource between the country of ori-gin and the obtainer.
Specialized forums have been created world-wide to deal with the com-
merce of biological material, such as the Convention on International Tradein Endangered Species of Wild Fauna and Flora - CITES, or forums
more closely related to the topic, such as the CBD Bioseafety Protocolunder negotiation. At a regional level regulations for access to geneticresources have also been established, such as Decision 391 of theCartagena Agreement. Even if it is true that in commercial and environ-mental issues there ought to be more cooperation for the control of illegaltrafficking of biological and /or genetic material, in the case of intellectualproperty rights, international regulations such as TRIPS or WIPO agree-ments cannot help to stop this kind of illegal traffic. The most that can bedone is to include in the patent applications an indication of the origin ofthe living matter which is used for an invention. Commercial and environ-mental national authorities are responsible for controlling the legality ofthe material extraction.
With regard to the regulations in Article 27.3 b (TRIPS) concerning
exclusions of patentability, the Member States, on deciding the applica-tion of this regulation in their internal legislation, ought to bear in mindthe norms contained in the CBD , should the states be party to both ofthese legal instruments. Furthermore, Member States should analyze theconsequences of the possibility of patenting animals and plants on con-servation, sustainable use, and the fair and equal distribution of the ben-efits derived from access to biodiversity. It would be convenient if pat-ents given to natural resources were awarded only to products and/or pro-cedures involving some kind of human technology. Other intellectual prop-erty rights, such as commercial trademarks, geographical indications etc.,can be awarded to any biological material that can be commercialized,whether or not processed.
In conclusion, it can be said that the CBD must work more closely
with TRIPS, so that decisions and recommendations regarding biodiversityissues may be coherent with intellectual property regulations in commerce. In the same way, TRIPS must consider the regulations established in theCBD when making decisions regarding the application of patents and otherintellectual property rights related to biodiversity components. Equally,countries belonging to both legal instruments must work to regulate theaccess to genetic resources nationally and regionally, in accordance withinternational regulations and in a manner which is consistent with obliga-tions contracted in both forums. B. Biotechnology and biosafety - its development with respect to ipr and benefits derived.
Biotechnology refers to any technological application that uses bio-
logical systems, living organisms, or derivatives thereof, to make ormodify products or processes for a specific use. In principle, it isdeveloped to improve the qualities of an organism which is present innature, adapting its conditions to man’s growing needs. Biotechnologyhas been classified, according to its biotechnological development, intofirst-, second- and third-generation. However, it is easier to talk about“classical” and “modern” biotechnology. The first refers to biotech-nology which does not require genetic engineering or laboratory pro-cesses, such as crossing or hybridization, while the second refers tothe biotechnology which is carried out through more complex scien-tific processes which directly use genetic information, among otherthings.
Biotechnology, and especially its relation to biosafety, has become
increasingly more important over recent years, mainly due to the rapidtechnological developments in fields such as agriculture1 , although inthis field traditional technique is still above modern techniques in agri-cultural production. Generally, we can see that the use of living modi-fied organisms (LMO) produced by modern biotechnology has beenimplemented in different industrial applications such as textiles, food,cosmetics, medicine etc. It is worth noting that IPR and the possibilityof exclusivity in the commercialization of biotechnological inventionshave significantly contributed to their development. This is the rea-son why both topics are closely related.
The use of biotechnology has brought positive impacts to man, in-
creasing the quality and quantity of products, making products cheaper,and decreasing the loss of perishable modified products. Furthermore,microorganisms that attack certain types of contamination have been de-veloped, as well as new vaccines, etc. However, uncertainty has increased
concerning the possibilities of an undesirable expansion of the LMOs. This expansion can mean genetic erosion in wild relatives, or in thedevelopment of super-weeds; there has also been considerable discus-sion related to the repercussion that the use of LMOs may have onhuman health. As can be seen, although biotechnology plays an impor-tant and positive role in human development and in environmental pro-tection, it has become necessary to create mechanisms to control thenegative impacts that these organisms may have on humans and on theenvironment.
Therefore the CDB has emphasized the need of mechanisms for
the regulation, administration, handling, or controlling risks de-rived fron the use and release of LMOs, likely to have adverse ef-fects on biodiversity. Article 19 of the CDB calls the Parties toadopt administrative or policy measures to provide for the effec-tive participation in biotechnological reserach activities by thoseContracting Parties, specially developing countries, to promote andadvance priority access on a fair and equitable basis to the resultsand benefist arising from biotechnologies, as well as to provideinformation on this issue. For the CDB, biotechnology is conceivedas a mean of use of biodiversity (as well as a way of conservation), thatpromotes human development, and as it has been shown its applicationmay have positive and negative repercussions on the environment.
The Convention establishes the need to create a legally binding
instrument within the scope of the CBD, to regulate security pro-cedures in biotechnological activity, which is being negotiated as aProtocol on Biosafety. This Protocol is due to be signed in theyear 2000. Its scope is the transboundary movement of LMOs,based on an advance informed agreement procedure, the precau-tionary approach, and the handling and evaluation of possible risks. Equally, risks to human health and the development of capabilitiesin developing countries are being studied, so that these countriesmay have access to the necessary financial and technological re-sources to implement all regulations established both in the Pro-tocol and the CBD.
The relationship between the CBD and TRIPS is necessary because
the biological material which has undergone biotechnological trans-formations, as mentioned previously, is a candidate for patent protec-tion and thus enters the field of the protection awarded to industrialproperty rights. The patenting of a biotechnologically modified organ-ism does not ensure that it is safe. This is why it has become neces-sary to discuss the precautions in introducing and releasing this typeof inventions into the environment.
Although in TRIPS Article 27.2 discusses the possibility of not pat-
enting a product which causes damage to life and to the environment, asnoted previously, it must be remembered that damage is not always iden-tified clearly, and therefore it is more appropriate to talk about risks ofdamage. The question is whether to wait until the specific risk can bedetermined, or whether to take preventive measures until there is cer-tainty regarding this risk. For example, the WTO, SPS Agreement onthe Application of Sanitary and Phytosanitary Measures states in Ar-ticle 5.7 that “In cases where relevant scientific evidence is insuffi-cient, a Member may provisionally adopt sanitary or phytosanitarymeasures on the basis of available pertinent information, including thatfrom the relevant international organizations as well as from sanitaryor phytosanitary measures applied by other Members. In such circum-stances, Members shall seek to obtain the additional information nec-essary for a more objective assessment of risk and review the sanitaryor phytosanitary measure accordingly within a reasonable period oftime”. Thus, the WTO is allowing the opportunity to acquire more knowl-edge about a product, before releasing and commercializing it. The CDB,in Article 8 (g), also leaves room for establishing measures related toLMO risk control, bearing in mind that in its preamble it is clearlystated that the precautionary approach is an essential component of theConvention.
The negotiation of the Protocol on Biosafety is clearly a forum
which has contributed to the discussion regarding precautions in thehandling of biotechnological products. In principle, it seeks to establish
general measures for avoiding risks in the introduction and release ofbiotechnological LMOs into the environment. Currently, this has beenreduced to working on the safety measures which must be taken whentransboundary movement of these organisms, leaving to national legis-lation the regulations of risks to biodiversity and human health that maybe caused once introduced in a particular environment. This discus-sion has been closely related to the WTO. This negotiation is gaining asignificant commercial connotation, moreover when the focuss is noton establishing safety measures for release these organisms, but to regu-late their safety between the movement of importation and exporta-tion, wich is a commercial issue. Nonetheless, it must be understoodthat the real objective behind moving these organisms may be to applyLMOs both to scientific research and to commercial activity.
In the case of commercial activity, TRIPS is also relevant, pointing
out that measures must be adopted to control the commerce of goodsrelated to infringement of intellectual property rights. As noted previ-ously, the patenting of living matter is currently subject to much inter-national discussion, because it involves a product which can be bothprivatized and commercialized. We must not forget that LMOs arebiotechnologically modified living matter, and this alteration can inmany occasions result in innovation, inventiveness and industrial appli-cation, and may therefore eventually be patented. It is important that,in biotechnological terms, TRIPS and the CBD establish close links,with the objective of ensuring that LMO patenting and its later com-mercial exploitation does not endanger biodiversity. In doing this, pri-ority must be given to conservation, sustainable use and fair and equaldistribution of biodiversity benefits, ensuring that these objectives willnot become technical or tax barriers in the trading of biotechnologicallymodified organisms.
Some may consider important to ask how and when LMO patents
should be allowed, ensuring that both the procedures for obtaining them,as well as the final product (the modified organism), will not have re-percussions on the environment, fauna, flora and human beings. It is
also relevant to question whether the study of a LMO patent applicationthat may be harmful should no put in evidence damage against publicorder and morality. Doubts regarding establishment of trade barriers arealso relevant, and also the possible overlaps that may arise betweeninternational treaties regarding the environment and the trade ones. However, despite the many questions the issue may bring out, interna-tional property rights were not created to question the benefits or dam-ages arising from a particular invention. This is an issue which must bediscussed in other sectors such as environment and trade. AlthoughTRIPS states that the Member States must account for public healthprotection measures within their legislation, pointing out that patentscan be denied to inventions that are a threat to public health, life and theenvironment (Art.27.2) and the SPS states in its preamble that Mem-bers are free to adopt and apply necessary measures for the protectionof life and health of humans and animals as well as plant preservation,responsibility regarding this issue is mainly given to the health and en-vironmental authorities. 2. THE SHARING OF BENEFITS
Although TRIPS does not specifically mention the sharing of
benefits, in the terms that the CBD conceives it20 , it can be under-stood that through the promotion of technological developmentderived from the patents, mechanisms are established in the par-ticipation of benefits obtained from research, production and com-mercialization of biotechnology.
The royalties that an inventor may earn as a result of a patent
are private and individual. Therefore, it is necessary to study howcountries of origin or collection of biological and/or genetic re-sources can negotiate the economic and social benefits which areexpected from allowing access to these resources with the patentholder. The Convention offers some general ideas concerning thisissue in Article 19, but until specific mechanisms for calculatinghow these benefits can be distributed are developed by the inter-national community, it is the State’s responsibility to implementadequate measures internally.
Intellectual property rights may become a useful tool for equal
distribution of benefits resulting from access and use of geneticand biological resources. This is because patenting these productsnot only means profit for the inventors, but also for the countriesof origin of these resources. All this is based on the assumptionthat the regulations in TRIPS can complement the objectives ofthe Biological Diversity Convention, and all national regulationsregarding access to genetic and/or biological resources.
It must be remembered that IPR were created to protect
technological inventions (among others). However, given that realor potential value has been discovered in biodiversity resources,such as genetic resources, and that there has been an increase inthe application of technology to life forms to derive proceduresand products, intellectual property rights have also had to adapt tothe new invention requirements in this field. Because these pat-ented products and procedures are based on living matter extractedfrom a jurisdiction or territory of a State, involving previous in-formed consent for acces, measures must be adopted to ensurethat inventors´ investment and opportunity costs are conmesurateto the costs incurred by the State in conserving these resources. IV. Cooperation Mechanisms; relationship between regulation of intellectual property and biological diversity. A. Intergovernmental Cooperation. B Scientific and technicalcooperation. C. Research and education. D. Follow up E. Information sharing.A. INTERGOVERNMENTAL COOPERATION.
In the CBD, cooperation must be guided towards the States and in-
ternational organizations (governmental and non-governmental), withthe objective of conserving and sustainably using biodiversity, and ac-cording to common interests that may link different institutions andcountries.
Cooperation between TRIPS Member States is mainly directed to-
wards controlling commercial goods that infringe intellectual prop-erty rights. To do this, it has been agreed that there has to be a constantprocess of information sharing, the necessary notifications concern-ing commercialized products, and cooperation between customs au-thorities. TRIPS cooperation between governments goes beyond thesetopics. It not only involves cooperation with the Parties, but also worksto create close links with international organisations that deal with thistopic, such as WIPO with which it has a memorandum of understand-ing, UPOV21 , FAO22 , OECD23 , UNCTAD24 and the World Bank, amongothers. However, specific cooperation mechanisms with the CBD donot exist. Despite the fact that the CBD has called upon its Secretariatto attend as an observer to the WTO meetings in order to exchangeinformation (Decision CBD/III/17), the Convention´s presence in theTrade and Environment Committee and the TRIPS Council in the WorldTrade Organization has been practically non-existent. To date, the Con-vention Secretariat has limited itself to the distribution of a number ofreports to Member States concerning the activities developed withinthe organisms dealing with intellectual property rights, but so far therehave been no conclusive results25 .
As there are currently numerous debates among the international
community regarding the relationship between IPR, trade andbiodiversity, it has become necessary for the Convention to play anactive part in WTO meetings and negotiations, both in the Tradeand Environment Committee and in the Agreement on IntellectualProperty Rights. This participation must be reciprocal, and musttake into account all of the questions raised by Member States. Toachieve this objective it is necessary to create stronger links, andnot merely act as observers. Cooperation memoranda could beestablished between TRIPS and the CBD regarding the develop-ment of the key articles that deal with intellectual property rightsrelated to biological resources in the Convention.
The patenting of living matter is a topic which necessarily links
TRIPS and the Convention, and as long as the debate is carried outin two separate forums, it will remain difficult to try and solve prob-lems related to biological, ethical, moral, technical, commercialand even religious issues. If debates were to be held jointly, thiscould be a very useful way of identifying and clarifying certain dif-ferences. This is why an urgent call must be made to the CBD toimplement decisions resulting from the Conferences of the Par-ties regarding intellectual property rights issues, and to study thevarious repercussions of IPR related to biotechnology inbiodiversity within WTO. B. SCIENTIFIC AND TECHNICAL COOPERATION
TRIPS, through its Council (its senior organ), has been working
on the issue of science and technology cooperation, directed mainlyat the developing countries and especially at producers and usersof this technology. According to the Council, cooperation must befocused on the social and economic benefits of Member States,and to contribute, in first instance, to technological innovation, itstransfer and dissemination. For some Member States - developingcountries - the practical results of that cooperation has not yet pro-duced concrete results.
The CBD emphasizes on the importance of scientific and technical co-
operation, although its objective is obviously different to that of TRIPS. Asfar as the Convention is concerned, development and technology transfermust be based on the conservation and sustainable use of biological diver-sity. Encouragement in the use of technologies includes, among others,local and traditional technologies. As can be seen throughout this analy-sis, a fundamental focal point between the Convention and TRIPS is bio-technology. This is why the importance of cooperation and technologytransfer is essential when studying both treaties.
Up to now there has been no balance between the technical and scien-
tific capacity of developed countries in comparison to developing coun-tries, most of which, paradoxically, possess the greatest biodiversity inthe planet. Their natural resources are the raw material for the develop-ment of biotechnological processes, through research into the compo-nents that can create new technologies. However, in the majority ofcases, the countries that possess these resources do not have the techno-logical or financial capacity to conduct research. The Convention estab-lishes that access to resources must be accompanied by technology trans-fer, as an essential component of achieving its objectives. Furthermore,in the case of access to technologies, a special space is opened to devel-oping countries, enabling them to obtain these technologies under fairand most favourable terms. However, and even though TRIPS mentionsthe importance of this issue, it has not yet discussed exactly how thistransfer is to be effected, and this is a fundamental consideration in en-abling the less developed countries to exploit their own resources, or atleast to set the basis for explore their technological capacity.
In this field, the CBD, through its Clearing-House Mechanism (CHM),
has begun to strengthen scientific and technological cooperation. TRIPSis also encouraging technology transfer, and both treaties coincide in stat-ing that priority ought to be given to developing countries. However, coun-tries that have these resources have not yet received any concrete resultsregarding technology transfer, or priority access that would enable themto develop their resources, both in the bioprospection and biotechnologyfields.
Good intentions must not simply stay on paper: mechanisms must be
created to produce concrete results for the Member States. So far tech-nological and scientific cooperation has been restricted to financing spe-cific projects in countries, but no global mechanism has been created forall of the parties involved. The CHM, in the case of the CBD, can be con-sidered a first step in providing an appropriate mechanism, but up to nowcooperation has been restricted to information sharing. TRIPS has notdeveloped an adequate mechanism to deal with the problem of technologytransfer in intellectual property issues related to trade. In Article 7 TRIPSmentions that IPR protection and observance must contribute to techno-logical innovation and transfer, to benefit both technology producers andusers, in order to create a balance in rights and duties, as well as economicand social stability. The only method that the WTO text offers is thatMember States at the national level should establish adecuate mechanisms,and report the resulting cooperation activities. Is this enough to maketechnology transfer in the terms established in TRIPS a reality?
It is clear, that it has become necessary to create a process of techno-
logical and scientific cooperation and transfer, in order to balance re-sponsibilities, opportunities and benefits to all parties members of onetreaty or the other. To do this TRIPS must create some kind of a mecha-nism in the same way that the Convention has created CHM, specificallycalled upon to develop these issues, and to design plans, programs andmeasures, nationally and internationally, for scientific and technologicaldevelopment of all Member States. C. RESEARCH AND EDUCATION
The Convention emphasizes the need for developing countries to es-
tablish training and education programs in science and technology, as wellas in research, especially guided towards biological diversity areas.
Regrettably, TRIPS does not consider the issue of research and train-
ing, even when discussing technology transfer26 . If no mechanisms forhandling and developing technology exist, how can any progress be madeby the less-developed countries? It would be desirable that developing
countries which hold biological resources with potential industrial usecould develop their own methods, thus adding value to their resources,so that these countries could exploit their biological richness in thesame way as developed countries do. Again, this is why an adecuatetechnology transfer becomes essential. Training and education pro-grams in developing countries must be strengthened, so that they canimplement and develop technologies. To do this, courses should bedesigned, such as the one arranged by TRIPS and WIPO ( “Technicalcooperation guided towards improving human resources and institu-tional capacity required to apply the regulations about TRIPS, regard-ing national observance.“) Training and education programms, mustalso be open to anyone who has an interest in research in biotechnol-ogy. This type of support for research must not only come from theinternational offices, (TRIPS Council or Convention Secretariat), butit must also be an initiative of the countries which have some knowl-edge of the subject and can share it.
TRIPS has also abandoned the issues of public awareness and edu-
cation, even though it is backed by WIPO, whereas the CBD is begin-ning to implement measures designed to improve this aspect, espe-cially dealing with education in the development of national strategiesand plans of action, as well as initiatives to inform the community aboutthe regulations in the Convention. Within the work plan designed bythe COP in the CBD, education is a key factor in all areas discussed. UNESCO is invited to consider launching a global initiative for educa-tion, training and public conscience in biodiversity issues.
The WIPO has undertaken the task of disseminating information
regarding IPR, and TRIPS has agreed that it should remain responsiblefor this aspect. WIPO does have some specific mechanisms for educa-tion, such as seminars, workshops and conferences. These mechanismsare all addressed to issues regarding the regulation of the treaties un-der its wing, and make only tangential reference to TRIPS. Despite thecooperation memorandum between the Convention and WIPO, perhapsthe WTO should consider strengthening knowledge about TRIPS, es-pecially now that the Millennium Round is close, and with it, the re-view of TRIPS Article 27.3b. It is also worth noting that not only those
dedicated to intellectual property rights should work on the subject, butthat anyone interested should have information on this subject. This isbecause any individual can invent something which could be patented,and ignorance regarding mechanisms may result in the loss of recogni-tion for the invention. There is a certain amount of alarm among theinternational community regarding the patenting of living matter, andthis is largely due to the lack of information about TRIPS, and its appli-cation both nationally and internationally.
Issues concerning education must be discussed in each of the TRIPS
Member States, so that national intellectual property offices may il-lustrate the population about the IPR legal regime in each country, poli-cies to adopt, and international responsibilities. TRIPS, through itsCouncil, must call upon its Members to design national education plansin intellectual property rights, as well as attempt to offer adequate fi-nancing mechanisms. D. FOLLOW UP.
The follow up of TRIPS and the CBD refers to the supervision needed
to ensure that each one of the treaties is being complied with. How-ever, given their close relationship in certain subjects, it would be in-teresting if TRIPS were to establish a specific regulation for patents inbiotechnology, so that origin, commercialization and effects can beclarified. Although this task is being performed by national intellec-tual property offices, it would be convenient to centralize this infor-mation internationally, so that it can be made available to the public ingeneral. Supervising patented (or in the process of patenting) biologi-cal products and procedures can be a good mechanism for implement-ing biosafety measures concerning the trasboundary movement and tradeof living modified organisms that are in one way or another covered byan intellectual property right. In doing this, account should be takennot only of TRIPS regulations and procedures used in the National PatentOffices, but also of other WTO regulations, such as SPS. All of this isdesigned to make regulations regarding the trade in biotechnology morecoherent.
A fundamental supervising mechanism within the scope of CBD, is
the establishment of procedures to evaluate the activities that are likelyto have significant adverse effects on biodiversity. In the case of TRIPS,this topic is not dealt with, either in the text or in the annual reports,apart from Article 27, which mentions the possibility of denying a patentwhen grave danger to the environment is imminent. However, this is ahighly subjective measure, as it gives the parties the discretion to de-cide whether the trade in certain types of inventions is dangerous.
An evaluation of environmental impacts in the case of intellectual
property rights is very complicated, because it is not reasonable to in-clude measures to evaluate possible risks of a patent application thatcontains living matter. The best mechanism is supplied by the users ofthe patented products, which have the power to avoid or minimize trad-ing of products that could be harmful to the environment and to humanlife. However, it would be convenient to create or improve coopera-tion and information channels between national intellectual propertyoffices and national agencies responsible for environmental issues. E. INFORMATION SHARING.
This subject is covered by Article 17 of the CBD. The Article
points out the importance of sharing information regarding biodiversityconservation and sustainable use. This exchange of information mustinclude results of scientific, technical and socio-economic research. It must also contain information regarding training programs, local andtraditional practices, and repatriation of information where viable.
To facilitate information sharing, the Convention has devised CHM
(as mentioned previously), which is closely related to scientific andtechnological cooperation. This mechanism has established some fo-cal points (Member States and Secretariat), and some topical points(issues of interest to the Convention) in order to organize the infor-mation. CHM is working through websites in different countries27 andinternational organizations, connecting them up to the ConventionWebsite, http://www.biodiv.org
TRIPS mentions various kinds of information: first, the need to di-
vulge patent applications before titling them, and second, whether in-formation exchange has been practiced or not. In the first case, public-ity of an invention is required when a patent is requested and when theapplicant facilitates information concerning applications and patentsissued abroad. It contains an entire section that deals with non-divulgedinformation, in order to guarantee protection against unfair competi-tion. Second, it states that the Parties must publish all laws, regula-tions, decisions or administrative resolutions relating to TRIPS. How-ever, this will not force Members to disclose confidential informationthat may impede the application of the law, or that is contrary to thepublic interest, or that may harm the legitimate commercial interestsof private or public companies.
Although TRIPS stresses the importance of sharing information, it
has not yet centralized this mechanism properly. Although it has a pageon the WTO website, (http//www.wto.org/wto/intellec/intellec.htm) theinformation to be found there is in general poor. It should be extendedto include databases concerning patents applied for and granted in theMember States, workshops and courses, programs, addresses of na-tional intellectual property offices, etc.
This system of information is important, because it would provide
the community with access to patent applications lodged in the Mem-ber States, and the level of inventiveness or novelty in the new applica-tion could be appreciated by the community in general. It would alsoact as a means for supervising the grant of patents and other intellectualproperty rights which might be relevant. Access to this kind of infor-mation also contributes to the transparency of all patent processesthat could create controversy with regard to the environment, espe-cially in cases where living matter is involved.
It would also be convenient to create a direct link between TRIPS
and the Convention websites, in order to facilitate information sharingfor any issue of common interest. FINAL COMMENTS
Throughout this analysis we have been able to observe that WTO
Agreement on Intellectual Property Rights, has a very close relation tothe main themes of the Convenition on Biological Diversity. Up to now,TRIPS has been not too much active to specific biological consider-ations, although it does take into account the environment. For somecountries, as the United States of America, it is convenient that thedistance be maintained, but other countries, such as Colombia, con-sider necessary a study of the relations between intellectual propertyand biodiversity.
The existing relation between TRIPS and the CBD mainly focuses
on the patents that can be granted to certain biotechnological develop-ments in plants, animals or microorganisms, that can be subject ofpatentablity. These should include enough elements of inventive step,industrial applicability and novelty. This topic is being widely debatednow because of the different interpretations that can be given to TRIPSspecifications. However, the idea of applying IPR to biodiversity goesbeyond patents, if one takes into account that geographical indications,trademarks and industrial secrets can be equally related to the market-ing and privatization of tangible and intangible components of biologi-cal diversity. The discussion derived from this topic is mainly focusedon which of these components would be subject to this type of protec-tion.
As was noted throughout the analysis, TRIPS requires novelty, in-
ventive step, and industrial applicability as the basic conditions to startpatenting procedures. In this way, the components of biological diver-sity that could be included in this system would be those transformedor manipulated by man. This means that we would not be talking aboutpatenting wild life matter as such (an issue which could be consideredas the possibility of privatizing biodiversity) but of patenting life mat-ter which includes a certain degree of human intervention. Neverthe-less, TRIPS allows Members States to decide what is, or is not, patent-able within the framework of the Agreement. Some States consider
that, for instance, the mere isolation of a gene makes it patentable. In
this way, the United States, the European Union and the Andean Commu-nity of Nations, despite being member States of the Agreement, have con-siderable differences in their regulations related to the enforcement of TRIPSArticle 27.3.
It could be said that TRIPS may, at the end, be contradictory in its
specifications on the patenting of microorganisms. The prerogative whichthe Agreement gives to the States in relation to their will of accepting, ornot, the patenting of animals and plants, does not include microorgan-isms. Therefore, on a first reading, it could be considered that they areindeed included in the protection of the Agreement. However, when thethree requisites for granting patents are considered (novelty, inventive stepand industrial applicability) non-manipulated microorganisms would au-tomatically fall outside the scope of TRIPS. Thus, in the revision of Ar-ticle 27, it would be convenient to specify which type of microorganismsand / or microbial processes could be patentable, and which could not,explaining the difference between man-manipulated and non man-manipu-lated microorganisms.
It is not convenient to assert that some States, with technological and
financial capacity, are trying to take possession of the genetic and bio-logical resources of the less developed ones. Essentially, the biopiracyproblem meaning the illegal access to resources for research or com-mercial purposes, and extended to the application of IPR to their prod-ucts, is usually an activity undertaking by natural persons, and sometimes,by multinational companies. This is no an excuse for States to omit, intheir internal legislation, the regulation of access to genetic resourcesand its derivatives. In relation to the access to genetic resources, TRIPSdoes not regulate the topic; however, some specifications included in thenorm, such as geographical indications, can be useful when trying to knowthe origin of the live matter used in patents. Additionally, a closer way toinvolve TRIPS tools when making a follow up to the live matter beingaccessed, would be to include, as a requisite in the application forms, aprevious informed consent as well as an origin certificate from the coun-try where the live matter was collected.
It should be stressed that international legislation, and specifically TRIPS,
provides tools to protect human invention, and therefore, in its essence, itcannot open the door to biodiversity piracy. TRIPS has been forced tostudy the applicability of intellectual property rights in an area for which itwas not designed: biodiversity. Because of this, some incongruence hasbeen found at the time of establishing the most appropriate criteria for thedevelopment of technology through patents. This doesn’t necessary implythat these incongruencies are harmful for the conservation and sustainableuse of biological resources.
As was previously stated, there are several tendencies at international
level, on whether it is possible or not to patent biological and / or geneticmaterial. A clear case is the European Directive on Biotechnology – Di-rective 98/44/EC from the European Parliament and from the Council ofJuly 6, 1998 – in its Article 3.2. In addition, U S has allowed the patentingof discoveries of isolated genes. Although both legislations do not inter-fere with our internal normativity, they can at some point be applied tocolombian biological resources that can later be extracted and manipu-lated in Europe or the United States. On the other hand, in Colombia andin the countries of the Andean sub-region, a tendency can be seen whichforbids the patenting of live matter existing in nature. Nevertheless, re-gional regulation on industrial property is being modified (Decision 344from the Cartagena Agreement). Colombia could present defective legallegislation concerning the regulation of intellectual property rights whenconsidering live matter, created or transformed, its trading3 9, use, andbenefit distribution, since it is only now that modifications redifining thetheme are being written. It cannot be denied that some countries havereceived international pressures to adopt the widest interpretation allowedby WIPO, related to the patenting live matter. It is also true that there ispressure to transform into international legislation some measures whichup to now have been regional. There could be some problems if thesemeasures contradict the conservation and sustainable use of the compo-nents of biodiversity, or if they induce an unfair distribution of the ben-efits derived from their use. Therefore, if a clear normativity is estab-lished at national level, and CBD regulations are taken into account, anequilibrium could be obtained among the interests of the countries in re-lation to live matter patenting.
The wide scope, or ambiguity, with which TRIPS regulates patentable
live matter, establishes a complex legal framework that may have voids. Up to now, Andean Resolution 344 has ruled over industrial propertywith the purpose to protect and respect biodiversity. Nevertheless, na-tional and regional legislations from other parts of the world, and thesame WTO discussions, have encouraged CAN members to drasticallymodify the current concepts on the topic, especially those related tobiotechnology, in order to adapt the legislation to the positions heldinside TRIPS.
In relation to this topic it must be mentioned that by making a spe-
cific regulation we do not intend to establish laws which would leave usoutside from the international scope. On the contrary, since Colombiais a member State of WTO, it must be alert to encourage technologicaldevelopment and free trade in a transparent and fair way.
The formal relation between TRIPS Council and CBD’s Secretariat
can be substantially improved. The CBD, under the command of its Con-ference of the Parties, should be much more specific in its recommenda-tions for concrete actions related to the development of Article 16, andof all those articles which could be associated to intellectual propertyrights. It should also specify more clearly the function of its Secretary inrelation to the ties that could be established with TRIPS Council.
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