Implementation of Article 27.3(b): Drafting
To review the various options that WTO Members have regarding the implementation of Article 27.3(b) of the TRIPS Agreement which obliges Members to provide for intellectual property protection of plant varieties. The module also discusses the pros and cons of each of these alternatives and describes the possible elements that a sui generis system for the protection of new varieties of plants might include.
7.2 Protection of plant varieties by patents
7.3 Protection of plant varieties by a sui generis system
7.4 Possible elements of a sui generis system
7.5 Protection of plant varieties by any combination of patents and a sui generis system
The TRIPS Agreement does not devote a specific section to the protection of plant varieties. Instead, it indirectly deals with it when addressing patents. In fact, Part II of the Agreement addresses each intellectual property right in succession, each in a separate section (copyright, trademarks, geographical indications, industrial designs, patents, layout-designs of integrated circuits, undisclosed information or trade secrets, and control of anti-competitive practices in contractual licences), without addressing plant variety protection directly. Only when addressing patents (Section 5: Articles 27-34), does the TRIPS Agreement refer to the possibility of excluding plants and animals from patentability, and to the obligation of protecting plant varieties through a sui generis system if they are not protected through patents. The options available are three: patents, an effective sui generis system or any combination thereof.
The TRIPS Agreement, as a part of the Agreement Establishing the WTO, came into effect on 1 January 1995. The various transition periods available to Members to comply with the WTO Agreements were outlined in Module IV.2.
The fact that the specific provisions of Article 27.3(b) are reviewed in 1999, namely four years after the date of entry into force of the WTO Agreement, but still one year before the obligation of most developing countries to implement the TRIPS Agreement (1 January 2000), is no justification for postponing implementation, or justifying delays.
Regarding implementation, Article 27.3(b) of the TRIPS Agreement gives the first basic indication of the options available to implement protection of plant varieties: "Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof". Three alternatives are mentioned for the protection of plant varieties:
(ii) an effective sui generis system; or
(iii) any combination thereof.
A simple analysis of these three alternatives shows the complexity of the subject. To begin with, these alternatives have to be understood within the context of the TRIPS Agreement. In addition, the expression sui generis, although always meaning a system of intellectual property rights (IPR) referring to plant variety protection, is not used in a consistent manner, and the number of possible combinations of elements from patents and from sui generis systems could be unlimited. And, finally, the system has to be "effective". However, these three alternatives, as set out in the text of the TRIPS Agreement, are the basic options and must be our starting point.
This module covers the following aspects:
During the negotiation of the TRIPS Agreement, three main proposals were submitted on the question of patentability of plants and animals. The first proposal, advanced by some industrialized countries (i.e. the United States of America), suggested that there be no exceptions in this area from the general rule of patentability. The second proposal, following the provisions of the European Patent Convention and applied widely in Europe, suggested that plant and animal varieties and essentially biological processes, other than micro-biological processes, be excluded from the general rule of patentability. The third proposal allowed Member Governments a good deal more freedom to exclude biotechnology from the general rule of patentability.
The final outcome of the negotiations, as reflected in the TRIPS Agreement, was a combination of the second and third proposals with the understanding that some kind of review clause be included. Countries were given more room for exclusions from patentability than originally proposed by the second position; in fact not only plant and animal varieties may be excluded but plants and animals in general1.
For a long time, breeders tended to seek protection under the industrial patent system. But a number of technical difficulties were encountered in seeking to apply the rules designed for technical inventions to plant varieties2. As previously mentioned, the issue of patentability of living matter involves highly intricate political questions such as domestic food supply as well as ethical considerations, and may have negative implications for several countries.
Reflecting these differences, the exclusion clause under Article 27.3(b) leaves to the discretion of the Members what sort of IPR system they wish to apply. The exclusion clause of Article 27.3(b) does not rule out patentability. Members are free to subject any sort of plant material to intellectual property rights. They are, however, not obliged to do so as regards all sorts of plant material to the extent that such material is not considered a micro-organism nor the product directly obtained by a microbiological or non-biological process.
Although there is a trend in some industrialized nations to permit patenting of an ever larger spectrum of living material, most countries take a rather negative approach in the specific case of patenting of plant varieties. The political questions and the ethical aspects under debate as well as the positive and constructive experience of the "sui generis" system of the International Union for the Protection of New Varieties of Plants (UPOV) seem to strengthen this negative approach. The patent regime simply appears not to be sufficiently flexible to incorporate all relevant aspects, and results too costly to non industrial breeders.
Given that patents were created to protect technical inventions, they cannot always ensure a wide distribution of the benefits arisen from a given research and this is mainly due to:
The first question to be answered is what is meant by the expression "sui generis system" or, to take the exact wording of Article 27.3(b) of the TRIPS Agreement, "an effective sui generis system" of protection for plant varieties. The expression has no uniform meaning. In general, it refers to a special form of protection, a form that is particularly adapted to a specific subject or to specific circumstances, that is especially tailored to specific needs, priorities and reality.
Since this expression is used in the TRIPS Agreement, one should try to understand it against the background and in the context of this Agreement. Unfortunately, the expression is not defined in it nor was it the subject of a specific, wide-reaching discussion during the TRIPS negotiations. In fact, it seems that there is no drafting history that could help us explain the exact meaning of the expression3.
May be based on UPOV but not required to be
The "effective sui generis system" referred to in Article 27.3(b) of the TRIPS Agreement is clearly intended to be an alternative to the patent system. In this connection, it is useful to recall that the UPOV system was also established, in 1961, as a special form of protection, in lieu of the patent system, covering only plant varieties and specifically adapted to plant varieties. In this sense, the UPOV system was already conceived in 1961 as a sui generis form of protection, alternative to the patent system.
However, as mentioned in Module IV.2, the TRIPS Agreement uses the concept of sui generis plant variety protection in general, without limiting it to the UPOV Convention, leaving open the possibility of other sui generis systems with different provisions.
The TRIPS Agreement does not give any direct indication of the elements or components that should be included in an effective sui generis system. Nevertheless, it is possible to infer from the general context as well as from the particular context of Article 27.3(b) some of the minimum requirements that can be considered as necessary for such a system4. They include:
(i) The sui generis system has to be an IPR system
The TRIPS Agreement encompasses, in principle, all forms of intellectual property in relation to trade. In fact, Annex 1C of the "Marrakesh Agreement establishing the World Trade Organization" is entitled "Agreement on Trade-Related Aspects of Intellectual Property Rights".
As seen above, Part II of the TRIPS Agreement addresses each intellectual property right in succession. It is noteworthy that, in the enumeration of these rights, two special forms of protection are missing: Breeder's Rights and utility models5. This does not mean that Breeder's Rights and utility models cannot be considered specific kinds of intellectual property right (or, more precisely, of industrial property) since both Breeder's Rights and utility models convey all the characteristics of such rights6 . As we have already indicated, the exclusion of Breeder's Rights from the enumeration is due only to the fact that major actors in the negotiation of the TRIPS Agreement preferred a patent approach with regard to issues relating to innovations in the field of plants, while other actors favoured a Breeder's Rights approach. This seems to be the reason why, instead of referring to Breeder's Rights, the Agreement makes a general reference to a sui generis system of protection without entering into the controversial issue.
System must protect a property right
From the context of Article 68 of the TRIPS Agreement, it follows clearly that the sui generis system is a form of Intellectual Property Right. On one hand, the TRIPS Council, according to this Article, has to monitor the operation of the Agreement and the Members' compliance with their obligations under it. On the other hand, Members have to notify, under Article 63.2, only those laws and regulations that are of relevance to the TRIPS Agreement. The fact that the Council is actually requesting Members to notify their sui generis laws and regulations indicates that sui generis systems are regarded as IPR.
When the TRIPS Agreement, in the context of Article 27.3(b), refers to a sui generis system, it implies that it has to be a form of intellectual property protection, an alternative (in relation to patents) intellectual property right specifically applying to plant varieties. The concept of intellectual property right has to be understood here in a broad sense, namely as a legally enforceable right to exclude others from certain acts regarding the subject matter protected. This is basic to all intellectual property rights dealt with in the TRIPS Agreement and, consequently, to the sui generis system.
(ii) The sui generis system has to be applicable, in principle, to all trade-related plant varieties (subject of protection)
The TRIPS Agreement sets out a general obligation to provide for the protection of plant varieties, without exception, within the transition periods referred to in Part VI (Articles 65 and 66).
The Agreement does not define the expression plant variety nor specify how many species or genera or varieties have to be protected. From this, it seems clear that the protection applies to all species and genera. Two characteristics seem to be present in all definitions: the variety is a group of plants with some agreed degree of similarity by which they can be distinguished from other groups. Furthermore, the TRIPS Agreement leaves the option to protect additional subject matter. The Agreement does not restrict Members to the definitions developed by UPOV7 , nor does it preclude them from additionally granting protection under a sui generis system to subject matter other than plant varieties.
(iii) The sui generis system has to be effective, that is, enforceable
The TRIPS Agreement does not define the concept of effectiveness nor does it indicate any criteria to apply it. The word has often been interpreted in the context of the Agreement as referring to a minimum amount of essential rights conferred by the sui generis system. This interpretation, although reasonable at a first glance, presents many difficulties as soon as one attempts to define these minimum rights. The UPOV Convention may not be taken as a point of reference, since it is not even mentioned in the TRIPS Agreement.
An effective system means rights must be enforceable
The TRIPS Agreement however, suggests a different interpretation. It employs the term effective in the context of the national enforcement of rights and the procedures for the prevention and settlement of disputes between Governments (see Preamble and Article 41.1). This means that effective relates to the possibility of using legal or administrative action to enforce a specific right or to prevent an infringement of such right. A sui generis system should guarantee such action, irrespective of the content (quality or number of requirements, or level of protection) of the right. Intellectual Property Rights are, basically, private rights for the enforcement of which the Member States have to provide the legal and administrative procedures. An effective sui generis system means a system where such procedures are present.
(iv) The sui generis system has to be non-discriminatory as regards the country of origin of the applicant
Principle of national treatment
According to the TRIPS Agreement's general principles, any sui generis system must be non-discriminatory as regards the country of origin of the applicant (principle of national treatment). This means that Member States have to accord to the nationals of all other Member States a treatment that is not less favourable than the treatment accorded to their own nationals with regard to the protection of plant varieties. This principle applies to all categories of intellectual property, therefore including the sui generis systems (Article 3.1).
A consequence of this principle is that, for instance, by merely implementing the UPOV Convention, States would not fully comply with the TRIPS Agreement in this respect. In fact, under the UPOV Conventions, UPOV Member States have to apply this principle only to other UPOV Members. Such a limited reciprocity would appear to be against the TRIPS general principle8 .
(v) The sui generis system has to accord the most-favoured-nation treatment
The most-favoured-nation treatment must also be complied with. This means that any advantage granted by a Member to the nationals of any other country with regard to the protection of plant varieties has to be accorded to the nationals of all other Members.
(vi) Other principles of International Law relevant to a sui generis system
As seen above, there are several international agreements related to plant genetic resources and intellectual property rights that are of relevance to the TRIPS implementation. These international agreements constitute an important framework that should be taken into account, at least as a reference, in developing any sui generis system.
The exact influence, which the different agreements will have on the implementing Governments, is yet to be analysed in the specific cases, since this may depend on the agreements to which the implementing countries are Parties.
A set of principles and obligations deriving from these international agreements and conventions have been widely accepted and are relevant in the shaping of sui generis systems. This does not mean that a sui generis system, as required by the TRIPS Agreement, would be the best instrument to realize all aspects of such principles or obligations. But, at least, it means that such principles and obligations must be taken fully into account in determining the scope and objectives of the sui generis system so that neither the sui generis system nor any of its elements run counter to these principles or obligations.
Governments developing a sui generis system should therefore create a legal framework that promotes, or contains potential promotion alternatives for the main principles and objectives recognized by the global community within the different agreements. The most important principles are the following:
Relationship between two international agreements
Possible conflicts with the Convention on Biological Diversity
The relationship between the TRIPS Agreement and the Convention on Biological Diversity presents some areas of ambiguity. The TRIPS Agreement, although the latest of the two treaties, does not address the issue of conservation of genetic resources. On the other hand, the Convention on Biological Diversity addresses some aspects of intellectual property rights, explicitly requiring Contracting Parties to ensure that patents and intellectual property rights are supportive of and do not run counter to the objectives of the Convention (Article 16.5)9 , and establishing that access to and transfer of technology shall only be provided on terms "which recognize and are consistent with the adequate and effective protection of intellectual property rights" (Article 16.2)10 .
Neither the TRIPS Agreement nor the Convention on Biological Diversity provide rules for the settlement of eventual conflicts of laws between the two instruments11 .
National sovereignty over genetic resources
The Convention on Biological Diversity builds upon the principle of national sovereignty over genetic resources. The sovereign rights of States over their natural resources are recognized and are referred to in the Preamble and the text (Articles 3 and 15.1). Article 15.1 reads: "[r]ecognizing the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation".
The Convention on Biological Diversity infers from the sovereign rights of States their authority to determine access to genetic resources. The principle of national sovereignty over genetic resources may no longer be questioned. A different question is the fact that the exercise of this right may encounter special difficulties (particularly in connection with the eventual non-exclusiveness of the sovereign rights and the difficult controllability of access to genetic resources).
Access to plant genetic resources
…balanced by access principle
It should also be noted that the Convention on Biological Diversity puts some legal limits on the sovereign rights. In fact, the stress on national sovereignty is balanced by the recognition that the conservation of biological diversity is a common concern of humankind (Preamble) and by the obligation of each Contracting Party "to endeavour to create conditions to facilitate access to genetic resources ... and not to impose restrictions that run counter to the objectives of the Convention" (Article 15.2).
The Convention on Biological Diversity adds that "access, where granted, shall be on mutually agreed terms ..." (Article 15.4). The expression mutually agreed terms has not been explicitly defined, but it is undoubtedly linked with the prior informed consent (Article 15.5) and with the sharing of benefits concepts (Article 15.7).
Sharing of benefits
Extending the benefit sharing principle…
According to Article 15.7 of the Convention on Biological Diversity, Contracting Parties shall take legislative, administrative or policy measures "with the aim of sharing in a fair and equitable way the results of research and development and the benefits arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Such sharing shall be upon mutually agreed terms".
In addition, the Convention on Biological Diversity urges Contracting Parties to encourage, also at the national level, the equitable sharing of benefits arising from the use of traditional knowledge, innovations and practices (Article 8(j))12 .
…to indigenous knowledge
The expression traditional rights encompasses various types of rights relating to the traditional or customary use of resources by indigenous peoples and local farming communities.
The Convention on Biological Diversity affirms the obligations of the Parties to respect, protect and maintain knowledge, innovations and practices of indigenous peoples and local communities13 .
The fact that knowledge of indigenous peoples and local communities are held collectively, are evolved over time and often lack the prerequisite of novelty makes it difficult to apply the existing intellectual property systems to such knowledge. In an analogous situation are the holders of the Farmers' Rights, who have similar interests in relation to the protection of their knowledge, innovations and practices relating to plant genetic resources. As seen above, Farmers' Rights and rights of indigenous peoples and local communities cannot be considered as a type of the existing Intellectual Property Rights (similar to Plant Breeder's Rights or patents) since they cannot be claimed by individual farmers and are not directed to a specific subject or area (for instance, a plant variety) as defined by present international agreements on intellectual property rights.
Any sui generis system for plant variety protection may be constituted by a broad range of elements. These elements may be inferred from the very concept of protection of plant varieties, from the analysis of the elements of the existing systems of protection (patents and Plant Breeder's Rights), from the additional obligations required by International Law, as well as from the relationship, in individual national legislation, with the other forms of protection of intellectual property.
In the following paragraphs, a brief enumeration of the main elements that could be included in a sui generis system is undertaken, drawing attention to the range of possibilities within each of the elements left open to the Parties to the TRIPS Agreement14 . It should be observed that Parties have several alternatives in conforming to the sui generis system and adapting it to their own policies and priorities. It should also be noted that most of these elements are interdependent so that they constitute a package of decisions rather than several isolated decisions on single elements.
Plant variety definition
According to Article 27.3(b) of the TRIPS Agreement, Parties have to provide for the protection of plant varieties, but the Agreement does not provide any definition of plant variety. There are several ways to define the term plant variety.
While the UPOV Act of 1978 does not provide any definition of plant variety, the UPOV 1991 Act includes one15 . This definition explicitly recognizes the existence of plant groupings, which are less uniform than required to fulfil the UPOV uniformity requirement, and which can still be called plant varieties even if cannot be granted Plant Breeder's Rights. This could be the case for many traditional or local varieties. The Decision 345 of the "Junta del Acuerdo de Cartagena" excludes non-cultivated plant groupings (i.e. wild species or sub-species) in its definition of protectable subject matter16 .
Two characteristics seem to be present in all definitions: the variety is a group of plants with some agreed degree of similarity by which they can be distinguished from other groups.
Furthermore, the TRIPS Agreement leaves the option to protect additional subject matter. The TRIPS Agreement does not restrict Members to the definitions developed by UPOV, nor does it preclude them from additionally granting protection under a sui generis system to subject matter other than plant varieties.
At present, existing sui generis systems, namely UPOV, require that a plant variety, in addition to being new, be distinct, homogeneous (uniform) and stable in order to be eligible for protection. These criteria have been subject to criticism, above all the criterion of homogeneity, which, according to some critics, reinforces trends towards genetic uniformity, and a higher degree of genetic vulnerability.
The criteria of distinctness, uniformity and stability (the so called DUS criteria) are closely interrelated and their purpose is to define the subject matter to be protected. The TRIPS Agreement, however, does not make the DUS criteria obligatory requirements for a sui generis system, so that it could be worthwhile considering whether these criteria could be adapted to the needs of a specific country or sui generis system, either generally or for specific species.
In this context, it has been said that the levels of uniformity currently required by national authorities and international guidelines are far higher than justified by the needs of agricultural production or processing industries. Much of today's very narrow limits of accepted heterogeneity are not due to the requirements as laid down by the UPOV Convention or by national laws but rather to the technical test Guidelines set up by UPOV or related practices of national competent authorities17 .
Similarly, it has been proposed that a sui generis system might interpret the criteria of distinctness and uniformity much less strictly in technical terms than at present, so that landraces, local or traditional varieties would not be excluded from protection. It might even be possible to completely replace the criteria of uniformity and stability by the requirement of identifiability, hence Distinctness and Identifiability (DI) instead of DUS18 .
As they presently stand and are interpreted, the UPOV requirements for protection cannot provide for the protection of landraces or local varieties. However, a sui generis system could provide one or more forms of protection, such as one for heterogeneous plant varieties and another for less heterogeneous plant varieties. Although distinctness is necessary, it can be assured through a minimum number of agricultural and commercial traits, while, for the rest of the genome (including genes responsible for the rest of characters) genetic polymorphism should be allowed or even required.
In addition, nothing in the TRIPS Agreement prevents a sui generis system from requiring the applicants for a "sui generis right" to identify the provider of the genetic material from which the variety to be protected has been derived (declaration of geographical origin). This requirement would not be possible under the UPOV Convention since the 1978 and 1991 Act state that "the grant of the breeder's right shall not be subject to any further or different conditions" than those set forth in the Convention.
Countries have here a double alternative as regards the material protected. They may choose between granting protection in respect of acts concerning:
According to the UPOV Convention 1978 Act, Parties have the possibility to extend protection to the marketed product. According to the UPOV Convention Act of 1991, acts in respect of harvested material require the right-holder's authorization only when the harvest has been produced through the unauthorized use of protected material.
The UPOV Convention covers acts related to vegetative and reproductive propagating material. The US Patent Act of 1930 exclusively covers acts in respect of vegetative propagating material. Considering that only a limited number of plant varieties are propagated vegetatively, the sui generis system should probably cover both the vegetative and reproductive propagating material.
In developing a sui generis system of variety protection adapted to its needs, a country may consider modelling the scope of protection granted to the right-holder (in practice, determining the acts requiring the holder's prior authorization) in a very broad way. In fact, they may consider a wide scope, such as the one present under patent law; they may consider accepting the scope of the UPOV Convention; or they may provide for a minimum amount of protection, providing, for example, only for an exclusive right to market material of a variety under some form of Plant Variety Protection Seal19 .
…and the extent of any exceptions
It should be noted, in this respect, that the UPOV Convention Act of 1978 implicitly allows the production of propagating material of a protected variety for non-commercial purposes (the Farmer's Privilege).
The scope of the Farmer's Privilege varies from one country to another: some countries only allow to plant back seeds and to exchange limited amounts of them over the fence, on a strictly non commercial basis, while others (especially the United States of America) interpreted the privilege as allowing farmers not only to replant seed but also to sell limited quantities of them for reproductive purposes (brown bagging).
It should be noted, however, that the Farmer's Privilege as permitted by the UPOV Convention of 1991 allows farmers to exchange seed with other farmers for propagating purposes only under certain circumstances. In fact, "each contracting Party may, within reasonable limits and subject to the safeguarding of the legitimate interest of the breeder, restrict the breeder's right in relation to any variety in order to permit farmers to use for propagating purposes, on their own holdings, the product of the harvest which they have obtained by planting, on their own holdings, the protected variety ..."20. Farmers may only propagate "on their own holdings" the product of the harvest, which they have obtained "on their own holdings". Given the fact that many farmers in developing and also in industrialized countries exchange seed for propagating purposes and that this practice facilitates variety rotation, the Farmer's Privilege as permitted under the UPOV Convention 1991 Act would seem not to meet the needs of some countries. The development of a new system remains essential in several countries.
Period of protection
The TRIPS Agreement does not specify the duration of rights under a sui generis system. The sui generis system, as with any other system of intellectual property rights, should grant protection for a limited period of time.
Relationship to patent system
Countries establishing a sui generis system should carefully consider the relationship between such a system and other forms of protection. This is especially important in the case of patents. In fact, while under the TRIPS Agreement plant genes in general may be excluded from patentability, genes isolated from micro-organisms may not be excluded.
A country may include in the sui generis system any of the principles of International Law referred to above, in accordance with its priorities.
The third alternative proposed by the TRIPS Agreement for the protection of plant varieties, namely by any combination of patents and a sui generis system, clearly indicates that the range of possibilities open to countries in the drafting of their legislation is remarkably wide. The range of elements that could be included in the system are practically unlimited, taking them from a very tight patent system to all the possibilities discussed in the previous paragraphs.
It is not the intention of this module to discuss the possible combinations of the different elements of a sui generis system that could be applied to different countries. This would be an impracticable task since such elements are manifold and their combination countless. More important, the advantages and disadvantages of many of the elements and of the combinations can hardly be assessed in an objective manner due to the fact that this field is still unexplored and there is a lack of experience regarding the effects of each combination. In addition, such effects depend on many variable factors, such as the country's economic situation, its agricultural and industrial policy, the role of public research and breeding, the special needs of small farmers and indigenous communities, and the general development strategy.
A detailed suggestion for specific countries may only be based on general considerations as made in this module as well as on opinions gathered among public institutions and private enterprises of the concerned country and on the specific requests made by the implementing Government.
The elements that should be considered by national authorities when establishing a system of protection of plant varieties are identified in the following paragraphs:
Objectives of a plant variety protection system
The system of protection should provide incentives for the technological advancement necessary for economic growth and development, facilitate technology transfer and access to foreign varieties, stimulate investment, including that of foreign firms, and encourage local breeders.
At the same time, the system should avoid, as far as possible, the disadvantages that often go together with the present systems of plant variety protection, such as limitations on the flow of varieties in the local seed system (i.e. prohibition against small farmers using and exchanging farm-saved seed), direct and indirect loss of biological diversity through the global expansion of today's uniform varieties, loss of local landraces and farmers' varieties, limitation of protection to the efforts and investments of the modern breeder while disregarding the efforts and investments of past generations.
Most countries that are Members of the WTO are also Parties to the Convention on Biological Diversity. In this case, it is necessary to legislate not only on plant variety protection, but also on access to genetic resources, bearing in mind that any system of intellectual property rights protection has to be in line with the CBD. This legislation should deal with the issues of access and equitable sharing of benefits (transfer of technology, capacity building, training), following the provisions of the CBD, and the protection of the breeders of new varieties of plants, without leaving aside concerns like those of Farmers' Rights and the participation of native communities and indigenous peoples in the relevant benefits.
The question is whether all these elements need to be combined in a single, comprehensive Act or whether they might not be treated in separate Acts. This depends on the country' s legal structure and further peculiarities.
The legislation on variety protection does not need to deal with such matters as access to plant genetic resources, sharing of benefits, Farmers' Rights and traditional knowledge rights. However, these matters are closely related to plant variety protection and must be considered when developing a sui generis system. Even if they are included in a separate Act, they should be treated in the same logical perspective and at the same time as variety protection.
Role of UPOV - either membership…
The elements of a sui generis system will further depend on whether a country wishes to join UPOV. The main advantage of joining the UPOV Convention is the possibility of profiting from the rich experience developed under the UPOV Convention, in particular regarding the technical guidelines adopted, as well as from the technical assistance that the UPOV could provide21 . The UPOV system has some undeniable benefits, above all if compared with the patent system.
The UPOV system could be taken as a basis for the design of a sui generis system. In such a case, some aspects should be considered in order to make the sui generis system really suited to the national needs.
…or the basis for design of a sui generis system
One element to be considered is the use of farm-saved seed and non-commercial movement of seed within a community. In some cases this should be unrestricted or, at least not so restricted. It is considered in many developing countries that some of the provisions of the UPOV system in this respect (mainly the 1991 Act) are suitable only for countries where farm families are being increasingly replaced by large agri-business companies, posing a threat to countries where farming is both a way of life and the means of livelihood for millions of families. The exchange of seed on a regular basis for propagating purposes, facilitating crop and variety rotation, is limited since farmers may only propagate on their own holdings the product of the harvest which they have obtained by planting, on their own holdings, the protected variety. Thus, the system does not meet the need of seed exchange, which is a common practice in most developing countries.
Another element that needs consideration is that of uniformity. Uniformity standards for plant variety protection should not result in discouragement of agronomically valuable intra-varietal heterogeneity. Consideration should be given to the possibility of (i) replacing the criteria of uniformity and stability by the requirement of identifiability; (ii) establishing two forms of protection (heterogeneous and less heterogeneous plant varieties); and (iii) imposing the obligation of declaring the geographical origin.
In addition, adoption of the UPOV principles should be complemented by consideration of issues like extension of the Farmer's Privilege, equitable sharing of benefits, Farmers' Rights, a scheme of monetary compensation, transfer of technology, commercialization, access and training.
Soften uniformity requirements
The possibility to moderate or completely avoid uniformity requirements, other than those strictly needed for the identifiability of a variety, should be considered carefully. A certain level of uniformity may represent, in certain cases, an advantage in agricultural production and may improve the quality of final products. However, the limits set up by many plant variety protection regimes seem not to be justified by practical needs. The introduction of a certain level of heterogeneity in plant groupings eligible for protection would run counter to genetic uniformity and hence, vulnerability, to which the uniformity requirement is leading.
If the uniformity requirement were softened, at least in some cases, landraces or local varieties could be included in the sui generis system, and thus the high degree of diversity, which is typical of many landraces, would be maintained. This would grant rewards to the informal innovative sector (farmers or local communities) as a way of compensation for its contribution to the formal sector.
Important features to be incorporated in a sui-generis system of protection are the Breeder's Exemption and the Farmer's Privilege. Provisions aimed at promoting genetic diversity and mitigating potential negative impacts, should also be considered in a system adapted to the particular situations and needs of the countries.
The sharing of benefits is one the most important principles yet one of the most difficult to be put into practice. The subject is recurrently discussed in meetings and publications and various methods are being proposed to realize the sharing of benefits but there is little experience on the feasibility and the political and economic impact of such methods, whether on national and international levels.
The sharing of benefits is generally based on the understanding that the users of genetic resources (the beneficiaries) should share the benefits (usually expressed as commercial gain or funds) with the suppliers of genetic resources. Depending on whether beneficiaries are seen to be plant breeders, farmers or consumers, various means may be proposed to collect the funds to be shared. For example, in the case of breeders, a one-time payment at the time of registration of the variety or a tax on the commercial profit of the protected variety; in the case of farmers, a tax on the use of seed of the cultivated variety or of any seed; in the case of consumers, a general taxation or a taxation on sales of certain agricultural products.
Mechanisms of compensating suppliers of genetic resources
Of course, the sharing of benefits could be realized not only through monetary transfers (including the establishment of national or international funds) but also through other means of compensation such as the transfer of technology, access to genetic resources, training activities and, last but not least, direct support to the conservation and utilization of genetic resources.
In this connection, a distinction should be made between genetic resources as a source of pharmaceuticals, where a bilateral approach could prevail, and genetic resources for food and agriculture, where the interdependence among countries and regions and the underlying issue of food security seem to advocate, at least in the case of some basic crops, a more complex approach on an international basis22 . In the case of genetic resources for food and agriculture, the benefit-sharing could include access to better planting material, general support for development as well as promotion of in situ and ex situ conservation.
Governments should explore ways and means to involve the public sector, as well as the private sector, in the sui generis system and to use financial incentives to promote small farmer development and to preserve biodiversity.
In Malaysia, in the agricultural field, there is a very interesting example of a mechanism that could serve as a pioneer for the purpose of research and sharing of benefits: the Fund of the Palm Oil Research Institute of Malaysia (PORIM), the Porim Fund. By Act 218 (Palm Oil Research and Development Act 1979), the Palm Oil Research Institute and Board and a fund were established for the purpose of financing research and providing for matters connected therewith. According to Section 10 of the Act, the fund shall be applied to defray the expenses for research and development concerned with the production, extraction, processing, storage, transportation, marketing, consumption and uses of palm oil and oil palm products; as well as for the dissemination of information and publicity aimed at stimulating increase or improvement in the production, marketing and consumption of palm oil and oil palm products.
The fund consists of monies collected from a research excise levied on crude palm oil and palm kernel oil, so the palm oil industry is the main contributor. This is a successful model, especially considering that exports of palm oil and its products represent six percent of the total export earnings of the country. The current rate of the excise is two percent on the value of exported products.
Monetary compensation schemes or funds for the implementation of the sharing of benefits or, more particularly, for the implementation of Farmers' Rights, could follow the Porim Fund model. The means would be used for research and conservation purposes, among others.
National sui generis systems for plant variety protection should be developed in such a way as to facilitate the realization of Farmers' Rights.
The concept of Farmers' Rights counterbalances to a certain extent the intellectual property rights over plant varieties (i.e. Breeder's Rights). The Breeder's Rights were designed to compensate for the latest innovations but do not give enough consideration to the fact that, in many cases, these innovations are only the last step of cumulative knowledge and inventions carried out by many generations of human beings over millennia in various parts of the world.
Recognizing Plant Breeder's Rights, without reciprocal recognition of Farmers' Rights and the related benefits and compensation due to countries providing the biological diversity, could set up difficult barriers preventing access to genetic resources23 .
Incorporate conservation objectives
In promoting mechanisms to reward innovators of new biotechnologies, little or no consideration has been given until now to the impact on the future conservation and exchange of biological resources. To the extent that intellectual property rights are intended as an incentive to develop improved, usually homogeneous varieties, they contribute to the displacement and loss of landrace genetic diversity. They also lead to restrictions on access to genetic resources.
Governments engaged in the process of implementation need to further consider promoting the conservation of plant genetic resources in situ and ex situ as a complement to variety protection.
Some element of the sui generis system (such as the softening of the DUS requirements, the recognition of Farmers' Rights and of traditional knowledge) could lead to better conservation, or at least to a lesser erosion, of genetic diversity.
An access regime could provide for a Prior Informed Consent procedure for the utilization of genetic resources as contemplated in the Convention on Biological Diversity. The Prior Informed Consent could be incorporated into a sui generis system in order to facilitate, whenever possible, the sharing of benefits.
Another instrument to facilitate the sharing of benefits between users and providers of germplasm could be to make it an obligation to make a statement regarding the geographical origin of the genetic material used as raw material of the new variety, at the moment of submitting an application for intellectual property rights.
The said additional requirement would have the purpose of reinforcing compliance with national access legislation and expediting the sharing of benefits with communities in the region of origin of genetic material contained in protected varieties. However difficult, costly and time-consuming, the indication of origin of genetic materials would facilitate the monitoring of compliance with national access regimes, and sharing of benefits at the national and international levels.
Governments should avoid seeing plant variety protection only in legal terms, but should analyse the likely effects of a sui generis system on its overall agricultural development and integrate it into their overall planning.
For this reason, the elements of a sui generis system should be decided on the basis of each country's development objectives. Before proceeding to the development of a plant variety protection system, Governments should therefore determine what they wish to achieve from such a system.
Any sui generis system must be supported by enforcement mechanisms, in situ and ex situ conservation mechanisms, seed certification mechanisms, etc., all of which should be considered together in developing the sui generis system. Governments should also address and make provisions for the full range of intended costs.
Any country developing plant variety protection will eventually be confronted with providing an institutional framework to ensure implementation. The main issue within this framework will be the distribution of authority among governmental agencies. Again, detailed suggestions may only be provided after analysis of the specific case considering necessities and requests. Hence, the following should be regarded as general aspects that need to be kept in mind when designing the relevant institutional setting.
Institutional arrangements should facilitate use of available expertise
In most countries IPR-related subjects are administered by an IPR Office (usually called the Patent Office) under the Ministry of Industry or the Ministry of Commerce. The protection of plant varieties implies aspects reaching far beyond the knowledge available within sole industrial or commercial domains. A satisfactory solution may thus only be reached by establishing an administrative structure encompassing different technical and scientific domains.
Although advisable, in most cases the establishment of specific administrative structures dealing exclusively with plant variety protection and related issues will encounter technical, policy and, last but not least, financial difficulties. A valuable solution may thus be reached by creating an independent IPR Office under the Ministry of Agriculture, which deals with the specific subject matter of IPR over plant varieties for which special scientific knowledge and expertise are required. Since it is the Ministries of Agriculture that deal with agricultural matters, it is indeed the only Ministry with sufficient background, specialization, experience, and expertise in plant breeding, variety testing and related issues.
Another option, less recommended, is that of a combined system. In such a system the Patent Office handles the relevant administrative tasks (e.g. formal examination of applications, registration of protected varieties and upkeep of the respective register, publication of notices of application, maintenance and release of information, issuance of plant variety protection (PVP) certificates, cooperation with national and international bodies related to the subject matter, etc.) while an Office in the Ministry of Agriculture is given the responsibility of conducting the DUS tests and determining compliance of a variety with the requirements established in order to be granted PVP. Only after this body has given technical clearance would the Patent Office grant PVP. To realize this purpose, this second body should establish and implement procedures and criteria for the analysis, approval, registration, review, release and discontinuation of varieties in the country.
1 See Otten, A. 1996. Viewpoint of the WTO. In Agrobiodiversity and Farmers' Rights. Proceedings of a Technical Consultation on an Implementation framework for Farmer's Rights. Madras, M.S. Swaminathan Research Foundation.
2 See Heitz, A. 1994. The History of the UPOV Convention and the Rationale for Plant Breeders' Rights. In Seminar on the Nature of and Rationale for the Protection of Plant Varieties under the UPOV Convention, Buenos Aires, November 26-27, 1991. Geneva, International Union for the Protection of New Varieties of Plants (UPOV).
3 See Otten, op. cit
4 See Leskien, D. and Flitner, M. 1997. Intellectual property Rights and Plant Genetic Resources: Options for a "sui Generis" System. Issues in Genetic Resources No 6. Volume Editor: Jan Engels. Rome, International Plant Genetic Resources Institute (IPGRI).
5 Utility models are inventions of a lower category that imply a change, with technical effects, of an object, gadget, instrument or mechanism. As in the case of patents for inventions, patents are granted for utility models conferring exclusive rights to their holders.
6 See Correa, C. 1994. Sovereign and property rights over plant genetic resources, Background Study, Paper No. 2, for the FAO Commission on Plant Genetic Resource, FAO, Rome, p. 25. The utility models or "petty patents" protect minor innovations, mainly in the mechanical field, and are deemed to be of particular importance for developing countries.
7 The UPOV Convention 1978 Act requires Member States to protect a minimum of five genera or species on accession to the Convention and, thereafter, to extend the protection to other genera or species on a progressive basis, leading to a minimum of 24 genera or species after eight years. The UPOV Convention 1991 Act changes this approach and requires existing UPOV Member States to protect all plant genera and species five years after becoming bound by the 1991 Act and requires new Member States to protect all plant genera and species ten years after they become bound by the 1991 Act, so that, in the foreseeable future, the UPOV system of plant variety protection will require all Member States to protect all plant genera and species.
8 See Leskien and Flitner, op. cit., p. 31.
9 Art. 16.5 states: Parties, "recognizing that patents and other intellectual property rights may have an influence on the implementation of this Convention, shall cooperate in this regard subject to national legislation and international law in order to ensure that such rights are supportive of and do not run counter to this objectives".
10 See The Convention on Biological Diversity and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS): Relationship and synergies, Document No UNEP/CBD/COP/3/23 prepared for the Third Meeting of the Conference of the Parties of the Convention on Biological Diversity, Buenos Aires, Argentina, 4-15 November 1996.
11 According to the general principles of Treaty Law, such conflicts of law are normally solved by giving priority to the later agreement over the previously adopted one, in case both agreements specifically address the same issue in different ways, which seems not to be the case. The other principle of law applicable to such cases states that the more specific treaty has priority over the more general one.
12 Article 8(j) requires each Party, as far as possible and as appropriate and subject to its national legislation, to "respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices".
13 See previous footnote.
14 In this exposition the approach of Leskien and Flitner, op. cit., p. 48 and ff., is closely followed.
15 According to the definition given in Article 1, "variety" means "a plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a breeder's right are fully met, can be (i) defined by the expression of the characteristics resulting from a given genotype or combination of genotypes, (ii) distinguished from any other plant grouping by the expression of at least one of the said characteristics and (iii) considered as a unit with regard to its suitability for being propagated unchanged".
16 See Decisión 345: Régimen Común de Protección de los Derechos de los Obtentores de Variedades Vegetales, Gaceta Oficial del Acuerdo de Cartagena, 29 de Octubre de 1993. In July 1996, the Commission of the Cartagena Accord (Comisión del Acuerdo de Cartagena) introduced a regional measure on access and benefit-sharing, effective in the five Member Countries (Bolivia, Colombia, Ecuador, Peru and Venezuela). Decision 391 introduces the Common System on Access to Genetic Resources. See Decisión 391: Régimen Común sobre Acceso a los Recursos Genéticos, Gaceta Oficial del Acuerdo de Cartagena, 17 de Julio de 1996.
17 See Leskien and Flitner, op. cit., p. 54-55.
19 Ibidem, p. 63-64. The Plant Variety Protection Seal is a concept that goes back to the historical roots of plant variety protection laws and certification schemes. The holder of such seal would have the exclusive right to use this seal for material of a specified, registered variety in combination with its registered denomination. It is a concept that should be further studied; it may open some new perspectives.
20 International Convention for the Protection of New Varieties of Plants, of December 2, 1961, as revised at Geneva on November 10, 1972, on October 23, 1978, and on March 19, 1991, Article 15.2.
21 The advantage of national treatment among UPOV Members might have become not so relevant after the entry into force of the TRIPS Agreement. In fact, the principle of national treatment, as set out by the TRIPS Agreement, is applicable to all intellectual property rights covered by the Agreement, including the sui generis system.
22 An important example of bilateral
benefit-sharing in the case of pharmaceuticals is the partnership agreement
between Merck & Co. (the world's largest pharmaceutical firm) and the National
Biodiversity Institute of Costa Rica (InBIO, a private non-profit organization),
signed in 1991. On the one hand Merck has given InBIO US$1 million to help it
develop into a biochemical prospecting business. On the other hand, InBIO has
to carry out systematic analysis of plants and insects in Costa Rica's parks
and reserves, screening species for medical potential purposes and sending Merck
samples of all promising extracts derived from biological material. Merck has
the exclusive right to develop into pharmaceuticals all extracts it receives
from InBIO and has agreed to pay royalties on future drug sales. Not only InBIO,
but also the Government of Costa Rica will receive a share of the royalties,
to be used for the country's conservation programme.
Indigenous knowledge is not involved in this kind of agreement. InBIO does not count on cultural knowledge to preselect plants and insects to analyse. Its approach is ecological, this means it involves observation of plant and animal behaviour to obtain clues to chemical activity.
The risk of unauthorized persons collecting the same materials and the possibility that the same species exist in other countries, and may thus be available to competitors is foreseen in the agreement: research towards an invention may go uncompensated if a competitor discovers and patents the same invention first.
23 The Indian draft Act developed
at the 1994 Madras Dialogue provided for a mechanism for giving operational
content to the concept of Farmers' Rights at national level. It proposed the
creation of a Community Gene Fund to which the royalties due to farmer-conservers
could be credited and which could be used for strengthening the in-situ
and ex-situ conservation practices of tribal and rural families. The
rights would not accrue to the farmers themselves, but to the Fund representing
the farmers' interests (or could go to the Government). Its funds would be utilized
in trust of Indian farmers for collecting, evaluating, upgrading, conserving
and utilizing genetic variability.
A royalty rate of 15 percent of the price per tonne of certified seed was proposed in the draft. Out of the 15 percent, 10 percent would be for the plant breeder and 5 percent would go to the farmer-conserver through the Community Gene Fund. This would be a way of sharing the benefits of scientific innovation, stimulating at the same time both investment and initiative in breeding research, and in-situ conservation of genetic resources.
See Swaminathan, M.S. 1995. Farmers' Rights and Plant Genetic Resources, Dr. B.P. Pal Memorial Lecture. New Delhi, Indian Agricultural Research Institute.