SIGNPOSTS TO SUI GENERIS RIGHTS: 4 The TRIPS Agreement and Intellectual Property Rights for Plant Varieties by Dan Leskien & Michael Flitner In the debate over genetic resources, the term 'sui generis system' has no uniform meaning. It is used in the TRIPS agreement's Article 27.3 dealing with intellectual property protection for plants. In other contexts, the term is also used to denote alternative rights regimes for the protection of community innovations that are not protectable under conventional intellectual property laws, and, in an even broader perspective, for systems embodying Farmers' or indigenous peoples' rights. This paper aims to explore options for sui generis systems not in this wider sense, but strictly in accordance with its meaning within the TRIPS Agreement's Art. 27.3 (b). Yet it should be stated clearly right at the beginning of this paper, that WTO member states are free to establish protection systems which go beyond the intellectual property rights covered by the TRIPS Agreement provided that such protection does not contravene the provisions of the TRIPS Agreement.  Pursuant to TRIPS Article 27.3(b), Member states which do not provide for the protection of plant varieties by patents have to provide for their protection by an "effective sui generis system." Although the TRIPS Agreement does not define what is meant by the term "effective sui generis system", certain minimum requirements such a system would have to fulfil can be drawn from the context of Article 27.3(b), the context of TRIPS as an integral part of the WTO Agreement and, finally, from the objectives of the TRIPS Agreement itself. The sui generis system has to provide for the protection of plant varieties of all species and genera by an IPR to which the obligations under TRIPS Art. 3 (national treatment) and Art. 4 (most-favoured nation treatment) fully apply. In order to be effective, the sui generis system needs to permit effective action against any act of infringement of the right available under the sui generis system. There is, nonetheless, a wide range of possible sui generis systems as required by Art. 27.3 (b) TRIPS and there is wide agreement that countries have considerable room to develop their own systems. Such alternative systems should be explored and discussed before ready-made protection systems currently being used in many industrialised countries are adopted. On the basis of the legal requirements laid down in the TRIPS Agreement we suggest to consider possible combinations of elements for the design of protection systems, appropriate for the different economic and social conditions in developing countries, and the requirements and consequences from the economic, ecological, legal, technical and administrative points of view. For this purpose possible goals policy makers may pursue with a protection system for plant varieties need to be identified and elements to be assessed in relation to their impact on these goals. 4.1 THE TIME FRAME The Agreement establishing the World Trade Organisation came into effect on 1 January 1995. Member states are obliged to apply the provisions of the Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS) from 1 January 1996 (TRIPS Art. 65.1). However, developing country members and, under certain conditions, also members in the process of transformation from a centrally-planned to a free-enterprise market economy may delay the date of application of the TRIPS Agreement to 1 January 2000 (TRIPS Art. 65.2). Least-developed countries are not required to apply the provisions of the TRIPS Agreement before 1 January 2006. However, insofar as they provide for intellectual property protection, developing and least-developed countries have to treat nationals of other WTO members no less favourably than their own nationals ("national treatment"). They also have to accord any advantage, privilege or immunity granted to the nationals of any other country to the nationals of all other WTO members (TRIPS Art. 65.1 and Art. 66.1). It is important to bear in mind that, in 1999, just one year before developing countries will have to apply the TRIPS Agreement and thus grant sui generis if not patent protection for plant varieties, Art. 27.3(b) -- the provision which requires the protection of plant varieties -- is to be reviewed. The outcome of this review is not predictable. Whatever the outcome, however, the elaboration of possible elements of a sui generis rights regime does not seem premature. If this provision passes the review in 1999 unchanged, there would be less than a year for the development and thorough discussion of a "sui generis system". Furthermore, and perhaps more importantly, the outcome of the review may very much depend on the existence of different sui generis systems already in place if not in advanced stages of development. 4.2 MINIMUM REQUIREMENTS FOR A SUI GENERIS SYSTEM FOR THE PROTECTION OF PLANT VARIETIES UNDER TRIPS  The TRIPS Agreement goes no further towards defining the words "effective sui generis system" and there is no drafting history which can be invoked to explain these terms. While the main sui generis systems existing at the time of the conclusion of the TRIPS negotiations relating to plant varieties were embodied in the various UPOV Acts and reflected in the national laws of UPOV member states, the TRIPS Agreement does not refer to UPOV. Thus, TRIPS Art. 27.3(b) neither includes an obligation to become a member of UPOV, nor does it oblige member states to adopt legislation identical to, or consistent with, any of the UPOV Acts. On the other hand, WTO member states that exclude plants from patentability do not satisfy TRIPS Art. 27.3(b) by having implemented the UPOV minimum standards. It is true, the former Director General of GATT, Peter Sutherland, explained in 1993, that "while the TRIPS provisions on plant variety protection do not refer to any international convention, it is clear that, if the standards of protection of UPOV 1978 were to be followed, it would be reasonable to claim that an effective sui generis protection had been provided."  However, this statement is misunderstood to mean that if a country's legislation conforms to the minimum standards as required by UPOV 1978, it would be unlikely to be successfully challenged. Sutherland limited his statement on the compatibility of the TRIPS to the standard of protection as foreseen by the UPOV Convention of 1978 and did not address the required coverage or scope of a sui generis system. Nor did he address the question of whether member states are required to apply the basic principles of the TRIPS Agreement to the sui generis system. 4.2.1 Plant Varieties The statement quoted above by the former Director General of GATT, Peter Sutherland, is sometimes understood to mean that as under the UPOV Act of 1978  member states do not have to provide for the protection of plant varieties of all botanical genera and species under the TRIPS Agreement. However, as has been stated already, Sutherland limited his statement to the standard of protection as foreseen by the UPOV Convention of 1978 and did not address the required coverage or scope of a sui generis system. Since the TRIPS Agreement neither defines the term 'plant variety' nor specifies any species or genera the varieties of which have to be protected, it seems clear that member states have to provide for the protection of plant varieties of all species and botanical genera. Any other interpretation of Art. 27.3(b) TRIPS would have to indicate for how many species or for which type of species member states have to grant sui generis protection and there is no such provision in the TRIPS Agreement. 4.2.2 Intellectual Property Right According to Art. 1.2 of the TRIPS Agreement the term 'intellectual property' refers for the purposes of this Agreement "to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II" . These sections deal with copyrights and related rights, trademarks, geographical indications, industrial designs, layout designs of integrated circuits, patents, and the protection of undisclosed information (trade secret). The requirement to provide for the protection of plant varieties by patents or by an effective sui generis system or by any combination thereof is the subject of Section 5 of the TRIPS Agreement. It follows that, like patents and all the other rights mentioned in sections 1 through 7, the sui generis system as foreseen in the TRIPS Agreement also has to be an IPR. It has been suggested that the TRIPS Agreement considers the protection of plant varieties only casually as an exception to patentability, defining neither the requirements nor the scope of protection a sui generis system would have to foresee, and that therefore the sui generis system does not fall under the category of "intellectual property rights" within the meaning of TRIPS Art. 1.2. However, the purpose of TRIPS as a whole does not seem to allow such interpretation. Since the national treatment principle and the principle of most-favoured nation treatment only have to be applied to IPR (cf. TRIPS Art. 3.1 and Art. 4), neither principle would apply, if the sui generis system were not to be considered as an IPR within the meaning of Art. 1.2. This would, however, mean that member states would be allowed to refuse nationals of other member states any plant variety protection. The TRIPS requirement to provide for the protection of plant varieties would therefore be of no use to (the nationals of) other member states. However, the very purpose of the TRIPS Agreement is without doubt to make the property rights covered by it available to the nationals of all the member states. It is inconceivable that the mutual obligation to establish a protection system for plant varieties should not result in any mutual rights. Furthermore, Art. 68 of TRIPS indicates that the sui generis system needs to be an IPR. According to Art. 68, the TRIPS Council has to monitor the operation of this agreement and, in particular, Members' compliance with their obligations under TRIPS. If the sui generis system was not an IPR within the meaning of TRIPS, members would not have to notify their sui generis laws since Art. 63.2 only requires them to notify those laws and regulations, final judicial decisions and administrative rulings which are of relevance for IPRs. Thus, if the sui generis system were not a form of IPR, the TRIPS Council would be obliged to monitor the member states' sui generis provisions but would not have the right to be informed by the member states about these provisions. It should be noted, that by asking member states to notify their sui generis laws for the protection of plant varieties under Art. 63.2, the TRIPS Council itself has actuallly indicated that it regards the sui generis system as an IPR. Thus, from the wording and context of Art. 27.3(b) and the aim of the TRIPS Agreement as a whole, it seems obvious that the sui generis system for the protection of plant varieties has to be an IPR within the meaning of TRIPS Art. 1.2. Intellectual property rights covered by the TRIPS Agreement The TRIPS Agreement does not define in detail the term "intellectual property right". Intellectual property rights are usually defined as rights granted by a state authority for certain products of intellectual effort and ingenuity. Most often the term IPR is used as a collective name for rights such as those dealt with by the TRIPS Agreement. From an analysis of the other IPR covered by TRIPS one can further draw the conclusion that IPR are rights either to exclude others from certain commercially interesting acts in relation to the described subject matter and/or rights to obtain a remuneration in respect of those acts. The sui generis system as an additional IPR In many cases a product of intellectual effort or ingenuity may be protected by several IPRs. The inventor of a new can opener may, for example, apply for a patent and at the same time register a certain name for this opener as a trademark. The question may therefore arise whether a member state would fulfil the requirement to provide for the protection of plant varieties by referring, for example, to the possibility of registering the name of a plant variety as a trademark. The sui generis system certainly needs to confer on the holders an additional right which WTO members do not have to make available in relation to plant varieties according to other obligations posed by the TRIPS Agreement. A WTO member could not satisfy Art. 27.3(b) TRIPS by allowing variety denominations to be registered as trademarks since, under Art. 15 TRIPS, member states already have to register variety names as trademarks. If the negotiators of the TRIPS Agreement had felt that such trademark protection was sufficient, they would certainly not have included the requirement to establish an additional system for the protection of plant varieties. Thus, the sui generis system has to be an IPR conferring on the right holders an additional right, i.e. a right which is not yet foreseen by the TRIPS Agreement. Sui generis legislation and Farmers' Rights It has been suggested that the sui generis system provided for in Art. 27.3(b) TRIPS could be implemented by Farmers' Rights. Given that the sui generis system has to provide for an IPR this approach might not conform with the TRIPS Agreement if one accepts that Farmers' Rights are a concept rather aiming at counterbalancing IPR than creating any additional intellectual property right. This does not, however, prevent the inclusion of provisions that implement Farmers' Rights and/or traditional resource rights into a sui generis system. Such an incorporation of Farmers' Rights based, for example, on the Indian proposals for Community Intellectual Property Rights and the Plant Variety Recognition and Rights Model Act, could complement the sui generis system by compensating those who have been conserving plant genetic resources (PGR) for the past centuries and thereby have contributed until now to the development of plant varieties protectable under the sui generis system foreseen in the TRIPS Agreement. 4.2.3 National treatment As an IPR any sui generis system needs to comply with the basic principle of national treatment. The national treatment principle as laid down in the Paris Convention only relates to specific rights.  But as defined in Article 3.1 of TRIPS, the principle applies to "all categories of intellectual property that are the subject of Sections 1 through 7 of Part II" of the TRIPS Agreement and this includes the sui generis system for the protection of plant varieties. Thus, as an IPR, any sui generis system needs to comply with the basic principle of national treatment. This means that members have to accord to the nationals of other members treatment no less favourable than they accord to their own nationals with regard to the protection of plant varieties. A rather astonishing consequence of the applicability of the principle of national treatment to the sui generis system is, that by implementing the minimum standards of the UPOV Acts of 1978 and 1991, WTO member states would not fully comply with their obligation laid down by the TRIPS Agreement. According to the UPOV Acts, UPOV member states only have to afford the nationals and residents of all the other UPOV member states and legal persons having their headquarters there the same treatment as their laws provide for their own nationals. Under the UPOV Act of 1978 member states may even limit the right to apply for protection of a variety to nationals or residents of those member states which also apply that Act to the genus or species to which the variety belongs. This reciprocity rule, as well as the limitation of national treatment to nationals and residents of other UPOV member states, would clearly fall foul of the national treatment requirement as laid down in Article 3 of the TRIPS Agreement. With regard to the protection of plant varieties, UPOV member states have to accord treatment no less favourable than they accord to their own nationals to the nationals of all WTO member states, whether these are UPOV members or not. It is clear that the applicability of the national treatment principle to the sui generis system makes it far less attractive for WTO members to join UPOV. Since UPOV members have to apply their plant variety protection laws in compliance with the TRIPS national treatment principle, there is no need for WTO member states to join UPOV just because they want to benefit from the legal protection available for plant varieties in UPOV member states. This may be why some UPOV member states argue that the TRIPS national treatment principle is not applicable to the sui generis system.  4.2.4 Most-favoured-nation treatment Any advantage, favour, privilege or immunity granted by a member to the nationals of any other country with regard to the protection of plant varieties has to be accorded immediately and unconditionally to the nationals of all the other member states. It should be noted, however, that in the field of intellectual property the most-favoured-nation principle is of rather minor practical relevance, since only in exceptional cases would countries be likely to grant more protection to foreigners than to their own nationals. 4.2.5 Effective enforcement Art. 27.3(b) requires explicitly that the sui generis system be "effective". However, the TRIPS Agreement does not specify any criteria for effectiveness. It has been suggested that effectiveness relates to the level of protection of the sui generis system and therefore requires certain substantial minimum rights to be conferred by the sui generis right. Such interpretation, however, causes enormous difficulties as soon as one attempts to define those minimum rights. The UPOV Acts do not qualify as a measuring stick since, while there are many references to relevant international IPR treaties in the TRIPS Agreement, references to the UPOV Acts are conspicuous by their absence. Furthermore, and more important, it might be impossible to define effectiveness on a global scale. The same protection system may be of different effectiveness in different countries whatever specific criteria are being used for evaluating the effectiveness. It is, finally, the TRIPS Agreement itself which points at a different interpretation of the term "effective". The TRIPS Agreement employs the term "effective" in particular in the context of the national enforcement of rights and the procedures for the multilateral prevention and settlement of disputes between governments (cf. Preamble and Art. 41.1), while the rights to be conferred by an IPR are either defined in detail or as "equitable remuneration" (Art. 14.4 and Art. 70.4). Against this background an "effective" sui generis system needs to allow effective action against any act of infringement as required by TRIPS Art. 42-49. Its effectiveness does not, however, depend on its requirements for, or on the level of, protection. It should be noted that the civil and administrative procedures as required by Art. 42-49 of TRIPS are based on the presumption, also emphasised in the preamble to the TRIPS Agreement, that IPR are private rights for the enforcement of which members only have to provide the judicial procedures. The right holders are responsible for uncovering infringements of their rights and, subsequently, taking the appropriate action in court, if they so wish. Apart from its enormous transaction costs, a sui generis system providing for a form of distribution of revenues obtained from a seed tax levied by the government, does not seem to fit the concept of the civil and administrative procedures and remedies as required by the TRIPS Agreement. Such a system would require the state to control compliance with the sui generis system, which means the state would have to ensure that consumers actually pay tax when they buy or plant back seed of a protected variety. The right holder, however, would certainly not be in a position to take action against any act of infringement, i.e. tax evasion, which would mean that the civil and administrative procedures and remedies as foreseen by the TRIPS Agreement could not be made use of. A remuneration system based on a seed tax system does not therefore seem to comply with the TRIPS Agreement. 4.3 OPTIONS FOR AN IPR FOR THE PROTECTION OF PLANT VARIETIES There are various options for an IPR for the protection of plant varieties. The TRIPS Agreement itself mentions three different possible options: members shall provide for the protection of plant varieties either by patents, or by an effective sui generis system or by any combination thereof. 1. One option certainly is not to exclude plant varieties from patentability. Given that depending on their interpretation the patent requirements as such may pose significant hurdles to plant varietiesvii this option may even seem attractive for members which wish to avoid strong intellectual property protection in the field of plant breeding. However these hurdles may be overcome with increasing progress in plant biotechnology. 2. The second option is the establishment of a sui generis system. Yet there are various options for a sui generis system as required by Art. 27.3 (b). There are several ways to define the term plant variety. Furthermore, the TRIPS Agreement leaves the option to protect additional subject matter. i. The 'traditional' requirements for the protection of plant varieties -- that they be novel, distinct, uniform and stable -- can be altered substantially. But the plant grouping to be protected still has to be distinct from other plant groupings and it must be possible to clearly identify it with reasonable effort. Moreover, additional requirements for protection may be set up, such as Value for Cultivation and Use (VCU) or declaration of origin. While the former may allow member states to provide for incentives to fit their specific priorities in plant breeding, the latter may for example be helpful in verifying whether the prior informed consent of the providers of breeding material has been obtained. ii. In relation to the physical elements (representing a plant variety) to be covered by the right, member states have several options: the sui generis right may be limited to vegetative or reproductive propagating material, or extend even to harvested material. iii. In relation to the acts which shall require the authorisation of the right holder, member states may follow the models provided by current patent law or by the different UPOV Acts. They may also define a different scope of protection subject to the minimum requirements as set out above. In our opinion, this includes for example the option to grant the exclusive right to use a PVP seal for material of a specified, registered variety in combination with its registered denomination. Such a seal would not relate to the material as such. iv. The TRIPS Agreement does not specify the period of duration of the sui generis right. Thus, member states are free in taking a decision on this important factor. v. There are different ways to design the interface of the sui generis system with other IPRs. vi. There is a package of elements that may be introduced to balance the privilege conferred to the right holder under the sui generis system, such as community gene funds, registers to facilitate benefit-sharing mechanisms and the institute of a public defender. Each single element must be carefully designed, but the main focus should be directed at balancing the different interests in the overall package of elements establishing the sui generis system. vii. In relation to patents the TRIPS Agreement does not allow any discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. However, this principle is not applicable to the sui generis system for the protection of plant varieties. Therefore, member states may, for example, discriminate plant varieties which have not been bred or propagated domestically. 3. The third option is the protection of plant varieties by a combination of a sui generis system and patents. While this option is reflected by the European Patent Convention, it raises the difficult issue of the relationship between both systems.  4.4 SHAPING SUI GENERIS SYSTEMS 4.4.1 Aims of IPR protection in the field of plant breeding The historical aim of IPR protection for plant varieties is to provide private breeders with an opportunity to receive a reasonable return on past investments and thereby to provide an incentive for continued private investment in plant breeding. IPR protection aims at facilitating trade and the transfer of technology. By providing for the protection of plant varieties countries may attract foreign investment in domestic plant breeding and may thereby also benefit from an increased transfer of related technology. It is, however, widely acknowledged that the level of protection may have a positive impact on the international transfer of technology only if certain preconditions (such as scientific infrastructure, attractive economic environment and a skilled work force) are fulfilled. Countries which lack these conditions will hardly be able to benefit from a high level of IPR protection at least in the short term. They run the risk that the protection system instead of attracting foreign investment and technology is being used only to secure imports. IPR protection may also improve the possibilities to import from or export to countries that provide for such protection. It should be noted, however, that the TRIPS Agreement makes sure that WTO member states have to accord to the nationals of other member states treatment no less favourable than they accord to their own nationals with regard to the protection of plant varieties. A member state may therefore benefit from high level protection in other countries, even if it does not grant the same level of protection. Today, while there is still a debate on the advantages and disadvantages of IPR, new objectives are on the international agenda. Apart from the minimum requirements laid down by the TRIPS Agreement, any sui generis system should also take into account those objectives of other, in particular the most recent, international treaties and/or emerging principles of the international community, especially those dealing with plant genetic resources and traditional resource rights. Soft law is contained in a wide range of instruments, such as the Rio Declaration, Agenda 21, the International Undertaking on Plant Genetic Resources, the UNESCO/WIPO Model Provisions for National Laws on the Protection of Expression of Folklore, and the Draft Declaration on Indigenous Rights. Relevant multilateral treaties include the Convention on Biological Diversity and the ILO Convention 169. A set of obligations and widely accepted principles emerges from these instruments that are most relevant in the shaping of a sui generis system: * States have the sovereign right over their own natural resources including their genetic resources. * Farmers' Rights arising from the past, present and future contributions of farmers in conserving, improving and making available plant genetic resources are recognised in order to allow farmers, their communities, and countries in all regions of the world to participate fully in the benefits derived at present and in the future, from the improved use of plant genetic resources, through plant breeding or other scientific methods. * Biological diversity including genetic diversity shall be conserved, enhanced and sustainably used. Patents and other IPR shall be supportive of and not run counter to this objective. * Access to genetic resources shall be subject to prior informed consent. Where granted, access shall be on mutually agreed terms. * Benefits arising from the commercial and other utilisation of genetic resources shall be shared in a fair and equitable way upon mutually agreed terms, multilaterally or on a bilateral basis. * The results of research and development arising from the utilisation of genetic resources, as well as the technology using such resources, shall be shared in a fair and equitable way on terms mutually agreed upon. Access to, and transfer of technologies relevant to the conservation of biological diversity, to the sustainable use of its components, and to technologies that make use of genetic resources shall be provided and/or facilitated under fair and most favourable terms. * Indigenous and farming communities' knowledge, innovation and practices related to plants and plant genetic resources shall be protected and encouraged. Special measures shall be taken to ensure this, including mechanisms of free and informed consent. While the question is still open whether WTO member states may invoke the objectives of the Convention on Biological Diversity in order to justify any measures which are contrary to the TRIPS Agreement, member states should certainly try to avoid any such conflicts as far as possible. On the basis of the legal requirements laid down in the TRIPS Agreement, we suggest to consider possible combinations of elements for the design of protection systems, appropriate for the different economic and social conditions in developing countries, and the requirements and consequences from the economic, ecological, legal, technical and administrative points of view. It is of particular importance, how the new international principles and obligations may be taken into acount by the sui generis system for the protection of plant varieties. 4.2.2 Taking into account the new objectives Strengthening conservation efforts Intellectual property rights for the protection of plant varieties are not aimed at the conservation of agricultural biodiversity nor are they particularly suited for that purpose. While it is sometimes maintained that IPR have a strong negative impact on diversity, others argue that plant variety protection may increase diversity by inciting efforts to create new plant varieties. Due to the fact that genetic erosion has multiple causes it is extremely difficult to assess the impact IPR actually have on the maintenance of agricultural biodiversity. On the other hand, the number of new plant varieties which actually may correlate with the level of IP protection does not qualify as a measuring stick for genetic diversity. The need to describe plant varieties for the purpose of their protection no doubt implies a tendency towards uniform varieties with a rather narrow genetic basis. In order to allow for more agricultural genetic diversity, member states may therefore consider applying the requirements of uniformity and stability more flexibly or even to replace them by the requirement of identifiability. It is widely acknowledged that in order to conserve agricultural biodiversity, on-farm conservation efforts have to be substantially increased on a global scale. The planting back of seeds, the local exchange and selling of farm-saved seeds and adaptive breeding by cultivation are preconditions of large-scale on-farm conservation. The different IPR protection models provide for a different scope of protection with the patent model being the most restrictive. Depending on the definition of its scope, the concept of "essential derivation" may support conservation efforts by requiring larger genetic distances between new varieties. However the concept of "essential derivation" might in practice require a high degree of uniformity and stability of varieties. Supporting the breeding of heterogeneous varieties There is wide consensus today that in many situations, especially in risk prone areas, it is an advantage to have a comparably high degree of variability in the fields. The requirements of uniformity and stability as currently applied by UPOV member states do not allow for the heterogeneity required in such situations. Furthermore, the levels of uniformity at present required by national authorities and international guidelines seem to be far higher than justified by the need to identify a plant variety. This is reflected by the definition of "plant variety" employed by the UPOV Act of 1991. To facilitate and create incentives for the breeding of heterogeneous varieties which are better adapted to the needs of indigenous and small-scale farmers, it may therefore be recommendable to lower the required level of uniformity/stability. This is the background of the proposal to switch from Distinctness, Uniformity and Stability (DUS) to Distinctness and Identifiability (DI).  On the other hand, it is clear that the broadening of the acceptable limits of heterogeneity within a plant variety to be protected inevitably leads to broader property claims. This has to be taken into account when defining the acts requiring the right holders' authorisation in relation to the protected variety. The scope of protection has to correspond with the requirements for protection and the breadth of the claims. Imposing minimum restrictions on the use of plant varieties IPR are, by definition, rights to exclude others from certain commercially interesting acts in relation to the described subject matter and/or to obtain a remuneration in respect of those acts. However, the unrestricted planting back and the selling of seeds is an important and common practice in large parts of the world. The planting back of the protected variety is allowable without authorisation of the right holder under the 1978 UPOV Act and the PVP seal model. Under TRIPS-style patent law, the planting back of seed requires the right holder's authorisation. According to the 1991 UPOV Act, farm-saved seed may be exempted from the breeder's right only within reasonable limits and subject to safeguarding the legitimate interest of the breeder. Some UPOV states give farmers an unconditional right to save seed from their previous harvest, while others have opted to limit this right to certain crops and/or to small-scale farmers. The selling of farm-saved seed requires authorisation of the right holders under TRIPS style patent law and the UPOV Acts of 1978 and 1991. Only under the PVP seal model the selling of farm-saved seed is not subject to the authorisation of the right holder. The opportunity to use plant varieties freely as initial source of variation for breeding purposes is an essential element of plant breeding -- by whomever, whenever, wherever. This reality is reflected in both UPOV Acts. Under the 1978 UPOV Act, protected varieties may freely be used for breeding purposes. According to the UPOV Act of 1991, protected varieties may also be used freely but if the new variety that results is deemed "essentially derived" from the original protected variety, it may only be marketed if the breeder of the initial variety gives permission. There is no such thing as a breeders' exemption in common patent law and it is clear that the research exemption does not cover the commercial use of protected subject matter, e.g. in a breeding programme. The concept of unrestricted use of plant varieties and the concept of a financial case-by-case sharing of benefits obtained from the use of genetic resources may conflict with each other. If the use of plant genetic resources requires authorisation of the country of origin, it can hardly be expected that plant varieties which are based on such resources can subsequently be used freely by third parties since this would discriminate first users. Preventing unauthorised access to and appropriation of PGR It has been suggested that by providing intellectual property rights for plant genetic resources and plant varieties a country could prevent the unauthorised access to, appropriation, and/or use of genetic resources by foreign entities, be they public or private. However, according to the TRIPS Agreement, member states shall accord to the nationals of other member states treatment no less favourable than they accord to their own nationals with regard to the availability, acquisition, scope, maintenance and enforcement of IPR. Therefore, WTO member states are not allowed to discriminate nationals of other WTO member states as to the availability of the sui generis or other IPR. By providing strong IPR protection, a country with rather low technological and breeding capacity might therefore face a strong rise of foreign applications while the level of domestic applications might remain low. From this point of view it is not conceivable how an IPR system could contribute to curbing "biopiracy". By making prior informed consent (PIC) of the donors of genetic resources or associated knowledge a requirement for the granting of IPR, member states could try to avoid or make more difficult the granting of sui generis rights in relation to material originating from their own biodiversity. Still, they would have to apply the PIC requirement to applications from their own nationals as well, since the modalities of and conditions under which consent is given have to comply with the principle of national treatment.  Sharing the benefits equitably The sui generis system as required by the TRIPS Agreement is certainly neither the only nor the most adequate instrument to fulfill the obligations posed by the Convention on Biological Diversity (CBD) in relation to access to plant genetic resources. By definition, such as system cannot cover all plant genetic resources. Nevertheless, a sui generis system may be used as a trigger for the sharing of benefits gained from the use of those materials and/or knowledge which were granted sui generis protection. The instruments for implementing a benefit-sharing mechanism as part of a sui generis right include PIC and declaration of origin.  The inclusion of such instruments as additional protection requirements is, however, incompatible with the UPOV Acts. If the sui generis system shall be used for the purpose of financial benefit-sharing it would seem to be comprehensive to design the coverage of this system as broad as possible, the protection requirements as soft as possible, and to grant strong exclusive rights in order to generate maximum monetary returns that could be shared. Such a system, however, would have tremendous shortcomings since it would allow all plant genetic resources to be monopolised within a very short time. Plant breeding would thus come to a standstill and would cease to create any returns. There are two extreme scenarios to deal with this problem. If the protection conferred by the sui generis rights is strong, it is necessary to set up rather strict requirements for protection in order to avoid the pitfall of complete monopolisation of PGR. In this case the returns raised per application could be rather high; however due to the strict requirements rather few PGR would fall into the scope of the system. If, on the other hand, the protection is rather weak, softer protection requirements may be acceptable. In this case the benefits per application would be rather low; the system would, however, cover quite a broad range of PGR. It is difficult to predict which of these models would finally raise more returns. 4.4.3 Balancing the sui generis system with other IPR Whatever form of sui generis system member states choose to establish, the interface of this system with other IPR is of utmost importance. The UPOV Act of 1978 leaves each state party to the Act free to grant protection to new varieties of plants by means of a 'special title of protection' -- that is, a title specially created for plant varieties -- or a patent. However, member states whose national laws admit protection under both these forms may provide only one of them for one and the same botanical genus or species. This ban on double protection was not included into the 1991 Act. The ban on double protection as foreseen in the UPOV Act of 1978 does not, however, address the issue of overlapping IPR. The need to regulate the interface of different forms of protection is demonstrated by the following example. If a patented gene is inserted into a plant which is protected under a UPOV-style breeders' right, the question arises whether the plant may be used freely under the breeders' exemption as an initial source for breeding a new variety, or whether such use would infringe the patent on the inserted gene. The answer to this question is actually far from clear. While some argue that the plant should be freely usable for breeding purposes, others maintain that any use of the plant would also make use of the patented gene and thus require the patent holder's authorisation. Between these two positions, one may also argue that the use of the plant is allowable without the patent holder's authorisation, as long as the new variety does not contain the gene, or, if it contains the gene, does not express it. Whatever solution is chosen, it is obvious that the overlap of patents and weaker forms of protection tends to privilege the patent holder and complicates the legal situation of the holder of the weaker right considerably. Countries establishing a sui generis system for the protection of plant varieties should therefore consider carefully the interface between the sui generis rights and other forms of protection. To this end, it might not be enough just to provide that plants are unpatentable, but also that parts of plants are excluded from patentability and that the scope of protection of a gene patent does not extend to plants into which this gene has been inserted. It should be ensured that the scope of patents claiming genetic material does not extend to subject matter which is excluded from patentability. Footnotes:  See Carlos Correa's paper in this book.  This chapter is based on Leskien & Flitner, "Intellectual Property Rights and Plant Genetic Resources: Options for a Sui Generis System", Issues in Genetic Resources No. 6, IPGRI, Rome 1997.  Quoted in The Times of India, New Delhi, 12 March 1993.  The 1978 UPOV Act only requires contracting parties to apply the UPOV Convention to a minimum of five genera when first acceding to the Convention and then within three years apply it to at least ten genera or species within six years to at least eighteen, and within eight years to at least twenty-four genera or species in all (Art. 4).  Art. 1.2 of the Paris Convention for the Protection of Industrial Property reads: "The protection of industrial property has as its object patents,utility models, industrial designs, trademarks, service marks, trade names, indications of source or appellations of origin, and the repression of unfair competition."  Although, as mentioned above, this position is barely compatible with the TRIPS Agreement, it raises the question of whether not to implement any sui generis system would be a political option. If for their own interest UPOV members themselves do not regard the sui generis system as an IPR they might not be interested in challenging a country on the grounds of a lack of sui generis protection for plant varieties. However, it should be noted that some UPOV members do regard the sui generis system as an IPR as do other WTO members. WTO members should therefore not rely on those members which currently argue that the sui generis system is not an IPR and, consequently, does not have to comply with the national treatment principle. Rather, they should start to develop and implement a TRIPS-compatible sui generis system that meets their needs. The existence of such a system might be particularly helpful for the review of Art. 27.3(b) TRIPS in 1999.  See pages 5-18 of Leskien & Flitner, op.cit.  For problems of the interface between both systems see below.  See pages 54 and 55 of Leskien & Flitner, op cit.  This also means that a PIC requirement designed to refuse only nationals of other member states sui generis rights for plant varieties which are based on domestic genetic material or related knowledge, would seem to fall foul of the TRIPS Agreement.  On 16 July 1997 the European Parliament voted in favour of an amendment of the proposal for a directive on the legal protection of biotechnological inventions (COM (95) 661) which aims at the implementation of PIC. The wording of the amendment (76/rev.) reads as follows: "If the object of an invention consists of biological material of plant or animal origin or if it uses such material, a patent on this invention shall be granted only when the patent specification publishes the geographical place of origin of the material and the application for the patent provides evidence to the patent authorities that the material was used in accordance with the legal access and export provisions in force in the place of origin."