Plants, Germplasm, Genebanks, and Intellectual Property: Principles, Options, and Management

CHAPTER 4.6

JOHN DODDS, Founder, Dodds & Associates, U.S.A. ANATOLE KRATTIGER, Research Professor, the Biodesign Institute at Arizona State University, Chair, bioDevelopments-International Institute; and Adjunct Professor, Cornell University, U.S.A. STANLEY P. KOWALSKI, Visiting Scholar, The Franklin Pierce Law Center, U.S.A.

ABSTRACT global food production will have to increase to In ever-increasing numbers, institutions are establishing more than 3,000 million metric tons from the technology transfer offices (TTOs). These offices serve a current 1,800 million metric tons. At the same variety of functions, all of which must be integrated to cost effectively transfer technologies and to benefit the -in time, productive farmland is, and will continue stitutions. A critical function of the TTO is to proactive- to be, diverted at an increasing rate to nonfarm ly manage intellectual property (IP) issues pertinent to uses, and access to water will continue to be a ma- crops. Crops can be covered by more than one form of IP jor limiting factor for agricultural productivity. rights protection, often simultaneously. These rights protections include trademarks, trade secrets, plant and util- To address the challenge of meeting the ity patents, and plant variety protection (PVP). Closely needs of the world’s growing population, plant related is the importance of careful and organized gene- breeders are developing improved plants that bank management, a critical component of an overall IP can produce more, while using less land and less and tangible property management system. PVP provides water. As trained professionals whose endeavor is one type of protection that allows TTOs to responsively serve clients and generate revenue. PVP is a form of IP developing plants that are genetically equipped to rights protection for crops with potentially global appli- produce higher yields of quality products, plant cations, and either a PVP office, or a PVP subsection in breeders will contribute significantly to meeting the TTO, would be wisely established by an institution. these challenges. While producing higher yields, In addition, this chapter provides important information to assist in establishing a national PVP office and in the these improved plants will also be more resistant selection and implementation of various types of IP rights to pests and diseases, so they can potentially re- protection for crops and germplasm. duce the need for large (and expensive) applications of fertilizers and crop protection chemicals. Finally, these plants reduce the need for additional 1. Introduction irrigation from precious water resources, thereby Plants affect people’s everyday lives in terms of contributing to further conservation. quality and cost—the cost of food, feed, fiber, The breeding of new plant varieties is thus fuel, and other necessities. Plants provide raw an economically important activity that con- materials for industry, such as vegetable oils, rub- tributes in many different ways to the social ber, and drugs and other health care items. By and economic well-being of societies. In many 2020 the Earth’s population is likely to reach 9 cases, new plant varieties are absolutely essential billion. To meet the increasing demand, annual for human survival. However, there are many

Dodds J, A Krattiger and SP Kowalski. 2007. Plants, Germplasm, Genebanks, and Intellectual Property: Principles, Op- tions, and Management. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org. © 2007. J Dodds, A Krattiger and SP Kowalski. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.

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challenges associated with crop breeding. For of the accessions. This process may entail example, experience has shown that a breeder simple selection. has difficulty recovering his financial investment • gene. The fundamental physical and func- when he sells his initial supplies in the first years tional unit of heredity. A gene is an ordered of a new variety’s life. The breeder’s competitors sequence of nucleotides in a particular po- can secure supplies of propagating material and, sition, on a particular chromosome, encod- in a short time, be in a position to compete with ing a specific functional product. the breeder, thus profiting from the many years of • genebank. A genebank is a special facility effort invested by the breeder. In this way, the re- that stores living samples of the diversity of wards of the plant breeder’s innovative efforts can crop varieties and their wild relatives. These be rapidly lost to himself or herself. The initial samples are usually in the form of seeds or phase of protection is therefore critical, because other plant parts. Some of the plants that developing new varieties in most plant species genebanks hold are extinct in the wild. The may take between ten and 20 years. value of the genetic resources conserved These new varieties are crucial to the needs in genebanks encompasses not only their of modern society. They contribute to a varied current use value and expected future use diet and provide for a wide choice of ornamental value, but also the option value associated and amenity plants. Generating sufficient variety, with the flexibility to respond to some un- however, requires substantial investment in crop known future events. breeding programs. Accordingly, many countries, • genetic resource. Often used as a synonym while continuing to invest in public sector plant to germplasm, this is a seed, plant, or plant breeding research, have established open free- part that is useful in crop breeding, research, market systems in which exclusive rights of ex- or conservation because of its genetic attri- ploitation (patent-like protections) are granted to butes. Genetic resources are maintained for the breeders of new varieties of plants. the purposes of studying, managing, or us- This chapter presents a general overview of ing the genetic information they possess. the types of IP protections that are available for • improved material. An elite breeding line. plants. It then focuses on plant variety protection • landrace. A population of plants, typically (PVP) as one key example of plant IP rights pro- genetically heterogeneous, commonly de- tection, an option that can be broadly applied to veloped in traditional agriculture from the needs of developing countries. many years of farmer-directed selection and specifically adapted to local conditions. • public domain. Public ownership status of 2. Definitions information not protected by patents or Before discussing some specific issues in relation copyrights. to crops, germplasm, and genebanks, it is impor- • wild species. A species that has not been sub- tant to have a common understanding of what is ject to breeding with intent to alter them meant by certain words: from their wild state. • breed. To develop new or improved strains of organisms, chiefly through controlled mating or pollination and the selection of 3. IP issues that AFFEct genetic offspring for desirable traits. resource management • breeding line. Genetic group that has been It is useful to recall that plant breeding is a knowl- selected and bred for special combinations edge-based activity. Consequently, it is a nonex- of traits. haustive activity. In other words, the results of ap- • enhancement. The process of improving plying the knowledge are not decreased if shared germplasm accessions by breeding, while re- with others. What is lost in sharing, however, is taining the important genetic contributions market value. In other words, a plant breeder who

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has invested millions of dollars over many years propagation. Discovery itself, however, does not cannot extract value if others appropriate the new constitute breeding. variety and sell it at the mere cost of seed produc- The PVP Act (PVPA), enacted in December tion. The free distribution of varieties provides of 1970 and amended in 1994, provides legal IP the breeder with no incentive to invest. IP sys- rights protection to developers of new varieties tems remedy this situation by providing a level of of plants that are sexually reproduced (by seed) protection to breeders. or are tuber propagated. Bacteria and fungi are IP rights is a broad term for the various rights excluded. The PVPA is administered by the U.S. that the law provides for the protection of eco- Department of Agriculture. nomic investment in creative effort. The principal A Certificate of Protection is awarded to an categories of IP protections relevant to agricultur- owner of a variety after an examination shows that al research are patents, plant variety rights, trade the variety is new and distinct from other variet- secrets, copyrights, and trademarks. ies and is genetically uniform and stable though successive generations. The term of protection is 3.1 Patents 20 years, for most crops, and 25 years for trees, Patents are a statutory form of protection that shrubs, and vines. The owner of a U.S.-protected allows an inventor rights of exclusivity on the variety has exclusive rights to multiply and mar- sale or use of his or her invention for a lim- ket the seed of that variety. ited period of time, in a particular territory, The characteristics of the PVP systems are in exchange for a full public disclosure of the summarized in Table 1 and are compared both invention. to plant patents and utility patents. A detailed In the case of plants, there are two forms discussion of PVP and its global applicability is of patenting. The first is called a plant patent. published by Blakeney�� and colleagues.1 It applies only to materials that are asexually propagated, such as pineapples and bananas. 3.3 Trade secrets The second is called a “utility patent.” This does U.S. trade secret laws have been used to protect not protect the plant per se, but rather the in- in-house breeding materials, such as the inbred vention that is embodied in the plant (for ex- lines of maize used as parents of hybrids. These ample, a method for conferring insect resistance laws do not, however, protect against indepen- through the incorporation of resistant genes into dent discovery or reverse engineering of products the plant). by the purchasers. It should be remembered, moreover, that ge- 3.2 Plant variety protection netic resources have a dual property nature: they Plant variety protection (PVP) is another form of are physical material (tangible property) that may IP protection for plants. PVP gives the breeder be associated with human-made improvements exclusive rights to a new and distinct plant variety (IP). This dual nature is the reason for genetic re- so that the breeder can exploit it. sources to be, on the one hand, physical property The breeder is defined by the 1991 UPOV in the form of germplasm and, on the other hand, (International Union for the Protection of New IP in the form of modified genetic information Varieties of Plants) Convention as the person constituting inventions, trade secrets, and new who bred, or discovered, and developed a variety. plant varieties. Therefore, protection is not limited to breeders who produce a variety as a result of crossing par- 3.4 Copyrights ent plants and selecting from the progeny. The Copyrights are becoming more important for pro- term breeder also includes a person who discov- tecting IP in the field of plant breeding because ers a mutation and converts that discovery into the databases that hold information about plant a cultivated variety by a process of selective genes can often be copyrighted. Such copyrights

HANDBOOK OF BEST PRACTICES | 391 DODDS, KRATTIGER & KOWALSKI 4 nited States) nited U

3 PVP Act PVP 1970; (since plants reproduced Sexually hybrids, First-generation plants uncultivated uniformity, Distinctness, stability Description of novel and characteristics seed deposit genealogy, claim Single varietal others from Prevents importing sexually or selling, reproducing, or asexually distributing without proper a hybrid producing notice, using the or new variety, claimed plant developing for Exemptions and or variety a new hybrid and sale saving farmers’ for license compulsory of seed; provision is while application Protected from plus 20 years pending, most crops for issuance date vines and trees) for (25 years First to file in the United or another UPOV States member country

Source: Modified from Krattiger and Potter. and Krattiger Modified from Source: Plant Patent Act Patent Plant U nited States) (since 1930; plants, reproduced Asexually and mutant, including cultivated, hybrid and tuber- Uncultivated plants propagated stability distinctness, Novelty, as possible As complete or drawings photographs claim Single varietal asexually others from Prevents or using selling, reproducing, claimed plant Does not protect sexual of claimed plant; reproduction does not protect plant products filing date effective from 20 years from 17 years 8 June 1995); (after (prior issue date to 8 June 1995) in the United States First to invent

tility Patents U tility Patents U nited States) (since 1985; Plant genotypes not normally found in nature nonobviousness, utility, Novelty, enablement best mode Enabling disclosure, material deposit of novel disclosure, claims generic claims, claim, Varietal vectors, gene transfer to plant genes, and plants, producing for processes so on using, making, others from Prevents or from or selling claimed invention, of selling a component the claimed invention filing date effective from 20 years issue from 17 years 8 June 1995); (after (prior date to 8 June 1995) in the United States First to invent

2 aw TRIPS Compatible TRIPS Compatible L Patent All plant species and enabling technologies enablement inventiveness, Novelty, characteristics Description of novel enabling disclosure, and genealogy, material deposit of novel Not determined making others from Prevents using the product, the patented offering or using, process, patented selling or importing for sale, for those purposes the patented product or the product obtained by (extends to process the patented material) harvested rights, and farmers’ rights Breeders’ TRIPS with in principle compatible but not yet tested of filing date from 20 years Table 1: Comparison of Plant Variety Protection Systems Systems Protection Variety Plant of Comparison 1: Table POV 91 POV U and species of all genera Varieties uniformity, distinctness, Novelty, stability or producing others from Prevents the for conditioning reproducing, offering purpose of propagation, selling or other marketing, sale, for stocking for importing, exporting, purposes detailed above any except breeding for Exemptions is essentially new variety where optional farmers’ derived; use on same and only for exemption and subjectfarm to a license and/or use and research private fee; for most (25 years crops for 20 years and trees) grapevines allowed by both patents Protection and PVP POV 78 POV U of selected Varieties and species as genera listed distinctness, Novelty, stability uniformity, others from Prevents commercial for producing sale, for offering purpose, marketing breeding for Exemptions to save farmers and for own seed mandatory most crops for 15 years grapevines for (20 years and trees) by both patent Protection notand PVP allowed Action or stipulation Protects Excludes Requires Disclosure Claims Rights Exemptions of Duration protection Priority Double protection

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4 do not, however, affect trade in products devel- for allowing the registration of descriptors for oped using the protected information. indigenous materials. These descriptors are re- nited States) nited U

3 viewed as part of the examination process for awarding a PVP certificate.

PVP Act PVP 1970; (since plants reproduced Sexually hybrids, First-generation plants uncultivated uniformity, Distinctness, stability Description of novel and characteristics seed deposit genealogy, claim Single varietal others from Prevents importing sexually or selling, reproducing, or asexually distributing without proper a hybrid producing notice, using the or new variety, claimed plant developing for Exemptions and or variety a new hybrid and sale saving farmers’ for license compulsory of seed; provision is while application Protected from plus 20 years pending, most crops for issuance date vines and trees) for (25 years First to file in the United or another UPOV States member country 3.5 Trademarks Trademarks can be used to protect brand names, 4.2 Material transfer agreements such as Monsanto’s Roundup Ready®. But trade- When genetic resources are transferred, it is in- marks protect only the names and other symbols creasingly common for them to be accompanied denoting products or technologies, not the tech- by an MTA. Such a document forms a contractual nologies themselves. Still, trademarks may give relationship between the shipper and the recipi- customers a proof of quality, and so they may be ent. It is common for MTA agreements to attach Source: Modified from Krattiger and Potter. and Krattiger Modified from Source: as important as variety protection. terms and conditions regarding both the approved

Plant Patent Act Patent Plant U nited States) (since 1930; plants, reproduced Asexually and mutant, including cultivated, hybrid and tuber- Uncultivated plants propagated stability distinctness, Novelty, as possible As complete or drawings photographs claim Single varietal asexually others from Prevents or using selling, reproducing, claimed plant Does not protect sexual of claimed plant; reproduction does not protect plant products filing date effective from 20 years from 17 years 8 June 1995); (after (prior issue date to 8 June 1995) in the United States First to invent use of genetic resources and the rights to ownership of such materials or their derivatives. 4. “Non-IP” matters AFFEcting MTA agreements can appear in a number of genetic resources management forms. While the most common is a conventional As indicated above, there are tangible property sheet of paper, it is also possible for the material rights that have a bearing on the ownership of to come with language included on the bag. The genetic resources. The Convention on Biological use of so-called bag-tag language is becoming in- Diversity (see below) affirmed the sovereign rights creasingly common. At issue, however, is whether of nations over their genetic resources. Such own- the “shipper” who applies the MTA language ac- tility Patents U tility Patents U nited States) (since 1985; Plant genotypes not normally found in nature nonobviousness, utility, Novelty, enablement best mode Enabling disclosure, material deposit of novel disclosure, claims generic claims, claim, Varietal vectors, gene transfer to plant genes, and plants, producing for processes so on using, making, others from Prevents or from or selling claimed invention, of selling a component the claimed invention filing date effective from 20 years issue from 17 years 8 June 1995); (after (prior date to 8 June 1995) in the United States First to invent ership is a tangible property right on the owner- tually owns title to the materials and has the right ship of the actual material. to allocate ownership rights. There exist, however, a number of other non-IP matters that affect the day-to-day lives

of genetic resource specialists working in the 5. International treaties

2 field. These most typically include indigenous Generally, plant genetic resources are governed by

aw knowledge issues and access to and transfer of national, regional and international laws, which materials. regulate ownership, access, and benefit sharing.

TRIPS Compatible TRIPS Compatible L Patent All plant species and enabling technologies enablement inventiveness, Novelty, characteristics Description of novel enabling disclosure, and genealogy, material deposit of novel Not determined making others from Prevents using the product, the patented offering or using, process, patented selling or importing for sale, for those purposes the patented product or the product obtained by (extends to process the patented material) harvested rights, and farmers’ rights Breeders’ TRIPS with in principle compatible but not yet tested of filing date from 20 years Internationally, these concerns are regulated by 4.1 Indigenous knowledge treaties such as the CBD, the International Union The formal IP system of patents, PVP, copy- for the Protection of New Varieties of Plants rights, and so on is based on a set of statutory (UPOV) Convention, the International Treaty Table 1: Comparison of Plant Variety Protection Systems Systems Protection Variety Plant of Comparison 1: Table (legislative) rules. The current system allows of Plant Genetic Resources, and the Agreement so-called prior art to be used as a way of deter- on Trade-Related Aspects of Intellectual Property mining whether novelty exists with regard to an Rights (TRIPS). invention. The current formal system does not

POV 91 POV adequately allow for indigenous knowledge to 5.1 The Convention on Biological Diversity (CBD) U and species of all genera Varieties uniformity, distinctness, Novelty, stability or producing others from Prevents the for conditioning reproducing, offering purpose of propagation, selling or other marketing, sale, for stocking for importing, exporting, purposes detailed above any except breeding for Exemptions is essentially new variety where optional farmers’ derived; use on same and only for exemption and subjectfarm to a license and/or use and research private fee; for most (25 years crops for 20 years and trees) grapevines allowed by both patents Protection and PVP form the basis of prior art or allow indigenous The CBD is the central instrument related to people to be the inventors or breeders. This has international biodiversity. It broadly delimits led to significant controversy in the international the rights of states and other relevant actors over community. Both WIPO (World Intellectual biological resources and affirms the sovereign Property Organization) and UPOV are actively rights of states to exploit their own resources reviewing and debating this topic to try to devel- pursuant to their own environmental policies. POV 78 POV U of selected Varieties and species as genera listed distinctness, Novelty, stability uniformity, others from Prevents commercial for producing sale, for offering purpose, marketing breeding for Exemptions to save farmers and for own seed mandatory most crops for 15 years grapevines for (20 years and trees) by both patent Protection notand PVP allowed op a mechanism that would prescribe a role for The sovereign rights of states over their own bio- such knowledge within the formal system. One logical resources are limited by the recognition noteworthy example within a national program that these resources are a common concern of is the PVP Office of the Philippines’ mechanism humankind. Action or stipulation Protects Excludes Requires Disclosure Claims Rights Exemptions of Duration protection Priority Double protection

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The Convention also provides a broad frame- genetic resources, with minimal procedural and work for member states’ policies concerning administrative costs. Initially, the treaty applies access, development and the transfer of technolo- to 35 crops and some 80 forages that are un- gies. It also acknowledges the necessity for all par- der the control of member governments and ties to recognize and protect IP rights in this field. that are not subject to IP rights. Thus, the treaty The Convention further recognizes both the de- includes practically all the crops that humanity pendence of local communities on biological re- depends on for its food supply. The treaty in- sources and the roles that these communities play vites all holders of listed plant genetic resources in the conservation and sustainable use of these re- to join the multilateral system. The list itself can sources. Finally, it points to the need for equitably be changed with the consensus of the parties to sharing the benefits that arise from the use of tra- the treaty. ditional knowledge, innovations, and practices. The multilateral system is intended to be ef- ficient, effective, and transparent. It aims to ease 5.2 UPOV access, not only to plant genetic resources for The UPOV Covention is the only international food and agriculture, but also to information treaty focusing on PVP. It recognizes not only the about those resources, so that any benefits that rights of individual plant breeders who have de- may arise from their use can be shared fairly and veloped or discovered plant varieties that are new, equitably. distinct, uniform, and stable, but also accords cer- In this context, it is worth dwelling�� briefly on tain rights to farmers. Under the 1978 version of the difference between farmers’ rights and farmers’ the Convention, farmers are permitted to reuse exemption/privilege. Because the terms are often propagating material from the previous year’s har- used interchangeably, there has been significant vest, and they can freely exchange the seeds of pro- confusion regarding their use. Farmers’ rights tected varieties with other farmers. Plant breeders is a term developed by FAO under the Revised are also allowed to use protected varieties to breed Undertaking for Plant Genetic Resources. and commercialize other new varieties. Resolution 5/89 of the treaty states, “…rights The latest revision of the Convention, ad- arising from the past, present and future contribu- opted in 1991, has further strengthened the tions of farmers in conserving, improving and mak- rights of commercial plant breeders. These revi- ing available plant genetic resources.” Resolution sions include the obligation for member states to 3/91 states that these rights are to be “implement- provide protection to all plant genera and species. ed through an international fund on plant genetic Furthermore, it extends breeders’ rights to all seed resources that will support plant genetic conserva- production of a protected variety, even though tion and utilisation programmes, particularly, but countries can decide on their own internal laws not exclusively, in the developing countries….” regarding this issue. In some cases, the revision The difference is further elaborated in the grants to commercial breeders the rights to the FAO Treaty. However, no specific future action harvested material of the variety and extends pro- is targeted here; instead, the treaty gives voice to tection to varieties that are “essentially derived” a general equity objective. These areas are still the from a protected variety. subject of much debate, and the mechanism with which to ensure both participation and benefit 5.3 The International Treaty on Plant Genetic sharing has not yet been elucidated. Resources for Food and Agriculture The concept of farmers’ exemption or farm- The International Treaty on Plant Genetic ers’ privilege in PVP legislation, on the other Resources for Food and Agriculture was adopted hand, hinges on the notion that a farmer has a by consensus of the member states of the United right to “fair use” of his or her own produced Nations Food and Agriculture Organization seed. Most national legislations embrace this no- (FAO) in November 2001. The Treaty envisions tion of fair use, as do UPOV’s model laws, and a multilateral system to facilitate access to key allow farmers to use seed produced on their own

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farms for further sowing. Only if the farmer sells cates the rights that the owner is giving to the or trades the seeds is an infringement of the PVP genebank in terms of using and distributing holder’s rights committed. Article 15 of UPOV such materials. 1991 states that: In-house materials may include those acquired a) [Compulsory exception] The breeder’s right prior to the CBD. These may be in the form of shall not extend to: genebanks, botanic gardens, and so on. While the (i) Acts done privately and for non-com- ownership of in-house materials is still conten- mercial purposes; tious, the law is clear that such materials may be (ii) Acts done for experimental purposes; used freely without prior permissions. It is very […] important here to distinguish between “genetic resources” collected in nature and “improved b) [Optional exception] Notwithstanding materials.” IP rights will attach only to the latter. Article 14, each Contracting Party may, Indeed, a sound knowledge of the biology of the within reasonable limits and subject to the materials and the ownership and legal rights as- safeguarding of the legitimate interests of the sociated with them is essential. breeder, restrict the breeder’s right in relation Outgoing materials are those materials the to any variety in order to permit farmers to genebank manager distributes to others, either use for propagating purposes, on their own for research, direct use, or for use in improve- holdings, the product of the harvest that ment programs. This is often when problems they have obtained by planting, on their arise. Carefully using appropriate MTAs is the own holdings, the protected variety or a va- most effective way to deal with these issues. The riety covered by Article 14(5)(a)(i) or (ii). MTA should reflect a range of matters: international law, policy of the organization, nature of 5.4 The TRIPS Agreement the material, nature of the recipient, nature of the TRIPS was the result of an initiative by developed acquisition of the material, and conditions relat- countries to introduce more stringent IP rights ing to incoming MTA on the material (see ex- trade rules. The agreement sought to extend the amples included in this Handbook). security of IP rights internationally. Article 27.1 Genebank management has recently become of the TRIPS Agreement implies that patents a very sensitive issue. An organized, stepwise ap- may be available in biotechnology fields, a posi- proach is vital for effectively managing a genebank tion that Article 27.3 consolidates with regard to and for avoiding difficulties. Potential ownership granting IP rights in biotechnology, particularly issues about genetic resources must be clearly ana- as it relates to plants. lyzed, and documentation procedures for the acquisition and distribution of such materials must be effective and thorough. 6. Specific issues related to The legal issues surrounding genebanks have genebank management changed dramatically over the last decade. Such A genebank manager addresses both the many changes will continue, and genebank manag- technical aspects relevant to the use of genetic ers must be alert to the effects of these changes. resources and issues related to the ownership When appropriate, managers should seek profes- of genetic resources. As outlined below, these sional advice about how these changes affect their issues usually come in different phases of the respective institutions. Genebank managers must work. not, however, lose sight of their crucial social role: In accordance with the CBD, incoming they guard and preserve the basic building blocks material must be acquired with the consent of upon which human survival and food security de- the nation that “owns” these resources. This pend. They work not only for this generation but is achieved through a germplasm acquisition for generations to come. agreement (GAA) or an MTA that clearly indi-

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7. PVP: IP protection for crop inventive nature of the product and/or process to varieties be filed. Finally, the new variety name is usually PVP addresses a specific need that applies broadly trademarked. (For more information about the across the globe, in both developed and develop- U.S. PVP system, see section 3.2.) ing countries. So-called PVP regimes are imple- The model law of UPOV, and effectively of mented in order to: all national legislatures, also allows a government • provide breeders (both public and private to issue a compulsory use license. In effect, if a sectors) with an opportunity to receive a country has a compelling need to multiply a pro- reasonable return on past investments tected variety, then the government can issue a li- • provide an incentive for continued or in- cense for its use. The PVP holder would, however, creased investment in future breeding still have the legal right to be given a reasonable research royalty payment. • recognize the legal right of the innovator to To qualify as a protected variety, the plant va- be recognized as such riety coming out of a breeding program must be • acknowledge his or her economic right to able to demonstrate: remuneration for his or her efforts • distinctness • uniformity In order to foster these laws and agreements • stability within the global economy, UPOV was formed through a union of states. These states agreed to The way in which these criteria are met is de- grant exclusive exploitation rights to the breeders scribed in more detail in section 7.3 below. of new plant varieties on an internationally har- monized basis. UPOV developed a set of model 7.1 PVP application process laws that provided a general legislative framework PVP application forms and the supporting docu- for PVP. Indeed, some provisions of TRIPS re- mentation, such as the UPOV crop guides, will fer to the use of UPOV standards as an effective guide the applicant (and examiner) through the mechanism for complying with WTO standards. steps of describing the history, breeding origin, One very effective aspect of this arrangement is and variety, making seed deposits, paying fees, the provision for mutuality, which allows cross and, if all is as required, obtaining a PVP certifi- protection between jurisdictions for states that cate. If application materials exist, the relevant are members of the UPOV system. Countries ministry of agriculture will have them; if applica- often use the model law produced by UPOV as tion materials are not available, this chapter pro- a framework for developing their own legisla- vides information to help develop them. tive standards. This is not to say that the system Anyone who is the owner, breeder, de- is wrinkle free. For example, the differences be- veloper, or discoverer of a unique cultivar of a tween protected varieties and other forms of plant sexually reproduced or tuber-propagated plant genetic material (including genetic resources and may apply for PVP. This applies to any citizen landraces) has yet to be established. in any UPOV member country. The applicant The U.S. system is a useful model andbe- may be an individual, a public institution, or a cause of the UPOV system’s efforts toward har- corporation. monization, most of the provisions in the U.S. The protection works by prohibiting a per- PVP system are consistent with those in other ju- son from selling, marketing, offering, delivering, risdictions. It should be noted that many jurisdic- consigning, exchanging, or exposing the variety tions have patent laws allowing for the protection for sale without explicit consent of the owner. In of plants. This is complementary to the PVP leg- addition, a person is prohibited from soliciting islation. It is possible, and increasingly common an offer to buy the variety, or transfer or possess in the United States, for protection to be taken on it in any manner. It is also illegal to import or ex- the variety, and, in addition, for a patent on the port the variety, sexually multiply it, propagate it

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by tuber, use the variety in producing (as distin- distinctness. In the United States, the PVP office guished from developing) a hybrid, or condition does not perform tests to confirm the distinct- the variety for the purpose of propagation. It is ness of a variety. That responsibility rests with the worth adding here that plant parts (flowers, pol- applicant. len, and so on) are also protected. This is critical For uniformity, a statement must report in reviewing infringement actions to determine the level of variability in any characteristic of where the material has been used. the variety. Variation, which is predictable, de- scribable, and commercially acceptable, may be 7.2 Exemptions allowed. In general, there are two exemptions to the For stability, a statement of genetic stability protection provided: 1) a research exemption is required, showing the number of cycles of seed and 2) a farmer’s exemption (also called farmer’s reproduction for which the variety has remained privilege).5 unchanged in all distinguishing characteristics. A research exemption allows for breeding to Special mention should be made of essential- develop a new variety; a farmer’s exemption allows ly derived materials. Good examples are so called for the saving of seed for the sole use of replanting “sports.” If PVP protection has been obtained on the farmer’s land. However, if the farmer sells or a potato variety that has a red skin after decades of trades the seeds, he infringes on the rights of the breeding, and then someone selects a field sport PVP holder. The controversies surrounding this with a white skin, the new white skin material provision turn largely on the definition of terms. is determined to be essentially derived from the It should be noted that neither plant patents nor original variety and will be protected under the utility patents provide these exemptions. 1991 UPOV act.

7.3 Examination standards 7.4 Enforcement The owner must prove the distinctness, uni- The owner of a protected variety may bring civil formity, and stability of the new variety. The bur- action against persons infringing on his or her den is entirely on the applicant. rights, and the owner may ask a court to issue an For distinctness, the applicant may: injunction to prevent others from further viola- • list the single variety he or she believes is tions. The owner of the protected variety must most similar to the new variety and de- bring suit in such cases—the USDA will not take scribe how the new variety differs from it that action. In the United States, IP protection • list a group of varieties that are similar to for plants is provided through plant patents, PVP, the new variety and describe how it differs and utility patents. Plant patents provide protec- from varieties within that group tion for asexually reproduced (by vegetation) va- • describe how the variety differs from all rieties excluding tubers. PVP provides protection other known varieties in the crop kind for sexually (by seed) reproduced varieties includ-

ing tubers, F1 hybrids, and essentially derived va- The PVP office maintains databases of both rieties. Utility patents currently offer protection public and private varieties of crops. The exam- for any plant type or plant parts. A plant variety iner uses these and other sources to determine can also receive double protection under a utility which, if any, varieties are indistinguishable from patent and PVP. the new one. If the examiner finds varieties that appear to be indistinguishable from the applica- 7.5 Contents of a complete application and tion variety, the applicant will be notified that exhibit forms supplemental data is necessary. To obtain addi- A PVP application consists of a completed and tional data, applicants may perform additional signed form that includes Exhibits A, B, C, and E field or greenhouse replications and may use (Exhibit D is optional): DNA profiling and other analyses to substantiate A) Exhibit A (Breeding History)

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B) Exhibit B (Statement of Distinctness, pre- or photographs (prints) of seed and plant com- viously called “Novelty Statement”) parisons that clearly indicate distinctness. C) Exhibit C (Objective Description) D)Exhibit D (Additional descriptive 7.5.3 Exhibit C: Objective Description of Variety Information) The PVP office has prepared forms for the appli- E) Exhibit E (Statement of Ownership) cant to provide a botanical description of the variety for most crops. These forms list the botanical Also required is a sample of at least 2,500 un- characteristics for a kind of crop and the degree treated viable seeds, capable of propagating the of expression of each characteristic. These forms application variety, and, for a tuber-propagated also provide a list of recommended varieties that variety, verification that a viable cell culture will the applicant should compare to the application be deposited. A check for the filing fee is also variety. The applicant needs to complete the form required. for his or her variety as thoroughly as possible.

7.5.1 Exhibit A: Breeding History 7.5.4 Exhibit D: Optional Supporting The applicant is required to provide the Information following: The applicant may provide additional informa- • full disclosure of the genealogy back to tion, specimens, and/or materials in support of publicly known varieties, lines, or clones, the claims of the application. including the breeding method • details of subsequent stages of selection and 7.5.5 Exhibit E: Statement of Ownership multiplication used to develop the variety The applicant is required to furnish a statement • statement of uniformity reporting the level for the basis of the applicant’s ownership. The of variability in any characteristics of the PVP office has prepared a form to simplify this variety (commercially acceptable variability requirement. The form also includes a statement is allowed) to verify that the applicant is eligible to file for • statement of genetic stability showing the PVP in the United States. number of cycles of seed reproduction for which the variety has remained unchanged 7.6 Steps needed to start and operate in all distinguishing characteristics a national PVP office • information about the type and frequency You may be reading this chapter because you are of variants observed during reproduction in the process of setting up a PVP office. If that and multiplication is the case, then the topics below will help you ef- • information about the frequency of off- fectively and efficiently establish the office. types (in other words, impure lines) ob- The basic operation of this office and its ac- served or known to occur tions can be translated into the following steps: 1. Setting up the office. The initial setting up 7.5.2 Exhibit B: Statement of Distinctness of the office will have a physical component The applicant is required to give a summary of (obtaining the necessary space, equipment, the variety’s distinctness, stating clearly how the and other physical resources) and a legis- application variety may be distinguished from all lative component (setting up the laws and other varieties in the same crop. If the variety is regulations, and examining guidelines). most similar to one variety or group of varieties, 2. Appointing the staff. A registrar for the the applicant must (1) identify these varieties and PVP office, a number of examiners, and state all differences objectively, (2) attach statisti- support staff, both clerical and technical, cal data for characters expressed numerically and will need to be appointed. demonstrate that these are clear differences and 3. Training the staff. The PVP office staff (3) submit, if helpful, seed and plant specimens needs to be trained in both the technical

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processes related to the examination and cation with senior policy-makers. The the legal and clerical matters related to is- act and regulations will need legislative suing and registering the certificate. action, and they must also be consistent 4. Establishing the formal procedure. The of- with other domestic laws. Regulations fice must set up formal procedures, such as will also often need to comply with WTO law enactment, rule approval, and exami- requirements. nation standards. 13. Storing deposits. Facilities must be 5. Notifying the public that the office is func- arranged for storing exhibits of the tional. Once the PVP office is functional, materials. staff must inform the public that they may 14. Preparing certificates. A format and style avail themselves of the services the office must be established for the production and provides. registration of PVP certificates. 6. Distributing information and application 15. Dealing with disputes. The legislation and material. As part of the public awareness regulations will usually contain provisions campaign, staff should make information allowing for applicants who are refused a and forms publicly available. In an increas- PVP certificate to appeal the decision either ing number of jurisdictions, application through the PVP office and/or through the forms are available online at the PVP office judicial system. Web site. 16. Sample deposits. An appropriate, adequate 7. Informing and educating the public system must be in place for applicants to about how to apply. Attorneys and agents deposit seed or plant materials. This facility may need to be educated about the actual may belong to the ministry of agriculture mechanics of preparing and submitting in most countries or may be managed by applications. a related organization. The facility should 8. Receiving application. The filing date is a meet appropriate international seed stor- critical component of the application pro- age guidelines and have adequate mecha- cess, and detailed rules should inform ap- nisms for safekeeping/security of the seed plicants about the application filing date. samples. 9. Reviewing the applications. This is the heart of the process. Applications are re- viewed (1) for compliance with general ap- 8. Conclusions plications standards and (2) for technical It is clear that a PVP regime effectively harmo- content. nized across different countries would significant- 10. Examinations standards and their applica- ly lower the costs for users, and hence increase re- tion. The 1991 UPOV act, the rules, and turns on plant-breeding investments. This would possibly the examiner’s manual provide an undoubtedly lead to more varieties and more objective set of standards that can be ap- choices for farmers. A costly regime, on the other plied to particular applications. The impor- hand, discourages smaller national companies tance of such objectivity for the credibility from filing for PVP protection and increases the of the system cannot be overstated. cost of participating in foreign markets that, in 11. Communicating with the client. Effective turn, favors large multinational companies with communication with the applicant is abso- the resources and infrastructure to operate across lutely essential. All correspondence must be multiple national regimes. consistently dated, numbered, and sent by All of the IP protection mechanisms dis- registered or certified mail. cussed in this chapter depend upon enforcement 12. Communicating with policy-makers. by national governments. If a law is only as good When establishing the office, it will be as its enforcement, then a regulatory body such crucial to keep in very close communi- as a PVP office is only as good as the people who

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implement the regulations. In order to reinforce 1 Blakeney M, JI Cohen and S Crespi. 1999. Intellectual national policy initiatives in many countries, a Property Rights and Agricultural Biotechnology. In Managing Agricultural Biotechnology. Addressing comprehensive, in-depth training program is Research Program Needs and Policy Implications (ed. JI recommended to equip personnel with the infor- Cohen). pp. 209-227. CAB International Press; Blakeney mation and experience required to establish the M. 1999. Agricultural Research and the Management long-term health of a PVP system. This training of Intellectual Property. In Managing Agricultural Biotechnology. Addressing Research Program Needs could be combined with a coordinated effort to and Policy Implications (ed. JI Cohen). pp. 228-40. CAB regionalize the PVP system through jointly train- International Press. ing administrators from a number of countries, 2 Modified from Helfer LR. 2002. Intellectual Property which would increase cooperation and harmoni- Rights in Plant Varieties: An Overview with Options for zation within the region. National Governments FAO Legal Papers Online, No. 31. www.fao.org/Legal/Prs-OL/lpo31.pdf. Of course, different people within the system 3 The initial PVP Act of the United States was not UPOV require different training. As a starting point, all compliant, but in 1980 the United States acceded to participants, whether officers, management, or UPOV 1978 and later to UPOV 1991. A further jump in even individuals in breeding companies, need to investment was seen after 1986 when the U.S. Patent be brought to a certain minimum level of com- and Trademark Office established that plant varieties were patentable subject matter. petence in the application of the regulations. A 4 Krattiger AF and RH Potter. 2002. The Status of Plant general program, such as a Web-based training Variety Protection Issues in the Asia-Pacific Region: An course or other distance-learning approaches, Overview. Asian Seed 9(5): 17–20. could help to achieve this goal. For management 5 Farmer’s exemption or farmer’s privilege should not staff, tailored workshops could be used to expose be confused with “Farmer’s Rights”. Farmer’s rights staff members to areas of conflict and to increase is a concept that became popular during the 1980s through the FAO Revised Undertaking for Plant their knowledge of the importance of PVP in the Genetic Resources (Resolution 5/89) in an attempt development of plant breeding businesses. These to recognize and reward the “…rights arising from courses and workshops could be augmented by the past, present and future contributions of farmers in conserving, improving and making available plant an internship program, in which selected indi- genetic resources…” (see www.fao.org/docrep/X0255E/ viduals would be given more intensive training x0255e03.htm for a detailed history). The term now through collaboration with public and private constitutes a central element in the International institutions from countries with well-established Treaty on Plant Genetic Resources for Food and Agriculture where it is called “Farmers’ Rights.” ftp:// PVP systems. These highly trained individuals ftp.fao.org/ag/cgrfa/it/ITPGRe.pdf.æ could form a core group that would then further develop staff expertise.■

John Dodds, Founder, Dodds and Associates, 1707 N Street NW, Washington., D.C., 20036, U.S.A. j.dodds@ doddsassociates.com

Anatole Krattiger, Research Professor, the Biodesign Institute at Arizona State University; Chair, bioDevel- opments-International Institute; and Adjunct Professor, Cornell University. PO Box 26, Interlaken, NY, 14847, U.S.A. [email protected]

Stanley P. Kowalski, Visiting Scholar, The Franklin Pierce Law Center, 2 White Street, Concord, NH, 03301, U.S.A. [email protected] or [email protected]

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