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DuPont Agriculture and Nutrition, Pioneer Hi-Bred, Crop Genetics Research and Development, 7300 NW 62nd Ave., Johnston, IA 50131
* Corresponding author (Stephen.Smith{at}Pioneer.com).
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ABSTRACT |
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 TOPNOTES ABSTRACT INTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Abbreviations: BSSS, Iowa Stiff Stalk Synthetic • DH, doubled haploid • EDV, essentially derived variety • IPP, intellectual property protection • PVP, plant variety protection • SSR, simple sequence repeat • UPOV, International Union for the Protection of New Varieties of Plants • v-GURT, variety Genetic Use Restriction Technology
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INTRODUCTION |
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TOPNOTESABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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From today's perspective, we might be forgiven if we interpreted 1930 as a year during which revolutions in agriculture were either in their infancy or still to occur. By that time, the first commercially developed maize (Zea mays L.) hybrid had only been on the market for three years; over 90% of U.S. maize acreage was still planted to open-pollinated farmer-developed landrace varieties. The structure of DNA would not be discovered for nearly a generation. Molecular markers would not be available for at least three decades. And, while H. G. Wells had raised the specter of a Martian invasion, space flight, and time travel; no one had considered the creation of transgenic plant varieties as being even within the realm of science fiction.
Henry A. Wallace (1923) was among the first to question whether the outward appearance of an ear of maize provided a reliable basis for determining yield potential of the seed. Wallace concluded that "the tendency of the judges [is] to emphasize length of ear, whereas Mother Nature ... lays her outstanding emphasis on weight of kernel." The decades-old tradition of saving the prettiest ears as sources of seed for next season's crop was found to be an ineffective way to select superior yielding seed and would soon be abandoned. Annual purchases of hybrid seed represented a radical change in tradition from the era of farm-saved seed. Farmers began to purchase maize seed on an annual basis because such expenditures represented sound investments, rather than because of any overt legal requirements relating to intellectual property protection (IPP). By the 1940s over 90% of U.S. maize was planted to hybrid seed. Business opportunities to engage in research and to produce hybrid seed stemmed from two sources: (i) the application of science-based knowledge to the development of increasingly superior products and (ii) the ability to protect intellectual property that was vested in seed created as an outcome of research. The former provides opportunities to generate useful products, while the latter encourages privately funded investments to support research and development.
The United States provides comprehensive subject matter that can be used to explore the practical effects of using various forms of IPP because a range of types has been used over the course of several decades. For example, the United States introduced patents for nontuberous vegetatively propagated varieties in 1930. In contrast, respect for trade secrets (Brown, 1986) formed the initial bases for intellectual property in U.S. maize agriculture. Today, IPP can be obtained for plant varieties by various means (Krattiger, 2004). A brief review of methods to obtain IPP is provided below. For more comprehensive treatments, the reader is directed toward Le Buanec (2004) and to Tripp et al. (2007) for global overviews and to Williams and Weber (1989) and Fernandez-Cornejo (2004) for detailed reviews of IPP in the United States. See also Ghijsen (2007) for a comparison of plant variety protection (PVP) regimes and Lesser and Mutschler (2004) for a detailed background on the concept of an essentially derived variety, an important component of more recently enacted PVP laws.
The most important means and elements of obtaining IPP for plant varieties can be summarized as follows (see Table 1 ). Under the auspices of the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS) within the World Trade Organization (http://www.wto.org/), countries may exclude plants and animals from patentability. In contrast, microorganisms and essentially biological processes for the production of plants or animals cannot be excluded from patentability. However, any country that does exclude plant varieties from patent protection is then obligated to provide an effective sui generis system of protection. Plant breeders started to advocate for a sui generis system in the 1940s and 1950s (Le Buanec, 2004). Two diplomatic conferences were held, in 1957 and in 1961. These resulted in the creation of the Union internationale pour la protection des obtentions végétales (International Union for the Protection of New Varieties of Plants [UPOV]; http://www.upov.int/). Today, UPOV prescribes the most widely used system to protect plant varieties globally, which is through the use of PVP. Under this system, national or community (e.g., the European Union) PVP laws enacted by legislatures follow guidelines provided by UPOV. To be eligible for protection under PVP, a plant variety must be distinct from all previous publicly known varieties, uniform, and stable, the so-called DUS criteria. Currently, two versions of UPOV, 1978 and 1991, are of primary importance (UPOV, 1996). These versions differ chiefly with regard to two aspects. The first is whether, to what extent, and under what conditions farmers can use harvested seed from protected varieties for resowing a future crop. The second aspect is in regard to the ability to declare a derived variety as essentially derived depending on its degree of conformity to an initial parental variety or inbred line. The 1991 revision of UPOV provides more effective IPP. For example, under UPOV 1991, farmer resowing of seed that is harvested from a protected variety can be restricted to "safeguard the legitimate interests of the breeder." Also, under UPOV 1991, when a variety is declared as essentially derived, it is then subject to ownership rights of the owner of the initial variety to which it is dependent. Further differences can arise as individual countries enact their national PVP laws. For example, India has enacted a PVP Act that provides lower levels of IP for plant breeders than does UPOV 1978. Also, the U.S. PVP Act of 1994 has been criticized because, in contrast to PVP laws in the European Union, the U.S. PVP Act does not require mandatory payment of royalties to breeders when farmers plant seed harvested from a variety covered by PVP. These disparities exist even though both U.S. and EU PVP laws are formulated on UPOV 1991.
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Although plant varieties per se are excluded from eligibility for patent protection in the vast majority of countries, including in the European Union, the scope of patent protection of a patented transgene can extend to the plant within which the transgene has been integrated. Thus, according to Article 8 of the European Directive on the Protection of Biotechnological Inventions and a decision of the Enlarged Boards of Appeal of the European Union in the "Novartis case," germplasm of varieties can be included in the scope of a patent claim so long as protection is not limited to a single variety (Le Buanec, 2004). However, some countries (France and Germany) have incorporated breeder exemption clauses in their patent laws. In contrast, in J.E.M. Ag Supply Inc. vs. Pioneer Hi-Bred International, the U.S. Supreme Court ruled Congress had no intent to preclude varieties of sexually reproduced species from eligibility for patent protection, thereby confirming U.S. practice of allowing both PVP and patents for plant varieties (Sease, 2006; Sease and Hodgson, 2006). Trade secrets and contractual law can also contribute to IPP. Biological systems, such as variety Genetic Use Restriction Technologies (v-GURTS), that repress germination of second generation seed could be used to provide IPP (FAO, 2001; Lence et al., 2005). A series of partially overlapping patchwork quilts may therefore provide an apt metaphor to describe the global coverage of IPP for plant varieties. Consequentially, the level of IPP that is available for plant varieties globally is neither consistent nor, in some cases, entirely predictable. Further differences can arise because the level of IPP available within individual countries is also dependent on the effectiveness of contract law, trade secret law, and the robustness of the judicial process itself.
Additional complexity arises because the effective level of IPP available to plant breeders is also influenced by the use of new technologies and changes in breeding practice (Donnenwirth et al., 2004; LeBuanec, 2004, 2005; Heckenberger et al., 2005; Lence et al., 2005; McConnell, 2004; Smolders, 2005; Kock et al., 2006; Smith et al., 2008). For example, transgenic approaches were developed during the 1980s that allowed new distinct varieties to be rapidly created from existing varieties (LeBuanec, 2004: Kock et al., 2006). Thus, under PVP laws enacted in accordance with the 1978 revision of UPOV, it is possible to "pirate" existing varieties, for example, through their conversion to herbicide or insect-resistant versions. Capabilities of making transgenic conversions of existing varieties provided the main impetus leading to UPOV 1991. The most important component of this revision of UPOV was the introduction of the concept of the essentially derived variety (EDV). According to UPOV (1996) a distinct variety is "deemed to be essentially derived from another variety (‘the initial variety’) when ... it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype of combination of genotypes of the initial variety ... and except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety."
Other approaches that could be used to undermine IPP using technologies and breeding strategies were already in place. Consequently, UPOV 1991 also took into account the potential impact of these approaches, as evidenced by the statement, "Essentially derived varieties may be obtained for example by the selection of a natural or induced mutant, or of a somoclonal variant, the selection of a variant individual from plants of the initial variety, backcrossing, or transformation by genetic engineering" (UPOV, 1996). As Bugos and Kevles (1992) noted, "The historical record makes indelibly clear that the current system has been produced by the melding of technical developments with economic and political forces." New technologies that could be used to further facilitate access to germplasm continued to be developed and used during the 1990s and into the next decade. For example, molecular markers can be used to preferentially select particular germplasm from existing varieties; selection can be directed toward specific chromosomal regions associated with important agronomic traits (quantitative trait loci; Johnson, 1998; Graham, 2007) and/or toward a specific level of overall genomic similarity to, or distance from, the initial parental variety.
Ultimately, the scope of discussions fomented initially by the question of how to implement the concept of EDV has broadened so that it extends to a more fundamental issue with regard to the field of plant breeding. The merits of particular forms of IPP per se are now under discussion (Bugos and Kevles, 1992; Janis, 2001; Janis and Kesan, 2001; Dhar, 2002; Kingston, 2002; 2007; Strauss, 2002; Donnenwirth et al., 2004; Koo et al., 2004; Lesser and Mutschler, 2004; McConnell, 2004; Chen, 2006; Janis and Smith, 2006; Kock et al., 2006; Moschini and Yerokhin, 2006, Sease and Hodgson, 2006; World Bank, 2006). These forms of IPP cover a wide range, from the very weak to the very strong. Starting with examples of weak IPP, Troyer and Rocheford (2002), for example, argued for a relatively high level of genomic similarity (90% plus) to establish EDV status coupled with a short maximum royalty term of five years. Further, they appear to advocate, in contradiction to UPOV 1991, that an EDV should escape ownership rights that stem from the initial variety and thus, itself, become eligible as an initial variety. Smolders (2005) acknowledged that technical advances can facilitate access to existing varieties but concluded that concern "should not be overrated" and, thus, no change in UPOV 1991 is warranted. Others have argued not only for a more effective PVP but also for global acceptance that plant varieties per se should be patentable (McConnell, 2004). It is also worth noting that the practice of IPP is not restricted to privately funded plant breeders situated in industrially developed countries. For example, Linares (2002) described conditions under which the Jola women of West Africa exchange rice varieties. Exchange of varieties is not free but, rather, only occurs when mutually agreeable and beneficial to both parties. Linares (2002) seems to be describing a traditional process of access and benefit sharing with prior informed consent. These practices predate the establishment of formal criteria for access and benefit sharing that have been formulated more recently under the auspices of the Convention of Biological Diversity (UN, 1993).
The goal of this paper is to examine the application of IPP in maize breeding. To do this, I first survey the relative breadth of germplasm diversity that formed the basis for genetic gain during the most recent five decades of the U.S. maize industry. Was genetic gain dependent on small incremental changes in germplasm constitution as suggested by Troyer and Rocheford (2002)? Alternatively, was genetic gain founded on more substantive germplasm changes? If progress in genetic gain was made primarily through making relatively small incremental genetic changes then this model of progress would fit the low IPP model as recommended by (Troyer and Rocheford, 2002). Alternately, if progress was founded on more significant genetic changes, then this approach represents a more unpredictable, risky, and resource demanding means of advancing productivity. Such an approach is more appropriately aligned with a stronger IPP model, one that is more effective at encouraging research and product development (Moschini and Yerokhin, 2006, 2007). Next, I examine the impact that concerted use of new technologies and breeding strategies can have in facilitating access to germplasm present in existing well-adapted and protected varieties or hybrids and their parental lines. I explore the implications of using these technologies to facilitate access and use of germplasm that is already well adapted and widely used in cultivation in relation to the establishment of an EDV threshold for maize. I discuss whether application of the EDV concept can effectively protect breeders' rights. Outcomes from these analyses provide information regarding the practical effectiveness of various IPP systems. I discuss how these IPP systems could be enacted in the context of a broader global system, including issues of conservation, benefit sharing and social welfare. Third, I review challenges to providing increased productivity that maize breeders will be called on to meet in the 21st century. Finally, I discuss options to provide an effective level of IPP to provide a global research and product development environment that will be commensurate with the requirements of investors and the needs of current and future generations to direct those investments toward the more effective use and stewardship of genetic resources. While this discussion focuses specifically on maize, I suggest that the implications apply more broadly to include other crop species.
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MATERIALS AND METHODS |
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TOPNOTESABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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RESULTS |
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TOPNOTESABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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Pedigree and Molecular Marker Measures of Similarity between Inbred Lines and Parents: Widely Used Public and Proprietary Inbreds 1980 to 2004
Eighty-four inbred lines were cited by Mikel and Dudley (2006, their Tables 3 and 4). Six (7%) are public inbred lines; three of these (A632, B73, Mo17) were also cited by Darrah and Zuber (1986). The complete lineage of seven inbreds listed by Mikel and Dudley (2006) are not traceable to public germplasm, at least by this author. Consequently the following synopsis refers to 77 inbreds listed in Table 2. For these inbred lines, the expected maximum contribution by pedigree from a single parent ranges from 6.25 to 96.88%. Among the 77 inbreds, the distributions of inbreds (percentage of 77 inbreds in parentheses) according to maximum expected contribution by a single inbred line on the basis of pedigree were 1 to 25% by pedigree (28%), 26 to 50% by pedigree (55%), 51 to 75% by pedigree (12%), 76 to 87.5% by pedigree (1%), and >88% by pedigree (4%).
Mikel and Dudley (2006) cited seven inbred lines as contributing "much of today's germplasm." The percentage expected contribution by pedigree for the main parental contributor(s) for each of these inbred lines is also given in Table 2. Contributions of the chief parental contributors by pedigree among these inbreds ranged from 6.25 to 50%.
Pedigree and molecular marker data were also further examined for Pioneer proprietary inbreds included in Table 2. Percent similarity of parents to progeny inbreds based on pedigree records ranged from 20% to 80% with a mean of 58%. Percent molecular marker (SSR) similarities between parents and progeny ranged from 57 to 87%, with a mean of 71% (Table 3 ).
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DISCUSSION |
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TOPNOTESABSTRACTINTRODUCTIONMATERIALS AND METHODSRESULTSDISCUSSIONCONCLUSIONSREFERENCES |
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The Degree of Genetic Change That Has Formed the Historic and Current Basis for Success in U.S. Maize Breeding
Troyer and Rocheford (2002) based their recommendation for a very low level of IPP on an analysis of a very small set of inbred lines. Indeed, their selection of inbred lines was purposely biased to demonstrate that small targeted genetic changes can affect important agronomic traits. By comparison, in this paper, I report on a more comprehensive sampling of inbred lines, one that is more inclusive and representative of inbred lines that have contributed to gains in U.S. maize productivity. A picture then emerges that shows use in most breeding crosses of a broader range of segregating germplasm diversity compared with that for each of the three inbred lines cited by Troyer and Rocheford (2002). For example, from among 14 public inbred lines identified as important by surveys initiated in 1956 and continued through 1984, 6 (42%) had pedigree backgrounds that were even more diverse than would be the case if they originated from single-crosses of two unrelated inbred lines. Of the remaining inbreds, 3 had pedigrees that were from single-crosses of unrelated inbred lines. Only 5 out of 14 (36%), had backcross pedigrees. Four of these involved B14 as a recurrent parent; the fifth had Oh43 as a recurrent parent. Both of these recurrent parents were bred from diverse pedigree backgrounds. When additional important U.S. maize inbred lines are examined, a similar picture emerges. From among 77 inbreds that are, or have been, widely used in the U.S. maize industry during the past 25 years, only a small minority (13%) has pedigree relationships of greater than 51% to a parental line. For the seven inbreds cited by Mikel and Dudley (2006) as being the most widely used in the U.S. maize industry, none has a pedigree more than 51% related to a parental inbred line. To directly compare with pedigree relatedness, marker similarity percentages need to be revised upward to take into account the approximately 35% of SSR alleles that are monomorphic by chance among unrelated individuals. On this basis, for example, a level of 75% similarity for segregating loci translates to [(65 x 0.75) + 35] = 83.75% SSR allele similarity. And consequently, a value of 71% SSR allele similarity, when measured over both segregating and nonsegregating loci, equates approximately to a cross where inbred lines are only 54% related by pedigree: [(65 x 0.54) + 35] = 70.75. Marker data therefore corroborated pedigree data in showing that germplasm similarities between inbred progeny and their parental lines are far less close than would be expected from a single backcross.
The making of relatively small genetic changes, although important, is not a strategy that accurately represents the pedigree backgrounds and breeding strategies that have contributed to the development of most of the widely used U.S. inbred lines bred during the past five decades. More significant genetic changes have, for the most part, been created using a broader base of segregating germplasm for the majority of parental crosses. Breeding with a greater base of segregating germplasm is inherently less predictable in its outcome and requires more resources and thus engenders more overall risks than does the making of relatively small genetic changes involving backcrossing. Backcrossing has demonstrably been used to create inbred lines that have significant agronomic improvements for several traits. However, the creation of both recurrent and nonrecurrent parents in the first instance, a prerequisite for backcrossing, also depends on the availability of parents that collectively span a relatively broad germplasm or pedigree base.
Change in the Effective Level of Intellectual Property Protection
The effective level of IPP available to maize breeders in the 1920s and during the decades immediately following was relatively high. Indeed, the availability of IPP for maize inbreds and hybrids predated the first legal instrument for IPP that was enacted by the U.S. Congress, the U.S. Plant Patent Act of 1930. The strength of IPP during the initial decades of hybrid maize breeding in the United States stemmed from two factors. First, farmers decided to purchase new seed annually, largely because the yield potential of harvested seed, when replanted, was significantly reduced compared to F1 seed. The importance of F1 vigor to effective IPP remains unchanged. Second, breeders of hybrids had the capability to maintain parental inbred lines as trade secrets. Maize breeders reportedly respected private property vested in inbred lines with seed exchanges occurring through "gentlemen's agreements." There was an unwritten code of ethical conduct and business practice regarding ownership of the products of privately funded research (proprietary inbred lines) that endured, at least during several decades following the introduction of hybrids (Brown, 1986). In addition, competitors were reluctant to breed from commercially available F1 hybrids bred by others because, first, pedigrees were also maintained as trade secrets, and second, if those pedigrees were not aligned with the heterotic group assignations of inbreds in one's own breeding program, then the introduction of such materials could disrupt product development (Betrán et al., 2004)
Conditions relating to access and use began to change during the 1980s, facilitated by advances in molecular markers and breeding technologies coupled with greater routine use of off-season nurseries. These technologies collectively facilitated the direct use of inbred parents of commercial hybrids by breeders in other organizations in circumstances whereby those inbred parents were not protected by utility patents (Garing, 2000; Larkins, 2000). The use of isozyme electrophoresis, which by present-day standards is a relatively crude molecular marker technology, greatly facilitated identification and use of parental seed. Further development of molecular markers continued during the 1990s and 2000s, greatly increasing the analytical speed, genomic coverage, and discrimination power of these technologies. Simple sequence repeats or single nucleotide polymorphisms now allow marker profiles of both inbred line parents of hybrids to be generated directly from F1 hybrid grain (Wang et al., 2001). Breeders can therefore view competitor hybrids directly in terms of the genetic makeup of their proprietary inbred parental lines.
Through the generation of doubled haploid (DH) progeny, maize breeders can rapidly reselect both the female and the male germplasm from hybrids (Frisch and Melchinger, 2006; Smith et al., 2008). Another postulated approach to re-creating hybrid germplasm is by "reverse-breeding" a hybrid by creating inbred lines that are new recombinations of the hybrid parents, but which, when crossed, re-create that hybrid (Dirks et al., 2003; Van Dun et al., 2006). Progeny equivalent to one backcross similarity of to the recurrent parent can be created within the first generation of progeny created using doubled haploidy (Smith et al., 2008). In an array of 180 DH progeny developed from an F1 hybrid, we found one individual that was 88.4% similar in marker profile to a parent of the initial breeding cross (Smith et al., 2008). Doubled haploid selections are homozygous at all loci and so are immediately available for test crossing. Coupling DH and marker technologies with the use of off-season nurseries provides powerfully synergistic tools that give unprecedented capabilities to extract and use parental germplasm from hybrids. These technologies can be used to facilitate germplasm access as long as the only form of IPP that is used does not restrict access for further breeding. In this light, the breeder exemption clause, whether in PVP or when implemented as a component of patent law, rather resembles an Achilles heel for IPP of germplasm. Consequently, the added level of protection that utility patents can provide by virtue of restricting unlicensed access during the life of protection, when enacted without a breeder exemption, was found to be very important and has become widely used by maize breeders in the United States. However, the United States is one of only three countries in the world that allow utility patents on varieties per se; it is the only major maize-producing country that allows such an effective form of IPP. Consequently, it is PVP, or some other form of sui generis approach, that prescribes the IPP environment for plant breeders in the vast majority of countries. And even within the United States, the breeder exemption of PVP can effectively impinge on IPP provided by a utility patent because, depending on patent claims, it could be possible to introduce into the United States progeny bred from a variety that is patented in the United States but which is also sold and accessed for further breeding in another country via the relevant exemption clause of PVP.
Future Challenges for U.S. Maize Breeders
The contributions to increased productivity that U.S. maize breeders have generated through genetic gain are well documented (Castleberry et al., 1984; Duvick, 1977, 1984; Russell, 1991; Duvick et al., 2004). Roughly half of the gains in U.S. maize productivity that were achieved during the 20th century were dependent on genetic changes wrought by plant breeding. Impressive as this record is, it will need to be surpassed to equip U.S. maize agriculture with the genetic technologies required to continue further increases in productivity. The proportions of gain that will be required from genetic changes rises as productivity gains from chemical control of pests, diseases, and weeds plateau or decline, as yield gains from fertilizer application plateau or decline, and as varieties with increased resistance to abiotic stresses are needed.
Future genetic gains will require more effective use of a broader germplasm base, including unadapted and relatively uncharacterized landraces. Continued recycling of inbred lines reduces genetic diversity (Hallauer and Miranda, 1988; Taller and Bernardo, 2004). Additional studies by Mikel and Dudley (2006) and Smith (2007) indicate that the breadth of the U.S. maize germplasm base has narrowed during the past 25 years due to a confluence by several breeding organizations toward access of germplasm that was already widely used and well adapted to the United States. Indeed, Lu and Bernardo (2001) stated: "We therefore speculate that exploiting other germplasm pools or utilizing exotic germplasm is necessary for sustaining breeding progress in maize." It is inconceivable that maize breeders will be able to meet future challenges to increase productivity by continuing to achieve continued genetic gain if they rely only on germplasm that is already well adapted to the United States and which is situated even further toward the ever-narrowing confines of a pyramidal apex. Furthermore, McConnell (2004) anticipated that a "trend of minimal public sector funding for developing commercially available varieties will likely continue." All of these factors lead to the conclusion that much more will be expected of private sector commercially funded U.S. maize breeders in the future than at any time in the past.
What Is an Effective Type or System of Intellectual Property Protection for U.S. Maize Breeding?
Is Application of the Essentially Derived Variety Concept under Plant Variety Protection Sufficient?
Many discussions have addressed the threshold of similarity that would provide the basis for identifying inbred lines or varieties that could be considered as potential EDVs (Smith and Smith, 1989; Troyer and Rocheford, 2002). Based on their argument that continuous progress in breeding can be made in small increments, Troyer and Rocheford (2002) recommended an SSR marker similarity threshold for maize inbreds of >95% to denote EDV status. In contrast, the International Seed Federation (2007) proposed that similarity based on SSRs from 82.0 to 89.9% denote possible EDV status with a similarity of over 90% being a strong indication of EDV status. Data presented here demonstrate that gains in U.S. maize productivity have been dependent on more significant genomic changes than was the case for the examples cited by Troyer and Rocheford (2002). The scenario presented here suggests that an EDV threshold of 82.0% similarity on the basis of SSR profile comparisons should be considered as a relatively high threshold for evidence of EDV status; a lower threshold of SSR similarity to denote potential EDV status would provide more effective IPP.
Weak IPP systems allow competitors to simultaneously benefit ("free-ride") from research initially performed by privately funded developers. A lack of effective IPP therefore causes the level of subsequent research investments by individual private sector organizations to be reduced or to even stop. The flow of new, more productive varieties that are developed by the private sector slows and genetic diversity in farmers' fields narrows, thereby making agriculture potentially more vulnerable to inclement weather and attacks by pathogens. Such a low standard IPP environment exists when it is based solely on PVP as provided for under UPOV 1978. What is the situation under UPOV 1991? More specifically, can application of the EDV concept reinstate IPP for germplasm of parental inbred lines to the level that existed when PVP was initially introduced?
Lesser and Mutschler (2004) concluded that the UPOV EDV system as it is currently conceived cannot redress the loss of protection resulting from modern breeding practices because it can be too easily evaded and thus, it is inherently flawed. Molecular marker data describe genomic regions associated with important agronomic traits, and they can be used to preferentially select for those regions in the creation of new derivatives (Johnson, 1998; Graham, 2007). Molecular technologies could be used to evade EDV by providing the capability to select progeny that fall just below any predetermined EDV threshold while still extracting the essential genetic components of competitor germplasm. Kock et al. (2006) noted: "The current PVP system encourages low-risk and inexpensive use of existing plant varieties with well-known characteristics. This leads to small genetic changes or combinations of already existing characteristics. On the other hand, the high risks and expense of screening land races for new characteristics is hard to justify given that competitors can obtain unrestricted use. This is a real obstacle to sustained advances in plant breeding." Consequently, breeding programs that are engaged in forward breeding and that do not use patent protection are vulnerable to others who focus on using new varieties as templates for the relatively rapid creation of "look-alikes." These look-alike varieties can be available on the market within three to five years of commercialization of the initial variety and can be sold at a lower price because of free-riding on the initial research costs. Therefore, an inherently stronger form of protection involving a temporary suspension of the breeder exemption, or more global acceptance of utility patent protection for varieties per se, is required (Donnenwirth et al., 2004; McConnell, 2004; Moschini and Yerokhin, 2006).
Is Utility Patent Protection Alone Sufficient?
Maize breeders in the United States have the option of applying for utility patent protection and also for a sui generis form of protection. However, it is realistic to suppose that PVP will continue to provide the IPP environment that will be a crucial factor determining the level and area of engagement by the private sector in plant breeding for most countries and for several decades ahead. Consequently, a revised PVP system that is strengthened to encourage continued investments into the development of improved germplasm has a very important role to play. The future importance of such a revised form of PVP is applicable to countries that allow patenting of traits but with a breeder exemption. A revised PVP system is also applicable to a country, such as the United States, that does not incorporate a breeder exemption in its patent laws. The future potential relevance of a revised PVP system to the United States relates to the patentability criterion of unobviousness. If, in the future, higher standards of unobviousness are required to meet patentability criteria, such as requiring the detailed characterization and elucidation of genetic control mechanisms and physiological pathways, then the very complexity of many genetic and physiological processes that contribute to harvestable yield might cause the scope of germplasm diversity that is currently eligible for patent protection in the United States to be narrowed. Discovery of the genetic control of physiological pathways should obviously be encouraged. However, the inherent intractability of fully understanding the genetic basis of agronomic traits should not serve as an obstacle for creating incentives to invest in germplasm development to improve agronomic performance. Thus, encouragement of research investments into plant breeding will require a balanced approach, one that includes both patenting and a strengthened sui generis system. An over-reliance on patenting could risk putting a premium on investments into relatively narrow areas in which a basis of scientific understanding already exists. For example, Bugos and Kevles (1992) note that "The greater the degree of specificity and control, the stronger the incentive for private breeders to invest in innovation, because they could define it and thus seek to protect and enforce their rights in it." However, important agronomic traits such as yield are controlled by numerous genes that exhibit complex interactions (Song et al., 2007). Even characteristics such as plant height in maize, which are considered to be under relatively simple genetic control, are associated with at least 20 genetic regions (Lubberstedt et al., 1997). Namkoong et al. (2004) also argue for an intellectual property environment that is more broadly supportive of germplasm improvement through plant breeding; they warn that "it is critical that this technology [biotechnology] not replace or even limit the expansion of more traditional breeding activities. Biotechnology firms create a situation where investors require almost immediate returns. Globally, this may be at the expense of longer-term returns that will arise from investments in different types of pre-breeding, breeding, testing and selection efforts that are needed." Consequently, PVP that is revised to be made more effective, and indeed simpler to enact through a revision of the breeder exemption clause, could provide additional incentives to access a broader base of germplasm and be a complement to patent protection.
An Intellectual Property Protection Environment for the Twenty-first Century
As Lence et al. (2005) noted, "The agricultural seeds market tends to be unique in that, unlike the medicinal sector where the customer usually consumes the newly developed technology directly, the seed customer is a farmer who sells the resulting crop from the newly developed technology into a competitive market.... Yield improvements brought about by research and development encourage the farmer to utilize the newly developed hybrid/variety, but may or may not improve the overall welfare of the customer farmers in aggregate if the research and development firm is able to capture the greater amount of the benefits." There is therefore a sense of balance that must be sought for IPP in respect to generating welfare benefits. For example, if IPP could be continued indefinitely, then a great deal of power could potentially rest in the hands of a single research and development firm. Such a concentration of power might then stifle development by others, restrict the addition of technologies or germplasm to the public domain, and provide overly strong bargaining power in pricing. Alternatively, if the level of IPP is relatively weak, then there could be insufficient encouragement to invest in the research and development required to introduce new technologies or new germplasm. A low level of IPP would result in failures to improve productivity and could put the existing well-adapted germplasm base at risk.
McGuire (1997) noted that the endeavor of plant breeding exhibits "path-dependence." Progress along a new path, such as the use of exotic germplasm, places high costs and risks on the initial breeder. The initial breeder provides an eventual public good by adding new diversity and reducing risks for all subsequent breeders who use that increasingly well characterized and well adapted germplasm. Smolders (2005) argued that stronger IPP is in conflict with facilitating access to germplasm, as evidenced in the title of his paper: "Plant Genetic Resources for Food and Agriculture: Facilitated Access or Utility Patents on Plant Varieties." Troyer and Rocheford (2002) argued for a very low level of IPP on the basis that maize inbred lines that exhibit significant performance improvement can be developed through the making of relatively small genetic changes from at least one of their parental lines. However, the current, more comprehensive survey of maize inbred lines that have contributed sustained gains in productivity shows that more significant genetic changes provided the basis for improved U.S. maize productivity. Future needs will require use of an even broader range of genetic diversity, and much of that genetic diversity will be even more resource demanding to use. Someone, or some organization, must first take the initial, time-consuming, and risky steps to access exotic germplasm; otherwise, there can be no access and consequently, no benefits. As public investments in the evaluation and use of exotic germplasm decline, the private sector becomes increasingly important as a resource to develop new well-adapted genetic materials. Effective IPP is therefore an increasingly important and necessary means to encourage greater participation by the private sector in their use of a broader base of germplasm. Unless the path is initially trodden, there can be no path dependence. However, overly facilitated access to well-adapted, already widely used germplasm undermines any willingness to take the initial steps that are required to breed with a broader germplasm base (Kock et al., 2006; Smith, 2007).
Sneller (2003) raised concerns that incentives provided by utility patents have led to isolation among germplasm pools for U.S. soybean [Glycine max (L.)] breeders. However, an alternative interpretation is that such a situation reflects the creation of initial germplasm paths that collectively encompass greater genetic diversity than does any single path (breeding program). Concerns that further potential genetic gains might be lost due to isolation among these germplasm pools can be assuaged when one remembers that all of the patented varieties will be placed into the public domain when their period of protection expires. This latter perspective reflects the importance of achieving an appropriate balance between germplasm access and incentives for private sector plant breeders to invest into research and product development. In this respect, it is important to consider access more broadly, not only in respect to access to germplasm of varieties that are already widely used and well adapted, but also in terms of increasing access to exotic, unadapted, and little characterized germplasm—activities that are inherently more risky and resource consuming. Lence et al. (2005) also examined the aspect of balance in IPP systems from an econometric perspective. They concluded: "Our results suggest that the optimum level of IPP is greater than that which existed in the North American seed corn market in 1996 and 1997, but that it is lower than that would exist if v-GURT's were to become widely used." In other words, the level of IPP provided by utility patents in the United States is slightly suboptimal in terms of providing maximum social welfare. It then follows that the level of protection afforded by PVP must be far below the optimal. Likewise, utility patent protection when enacted with a breeder exemption clause also falls far below the optimal level of IPP.
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Plant breeders should be able to apply for the form(s) of IPP they deem appropriate or adequate. A revised UPOV could be improved by providing assured access for further breeding to commercially available varieties that include IT germplasm (germplasm accessed under the conditions of the standard International Treaty for Plant Genetic Resource for Food and Agriculture) during the life of their protection, an option for a phased-in breeder's exemption with mandatory royalties to the IT for the period when varieties derived from IT germplasm are not publicly available for further breeding, assured access to all deposits after protection expires, a standardized royalty collection for farm-saved seed of protected varieties with a percentage of the proceeds used to support global germplasm conservation, and an international filing system similar to the Patent Cooperation Treaty. Increased demands are already being made on maize breeders to further improve productivity; future demands will surely be still greater. Demands that will be made on privately funded maize breeders can only be met in an IPP environment in which they can conduct research and product development programs at the level of risk, persistence, and innovation to introduce new improved germplasm from exotic sources into agriculture.
Finally, what are the trends in investments in U.S. maize breeding and for the genetic diversity of U.S. maize germplasm? Does an increase in privately funded research and product development directed to maize provide evidence that the existing IPP environment is sufficiently adequate to encourage germplasm development per se? Data on research investments (in constant 1996 dollars) for the period 1960 to 1995 (from Fig. 14 of Fernandez-Cornejo [2004]) show annual public expenditures at $220 million, increasing to a maximum of $320 million and falling to $250 million. This same period saw an increase in U.S. privately funded research in plant breeding and biotechnology from $35 million in 1960 to $550 million (1996 dollars); as of 1995, 34% of these private research dollars was directed to maize. However, much private expenditure is directed toward biotechnology, ranging by company from 11 to 100%, with a mean per company of 37%, (Table 27 of Fernandez-Cornejo [2004]). With regard to genetic diversity of U.S. maize, there has been no survey of U.S. maize hybrid diversity since the 1989 harvest (Smith et al., 1992). Pedigree data for inbred lines indicate that genetic diversity for U.S. maize may have narrowed during the last 25 years because several major companies have focused on sourcing their breeding materials from a common source of well-adapted germplasm (Troyer, 2004; Mikel and Dudley, 2006; Smith, 2007). A molecular marker survey of maize genetic diversity currently used on U.S. farms is needed (Mikel and Dudley, 2006). These data could then help determine whether, and to what extent, U.S. maize breeders have, so far at least, taken advantage of the existing level of IPP to expand the adapted germplasm base. These data are also necessary prerequisites for establishing the baseline from which genetic diversity in U.S. maize agriculture can be monitored in the future.
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Received for publication August 2, 2007.
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