Current Status of Patents for Plants

Patents for Plants: Context and Current Status
Jim M. Dunwell

School of Biological Sciences, University of Reading

Whiteknights, Reading RG6 6AS

United Kingdom

Keywords: transgenic, transformation, genetic modification, intellectual property, horticulture
Abstract

One of the important themes in any discussion concerning the application of genetic transformation technology in horticulture or elsewhere is the role of Intellectual Property Rights (IPR). This term covers both the content of patents and the confidential expertise, usually related to methodology and referred to as “Trade Secrets”. This review will explain the concepts behind patent protection, and will discuss the wide-ranging scope of existing patents that cover novel genotypes of plants as well as all aspects of transgenic technology, from selectable markers and novel promoters to methods of gene introduction. Although few of these patents have any significant commercial value there are a small number of key patents that may restrict the “freedom to operate” of any company seeking to exploit the methods in the production of transgenic varieties. Over the last twenty years, these restrictions have forced extensive cross-licensing between ag-biotech companies and have been one of the driving forces behind the consolidation of these companies. Although such issues may have limited relevance in the horticultural sector, and are often considered to be of little interest to the academic scientist working in the public sector, they are of great importance in any debate about the role of “public-good breeding” and of the relationship between the public and private sectors.

INTRODUCTION

The present and future status of genetically modified (transgenic) crops has been the subject of several recent reviews (Dunwell, 2000, 2002, 2004, 2011). Although these reviews have included some information extracted from patent databases this analysis has been necessarily limited in scope. The present review will supplement the information published previously (Dunwell, 2005, 2006) and will extend to a discussion of intellectual property from the perspective of the research scientist (Shear and Kelley, 2003) and of those interested in international developments (Koo et al., 2004), globalization (Parayil, 2003) and the more general ethical aspects of the public- and private-sector relationships (Hails, 2004).
HISTORICAL PERSPECTIVE

More than a century ago in July 1899 an international conference organised by the Royal Horticultural Society (RHS) was held in London. The subject of the conference was hybridisation and during the many speeches given at the banquet was one by the leading British judge, Lord Justice Lindley (Anon. 1900). In this address he made the following prediction:- “I have heard something about hybridisation of which I know little. I have heard something which leads me to suppose that the development of that art may react with the profession to which I have the honour to belong. Without being a prophet, I seem to see before me a vista of patent hybrids! What a treat for the patent lawyers! And what an accession of work for her Majesty’s Judges!”.

By 1906, the emphasis on patents had already been demonstrated in the chemical sector where it was reported (Anon. 1906) that “the German company Baeyer had achieved a monopoly position in novel chemicals, with 1000 patents at home and 1200 overseas”. However, the first real discussion of patents in relation to plant breeding is probably that from the subsequent Third International Conference on Genetics, organised by the RHS in 1906 and most famous for the coining of the term “genetics” by William Bateson (Dunwell, 2007). During this meeting, there was a session entitled:- “Copyright” for Raisers of Novelties (Anon. 1907). It is reported that Mr George Paul whilst remarking on the absence of several well known plant breeders, stated “The fact is, these gentlemen do not like to tell us, or to show, what they have done in their experiments, because once their knowledge become public, they have not the slightest chance of receiving any pecuniary reward for their labours. If they were properly protected from being deprived of the due reward of their labours, they would no doubt be much more willing to come forward and help us and place their experience at our disposal”. During discussion, Professor Hanson responded “I believe, in law, a seedling is regarded as the gift of God, and it would be hard to patent that; but could we not hope to have some law fashioned that would give a bonus to the man who does such skilled and valuable work as that which has come before us over and over again during the sessions of this conference”.

The chairman of the session, whilst sympathising with the Mr Paul, concluded that it would be unwise to pass a resolution on the subject since the discussions had demonstrated “What very great difficulty there would be in enforcing such a law, because we have gentlemen from all parts of the world maintaining that a thing is new, and others, equally capable, maintaining that it is old”.

Following these early prescient comments and debates, it was to be several years before any legal protection for plants was enacted, and then only for clonal material in the USA. The first US plant patent (PP00001) was issued to for a climbing rose in 1931 (Cook 1931a). This was soon followed by further examples (Cook, 1931b; 1933). It is notable that even in those days the topic remained the subject of controversy from both scientific and legal experts (Allyn, 1933; Barrons, 1936; Cook, 1936; Fay, 1937). Much of the debate today, almost 100 years after the first discussion, follows the same themes.

WHAT ARE PATENTS?

The history of patent law dates back several centuries, but in summary, "A patent gives an inventor a period of exclusive exploitation (up to 20 years in the UK) in return for a disclosure of the invention" (Huskisson, 1997). According to the UNCTAD site (http://www.iprsonline.org/guide/index.htm) a patent application must satisfy the patent examiners that the invention is:

- useful (i.e., has industrial application): ideas, theories, and scientific formulas are not sufficiently useful or industrially applicable to be patentable;

- novel: the invention should be recent and original, but perhaps most importantly it should not already be known (in the public domain). In most countries (except the USA) the patent is awarded to the first person to apply, regardless of whether this person was the first to invent;

- non-obvious or must involve an inventive step: not obvious to a person skilled in the technology and more inventive than mere discovery of what already exists in nature (such as a gene with no known function). The invention must be disclosed to the patent examiners in a detailed way that would enable a skilled technician to make and use it. In the case of an invented process, the patent can cover a non-obvious way of making something already known (i.e., previously invented or discovered). In the case of an invented product, the non-obvious/inventive step requirement does not require it to be made by a novel method.

This disclosure of an invention takes the form of a publication from the relevant patent office. In the case of most authorities, the patent application is published 18 months after the date of filing and it is then available for inspection. Exceptionally, until 15^th March 2001, the US maintained secrecy until the time the patent was granted, a period which can range from an average of 2-3 years upwards to more than 20 years. As an example of the length of time sometimes involved, it took approximately 20 years for resolution of a dispute concerning key patents which cover elements of Agrobacterium-based transformation. Under the agreement, announced on 4^th Feb 2005, Max Planck Society, Bayer CropScience, Garching Innovation, and Monsanto will cross license their respective technologies worldwide. Bayer CropScience, Max Planck’s exclusive licensee, and Monsanto will provide each other, in selected areas of the world, non-exclusive licenses related to the development, use and sale of transgenic crops. Monsanto will also provide Max Planck Society with a license in the United States for research purposes.

An important difference between the US and other patent systems is that the 17 year duration of a US patent filed prior to 2001 only starts from the time at which it was granted, whereas in Europe (and now in the US) the 20 year period of exclusivity starts from the time of filing the application. Some of the consequences of this change will be discussed in more detail below.
SOURCES OF PATENT AND OTHER RELEVANT INFORMATION

During the preparation of this review extensive use has been made of the freely available patent databases in the US (http://www.uspto.gov/patft/index.html), Europe (http://ep.espacenet.com/), World International Patent Organisation (http://pctgazette.wipo.int/) and other international sites (eg http://www.surfip.gov.sg/; http://www.google.com/patents; http://www.freepatentsonline.com/; http://www.pat2pdf.org/) and the Patent Lens section of BiOS, Biological Innovation for Open Society, an initiative of CAMBIA (Center for the Application of Molecular Biology to International Agriculture) (http://www.bios.net/daisy/bios/patentlens.html). A very useful site with a summary of granted US ag-biotech patents from 1976-200 is provided by the Economic Research Service (ERS) of the US Department of Agriculture (USDA) (http://www.ers.usda.gov/Data/AgBiotechIP/). It should be noted that the most detailed forms of patent analysis require commercial subscription from companies such as Derwent (http://www.derwent.com), MicroPatent (http://www.micropat.com/static/index.htm), or patentmaps.com (http://patentmaps.com/shop/v2/shophome.htm).

PATENTS AND PLANT BIOTECHNOLOGY

Apart from the natural genetic protection provided by F₁ hybrids (Duvick, 1999), there are a range of legalistic methods that can be used to protect novel types of plants produced by one company from being exploited by commercial competitors, with these methods varying from one country to another (Cahoon, 2000; Locke, 2007). An introduction to the various approaches, namely plant breeders rights (Chen, 2006) and patents (known collectively as Intellectual Property Rights – IPR), is available from several authors (Brown, 2003), and from BiOS (http://www.bios.net/daisy/bios/patentlens/tutorials.html).

Information relating to individual countries is available at the respective patent offices. For example, the latest note on patenting of plants in the UK “Examination Guidelines for Patent Applications relating to Biotechnological Inventions in the UK Intellectual Property Office” was published by the Intellectual Property Office in November 2006 (http://www.ipo.gov.uk/biotech.pdf). Similar information is available concerning the patentability of plants in the US (Merrill et al., 2004), Europe (Fleck and Baldock, 2003; Schrell et al., 2007), New Zealand (Ministry of Economic Development, 2002) and China. Additionally, the results of a detailed survey of actual practice of patent examiners in the three key patent offices, US, Europe and Japan has been published (Howlett and Christie, 2003). In a complementary study restricted to the present and future position in the US (Merrill et al., 2004), the authors conclude that the continuing high rates of innovation suggest that the patent system there is working well and does not require fundamental changes (Ryder, 2005), although they note that both economic and legal changes are putting new strains on the system.

There have been several, extensive reviews of the consequences, and implications of applying patent (and other IPR) protection to plants (Farnley et al., 2004; Adcock, 2007) and the reader is referred to these publications, most of which are freely available on the web. In one of the most comprehensive of these reviews (Binenbaum et al., 2003), the important conclusion is reached that as patenting becomes even more prevalent in biotechnology (Chapotin and Wolt, 2007; Wright, 2006; Wright and Pardey, 2006a) and elsewhere (Straus, 2007), the diversity of innovations utilized in developing modern cultivars means that the number of separate rights needed to produce a new innovation proliferates (Tokgoz, 2003). Where ownership of relevant rights is sufficiently diffuse, the multilateral bargaining problem can become impossible to resolve. For example, those who develop new technology by building on existing technologies often know neither the extent to which the latter have been claimed as IP nor the strength of any claims. Both the conduct of research and development and subsequent commercialization therefore entail navigating through a potential minefield of patent applications that have been filed but remain invisible pending publication by the patent office. Fortunately, the uncertainty arising from such “submarine” patents is becoming less important as the US has harmonized with the rest of the world, first by awarding a patent term of 20 years from the date of filing (previously 17 years from the date the patent was awarded), and secondly by publishing (from November 2000) patent applications within 18 months of filing.

Despite the complexity of biotechnological IPR (Eisenberg, 2006; Kukier, 2006), and the difficulties of making accurate perdition over extended time scales (Yerokhin and Moschini, 2007) it should be noted that a similar position exists in the electronics industry where products are assembled from numerous internationally sourced components covered by a multiplicity of patents.

PATENTS AND PLANT TRANSFORMATION

During the period since the production of the first transgenic plants a wide diversity of patents have been sought on all aspects of the process, ranging from the underlying tissue culture methods through to the means of introducing the heterologous DNA, and to the composition of the DNA construct so introduced (Dunwell, 2005; Pray and Naseem, 2005). It would be impossible to summarise all this information in the space available here; the amount of patent information available in the area of plant transformation can be judged by the fact that a search of the US application database alone for “transgenic plant” and “method” returned 5192 records on 6^th September 2007. Summaries of relevant recent granted patents and patent applications in the USA are given in Tables 1 and 2.
Table 1. Selection of US patents on transgenic plants published on 4 September 2007.

________________________________________________________________________

Number Company/Institution Subject

7,265,280 Senesco Inc. Senescence

7,265,278 Unknown Flowering

7,265,269 Bayer Bioscience Bt protein

7,265,267 CropDesign N.V. Cyclin-dependent kinase

7,265,266 University of Arizona Salt tolerance

7,265,265 Pioneer Hi-Bred International Galactomannan

7,265,264 Washington University Plant size

7,265,263 Iowa State University Tuber development

7,265,219 Pioneer Hi-Bred International, Inc. Dormancy promoter

7,265,207 Calgene Tocopherol synthesis

7,264,970 Univs. California, Oregon, Arizona Gene silencing

Table 2. Selection of US patent applications on transgenic plants published on 6 September 2007.

________________________________________________________________________

Number Company/Institution Subject

20070209092 CSIRO, BASF Vernolic acid

20070209089 Simplot Co. Marker-free transgenics

20070209088 Unknown Starch

20070209087 BASF Sugar and lipids

20070209086 Mendel Biotech Yield

20070209085 Monsanto Enzyme gene promoter

20070208168 (Monsanto) Bt proteins

20070207525 Genencor Phytase enzymes
For detailed analysis of several of the key areas under discussion, the reader is referred to detailed summaries published elsewhere, for example in the series of comprehensive CAMBIA White Papers (Mayer et al., 2004; Roa-Rodriguez, 2003; Roa-Rodriguez and Nottenburg, 2003a; 2003b), aspects of which will be considered below. Frequently, the main point of interest in these discussions is the coverage of the patent(s) in question. There are some well-known examples of patents with very broad coverage and this is often a topic of debate and the cause of concerted opposition. For example, European Patent 301749, granted to Agracetus (then a subsidiary of WR Grace & Co.) on 2^nd March 1994, is an exceptionally broad "species patent" which grants this company rights to all forms of transgenic soybean varieties and seeds - irrespective of the genes used or the transformation technique employed. Agracetus was purchased by Monsanto in April 1996, after which it withdrew its previous opposition to this patent. However, opposition continued from other companies and organisations and a hearing was finally agreed by the European Patent Office in May 2003, at which the patent was upheld, with the exception of Claim 25 covering plants other than soybean (http://www.european-patent-office.org/news/pressrel/2003_05_06_e.htm; http://www.european-patent-office.org/news/pressrel/pdf/bginfo_soya_e.pdf). The patent is due to expire in July 2008.

Transformation Methods

There are several techniques for the introduction of recombinant vectors containing heterologous genes of interest into plant cells, and the subsequent regeneration of plants from such cells. The two main methods are the use of Agrobacterium or the direct introduction of DNA on microparticles of metal, a technique known as Biolistics. The most extensive publication in this area is the CAMBIA White Paper (Roa-Rodrigues and Nottenburg 2003a) on Agrobacterium-mediated transformation. This document focuses on the patents directed to methods and materials used for transformation, mainly of plants, but also of other organisms such as fungi. It should be stressed that although much of the early development of this technique was performed in universities, most of the patents are consolidated in the hands of a few companies.

Patents and DNA sequences

Almost all the significant components of the constructs used in plant transformation have been the subject of patent coverage. These include the “effect gene” as well as its associated regulatory sequences, the selectable or screenable marker, and additional sequences that might be required for the subsequent excision of the transgene. This review does not cover details of the gene of interest and the reader is referred to other recent reviews that include summaries of the range of present and future transgenic crops (Dunwell, 2002, 2004).

Much of the debate in this area concerns the ability to apply for patents on DNA sequences of unproven function. There have been several attempts to do so, and the decisions on such applications have not been finalised. However, the fact remains that there is much useful sequence information available in patent databases and much of it is ignored by academic research scientists. Specifically, it is estimated that some 30-40% of all DNA sequences are only available in patent databases, since there is of course no obligation for commercial (or other) applicants to submit their sequences to public databases. Possibly, the best way to access this information is via the GENESEQ system, a commercial (Derwent) service, though free access to some patent sequence data is now available via the latest version of the Blast search system at NCBI.

Selection and identification of transformants

The production of transgenic organisms, including plants, involves the delivery of a gene of interest and the use of a selectable marker that enables the selection and recovery of transformed cells. This is necessary because only a minor fraction of the treated cells become transgenic while the majority remain untransformed. It has been estimated recently (Miki and McHugh, 2004) that approximately fifty marker genes used for transgenic and transplastomic plant research or crop development have been assessed for efficiency, biosafety, scientific applications and commercialization.

Selectable marker genes can be divided into several categories depending on whether they confer positive or negative selection and whether selection is conditional or non-conditional on the presence of external substrates. The most common strategy currently used for selection is negative selection, the elimination of non-transformed cells in conditions where the transformed cells are allowed to thrive. Elimination is often effected by treatment of cells with chemicals, (e.g. antibiotics or herbicides) in conjunction with a transgene that confers resistance or tolerance to the chemical through detoxification or modification of the chemical. A summary of the most important scientific aspects of such resistance genes has been published recently, together with an analysis of selected patents that relate to the most widely used ARMs (Roa-Rodriguez and Nottenburg, 2003b). Many of these marker genes are covered by patents or patent applications with the most thorough IP analysis available probably being that published on antibiotic markers and Basta resistance by CAMBIA (Mayer et al., 2004).

Promoters and other regulatory elements

Regulatory elements are crucial to gene expression in all organisms. The patent landscape of transcriptional regulators that are constitutively active, spatially active (e.g., tissue-specific), or temporally active (e.g., induced or active in response to a certain chemical or physical stimulus) has been well summarised (Roa-Rodriguez, 2003). In this review an assessment is presented of the possibilities for and limitations on further development of regulation of gene expression. Although the inventions protected by individual patents cannot be exactly the same, in certain cases there are patents that due to the breadth of their scope may encompass other protected inventions or there may be patents which share common features. Is this case, this review points out the juxtaposition of the different inventions and the possible room left to manoeuvre around the different entities in the field. It also needs to be taken into account that there are patents that while not totally directed to promoters may have an effect on gene expression control. This is the case for the restrictive reproductive technologies, for example, those termed as "Terminator" technologies, which may have a great impact on the use and development of methods to regulate the expression of genes related to plant reproduction and seed generation.

NOVEL PRODUCTS AND THE FREEDOM TO OPERATE

One of the issues of over-riding importance to all companies is whether or not they are free to commercialise any particular product (Lence et al., 2002). Such “freedom to operate” is determined by the status of any IPR that might cover the product in question and analysis of such IPR requires continuous (and therefore expensive) surveillance.

A well known example that can be used to demonstrate the complexity of this issue is "golden rice," a transgenic line enhanced for beta carotene (provitamin A) (Ye et al., 2000) and provides hope for alleviating the severe vitamin A deficiency that causes blindness in half a million children every year. It has been suggested that extensive patenting has hampered delivery of this rice to those in need since some forty organizations hold 72 patents on the technology underlying its production (Kryder et al., 2000). The range of patents covering various components of the pBin 19hpc plasmid used in the production of this rice include ones on the phytoene trait genes, the promoter sequences, the selectable marker and the transit peptide. This issue has now been overcome by a coordinated international programme designed to streamline the production and distribution of this material (http://www.goldenrice.org/). However, perceived problems with access to golden rice and essential medicines have stimulated debate within the US on the obligations of American universities to facilitate the provision of goods for the public benefit (Kowalski and Kryder, 2002; Phillips et al., 2004), an issue also considered below.

PATENTS AND COMMERCIAL CONSOLIDATION

Several summaries of this subject has been provided recently (Brennan et al., 2005; Bulut and Moschino, 2005, 2006; Chan, 2006; Schimmelpfennig and King, 2006). The latter authors conducted an analysis of agricultural biotechnology patents issued between 1976 and 2000, classified by their original patent holders and their 2002 owners. These data show how 95 percent of patents originally held by seed or small agbiotech firms had been acquired by large chemical or multinational corporations. Furthermore, none of the smaller firms acquired patents from the larger ones, and none of the patents changed hands among the different types of large firms. For instance, chemical companies retained all 651 patents for which they were the original owners, but also acquired 219 patents from agbiotech firms and 451 patents from seed companies. A related study of the role of patents in the pharmaceutical industry has also been published (Brusoni et al., 2005), together with a legal discussion of using IPR as collateral in trade (Dunn and Seiler, 2007).

PUBLIC AND PRIVATE SECTOR ISSUES

The most detailed review of this aspect of ag-biotech patents is probably that conducted by Graff et al. (2003) who summarised both the ownership of critical patents and compared the relative significance of the private and public sectors in each area of research relevant to the commercialisation of transgenic plants. The main findings of this review, and others (Heisey et al., 2005; Schimmelpfennig and King, 2006) are as follows. Six companies hold 75 percent of all agricultural patents and it has been suggested that such concentration exacerbates the challenge of delivering agricultural inventions to the neediest segments of the world's population. One solution could be the compulsory licensing of patented inventions that have failed to reach the neediest markets (see below for further detail). An alternative would be based on the fact that while the public sector holds less than three percent of all patents, it does have 24 percent of agricultural biotechnology patents, many covering genes of great potential interest. By exploiting these resources, universities and other public organizations therefore do have opportunities to deliver affordable biotechnological innovations (Morris et al., 2006).

Concern has also been expressed about the potential dangers (financial or otherwise) associated with the use of patented technologies by academic establishments (Kesselheim and Avorn, 2005). This is a complicated issue involving “experimental use exception” (Faye, 2005a,b), the policy that allows others to examine and test a patented discovery, but not to use it routinely.

Patents, Ethics and International Development

The moral aspects of transgenic plants have recently been considered (Myskja, 2006), and in a broader context, some people consider that the commercialization of biotechnology, especially research and development by transnational pharmaceutical and ag-biotech companies, is already excessive and is increasingly dangerous to distributive justice, human rights, and access of marginal populations to basic human goods (Shrader-Frechette, 2005). The various trends associated with these socio-economic aspects of ag-biotech development have also been reviewed (Parayil, 2003). Amongst the agencies involved, the various Consultative Group on International Agricultural Research (CGIAR) centres add value through selective breeding, and the superior varieties they generate are widely distributed without charge, thereby benefiting both developing and developed countries (Anon, 2001).

During the Gene Revolution, the situation changed, and much has been written over the last few years on the potentially deleterious effects of plant IPR on the freedom and commercial opportunities of farmers in developing countries (Bastuck, 2006; Chiarolla, 2006; Fukuda-Parr, 2006; Garrison, 2006; Hamilton, 2006; Wright and Pardey, 2006b). One of the major reasons that IPR have become an important factor in plant breeding (Lence et al., 2002) is through the greater use of utility patents (Summers, 2003; Kevles, 2007). Such patents have stimulated greater investment in crop improvement research in industrialized countries, but they are also creating major problems and potentially significant additional expense for the already financially constrained public-sector breeding programmes that produce seeds for poor farmers. For example, it has been calculated (Phillips et al. 2004) that developed countries spend about $5 in research and development for every $100 in agricultural output whereas developing countries spend only 66 cents.

Patents on biotechnology methods and materials, and even on plant varieties, are thus potentially complicating and undermining the collaborative relationships between international institutions. There is some concern that public-sector research institutions in industrialized countries no longer fully share new information and technology. Rather, they are inclined to patent and license and have special offices charged with maximizing their financial return from licensing (Brazell, 2000). Commercial production of any GM crop variety requires dozens of patents and licenses (see above). It is only the large companies that can afford to assemble the IPR portfolios necessary to give them the freedom to operate. Additionally, now, under the TRIPS agreement of the World Trade Organization (http://www.iprsonline.org/unctadictsd/docs/RB_Part2_2.5_nov02_fullpatents-updated.pdf), most developing countries are required to put in place their own IPR systems, including IPR for plants (Giannakas, 2001).

Several proposals have been made on how the international community should deal with these present IPR realities affecting agriculture and horticulture (Delmer et al., 2003; Lence et al., 2007; Ramanna, 2005). With little competitive loss, seed companies could agree to use the Plant Variety Protection (PVP) system (including provisions allowing seed saving and sharing by farmers) in developing countries in cooperation with public plant-breeding agencies, rather than using patents to protect their varieties (Singh, 2004). To speed the development of biotechnology capacity in developing countries (Louwaars et al., 2005; Salazar et al., 2006; Léger, 2007), companies that have IPR claims over certain key techniques or materials might agree to license these for use in developing countries at no cost (Nottenburg et al., 2002). These authors also propose an agreement to share the financial rewards from IPR claims on crop varieties or crop traits of distinct national origin (Kartal, 2007), such as South Asian Basmati rice or Thailand’s Jasmine rice.

For all the reasons discussed above, new organizations such as Public Intellectual Property Resource for Agriculture (http://www.pipra.org/) and the African Agricultural Technology Foundation (http://www.aftechfound.org/) have been established as a means of rationalizing the huge proliferation of patents, especially in plant biotechnology. It is the intention of these organizations to develop a freedom-to-operate information database, and to help public sector agricultural research institutions achieve their public missions (Cantley, 2004) by ensuring access to intellectual property required to develop and distribute improved staple crops and specialty crops.

Priorities in Horticultural Research

The application of biotechnology to crops, a process increasingly founded on the exploitation of IPR (Donnenwirth et al., 2004; Eaton, 2007; Eisenberg, 2006; Ryder, 2005), has rapidly transformed the agricultural economy of the US for the commodity crops, soybeans, corn, cotton and canola by providing genetic resistance to herbicides and insects. Since the first large-scale introduction in 1996, the global area planted to such transgenic crops has grown to 102 m ha in 2006, of which 54.6 m ha (53%) were in the US. In that year, GM varieties providing herbicide or insect resistance represented 57% of soybeans, 25% of cotton, 18% canola, and 14% of corn grown worldwide. However, biotechnology has had limited commercial success to date in horticultural crops (Laimer et al., 2005; Prakash, 2007), including fruits, vegetables, flowers and landscape plants (Bradford et al., 2004; Cook, 2004). Even though the first transgenic crop to reach the market (more than 10 years ago) was the Flavr Savr tomato, and sweet corn, potato, squash and papaya varieties engineered to resist insects and viruses have been approved for commercial use and marketed, papaya is the only horticultural crop for which transgenic varieties (SunUp and Rainbow) have achieved a significant market share (about 70% of the Hawaiian crop shipped to the continental US is transgenic) (Gonsalves, 2004).

In order to overcome these present limitations of GM technology in horticulture (Alston, 2004; Alston et al., 2006; Bradford and Alston, 2004; Clark et al., 2004) the following research priorities have recently been defined (Bradford et al., 2004; Graff et al., 2004):-

• Develop efficient transformation technologies for many specialty crops.

• Develop promoters for tissue-, development-, disease- and environment-specific gene expression.

• Develop targeted gene-insertion techniques to control the site of integration.

• Develop a Generally Recognized As Safe (GRAS) set of methodologies that would not require characterization and registration of individual genetic-insertion “events.”

• Develop products with clear and significant benefits for consumers.

Similarly, the following policy developments were recommended:-

• Develop a collaborative public-technology and intellectual-property resource.

• Develop technology and trait-licensing packages to enable public and entrepreneurial commercialization of specialty and subsistence crops.

• Target increased public research funding toward the application of genomics and biotechnology in horticultural crops, including methods that support traditional breeding.

The most recent review of the subject of IPR specifically in relation to horticulture (Delmer, 2003; Dubois, 2001) is that of Dixon and Ogier (2007).

CONCLUSION

It is generally agreed that agriculture and horticulture in the twenty-first century will need to be more productive and less damaging to the environment than they have been in the past and an increased effort is needed to assure that the benefits of research reach the hundreds of millions of poor farmers who have benefited little from previous research (Mayer, 2003). Application of transgenic methods is one approach that is likely to be a component part of this process, despite the present international diversity of attitudes to this technology (Dunwell, 2004).

Another outcome from this brief survey relates to exploitation of science for commercial gain. Although the 1906 “Genetics” conference (Anon. 1907) did receive commercial support and there were 20 pages of adverts in the proceedings, this funding was restricted to horticulture and associated gardening items. Bateson, in his after dinner speech to foreign guests, concluded “I expect a century must elapse before the … complete union of Science and Practice will be achieved”. A century has now elapsed and indeed the value of genetics in agriculture and horticulture has been proven. However, it is less easy to quantify the exact role played by patent protection in this period or to predict the future shape of the patent landscape over the coming years.

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