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
15th 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 Agrobacteriumbased transformation. Under the agreement, announced on 4th 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 6th 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
20070209089
20070209088
20070209087
20070209086
20070209085
20070208168
20070207525
CSIRO, BASF
Simplot Co.
Unknown
BASF
Mendel Biotech
Monsanto
(Monsanto)
Genencor
Vernolic acid
Marker-free transgenics
Starch
Sugar and lipids
Yield
Enzyme gene promoter
Bt proteins
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; RoaRodriguez 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
2nd 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.europeanpatent-office.org/news/pressrel/2003_05_06_e.htm;
http://www.european-patentoffice.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 (ShraderFrechette, 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 publicsector 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_fullpatentsupdated.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.
Literature Cited
Adcock, M. 2007. Intellectual property, genetically modified crops and bioethics.
Biotechnol J. 2:1088-1092.
Allyn, R.S. 1933. Plant patent queries. A patent attorney's views on the law. J. Hered. 24:
55-58.
Alston, J.M. 2004. Horticultural biotechnology faces significant economic and market
barriers. Calif. Agric. 58:80-88.
Alston, J.M., Bradford, K.J. and Kalaitzandonakes, N. 2006. The economics of
horticultural biotechnology. J. Crop Improvement. 18:413-431.
Anon. 1900. In: W. Wilks (ed.), Hybrid Conference Report 1900. J. Royal Hort. Soc. 24.
Anon. 1906. The relations between science and industry. Nature 74:386-387.
Anon. 1907. “Copyright” for raisers of novelties. p. 474-475. In: W. Wilks (ed.), Report
of the Third International Conference 1906 on Genetics; Hybridisation (The CrossBreeding of Genera or Species), The Cross-Breeding of Varieties and General Plant
Breeding. Royal Horticultural Society, London.
Anon. 2001. Booklet of CGIAR Centre Policy Instruments, Guidelines and Statements on
Genetic Resources, Biotechnology and Intellectual Property Rights. System-wide
Genetic Resources Programme (SGRP). Rome, Italy.
Barrons, K.C. 1936. A defense of basic plant patents. From the plant breeder's point of
view. J. Heredity 27:475-478.
Bastuck, C. 2006. ‘Biopiracy’ and Patents – Developing Countries’ fears are exaggerated.
Master Thesis for LLM by coursework and dissertation in International Law.
University of Capetown. 68 pp.
Binenbaum, E., Nottenburg, C., Pardey, P.G., Wright, B.D. and Zambrano, P. 2003.
South-North Trade, Intellectual Property Jurisdictions, and Freedom to Operate in
Agricultural Research on Staple Crops. Econ. Develop. Cult. Change 51:309-335.
Bradford, K.J. and Alston, J.M. 2004. Diversity of horticultural biotech crops contributes
to market hurdles. Calif. Agric. 58:84-85.
Bradford, K.J., Alston, J.M., Lemaux, P.G. and Sumner, D.A. 2004. Challenges and
opportunities for horticultural biotechnology. Calif. Agric. 58:68-71.
Brazell, L. 2000. Strategies for minimizing IP risks. Patent World 120:19-25.
Brennan, M., Pray, C., Naseem, A. and Oehmke, J.F. 2005. An innovation market
approach to analyzing impacts of mergers and acquisitions in the plant biotechnology
industry. AgBioForum, 8:89-99.
Brown, W.M. 2003. Intellectual property law: a primer for scientists. Mol. Biotechnol.
23:213-224.
Brusoni, S., Criscuolo, P. and Geuna, A. 2005. The knowledge bases of the world’s
largest pharmaceutical groups: what do patent citations to non-patent literature reveal?
Econ. Innov. New Techn. 14:395–415.
Bulut, H. and Moschini, G. 2005. Parallel Research, Multiple Intellectual Property Right
Protection Instruments, and the Correlation among R&D Projects. Center for
Agricultural and Rural Development, Iowa State University, Ames, Iowa, USA.
Working Paper 05-WP 404. 25 pp.
Bulut, H. and Moschini, G. 2006. Patents, trade secrets and the correlation among R&D
projects. Economics Letters 91:131–137.
Cahoon, R.S. 2000. Property rights and agricultural biotechnology. p. 203-215. In:
Hrazdina, G., (ed.), Use of Agriculturally Important Genes in Biotechnology. IOS
Press, Amsterdam.
Cantley, M. 2004. How should public policy respond to the challenges of modern
biotechnology? Curr. Opin. Biotechnol. 15:258-263.
Chan, H.P. 2006. International patent behavior of nine major agricultural biotechnology
firms. AgBioForum 9:59-68.
Chapotin, S.M. and Wolt, J.D. 2007. Genetically modified crops for the bioeconomy:
meeting public and regulatory expectations. Transgenic Res. 16:675-688.
Chen, J. 2006. The parable of the seeds: interpreting the plant variety protection act in
furtherance of innovation policy. Notre Dame Law Review 81: No. 4. 51 pp.
Chiarolla, C. 2006. Commodifying agricultural biodiversity and development-related
issues. J. World Intellect. Prop. 9:25-60.
Clark, D., Klee, H. and Dandekar, A. 2004. Despite benefits, commercialization of
transgenic horticultural crops lags. Calif. Agric. 58:89-98.
Cook, R.C. 1931a. The first plant patent. J. Hered. 22:313-319.
Cook, R.C. 1931b. Three more plant patents. J. Hered. 22:369-372.
Cook, R.C. 1933. Other plant patents. J. Hered. 24:49-54.
Cook, R.C. 1936. Plant patent 110 declared invalid. J. Hered. 27:394-400.
Cook, R.L. 2004. Transgenic produce slow to enter evolving global marketplace. Calif.
Agric. 58:82-83.
Delmer, D. 2003. The congested intellectual property landscape and its effect on the use
of biotechnology for the development of horticultural and subsistence crops. Acta
Hort. 625:439-443.
Delmer, D.P., Nottenburg, C., Graff, G.D. and Bennett, A.B. 2003. Intellectual property
resources for international development in agriculture. Plant Physiol. 133:1666-1670.
Dixon, G.R. and Ogier, J. 2007. Understanding and protecting horticulture's intellectual
property - a review of opportunities. Acta Hort. 760:61-68.
Donnenwirth, J., Grace, J. and Smith, S. 2004. Intellectual property rights, patents, plant
variety protection and contracts: a perspective from the private sector. IP Strategy
Today 9:19-34.
Dubois, L.A.M. 2001. Intellectual property rights on plants, with special reference to
vegetatively propagated ornamentals. Acta Hort. 552:207-214.
Dunn, J.D. and Seiler, P.F. 2007. Trade Secrets and Non-Traditional Categories of
Intellectual Property as Collateral. Presented to: UNCITRAL Second International
Colloquium on Secured Transactions: Security Interests in Intellectual Property
Rights. 13 pp.
Dunwell, J.M. 2000. Transgenic approaches to crop improvement. J. Exp. Bot. 51 Spec
No:487-496.
Dunwell, J.M. 2002. Future prospects for transgenic crops. Phytochem. Rev. 1:1-12.
Dunwell, J.M. 2004. Transgenic crops: the current and next generations. Methods Mol.
Biol. 286:377-398.
Dunwell, J.M. 2005. Review: intellectual property aspects of plant transformation. Plant
Biotech. J. 3:371-384.
Dunwell, J.M. 2006. Patents and transgenic plants. Acta Hort. 725:719-732.
Dunwell, J.M. 2007. 100 years on: a century of genetics. Nat. Rev. Genet. 8:231-235.
Dunwell, J.M. 2011. Crop biotechnology: prospects and opportunities. J. Agr. Sci.
149:17-27.
Duvick, D. N. 1999. Commercial strategies for exploitation of heterosis. p. 295-304. In:
J.G. Coors and S. Pandey (eds.) Genetics and Exploitation of Heterosis in Crops. Am.
Soc. Agron., Madison, USA.
Eaton, D. 2007. Intellectual property rights in plant breeding and biotechnology: a
comparative institutional analysis. Presented at:- 11th Annual Conference of the
International Society for New Institutional Economics (ISNIE), Reykjavik, Iceland,
21-23 June 2007. 25 pp.
Eisenberg, R.S. 2006. Biotech patents: looking backward while moving forward. Nat.
Biotech. 24:317-319.
Farnley, S., Morey-Nase, P. and Sternfeld, D. 2004. Biotechnology--a challenge to the
patent system. Curr. Opin. Biotechnol. 15:254-257.
Fay, A.E. 1937. Are plant patents “inventions”? J. Hered. 28:261-262.
Faye, D.J. 2005a. Exploitation of research tools in plant biotechnology: Access through
application of the experimental use exception (Part 1). Bio-Science Law Report. 8th
Feb 2005.
Faye, D.J. 2005b. Exploitation of research tools in plant biotechnology: Access through
application of the experimental use exception (Part 2). Bio-Science Law Report. 12th
April 2005.
Fleck, B. and Baldock, C. 2003. Intellectual property protection for plant-related
inventions in Europe. Nat. Rev. Genet. 4:834-838.
Fukuda-Parr, S. 2006. Introduction: Global actors, markets and rules driving the diffusion
of genetically modified (GM) crops in developing countries. Int. J. Technol. Globalis.
2:1-11.
Garrison, C. 2006. Exceptions to Patent Rights in Developing Countries. International
Centre for Trade and Sustainable Development (ICTSD). Issue Paper No. 17. 104 pp.
Giannakas, K. 2001. The Economics of Intellectual Property Rights under Imperfect
Enforcement: Developing Countries, Biotechnology, and the Trips Agreement. EPTD
Discussion Paper No. 80. International Food Policy Research Institute, Washington,
USA.
Gonsalves, D. 2004. Virus-resistant transgenic papaya helps save Hawaiian industry.
Calif. Agric. 58:92-93
Graff, G.D., Cullen, S.E., Bradford, K.J., Zilberman, D. and Bennett, A.B. 2003. The
public-private structure of intellectual property ownership in agricultural
biotechnology. Nat. Biotechnol. 21:989-995.
Graff, G.D., Wright, B.D., Bennett, A.B. and Zilberman, D. 2004. Access to intellectual
property is a major obstacle to developing transgenic horticultural crops. Calif. Agric.
58:120-127.
Hails, R. 2004. Bioethics for technology? Curr. Opin. Biotechnol. 15:250-253.
Hamilton, C. 2006. Biodiversity, biopiracy and benefits: what allegations of biopiracy tell
us about intellectual property. Develop. World Bioethics 6:158-173.
Heisey, P.W., King, J.L. and Rubenstein, K.D. 2005. Patterns of public-sector and
private-sector patenting in agricultural biotechnology. AgBioForum 8:73-82.
Helfer, L.R. 2004. Intellectual property rights in plant varieties. International legal
regimes and policy options for national governments. FAO Legislative Study 85. 113
pp.
Howlett, M.J. and Christie, A.J. 2003. An analysis of the approach of the European,
Japanese and United States Patent Offices to partial DNA sequences (ESTs). Int. Rev.
Indust. Prop. Copyright Law 34:581-710.
Huskisson, F.M. 1996. Patents and Biotechnology, p. 313-328, - In: Owen, M.R.L. and
Pen, J. (eds.), Transgenic Plants: A Production System for Industrial and
Pharmaceutical Proteins. Wiley, New York.
Kartal, M. 2007. Intellectual property protection in the natural product drug discovery,
traditional herbal medicine and herbal medicinal products. Phytother. Res. 21:113119.
Kent J. Bradford, K.J. and Alston, J.M. 2004. Horticultural biotechnology: Challenges for
commercial development. Chron. Hortic. 44:4-8.
Kesselheim, A.S. and Avorn, J. 2005. University-based science and biotechnology
products: defining the boundaries of intellectual property. J. Amer. Med. Assoc.
293:850-854.
Kevles, D.J. 2007. Patents, protections, and privileges. The establishment of intellectual
property in animals and plants. ISIS 98:323–331.
Koo, B., Nottenburg, C. and Pardey, P.G. 2004. Intellectual property. Plants and
intellectual property: an international appraisal. Science 306:1295-1297.
Kowalski, S.P. and Kryder, R.D. 2002. Golden rice: a case study in intellectual property
management and international capacity building. RISK: Health Safety Environ. 13:4767.
Kryder, R.D., Kowalski, S.P. and Krattiger, A.F. 2000. The Intellectual and Technical
Property Components of pro-Vitamin A Rice (GoldenRiceTM): A Preliminary
Freedom-To-Operate Review. ISAAA Brief Number 20. Ithaca, New York.
International Service for the Acquisition of Agri-Biotech Resources.
Kukier, K.N. 2006. Navigating the future(s) of biotech intellectual property. Nat. Biotech.
24: 249-251.
Laimer, M., Mendonca, D., Maghuly, F., Marzban, G., Leopold, S., Khan, M., Balla, I.
and Katinger, H. 2005. Biotechnology of temperate fruit trees and grapevines. Acta
Biochim. Polon. 52:673-678.
Léger, A. 2007. The Role(s) of Intellectual Property Rights for Innovation: A Review of
the Empirical Evidence and Implications for Developing Countries. Discussion papers
707. DIW Berlin. German Institute for Economic Research. 51 pp.
Lence, S.H., Hayes, D.J., McCunn, A., Smith, S. and Niebur, B. 2002. Welfare Impacts of
Property
Rights
in
the
Seed
Industry.
http://www.econ.iastate.edu/department/seminar/ispw/Sergio-Dermot-seed-paper.pdf
Lence, S.H. and Hayes, D.J. 2007. Welfare Impacts of Cross-Country Spillovers in
Agricultural Research. Center for Agricultural and Rural Development, Iowa State
University, Ames, Iowa, USA. Working Paper 07-WP 446. 27 pp.
Locke, S.D. 2007. Intellectual property for the botanist and the plant breeder: an overview
of protection afforded by plant patents and plant variety protection certificates.
Chicago-Kent J. Intellect. Prop. 6:198-212.
Louwaars, N.P., Tripp, R., Eaton, D., Henson-Apollonio, V., Hu, R., Mendoza, M.,
Muhhuku, F., Pal, S. and Wekundah, J. 2005. Impacts of Strengthened Intellectual
Property Rights Regimes on the Plant Breeding Industry in Developing Countries: A
Synthesis of Five Case Studies. Wageningen UR, The Netherlands.
Mayer, J.E. 2003. Intellectual property rights and access to agbiotech by developing
countries. AgBiotechNet 5 March, ABN 108.
Mayer, J., Sharples, J. and Nottenburg, C. 2004. Resistance to Phosphinothricin.
CAMBIA Intellectual Property, Canberra, Australia.
Merrill, S.A., Levin, R.C. and Myers, M.B. 2004. A Patent System for the 21st Century.
The National Academies Press, Washington DC, USA.
Miki, B. and McHugh, S. 2004. Selectable marker genes in transgenic plants:
applications, alternatives and biosafety. J. Biotechnol. 107:193-232.
Ministry of Economic Development. 2002. New issues in patentability 1:
Biotechnological patents. p. 29-40. In: Review of the Patents Act 1953: Boundaries to
Patentability. Wellington, New Zealand.
Morris, M., Edmeades, G. and Pehu, E. 2006. The global need for plant breeding
capacity: what roles for the public and private sectors? HortSci. 41:30-39.
Myskja, B.K. 2006. The moral difference between intragenic and transgenic modification
of plants. J. Agric. Environ. Ethics. 19:225-238.
Nottenburg, C., Pardey, P.G. and Wright, B.D. 2002. Accessing other people’s
technology for non-profit research. Austral. J. Agr. Resource Econ. 48:389-416.
Parayil, G. 2003. Mapping technological trajectories of the green revolution and the gene
revolution from modernization to globalisation. Research Policy 32:971-990.
Pardey, P.G., Wright, B.D., Nottenburg, C., Binenbaum, E. and Zambrano, P. 2003.
Intellectual Property and Developing Countries: Freedom to Operate in Agricultural
Biotechnology. Biotechnology and Genetic Resource Policies: Brief 3. International
Food Policy Research Institute (IFPRI) Washington, USA.
Pardey, P.G., Koo, B. and Nottenburg, C. 2004. Creating, Protecting, and Using Crop
Biotechnologies Worldwide in an Era of Intellectual Property. Department of Applied
Economics College of Agricultural, Food, and Environmental Sciences. University of
Minnesota. Staff Paper P04-4. 57 pp.
Phillips, R.L., Chen, J., Okediji, R. and Burk, D. 2004. Intellectual property rights and the
public good. The Scientist 18:8.
Prakash, J. 2007. Intellectual property rights and regulatory issues related to
biotechnology of tropical species in India. Acta Hort. 738:479-485.
Pray, C.E. and Naseem, A. 2005. Intellectual property rights on research tools: Incentives
or barriers to innovation? Case studies of rice genomics and plant transformation
technologies. AgBioForum 8: 108-117.
Ramanna, A. 2005. Intellectual property rights, agriculture, and rural communities. J.
Agric. Saf. Health. 11:423-430.
Ryder, E. J. 2005. Intellectual property rights for plants. The case for a new law. Chron.
Hortic. 45: 5-11.
Roa-Rodrigues, C. 2003. Promoters Used to Regulate Gene Expression. CAMBIA
Intellectual Property, Canberra, Australia.
Roa-Rodrigues, C. and Nottenburg, C. 2003a. Agrobacterium-mediated Transformation
of Plants. CAMBIA Intellectual Property, Canberra, Australia.
Roa-Rodrigues, C. and Nottenburg, C. 2003b. Antibiotic Resistance Genes and Their
Uses in Genetic Transformation, Especially in Plants. CAMBIA Intellectual Property,
Canberra, Australia.
Salazar, R., Louwaars, N.P. and Visser, B. 2006. On Protecting Farmers’ New Varieties:
New Approaches to Rights on Collective Innovations in Plant Genetic Resources.
CAPRi Working Paper No. 45. IFPRI. 40 pp.
Schimmelpfennig, D. and King, J. 2006. Mergers, acquisitions and flows of agbiotech
intellectual property. In: R.E. Evenson and V. Santaniello (eds.), International Trade
and Policies for Genetically Modified Products. CABI Publishing, Wallingford,
UK. pp. 97-109.
Schrell, A., Bauser, H., Brunner, H. 2007. Biotechnology patenting policy in the
European Union-as exemplified by the development in Germany. Adv. Biochem. Eng.
Biotechnol. 107:13-39.
Shear, R.H. and Kelley, T.E. 2003. A researcher's guide to patents. Plant Physiol.
132:1127-1130.
Shrader-Frechette, K. 2005. Property rights and genetic engineering: developing nations
at risk. Sci. Eng. Ethics. 11:137-149.
Singh, H. 2004. Intellectual property rights (IPR) issues in horticulture: an Indian scenario
with particular reference to medicinal plants. Acta Hort. 662:465-470.
Straus, J. 2007. The impact of the new world order on economic development: The role of
the intellectual property rights system. Europ. Rev. 15:47–63.
Summers, T.M. 2003. The scope of utility in the twenty-first century: new guidance for
gene-related patents. Georgetown Law J. 91:475-509.
Tokgoz, S. 2003. R&D Spillovers in Agriculture: Results from a Trade Model. Center for
Agricultural and Rural Development, Iowa State University, Ames, Iowa, USA.
Working Paper 03-WP 344. 27 pp.
Wright, B.D. 2006. Plant Genetic Engineering and Intellectual Property Protection.
Agricultural Biotechnology In California Series. Publication 8186.
Wright, B.D. and Pardey, P.G. 2006. The evolving rights to intellectual property
protection in the agricultural biosciences. Int. J. Technol. Globalis. 2:12-29.
Wright, B.D. and Pardey, P.G. 2006. Changing intellectual property regimes: implications
for developing country agriculture. Int. J. Technol. Globalis. 2:93-114.
Yerokhin, O. and Moschini, G. 2007. Intellectual Property Rights and Crop-Improving
R&D under Adaptive Destruction. Center for Agricultural and Rural Development,
Iowa State University, Ames, Iowa, USA. Working Paper 07-WP 449. 32 pp.
Ye, X., Al-Babili, S., Kloti, A., Zhang, J., Lucca, P., Beyer, P. and Potrykus, I. 2000.
Engineering the provitamin A (-carotene) biosynthetic pathway into (carotenoidfree) rice endosperm. Science 287:303-305.