Intellectual Property Rights in Plant Biotechnology

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Dec 27, 2007 - ways of patent filing to consider: either first to file or first to invent. In most countries ... The Leahy–Smith America Invents Act, which was passed.
20 Intellectual Property Rights in Plant Biotechnology: Relevance, Present Status, and Future Prospects Dinesh Yadav, Gautam Anand, Sangeeta Yadav, Amit K. Dubey, Naveen C. Bisht, and Bijaya K. Sarangi CONTENTS 20.1 Intellectual Property Rights: General Concept and Relevance.................................... 621 20.2 IPR and Its Different Forms.............................................................................................. 622 20.2.1 Patents....................................................................................................................... 622 20.2.2 Copyright................................................................................................................. 623 20.2.3 Trademarks.............................................................................................................. 624 20.2.4 Trade Secrets............................................................................................................ 624 20.3 Technological Innovations in Agriculture and Emergence of Plant Biotechnology...... 624 20.4 Transgenic Crops: Present Status and Future Prospects.............................................. 625 20.5 International Treaties and Forms of IPR Applicable to Agriculture and Plant Biotechnology...................................................................................................................... 627 20.5.1 International Treaties for Promoting Agricultural Innovations...................... 627 20.5.1.1 Trade-Related Aspects of Intellectual Property Rights (TRIPS)....... 627 20.5.1.2 Convention on Biological Diversity (CBD) and Its Impact on Plant IPRs.................................................................................................. 627 20.5.1.3 International Treaty on Plant Genetic Resources for Food and Agriculture (IT-PGRFA).................................................................. 628 20.5.1.4 Public Intellectual Property Resources for Agriculture (PIPRA)....... 628 20.5.2 Different Forms of IPR Relevant to Agriculture................................................ 629 20.5.2.1 Plant Patents.............................................................................................. 629 20.5.2.2 PVP............................................................................................................. 629 20.5.2.3 Farmers’ Rights........................................................................................630 20.5.2.4 Utility Patents........................................................................................... 631 20.6 Innovations in Plant Biotechnology and IPR Issues...................................................... 631 20.7 General Considerations for Patent Filing in Plant Biotechnology...............................664 20.8 Conclusion........................................................................................................................... 665 References...................................................................................................................................... 666

20.1  Intellectual Property Rights: General Concept and Relevance Intellectual Property Right (IPR) is a legal term that covers innovations, novel ideas, thoughts, and information having commercial values. An IPR gives the innovator a right to protect his or her creation from being used by others. Such creations include a wide range of intangible properties ranging from information to inventions. With globalization, the concept of IPR 621

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has become more relevant and this generic tag is often used for a group of legal regimes, each of which, to different degrees, confers rights of ownership in a particular subject matter. IPRs generally include patents, copyrights, and trademarks, providing legal rights to protect ideas, the expression of ideas, and the names, logos, and marks used to identify the business of a specific product (Marshall 1997). An IPR bears a similarity with a physical property in the sense that it can be bought and sold or rented. If the IPR is granted, the owner has the exclusive right and is thus protected from infringement. In order to claim for an IPR, the novelty of an idea is very important and the idea should be unknown to anyone else. The novelty, however, does not have to be absolute and it is very important that at the time of claiming for the IPR, the idea is thought to be generally unknown. Intellectual property (IP) law serves a variety of societal goals, including fostering innovation and promoting economic and cultural development. In the modern world, knowledge capital is considered to be more important than physical capital and this ultimately drives the economy of a country. IPRs promote innovations in diverse fields and also protect innovations having commercial values by giving exclusive right to the innovator to prevent others using his or her innovation without permission. These legal rights may vary from country to country, but, in general, this creates competitiveness and also leads to innovations in different sectors with the potential for commercialization. These exclusive rights prevent others from free riding on the innovator’s investment and enable the rightful owner to exploit his or her knowledge or creativity in the market, thus creating incentives to innovate. Further, there is a need to disclose an innovation to the public to promote further developments (Wendt and Izquierdo 2001). The IPR has relevance to each and every field of development, such as health, agriculture, education, trade, biodiversity management, biotechnology, information technology, the entertainment and media industries, and so on. Further, with the advent of the IPR, the gap between developed, developing, and least-developed countries is widening and there is a need for its stringent regulation worldwide. There has been substantial advancement in scientific research owing to collaborations but the issue of IPR needs to be addressed (Hane 2013).

20.2  IPR and Its Different Forms The common forms of IPRs are patents, copyrights and related rights, industrial designs, trademarks, trade secrets, plant breeders’ rights (PBRs), geographical indications, and rights to the layout designs of integrated circuits. Of these, patents, copyrights, and trademarks are arguably the most economically significant. Inventions, literary works, artistic works, designs, and trademarks formed the subject matter of early IP law. IPRs also include specific marks on products to indicate their difference from similar products sold by their various competitors. The concept of IP law, its diverse applications, and its controversies from a scientific point of view have been reviewed (Brown 2003). 20.2.1 Patents It is a legal right to protect a new innovation, invention, idea, discovery, or concept having a commercial value. The sole purpose of a patent is to encourage and stimulate inventors to bring new and useful products to the marketplace for the benefit of mankind. It is a timelimited legal right assigned to an inventor by the government of a country where the patent is filed to protect the invention from being misused. The patent gives an exclusive right

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to the patentee (patent owner) to exclude others from making, using, selling, or importing the invention for a limited time and, in doing so, the patentee needs to describe the invention in detail for the benefit of the public or others working in that specific field. Once the patent expires, it can be used by anyone or, more precisely, the invention is in the public domain. Since a patent is granted by a government, if the inventor seeks a patent in a different country, he or she needs to apply for the patent in that country, that is, a filed patent is not universal or we can assume that there is no global patent. It is a misperception that a patent promotes a monopoly as it merely permits the inventor to stop someone else doing or using his or her invention. The patentee may assign the patent rights to another or the patentee may retain the ownership rights and license such rights to others, so that they can use the invention without owning it. In biotechnology, the Cohen–Boyer and PCR patent is a well-known example, having a very high commercial value (Dickson 1993; Lehrman 1993a). The basic criteria for the patentability of an innovation are that it should be novel, nonobvious, and useful (Barton 2000). Three types of patents, namely, utility patents, design patents, and plant patents, exist under U.S. law. A utility patent has broad coverage for any invention or discovery that is a new and useful composition of matter, process, product, or machine. Design patents give legal protection to the appearance of an article, while plant patents include inventions in plants accomplished by crossbreeding or the discovery of new plants, which may include cultivated mutants, hybrids, and seedlings. There are two ways of patent filing to consider: either first to file or first to invent. In most countries, the first-to-file system is prevalent. The Leahy–Smith America Invents Act, which was passed in late 2011, has changed the U.S. patent regime to a first-to-file system for all patents, including plant patents and all utility patents applicable to plants (Pardey et al. 2013). The patenting of genetically modified (GM) microorganisms came into existence in 1980 after the U.S. Supreme Court’s ruling in Chakrabarty for Pseudomonas bacteria capable of cleaning oil (Wade 1980). The judgment in this particular matter was highlighted as “anything under the sun that is made by man” may be patentable under U.S. law. Similarly, in 1988, the U.S. Patent Office was first to grant a patent on transgenic animals, that is, a mouse having an activated mouse oncogene (myc), popularly referred to as the Harvard Oncomouse (Booth 1988). This was the beginning for the patenting of transgenic animals and several U.S. patents have been granted on transgenic animals thereafter (Lehrman 1993b), in contrast to the European Patent Office (EPO) (Abbott 1993; Spillmann-Furst 1990). Two highly significant developments in biotechnology need to be mentioned here with reference to patents. One was the Cohen–Boyer patent (U.S. Patent No. 4,237,224) on methods of gene cloning and expression, which expired in 1997, resulting in Stanford University and the University of California, San Francisco, where Stanley Cohen and Herbert Boyer were employed, making millions of dollar simply by selling this invention to different biotechnology industries. In contrast, the British Medical Research Council (BMRC) could not benefit from the invention of monoclonal antibodies by their employees Kohler and Milstein, while several patents were granted thereafter on specific monoclonal antibodies and diverse applications (Uhr 1984; Greene and Duft 1990). 20.2.2 Copyright Copyright is the legal right of an artist, author, or any person who attempts to make any creative work in any field, such as paintings, designs, patterns, fiction, and photographs, which is fixed in a tangible medium such as paper, film, canvas, floppy disk, and the like. The purpose of copyright is that the work remains that of its creator and it should not be

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copied without his or her consent. This is not applicable to protecting ideas but only the form used to express the ideas. This copyright law is important for scientists and academicians who are associated with writing books. As compared to patents, a copyright need not be registered and it is comparatively weaker than patent law.

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20.2.3 Trademarks The sole purpose of a trademark is to highlight the source or origin of a good or service, which ultimately provides the consumer with a warranty of the quality of the good or service associated with the mark. This is applicable to all fields including the scientific field. The legal protection for trademarks is provided by a well-developed system of registration as in the case of patents. A trademark is generally denoted by a symbol, a word or a series of words, logos, or any other marking that distinguishes one product from another, or, in other words, it is a symbol for that specific product that cannot be copied by others in the same field. Trademarks signify the source of the product and hence are viewed as a marketing strategy, while patents and copyrights are based on creative products or ideas. Trademarks have an indefinite life span and they need not be registered. 20.2.4  Trade Secrets A very simple way of protecting one’s invention is by simply maintaining its secrecy, not disclosing it to anyone, and solely using it for commercialization. One excellent example of a trade secret is the formula for Coca Cola, which still exists with its owner. The main advantage of the trade secret is that it does not have an expiry time; however, it does need to be maintained by the owner and if it is disclosed, there is no means of protecting it under existing laws. It is quite applicable in case of hybrids, where the identification of the hybrid’s parental lines is considered to be a trade secret belonging to the innovator (Moschini 2001; Tandon and Yadav 2012). As a result, the parental lines are kept a trade secret and are not accessible to anyone unless they are disclosed by the innovator, whereas in the case of patents, they have a limited time period after which they are made public and can be accessed by anyone.

20.3 Technological Innovations in Agriculture and Emergence of Plant Biotechnology Conventional plant breeding has significantly contributed to the development of agriculture worldwide by releasing several varieties of different crops with desirable traits that emphasize more on the yield and biotic stress tolerance. The well-known concept of the green revolution, a term coined in 1968 by William Gaud, the director of the U.S. Agency of International Development, and manifested by Nobel laureate Dr. Norman E. Borlaug and Indian agricultural scientists Dr. M.S. Swaminathan and Dr. G.S. Khush, was based on conventional plant breeding for high-yielding dwarf varieties of wheat and rice with efficient irrigation and effective fertilizers and pesticides applications. Another revolution in agriculture is needed to feed the growing human population, which is expected to reach more than 9 billion by 2025. Several constraints, such as urbanization, industrialization, climate change, various biotic (pests, diseases, and weeds) and abiotic stresses (salinity,

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drought, heat, etc.), and the shrinkage of arable lands, demand newer technology for the development of crops with enhanced yield and tolerance to the various biotic and abiotic stresses. The major limitation with conventional plant breeding is the nonavailability of diverse genetic resources with the desired traits for the selection of parents to undergo relevant crossing for the development of suitable varieties of plants. Another limitation is that even though the genetic resources are available, they cannot be used beyond species, that is, the problem of sexual incompatibility and also the time required to develop a variety ranges from 8 to 10 years. Globally, the need for biotechnological interventions to attain global food security is being addressed (Mittler and Blumwald 2010; Yadav et al. 2010a). The advent of genetic engineering technology and the recent advances in plant genomics with the deciphering of the genome sequences of important crops such as rice, maize, sorghum, soybean, pigeonpea, barley, potato, chickpea, watermelon, and melon (IRGSP 2005; Schnable et al. 2009; Paterson et al. 2009; Schmutz et al. 2010; Potato Genome Sequencing Consortium 2011; Singh et al. 2012; Varshney et al. 2012a, 2013; International Barley Genome Sequencing Consortium 2012; Garcia-Mas et al. 2012; Guo et al. 2013) have opened up new avenues for crop improvement. The availability of genomic sequences has contributed to sequence-based marker development for traits leading to the emergence of molecular breeding and relevant concepts such as marker-assisted selection (MAS) and genomicassisted selection (GAS) with immense potential for crop improvement programs worldwide (Mittler and Blumwald 2010). This development has also resulted in allele mining for crop improvement (Kumar et al. 2010). In recent years, several review articles reflecting the recent development in agricultural biotechnology and its implications in attaining global food and nutritional security have been published (White and Broadear 2009; Fleury et al. 2010; Kumar et al. 2010; Cook and Varshney 2010; Varshney et al. 2012b; Morrell et al. 2012; Farre et al. 2011; Mir et al. 2012; Ahmad et al. 2012). Several other state-of-the-art technologies in plant breeding, namely, zinc-finger nuclease (ZFN) technology (Townsend et al. 2009; Shukla et al. 2009), oligonucleotide-directed mutagenesis (ODM) (Zhu et al. 2000), cis-genesis and intragenesis (Schouten and Jacobsen 2008), RNA-dependent DNA methylation (RdDM) (Aufsatz et al. 2002), grafting (on GM rootstock) (Stegemann and Bock 2009), reverse breeding (Dirks et al. 2009), and agroinfiltration (Vezina et al. 2009), have shown great potential for crop improvements. The role of epigenetics in crop improvement cannot be ignored. Epigenetics significantly influences the natural variations in crops and its regulation affects the transgene integration, expression, and stability (Springer 2012). The various constraints on the agricultural sector and the potential of several technological innovations for attaining food and nutritional security are shown in Figure 20.1.

20.4  Transgenic Crops: Present Status and Future Prospects Transgenic technology takes advantage of the vast gene pool available without any hindrance or sexual barrier, using the tools of genetic engineering to develop crops with desirable traits in a time span that is comparatively less than that for conventional plant breeding. The creation of transgenic crops involves the following steps: (i) the isolation, characterization, and manipulation of genes conferring the desired traits and making a gene construct having a gene of interest with suitable promoters,

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Constraints

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Population expansion Urbanization Shrinking of arable lands Biotic stresses Abiotic stresses Climate change

Technological innovations

Conventional plant breeding Hybrid seed technology Plant tissue culture Epigenetics Mutation breeding Molecular genetics and breeding Transgenic technology New biotechnologies in plant breeding Zinc-finger nuclease (ZFN) technology Oligonucleotide-directed mutagenesis (ODM) Cis-genesis and intragenesis RNA-dependent DNA methylation (RdDM) Grafting (on GM rootstock) Reverse breeding Agroinfiltration

Green revolution/gene revolution/evergreen revolution Global food and nutritional security FIGURE 20.1 Technological innovations in agricultural sciences for overcoming the constraints for attaining global food and nutritional security.

terminators, and a selectable marker or reporter gene; (ii) the transfer of the gene construct by different methods, such as biolistic or Agrobacterium mediated in specific cells or tissues amenable to in  vitro regeneration; (iii) the development of an in vitro regeneration protocol using suitable explants of targeted crops for the development of transgenic lines; and (iv) the screening and validation of transgenes for a few generations for their integrity, stability, and expression level. Each step in creating transgenic crops has the potential for patentability and, to date, several patents have been granted for the same. Transgenic crops are also known by several names such as genetically modified crops, biotech crops, or designer crops. Over the years there has been a substantial increase in the cultivation of biotech crops, from 1.7 million hectares in 1996 to 160 million hectares in 2011, and currently, 29 countries are commercializing these crops worldwide (Clive 2011). The latest developments and statistics on biotech crops can be retrieved from a website (http:// www.isaaa.org) that is maintained by the International Service for Acquisition of Agribiotech Applications (ISAAA), a not-for-profit international organization that is associated with sharing the benefits of crop biotechnology in different sectors. Among the different crops, the biotech soybean continued to be the principal biotech crop in 2011, occupying 75.4 million hectares or 47% of the global biotech area, followed by biotech maize (51 million hectares or 32%), biotech cotton (24.7 million hectares or 15%), and biotech canola (8.2 million hectares or 5%) of the global biotech crop area. With reference to the traits in biotech crops subjected to commercialization from 1996 to 2011, herbicide tolerance has consistently been the dominant trait. In 2011, the herbicide tolerance deployed in soybean,

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maize, canola, cotton, sugarbeet, and alfalfa occupied 59% or 93.9 million hectares of the global biotech area of 160 million hectares. A total of 1045 approvals have been granted for 196 events for 25 crops (Clive 2011). The first- and second-generation transgenic crops with traits such as herbicides resistance, insect resistance, and nutritional quality have been successfully produced and now thirdgeneration transgenic crops associated with molecular farming are also being attempted (Azadi and Ho 2010; Peters and Stoger 2011; Farre et al. 2011; Ahmad et al. 2012; Bhullar and Gruissem 2013). The molecular strategies for gene containment in transgenic crops, the concern for biosafety, and their biodiversity have also been addressed in recent reviews (Daniell 2002; Lee and Natesan 2006; Hill et al. 2007; Penna and Ganapathi 2010; Raven 2010; Manimaran et al. 2011; Mehrotra and Goyal 2013).

20.5 International Treaties and Forms of IPR Applicable to Agriculture and Plant Biotechnology The innovation in biotechnology has led to several issues related to IPRs (Gold et al. 2002). The innovation in agriculture and plant biotechnology is also a subject matter of IPRs and, in general, plant-based research, plant variety protection (PVP), and utility patents or patents (in the United States) are a few of the forms of IPR (Sechley and Schroeder 2002). 20.5.1  International Treaties for Promoting Agricultural Innovations 20.5.1.1  Trade-Related Aspects of Intellectual Property Rights (TRIPS) The genesis of IPRs in agriculture was the global intellectual property treaty agreement of TRIPS (http://www.wto.org/english/docs_e/legal_e/27-trips-pdf). This was the outcome of a multilateral agreement between the 134 World Trade Organization (WTO) member countries, which was negotiated during the 1986–1994 Uruguay round of the General Agreement on Tariffs and Trade (GATT). The minimum criteria for patentability were novelty, nonobviousness, usefulness, and enablement, and any inventions, whether products or processes, in all fields of technology can be patented. According to TRIPS, microorganisms and microbiological processes are patentable subject matter. Article 27(2) emphasizes the exclusion of inventions whose commercial exploitation would threaten public order or morality. These include diagnostic, therapeutic, and surgical methods for the treatment of humans or animals, life-forms other than microorganisms, and processes for the production of plants or animals. This provision was made optional and not universal and it varies from country to country. Article 27(3) of TRIPS states that all plants may be excluded from patentability, provided that the member country adopts alternative IP legislation, such as PBRs, or any other effective sui generis system to include plant varieties. 20.5.1.2  Convention on Biological Diversity (CBD) and Its Impact on Plant IPRs This international treaty came into existence on December 29, 1993, as an outcome of the Earth Summit in Rio de Janeiro on June 5, 1992, with the goal of the conservation and sustainable use of biological diversity. More than 186 countries, including all of the developed countries except the United States, are party to the convention. The objectives of this

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convention are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies taking into account all rights over those resources and technologies, and by appropriate funding. It increasingly focused on biotechnology, technology transfer, and IPRs (Dutfield 2002), and the Cartagena Protocol on Biosafety (CBD) was one major outcome. The important features of this treaty are national sovereignty over biological resources, the establishment of property rights for both indigenous knowledge and genetic resources, the promotion of the rights of indigenous populations over access to biodiversity, and the provision of access and benefit-sharing legislation (Diaz 2000; Boisvert and Caron 2000). The CBD has initiated the IPR debate between developing countries with rich natural resources and environmentalists mainly from developed countries with reference to the conservation of biodiversity, which has led to the emergence of issues such as biopiracy (Odek 1994; Shiva 1997; Hamilton 2006). The CBD guarantees the protection of IPRs under existing international laws and does not intend to restrict the availability of genetic resources. However, the convention rejects the free flow of resources and emphasizes signing the equivalent of a Material Transfer Agreement so that it is assured that the donor nation receives a share of any profits that may be realized from the material. 20.5.1.3 International Treaty on Plant Genetic Resources for Food and Agriculture (IT-PGRFA) The IT-PGRFA came into existence on November 2, 2001, and it was adopted by 116 countries excluding the United States and Japan. Before the treaty comes into effect, it must be ratified by 40 countries. This treaty recommends that the raw materials used to develop new crop varieties should remain in the public domain. It promotes the conservation of plant genetic resources for food and agriculture. It exists in a legal and political space between the CBD and the TRIPS agreements and promotes the free exchange of germplasm as fundamental to global food security. It has made provisions for farmers’ rights, but legally, these are not well defined. The main aim of this treaty is to develop a multilateral system comprising an aggregate of genetic material from the member countries, so that, after paying a fee, members can have access to the genetic material. The provision of IPRs is not adequately defined in this treaty. 20.5.1.4  Public Intellectual Property Resources for Agriculture (PIPRA) PIPRA was created in 2004 by the Rockefeller Foundation to address the IP issues in agriculture that influence public investment, especially in developing countries. The delay in utilizing newer agricultural biotechnology, high transaction costs, and limited access to advanced technologies for the benefit of developing countries were the major concerns (Atkinson et al. 2003; Delmer et al. 2003; Grimes et al. 2011). Currently, PIPRA has a network that extends to 60 universities and research institutions in 17 countries worldwide. Since the public sector is the sole player in agricultural research and development in developing countries, PIPRA has a vital role to play in encouraging public sector involvement in agricultural research in the era of IPRs. There is an immediate need for sharing of intellectual property in agricultural biotechnology with references to the transgenic technology for easy accessibility to developing countries for attaining food and nutritional security (Chi-Ham et al. 2012). In addition to PIPRA, there are several other public sector initiatives for promoting agricultural research worldwide taking into consideration the growing awareness of IPRs. Some of these are:

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Centre for Application of Molecular Biology to International Agriculture (CAMBIA) Public Interest Property Advisors (PIPA) African Agricultural Technology Foundation (AATF) International Service for the Acquisition of Agri-biotech Applications (ISAAA)

20.5.2  Different Forms of IPR Relevant to Agriculture

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20.5.2.1  Plant Patents In the United States, a unique form of protection in the form of a plant patent exists, which includes plants that reproduce through asexual reproduction with tuber-propagated plants as an exception. This is framed legally under the Plant Patent Act (PPA) of 1930. It provides a 20-year patent protection for inventions derived from asexually reproduced varieties (Fuglie et al. 1996). This largely includes ornamental plants and fruits. The plant patent in the United States requires no yearly maintenance fee to remain in effect. In the United States, it is possible to get dual protection for plant varieties through a utility patent and a plant patent, or a PVP certificate and a utility patent, but not a PVP certificate and a plant patent (Pardey et al. 2013). In Europe, the patenting of plant varieties is excluded and the European Patent Convention (EPC) excludes the patenting of “plant or animal varieties or essentially biological processes for the production of plants or animals,” though this is not applicable to microbiological processes or the products thereof (Blakeney 2012). 20.5.2.2 PVP The preexisting patent laws were not considered suitable for covering innovations related to the development of new plant varieties using conventional plant breeding techniques. The International Union for the Protection of New Varieties of Plants (UPOV) global agreement came into existence in 1961 and it was later revised in 1972, 1978, and 1991 to frame a minimum standard for the protection of plant varieties similar to TRIPS. Up to April 4, 2011, a total of 69 countries have signed the UPOV Convention. These rights are distinct from patent protection, and are focused on the specific needs and interests of the plant breeding and propagation processes, originally based on traditional plant breeding methods. The members signing this agreement have the right to frame legislation in their respective countries with the inclusion of the minimum standards highlighted in the UPOV. This offers protection for plant varieties that are new, distinct, uniform, and stable. A plant variety is considered distinct if it is clearly distinguishable from any other variety whose existence is a matter of common knowledge. It is considered to be uniform if it shows its relevant characteristics on propagation, and stable if its relevant characteristics remain unchanged after repeated propagation. Further, the agreement protects not only the plant variety and its propagating materials, but also the harvested product, which may include the entire plant or parts of the plant. Not only is there provision for the granting of exclusive rights to the owner/innovator, but the agreement also gives access to other innovators to use the protected materials for research purposes and allows farmers to save the seeds for planting in subsequent generations. The protection only applies to new plant varieties as such, which are generally defined as the lowest level of taxonomy (or classification) within the plant kingdom—that is, plant varieties that are distinct variations within a given species. These rights are granted by the state to plant breeders to exclude others from producing or commercializing the material of a specific plant variety and are generally for 25 years in the case of trees and vines and 20 years for any other variety. A country can develop its own system of protection, referred

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to as a sui generis system, that is, a system of rights designed to fit a particular context and need that is a unique alternative to standard patent protection (Mauria 2000). The developments and implications of plant varietal rights (PVRs) in the United States since their inception in 1930–2008 have recently been reviewed (Pardey et al. 2013). PVRs are also manifested in the form of PBRs, which allow innovators/agricultural scientists to use the protected materials for research purposes, and farmers’ privilege, which gives farmers the right to save seeds for planting in subsequent seasons. Great flexibility exists for farmers’ privilege and it is solely a national option; a nation may allow farmers’ privilege as an exception under certain circumstances. The latest version of the UPOV (1991) has expanded the scope of breeders’ rights, it has introduced the concept of “essentially derived” varieties, and it has considered farmers’ privilege to be a national option (Kolady and Lesser 2009). India is rather inclined to have a sui generis system of legislation, which is nonpatent based. The various legislative systems concerned with providing IPRs in agriculture biotechnology in India are: • • • • •

The Protection of Plant Varieties and Farmers’ Rights Act (PPVFR), 2001 Biological Diversity Act, 2002 Seeds Act, 1996 Plant Quarantine (Regulation of Import into India) Order, 2003 Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms and Genetically Engineered Organisms or Cells, 1989

The PPVFR was passed by the Indian Government in 2001. The act covers all categories of plants, except microorganisms. India’s law is unique in that it simultaneously aims to protect both breeders and farmers. The act grants PVP on new varieties, extant varieties, and essentially derived varieties. Extant varieties include farmers’ varieties, varieties in the public domain, and varieties about which there is common knowledge. Different rights have been given to farmers under the act including the rights to save, exchange, and sell seeds and propagating material; the right to register varieties; the right to recognition and reward for the conservation of varieties; the right to benefit from sharing; the right to information about the expected performance of a variety; the right to compensation for the failure of a variety to perform; the right to the availability of seeds of a registered variety; the right to free services for registration; the right to conduct tests on varieties; the right to legal claims under the act; and the right to protection from infringement. The main objectives of the act are as follows: • To provide for the establishment of an effective system for the protection of plant varieties • To provide for the rights of farmers and plant breeders • To stimulate investment for research and development and to facilitate the growth of the seed industry • To ensure the availability of high-quality seeds and planting materials of improved varieties to farmers 20.5.2.3  Farmers’ Rights India’s ability to be one of the first countries in the world to forge a national legislation on farmers’ rights is a significant landmark. The act recognizes the farmer not just as a

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cultivator but also as a conserver of the agricultural gene pool and a breeder who has bred several successful varieties. The act makes provisions for such farmers’ varieties to be registered, with the help of nongovernmental organizations (NGOs) so that they are protected against being scavenged by formal sector breeders. The rights of rural communities are also duly acknowledged. The farmers’ rights of the act define the privilege of farmers and their right to protect the varieties that they have developed or conserved. Farmers can save, use, sow, resow, exchange, share, and sell farm produce of a protected variety except that for sale under a commercial marketing arrangement (branded seeds) [Section 39 (1), (i)–(iv)]. Farmers’ rights were first formulated in Resolution 5/89 of a 1989 conference of the Food and Agriculture Organization (FAO) of the United Nations. Farmers’ rights means “rights arising from the past, present and future contributions of farmers in conserving, improving, and making available plant genetic resources, particularly those in the centers of origin/diversity.” The pupose of farmers’ rights was to recognize the role of farmers and members of indigenous rural or traditional communities in creating, domesticating source of agricultural varieties and diversity for food and agriculture. Ironically, to date, farmers’ rights have not been given any practical legal expression. Although Article 27(3) of the TRIPS agreement of April 1994 envisaged special types of legal systems for protecting plant and animal varieties, these have not yet been defined. Further, farmers have also been provided with the protection of innocent infringement when, at the time of the infringement, a farmer is not aware of the existence of breeder rights. This formulation allows the farmer to sell seed in the way he or she has always done, with the restriction that this seed cannot be branded with the breeder’s registered name. In this way, both the farmer’s and the breeder’s rights are protected. The breeder is rewarded for his or her innovation by having control of the commercial marketplace but without being able to threaten the farmer’s ability to independently engage in his or her livelihood, and supporting the livelihood of other farmers. 20.5.2.4  Utility Patents The Diamond v. Chakrabarty (447US303, 1980) U.S. Supreme Court decision in 1980 was a landmark decision that gave way to the patenting of life-forms (Chakrabarty 1988, 2010). The utility patents can be used for the patenting of plants or higher life-forms (HLFs) in many countries. The Pioneer Hi-Bred International, Inc., v. J.E.M. AG Supply, Inc. et al. (2001) was an important decision for the consideration of utility patents for plants. The scope of the protection offered by a utility patent is broader as compared to PVP or plant patents and it covers many kinds of different innovations in plant biotechnology, such as transformation processes, vectors and their various components, namely, promoters, selectable markers, genes of interest, as well as organisms and their parts. The basic requirements in utility patents are novel, useful, nonobvious, and prior art, while in PVP they are distinct, uniform, and stable.

20.6  Innovations in Plant Biotechnology and IPR Issues In recent years, the success of transgenic technology and its potential for commercialization have led to the filing of several patents by both public and private sector-based research organizations globally. Genetic engineering is perceived as an important tool that can cater to the future food, feed, and energy requirements globally, but there are several issues and

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OMICS Applications in Crop Science

concerns for the commercialization of genetically engineered crops (Rommens 2010). The IPR has a significant role to play in the context of plant biotechnology, biodiversity, and biopiracy in the era of globalization (Blakeney et al. 1999; Sechley and Schroeder 2002; Kowalski et al. 2002; Gold et al. 2002; Boettiger et al. 2004; Yadav et al. 2010b). There has been a substantial increase in the patents granted to plant biotechnology-based innovations. More than a thousand patents have been granted for transgenic plants in the United States (Koo et al. 2004; Lacroix et al. 2008). Some of the patents granted to plant biotechnology-based innovations are listed in Table 20.1. Recently, transgenic drought-resistant maize and soybean with stacked traits of improved fatty acid profiles in the United States by the Monsanto Company and a transgenic bean resistant to bean yellow mosaic virus in Brazil by the Brazilian Agricultural Research Corporation have been approved for commercialization (Marshall 2012). The plant transformation technology comprising different components ranging from vectors, promoters, genes of interest, methods of gene transfer, selectable marker genes, in vitro regeneration protocols, and transformation stability/heritability are all subject matters of patents (Dunwell 2005). Tables 20.2 and 20.3, list some of the patents granted for selectable markers and transformation technology, respectively. The highly acclaimed Golden rice, a transgenic rice with enhanced levels of β-carotene for alleviating severe vitamin A deficiency, has 72 patents claimed by 40 different organizations (Ye et al. 2000; Kryder et al. 2000). This includes patents for the phytoene trait genes, promoters, terminators, selectable markers, and transit peptides that are used in its construct. The patents granted on several plant biotechnological innovations for some important crops, namely, rice, maize, potato, Brassica, cotton, sugarcane, tea, and rose, are shown in Table 20.4. The patenting of DNA, genes, sequences, and gene technologies influencing agricultural, biomedical, and several industrial sectors is a recent development with the deciphering of several plants, microbial and fungal, and animal genome sequences (Yadav et al. 2012). Whole-genome sequencing does not infringe the gene patent; the “gene patent” is actually a misnomer, as gene patent holders do not actually own the genes that are the subject of their patents. They have the right to exclude others from making, using, selling, or importing a nonnaturally occurring, man-made product or process, as defined by the patent’s claims (Holman 2012). Agricultural innovation can also reorient plant breeding to generate smart crops with an enhanced yield using fewer inputs and the ability to tolerate the changing climatic conditions (Mba et al. 2012). The MAS in breeding has been very successful in reducing the number of generations for evaluating breeding materials with enhanced efficiency for both monogenic and polygenic traits (Eathington et al. 2007; Choudhary et al. 2008). The Consultative Group on International Agricultural Research (CGIAR) has developed the integrated breeding platform (IBP) of the Generation Challenge Program (Clive 2011) to make available the MAS techniques for developing elite varieties of food security crops in developing countries. Multinational companies have already implemented MAS in various crops but it is still not routinely used in public crop improvement programs due to its high set-up costs and IPR restrictions. The following is a list of the emerging biotechnology techniques influencing plant breeding, which have recently been reviewed (Lusser et al. 2012).

1. ZFN technology—designed to create site-specific mutations or gene inactivation for a desired phenotype; ZFNs are basically synthetic restriction endonucleases consisting of a zinc-finger domain that recognizes specific DNA sequences and nucleases domains that assist in cutting. 2. ODM—associated with creating targeted mutations of one or a few nucleotides and also known as targeted gene repair, genoplasty, and chimeraplasty.

List of Some Patents in Plant Biotechnology

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S. No.

Patent No.

Inventor

Assignee

Title

1

EP0513884 A1

Josephus Nicholaas Maria Mol, Ingrid Maria Van Der Meer, Andrianus Jhohannes Van Tunen

Mogen International N.V.

Male-sterile plants, methods for obtaining malesterile plants and recombinant DNA for use therein

2

US5917117

Phytotech Inc.

Inducing hyperaccumulation of metals in plant shoots

3

US5947041

Burt D. Ensley, Michael J. Blaylock, Slavik Dushenkov, Nanda P.B.A. Kumar, Yoram Kapulnik/ Phytotech Inc. Louis A. Licht

Ecolotree Inc. USA

Methods for using tree crops as pollutant control

Description

Filing Date

Issue Date

It provides male-sterile plants, 4/15/1992 characterized in that the said plants have a recombinant polynucleotide integrated into their genome, essentially comprising an inhibitory gene, which, upon proper expression in the anthers of the plant, is capable of inhibiting expression of one or more genes encoding an enzyme involved in the synthesis of chalcone, or one of its precursors It provides methods by which the 3/21/1996 hyperaccumulation of metals in plant shoots is induced by exposure to inducing agents such as low pH, chelators, herbicides, and high levels of heavy metals

11/19/1992

A method of naturally removing or inhibiting pollutants is described. Tree stems from trees having preformed root initials and a perennial root system are planted adjacent to the area where water is to be decontaminated. The stems are densely planted to achieve maximum pollution control and environmental effects. Row planting is used and the crop is harvested on a rotating basis

9/7/1999

2/4/1991

6/29/1999

633

(continued)

Intellectual Property Rights in Plant Biotechnology

TABLE 20.1

634

TABLE 20.1 (Continued) List of Some Patents in Plant Biotechnology Patent No.

Inventor

Assignee

US6100092

Mykola Borysyuk, Lyudmyla Borysyuk, IIya Raskin

Rutgers, The State University of New Jersey

5

US6159270

IIya Raskin, Nanda P.B.A. Kumar, Slavik Douchenkov

Edenspace Systems Corporation

6

EP0889691 B1

Jr G. Bradford Proguard Inc. Crandall, W. Ralph Emerson

7

EP1346622 A1

Andy Dwayne Deere & Company Beck, Stephen Micheal Faivre, Geord Larcheid, et al.

8

EP1463811A2

Haviva Ramot at Tel Aviv Eilenberg, University Ltd. Silvia Schuster, Aviah Zilverstein

Title Materials and methods for amplifying polynucleotides in plants

Description

The products include nucleic acids containing a plant active amplification promoting sequence (APS) and the methods exploit these products in amplifying target nucleic acids Phytoremediation of The process is based on metals manipulating the growth of crop and crop-related members of the plant family Brassicaceae in metal-containing soils so that the metal in the soils is made more available to the plants Use of aromatic Methods and compositions based on aldehydes as natural compounds, including pesticides balsam, cinnamic aldehyde, α-hexyl cinnamic aldehyde, and coniferyl aldehyde are provided, which find use as pesticides Methods and system The invention refers to a system for for automated and a method of tracing a crop by tracing of an electronic regarding of various agricultural product information, forming a data profile, segregating the crops from intermixing, electronically recording a storage identifier, and associating the formed data profile with the storage identifier Chitinases, derived It provides an enzymatic from carnivorous composition comprising at least one plants polynucleotide protein isolated from a tissue or sequences encoding soup of a carnivorous plant, with at thereof, and methods least one protein being of isolating and using characterized with an endochitinase same activity

Filing Date

Issue Date

6/15/1998

8/8/2000

3/18/1998

12/12/2000

3/25/1997

1/29/2003

3/19/2003

9/24/2003

6/17/2002

10/6/2004

OMICS Applications in Crop Science

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S. No. 4

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EP1551985 A2

Commercial use of Arabidopsis for the production of human and animal therapeutic and diagnostic proteins

10

EP1671534A1

11

EP1613796A4

Hyoung-Joon Jin, L. David Kaplan, Ung-Jin Kim, Jaeyung Park

Concentrate aqueous silk fibroin solution and use thereof

12

EP1848265A2 US20090119793 US20090300802

Alisa Huffaker, Washington State L. Gregory University Research Pearce, A. Foundation Clarence Ryan, Yube Yamaguchi

Tufts University

Methods for altering levels of phenolic compounds in plant cells

Plant defense signal peptides

It provides methods that make it possible to take advantage of the various growth parameters of Arabidopsis in order to grow dense populations of the plant in controlled indoor environments for the purpose of harvesting the biomass and isolating proteins, particularly recombinant proteins suitable for pharmaceutical applications It provides a plant-derived extract comprising inhibitory activity against HIV integrase. In addition, methods for the isolation of enzymes and their encoding genes, which are involved in the biosynthesis of selected phenolic compounds such as depsides are provided as well as transgenic organisms transformed therewith It provides for concentrated aqueous silk fibroin solutions and an all-aqueous mode for the preparation of concentrated aqueous fibroin solutions that avoids the use of organic solvents, direct additives, or harsh chemicals. The invention further provides for the use of these solutions in the production of materials, for example, fibers, films, foams, meshes, scaffolds, and hydrogels AtPtpl plays an important role as a signaling component of the innate immune system of Arabidopsis. AtPcpl and its seven paralogs and orthologs play important roles as endogenous signals to amplify innate immunity

7/26/2002

7/13/2005

12/16/2004

6/21/2006

4/12/2004

8/15/2007

1/24/2006

10/31/2007

(continued)

635

Newell Icon Genetics Inc. Bascomb, Mark Bossie, Melissa Campo Andrei Golovko, Gerald Hall, Lynne Hirayama, Thomas Petty, Marina Claudio Stiftung Caesar Cerboncini, Centre of Advanced Heide Schnabl, European Studies Ralf Theisen and Research

Intellectual Property Rights in Plant Biotechnology

9

636

TABLE 20.1 (Continued) List of Some Patents in Plant Biotechnology Patent No.

13

EPI885861A2

14

EP1750497A4

15

EP2187730A1

Inventor

Assignee

Jason bull, Monsanto David Technology LLC Butruille, Sam Eathington, Marlin Edwards, Anju Gupta, Richard Johnson, Wayne Kennard, Jennifer Rinehart, Kunsheng Wu L. Stephen The University of Goldman, V. Toledo Sairam Rudrabhatla

Filippa Brugliera

International Flower Developments Pty Ltd.

Title Methods and compositions to enhance plant breeding

Description It relates to the field of plant breeding and plant biotechnology, in particular to a transgene inserted into the genetic linkage with a genomic region of a plant, and to the use of the transgene/genomic region to enhance the germplasm and to accumulate other favorable genomic regions in breeding populations

Filing Date 5/26/2006

A method for It relates to a method of 5/27/2005 producing direct reprogramming plant development in vitro flowering that allows flower buds and seeds and viable seed from to arise de novo, directly from a cotyledons, radicle, cotyledon or radicle explants or and leaf explants from shoots produced on a and plants produced cotyledon or radicle. The present there from invention also provides for an improved culturing media that provide for in vitro flowering Genetically modified It relates to genetically modified 11/14/2008 chrysanthemums chrysanthemum plants expressing altered inflorescence. The chrysanthemum flavonoid pathway is manipulated to produce plants with blue or violet inflorescence. Blue delphinidin pigments are produced by the expression of flavonoid 3’5’ hydroxylase and (optionally) the suppression of flavonoid 3’ hydroxylase activity

Issue Date 2/13/2008

8/19/2009

5/26/2010

OMICS Applications in Crop Science

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S. No.

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EP2199304A1 EP1974049A2

Astrid Blau, Metanomics GmbH Beate Kamlage, Ralf Looser, Gunnar Plesch, Piotr Puzio, Oliver Schmitz, Bright Wendel

17

EP2344644A1

Markus Frank, Gunnar Plesh, Piotr Puzio

18

EP2390256A1

Steven Agrisoma Inc., Calyx Fabijanski, Bio-Ventures Inc. Carl Parez, Edward Pekins

BASF Plant Science GmbH

Process for the control It relates further to a process for the of production of fine control of the production of fine chemicals chemical in a microorganism, a plant cell, a plant, a plant tissue, or in one or more parts thereof. The invention furthermore relates to nucleic acid molecules, polypeptides, nucleic acid constructs, vectors, antisense molecules, antibodies, host cells, plant tissue, propagation material, harvested material, plants, microorganisms, as well as agricultural compositions and to their use Methods for It relates to the control of producing pathogens. Disclosed herein are transgenic plant cell, methods of producing transgenic a plant or a part plants with increased pathogen thereof with resistance, expression vectors increased resistance comprising polynucleotides to biotic stress encoding for functional proteins, and transgenic plants and seeds generated thereof Plant artificial Methods for preparing cell lines that chromosomes, use contain plant artificial thereof and methods chromosomes, methods for the of preparing plant preparation of plant artificial artificial chromosomes, methods for the chromosomes targeted insertion of heterologous DNA into plant artificial chromosomes, and methods for the delivery of plant chromosomes to selected cells and tissues are provided

12/19/2005

6/23/2010

9/28/2009

7/20/2011

5/30/2002

11/30/2011

Intellectual Property Rights in Plant Biotechnology

16

(continued)

637

638

List of Some Patents in Plant Biotechnology S. No.

Patent No.

Inventor

Assignee

19

W0 2010091248 US20100204921 EP2399214

Byrum J. Clarke Syngenta JDV, Guo Z, Participations Gutierrez RLA, (Basel) Kishore VK, Li M, Wang D

20

US20120035354

Bloksberg LN, Havukkala I

21

EP2424372A2

Niranjan Jeneil Bio surfactant Ramanlal Company LLC Gandhi, Palmer Victoria Skebba, A. Gary Strobbel/

ArborGen (Summerville, SC, USA), Rubicon Forests Holdings (Auckland, NZ)

Title Method for selecting statistically validated candidate genes

Description

Filing Date

A method of selecting one or more 2/6/2009, markers associated with a trait of 2/4/2010 interest in a species of interest, comprising identifying markers associated with the trait of interest in a population of the species using a suitably programmed computer to perform genome-wide association mapping Materials and A polynucleotide isolated from 3/9/2011 methods for the Eucalyptus grandis and Pinus radiata, modification of plant useful for modifying the content, lignin content structure, and composition of lignin in target organisms such as plants; useful for wood processing for producing paper, genome mapping, physical mapping, positional cloning of genes, and designing oligonucleotide probes and primers Antimicrobial Antimicrobial compositions 4/27/2010 compositions and comprising one or more compound related methods of components generally recognized use as safe for human consumption, and related methods of use, such compositions and methods as can be employed in a wide range of agricultural, industrial, building, pharmaceutical, and personal care products and applications

Issue Date 8/12/2010, 12/28/2011

2/9/2012

3/7/2012

OMICS Applications in Crop Science

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TABLE 20.1 (Continued)

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EP1874938B1

Christian BASF Plant Science Dammann, GmbH Christina E. Roche, Hee-Sook Song

23

US20120119080 WO2012068217

Hazabroek J, Janni J, Lightner J

24

CN102478563

Chang Y, Lu X, Xu G, Zhao C, Zhao Y, Zhou J

Starchy-endosperm and germinating embryo-specific expression in monocotyledonous plants

The present invention relates to the 4/13/2006 field of agricultural biotechnology. Disclosed herein are expression constructs with the expression specificity for the starchy endosperm and the germinating embryo, transgenic plants comprising such expression constructs, and methods of making and using such DNA constructs and transgenic plants Pioneer Hi-Bred Prediction of A method for establishing an 11/16/2011 (Johnston, IA, USA) phenotypes and unbiased model using the metabolic traits based on the profile, phenotype profile, and trait metabolome profile of two groups of plants, involving separating and extracting metabolites from two groups of plants by chromatography to generate a data set and comparing this to another data set generated using mass spectrometry Dalian Institute of A method for It claims an analysis method is 11/25/2010 Chemical Physics, researching simple and fast and the Chinese Academy of metabolic differences repeatability is good and suitable Sciences (Dalian, between transgenic for a real sample of mass analysis China) rice and nontransgenic rice, involving analyzing rice seed extracted by a liquid-phase chromatographymass spectrometry technology for obtaining a rice metabolic profile spectrum

4/4/2012

5/17/2012, 5/24/2012

Intellectual Property Rights in Plant Biotechnology

22

5/30/2012

(continued)

639

640

TABLE 20.1 (Continued) List of Some Patents in Plant Biotechnology Patent No.

Inventor

Assignee

25

EP2477477A1

Benjamin Edgar Donald Danforth Cahoon, G. Jan Plant Science Centre Jaworski, Nii Metabolix Inc. Patterson, P. Oliver Peoples, D. Kristi Snell, Jihong Tang, Wenyu Yang

26

US8247541B2

Ken W. Richards. Wesley G. Taylor

27

US20120220464A1 Sabine Evonik Goldschmidt EP2482647A1 Giessler-Blank, GmbH Martin Schillin, Ewald Sieverding

28

US20120225923

Thomas Himmler, Thomas Seitz, Ulrike WachendorffNeumann

Her Majesty the Queen in Right of Canada, as represented by The Minister of Agriculture and Agri-food

Bayer CropScience AG

Title

Description

Generation of high Transgenic oilseed plants synthesize polyhydroxybutyrate (poly)3-hydroxybutyrate (PHB) in producing oilseeds the seed. Genes utilized include phaA, phaB, and phaC, all of which are known in the art. The genes can be introduced in the plant, plant tissue, or plant cell using conventional plant molecular biology techniques Plant compositions It provided a method of producing a enriched in plant composition comprising dehydrosoyasaponin dehydrosoyasaponin I (D-I), the I (D-I) and methods method comprising the steps of of producing such extracting a plant flour with a compositions solvent capable of extracting soyasaponins to produce an extract, and treating the extract with light. Also provided are compositions produced according to the method of the present invention Use of sophorolipids Use of sophorolipids as adjuvants in and derivatives combination with pesticides as a thereof in tank mix additive and as a combination with formulation additive for crop pesticides as protection and for the industrial adjuvant/additive noncrop sector for plant protection and the industrial noncrop field Dithiinetetra(thio) Novel dithiinetetra(thio) carboximides carboximides for the control of harmful microorganisms in crop protection and in the protection of materials and as plant growth regulators

Filing Date

Issue Date

9/15/2010

7/25/2012

12/14/2007

8/21/2012

8/30/2010

8/30/2012

9/3/2011

9/6/2012

OMICS Applications in Crop Science

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S. No.

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US20120227132A1 Mei Guo, Howard P. Hershey, Carl R. Simmons

Pioneer Hi-Bred International Inc.

Cell number polynucleotides and polypeptides and methods of use thereof

30

EP2501219A1

Benjamin Agriculture Victoria Greame Cocks, Services Pty Ltd. Matthew Knight, Aidyn Mouradov, German Spangenberg, Jianghui Wang

Angiogenin expression in plants

31

US8283519B2

Robert A. Creelman, Neal I. Gutterson, Jacqueline E. Heard, et al.

Mendel Biotechnology Inc.

Plant transcriptional regulators of abiotic stress

32

US20120272408A1 Rudy Maor

Maor Rudy

Compositions and methods for enhancing plants resistance to abiotic stress

33

US20120272353A1 Mei Guo, Dale F. Loussaert, Yonjhong Wu

Pioneer Hi-Bred International Inc.

Methods to increase crop grain yield utilizing complementary paired growth and yield genes

It provides polynucleotides and related polypeptides of the protein CNR. The invention provides genomic sequence for the CNR gene. CNR is responsible for controlling cell numbers It relates to plant-produced angiogenins, to related plant cells, plant calli, plants, seeds, and other plant parts and products derived therefrom and to uses of plantproduced angiogenins. The present invention also relates to the expression of angiogenin genes in plants and to related nucleic acids, constructs, and methods It relates to plant transcription factor polypeptides, polynucleotides that encode them, homologs from a variety of plant species, variants of naturally occurring sequences, and methods of using the polynucleotides and polypeptides to produce transgenic plants A method of increasing the tolerance of a plant to an abiotic stress or increasing the biomass, vigor, or yield of a plant by upregulating within the plant an exogenous polynucleotide of a micro-RNA The specific genes increase female reproductive organs and are paired with genes responsible for modifying the growth of nonyieldspecific plant tissues

5/15/2012

9/6/2012

11/18/2010

9/26/2012

5/4/2004

10/9/2012

12/6/2010

10/25/2012

6/25/2012

10/25/2012

641

(continued)

Intellectual Property Rights in Plant Biotechnology

29

642

TABLE 20.1 (Continued) List of Some Patents in Plant Biotechnology Patent No.

Inventor

Assignee

US20120284876A1 Howard P. Pioneer Hi-Bred Hershey, Dale International Inc. Loussaert, Carl R. Simmons

35

US20120291154A1 Scott Anderson, Scott Anderson, James Crowley, James Crowley, Brandon J Brandon J Fabbri, Fabbri, Bo-Xing Qui, Steven Bo-Xing Qui, E. Screen Steven E. Screen

36

US8318436B2

37

Stephen Sapphire Energy Inc., Mayfield, The Scripps Michael Research Institute Mendez, Bryan O’ Neill, Yan Poon US20120324597A1 Yaakov Tadmor, The State of Israel, Yosef Burger, Ministry of Nurit Katzir, et Agriculture and al. Rural Development Research Organization

Title

Description

Filing Date

Genes for enhancing nitrogen utilization efficiency in crop plants

Issue Date

It provides isolated nitrogen 7/17/2012 utilization efficiency (NUE) nucleic acids and their encoded proteins. The present invention provides methods and compositions relating to altering nitrogen utilization and uptake in plants. The invention further provides recombinant expression cassettes, host cells and, transgenic plants Corn plants and seeds It relates to DNA constructs that 12/27/2011 enhanced for provide expression in the transgenic asparagine and corn cells of an asparagine protein synthetase enzyme. The DNA constructs are used in a method to produce transgenic corn plants and seeds and to select plants and seeds with enhanced levels of protein and amino acids Use of genetically It provides methods of producing 10/7/2011 modified organism one or more proteins, including to generate biomass biomass-degrading enzymes in a degrading enzymes plant

11/8/2012

Melon plants comprising tetra-cis-lycopene

12/20/2012

A Cucumis melo plant is disclosed, wherein the flesh of the fruit of the plant comprises tetra-cis-lycopene (prolycopene). Methods of generating same are also disclosed

2/22/2011

11/15/2012

11/27/2012

OMICS Applications in Crop Science

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S. No. 34

List of Patents for Selectable Markers Used in Transgenic Technology

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S. No.

Patent No.

Inventor

Assignee

Title

1

EP0289478A2

Maria Burmaz Hayford, Harry John Klee, Stephen Gary Rogers

Monsanto

Gentamicin marker genes for plant transformation

2

EP0800583A1 US5633153

M. Virginia Ursin

Calgene Inc.

Aldehyde dehydrogenase markers for plant transformation

3

EP1090134A1 US6284956

Ning Huang, L. Raymond Rodriguez

Applied Phytologics Inc.

Plant selectable marker and plant transformation method

4

EP0698106B1 EP0698106A1 US5962768

Marcus Cornelissen, Veronique Gossele, Arlette Reynaerts, Roel Van Aarssen

Aventis CropScience N.V.

Marker gene

Description

Issue Date

4/26/1988

11/2/1988

10/12/1995

11/15/1997

6/25/1999

4/11/2001

5/11/1994

8/1/2001

(continued)

643

It involves the use of a selectable plant marker gene encoding a gentamicin-3N-acetyltransferase enzyme. The invention also provides transformed plant cells that contain the gentamicin marker genes as well as differentiated plants containing transformed plant cells It relates to a method of plant transformation in which plant cells are transformed with an aldehyde dehydrogenase gene capable of detoxifying a phytotoxic aldehyde selective agent. The gene construct is linked to another gene construct of interest for expression in plant cells, wherein the aldehyde dehydrogenase gene acts as a selectable marker for transgenic plant cells It relates to plant transformation expression cassettes with a selectable marker gene. The cassette contains a DNA promoter sequence from the rice beta-glucanase 9 (gns9) gene, a selectable marker gene and a 3’ untranslated terminator region in 5’-3’ direction The application discloses a method to select and identify transformed plant cells by expressing a chimeric gene encoding an aminoglycoside-6’-Nacetyltransferase in the plant cells in the presence of an aminoglycoside antibiotic

Filing Date

Intellectual Property Rights in Plant Biotechnology

TABLE 20.2

644

TABLE 20.2 (Continued) List of Patents for Selectable Markers Used in Transgenic Technology S. No.

6

7

Inventor

Assignee

EP1171620A1 US7148398

V. Oleg Bougri, Monsanto T.M Caius Technology Rommens, LLC Neelam Srivastava, M. Kathleen Swords EP1368484A2 Jeffrey L. Dangle, Thomas Eulgen, Jane Glazebrook, Xun Wang, Tong Zhu EP1370650A2 Alfred Puhler Bayer US20050081267 CropSciences N.V.

8

EP1781821A2 US7507874

Feng Han, Pioneer Bradley Hedges, Hi-Bred Hong Lu, Scott International Sebastian, Debra Inc. Steiger

9

EP1871879A1

Ronald Koes, Francesca Quattrocchio, Kees Spelt, Walter Verweij

International Flower Development Proprietary Ltd.

Title Acquired resistance genes in plants

Description

Filing Date

It describes new acquired resistance 5/12/2000 genes in plants. A method of using the genes to make transgenic plants that are resistant to disease is also provided

Plant genes, the Methods to identify genes, the expression of which are expression of which are altered in altered by pathogen response to pathogen infection, are infection provided, as well as the genes identified thereby Novel genes for It relates to novel DNA molecules conditional cell ablation encoding a protein having the biological activity of a deacetylase. These genes are particularly useful for the production of transgenic plants with plant parts that can be destroyed by treatment with N-acetyl-PPT Genetic loci associated It relates to methods and compositions with Phytophthora for identifying soybean plants that are tolerance in soybean tolerant, have improved tolerance, or are susceptible to Phytophthora root rot infection. The methods use molecular genetic markers to identify, select, and construct disease-tolerant plants or identify and counterselect diseasesusceptible plants Plant genetic sequences It provides genetic and proteinaceous with vacuolar pH and agents capable of modulating or uses thereof altering the level of acidity or alkalinity in a cell, a group of cells, an organelle, a part, or a reproductive portion of a plant

Issue Date 1/16/2002

9/14/2001

12/10/2003

3/12/2002

12/17/2003

8/8/2005

5/9/2007

4/4/2006

1/2/2008

OMICS Applications in Crop Science

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5

Patent No.

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Helaine Carrer, Sumita Chaudhary, Pal Maliga

Rutgers, The State University of New Jersey

Editing-based selectable plastid marker genes

11

EP2102364A2 Sadik El Sayed, Pioneer US20080178325 Eric Hoeft, Hi-Bred US20110041214 Zenglu Li, International US7872170 Lomas Tulseiram Inc.

Genetic markers for Orobanche resistance in sunflower

12

EP2121982A2

Maize plants characterized by quantitative trait loci (qtl)

13

EP2152063A1 Henricus Maria EP1949785A1 Clemens Nicolaas EP1949785A9 De Vetten, Evert US20100146662 Jacobsen, Gerard Andries Edwin Van der Vossen, Franciscus Gerardus Richard Visser, Agnes Maria Anna Wolters

Pascal Delage, Syngenta Denis Participation Lespinasse, AG Jean-Paul Muller, Michel Ragot

Use of R-genes as a selection marker in plant transformation and use of cis-genes in plant transformation

It relates to novel DNA constructs for selecting plastid transformants in higher plants. Also disclosed are editing-based selectable marker genes that require editing at the transcriptional level for the expression of the selectable marker gene Methods for identifying sunflower plants or germplasm that display resistance, improved resistance, or susceptibility to Orobanche cumana are provided. Sunflower plants or germplasm that are resistant or have improved resistance to Orobanche cumana are created It relates to maize plants with a genome comprising a unique allele profile associated with the corresponding QTLs contributing to the expression of a variety of phenotypic traits of economic interest selected from the group of grain yield, grain moisture at harvest, early and late root lodging, stalk lodging, common smut incidence, fusarium ear rot incidence, sυlcotrione resistance, and tassel architecture It discloses plant transformation of Solanaceae, potato in particular. Potato plant with functional R-genes to provide resistance against Phytophthora infestans, wherein the said R-gene can be used as a selectable marker

6/13/1997

5/21/2008

12/27/2007

9/23/2009

1/18/2008

11/25/2009

1/28/2008

2/17/2010

(continued)

645

EP0960209B1

Intellectual Property Rights in Plant Biotechnology

10

646

TABLE 20.2 (Continued) List of Patents for Selectable Markers Used in Transgenic Technology S. No.

15

16

17

Inventor

EP1521835B1 Mariette EP1521835A1 Andersson, Per EP2202311A2 Hofvander, EP2292768A1 Adelina US20060174366 Trifonova EP2210951A2 Carl F. Beher, Gregoery R. Heck, Catherine Hironaka, Jinsong You

Assignee BASF Plant Science GmbH

Monsanto Technology LLC

EP2356243A1 M. Stephen Allen, E.I. du Pont de US20100122370 Singh Nemours and US20110283415 Kanwarpal Company, Dhugga Susanne Pioneer Groh, Victor Hi-Bred Llaca, Stanley International Luck, Bernhard Inc. Rietmann EP1545190B1 Fang-Ming Lai, S. BASF Plant Benoit Landry Science GmbH DNA landmarks Inc.

Title

Description

Use of ahas It is about the mutated AHAS genes (acetohydroxy acid conferring resistance to herbicides and synthase) mutant genes providing an efficient system for the as a selection marker in selection of transgenic potato lines potato transformation Corn event PV-ZMGT32 It is about a DNA construct that (NK603) and provides tolerance to transgenic corn compositions and plant. It also provide assays for methods for detection detecting the presence of the thereof PV-ZMGT32(nk603) corn event based on the DNA sequence of the recombinant construct inserted into the corn genome and of genomic sequences flanking the insertion site Genetic loci associated It is about methods and compositions with cell wall for identifying maize plants with digestibility in maize increased cell wall digestibility. It uses molecular markers to identify and select plants with increased cell wall digestibility or to identify and counterselect plants with decreased cell wall digestibility Male sterility restoration It provides for the fertility restorer as a selectable marker genes to restore fertility in Brassica in plant transformation napus. It also includes vectors that have male sterility genes flanked by recombinase sites, a fertility restorer gene, and a nucleotide sequence of interest flanked by recombinase sites, and methods of using such vectors to produce transgenic plants, using the restoration of male fertility as the selection for transformation events

Filing Date

Issue Date

7/3/2003

3/10/2010

6/15/2001

7/28/2010

11/6/2009

8/17/2011

8/25/2003

6/20/2012

OMICS Applications in Crop Science

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14

Patent No.

Downloaded by [Debmalya Barh] at 11:48 10 February 2014

US8278505B2 Justin M. Lira, EP2145007A2 Donald J. Merlo, US20100251432 Andrew E. Robinson, Erika Megan Snodderley, Terry R. Wright

19

EP2515630A2

Dow Agrosciences

Genetic markers associated with drought tolerance in maize

It provides novel plants that are resistant 5/9/2008 to 2,4-D and pyridyloxyacetate herbicide. The invention also provides novel methods of preventing the development of, and controlling, strains of weeds that are resistant to one or more herbicides such as glyphosate. The main enzyme and gene for use are referred to as AAD-13 (aryloxyalkanoate dioxygenase) It provides methods and compositions 12/23/2010 for identifying, selecting, and producing drought-tolerant maize plants or germplasm. The subject matter relates to maize lines, such as Zea mays lines, with one or more improved water optimization genotypes, and methods for breeding that involve genetic marker analysis and nucleic acid sequence analysis

10/2/2012

10/31/2012

(continued)

647

Paul Altendorf, Syngenta John Arbuckle, Participations William Briggs, AG Christine Chaulk-Grace, Dallas Joseph Clarke, Gayle Dace, Molly Dunn, David Foster, Sonali Gandhi, Andres Libardo Gutierrez Rojas, Krishna Venkata Kishore, Vance Cary Kramer, Denise Kari Kust, Meijuan Li, Lynn Robert Miller, Martin Nicolas, Joseph Thomas Prest Tucker Jon Aaron Reinders, Allen Sessions, Wayne Dale Skalla, Daolong Wang, Todd Warner, Chris Zinselmeier

Herbicide resistance genes for resistance to aryloxyalkanoate herbicides

Intellectual Property Rights in Plant Biotechnology

18

List of Patents for Selectable Markers Used in Transgenic Technology S. No. 20

Patent No. EP2531601A1

Inventor Flavie Coulombier, Helene Eckert, Yannick Favre, Bernard Pellisier

Assignee Bayer CropScience AG

Title

Description

Filing Date

Soybean transformation It relates to the Agrobacterium-mediated 2/1/2011 using transformation of soybean hydroxyphenylpyruvate organogenic tissue using a gene or dioxygenase (HPPD) genes for tolerance to HPPD inhibitors inhibitors as selecting as selection marker. The methods for agents regenerating transgenic soybean plants from the said transformed soybean cells or tissue are also covered in the application

Issue Date 12/12/2012

OMICS Applications in Crop Science

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648

TABLE 20.2 (Continued)

List of Patents for Plant Genetic Transformation Technology

Downloaded by [Debmalya Barh] at 11:48 10 February 2014

S. No.

Patent No.

Inventor

Assignee

Title

Description

It relates to a novel method for efficiently carrying out pollenmediated gene transformation of flowering plants by utilizing novel DNA constructs incorporating exogenous DNA fragments coding for specific enzymes Method for transporting It relates to inert or biologically active substances into living particles that are propelled at cells at a cells and tissues and speed whereby the particles penetrate apparatus there for the surface of the cells and become incorporated into the interior of the cells. The apparatus for propelling the particles toward target cells or tissues are also disclosed Particle-mediated It relates to the method and apparatus transformation of for the genetic transformation of soybean plants and soybean plants by particle-mediated lines transformation. Foreign genes are introduced into regenerable soybean tissues by coating on carrier particles that are physically accelerated into plant tissues Ballistic transformation A method of transforming conifers with of conifers a DNA construct comprising an expression cassette is disclosed herein. It involves propelling the DNA construct to the plant tissue target at a velocity sufficient to pierce the cell walls and deposit the DNA construct within a cell of the target tissue

Filing Date

Issue Date

1

EP0275069 A2

Charles J. Arnizen, E.I. DuPont de Pollen-mediated gene Lorin R. DeBonte, Nemours, DNA transformation in Jr., David A. Plant Technology plants Evans, Willie H. Inc. Loh, Joan T. O’Dell

1/11/1988

7/20/1988

2

US4945050

John C. Sanford, Edward D. Wolf, Nelson K Allen

Cornell Research Foundation Inc.

11/13/1984

7/31/1990

3

US5015580

Paul Christou, Dennis McCabe, William F. Swain, Kenneth A. Barton

Agracetus

5/12/1988

5/14/1991

4

US5122466

Anne-Marie Stomp, North Carolina Arthur K. State University Weissinger, Ronald R. Sederoff

6/13/1989

6/16/1992

649

(continued)

Intellectual Property Rights in Plant Biotechnology

TABLE 20.3

650

TABLE 20.3 (Continued) List of Patents for Plant Genetic Transformation Technology Patent No.

Inventor

Assignee

Title

5

US5169770

Paula P. Chee, Stephen L. Goldman, Anne C.F. Graves, Jerry L. Slightom

The University of Toledo

Agrobacterium-mediated transformation of germinating plant seeds

6

US5231019

Jerzy Paszkowski, Ingo Potrykus, Barbara Hohn, Raymond D. Shillito, Thomas Hohn, Michael W. Saul, Vaclav Mandak

Ciba-Geigy Corporation

Transformation of hereditary material of plants

7

US5371003

Lynne E. Murry, Sandoz Ltd. Ralph M. Sinibaldi, Paul S. Dietrich, Sharon C.H. Alfinito

Electrotransformation process

8

US5384253

Richard A. Krzyzek, DeKalb Genetics Cheryl R. M. Corporation Laursen, Paul C. Anderson

10

US5538877

Ronald C. Lundquist, David A. Walters

Genetic transformation of maize cells by electroporation of cells pretreated with pectin-degrading enzymes Method for preparing fertile transgenic corn plants

DeKalb Genetics Corporation

Description The present invention relates to a nontissue culture process using Agrobacterium-mediated vectors to produce transgenic plants from seeds of such plants as the common bean and soybean It comprises a novel method for direct foreign gene transfer to a plant cell. The method provides for placing a gene under the control of plant expression signals and transferring it, by contact with protoplasts without the aid of natural systems for infecting plants, directly to the plant cells from which genetically transformed plants can subsequently be derived It relates to a novel processes for introducing DNA into plant material utilizing nonpulsed electric current, and plant cell lines, differentiated plant tissues, and plants produced by said processes It provides a method to increase the susceptibility of cultured Zea mays cells to stable transformation with recombinant DNA via electroporation, by pretreating the Zea mays cells with certain pectin-degrading enzymes Fertile transgenic Zea mays plants that stably express heterologous DNA and a process for producing said plants is disclosed. The process comprises the microjectile bombardment of friable embryogenic callus from the plant to be transformed

Filing Date

Issue Date

6/21/1990

12/8/1992

2/23/1990

7/27/1993

9/23/1993

12/6/1994

12/28/1990

1/24/1995

11/10/1992

7/23/1996

OMICS Applications in Crop Science

Downloaded by [Debmalya Barh] at 11:48 10 February 2014

S. No.

Downloaded by [Debmalya Barh] at 11:48 10 February 2014

US5563055

12

US5591616

13

US5681730

14

US5693512

15

US5859327

Jeffrey A. Townsend, Laurie A. Thomas

Pioneer Hi-Bred Method of International Inc. Agrobacteriummediated transformation of cultured soybean cells

3/28/1994

10/8/1996

5/3/1994

1/7/1997

12/21/1993

10/28/1997

3/1/1996

12/2/1997

8/22/1995

1/12/1999

(continued)

651

A method for producing transgenic soybean plants is disclosed. The method employs conditions necessary for genotype-independent, Agrobacterium-mediated transformation of soybean explants and the utilization of a specialized medium to cause root induction Yokoh Hiei, Japan Tobacco Inc. Method for It provides a method for transforming a Toshihiko Komari transforming monocotyledon by transforming a monocotyledons cultured tissue during a dedifferentiation process or a dedifferentiated cultured tissue of said monocotyledon with a bacterium belonging to the genus Agrobacterium containing a desired gene David E. Ellis Wisconsin Alumni Particle-mediated It involves accelerated particle Research transformation of transformation of gymnosperms. Foundation gymnosperms Somatic embryos are produced by the callus and then subjected to an accelerated particle transformation process. The treated embryos are then induced to form embryogenic callus cultures and selected for the presence of gene products coded by the introduced genes John J. Finer, Harold The Ohio State Method for The plant sample to be transformed is N. Trick Research transforming plant sonicated in the presence of a vector, Foundation tissue by sonication preferably Agrobacterium, containing the gene of interest. Then the sample is cultured to induce morphogenesis to form the transformed plant S.B. Dev. Yasuhiko Genetronics Inc. ElectroporationIt provides a method for producing a Hayakawa mediated molecular genetically modified plant by transfer in intact plants introducing a polynucleotide to an intact plant or plant cell(s) by electroporation, in the absence of cell wall-degrading enzymes

Intellectual Property Rights in Plant Biotechnology

11

652

TABLE 20.3 (Continued)

S. No.

Patent No.

16

US5932782

17

US6369298

18

US6384301

19

US6455761

Inventor Dennis Bidney

Assignee

Title

Pioneer Hi-Bred Plant transformation International Inc. method using Agrobacterium species adhered to microprojectiles

Description

It provides for high rates of stable transformation when bacteria of the species Agrobacterium are applied to particles that are used in a typical particle gun in a manner that retains their viability after the dry-down process involved in microparticle bombardment Agrobacterium-mediated The method involves infection with Tishu Cai, Dorothy Pioneer Hi-Bred Agrobacterium, particularly those A. Pierce, Laura A. International Inc. transformation of Tagliani, Zuo-Yu sorghum comprising a super-binary vector. In Zhao this manner, any gene of interest can be introduced into the sorghum plant Brian J. Martinell, Monsanto Soybean Agrobacterium The method is based on an Lori S. Julson, Technology LLC transformation method Agrobacterium-mediated gene delivery Carol A. Emler, to individual cells in a freshly Yong Huang, germinated soybean meristem, Dennis E. McCabe, wherein cells are induced directly to Edward J. form shoots and give rise to transgenic Williams plants. This method does not involve a callus-phase tissue culture and is rapid and efficient Viktor Kuvshinov, Helsinki Agrobacterium-mediated It relates to a novel transformation Kimm o Koivu, University transformation of protocol for obtaining transgenic Anne Kanerva, Licensing Ltd. turnip rape turnip rape plants with AgrobacteriumEija Pehu mediated transformation. In the protocol, an internode section of the inflorescence-carrying stem of mature turnip rape is used as explant

Filing Date

Issue Date

11/14/1990

8/3/1999

4/7/1998

4/9/2002

1/14/2000

5/7/2002

3/10/2000

9/24/2002

OMICS Applications in Crop Science

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List of Patents for Plant Genetic Transformation Technology

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US6822144

Zuo-Yu Zhao, Pioneer Hi-Bred Methods for Weining Gu, Tishu International Inc. AgrobacteriumCai, Dorothy A. mediated Pierce transformation

21

US7064248

Ronald C. DeKalb Genetics Lundquist, David Corporation A. Walters, Julie A. Kirihara

Method of preparing fertile transgenic corn plants by microprojectile bombardment

22

US7161064

Anne-Marie Stomp, Nirmala Rajbhandari

Method for producing stably transformed duckweed using microprojectile bombardment

North Carolina State University

It relates to methods for improving the 11/3/1997 transformation frequency of Agrobacterium-mediated transformation of maize embryos by contacting at least one immature embryo from a maize plant with Agrobacterium capable of transferring at least one gene to said embryo; cocultivating the embryos with Agrobacterium; culturing the embryos in medium comprising N6 salts, an antibiotic capable of inhibiting the growth of Agrobacterium, and a selective agent to select for embryos expressing the gene; and regenerating plants expressing the gene A method of preparing fertile 3/27/2001 transgenic Zea mays (corn) plants that stably express DNA encoding a Bacillus thuringiensis endotoxin, so as to impart insect resistance to the fertile transgenic plants is disclosed. It involves bombarding regenerable corn cells with DNA-coated microprojectiles and regenerating fertile transgenic plants from the transformed cells Efficient transformation of duckweed 10/18/2002 by ballistic bombardment is disclosed. Transformed duckweed plant tissue culture and methods of producing recombinant proteins and peptides from transformed duckweed plants are also included

11/23/2004

6/20/2006

Intellectual Property Rights in Plant Biotechnology

20

1/9/2007

(continued)

653

List of Patents for Plant Genetic Transformation Technology S. No.

Patent No.

Inventor

Assignee

Title

23

US7611898

Zengyu Wang, Yaxin Ge

The Samuel Roberts Noble Foundation

Agrobacterium transformation of stolons

24

US8030076

Brian J. Martinell, Lori S. Julson, Carol A. Emler, Yong Huang, Dennis E McCabe, Edward J. Williams

Monsanto Technology LLC

Soybean transformation method

Description

Filing Date

It provides methods for transforming 5/9/2006 monocotyledonous plants with Agrobacterium using stolons as a target tissue. The invention allows the creation of transgenic plants without the need for a callus as a target tissue for transformation, thus providing a rapid method for the production of transgenic plants It is about Agrobacterium-mediated 11/12/2008 germ line genetic transformation of soybean. The method is based on Agrobacterium-mediated gene delivery to individual cells in a freshly germinated soybean meristem, from which cells can be induced directly to form shoots that give rise to transgenic plants

Issue Date 11/3/2009

10/4/2011

OMICS Applications in Crop Science

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654

TABLE 20.3 (Continued)

List of Patents Granted for Biotechnological Innovations in Some Important Crops

Downloaded by [Debmalya Barh] at 11:48 10 February 2014

S. No. Rice 1

Patent No.

Inventor

Assignee

Title

EP1539949 A4 EP1539949A2 US6956115

B. Manuel Sainz, John Salmeron

Syngenta Participations AG

Nucleic acid molecules from rice encoding rar1 disease resistance proteins and uses

2

EP1960528 A2 US20090328248

Jan Theodoor Michiel De Both et al.

Keygene N.V

Constitutive plant promoters

3

US20120240292 A1 EP2471808A1

Xinjie Xia

Xia Xinjie

Proteins relating to grain shape and leaf shape of rice, coding genes and uses thereof

4

US8283536 B1

Billy Gene Jordan, Jose Vicente Re

Ricetec AG

Rice hybrid XP753

5

US8318636 B2

Emily Alff, Harsh Bais, Darla Janine Sherrier

University of Delaware

Compositions and methods for improving rice growth and restricting arsenic uptake

Description It relates to methods of enhancing the expression of resistance genes, disease resistance signal transduction genes, genes involved in mediating disease resistance or those involved in the synthesis of molecules mediating disease resistance Strong, constitutive plant promoters referred as AA6 promoters under biotic and abiotic stress conditions. It also provides the methods for expressing nucleic acid sequences using AA6 promoters Transgenic rice overexpressing OsXCL gene present phenotypes as increases of grain length, grain weight, and number of grains per panicle, and leaf rolling and also includes a method for obtaining transgenic plants The invention relates to the seeds of rice hybrid XP753, to the plants of rice hybrid XP753 and to methods for producing a rice plant produced by crossing the hybrid XP753 with itself or another rice plant It relates to administering one or more rice rhizosphere isolates to a plant, particularly a rice plant, to the seed of the plant, or to the soil surrounding the plant in an amount effective to inhibit infection by a plant pathogen, particularly rice blast, to increase the biomass of the plant, and to decrease arsenic uptake by the plant

Date of Filing

Date of Issue

11/27/2002

11/30/2005

12/12/2006

8/27/2008

7/8/2010

9/20/2012

10/10/2011

10/9/2012

03/01/2011

11/27/2012

655

(continued)

Intellectual Property Rights in Plant Biotechnology

TABLE 20.4

656

List of Patents Granted for Biotechnological Innovations in Some Important Crops S. No.

Patent No.

Maize 1 EP0721509A1

Inventor

Assignee

C. Paul Anderson et al.

DeKalb Genetics Corporation

Title Fertile, transgenic maize plants and methods for their production Generation of plants with improved drought tolerance

2

EP1685242A2

Catherine Anderson et al.

Agrigenetics Inc.

3

EP2503872A1

C.C. Paul Feng et al.

Monsanto Technology Transgenic maize LLC event mon 87427 and the relative development scale

4

US8330006 B2

Alain Murigneux et al.

Biogemma

Maize with good digestibility and disease resistant

5

US8338677B1

Gustavo Marcelo Garcia

Pioneer Hi-Bred International Inc.

Inbred maize variety PH13C9

Description It relates to a reproducible system for the production of stable, genetically transformed maize cells, and to methods of selecting cells that have been transformed It is directed to plants that display a drought tolerance phenotype due to altered expression of a DRO5 nucleic acid. The invention is further directed to methods of generating plants with a drought tolerance phenotype It provides transgenic maize event MON 87427, its nucleotide, roundup hybridization system (RHS), and relative development stages useful for monitoring and determining the reproductive development in maize It relates to the field of the improvement of the digestibility and the tolerance of maize to fungal pathogens and especially to fusariosis by modification of the C4H gene A novel maize variety designated PH13C9, its method of production and its genetic material, one or more traits introgressed into PH13C9 through backcross conversion and transformation, and to the maize seed, plant, and plant part produced thereby

Date of Filing

Date of Issue

8/24/1994

7/17/1996

6/23/2004

4/20/2011

11/16/2010

10/3/2012

10/23/2007

12/11/2012

5/25/2010

12/25/2012

OMICS Applications in Crop Science

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TABLE 20.4 (Continued)

Downloaded by [Debmalya Barh] at 11:48 10 February 2014

1

EP0375092B1

Dr. Wolf-Bernd Institut Fuer Frommer et al. Genbiologische Forschung Berlin GmbH

Potato tuber specific Use of the regulatory region (promoter) of transcriptional the 1527 kb long DraI/DraI fragment regulation which is located on the KpnI/HindIIIfragment of the patatin gene B33

12/18/1989

1/24/1996

2

EP1425958A1

The Coöperatieve designation of Verkoop- en the inventor Productievereniging has not yet van Aardappelmeel been filed en Derivaten

Potatoes with increased protein content

It provides a potato plant or part derived thereof having at least one amf-allele, the said potato plant or part is further provided with an increased capacity to store a protein as characterized by the increased protein content of its tubers

12/4/2002

6/9/2004

3

EP1734123A1

Per Hofvander et al.

BASF Plant Science GmbH

Genetically engineered modification of potato to form amylopectin-type starch

The function of the GBSS gene and thus the 12/20/1991 amylose production in potato are inhibited by using completely new antisense constructs. The genomic GBSS gene is used as a basis in order to achieve an inhibition of GBSS and consequently of the amylose production

12/20/2006

4

US20120311734

Ian S. Curtis et al.

The Texas A&M University System

Potato transformation compositions, systems, methods, microorganisms, and plants

A method of transforming and transfecting an Atlantic potato plant, its growth, removal of leaf sections, its cultivation and transformation through Agrobacterium

6/4/2012

12/6/2012

5

US8330005B2

Robert W. Hoopes

Frito-Lay North America Inc.

Potato cultivar FL 2137

A potato cultivar designated FL 2137 produced by crossing potato cultivar FL 2137 with itself or with another potato variety

3/6/2008

12/11/2012

Intellectual Property Rights in Plant Biotechnology

Potato

(continued)

657

658

TABLE 20.4 (Continued) List of Patents Granted for Biotechnological Innovations in Some Important Crops Patent No.

Brassica 1 EP2144490A1

Inventor

Assignee

R. Wayne Leitch et al.

Pioneer Hi-Bred International Inc.

2

US7741541

Naveen Chandra Bisht, Arun Jagannath, Vibha Gupta et al.

Viterra Inc. Dhara Vegetable Oil and Food Corporation Ltd.

3

EP2480065A1

William Briggs et al.

Syngenta Participations AG

4

US8304610

Daryl Males et al.

Viterra Inc.

Title High oil hybrid Brassica line 46p50

Description

The Brassica hybrid produces seeds having an average weight of oil per gram of mature dried seed that is between about 2.7% and 3.3% points higher than that produced by current commercial hybrids when grown under the same environmental condition A novel method for The invention relates to the simultaneous obtaining use of two different gene sequences improved fertility encoding the same protein product, one restorer lines for being the naturally occurring wild-type transgenic sequence and the other sequence being male-sterile crop generated by modification of the wild-type plants and a DNA sequence for expression in crop plants by construct for use in using codon degeneracy. Each of the said said method sequences being placed under independent transcriptional control of different overlapping plant tissue-specific regulatory elements in the same DNA construct Brassica oleracea It relates to the methods of making such plants resistant to plants and for producing seeds. It also Albugo candida includes molecular markers and their use in marker-assisted breeding and for identifying the Albugo candida resistance trait in Brassica oleracea plants Brassica juncea lines It provides Brassica juncea plants, seeds, with high oleic cells, nucleic acid sequences, and oils. acid profile in seed Edible oil derived from plants of the oil invention may have significantly higher oleic acid content than other B. juncea plants

Date of Filing

Date of Issue

4/24/2008

1/20/2010

7/7/2003

6/22/2010

9/19/2010

8/1/2012

2/25/2008

11/6/2012

OMICS Applications in Crop Science

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S. No.

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US20120304338

Igor Falak et al. Pioneer Hi-Bred International Inc.

6

EP2543731A1

Kening Yao et al.

Viterra Inc.

Jason Barnett et al.

Syngenta Participations AG

Cotton 1 EP1917358 A2

2

EP2035459 B1

Bernard Bizzini Franzoni Filati S.P.A. et al.

3

EP2333082

John W. Pellow Dow AgroSciences et al. LLC

It provides Brassica plants and lines having 8/6/2012 an improved Sclerotinia sclerotiorum disease incidence (SSDI%) score and is represented by, or descended from, ATCC accession number PTA-6779 or PTA-6778 Herbicide-resistant It provides transgenic or nontransgenic 4/3/2008 Brassica plants and plants with improved levels of tolerance to methods of use AHAS-inhibiting herbicides

11/29/2012

Transgenic cotton insecticide CE44-69D expressing cry1ab

5/7/2008

Sclerotinia-resistant Brassica

12/16/2009

6/15/2011

(continued)

659

It relates to a specific event, designated 5/15/2006 CE44-69D. The application also relates to polynucleotides that are characteristic of the CE44-69D event, plants comprising of the said polynucleotides, and methods of detecting the CE44-69D event Covalent conjugates The conjugates obtained by the new process 5/22/2007 of cotton and are characterized by high stability, while substitutes (viscose, maintaining in the long-term the antiseptic, modal cotton) with sanitizing, acaricidal, and insect repellent bioactive activity imparted by the procedure substances having described antiseptic, sanitizing, acaricidal, and insect repellent activity, and a method for obtaining them Cry1F and Cry1AC It relates to plant breeding and the protection 10/13/2004 transgenic cotton of plants from insects. The present invention lines and provides DNA and related assays for event-specific detecting the presence of certain insect identification resistance events in cotton. The assays are thereof based on the DNA sequences of recombinant constructs inserted into the cotton genome and of the genomic sequences flanking the insertion sites

1/9/2013

Intellectual Property Rights in Plant Biotechnology

5

660

TABLE 20.4 (Continued) List of Patents Granted for Biotechnological Innovations in Some Important Crops Patent No.

Inventor

Assignee

Title

4

EP1417312B1

Marc De Beuckeleer et al.

Bayer Bioscience N.V.

5

US20120255050 A1

Ronald J. Brinker et al.

Ronald J. Brinker et al Cotton transgenic event mon 88701 and methods of use thereof

David G. Holder

U.S. Sugar Corporation

Board of Supervisors of Louisiana State University and Agricultural and Mechanical College Syngenta Participations AG

Sugarcane 1 USPP10839

2

USPP18826

Kenneth A et al.

3

EP2456893 A1

Pierluigi Barone et al.

Herbicide-tolerant cotton plants and methods for producing and identifying same

Sugarcane variety CL77-797

Date of Filing

Date of Issue

It pertains to transgenic cotton plants, plant 7/19/2002 material, and seeds, characterized by harboring a specific transformation event, particularly by the presence of a gene encoding a protein that confers herbicide tolerance, at a specific location in the cotton genome It provides cotton event MON 88701, and 4/13/2012 plants, plant cells, seeds, plant parts, and commodity products comprising event MON 88701. The invention also provides polynucleotides specific for event MON 88701 and plants, plant cells, seeds, plant parts, and commodity products comprising polynucleotides specific for event MON 88701

9/14/2011

Description

A cross between a female variety known as 2/8/1996 CL61-620 with a mixture of male varieties has produced an improved variety of sugarcane Sugarcane variety A new variety of sugarcane, identified as 11/15/2006 named L99-233 L99-233, is disclosed as having superior sugarcane rust-disease resistance, excellent ratooning ability, and high sugar/sucrose content and cane yield characteristics Sugarcane It is generally related to sugarcane mini7/23/2010 centromere chromosomes and recombinant sequences and chromosomes containing sugarcane mini-chromosomes centromere sequences; it also includes sugarcane mini-chromosomes with novel compositions and structures are used to transform sugarcane cells, which are, in turn, used to generate sugarcane plants

10/4/2012

3/23/1999

5/20/2008

5/30/2012

OMICS Applications in Crop Science

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S. No.

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US8252976 B2

Elke Hellwege, Karola Knuth

Bayer CropScience AG

Sugarcane plants with an increased storage carbohydrate content

It relates to a method for increasing the storage carbohydrate content of sugarcane plants

8/24/2010

Tea 1

US6930227

Misako Mizuno Mitsui Chemicals Inc. Camellia sinensis et al. gene encoding a caffeine synthesis associated with N-methyl transferase

8/16/2005

2

EP1349560 B1

Yu Kuang Chen et al.

Rutgers, The State University of New Jersey

7/11/2012

3

EP2491939 A1

Michael Koganov

Michael Koganov

4

EP2510014 A1

Ruud Albers et al.

Hindustan Unilever Ltd.

It makes it possible to efficiently produce an 5/25/2000 N-methyl transferase with 7-methylxanthine N3 methyl transferase, theobromine N1 methyl transferase, and paraxanthine N3 methyl transferase activities that can be utilized as an industrial, food, or medical enzyme Black tea extract for Compositions and methods for preventing 11/14/2001 prevention of and treating disease are provided. The disease compositions are extracts of black tea that include a mixture of theaflavin-3-gallate and theaflavin-3’-gallate Bioactive It relates to methods for isolating bioactive 1/12/2005 compositions from fractions derived from cell juice or a cell Theacea plants and wall component of a Theacea plant and its processes for their isolation, the formulation of bioactive production and compositions and uses use Polysaccharide It provides such polysaccharides obtained 11/16/2010 suitable to from the species Camellia sinensis, which modulate the comprise a rhamnogalacturonan-l core, immune response and wherein the molar ratio of galacturonyl acid residues to rhamnosyl residues in the backbone of the polysaccharide is close to 1:1

8/28/2012

8/29/2012

Intellectual Property Rights in Plant Biotechnology

4

10/17/2012

(continued)

661

List of Patents Granted for Biotechnological Innovations in Some Important Crops S. No.

Patent No.

Catharanthus roseus 1 EP0425597 A1

2

EP0710240 B1

Inventor

Assignee

Normand Brisson et al.

National Research Council of Canada

Christian Berrier et al.

Pierre Fabre Medicament

Title A tryptamine producing tryptophan decarboxylase gene of plant origin

Description

Date of Filing

Isolation and cloning of the cDNA sequence 2/21/1990 of the tryptophan decarboxylase gene from Catharanthus roseus and the development of the cDNA sequence in a plasmid vector capable of transforming cell lines that will produce the tryptophan decarboxylase enzyme Novel antimitotic Novel fluorinated derivatives of the 7/19/1994 binary alkaloid vinblastine and vinorelbine family of derivatives general formula and the therapeutically extracted from acceptable salts of these molecules. The Catharanthus roseus invention also concerns the application of said compounds in therapy and their methods of preparation

Date of Issue 5/8/1991

12/18/1996

OMICS Applications in Crop Science

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662

TABLE 20.4 (Continued)

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EP0740504 B1

Robert M. Bowman

Goldsmith Seeds Inc.

4

USPP18315

Sushil Kumar et al.

Council of Scientific and Industrial Research

5

EP1934355 A2

Alain Goossens Universiteit Gent et al.

It relates to a Catharanthus plant having 1/18/1995 resistance to the fungal disease Phytophthora. The invention also relates to an increased level of resistance to aphids and other pests and an increased level of total alkaloid content Plant variety of It relates to the development of a unique 5/4/2004 Catharanthus roseus inflorescence-bearing mutant plant-type named lli lli/lli (LEAF-LESS INFLORESCENCE). Further, the present invention relates to the development of a unique inflorescence bearing mutant plant type lli/lli (LEAFLESS INFLORESCENCE) through chemical mutagenesis Means and methods It relates to the production of the anticancer 9/14/2006 to enhance the metabolites vincristine and vinblastine. production of The invention provides novel vinblastine and polynucleotide sequences derived from vincristine in Catharanthus roseus and the use of said Catharanthus roseus polynucleotide sequences to stimulate the production of vinblastine and vincristine in plants of Catharanthus roseus and plant cell lines derived thereof Phytophthora resistance gene of catharanthus and its use

1/2/2003

12/18/2007

6/25/2008

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3

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3. Cisgenesis and intragenesis—similar to transgenic technology but the DNA/ genes transferred belong to the same species of the transformed plant, or to a cross-compatible species. 4. RdDM—associated with gene silencing by methylation of the promoter sequences and it provides breeders with an opportunity to modify the gene expression epigenetically. 5. Grafting on GM rootstock—achieved by simply grafting a non-GM scion onto a GM rootstock for the desired improvements. 6. Agroinfiltration—Agrobacterium sp. containing the gene of interest is used to infiltrate plant tissues, mostly leaves, so that the gene is locally expressed at a high level, without being integrated into the plant genome. This can be used for screening for plants with valuable phenotypes for breeding programs. 7. Reverse breeding—used to rapidly generate suitable transgene-free homozygous parental lines for elite heterozygous genotypes by silencing the genes involved in the meiotic recombination process. 8. Synthetic genomics—not directly related with breeding techniques but they are generally used for constructing viable minimal genomes that can serve as platforms for the biochemical production of chemicals such as biofuels and pharmaceuticals. These techniques have been used to introduce variable traits such as herbicide tolerance, fungal, bacterial, and viral resistances, male sterility, modified starch content, reduced flower pigmentation, and the production of hepatitis B vaccine in crops such as maize, tobacco, rice, oilseed rape, potato, apple, melon, petunia, grapevine, watermelon, cucumber, plum, walnut, and the like. Since 2000, more than 84 patents have been filed on these newer techniques of plant breeding (Lusser et al. 2012). The U.S. Food and Drug Administration has approved the first plant-made drug, Elelyso (taliglucerase alfa), an enzyme produced by genetically engineered carrot cells for treating type 1 Gaucher’s disease (Fox 2012). In the case of the plant-made pharmaceuticals (PMP) sector, public-funded research has led to more than 50% patented technologies as compared to the industrial contribution, reflecting the academic contribution to patented research in the biopharmaceutical sector (Thangaraj et al. 2009). The inclination for patenting by academic institutions has been facilitated by the U.S. Bayh–Dole Act and similar legislation elsewhere that permits universities to gain a return by patenting their innovations. In India, there has been a substantial increase in patent applications related to herbal drugs for diabetes, cancer, cardiovascular diseases, asthma, and arthritis (Sahoo et al. 2011). In environmental biotechnology, several patents have been granted on phytoremediation, which is an eco-friendly approach to the remediation of contaminated soil and water using plants (Suresh and Ravishankar 2004).

20.7  General Considerations for Patent Filing in Plant Biotechnology In general, patent filing is a long process and involves several steps before the patent is granted. A filed patent is not universal, that is, it will be applicable to the country in which it is filed and if one desires to have patents in different countries, then such patents have

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to be applied for separately according to the norms of that country’s patent rules. Patent filing involves the following steps: • Identification of the innovation/invention by the innovator • Prior art search (patents, periodicals, books, products, etc.) • Preparation of patent specification (claim should be defined properly and extensively) • Clarifying the ownership of the patent filed • Patent filing (self or with the help of an advocate) • Prosecuting through the patent office (depends on the country where the patent is filed) • Patent registration • Patent issued (if found suitable based on the claims) Patent searching is crucial and one needs to have a sound search strategy so that one can claim for a patent on a new innovation. The search will be more effective if one defines it properly based on the innovation. The relevant literature in the form of research papers, reviews, products and processes in commercial use, and various internet search engines should be properly consulted prior to patent filing. There is a provision for online patent searching by various national patent offices, such as the U.S. Patent and Trademark Office (USPTO), the EPO, and the Japanese Patent Office (JPO). The USPTO has two separate databases (http://patft.uspto.gov/) for granted patents (PatFT) and patent applications (Ap-pFT). Similarly, the JPO has a provision for both granted patents and patent applications (http:// www.jpo.go.jp). The EPO (http://www.espacenet.com) has a publicly available database that includes patents administered by the World Intellectual Property Organization (WIPO) representing over 80 countries. Similarly, another database, PatentScope (http:// www.wipo.int/patentscope/search/en/search.jsf), is widely used for patent searches and one major advantage of this database is its ability to search the claims field independently of the full patent specifications/text. The patent searching strategy with reference to plant biotechnology innovations has recently been reviewed (Parisi et al. 2013).

20.8 Conclusion IPRs in plant biotechnology are a matter of debate especially with reference to plant varieties and plant breeding methods. The emerging new technologies in the agricultural sciences have immense potential for crop improvement to attain global food and nutritional security. The increasing world population, the limitation of arable lands, and the influence of biotic and abiotic stresses are major constraints that require innovative techniques to supplement the tools of conventional plant breeding for developing suitable varieties. Biotech crops are quite promising as evident by the recent increase in their production and also their acceptance by several countries, including developing countries. IPRs have greatly influenced agricultural research in recent years with the development of several private sector companies with the sole aim to commercialize their products. The research in the public sector has also been influenced by the IPR regimes and has led to several

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patents. An integrated strategy needs to be developed between science, technology, and the market in the context of growing IPR issues in the agricultural sector globally. There is a need for developing countries to establish an effective system to protect IPRs that are relevant to agricultural innovations and to utilize the global germplasm available. There is some concern that IPRs do not recognize or reward the contribution of communities of farmers who have developed, over long periods of time, the landraces that form the basis of the pedigrees of modern crop varieties. The strengthening of IPRs has undoubtedly stimulated the research and development that have made genetically engineered varieties of major crops available to farmers. The legal control of key enabling technologies for transgenic crop production in the form of several patents granted to giant agricultural companies is hampering the development of other genetically engineered crops, in particular small-acreage crops that are relevant to developing countries. International collaboration in the form of treaties is needed to safeguard the genetic resources of each country and to develop an amicable solution for using them globally in the development of superior crop varieties for the benefit of mankind.

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