Chinese Genetically Engineered Rice in Foreign Patent Trap?

“Chinese” Genetically Engineered Rice in Foreign Patent Trap?

April 2008 Table of Content

Major findings in the research...... 2 Executive Summary...... 3 1. Introduction...... 7 2. Methodology...... 9 3. Standard methods for GE rice development...... 10 4. Foreign patent research of Chinese GE rice...... 12 1) Foreign patent research of Chinese Bt rice...... 12 2) Foreign patent research of Chinese CpTI rice...... 13 3) Foreign patent research of Chinese CpTI/Bt rice...... 13 5. Patents and their scopes...... 14 6. The monopoly of patents...... 17 7. Case: GE rice Bt 63...... 18 8. Implications of foreign patents for commercialization...... 19 1) Food security consequences...... 19 2) Effects of increased seed prices on farmer’s livelihood...... 20 3) Social effects of increased production costs and rice prices ...... 22 4) The threat of lawsuits...... 22 9. Suggestions...... 24 10. Conclusion...... 25 Acoknowledgements...... 26 Annex 1...... 27 Annex 2...... 28 Annex 3...... 30 Annex 4...... 31 Annex 5...... 33 Reference...... 35

1 Major Findings in the Research

1. The genetically engineered (GE) rice lines that are the closest to commercialization in China are lines with the insecticidal protein gene from Bacillus thuringiensis (Bt), the Cowpea Trypsin Inhibitor (CpTI) gene and with a combination of CpTI/Bt genes. It is found that there are many foreign patents related to the research and development of these GE rice lines. The foreign patents cover the GE technology and genes themselves. The situation is not in compliance with the national policy of China.

2. GE crops rely on standard technology and methods. All three GE rice lines in the research apply the standard technology. Five patents are held by foreign companies. The patent holders include Monsanto and Pioneer/DuPont.

3. At least 11-12 patents are involved in the GE Bt rice developed by Huazhong Agriculture University, of which the patent holders include Monsanto, Rhone Poulenc Agrochimie/Bayer Crops and Novartis/Syngenta.

4. The GE CpTI rice developed by the Institute of Genetics and Developmental Biology,

5. China Academy of Sciences is related to at least 5-7 foreign-owned patents. The patent holders include Monsanto and Rhone Poulenc Agrochimie/Bayer Crops.

6. The development of the Chinese CpTI/Bt rice was led by the Fujian Academy of Agricultural Sciences. At least 10-11 foreign-owned patents are related to it. Patent holders include Monsanto among others.

7. Based on an analysis of international cases that have occurred in the past, foreign patents may negatively affect national food security, farmers’ livelihood and food prices. Foreign patent holders may also file lawsuits against farmers and seed companies. Therefore, the effect of foreign patents generated after GE rice commercialization should be investigated carefully.

2 Executive Summary

Currently, climate change, deficiency of water resources and decreasing farmland threatens food production in China. At the same time the change of nutritional structure and population increase have resulted in rising consumption. There are emerging concerns that China’s self sufficiency in food production may be at risk. Thus some government officials and agricultural experts have seen genetically engineered (GE) crops as a quick solution to the huge and complex food supply challenge.

Many scientists and considerable investment have been concentrated in the research and development (R&D) of GE crops in China. As rice is the most important crop, one third of R&D resources had been targeted for the development of GE rice in the past twenty years. In 2004 alone, the allocation was more than RMB 500 million (about USD 60 million at 2004 exchange rates). In the Eleventh 5-year Plan on Biological Industry Development (2006-2010), the goal is to develop this sector as a strategic industry of high priority with good competitive prospects. The generation of independent (domestically owned) intellectual property is particularly emphasized.

Against this background, Greenpeace and Third World Network believe that it is necessary to conduct research on the development of Chinese GE rice to see whether the intellectual property of Chinese GE rice lines are domestically owned; whether GE rice can help China deal with a food crisis if it occurs; and whether there has been enough assessment about the implications of GE rice commercialization.

Major Findings in the Research

Although the Chinese government has invested heavily in the development of GE rice with domestic ownership of the related intellectual property rights, published scientific papers and patent database research reveal that for the three major GE rice lines closest to commercialization in China, there are a number of patents involved that are owned by foreign companies or research institutes. The three lines are: the line with the insecticidal protein gene from Bacillus thuringiensis (Bt); the line with the Cowpea Trypsin Inhibitor (CpTI) gene; and the line with a combination of CpTI/Bt genes. Among the foreign-owned patents, 11-12 of these are related to Bt, 5-7 to CpTI, and 10-11 to CpTI/Bt.

According to the research conducted by Greenpeace and Third World Network, the patents concerned have been granted in China, the United States, the European Union, Japan and other countries. In general, the scope of the patent protection in China covers some basic elements such as the gene itself and the method used for developing the GE rice line. Sometimes the patent scope also covers the GE plant itself. However, in regions or countries like the U.S, E.U. and Japan, in addition to the above scope of protection, the GE plant, seed and subsequent generations of the seed/plant are also protected. Whenever the patented technology and gene are used in commercialization, the patent holders can assert their legal rights. Therefore, the effects of foreign patents in the commercialization of GE rice should be considered.

3 The implications of foreign patents for commercialization

Serious debate continues over the long-term effects of GE plants and food on the environment and health. If China approves the commercialization of GE rice, it could trigger enormous risks with uncertainty for the staple food grain on which 1.3 billion people rely for survival. Significantly, many genetic engineering technologies are controlled by a few foreign companies and research institutes through patents. Some of these patents are involved in the Chinese GE rice lines development waiting for commercialization approval. If the commercialization of GE rice were approved, it would affect the long-term control over rice, the most staple food grain in China.

What would be the specific effects? To answer this question, detailed information needs to be collected about the nature of the patents concerned, their protection scope and whether there is any specific agreement on the use of the patented material or technology. However, some of this crucial information is not publicly available, such as any agreement for the use of the patented material or technology between Chinese scientists and foreign entities. Thus this report can only analyze the potential effects on China based on available information and similar international cases.

1. Food Security consequences

Is China at risk to lose control over its staple crop? The current fact is that most of the standard methods, technology and genes in Chinese Bt, CpTI and Bt/CpTI rice lines are related to the patents owned by foreign companies and institutes. It raises concerns on food security. Multinational corporations with a history of using (or threatening the use of) lawsuits to protect their patents own many of the GE rice patents in China. The Chinese Government should thus place more emphasis on the threats to food security from foreign patents on Chinese GE rice lines. In the research, the authors identify many patents controlled by Monsanto, Syngenta, Rhone Poulenc Agrochimie/Bayer and Pioneer/DuPont. Among the 15 patents in this research, Monsanto owns 5, and Pioneer/DuPont, Syngenta, Rhone Poulenc Agrochimie/Bayer own one respectively. When a company owns more patents, it has more power to define the terms and conditions for commercial working of the patents that enable the company and its shareholders to get more benefits.

2. Effects of increased seed prices on farmers’ livelihood

There are cases in other countries to show that the prices of seeds of GE crops are much higher than those of conventional non-GE seeds, and eventually it will result in price increases of seeds at large in the country concerned.

Because the patent holders or their authorized agents (i.e. seed companies) collect extra fees for the technology under signed agreements, the GE seeds are much more expensive than conventional seeds. For example, in 2005 Monsanto’s Bt corn seed cost twice, sometimes three times, higher than conventional corn hybrid seed in the Philippines. At the same time, the yield of the GE seed was found to be similar to the conventional ones.

4 The figures of the U.S. Department of Agriculture show that the prices of corn, soybean and cotton rose significantly during the period 1997-2006. Compared to previous years, overall prices rose continuously since the mid-1990s due to the higher price of GE seeds. The price of GE cotton seed was 2-4 times more expensive than conventional seeds, and conventional seeds were difficult to find in the market.

If GE rice were commercialized in China, there would be great interest by foreign patent holders and they might try to get benefits through various channels. Patent holders may collect the extra fee from farmers and local seed companies. Although the Chinese government tries to reduce the burden on farmers, commercialized GE rice could result in big price increases of the seed. The cost that farmers have to bear will increase significantly.

3. Social effects of increased production costs and rice prices

Higher seed prices and greater cost for farmers will affect the price which consumers pay for food. In the situation of continuing food price increases for the ordinary Chinese people, without question this will be one disaster after another.

If the interests of farmers were impinged, it would reduce their motivation to plant crops thus resulting in less long-term food supply. Meanwhile, consumption and demand always exist. A shortage of supply will further raise food prices hurting all consumers, especially the people with lower income for whom food expenses, including rice, constitutes a very big portion of their living budget. Rice is the staple food grain of most Chinese. Even if its price has a small variance, it will greatly impact the life of ordinary people.

4. The threat of lawsuits

The World Trade Organization (WTO) forces member countries to provide strict intellectual property rights for any technology including biotechnologies. China is a target of the U.S. and the E.U. and is required to implement “higher standards” on the protection of intellectual property. In the U.S. and Canada, patent holders often take legal action against the farmers who allegedly infringe their patents. Even some countries which have not granted seed patents have been affected. A well-known case is where Monsanto has filed lawsuits against European importers who import soybean meal from Argentina. By instituting lawsuits for alleged patent infringement in Europe, the company hopes to force Argentina to pay fees even though there are no patents related to the GE soya grown in the country.

In addition, it will be unavoidable that GE rice seed will contaminate conventional seeds in large scale planting of commercialized GE rice. The cause could be natural occurrences or human mistakes, such as leaking or mixing. If GE seed contaminates conventional seed, it may result in local seed companies and farmers being embroiled in lawsuits, including in cases where the GE seed has not been approved in the country. The legal consequences that they have to face could be that patent holders will enforce their patent right and require compensation. All these indicate that

5 commercialization of GE rice with foreign patents may lead to the threat of lawsuits against Chinese producers (majority of whom are small farmers) and companies.

Suggestions

Greenpeace and Third World Network suggest that the relevant government departments carefully investigate and analyze the possible implications of the foreign patents and take into consideration the additional costs, risks and uncertainties associated with GE rice commercialization. Before any such thorough investigation has been completed, any GE rice commercialization should be put on hold. Because of the potential enormous impact of GE rice commercialization, in the process of making policy and decisions, more stakeholders should be involved in the decision making process.

The authors also suggest that the government investigate and assess the benefits of other technologies, such as molecular marker assisted breeding and ecological rice farming methods. Molecular marker assisted breeding does not have the risks and uncertainty associated with GE rice, and the technology is much less controlled by foreign patents. This technology can be used to reduce pests too. Sophisticated ecological rice farming is also another option for the sustainable development of rice planting. Sophisticated ecological rice farming strictly adopts comprehensive control on pests, such as biological control and advanced agricultural management measures, among other approaches.

In this situation, China does not have to promote GE rice commercialization at great risks.

6 1. Introduction

Rice is the most important crop in China as on average a Chinese consumer consumes 97kg1 of rice per year. In total that is 1.7 billion2 tons of rice every year, which is approximately 35.7% of China’s total food supply3.

Currently, China is basically self-sufficient in rice production, with rice yield having continuously grown in the last 4 years. In 2006, import and export of rice were 0.5% of gross yield.4 However, along with the growth of population and increased living standard, rice consumption is expected to rise at a faster rate than production increases. During 1986 to 2006, the rice planting area decreased by 29,714K hectares.5 Over 2006 and 2007, total water resource decreased by 2.5%. 6 All these factors may affect rice production. More importantly, farmers who used to grow food now migrate to urban areas and become food consumers. Even though China has proved that it has capability to satisfy the food demand of the Chinese people in the past 50 years, there is a fear that in future China will have difficulties feeding its population.

With the pressure escalating, some Chinese government officials and agricultural experts see genetically engineered (GE) crops as a quick solution to the huge and complex food supply challenge. However, as a technology to be applied in food production, genetic engineering has a very short history; the first GE food appeared in 1994 and this technology’s potential long-term effects are still unclear.

Numerous scientific studies have however shown that GE single insect resistant crops such as those with Bt may have negative effects. Animal feeding studies have found signs of toxic effects on the liver and kidney.7 Other studies show that a Bt protein present in some GE insect resistant crops such as cotton induced allergenic-type responses in mice.8,9 In 2005 researchers in Australia found that GE peas that were considered safe as the foreign gene came from beans, caused serious health impacts in mice, e.g. the mice inhaled peas protein and this resulted in pneumonia, and the mice also became more sensitive to allergen.10 Moreover, a GE organism is a foreign element for nature; its effect on nature is irreversible. Numerous studies show that GE crops may have negative effects on for example, predatory species of pests11, may lead to more serious outbreaks of pests that were not a major problem before12,13, may affect headwater ecosystems14, and may lead to contamination of non-GE crops and of related wild species15,16,17,18, while they fail to lead to any sustained significant reduction of pesticides use19,20,21.

Despite these potential risks, there is still an enormous amount of research & development (R&D) resources in terms of human capital and research funds invested in GE crop development. The table below shows the estimated research staff and annual expenditure on plant biotechnology research in China from 1986 to 2003.22 Since 2003 till the present, the total investment from the government was RMB10 billion.

7 Table 1: Plant biotechnology research expenditure (1986 – 2003)

Year Staff Research Expenditure at 2000 price (Million RMB) 1986 740 38 1990 1067 68 1995 1447 87 2000 2128 322 2003 2690 463

As rice is the most important crop, one third of R&D resources have been targeted for the development of GE rice in the past twenty years. In 2004 alone, the allocation was more than RMB 500 million (about USD 60 million at 2004 exchange rates). Based on this effort, in early 2006 around 100 GE rice lines were at the stage of experimental tests, 8-10 at the stage of small scale environmental release, and 3 at the stage of approval for commercial production since 2004 according to the Centre for Chinese Agricultural Policy (CCCP)23.

The three GE rice lines are lines with an insecticidal protein gene from Bacillus thuringiensis (Bt), with Cowpea (a trypsin inhibitor gene: CpTI) and with insecticidal protein genes from both Cowpea and Bt. All these three lines are insecticidal GE rice, which are resistant against some selected pests (rice leaf roller and yellow rice borer). Bt rice has a modified gene from the soil bacterium Bacillus thuringiensis inserted into the rice DNA. This Bt gene enables the plant to produce toxin to kill some pests. CpTI rice has a gene from Cowpea inserted into the rice DNA for the same purpose. CpTI/Bt rice has two genes inserted into the rice DNA. These three lines are close to getting approval for commercialization, therefore this research is focused on them.

Unfortunately, many of the methods, technologies and genes used in the development of GE rice are under the control of foreign companies or institutes through patent protection. Worldwide the U.S. has 59% of the biotechnical patents while China and other developing countries have 5%.24 According to OECD’s data in October 2004, in the field of biotechnology applications under the Patent Cooperation Treaty (PCT), the US has a ratio of 38.3%, EU 35.2%, Japan 12.8% and China 0.8%.25

The importance of patents is obvious. In the Eleventh 5-year Plan on Biological Industry Development (2006-2010), drafted by the National Development and Reform Committee, the goal is to develop this sector as a strategic industry of high priority with good competitive prospects. The generation of independent (domestically owned) intellectual property is particularly emphasized.26

Even though China has realized the importance of independent (domestically owned) intellectual property rights in GE research, information about foreign patents on Chinese GE rice and a

8 comprehensive assessment about the implications are not yet publicly available. Because of this, based on publicly available information, the research searched for foreign patents that may apply to Chinese Bt, CpTI and CpTI/Bt rice lines and analyzed the implication of commercialization. The research showed that some key elements used to develop the Chinese GE rice are patented by foreign companies and institutes. This situation is not in compliance with relevant national policies and it poses a serious threat to the food security and economic development of China. (A summary of the foreign patents is presented in Sections 3 & 4.)

The World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) forces all WTO member countries to allow strict intellectual property rights for any technology including biotechnologies. Both the US and the EU have targeted China to adopt “higher standards” for patent protection. In the US, the broad and strict patent control over food crops has increased seed price and may have contributed to the increased food prices. In the US and Canada it is an increasingly common practice for patent holders to take legal actions against farmers for alleged patent violation. Even countries that so far do not allow patents on seeds have been affected. For example, Monsanto has launched legal actions against several European importers of Argentinean soymeal for alleged patent violation as a way to force Argentinean farmers to pay royalties even in the absence of a patent in Argentina. These suggest that China has to make a thorough investigation on foreign patents related to GE rice.

If GE rice that is under control of foreign patents were commercialized in China, foreign patent holders may assert their right. Patent holders may collect the extra fee from farmers and local seed companies. Chinese GE rice may face problems: although the Chinese government tries to reduce the burden on farmers, commercialized GE rice could result in big price increases of the seed. The cost that farmers have to bear will then increase significantly. The cost will be transferred to consumers eventually and will push the consumer price index that is already high to higher levels. High prices of rice will greatly impinge on the Chinese economy that depends on rice as a major crop, source of livelihood and stability of society. (The detailed analysis on these potential impacts is in Section 7 of the report.)

Based on the results of this research, we suggest that the government carefully investigates and analyzes the possible implications of the foreign patents and take into consideration the additional costs, risks and uncertainties associated with GE rice commercialization. Before any such thorough investigation has been carried out, any GE rice commercialization should be put on hold. We also suggest that investment be increased in other technologies, such as molecular marker assisted breeding and ecological rice farming methods. These technologies are not or much less under foreign patent control. As the government is increasing investment in the agriculture sector, more R&D resources should be directed to these areas.

2. Methodology

This patent research is focused on Chinese GE rice lines that are closest to commercialization approval, i.e. lines with insecticidal protein gene from the soil bacterium Bacillus thuringiensis (Bt), or from Cowpea (Cowpea Trypsin Inhibitor, CpTI) gene and with CpTI/Bt genes. It is based

9 on reviewing published international and domestic science articles. The articles provide a series of information on the technologies applied to the Chinese GE rice development, the genes, and the genetic elements used. Patent searches were then conducted for the identified technologies, genes and genetic elements by searching the online patent database provided by relevant patent offices. Primarily the database from the US and European patent offices were searched, as these online databases also disclose information if the same or similar patent has been applied for in other countries e.g. China, Japan, Brazil and region e.g. Africa.

This research cannot provide comprehensive information about foreign patents and other property rights attached to Chinese GE rice as relevant information that would allow a comprehensive patent search has not been found in published science literature. For example the Bt toxin gene is usually modified before it is inserted into plants. There are many different process patents for the modification of Bt toxin gene, and without disclosure of detailed information it is not possible to identify with certainty the patent or patents that apply to specific Bt rice varieties.

In summary the major limitations of our research are in the field of experimental material source, for example rice seeds, bacterial strains, vector information, complete gene construct information, methods used to modify the “natural gene”, etc. So this research covers only a small part of the technologies and materials used in the GE rice development. Due to lack of complete and detailed information, it is hard to have a search for all relevant patents.

Though the research is limited, the results show clear evidence that 5-12 patents are related to each of the three GE rice lines. It can be expected that many more patents can possibly be found if more detailed information is available.

3. Standard Methods for GE rice development

Scientists usually rely on standard technologies and methods to develop GE crops including GE rice. Briefly speaking, the difference between GE and conventional crops is due to the different genes introduced into the crops. For example, Bacillus thuringiensis (Bt) gene is introduced into Bt crop, and Cowpea Trypsin Inhibitor (CpTI) gene is introduced into CpTI crop.

The major technical pathways are showed in Figure 1-The Flowchart for GE Rice Development.

10 Figure 1 The Flowchart for GE Rice Development

During the development process, the basic steps are as follows: 1) isolation and culture of rice embryos; 2) isolation of the genes or genetic elements; 3) modification of the genes e.g. Bt gene; 4) construction of the gene adding a promoter and terminator; 5) cloning of the target gene into the transformation vector; 6) use of the particle bombardment method for transformation or agrobacterium mediated transformation method; 7) growing of the embryos in selective medium to screen out the transformed embryos with the desired genes; 8) regeneration of rice plantlets to obtain transgenic rice plants.

Our research found that the standard plant transformation technologies (the 6th stage) to obtain the transformed plant are covered by patents on “Methods for producing transgenic cereal plants” (US5736369) and “Plant transformation method” (US7285705). Another commonly used plant transformation technology (also the 6th stage) is covered by the patent on “Agrobacterium- mediated plant transformation method” (US6603061). The regeneration of transformed rice plants is related to the patent on “Method for regeneration of rice plants” (US5350688) (the 8th stage) and the patent on “Enhanced Regeneration System for Cereals” (US5589617) (the 8th stage). For details of the patents, please refer to Annex 1.

It appears that the Chinese GE rice lines, i.e. Bt, CpTI and CpTI/Bt, which we focused the patent research on all use the technologies identified in the previous paragraph. All these patents are owned by foreign companies or institutes, and all these patents have been granted in more than one country.

11 4. Foreign Patent Research of Chinese GE rice

As mentioned in the introduction, there are over 100 GE rice lines that have been developed in China. However, we focused our research on three GE rice lines which are close to be approved for commercialization. These are Bt, CpTI and CpTI/Bt rice lines. In this section, we will look at each rice line individually and examine the foreign patents attached to each rice line.

1) Foreign Patent Research of Chinese Bt Rice

The development of Bt rice was first carried out by the International Rice Research Institute (IRRI). Scientists from Huazhong Agricultural University also carried out the Chinese Bt rice research27.

Science literature research found that the gene construct below was used for the development of one Chinese Bt rice line.

Figure 2 Transformation Constructs Used in Bt Rice Development

Patent database search found that 7 foreign patents are attached to this construct.

In the experiments, the Rice Actin I promoter (~0.9Kb) and its first 5’ intro sequence was used to drive the expression of target Bt genes. This is related to the patent on “Rice actin gene and promoter” (US5641876). The 1344bp of Cry1A (b) N-terminus sequence and 486bp of Cry1A(c) C-terminus sequence were used to make a fusion Bt-gene and this is related to the patent on “Hybrid Bacillus thuringiensis .delta.-endotoxins with novel broad-spectrum insecticidal activity” (EP0943985). The use of fused Cry1A(b) and Cry1A(c) is also related to the patents on “Lepidopteran-active Bacillus thuringiensis delta-endotoxin polynucleotides, compositions, and methods of use” (US7078509) and “Novel pesticidal proteins and strains” (EP0792363). The use of nos terminator sequence to stop the transcription of the target fused Bt-gene is related to the patent on “Isolated DNA sequence which can serve as terminator region in a chimeric gene capable of being used for the transformation of plants” (US6313282). The modified Bt gene used for a higher level of protein expression, is related to the patent on “Synthetic insecticidal crystal protein gene” (US5380831). The experiments use the method for modifying gene sequences of Bt to enhance expression, which may belong to the patent on “Synthetic plant genes and method for preparation” (EP0413019). For details about the patents please refer to Annex 2.

When the foreign patents on the standard technologies and methods are added, about 11-12 foreign patents can be related to Bt gene obtainment, plant transformation to plant regeneration.

12 2) Foreign Patent Research of Chinese CpTI rice

The development process of the CpTI rice line by the Institute of Genetics and Developmental Biology (IGDB) of the Chinese Academy of Sciences (CAS) is quite similar to Bt rice except for the foreign gene (CpTI gene is introduced instead). Science literature research found that the gene construct below was used for the development of one Chinese CpTI rice line.28

Figure 3 CpTI Transformation Vector

The genetic elements used in this construct are related to some foreign owned patents. Patent database search found that about 3 foreign patents are involved.

In the experiments, the CpTI (SCK) gene sequence was used; this is related to the patent on “DNA Molecular Useful in Plant Protection” (US5218104). The nos terminator sequence was used to stop the transcription of the target fused gene; this is related to the patent on “Isolated DNA sequence which can serve as terminator region in a chimeric gene capable of being used for the transformation of plants” (US6313282). The npt II marker gene used in this construct is related to the patent on “Chimeric genes suitable for expression in plant cells” (US6174724). For detailed information of the patents, please refer to Annex 3.

When the foreign patents on the standard technologies and methods are added for the CpTI rice line, about 5-7 foreign patents can be related to CpTI gene obtainment, plant transformation to plant regeneration.

3) Foreign Patent Research of Chinese CpTI/Bt Rice

The development of the Chinese CpTI rice line was led by the Fujian Academy of Agricultural Sciences, Fudan University and other institutes or universities. The researchers used 3 rice lines that contain Bt gene (cry1Ac) driven by ubiquitin promoter and modified CpTI gene driven by rice ActID promoter. They also used a selectable marker for hygromycin resistance.29

Patent database search found that about 6 foreign patents are involved.

In the experiments, the use of Bt gene (cry1Ac) was related to the patent on “Hybrid Bacillus thuringiensis .delta.-endotoxins with novel broad-spectrum insecticidal activity” (EP0942985) and the patent on “Lepidopteran-active Bacillus thuringiensis delta-endotoxin polynucleotides, compositions, and methods of use” (US7078509). The Rice ActinID promoter

13 was used to drive the expression of target Bt genes. This is related to the patent on “Rice actin gene and promoter” (US5641876). In the experiments, the CpTI gene sequence was used and this is related to the patent on “DNA Molecular Useful in Plant Protection” (US5218104). The use of ubiquitin promoter is related to the patent on “Plant promoter sequences and methods of use for same” (US6977325). The experiments used modified Bt genes for a higher level of protein expression, that are related to the patent on “Synthetic insecticidal crystal protein gene” (US5380831). For details of the patents, please refer to Annex 4.

When the foreign patents on the standard technologies and methods are added for transgenic CpTi/Bt rice, about 10-11 foreign patents are involved from CpTI/Bt gene obtainment, plant transformation to plant regeneration.

The research shows that at least five foreign patents, and likely more, are attached to each of the three GE rice lines.

5. Patents and their scope

Patents protect investments in research, which enables the right of inventor (or institute/company employing the inventor) not to be violated. Patents create exclusivity (even monopoly) to be asserted by the patent holder. If anyone is going to use the subject matter protected by a patent, he has to obtain the permission from the patent holder and pay royalty for the use of the patent. According to international law as reaffirmed in the TRIPS Agreement and routinely practised at the national level, there would be no violation as long as the patented material is only used for research because research is an exception allowed under patent law where there is no need for payment of royalties to the patent holder. Furthermore, there would be no violation if there were a licensing agreement made between patent holders and relevant parties. However, if scientists used the technology or other subject matter legitimately protected by a patent to develop a new product and commercialize such a product without any licensing agreement, it would infringe the patent right. Patent holders can then demand and collect a royalty and if they were not satisfied, they might file a lawsuit.

For the Chinese GE rice, if the lines with foreign patents attached to them were commercialized, the patent holders concerned would have the right to collect royalty. If patent holders thought their rights were violated i.e. in the absence of licensing agreements, they might file a lawsuit. Therefore, patents can affect the planting, processing, consumption and exportation of GE rice and incur extra expenses. Section 7 in this report will give a more detailed analysis on the effects.

The specific claims made in a patent determine “how much” is actually protected by a patent. Does the patent holder “own” only the method/technique or also the product obtained through this method, or even more? When the scope is wider, its implications are broader and more far- reaching.

Patents are only valid in the country where they are granted. Patents can have different scope in different countries. The scope of patents in Annex 5 gives an example of how patents have

14 different scope in different countries. If a patented product is exported to a country that has granted a stricter and broader patent protection than the exporting country, the terms of the importing country applies as soon the product enters its territory.

In China and many other developing countries the patent scope is often narrow; patent protection usually covers an innovative method or technology, and sometimes gene sequences and cell. Patents on GE seed, plant and progeny are usually not granted. On the other hand, the US, EU, Japan, Australia and other developed countries have adopted a broad patent system that allow the granting of patents on methods, genes, GE plants, GE seeds including subsequent generations and even products derived from these plants.

For example, the patent “BROAD-SPECTRUM DELTA-ENDOTOXINS” (EP0942985) in the EU, which is owned by Monsanto and has been granted in several countries including China as identified in our research, its scope in the EU covers GE plant, seed and progeny. The scope in the EU is listed as below.

Claims: …

Claim49. A transgenic plant having incorporated into its genome a transgene that encodes a polypeptide comprising the amino sequence of SEQ ID NO:l0, SEQ ID NO:12,SEQ ID NO:14, SEQ ID NO:26, SEQ ID NO:28, SEQ ID NO:30, or SEQ ID NO:34. Claim50. The transgenic plant of claim 49, wherein said transgene comprises the nucleic acid sequence of SEQ ID NO:9, SEQ IDNO:1 1, SEQ ID NO:13, SEQ ID NO:25,SEQ ID NO:27, SEQ ID NO:29, or SEQ ID NO:33. Claim51. Progeny of the plant of claim 49 or 50. Claim52. Seed from the plant or progeny of any of claims 49 to 51. Claim53. A plant from the seed of claim 52.

If patent protection extends to the GE plant itself, the GE seed from this plant and the progeny as in the EU case above, every farmer who intends to grow this GE rice needs to have an agreement with many conditions from the patent holder. In North America the farmers usually have to sign a grower’s contract when they buy such patent protected GE seed. The box below gives an example of a grower’s contract (Technology Use Agreement) that Canadian farmers had to sign with Monsanto in 199830. This contract defines various terms on the behavior of the grower, among them, including a prohibition to keep seeds after a harvest, which violates a basic farmers’ right that was secured over hundreds of years.

15 Monsanto’s standard “Technology Use Agreement”

Because of the different patent scope, one GE rice variety may violate no patent granted in China.

16 However, when this rice or rice product is exported to other countries, it may violate several patents in the foreign country.

For instance, since 2005, Monsanto has filed a series of lawsuits against several importers of Argentinean soybean product in the EU. The reasons are most Argentinean soybean farmers plant Roundup Ready GE seeds. Monsanto does not have a patent on its GE soya in Argentina but it has patents on this GE soya in the European Union. Monsanto was unsuccessful in getting Argentina to change its patent law and allow patents on GE soya. Monsanto demanded that Argentinean producers pay up to US$15 per ton, an exorbitant amount even though its patents were not granted in Argentina. If such payment were to be made, it would cause thousands of producers to go bankrupt. When the Argentinean Government refused to compensate the fee for Roundup Ready seeds, Monsanto tried to get it from Europe. Argentina is one of the world’s top soybean exporters, with the EU as a major importer. Monsanto proceeded to file lawsuits in Denmark, the Netherlands, Spain and the UK against the European importers for compensatory fees, and in this connection requested that the European national customs authorities detain the shipments from Argentina31. In 2007, courts ruled against Monsanto in the first two cases that were heard, which were brought in the UK and Spain, rejecting the company claims. In Spain Monsanto was made to pay for the cost: High Court of Justice Chancery Division (Patent Court), 10 October, 2007.32 The court battles are still continuing.

6 The monopoly of patents

Our research has shown that more than one patent usually applies to any specific GE crop line. The more patents are held by the same patent owner, the more profits this owner can get in its business activities, eg. through licensing such patents for others to use or through its own product sales. Thus, many biotechnology companies acquire more patents by merging and restructuring with other companies.

The current six leading multinational agrochemical companies are: Bayer Crop Science, BASF, Dow, DuPont, Monsanto and Syngenta. Many of these leading companies are the outcome of a complex series of mergers and acquisitions. For example: Hoechst (Roussel Uclaf) + Schering (Fisons +Boots)  AgrEvo + Rhone-Poulenc (+ May and Baker + Pechiney-Progil)  Aventis CropScience + Bayer Crop Protection  Bayer CropScience.

Research of the European patent office database found that between 1999 and February 2008, 29 patents were granted for GE Bt crops. 23 of these patents were owned by the big 6 multinationals. Monsanto held 9 of these patents. In addition, there were 36 patent applications on GE Bt crops of which 34 were filed by the 6 big multinationals. Monsanto alone filed 12.

It is not surprising that over the last decades a big consolidation of patent ownership took place. For example, in relation to US patents relating to Bt, in the 1980s, the university and public sector accounted for 50% of the total of granted U.S patents. By 1994, independent biotechnology companies and individuals held 77%, but by 1999 the big companies held 67% of these patents on Bt in the U.S.34

17 Many of the patents on standard methods, techniques, genetic elements used in the development of GE crops are under the patent control of these few big companies. They are in a very powerful position to negotiate the most economically attractive terms of licensing agreements for themselves, or to stop others using the patented subject matter. Public institutes or small companies which have few patents risk facing court cases or may be forced into accepting the ‘unfavorable” licensing agreements when they want to launch their own products in the market.

7 Case: GE rice Bt 63

GE rice Bt63 was developed in the research led by Dr. Zhang Qifa, a scientist of the Chinese Academy of Sciences. Field trials have been done. The application for safety certificate was discussed in the national Biosafety Committee for the first time at the end of November 200435. This GE rice line is the closest to approval for commercialization in China.

GE rice Bt63 was developed at the National Key Laboratory of Crop Genetics Improvement in Huazhong Agriculture University36. Zhang Qifa is the chief of the laboratory and a professor of the University.

Since 1998, the laboratory has obtained a research fund of RMB 140 million and the projects led by Dr. Zhang Qifa received RMB 67 million. The fund was from the National Natural Science Foundation, “863”Plan, “973”Plan, Foundation for Key Teachers under Ministry of Education, Projects of Science and Technology of Hubei Province37. Since 2004, Dr. Zhang Qifa has obtained research funds of RM 8.1 million from the National Natural Science Foundation.

The authors found that in the development of GE Bt63, at least 11 foreign patents were attached to it. These include patents on technology (e.g. Synthetic plant genes and method for preparation (EP0413019) etc.) and gene (Synthetic insecticidal crystal protein gene (US5380831)). For the details of these patents please refer to Annex 1 and Annex 2.

These patents have been granted in the U.S, E.U, Japan and China. Patent holders include foreign research institutes and multinational companies such as Monsanto US, Bayer Cropscience Germany and Syngenta Switzerland.

Rice is the most important crop in China. If GE rice were commercialized, it would bring about a chain of implications. Based on the past and current international cases, there may be potential effects on food sovereignty, rising price of seeds (which would affect farmers’ livelihood), rising price of food and lawsuits by foreign patent holders.

In the 2007 annual report of National Key Laboratory of Crop Genetics Improvement in Huazhong Agriculture University38, it is shown that many biotechnology companies including Monsanto and Syngenta have working relationships with the laboratory. On 27 March 2007, Dr. Tong Zhu from Syngenta visited the laboratory and gave a speech. On 18 June 2007, Dr. Zhang Qifa visited Monsanto and gave a report about the developments in Chinese GE crop research.

18 Since information is unavailable to the public, the authors cannot learn if Chinese scientists have licensing agreement (or the terms of such agreements) with foreign companies for using the subject matter of relevant patents.

GE Bt63 is not only attached with foreign patents, but also related to illegal planting. In 2005, Greenpeace found GE rice lines were planted and sold without approval in several areas of Hubei Province. Such GE rice was found to have contaminated the rice in the local market. In 2006, GE rice was found in Guangzhou. There was also GE Bt63 ingredient found in baby food. In September 2006, it was further found in the rice products imported from China by France, the U.K and Germany. In early 2007, the same contamination was detected in Japan. At the time of writing, the contamination of the food chain with unauthorized GE Bt63 is still going on.

This case suggests that Chinese GE rice research is related to many foreign patents. The potential enormous impact in the approval process for commercialization should be investigated and more stakeholders should be involved in the decision making process. The role of Chinese scientists should be discussed. Government departments should investigate whether the scientists have considered the impact of foreign patents and whether they had licensing agreements with foreign companies and institutes, and what the terms of the agreements are, if any.

8 Implications of foreign patents for commercialization

Although the patent scope is narrow in China, foreign patents can still have an impact in different aspects if GE rice is commercialized.

1) Food Security consequences

China may lose control on its main crop. The fact that most of the standard methods, techniques and also gene and genetic elements that are used in the development of Chinese GE Bt, CpTi and Bt/CpTi rice lines are already owned by foreign companies and institutes raises many security concerns. This is especially so if it is taken into account that in many cases these patents are under the ownership of a few multinational companies and these companies have instituted many lawsuits against alleged patent infringement in other countries. The Chinese Government should place more emphasis on the threats to food security from foreign patents on Chinese GE rice lines.

The research here identified patents that are controlled by Monsanto, Syngenta and Rhone Poulenc/Bayer, Pioneer/DuPont. Among 15 patents in this research, Monsanto owns 5, and Pioneer/DuPont, Syngenta, Rhone Poulenc Agrochimie/Bayer own one respectively. The more patents one company owns the more power it has to dictate the terms and conditions for the commercial use of the patented subject matter to increase the benefits for the companies and their shareholders.

The current international trend is towards broader and stricter patent control for the patent holders at the expense of public interest. Developing countries are especially targeted to adjust their practice to U.S and E.U standards. As long as the international rules are not fundamentally

19 changed to expressly prohibit patents on seed and other life forms, and pressure continues to be made on developing countries to allow such patents under their national law, then those countries risk losing control over their staple food.

Rice is the most important crop in China. The risks of the GE rice commercialization will be extremely high. There are many risks and uncertainties associated with GE rice, for example, for the environment and human health. In addition, there is strong consumers rejection. In 2007 IPSOS China made a latest survey on consumers’ attitude in Beijing, Shanghai and Guangzhou for Greenpeace. It showed that 65% of interviewees selected non-GE products definitely and 97% of interviewees thought that it would be necessary to set up a labeling system for GE food. The costs and risk associated with commercialization of GE rice would already be too high even if there were no foreign patent rights are attached to GE rice.

2) Effects of increased seed prices on farmer’s livelihood

If GE rice is commercialized, the GE rice growers – farmers – will be affected heavily.

Patent holders or the seed companies that have a license agreement with the patent owner(s) charge a premium or technology fee for GE seed. GE seeds are more expensive than conventional seeds. For example, in the Philippines, Monsanto’s GE Bt corn seed cost approximately twice the price of the conventional hybrid corn seed in 2005. The GE Bt corn sold at P 4400 to 490039 (RMB 734.8 to 813.3) per 18-kg bag. Conventionally bred hybrid seeds sold at about P 1500 to 2700 40 (RMB 250.5 to 450.9) per 18-kg bag. The GE seed price was 3 times higher while the yield from the seeds was the same as with the non-GE seed.

Figure 4 Growth Chart of Seed Price

Seed Price in US

70 60 50 Corn 40

e Soybean c

i 30 r

P Cotton 20 10 0 1997 2006 Time

20 The above figure shows the rising of seed prices. According to the data of the U.S Department of Agriculture, during the period of 1997-2006, the average cost to farmers for seed to plant an acre of corn, soya and cotton rose dramatically from US$28.71, 19.72 and 17.63 to US$40.47, 34.06 and 61.69 respectively41. Comparing to previous seed prices, in mid-1990’s, the higher price can be correlated to the much higher cost of GE seeds, for instance, GE cotton seed costs from two to over four times as much as conventional seed in the U.S. But the supply of conventional cotton seed reduced by half during 2003 to 2006. 42

Currently in China patents do not extend to GE seed and the progeny, so in theory technology fee and price tags should not be passed on to Chinese farmers. But the case of Argentina shows that there is a risk that technology fees may be subsequently added as well in China.

In Argentina, Monsanto had no patents on its GE Roundup Ready (RR) soya (Roundup is a Monsanto herbicide, and GE RR soya was engineered to contain a bacterial gene that makes the soya resist this herbicide. The GE RR soya came as the patent on the herbicide expired). Nevertheless, Monsanto has benefited for 10 years since the commercial planting of the GE soya in Argentina in the 1990s, in the following ways: a) RR soybean dominated almost the total production of one of the world’s leading soya bean producers (Argentina); b) Monsanto participated in and made profit in the market with the sale of both the GE soya seeds and the herbicide Roundup that has to be used on the GE soya plant; c) Many Argentinean seed companies paid Monsanto royalties by entering into private licensing agreements (even in the absence of patents). 43

If China approved the commercialization of GE rice, the rice lines would almost inevitably be open to claims and thus control by foreign patent holders. The additional costs collected by patent holders will probably be passed on to Chinese farmers. Commercialized GE rice may significantly raise the seed price and cost to farmers. While the Chinese government strives to reduce the burden of farmers over many years, the positive effects will be offset.

GE crops cannot reduce the planting cost. Research on China’s GE cotton reveals that farmers are still massively overusing pesticides on GE cotton44. The research findings indicate that the insect resistance trait in Bt-varieties does not have a significant reducing effect on the use of insecticides targeting cotton bollworm. Instead farmers continue to use large amounts of insecticides targeting cotton bollworm 45. Increase in secondary pests also cause additional pesticide to be sprayed. After 7 years of growing GE Bt cotton in China, farmers have to spray as much insecticide as when they planted conventional cotton. “Though Bt farmers save a lot on primary pesticides, they have to spend more to suppress the outbreak of the secondary pests, leading to total pesticide expenditures between these two groups of farmers that are almost identical. In addition, the price for Bt seeds is 2 to 3 times higher than conventional seed in China. The extra cost of Bt seed must make the net revenue of Bt farmers lower than that of non-Bt farmers.”46 If the scenario for commercialized GE rice is the same as that for GE cotton, farmers may be affected badly by this commercialization.

21 The above research suggests that GE crops increase neither yield nor farmers’ income. In this case Chinese farmers will risk facing continuous high expenditure for pesticides and increased prices for seed. If farmers cannot afford the cost of seeds this results in less planting and income in the following year and lowers down their living standard. With less income farmers will have less seeds purchasing power. Then farmers will be trapped in a vicious circle towards poverty.

3) Social effects of increased production costs and rice prices

If the interests of farmers were impinged, it would reduce their motivation to plant crops and thus result in less long term food supply. Meanwhile, consumption and demand always exist even if the price is high. A shortage of supply will further raise food prices and impact all consumers, especially the people with lower income for whom food expenses, including rice, constitutes a very big portion of their living budget. Rice is the staple food grain of most Chinese. Even if its price has a small variance, it will greatly impact the life of ordinary people.

The recent increased CPI (Consumer Price Index) can be a good case. The increased price of commodity at this wave is due to increased price of pork, but behind, it is because of less profit in feeding pigs and lower motivation of feeders, which cause the great reduction of marketing rate of pigs and decrease the supply to market. Although the supply becomes less, the demand keeps unchanged, the price is rising highly.

In food habit of Chinese consumers, rice is more important than pork. Pork is replaceable, but rice is hard to be replaced and consumption of rice is much more. On average a Chinese consumer consumes 97kg of rice per year, but only 39.6kg of pork. Therefore, the variance of rice price will affect consumers much heavier.

The recent increased price of rice worldwide has caused big social instability in many parts of the world. Riots have happened in several countries such as Haiti, Egypt and Indonesia. As the major production origins, Asia has high dependency on rice. However in some countries like Thailand, India and Vietnam shortage of rice supply appeared in succession and consumers were rushing to buy. Thus rice price and supply are very important for the social stability.

4) The threat of lawsuits

A patent gives the owner the right to stop others from using the patent methods or products, or the owner can enter into negotiation to agree on the terms and conditions under which other parties can use the patented method or product through license agreements.

The patent holder has many means to enforce his right. For example, Monsanto is known to have hired private investigation services in North America to learn if its patent protected GE crops are growing in any farm without a grower’s contract, and has threatened farmers with legal action (see Monsanto’s letter to a Canadian farmer below47) or has taken legal action against them.

A letter to a Canadian Farmer from Monsanto

22 In North America Monsanto has sued about 100 farmers for alleged violation of Monsanto’s patents48. A well-known case is that of Percy Schmeiser vs Monsanto. Percy and Louise Schmeiser

23 had grown canola (rapeseed), wheat and legumes in Bruno (Saskatoon, Canada) on 1,400 acres of land for 47 years. In 1998, representatives of Monsanto arrived on the Schmeiser farm and claimed that they were infringing on the patent for Roundup Ready canola. Monsanto claimed to have found it in their fields without them having paid the necessary fees to cultivate it. Percy Schmeiser argued that the seeds were blown into their field or were dumped there by accident. Monsanto wanted to settle this case out of court, but Schmeiser refused. A federal court judge ruled in March 2000, that it was unlikely the patented canola ended up growing in Schmeiser's fields by accident. They were found guilty of patent infringement and ordered to pay a penalty, plus court costs for a total of almost US$400,000, including his legal fees. Schmeiser appealed the ruling to the Canadian Federal Court of Appeal and lost again on 4 September 2002. Schmeiser's legal battle ended on 20 May 2004, when the Canadian Supreme Court agreed with lower court rulings and sided with Monsanto. In March 2008, Percy and Louise Schmeiser finally earned a moral victory. Monsanto agreed to pay the Schmeisers US$660 to settle a small court case the couple had brought against the company for the costs associated with removing the patented GE canola from their field in 200549.

In Argentina, Monsanto had no patents on its GE soya, but it had a patent on this GE soya in the E.U. Monsanto filed lawsuits in EU countries against the importers for compensatory fees when importing Argentinean soybean or soybean meal.

Patents in general and their different scope can impact international trade. They provide an opportunity for patent holders to pursue enforcement of their patent rights. Depending on court rulings they may also be able to collect fees from other countries or as the example of Percy and Louise Schmeiser shows even from farmers who did not intend to use this patent protected product.

The Chinese owned rice seed industry, especially those companies that produce e.g. rice hybrid seed for domestic and foreign markets, may be particularly vulnerable to legal suits by foreign patent owners once GE rice is produced on a large scale in China. Large scale commercial production of GE rice will make it inevitable that traces of GE seed contaminate conventional seed by natural events or through human error such as spilling or mixing. If GE contaminated conventional hybrid seed finds its way to foreign countries, the Chinese company may face legal problems in case this specific GE seed is not authorized in that country and in addition the company may face legal problems from patent holders that try to enforce their patents and to collect compensation fees.

The patent research on Chinese GE rice lines, Bt, CpTI and CpTI/Bt suggests that least 5-10 patents are related to each of the 3 GE rice lines. This situation might cause serious patent disputes, and may lead to court cases in many countries.

Suggestions

The Chinese GE rice lines, Bt, CpTI and CpTI/Bt in this research are related to foreign patents. We suggest that the government carefully investigates and analyzes the possible implications of the

24 foreign patents and take into consideration the additional costs, risks and uncertainties associated with GE rice commercialization. Before such thorough investigation has been carried out, any GE rice commercialization should be put on hold

Another problem which has not been the focus of this research is if Chinese scientists in GE rice research and development have received any of the genes they used through cooperation with foreign companies and institutes. If some of the genes originated from foreign sources, it usually requires the signing of a material transfer agreement, especially if the source is a developed country. Do they have any agreement with such foreign companies and institutes? If they do have a kind of agreement, the terms and effect of the agreement should be investigated. In addition, because of the potential enormous impact of GE rice commercialization, in the process of making policy and decision, more stakeholders should be involved in the process, such as various government departments.

We also suggest investigating and assessing the benefit of other modern technologies, such as molecular marker assisted breeding and sophisticated ecological rice farming methods. Molecular marker assisted breeding does not have the risks and uncertainties like GE technology and is less under foreign patent control. This technology can reduce pests too50. Sophisticated ecological rice farming is also another option for the sustainable development of rice planting. It adopts biological control and advanced agricultural management measures on pests51.

Conclusion

In the past 20 years GE crops were regarded by some parties as a solution to future food security. China has put in a lot of investment and human resource to develop GE rice lines with independent (domestically owned) intellectual property. However many core technologies of GE technology are already controlled by foreign companies and agencies with patents. The authors find that many “Chinese” GE rice lines are related to many foreign patents. If such a GE rice line were commercialized on a large scale in China, foreign patents might bring about big price increases of the seed and then raise the price of rice, which would affect rice products and trade, affect farmers’ livelihood and threaten national food security further. We suggest that foreign patents attached to GE rice should be carefully investigated and analyzed for their possible implications. Before such thorough investigation has been carried out, for the national interest, food security of China and farmers’ livelihood, any GE rice commercialization should be put on hold.

This report aims to raise awareness on the threats posed by foreign intellectual property rights related to China’s most important staple food so that more research and analysis can be done on GE rice patents, as well as the cooperation between Chinese scientists and foreign companies and institutes. Pending such thorough investigation, any GE rice commercialization should be put on hold.

25 Acknowledgements: Greenpeace China and Third World Network would like to thank Mr. Li Hui for doing the search to identify the genetic methods and elements used in Chinese GE rice and conducting the patent database research. We would like to thank Christoph Then for providing the European Patent on Bt crops research and for his advice on this report. We would like to thank Toshio Yanagihara for helping with translation and advice on patents applied for or granted in Japan.

26 Annex 1

Details of Foreign Patents on Standard Methods used for GE Rice Development

Patent Patent Number Country Application Inventors Patent Date Holder Agrobacterium- AU6389200 Australia 20000728 Rout Jyotir (US); Monsanto mediated plant BR0013187 Brazil 20000728 Armstrong Charles Technology transformation CA2381254 Canada 20000728 L (US) LLC (US) method EP1200613 EU 20000728 JP2003506035T Japan 20000728 US6603061 United States 19990729 Method for AU697373B Australia 19950726 Bowen Benjamin A; Pioneer Hi producing BR9508341 Brazil 19950726 Lowe Keith; Ross Bred INT transgenic cereal Margot C; Sandahl CA2195206 Canada 19950726 plants Gary A; Tomes EP0772687 EU 19950726 Dwight T; Songstad JP10503374T Japan 19950726 David D; Gordon- NZ293737 New Zealand 19950726 kamm William J US5736369 United States 19950607 ZA9506302 South Africa 19950728 MX9700688 Mexico 19970726 Plant transformation US7285705 United States 20000419 Risacher Thierry Biogemma method AU775949B Australia 20000419 (GB); Craze SAS (FR) BR0011140 Brazil 20000419 Melanie (GB) CA2369428 Canada 20000419 CN1347457 China 20000419 EP1171621 EU 20000419 IL145686D Israel ? JP2002541853T Japan 20000419 Enhanced US5589617 United States 19940803 Nehra Narender S; Canada Nat Regeneration EP0688160 EU 19940310 Kartha Kutty K; Res Council System for Cereals AU6178194 Australia 19940310 Chibbar Ravindra N Method for US5350688 United States 19920616 Matsuno Tsukanori Kirin Brewery regeneration of rice (JP); Ishizaki (JP) plants Keiichiro (JP)

Note: ‘?’: The information about application date was not accessible though the patent databases that were searched..

27 Annex 2

Details of Patents that may be applied to Chinese Bt Rice Lines

Patent Patent Number Country Application Inventors Patent Date Holder Rice actin gene and AU7182791A Australia 19910104 Wu Ray; McElroy Cornell Res promoter D David Foundation US5641876 United States 19931027 Inc (US) Hybrid Bacillus US6962705 United States 20030926 Malvar Thomas Monsanto thuringiensis. delta.- ID25530 Indonesia 19971120 (US); Gilmer Amy Technology endotoxins with novel AU742971B Australia 19971120 Jelen (US) LLC (US) broad-spectrum BR9713373 Brazil 19971120 insecticidal activity CA2272843 Canada 19971120 CN1210402C China 19971120 EP0942985 EU 19971120 IL129988D Israel ? JP2001502555T Japan 19971120 OA11257 OAPI 19990519 TR9901109T Turkey 19971120 ZA9710429 S.Africa 19971119 Lepidopteran- US7078509 United States 20030502 Baum James A; Monsanto active Bacillus AU7491600 Australia 20000913 Chu Chih-rei; Technology thuringiensis delta- BR0014516 Brazil 20000913 Donovan William LLC (US) endotoxin P; Gilmer Amy J; CA2384967 Canada 20000913 polynucleotides, Rupar Mark J EP1218513 EU 20000913 compositions, and ZA200201610 S.Africa 20020226 methods of use Isolated DNA AU680899B Australia 19940624 Atanassova Rhone sequence which can BR9401842 Brazil 19940622 Rossitza; Rose Poulenc serve as terminator CA2126806 Canada 19940627 Richard De; Agrochimie region in a chimeric EP0633317 EU 19940623 Freyssinet (FR)/ Bayer gene capable of being CN1253570C China 19940627 Georges; Gigot Cropscience used for the JP7008278 Japan 19940624 Claude; Lebrun (SA)* transformation of IL110069 Israel 19940620 Michel plants US6313282 United States 19970718 Synthetic insecticidal AU4118289 Australia 19890908 Adang Michael J; Lubrizol crystal protein gene CA1341428 Canada 19890908 Rocheleau Genetics Inc/ CN1145698C China 19890909 Thomas A; Merlo Mycogen JP11266882 Japan 20011019 Donald J; Murray HK1030013 Hongkong 20010130 Elizabeth E EP0359472 EU 19890907 KR0168038B Korea 19890909

28 US5380831 United States 19930503 NZ230375 New Zealand 19890821 Synthetic plant genes EP0413019 EU 19900213 Fischhoff David Monsanto and method for AR243234 Argentina 19900223 Allen (US); Perlak Technology preparation AU638438B Australia 19900213 Frederick Joseph LLC (US) BR9007159 Brazil 19900213 (US) CA2024811 Canada 19900213 IL93513 Israel 19900223 NO904585 Norway 19901023 JP3364616B2 Japan 19900213 NZ232654 New Zealand 19900223 RU2107725 Russia 19900213 ZA9001417 South Africa 19900223 TR24354 Turkey 19900328 Novel pesticidal AU692934B Australia 19950927 Warren Gregory Ciba Geigy proteins and strains BR9509099 Brazil 19950927 Wayne; Koziel Ag (CH)/ CA2199049 Canada 19950927 Michael Gene; Novarits Ag/ CN1255539C China 19950927 Mullins Martha Syngenta EP0792363 EU 19950927 Alice; Nye Participations IL146109D Israel ? Gordon James; Ag (CH) JP10506532T Japan 19950927 Carr Brian; Desai MX9702212 Mexico 19970325 Malini Manoj; RU2196824 Russia 19950927 Kostichka Kristy; SG49845 Singapore 19940323 Duck Nicholas UA68345 Ukraine 19980402 Brendan; Estruch Juan Jose TR960263 Turkey 19950928 ZA9508121 South Africa 19950927

Note: ‘?’: The information about application date was not accessible though the patent databases that were searched ‘ *’: Patent holders might have changed through acquisition or/and merge. Spin offs patents might have been transferred to the new entities or other companies or may have remained with the original patents holders.

29 Annex 3

Details of Patents that may be applied to Chinese CpTI Rice Lines

Patent Patent Country Application Inventors Patent Holder Number Date DNA Molecules US5218104 United States 19910219 Hilder Vaughan Agricultural Useful in Plant Alan (GB); Genetics Co Protection Gatehouse (GB) Angharad Margaret Ro (GB); Gatehouse John Arthur (GB); Boulter David Isolated DNA AU680899B Australia 19940624 Atanassova Rhone Poulenc sequence which can BR9401842 Brazil 19940622 Rossitza; Rose Agrochimie serve as terminator CA2126806 Canada 19940627 Richerd De; (FR)/ Bayer region in a chimeric EP0633317 EU 19940623 Freyssinet Cropscience gene capable of CN1253570 China 19940627 Georges; Gigot (SA)* being used for the JP7008278 Japan 19940624 Claude; Lebrun transformation of IL110069 Israel 19940620 Michel plants US6313282 United States 19970718 Chimeric genes US6174724 United States 19950504 Rogers Stephen G Monsanto suitable for BR1101069 Brazil 19970514 (US); Fraley Technology expression in plant EP0131623 EU 19910603 Robert T (US) LLC (US) cells JP6315381 Japan 19940328

Note: *: Patent holders might have changed through acquisition or/and merge. Spin offs patents might have been transferred to the new entities or other companies or may have remained with the original patents holders.

30 Annex 4

Details of Patents that may be applied to Chinese CpTI/Bt Rice Lines

Patent Patent Number Country Applicatio Inventors Patent Holder n Date Rice actin gene and AU7182791A Australia 19910104 Wu Ray; McElroy Cornell Res promoter US5641876 United States 19931027 David Foundation Inc (US) Hybrid Bacillus US6962705 United States 20030926 Malvar Thomas Monsanto thuringiensis .delta.- ID25530 Indonesia 19971120 (US); Gilmer Amy Technology LLC endotoxins with AU742971B Australia 19971120 Jelen (US) (US) novel broad- BR9713373 Brazil 19971120 spectrum CA2272843 Canada 19971120 insecticidal activity CN1210402C China 19971120 EP0942985 EU 19971120 IL129988D Israel ? JP2001502555T Japan 19971120 OA11257 OAPI 19990519 TR9901109T Turkey 19971120 ZA9710429 S.Africa 19971119 Lepidopteran-active US7078509 United States 20030502 Baum James A; Chu Monsanto Bacillus AU7491600 Australia 20000913 Chih-rei; Donovan Technology LLC thuringiensis delta- BR0014516 Brazil 20000913 William P; Gilmer (US) endotoxin CA2384967 Canada 20000913 Amy J; Rupar Mark polynucleotides, EP1218513 EU 20000913 J compositions, and ZA200201610 S.Africa 20020226 methods of use DNA Molecules US5218104 United States 19910219 Hilder Vaughan Prodigene Inc Useful in Plant Alan (GB); (US) Protection Gatehouse Angharad Margaret Ro (GB); Gatehouse John Arthur (GB); Boulter David (GB) Plant promoter AU7543301 Australia 19940624 Jilka Joseph M; Prodigene Inc sequences and Hood Elizabeth E; (US) methods of use for US6,977,325 United States 20020228 Howard John A same Synthetic AU4118289 Australia 19890908 Adang Michael J; Lubrizol Genetics insecticidal crystal CA1341428 Canada 19890908 Rocheleau Thomas Inc/ Mycogen protein gene CN1145698C China 19890909 A; Merlo Donald J; JP11266882 Japan 20011019 Murray Elizabeth E

31 HK1030013 Hongkong 20010130 EP0359472 EU 19890907 KR0168038B Korea 19890909 US5380831 United States 19930503 NZ230375 New Zealand 19890821

Note: ‘?’: The information about application date was not accessible though the patent databases that were searched.

32 Annex 5 Patent Protection Scope in Different Countries

Patent Patent Number Country Protection Scope Hybrid Bacillus CN1210402C China 1) Gene sequence thuringiensis. 2) Usage methods delta.-endotoxins 3) Transformed host cells (Prokaryotic and eukaryotic with novel broad- cells, including plant cells) spectrum 4) Compositions insecticidal activity 5) Peptide 6) Respective antibody EP0942985 EU 1) Gene sequence 2) Usage methods 3) Host cells (Prokaryotic and eukaryotic cells, including plant cells) 4) Compositions 5) Respective peptide and protein 6) Respective antibody 7) Transformed plant, seeds and progeny US6962705 United Respective protein States JP2001502555T Japan 1) Gene sequence 2) Usage methods 3) Host cells (Prokaryotic and eukaryotic cells, including plant cells) 4) Compositions 5) Respective peptide and protein 6) Respective antibody 7) Transformed plant, seeds and progeny Isolated DNA EP0633317 EU 1) Gene sequence sequence which 2) Vector can serve as 3) Transformer cells terminator region 4) Transformed plants in a chimeric gene CN1253570C China 1) Gene sequence capable of being 2) Vector used for the 3) Transformer cells transformation of 4) Transformed plants plants JP7008278 Japan 1) Gene sequence 2) Vector 3) Transformer cells 4) Transformed plants

33 US6313282 United 1) Gene sequence States 2) Vector 3) Transformer cells 4) Transformed plants Plant CN1347457 China Transformation method transformation EP1171621 EU Transformation method method US7285705 United Transformation method States JP2002541853T Japan 1) Transformation method 2) Transformed plant tissue, seed and other propagation substance Synthetic CN1145698C China Gene modification method insecticidal crystal EP0359472 EU 1) Gene modification method protein gene 2) Gene sequence 3) Transformed cells US5380831 United 1) Gene modification method States 2) Gene sequence Novel pesticidal CN1255539C China 1) Gene sequence proteins and strains 2) Gene isolation method 2) Protein 3) Usage methods 4) Use of a oligonucleotide probe for screening EP0792363 EU 1) Gene sequence 2) Gene isolation method 3) Protein 4) Usage methods 5) Use of a oligonucleotide probe for screening 6) Transformed plant, seeds and progeny

34 Reference

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