A view on Plant variety under china's Plant IP Protection system

2011/9/15By Li Jinguang,[Patent]

[ABSTRACT]
There is no uniform definition of “plant variety” under China’s plant IP protection system. According to its meaning from amplified interpretation under Guidelines for Patent Examination, all plants including transgenic plants shall be excluded from patentable subject matter whereas the protection of the rights in new varieties of plants shall be limited to propagating material of protected variety. The various meanings of "plant variety" are not conducive to the encouragement of Chinese plant variety research and the protection of patentee’s actual rights and interests to some extent. This paper suggests that the meaning of “plant variety” should be cleared in Guidelines for Patent Examination in order to include those plants under the subject matter of non-“plant variety” in the scope of patent protection by way of drawing from the definition of “plant variety” under Seed Law of PRC and Act of 1991 International Convention for the Protection of New Varieties of Plants on the basis of taking the rights and interests of Chinese farmers into account.
 
 [KEY WORDS]
plant variety; various meaning; uniform definition; intellectual property; China
 
Agricultural development and food security is influenced by plants to a certain extent. Time has witnessed that more attention have been paid by all countries and economies to IP protection for their plants. Agricultural development and food security is influenced by plants to a certain extent. Time has witnessed that more attention have been paid by all countries and economies to IP protection for their plants, particularly against the background that Monsanto, DuPont and other transnational corporations have kept on applying for plant gene patent and popularizing their plant variety across the world in recent years. In China, the Outline of the 12th Five-Year Plan for National Economic and Social Development of the People’s Republic of China approved by the Fourth Session of the 11th National People’s Congress in 2011 stipulates that “Pace of agricultural biological growing, innovation, promotion, and application will be accelerated. We will develop new biological varieties with major application value and with indigenous intellectual property right.” Therefore, it is necessary to discuss the questions under China’s plant IP protection(PIPP) system and to explore the possible solutions in order to improve China’s PIPP system for reference.
 
I. Major Legal Objects of PIPP in China
 
At present, the PIPRP legal objects under China’s current PIPP system mainly refer to those protected objects related to patent right and the rights in new varieties of plants resulting from invention on plant development.
 
i.                    Objects of patent rights related to plant invention in China
The objects under the protection of China’s paten law system are those inventions-creations which can be granted the patent right and safeguarded by the law. According to China’s patent law, inventions-creations include inventions, utility models and designs. The substantive requirements for the patent right to invention is that the invention must possess novelty, inventiveness and practical applicability. Novelty means that, before the date of filing, no identical invention has been publicly disclosed in publications in China or abroad or has been publicly used or made known to the public by any other means in China, nor has any other person filed previously with the patent administrative organ under the State Council an application which described the identical invention and was published after the said date of filing. Inventiveness means that, as compared with the technology existing before the date of filing, the invention has prominent substantive features and represents a notable progress. Practical applicability means that the invention can be made or used and can produce effective results. After the grant of the patent right for an invention, except as otherwise provided for in patent law, no entity or individual may, without the authorization of the patentee, exploit the patent, that is, make, use, offer to sell, sell or import the patented product; or use the patented process or use, offer to sell, sell or import the product directly obtained by the patented process, for production or business purposes. Furthermore, the Patent Law also stipulates that no patent right shall be granted for any invention-creation that is contrary to the laws of the State or social morality or that is detrimental to public interest or that is mainly resulting from biological method or that is acquired in violation of the stipulation of laws and administrative regulations or that such inventions-creations are based on the exploitation of and completed relying on inheritance resources.
 
In fact, inventions-creations related to plant in China mainly refers to inventions. Where a patent is granted to such an invention, it must satisfy the requirement that its technical solution must be a non-plant variety or other than biological method. According to Guidelines for Patent Examination, a single plant and its propagating material (such as seed, etc.), which maintains its life by synthesizing carbohydrate and protein from the inorganic substance, such as water, carbon dioxide and mineral salt and so on through photosynthesis and transgenic plants, belong to the category of the "plant variety", whereas a cell, a tissue and an organ of a plant cannot be regarded as "plant varieties" if they do not possess the above-mentioned characteristic. It can be seen from this that transgenic plants, plant itself, and propagating material above cellular level are generally deemed as "plant varieties" and thus excluded from subject matter protection as patent during the process of examination of application for patent in China. When it comes to examine whether a method is “mainly resulting from biological method" or not, the result will depend on the extent of human involvement in the technology concerned. A method will not be deemed as “mainly resulting from biological method” where the purpose or effect the method intended to achieve is mainly controlled or decided by human technological involvement. Such methods as natural hybrid or choice to acquire a plant variety will be deemed as “mainly resulting from biological method” because of the non-decisive role of human technological involvement in plant varieties development. However, those methods exploiting growth regulators such as using CCC to cultivate plants can not be deemed as “mainly resulting from biological method” because the artificial introduction of CCC plays a decisive restrictive role in plant growth.
 
To sum up, the objects of inventions-creations related to plant inventions-creations under the protection of patent right in China are plant breeding methods, plant usage and plant materials not for propagating or below cellular level on the condition that their patent right are granted on the basis of its satisfaction of novelty, inventiveness and practical applicability, that human technological involvement plays a decisive role in the achievement of plant production and breeding, and that such inventions-creations must rely on the legitimate inheritance resources.
 
ii.                  The protected objects of the Rights in New Varieties of Plants in China
 
According to Regulations of the Peoples Republic of China on the Protection of New Varieties of Plants, the substantial requirement for the rights in new varieties of plants in China is that the applied variety is under the plant genera or species included in the National List of the Protected Plant Varieties, possess novelty, distinctness, uniformity and stability and an adequate denomination. Novelty means that at the date of filing of the application for a variety right the propagating material of the new variety has not been sold or with the authorization of the breeder within the territory of China earlier than one year before that date in a territory other than China earlier than four years or in the case of vines forest trees fruit trees and ornamental plants earlier than six years. Distinctness means that the variety for which a variety right is applied for must be clearly distinguishable from any other variety whose existence is a matter of common knowledge at the time of the application. Uniformity means that the variety for which a variety right is applied for is sufficiently uniform in its relevant features or characteristics after propagation, subject to variation that may be expected from the particular features of its propagation. Stability means that the variety for which a variety right is applied keeps its relevant features or characteristics unchanged after repeated propagation or at the end of a particular cycle of propagation. Adequate denomination means the denomination shall be distinguishable from that for any other known variety of the same or similar plant genera or species and the following shall also be avoided in the selection of a denomination for a new variety: those consisting of only numbers; those violating the State law or social morals or having the nature of discrimination against any nationality;those named after a country; those named after a place of an administrative regions at county level or above in China or a well-known place of a foreign country; those that are the same or similar to the denomination of intergovernmental international organizations, other internationally or domestically well-known organizations or marks as well, and those that are liable to mislead or to cause confusion concerning the features or characteristics of the new variety, or identity of the breeder. The said plants include agricultural and forestry plants, whereas agricultural plants shall cover those of food crops, cotton, oil crops, bast-fiber plants, sugar crops, vegetables (including water melon and melon), tobacco, mulberries, tea plants, fruit trees (except for dry fruits), ornamental plants (except ligneous plants), grasses, green manure, herbaceous medicinal plants, edible fungi, rubber tree and other tropical plants and crops. These regulations also stipulate that the entity which the person who has accomplished the breeding enjoys an exclusive right on his or its protected variety. No other entities or persons shall, without the authorization of the owner of the variety right, produce or sell for commercial purposes the propagating material of the said protected variety, or use repeatedly for commercial purposes the propagating material of the said protected variety in the production of the propagating material of another variety, with the exception of exploitation of the protected variety for breeding and other scientific research activities and the use by farmers for propagating purposes, on their own holdings, of the propagating material of the protected variety which they have obtained by planting on their own holdings. The agricultural propagating materials means planting materials or other parts of the body of a plant that can propagate plants including seeds and fruits as well as roots, stems, seedlings, buds and leaves, whereas the forestry propagating material is the whole plant (including stock), seed (including root, stem, leaf, flower and fruit etc.) and any part, which constitutes the plant body (including tissue and cell). The National List of the Protected Plant Varieties shall be determined and announced by the authority for the examination and approval of the right in new varieties. From 1999 to 2010, China’s Ministry of Agriculture has announced eight batches, and the State Forestry Administration four groups, with a total of 93 genera and 65 species.
 
In brief, the protected objects of the rights in new varieties of plants in China are in fact new plant propagating materials that possess novelty, distinctness, uniformity and stability and an adequate denomination, that be under the plant genera and species included in the National List of Protected New Plant Genera and Species announced by the State Forestry Administration and the Ministry of Agriculture, that should be granted rights in new varieties of plants, that it shall not be extended to include the parents and processing products of protected variety, and that they are different from any other plant’s propagating material.
 
II. The Problems under China’s Current PIPP System
 
The implementation of the system of patent right and of the rights in new varieties of plants have enhanced people’s awareness of and promoted PIPP. However, there are several questions as follows to be solved which can be seen from the actual scope of protected objects under China’s PIPP system discussed in the foregoing paragraphs.
 
i.                    Various meanings of “plant variety”
 
There is no clear definition of plant variety among all the laws, administrative regulations and administrative rules in China though plant variety has been mentioned here and there under PIPP system. There is only one related definition, namely, the one of new plant varieties stipulated in the Rules for the Implementation of the Regulations of the People’s Republic of China On the Protection of New Varieties of Plants (Forest Part), which means “a cultivated variety or a developed one based on a discovered wild plant which possesses novelty, distinctness, uniformity and stability, and which is designated by an adequate denomination”. Under Guidelines for Patent Examination, plant variety is extended so that a single plant and its reproductive material (such as seed, etc.), which maintains its life by synthesizing carbohydrate and protein from the inorganic substance, such as water, carbon dioxide and mineral salt and so on through photosynthesis and transgenic plants belong to the category of the “plant variety”, whereas a cell, a tissue and an organ of a plant cannot be regarded as “plant varieties” if they do not possess the above-mentioned characteristics. In fact, no law related to plants in China except the Seed Law gives a clear definition of “plant varieties”, namely, “the flora artificially bred or discovered and improved, and their morphological characteristics are in conformity with their biological characteristics and their hereditary properties are relatively stable”. It is obviously that, as far as plant variety is concerned, the definition of Seed Law is different from that of Guidelines for Patent Examination although the latter is an amplified interpretation, and the former is in fact, generally accepted by people as the true meaning of “plant varieties”. For this reason, people have found chaos in their understanding of the actual protected coverage of PIPP, and plant researchers have been not sure what kind of rights will protect their legal rights more effectively, patent examiners have found it difficult to make an exact decision whether the defined technical solution required by the right belongs to the category of the “plant variety” or not. Therefore, it is not conducive to an effective PIPP and international exchange as well.
 
ii.                  Not conducive to the encouragement of Chinese plant research
 
It can be concluded from the current situation of plant research and actual scope of PIPP objects that China’s PIPP system is not conducive to the encouragement of plant research. Firstly, the vast majority of Chinese plant researchers do their studies from the phenotype, and traditional methods such as hybridization, induced mutation, and etc. are still the dominant study approaches. However, traditional breeding methods can not be granted patent rights for the lack of inventiveness and cultivated hybrids cannot be granted the rights of new plant varieties for the lack of stability because the plant itself and its parts are not within the scope of protection of patent subject matter under China’s current PIPP system. The preponderant rice by distant hybridization is a good example in this regard. The hybrids itself have an advantage whereas its offspring have no advantage due to genetic segregation. Therefore, hybrids cannot be protected by the rights of new plant varieties because the rights require stability, and is not the subject matter under patent law because patent right cannot be granted to protect plant itself and its parts. Although the parents of hybrids can be protected by applying for the right in new varieties of plants under China’s current PIPP system, plant breeders will have to increase the applied number of variety rights and pay more fees on one hand, and are usually denied to grant variety rights due to lack of novelty on the other hand. Therefore, China’s current PIPP system is not conducive to the protection of the findings of the majority of Chinese researchers. Plant researchers will find it difficult to recover their research cost, and become unwilling to make further investment in this regard if such plant material is being stood outside of the protection of the law because these studies need intelligence, labor and costs, plant material with some characteristics still contains certain features and functions though they may not belong to plant varieties, such features and functions are discovered by exploitation of certain resources and intelligence, and some of them may have extensive value for use. Secondly, the right in new varieties of plants is granted only to the genera or species included in the National List of Protected New Plant Genera and Species and not to any other plant. However, the number in the list is very small in relation to our current plant varieties, which includes only 93 genera and 65 species. Therefore, the plant materials outside the list have not been given actual protection. This is unreasonable and should be changed because China is rich in plant resources and well-known for its status as one of eight centers of crops origin in the world.
 
iii.                Difficult to protect patentee’s actual rights and interests
 
At present, the protected scope of patented process has not been extended to the plant products not reproduced by such process after the sale of the patent directly by the process and the rights of new plant varieties cannot be used to protect plant breeding process and products by exploitation of features of protected variety. Firstly, patent right does not cover plant propagating material. Although a plant breeding process has been granted a patent right, it is not necessary to use the patented process in actual production for the reason that other breeding process can also achieve the same result in comparison with the adoption of the patented process, that it is easy to avoid the patented process, and that the other process is easier and has a higher economic efficiency. There may be an example in this respect. Where a process, which enables grape possesses disease-resistant features through transgenic technology, has been granted patent right patent, any person may cultivate a grape seedling with the said disease-resistant features through cottage with a branch of the said grape he bought and without repeating the transgenic process. The seedlings bred in this way can easily be excluded from the protection coverage of patent. Secondly, the protected coverage of the rights of new plant varieties is limited to propagating material of protected variety, whereas derived varieties and other plant materials possessing the features of the protected variety are not under protection. Derived varieties mean new ones with characteristics changed to some extent acquired by way of selected breeding of initial variety, natural or induced mutation, somatic cell cloning, gene transfer, backcrossing with its parents. Anyone may produce a plant with the features of the protected variety by way of exploiting derived ones possessing the features of the protected ones without the latter. Furthermore, he may apply for a patent for the functional genes of the protected variety in order to restrict the exploitation by others in any other plant. Therefore, the current PIPP system in China is not beneficial to the protection of patentee’s real rights and interests.
 
III. Possible Solutions to and Its Feasibility of the Existing Questions of China’s PIPP System
 
It can be said that the reason for the above-mentioned questions is that there are various meanings of “plant variety” under China’s PIPP system, which are embodied in the provisions of Guidelines for Patent Examination which expands the interpretation of Patent Law in terms of “plant variety” that shall not be granted patent right, and of Regulations of the Peoples Republic of China on the Protection of New Varieties of Plants which stipulates that the protected coverage of the rights in new varieties of plants shall be limited to the propagating material under the plant genera and species included in the National List of Protected Plant Genera and Species. Therefore, the simplest solution to these questions is to add a uniform and clear definition of plant variety to China’s PIPP system, and to make its meaning as same as or similar to the common knowledge to the utmost, which will result in a uniform understanding and a more convenient communication. People have become familiar to and find it easy to understand the definition of “plant varieties” of China’s Seed Law and Act of 1991 International Convention for the Protection of New Varieties of Plants (UPOV Convention 1991 Act) . In detail China’s Seed Law stipulates that varieties mean the flora artificially bred or discovered and improved, and their morphological characteristics are in conformity with their biological characteristics and their hereditary properties are relatively stable, whereas UPOV Convention 1991 Act provides that “variety” means a plant grouping within a single botanical taxon of the lowest known rank which can be defined by the expression of the characteristics, resulting from a given genotype or combination of genotypes, distinguished from any other plant grouping by the expression of at least one of the said characteristics and considered as a unit with regard to its suitability for being propagated unchanged. If a combination of the two definitions is made and introduced to Guidelines for Patent Examination, there will be a uniform and clear definition of plant variety to China’s PIPP system. For the reason that the meaning of “plant variety” under Guidelines for Patent Examination is more extensive than that under UPOV Convention 1991 Act, the introduction of the latter definition to the former will result in a question: should all plants including transgenic plants and their parts be included in the scope of patent subject matter protection under China’s current PIPP system or not? Therefore, the feasibility of the solution is in fact whether they should be included in the scope of patentability or not at present. However, the answer to the question is closely related to the technical development in plant studies of concerned country and to its farmers’ rights and interests. The author would like to explore the feasibility of the solution through the assessment of different opinions of China’s scholars on the adoption of patent right to protect plants.
 
i.                    On the point of opponents
 
Opponents insist that the entire agriculture, plant gene and the orientation of scientific and technical research in the future will also be manipulated by an individual or corporate because the plant patent gives the patentee a legal monopoly during a certain period. Furthermore, R & D in the fields of plants will be restricted, the opportunity for others to improve plants denied, scientific progress hampered, farmers’ rights and interests infringed, and biodiversity threatened because the right of the patentee shall be extended to the derived varieties.
 
The main concern of opponents is that public interests, including farmers’ rights and interests, will be infringed. However, they have exaggerated the exclusiveness of plant patent and its damage. Firstly, it is impossible for any person or company to do studies on all agricultural plants and their genes, and to control the entire agricultural industry and plant genes. Even if a certain types of plants and their genes are controlled by a person or company, any other person can still be permitted to make a reasonable exploitation of the patented technology to compete with the patentee in accordance with the provisions of compulsory license under Patent Law. Moreover, Patent Law also stipulates that it is free for any other person to uses the patent concerned solely for the purposes of scientific research and experimentation. Therefore, it will not decrease the opportunity for any other person to improve plants, nor it will hinder the progress of science and technology. On the contrary, one of the substantive conditions for patent right before grant is that the technical content applied for patent protection must be opened in a manner sufficiently clear and complete so as to enable a person skilled in the relevant field of technology to carry it out. The opening of plant material will be beneficial to the exploitation and popularization of the features of certain plant. Secondly, China’s Patent Law has made it clear that no patent right shall be granted for any invention-creation that is contrary to public interest. Furthermore, to grant a patent does not mean the actual exploitation of the patent by the patentee, which shall be examined and approved by the relevant state authorities before exploitation. Take transgenic plant as an example. Its production shall depend on the acceptance of the relevant departments of environmental protection and security, and the approval from relevant administrative departments. Thirdly, although the plants exploited in current agricultural production may possess genes included in transgenic plants, the plants shall not be prohibited because of its being included in the coverage of transgenic plants where they have naturally existed or their production on scale have been begun. Fourthly, it will be unfair for farmers where the exclusive right of plant patent takes no account of their rights and interests because the existing plants materials are largely preserved by countless generations of farmers on the basis of choice and protection. In China, farmers are not restricted from cultivating and exploiting propagating material of protected variety for personal use in accordance with disclaimer provisions under Regulations of the Peoples Republic of China on the Protection of New Varieties of Plants. However, there should be protection of farmers’ rights and interests if the plant itself be included in patentable subject matter. The foregoing disclaimer provisions should be learned. One way is to add an article in the interpretation of the patent protection coverage of plant materials which stipulates that farmers shall have the right to do successive breeding and cultivate after their bought of patented propagating material. In other words, farmers shall bear no responsibility for their exploitation of harvested products after their bought of patented plant in order to protect their rights and interests.
 
ii.                  on the point of proponents
 
Proponents’ claims are as follows: Firstly, the protection of plants by way of patent will protect variety right as same as patent right without different protection on different inventions-creations because of the application of different laws and is in consistent with social justice. Furthermore, abolition of the Office for the Protection of New Varieties Plants will streamline governmental organization, reduce fiscal expenditure of the State, and result in social cost saving. Secondly, the grant of patent to new varieties plants will conform to the development of technology in terms of transgenic plants and new varieties plants breeding, and expand the scope of protection in order to safeguard the rights and interests of the variety right holder more extensively and effectively. Thirdly, the grant of patent to plants will help maintain Chinese technological superiority because of Chinese advanced transgenic technology in agricultural research institutions and huge domestic market as well.
 
Generally speaking, proponents advocate the substitution of variety rights by plant patent with the inclusion of plant varieties. They are from the point of view of plant researchers and therefore too one-sided. Firstly, the methods of traditional breeding or seed selection have been most commonly used in China to cultivate new varieties of plants. In particular, it is only these conventional breeding methods that can be used by the vast majority of plant growers and/or research personnel for the limitations of technical skill and other conditions. It will be not conducive to the interests of the vast majority of Chinese plant researchers if only patent be employed to protect plant varieties and new varieties of plants be excluded from the IP protected coverage because the foregoing methods also requires intellectual, financial and material resources of breeders. Therefore, China can not just use patents to protect intellectual property rights on plants. Secondly, as far as the substantive conditions for right itself, any invention for which patent right may be granted must possess novelty and inventiveness, whereas inventiveness is not the requirement for the rights of new plant varieties and the standards of novelty are different between inventions and varieties. Novelty of varieties depends on whether the commercialization of the propagating material has begun or not within a certain period of time before the date of filing, whereas novelty of invention relies on whether the right sought for protection and technical solution sought for defined forms part of the prior art and other identical technical solution has filed previously before the date of filing or not. Thirdly, although it is ACT of 1978 International Convention for the Protection of New Varieties of Plants that China accedes to, which provides that the protected coverage of the rights of new plant varieties is limited to the propagating material of protected variety, whereas ACT of 1991 International Convention for the Protection of New Varieties of Plants stipulates that the scope of protection of the rights in new plant varieties contains harvested products and processed products of protected variety, which equals to the scope of protection of plant patent. It may be safe to say that time has witnessed the trend of expanding PIPP scope. Fourthly, from a point of technology and material resources, China is a leader across the world in terms of researches in field crops such as functional genes, hybrid rice, super hybrid rice and studies in theory and applied technology in the fields of bivalent transgenic cotton, three-line hybrid cotton and two-line hybrid wheat, with exception that many seeds (seedlings) of new varieties of horticultural crops are still dependent on imports from developed countries. Shouguang city, Shandong province is an example in this regard, where 80% of planted vegetable are “foreign species”. However, China has 10% biologic genetic resources of the world and a preservation of crop germplasm information of 30 million copies, ranking first in the world, which provides a wealth of material resource base for China’s study on genetically modified crops and other biotechnology. Furthermore, it will be easier to popularize the plants developed by exploitation of the feature of China’s existing plants. Therefore, the exclusive protection of researchers’ rights and interests, on the basis of protecting the ones of the owners of existing plant resources, is the most effective way to maintain our leading position in leading areas and to promote the development of existing resources. Therefore, it is necessary to expand the scope of protection of plant intellectual property right. Fifthly, the desire to benefit from plant intellectual property right in a country can be reflected in the applicants’ mind regardless of his application for patent for an invention or for the rights in new plant varieties. According to a report announced by China’s Department of Agriculture, domestic applications accounted for 93.7% among the amount of application for the rights of new plant varieties in China from 1999 to February 2011. According to statistics, of all the applications for inventions in China from 2000 to 2007 announced by the State Intellectual Property Office, applications from abroad for class A01H005, which is mainly used for the protection of plant itself, accounted for 71.2% of the total applications. However, the amount from domestic applications was almost three times the foreign applications in 2008. It can be concluded that in recent years, Chinese breeders has begun to take concrete measures to benefit from PIPP system.
 
CONCLUSIONS
 
In conclusion, there should not only be a good cooperation and uniformity between and among Patent Law, Regulations on the Protection of New Varieties of Plants, and Seed Law , but also bear in the mind that such solutions should be beneficial to international exchange, the protection farmers’ rights and interests, and the sustainable development in China’s plant research. In addition to the laws which protect the rights of new plant varieties and plant patent with the exclusion of plant varieties, the easiest solution is to add a uniform and clear definition of plant variety in Guidelines for Patent Examination, which is excluded from the subject matter under patent protection. The meaning of “plant variety” may be defined by a combination of the definition of Seed Law and UPOV Convention 1991 Act. More specifically, “plant variety” may be defined as: a known plant grouping, except microbiology, within a single botanical taxon of the lowest known rank which can be defined by phenotype with uniform morphological and biological characteristics resulting from a given genotype or combination of genotypes, distinguished from any other plant grouping in phenotype which shall remained unchanged after convention breeding. In this way, plant materials not falling within the definition may be deemed as patentable subject matter. Meanwhile, by way of announcement by the State Intellectual Property Office and judicial interpretation by the People’s Supreme Court, there may be a restriction on the protected coverage of patent right with plant material as subject matter under Guidelines for Patent Examination so that farmers’ exploitation of the yields after their bought of the plant material, namely, the scope of patent protection with subject matter defined as plant material shall not be used to limit farmers where they do successive breeding and cultivate by exploitation of harvested products after their bought of patented propagating material.
 
(Translated by Yuan Renhui)

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