——The Latest Development of the Judicial Practice of Variety Right from the Perspective of the Pioneer Case
The annual amounts of applications and grants of new varieties of plants in China have continuously reached record high, and the cases of infringement of the right of new varieties of plants also occur frequently[1]. At the legislative level, Supreme People's Court's Several Provisions on the Issue of Application of Specific Laws to Cases of Dispute Arising from Infringement of the Right of New Variety of Plants (2006) (hereinafter referred to as "Variety Right Judicial Interpretation") specifically relates to two types of infringement of variety right, and determines the features or characteristics of an alleged infringing article being identical with that of a granted variety as the assessment rule of infringement of the right of new varieties of plants[2]. It is stated in Understanding and Application of Supreme People's Court's Several Provisions on the Issue of Application of Specific Laws to Cases of Dispute Arising from Infringement of the Right of New Variety of Plants (hereinafter referred to as “Understanding and Application of Variety Right Judicial Interpretation”) that when establishing the act of infringing the right of a new variety of plants, the characteristics of the alleged infringing article must be identical with that of the granted variety, whereas the alleged infringing article having characteristics more or less than that of the granted variety does not constitute infringement.
The above provisions essentially determine identical features or characteristics as the necessary and sufficient condition of the establishment of infringement of the right of new varieties of plants from the positive and negative aspects (hereinafter referred to as "Rule of Features or Characteristics"). As a guide to practical operation, two unbiased methods are enumerated in Variety Right Judicial Interpretation, i.e., field observation and test (mainly DUS test[3]), and genetic fingerprinting test. The specific understanding and application of above rule in the current judicial practice will be analyzed through the following cases.
I. The present situation of the judicial practice of infringement of the right of new varieties of plants
1. The common practice in the judicial practice
There are mainly two kinds of evidence used in the practice to prove the establishment or not of the infringement of the right of new varieties of plants. First, the plaintiffs provide their own varieties and propagating materials of the alleged infringing articles under the law, these propagating materials can be used as the physical evidence for judgement if both the plaintiffs and the defendants do not object that they belong to the same (or different) varieties after cross examination. Second, the appraisal opinion provided by the appraisal organization[4].
Taking the results of case retrieval conducted on www.pkulaw.cn in October 2016 as an example, in all of the 77 retrieved cases of infringement of the right of new varieties of plants involving test, whether unilaterally commissioned by the parties or commissioned by the appraisal organization, the utilized test methods mostly are genetic fingerprinting test. This is also confirmed in Understanding and Application of Variety Right Judicial Interpretation. Moreover, all of the courts make judgements solely based on the fingerprinting evidence. For example, in the case of Dunhuang Seed Pioneer Hi-Bred Co., Ltd. vs. Xinjiang New Terry Co., Ltd., Xinjiang production and construction corps[5], the test center compared DNA fingerprinting of the seeds preserved by the court with that of the propagating materials of "Xianyu 335" deposited by Deposition Center of new varieties of plants, Ministry of Agriculture. The conclusions in the appraisal report showed that the number of different loci is zero, thus there is no clear difference between these two groups. The Supreme People's Court (hereinafter referred to as "the Supreme court") hereby established the infringement of the right of new varieties of plants.
In three of the few cases, the defendants doubted about the results of the fingerprinting as the basis for the judgements, and requested re-inspection. Nevertheless, the courts did not accept or approve such request for different reasons.
In the case of Henan Yuyu Seed Industry Co., Ltd. vs. Shandong Denghai Seed Industry Co., Ltd.[6], for example, the court held that the appraisal method of field plot planting would be limited by different factors such as long planting cycle, difficulty of sample supply in large amount, etc., thus is unrealistic for use in the litigation, and disadvantageous for timely trial. The appraisal organization took scientific DNA appraisal technology under legal appraisal procedure. The defendant did not recognize the appraisal conclusion, but failed to provide contrary evidence to support its viewpoint. In view of that, the initial trial had sufficient factual and legal basis to adopt the DNA appraisal conclusion of the test report.
In the case of Shanxi north seed industry Co., Ltd. vs. Beijing Origin Agritech Co., Ltd.[7], the court held that the laws, regulations or judicial interpretation do not prohibit using DNA fingerprinting technology as the means of authenticity identification of maize seeds. The defendant also did not prove that DNA fingerprinting technology should be prohibited for authenticity identification of maize seeds. The defendant's application of resampling for the field planting authentication also did not comply with the legal causes for re-authentication provided by Article 27 of Several Provisions of the Supreme People’s Court on Evidence in Civil Procedures, thus was disapproved by the court.
2. The new practice of the Supreme Court
In the case of Shandong Denghai Pioneer seed industry Co., Ltd. vs. Shanxi Dafeng seed Co., Ltd., Shanxi Nongfeng seed Co., Ltd.[8] (hereinafter referred to as "Pioneer case"), the Supreme court adopted a new practice different from above-mentioned common practice. In this case, the variety right owner advocated that the alleged infringing products, which were seized with the outer packaging of "Dafeng 30", but actually were the maize seeds of "Xianyu 335", infringed the variety right of "Xianyu 335". The variety right owner also submitted DNA fingerprinting test results to prove that the seized products and the granted variety "Xianyu 335" were the same variety. The alleged infringer objected and submitted the DUS test report of "Dafeng 30" for variety certification obtained before the litigation to prove the distinctness of "Dafeng 30" as compared with "Xianyu 335". Unlike the common practice of making a judgement solely based on the fingerprinting evidence without making further field planting test, the Supreme court overturned the DNA fingerprinting test results of the variety right owner based on the DUS test report.
The Supreme Court's juridical reasons are summarized as follows:
1) The Seed Law and the Regulations of The People's Republic of China on The Protection of New Varieties of Plants (hereinafter referred to as the Regulations) provide the propagating materials having novelty, distinctness, uniformity and stability as the necessary requirements for the grant of new varieties of plants. The substantial examination of the variety in application by the examination and approval authorities as well as the variety certification of main crops varieties all relay on the DUS test towards distinctness, uniformity and stability. Therefore, the features or characteristics of the living propagating materials should be subject to the characteristics determined by the DUS test via field planting.
2) The core primers (loci) adopted in the DNA test do not necessarily correspond to the characteristics determined by the DUS test. And the grant of the new variety right is based on the DUS test. When the DNA appraisal conclusion shows the tested varieties are identical or highly similar, the DUS test via field planting in pair can be directly conducted, so as to determine the identities via field phenotypes. When the alleged infringer advocates overturning the DNA fingerprinting test result with the distinctness result determined by the DUS test, he should submit evidence for proof.
3) The DUS test report submitted by Dafeng proves that "Dafeng 30" has distinctness as compared with "Xianyu 335" through field planting. According to the rule of "the features or characteristics of an alleged infringing article being identical with that of a granted variety, or the difference in the features or characteristics does not result from genetic modification", the Supreme court did not establish the infringement of the new variety right due to the different characteristics of the two varieties.
In the case of the DUS test result and the gene fingerprinting test result were contradictory, the Supreme court in this case upheld the Rule of Features or Characteristics and made the judgement based on the DUS test report towards the characteristics[9].
II. Prospect of judicial practice of infringement of the right of new varieties of plants
Pioneer case broke through the common practices, which will undoubtedly have a great impact on the judicial practice in the future.
In the establishment of infringement of the right of new varieties of plants, the appraisal conclusions obtained by different appraisal methods should be qualitatively consistent in most cases, possibly with different accuracy[10]. It is highly possible for the qualitative conclusion to reach legal reality and objective reality simultaneously. In view of the DUS test cycle is long, whereas the genetic fingerprinting test is fast, convenient and low-cost, taking the genetic fingerprinting test as the auxiliary or alternative method of DUS test in practice is feasible in most cases.
However, if the appraisal conclusions obtained by different appraisal methods are contradictory, according to the provisions of Understanding and Application of Variety Right Judicial Interpretation, the court shall determine the evidential force of the appraisal conclusions under the law, thereby solving the problem of adopting the appraisal conclusion as the basis for judgement in practice[11]. According to the general rules of evidence verification, when the appraisal conclusions obtained by different appraisal methods have authenticity and legitimacy, the field observation and test has rationality and priority under the system design of establishment of infringement of the right of new varieties of plants based on Rule of Features or Characteristics, which can also be confirmed from Pioneer case.
In addition to being the basis for the grant of right of new varieties, the DUS test is also widely used for variety certification and registration, seed purity quality monitoring, plant variety authenticity evaluation, and so on[12]. Therefore, when the alleged infringing variety once conducted DUS test for other reasons, and the test result regarding whether the alleged infringing variety has distinctness compared with the granted variety as the approximate variety is readily available, without needing additional time to obtain, the court might accept such test results according to Pioneer case. However, one unavoidable problem is how to prove the consistency of the seeds used in the previous test with the seeds involved in the current case. When the variety right owner will undoubtedly question the consistency, will the court allow the re-inspection of the seeds involved in the current case via field planting?
In case of absence of readily available test result, the trial standards in the future are still uncertain. One judge in charge of Pioneer case mentioned in other occasion that it is necessary to conduct re-inspection via field planting if the DNA test result is in dispute. According to DNA fingerprinting test standard, when the number of different loci between alleged infringing propagating materials and granted varieties is lower than the threshold and cannot prove the tested varieties are not the same variety, the request of the alleged infringer for field planting test may be approved, so as to determine the identity of the variety via field phenotype. Meanwhile, the judge also mentioned attention must be paid at the same time to the timely protection of the interests of the variety right owner, and avoidance of unnecessary litigation delay in the manner of requesting re-inspection via field planting test[13]. But it is unclear how to keep the balance therein. As of the complete of this article, we do not find later similar cases referring to this case. It is worth continuous attention and thinking on this issue.
III. Discussion on the Jurisprudence of Judicial Practice of Infringement of the Right of New Varieties of Plants
In order to deeply understand and answer above questions, it is necessary to make in-depth analysis of the respective features and applicabilities of the two methods, thereby explore the rationality of the Rule of Features or Characteristics per se and possible system design.
1. Field observation and test
The characteristics of plant varieties are obtained by DUS test organization via field observation and test, mainly DUS test. The tested varieties are grown in the same planting conditions as the similar varieties. The multiple qualitative characteristics, quantitative characteristics and pseudo-qualitative characteristics are observed and recorded at different stages of seed, seedling, flowering period and maturation period. The distinctness, uniformity and stability of the tested varieties are then determined according to the DUS test guidelines (generally national standards or industry standards for agriculture). This is the most widely recognized and most commonly used method for the identification of new varieties of plants at home and abroad.
However, the field planting test takes a long time. One growth cycle of annual plant is about one year. For perennial plants such as trees, the test will last 3 to 7 years. In addition, the field planting test has high requirement on the climate and soil of the planting plots, sowing time, etc., which is usually not synchronous with the trial, thus very easily leads to the delay of the trial. The right of the variety right owner cannot be timely protected, either.
Secondly, the characteristics reflect the phenotype of plant varieties. DUS test belongs to morphological identification. The DUS test organization generally makes observation and record on a plurality of qualitative characteristics, quantitative characteristics and pseudo-qualitative characteristics set forth in the respective DUS test guidelines of different tested plant varieties. The characteristics set forth in the DUS test guidelines are the artificially selected representatives of the respective plant varieties. The information represented by these characteristics is limited after all when they are used to reflect the entire morphology of the varieties. And the list of characteristics would be adjusted constantly[14]. Unlike the breeder and the variety certification institutions who always need to consider whether the variety of interest has economic value as compared with the currently popularized varieties at yield characteristics, qualitative characteristics or disease resistance characteristics, DUS test can determine the distinctness of a tested variety so long as it has one qualitative characteristic or more than two quantitative characteristics different from those of the similar variety, or one quantitative characteristic different from that of the similar variety at two or more codes. Many important economic characteristics of plants are quantitative characteristics, such as ear-corn length, crop yield, maturation period, etc. Since the DUS test adopts too many quantitative characteristics, it belongs to the classification method by experience in some extent, thus is inevitably subjective in the boundary of some characteristics and has some limitations. And the entire morphological characteristics also have inevitable limitations, mainly because morphological identification is easily affected by characteristics selection, determination of characteristics distance, testing place, year, environment, the subjectivity of the appraiser and gene dominance or recessiveness, the superiority of genetic expression is unstable[15].
Thirdly, in the Regulations formulated according to UPOV (1978), the Essentially Derived Variety system established in UPOV (1991) is absent[16]. The essentially derived variety bred from initial variety through simple modification can be granted the same right as the initial variety, so long as it has one characteristic clearly distinguished from the initial variety, even if such characteristic has no contribution to the economic or social benefit of the variety at all. This encourages the frequent bad behavior of using other’s varieties for commercial decorative breeding, such as "imitation breeding", "clone breeding"[17]. In addition, the breeding methods using the currently popularized varieties and the parent varieties to modify are also increasing. All of above lead to the assimilation phenomenon of germplasm resources and genetic background becoming obvious, as well as the frequent occurrence of highly similar varieties with no substantive difference in the examination, test and infringement dispute settlement of new varieties of plants, thus further exacerbate the difficulty and dispute of the establishment of infringement based on DUS test. In practice, the test varieties can be considered as different from the similar varieties when they have significantly different characteristics. However, when the test varieties and the similar varieties do not have significantly different characteristics, it is difficult to determine whether they belong to the same variety.
Fourthly, the main characteristics currently used in DUS test are the morphological and physiological characteristics of plants. Other characteristics such as disease and insect resistance characteristics, qualitative characteristics, etc., can also be used as the basis for DUS test of new varieties of plants. But these characteristics are easily affected by the environment, accompanied with strict test conditions, high test cost and low utilization rate. With the development of modern biotechnology, especially the application of transgenic technology in the field of plant breeding, there might be varieties having groundbreaking change in the intrinsic quality (such as the resistance of the variety), although having no significant difference with the granted varieties on the appearance characteristics[18]. This also raises new requirements to the current DUS test.
2. Genetic fingerprinting test[19]
Genetic fingerprinting technology is an applied genetic germplasm analysis method established with the development of molecular biology. According to the DNA composition of varieties, DNA molecular markers are used to construct the fingerprintings of the varieties, which reflect the difference of varieties on genomic DNA level. Taking the mainly used SSR fingerprinting test as an example, the subject SSR (simple repeat sequence) is a large number of repetitive sequences in the genome, which can be distributed in different positions of the whole genome, mostly located in the non-coding region. Because it has polymorphism far higher than that of the gene region, together with high individual specificity and stability, and the repeat times of SSR in genomic DNA of different varieties are different, so the DNA fingerprinting constructed by PCR amplification, electrophoresis and dyeing process can reflect the difference of genomic DNA of different varieties. Similar to human fingerprint, such fingerprinting can directly represent more abundant genome variation information of different varieties, thus can be used to identify varieties difficult to be distinguished based on phenotype. Further considering its higher coverage, tolerance to the environment, short test cycle and high accuracy, SSR fingerprinting test is widely used in the test and substantial examination of new varieties of plants as an auxiliary means, and used in the establishment of infringement in the case of dispute arising from infringement of the right of new variety of plants.
But there are inherent deficiencies for SSR fingerprinting test. Plant variety is a plant grouping defined by the expression of the characteristics resulting from a given genotype or combination of genotypes, and exhibits at least one of the said characteristics that distinguish from any other plant grouping. It is generally believed that the qualitative characteristics of plant varieties are controlled by one pair or a few pairs of major genes and exhibit as discontinuous characteristics, such as red and white color of pea flower, japonica and waxy rice, which have clear difference and boundary, thus are easily to be identified. In contrast, the quantitative characteristics are controlled by minor genes and easily affected by the environment. The distribution of quantitative characteristics is continuous, such as the height of the plant, fruit size, yield of seed, etc. The quantitative characteristics have no clear difference and need to be distinguished by statistics method. The genotypes embodied by the presence or absence of specific genes, the combination of different genes, and the intensity of gene expression determine the different phenotypes (characteristics) of plant varieties. Accordingly, the selected characteristics in DUS test are determined by a specific genotype or combination of genotypes[20].
Figure 1. Genotypes and phenotypes of two maize varieties
However, SSR fingerprinting test is conducted towards SSR, rather than the genotype or combination of genotypes determining the characteristics. As the location mark of genetic map, SSR reflects the genomic polymorphism of different individuals, but does not correspond to the characteristics determined in field planting[21]. This is also a common issue of genetic fingerprinting test. Therefore, even if the genetic fingerprinting test result shows no clear difference between the alleged infringing article and the granted variety, we still cannot conclude that they have the same characteristics.
3. The contradiction between current system design and two test methods is difficult to resolve.
DUS test is time-consuming and susceptible to external factors. Moreover, it is difficult to distinguish the similar varieties without clear differences in characteristics. Genetic fingerprinting test does not correspond to the characteristics. In addition, the subjects (characteristics or molecular markers) of these two test methods are all artificially selected from the plurality of known candidates of the same kind based on the experience, thus do not have sufficient representativeness. They can only reflect limited information of the entire morphology of the varieties, thus cannot avoid the problem of overgeneralization.
Under the system design of the assessment of infringement of the right of new varieties of plants based on Rule of Features or Characteristics, both of above two test methods cannot completely resolve the contradictions in practice. Although the comprehensive utilization of molecular markers and characteristics is not only conducive to the understanding of the genetic relationship between the varieties, but also able to meet the need for a clear classification in the protection of new varieties of plants, these two methods can at best be verified with each other or with other test method, so as to improve the accuracy of identification. In reality, however, factors such as time and cost are issues to be considered. In contrast, in the face of the contradictions and conflicts which are difficult to be solved in reality, the rationality of Rule of Features or Characteristics per se is also questioned, accordingly.
Technological innovation is the driving force of economic and social development. Restricted by the current level of science and technology, field observation test and genetic fingerprinting test may be the preferable identification method of new varieties of plants. But other alternative test methods are not excluded. With the advent of the post-genome era, as well as the increasing maturity and improvement of genomic sequencing technology and functional genomics, based on the description and integration of mass genetic information and biological function of varieties, it is expected to find closer and more relevant relationship between genetic information and phenotype, to find better balance between reliability and convenience, so as to drive system innovation with technological change, and provide new solutions to the above puzzle.
Author: Attorney at law of NTD Intellectual Property Attorneys, Ph.D. of Biology
[1] By the end of October 2016, the Ministry of agriculture received a total of 17277 applications for new varieties of plants, granted 7824 new varieties, the annual amount of applications ranked first of International Union for the Protection of New Varieties of Plants (UPOV) members. In 2016, State Forestry Administration received a total of 400 applications for new varieties, the annual amounts of acceptance and grant were both record high, the total amount of grant reached 1198. According to incomplete statistics, the amount of cases of dispute arising from infringement of the right of new varieties of plants heard in courts at all levels exceeded 370 in 2016.
[2] There is no clear definition of “features or characteristics” in Variety Right Judicial Interpretation. As a reference, it is stipulated in Rule 17 of Implementing Regulations of the Regulations of The People's Republic of China on The Protection of New Varieties of Plants (Agriculture) revised in 2014 that, "features or characteristics" refers to characteristics at least including those used in the distinctness, uniformity and stability test or those for the description of granted varieties. It is also indicated in Understanding and Application of Variety Right Judicial Interpretation that "features or characteristics" is the synonym of "characteristics". "Features" refers to the morphological characteristics of plants, such as color of flowers, shape of fruit, etc. "Characteristics" refers to the biological characteristics of plants, such as disease resistance, drought resistance, etc.
[3] DUS, acronym of Distinctness, Uniformity and Stability.
[4] Hou Yangkun, et al., Study on the Types of Infringement and Essential Evidence of the Right of New Varieties of Plants, Chinese seed industry, 2008 (12).
[5] See the Supreme People’s Court’s Civil Judgement No. Mintizi 26/2014.
[6] See the Civil Judgement No. Yufaminsanzhongzi 63/2007.
[7] See the Civil Judgement No. Ganminsanzhongzi 20/2006.
[8] See the Supreme People’s Court’s Civil Judgement No. Minshenzi 2633/2015.
[9] The author is of the opinion that the practice of the Supreme court in this case has no problem in jurisprudence, but the particular operation is questionable:
First, the Supreme court held that the alleged infringing products which were seized had the outer packaging of "Dafeng 30", whereas the variety right owner did not apply for judicial appraisal regarding whether it is true that the seeds contained therein were actually "Xianyu 335", but sold with imitation brand of "Dafeng 30".
In this case, the variety right owner has met the preliminary burden of proof that the alleged infringing products which were seized and "Xianyu 335" are the same variety. Then the burden of proof should be transferred to the alleged infringer. The variety right owner should not bear the burden of proof that whether the seized seeds are "Dafeng 30" or not.
Second, the Supreme court falsely asserted that the alleged infringing products which were seized is "Dafeng 30", and made the judgement based on the previously obtained DUS test report for "Dafeng 30".
Since the seeds used in the DUS test report have no relevance to the case, even if the seized seeds were absent in the second instance, which results in the re-examination via field planting cannot be conducted, according to the opinion of the judge in charge of this case mentioned in other occasions, the consequences of failure on burden of proof should be borne by the alleged infringer rather than the variety right owner.
[10] Jiang Zhipei, et al. The understanding and Application of Supreme People's Court's Several Provisions on the Issue of Application of Specific Laws to Cases of Dispute Arising from Infringement of the Right of New Variety of Plants. Http://www.cnpvp.cn/Detail.aspx?k=201&itemID=42, access time, March 17, 2017.
[11] Ibid.
[12] Yang Xuhong, Tang Hao, Yang Kun: improving the DUS test system to serve the development of modern seed industry, "China seed industry", 2015 (8).
[13] Luo Xia: Thinking about the infringement of the right of new plant variety, "People's Judicature", 2016 (7).
[14] As of September 2016, the total number of DUS test guidelines for new varieties of agricultural plants reached 186. Taking the DUS test guideline NY/T 2232-2012 (maize) as an example, it corresponds to the UPOV guideline TG/2/7, with the exception of increase of 15 characteristics, deletion of two characteristics, and adjustment of the expression state of three characteristics. It includes 43 basic characteristics (mainly the morphological and physiological characteristics of maize) necessary to be tested, and 11 characteristics (mainly the disease and insect resistance characteristics of maize) selected to be tested.
[15] Chen Hong: Exploration on the establishment of the protection system of Essentially Derived Variety in China -- taking rice as an example, China Agriculture Press, 2012, page 8.
[16] Essentially Derived Variety is a new variety obtained from initial variety through breeding, natural or induced mutation, somatic cell cloning, gene introduction and backcross with parents, with only partial characteristics changed. In UPOV (1991), the provisions on the protection of the right of the derived varieties are added. The territory of the right of the initial variety is extended to the essentially derived variety of the initial variety. In particular, an essentially derived variety is subject to the protection of plant varieties. Within the validity period of the initial varieties, however, the authorization of the initial variety right owner must be obtained before commercializing the essentially derived variety.
[17] Ibid. 15, page 38.
[18] Li Xiuli: An International Comparative Study on the Legal Protection System for the New Varieties of Plants, page 44, page 88.
[19] In order to facilitate understanding, the relevant biological concepts are briefly introduced:
Characteristics: the sum of all features of the organism, such as morphological features, physiological features, behavior, etc.
Fingerprinting: electrophoresis map reflecting the difference of biological individuals. It is called fingerprinting due to the high individual specificity, stability and reliability similar with human fingerprint, including protein electrophoresis fingerprinting and DNA fingerprinting.
SSR (Simple Sequence Repeats) molecular markers: a tandem repeat sequence composed of basic unit of several nucleotides (usually 2 to 4 nucleotides) in the genome, generally short, called Microsatellite or simple sequence repeat, such as (GA)n, ( AC)n, (GAA)n, etc.
Major gene: a gene with significantly phenotypic effects on quantitative characteristics.
Minor gene: a large number of genes, each gene has a slight effect on the phenotype, so they cannot be distinguished by their individual role.
[20] Figure 1 shows two different maize varieties, which have the same main gene A controlling the same qualitative characteristics, such as grain types, and minor genes B, C and D jointly controlling the quantitative characteristics, such as stem length. These two maize varieties have different stem length due to lack of gene D in variety 1. In order to facilitate the description of a characteristic, the description range is divided into several expression states or levels, for example, stem length: very short (1), short (3), medium (5), long (7), very long (9).
[21] Also in Figure 1, SSR1 and SSR2 are located in the non-coding region, and there is no corresponding relationship with the above characteristics. But SSR1 of variety 1 and SSR1 of variety 2 have different numbers of repeat sequences (7 vs. 6), SSR2 of variety 1 and SSR2 of variety 2 have different numbers of repeat sequences (5 vs. 6). The genetic fingerprinting test of these two varieties exhibits differences.
