Freedom‐to‐operate analysis of a transgenic multivitamin corn variety

In this article, we explore the intellectual property (IP) landscape relevant to the production and commercialization of Carolight^?, a transgenic multivitamin corn variety created on humanitarian grounds to address micronutrient deficiencies in low‐and‐middle‐income countries. The successful production of this variety requires IP rights risk management because there is a strong protection on inventions and processes via patent portfolios in both developing and industrialized countries. The IP framework is complex, and specialist patent lawyers are usually employed to perform such analysis, but the costs cannot always be met by small, publicly funded projects. We report an alternative strategy, a do‐it‐yourself patent analysis, to produce a review with limited legal value that can nevertheless lay the foundations for a subsequent more in‐depth professional freedom‐to‐operate opinion.     

“禁止反悔”对药物专利申请文件的撰写和修改的影响

申请人在专利实质审查的过程中,缩小其保护范围使得专利获得了授权,但在主张侵权诉讼中因为禁止反悔原则,却不能将因对权利要求的修改而放弃的技术方案再纳入到专利权的保护范围中。因此,申请人应重视专利授权或者无效宣告程序中权利要求的修改,知晓未公开的针对审查意见通知书的答复也会成为日后侵权判定过程中的一个重要证据,在此,申请人应仔细思考、斟酌每一次权利要求的修改以及每一次审查意见的答复,不能为了在较短的时间内获得授权就同意审查员的观点放弃权利要求中的技术特征,必要时,可以对审查员的观点予以否定。讨论了禁止反悔对药物专利申请文件的撰写和修改的影响。     

Alarm systems in higher plants

The defenses of higher plants against a variety of biotic and abiotic stress agents can be grouped into two categories: Preformed and Induced. Induced defensive responses by the plant, or “alarms”—the subject of the present review—can be localized or systemic. Certain alarms, especially those which are induced by necrotizing pathogens, are protective against a wide variety of biotic stress agents. Other responses appear protective but the degree of host plant involvement is unclear. Finally, there are a few induced plant responses which, although protective, do not easily fit our criteria of an “alarm.” Oligosaccharins may be involved as signals in both anti-herbivore and anti-pathogen alarm systems. Other specific components of plant alarms appear to be induced by only one type of stress agent. The specificity of protection, mechanisms of various alarms and comparisons between them are presented.     

Patenting of plant varieties and plant breeding methods

This article considers the relationship between patenting and plant variety rights protection, through a detailed analysis of the recent determination by the Extended Board of Appeal of the European Patent Office that methods for breeding broccoli and tomatoes were not patentable. It concludes that the right to patent agricultural innovations is increasingly located within a political context.     

Invertebrate pests and diseases of sweetpotato (Ipomoea batatas): a review and identification of research priorities for smallholder production

Sweetpotato has been the subject of little research worldwide compared with other major crop staples, and this is especially so for less developed countries where sweetpotato is critical for food security. This review synthesises information on plant protection issues that affect smallholder sweetpotato farmers in less developed countries to identify major issues and suggest research priorities. Though the pests and diseases of sweetpotato in less developed countries are largely common to industrialised systems, their relative importance differs and losses tend to be more severe as a result of differing agronomic practices and relative unavailability of management options and technical support that are important in developed countries. Smallholders are heavily reliant on cultural practices such as traditional forms of biological control using ants and livestock, fallowing and composting (sometimes with plant materials having biocidal properties). Crop protection methods that have been developed for use in sweetpotato production in developed countries, such as pathogen‐tested planting material, early maturing varieties, pheromone trapping and pesticides are less accessible to, and relevant for, smallholders. Smallholders also typically harvest a given crop progressively which extends the period over which storage roots are potentially vulnerable to attack but reduces the risk of post‐harvest losses. Human population growth in developing countries is leading to an increase in cropping intensity with shorter fallow periods and more years of continuous crops. This has the dual effect of depleting soil nutrients and increasing the potential for pest and pathogen build‐up. Associated with this, the adoption of strategies to manage crop nutrition, such as not burning crop residues, promote carryover of pests and pathogen inocula. As a consequence of these factors, sweetpotato yield losses from diseases, especially viruses, and pests, particularly weevils, can be high. Climate change is likely to result in more frequent drought and this will increase losses caused by sweetpotato weevils that are favoured by dry conditions. This review of sweetpotato pests and their management options concludes with suggestions for some future research priorities including the combination of traditional practices that have pest management outcomes with relevant practices from industrial production that are able to be transferred or modified for use in smallholder production. Increased technical support for decision making and diagnostics, including molecular approaches that have scope for field use, will be important in reducing the burden imposed by biotic threats to this important global crop.     

Patenting in biotechnology: a review of the 20th Symposium of ECB8

The patenting of biotechnological inventions is practically in harmony with the general requirements of patent protection. It stands still in the foreground of interests since this is the only technical field where the living material itself may be the subject matter of patents. In consequence ethical problems have arisen first of all in the patenting of human cells and genes in which there is no agreement between R&D firms, patent offices and green movements. This has called for the elaboration of special Directives. On the other hand, patent systems are instrumental in safeguarding biodiversity. This review gives a picture of the patenting situation in biotechnology in the European Patent Office and in Hungary, the host country of the Congress. It also gives practical advice to biotechnological researchers on how to draft the applications and to observe the time limits, as well as on the necessity and possibilities of the deposit of microorganisms.     

Antibody therapeutics - the evolving patent landscape

The antibody patent landscape has evolved dramatically over the past 30 years, particularly in areas of technology relating to antibody modification to reduce immunogenicity in humans or improve antibody function. In some cases antibody techniques that were developed in the 1980s are still the subject of patent protection in the United States or Canada.     

从Myriad案谈基因专利的正当性及美国对基因专利授权实质性要件分析

按照专利制度构建的本质,基因专利的作用在于激励产业创新,促进基因研究的发展。但基因专利从产生以来就一直存在着争议。2011年美国Myriad案对分离DNA序列的可专利性具有不同的观点,从Myriad I案认为分离的DNA是不可专利的客体,到Myriad II上诉案中联邦巡回上诉法院推翻地方法院的观点,认为分离的DNA具有不同的化学结构,满足专利客体的适格性,但同时也反射出了对DNA序列可专利性的怀疑。Myriad案引起了美国、欧洲和澳大利亚司法审判中就基因专利适格性问题的较大争议。本文结合美国Myriad案来分析DNA序列作为专利客体的适格性以及目前美国对基因专利授权的实质性条件。     

A Comparative Evaluation of Somaclonal,Gamma Ray and EMS Induced Variation in Brassica juncea

Tissue culture induced somaclonal (SC), chemical mutagen EMS (E) and gamma ray (I) induced variation among 269 third generation families in each category generated from a popular variety of Brassica juncea were evaluated for important agronomic traits, namely flowering time, plant height, number of primary and secondary branches, seed yield per plant and per plot. The frequency of somaclonal-lines significantly superior to control was higher than such EMS or irradiated lines, in general. Somaclones also showed higher heritability values. One somaclone, SC-122, is significantly superior to control for upto five traits, simultaneously, demonstrating the practical utility of somaclonal variation in improving productivity.     

跨国公司生物技术知识产权保护策略分析——以棉花转化体MON531为例

近年来,转基因棉花种植面积在多个国家得到了快速增长。为深入研究转基因抗虫棉花的技术体系和知识产权保护状况,现以棉花转化体MON531为例研究跨国生物公司的知识产权保护策略。结果显示,目前MON531转化体涉及3件处于有效保护期限内的专利,并在多个国家受到保护,实现了从功能基因及调控元件到最终商业化品种的全方位有效保护。申请人还通过申请植物品种权对下游的品种进行保护,美国有19件品种获得授权,在中国仅有1件相关申请处于审查中。对棉花转化体MON531技术体系的知识产权保护策略的研究,可以为我国研发转基因作物并采取知识产权保护提供有利的借鉴。     

Comparing and contrasting threat assessments of plant species at the global and sub-global level

Evidence-based assessments of extinction risk are established tools used to inform the conservation of plant species, and form the basis of key targets within the framework of the Global Strategy for Plant Conservation (GSPC). An overall picture of plants threat assessments is challenging due to the use of a variety of methodologies and range in scope from global to subnational. In this study, we quantify the state of progress in assessing the extinction risk of all land plants, determine the key geographic and taxonomic gaps with respect to our understanding of plant extinction risk, and evaluate the impact of different sources and methodologies on the utility of plant assessments. To this end, we have analyzed a cleaned dataset compiled from IUCN Red List of Threatened Species and Regional Red Lists. We reveal that there are assessments available for 89,810 distinct species or 25% of all accepted land plant species. However unlike with other major organismal lineages the bulk of the plant species assessments are derived from Regional Red Lists, and not the Global IUCN Red List. We demonstrate that this bias towards regional assessments results in distinct taxonomic and geographic strengths and weaknesses, and we identify substantial taxonomic and geographic gaps in the assessment coverage. With species that have been assessed in common at both global and regional levels, we explore the implications of combining threat assessments from different sources. We find that half of global and regional assessments do not agree on the exact category of extinction risk for a species. Regional assessments assign a higher risk of extinction; or underestimate extinction risk with almost equal frequency. We conclude with recommended interventions, but support the suggestion that all threat assessments should be pooled to provide more data and broaden the scope of threat assessments for monitoring progress towards GSPC targets.     

Minimising inter-laboratory variation when constructing a unified molecular database of plant varieties in an allogamous crop

The construction of large-scale databases of molecular profiles of plant varieties for variety identification and diversity analyses is of considerable interest. When varieties of an allogamous species such as oilseed rape are analysed and described using molecular markers such as microsatellites, care is needed to represent the variety in a meaningful yet useful way. It is possible to characterise such heterogeneous genotypes by analysing bulked samples comprising more than one individual seed or plant, but this approach may result in complex microsatellite profiles. Intuitively it would be reasonable to represent a variety by the common ‘major alleles’ in a profile, but how to define these ‘major alleles’ remains problematic. This paper describes methods of analysing DNA microsatellite data that will allow independent and objective data production at a number of laboratories. Methods for establishing allele scoring rules (thresholding) are described and the effect of these rules on the utility of the data is discussed.     

Rice straw, the role of silica and treatments to improve quality

Rice straw is unique relative to other cereal straws in being low in lignin and high in silica. Unlike other cereal straws taller varieties of rice straws tend to be leafy while the leaves are less digested than stems. This may contribute to higher straw value with rice yield. There is genetic variation in straw quality but has not been exploited and tends to be smaller than environmental variation. Effort in plant breeding has been to develop short varieties with higher grain yield. This development has reduced straw quantity but not nutritive value. The relationship between plant genetics and silica metabolism is virtually uninvestigated, although reviews from plant physiology indicate it is a major factor.

Silica and lignin in that order are the primary limiting factors in rice straw quality. Silicon is a nutrient element which has been overlooked largely because of its assumed inertness, but also because of its geochemical abundance that so greatly exceeds its metabolic use by plants and animals. Silicon is involved in several major roles in rice: carbohydrate synthesis, grain yield, phenolic synthesis and plant cell wall protection. These vectors interact with each other to eliminate statistical association of silica and lignin with straw digestibility when varieties are compared. Yield of grain is highly related to silica content of straw, which reflects soil availability. There are no detailed studies on rice straw lignin. Most papers reporting lignin contents in rice straw have used acid-detergent lignin by either the sulfuric acid or permanganate versions. There are undoubtedly soluble phenolics in rice straw that need investigation. The effects of ammonia and urea on silica is to crack the silicified cuticular layer. Silica is not dissolved by these reagents in contrast to the action of sodium hydroxide.

Treatments on rice straw follow those applied to other lignified materials. In order of frequency of reports, urea followed by ammonia with comparatively fewer papers on sodium hydroxide, steam and pressure treatments or exploded by pressure release, and only one or two papers on acid treatments and white rot fungi. There are reports on animal supplementation and a few growth studies with young animals. Field surveys in India and the southeast Asian countries only report the use of urea, although it appears less efficient than ammonia. Farmer acceptance is related to their perceptions on costs, labor, equipment, health, safety, i.e. the exposure to ammonia vapor, economic and other social factors. The various papers reporting treatments have used animal digestion trials; a variety of in sacco, in vitro digestions with rumen organisms or cellulase, some in combination with pepsin digestion or neutral-detergent extraction. Gas production from in vitro rumen fermentation has also been used. Results are expressed mainly on dry matter basis and fewer reports on organic matter. Results are difficult to compare and standardization of procedures is badly needed. However, most treatments with ammonia and urea show some increase in digestibility and intake where measured in in vivo trials. In vitro and in sacco evaluations tend to overestimate improvement in digestibility.     

International intellectual property strategies for therapeutic antibodies

Therapeutic antibodies need international patent protection as their markets expand to include industrialized and emerging countries. Because international intellectual property strategies are frequently complex and costly, applicants require sound information as a basis for decisions regarding the countries in which to pursue patents. While the most important factor is the size of a given market, other factors should also be considered.Key words: antibody, patent, international, PCT, filing strategy     

水稻分子育种技术专利分析

通过Thomson Innovation（TI）专利平台数据库中相关专利的检索,利用专利计量学的方法,从专利申请数量、受理国家、申请机构、技术生命周期以及研发热点等方面对水稻分子育种技术国际发展态势进行分析。结果表明,水稻分子育种技术目前整体呈快速发展趋势,并已趋于成熟。其中,美国的申请量最多,是全球最受重视的技术市场。大型跨国公司不仅是全球最主要的专利申请主体,而且在我国的专利申请活动也较为活跃。我国在水稻分子育种技术领域专利数量较多,并且具有一定优势,相关专利申请主体为科研机构和大学。对专利文献内容的深入分析表明,重要农艺性状的基因挖掘和转基因技术是分子育种技术领域当前的研发热点。     

Bioengineered bugs, drugs and contentious issues in patenting

Bioengineered bugs, as is the scope of this journal, have great potential in various practical applications. A corollary to bringing useful products to the market is that such products need protection from copying by other people or businesses. Such government-sponsored protections are legally enforced through a patent, copyright or trademark/trade secret system commonly known as intellectual property rights. A condition for obtaining a patent is that the invention must not be disclosed to public either through seminars, informal public disclosures or publications in journals, although in the United States, there is a one year grace period that is allowed to obtain a patent after public disclosure. This article describes my personal experience in obtaining a patent in 1980 on a genetically manipulated bacterium designed for oil spill cleanup. This patent application went through a series of court cases that finally ended up in the Supreme Court of the United States. I also mention a similar contentious legal issue that is on the horizon and that the readers of Bioengineered Bugs should be aware of. Finally, I have taken the opportunity to describe my current efforts to bring to the market some unique potential multi-disease-targeting candidate drugs from Pseudomonas aeruginosa and gonococci/meningococci that, if found non-toxic and efficacious in humans, will revolutionize the drug industry. To ensure their marketability, we are trying to develop a patent portfolio that will ensure that they will be legally protected and such protections will be broad-based and enforceable.     

Decoding the research exemption

While debate continues as to whether genetic sequences, which many argue represent natural phenomena rather than inventions, should be subject to standard patent protections, issuance of patents that claim DNA sequences remains common practice. In an attempt to insulate researchers from patent claims that could hinder scientific progress, many countries have provided general exemptions for scientific research. However, there is no international consensus about the extent of required protections, and even existing exemptions vary widely in clarity and are limited in practical application. We believe that gene patents raise several unique issues that are inadequately handled by the current research exemptions.