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.     

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。     

Clearing the Fog of Anticancer Patents from 1993–2013: Through an In-Depth Technology Landscape & Target Analysis from Pioneer Research Institutes and Universities Worldwide

Background

In a search for an effective anticancer therapy the R&D units from leading universities and institutes reveal numerous technologies in the form of patent documents. The article addressed comparative anticancer patent landscape and technology assessment of Council of Scientific and Industrial Research (CSIR): India’s largest R&D organisation with top twenty international public funded universities and institutes from eight different countries.

Methodology/Principal Findings

The methodology include quantitative and qualitative assessment based on the bibliometric parameters and manual technology categorisation to understand the changing patent trends and recent novel technologies. The research finding analysed 25,254 patent documents from the year 1993 to 2013 and reported the insights of latest anticancer technologies and targets through categorisation studies at the level of drug discovery, development and treatment & diagnosis. The article has reported the technology correlation matrix of twelve secondary class technologies with 34 tertiary sub-class research area to identify the leading technologies and scope of future research through whitespaces analysis. In addition, the results have also addressed the target analysis, leading inventor, assignee, collaboration network, geographical distribution, patent trend analysis, citation maps and technology assessment with respect to international patent classification systems such as CPC, IPC and CPI codes.

Conclusions/Significance

The result suggested peptide technology as the dominating research area next to gene therapy, vaccine and medical preparation containing organic compounds. The Indian CSIR has ranked itself at seventh position among the top 20 universities. Globally, the anticancer research was focused in the area of genetics and immunology, whereas Indian CSIR reported more patents related to plant extract and organic preparation. The article provided a glimpse of two decade anticancer scenario with respect to top public funded universities worldwide.     

基于专利计量分析的抗HIV 药物发展趋势研究

近年来,艾滋病感染人数急剧增加,已成为威胁人类健康的重大疾病。为了对抗HIV药物的研究现状和发展趋势进行深入分析,本文通过在Derwent Innovations Index数据库中检索2006-2012年的抗HIV药物专利。对采集的专利信息用TDA软件进行数据清洗,利用专利计量分析方法,借助可视化的分析工具,从专利申请数量、优先权国、专利技术机构和专利技术领域等方面进行分析。研究发现近几年抗HIV药物专利申请数量较为平稳;专利申请主要集中在美国、加拿大和中国;抗HIV药物的技术领域主要集中在天然产物、发酵工业和杂环化合物等方面。美国在专利申请数量方面远远领先于其他国家,足以见美国在抗HIV药物研发的活跃和强劲的技术实力。我国虽然在专利申请数量方面具有一定优势,但是与国外相比仍有较大差距。     

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.     

“一带一路”沿线国家生物技术发展趋势研究

“一带一路”贯穿亚欧非大陆,联结活跃的东亚经济圈和发达的欧洲经济圈,以及中间经济发展潜力巨大的广大腹地国家与地区,“一带一路”战略将对中国未来国内外的政治、经济、文化、科技发展产生重大深远影响。本报告分析了“一带一路”沿线国家的科技发展基础条件,研究了“一带一路”沿线国家在生物技术领域取得的基础研究进展和专利技术研发进展的总体情况,综述了“一带一路”沿线国家生物技术产业发展现状和国际专利布局情况,并针对中国与“一带一路”沿线国家在生物技术领域进一步深化合作互利共赢提出了发展建议。     

基于专利分析的转基因药用植物技术发展趋势研究

据世界卫生组织不完全统计,药用植物在发展中国家和发达国家的使用量均逐年上升。随着对药用植物需求和消耗的不断增加,许多药用植物资源急剧减少。面对日趋严峻的药用植物资源,利用转基因技术进行品种改良,提高其有效成分含量成为研究的重要方向之一。基于德温特数据库的专利信息,对收录的有关转基因药用植物领域的专利文献进行统计分析,分别从全球和中国本土两个层面对转基因药用植物的研究现状、核心技术、研究热点、技术分布与格局等方面进行研究。结果表明,在转基因药用植物领域美国技术实力最强,而中国专利数量名列前茅,但其国际影响力尚且不足。研究结果为相关企业和科研机构掌握转基因药用植物的发展趋势提供必要的情报支持。     

Intellectual property protection of plant biotechnology inventions

The intellectual property protection of biotechnology-related subject matter is undergoing significant change and several countries have revised their legislation and/or patent practice as a result of challenges from industry and members of the public. Plant-related subject matter can be protected using plant variety protection, utility patents or, in the USA, by plant patent. Although easier to obtain than a utility patent, plant variety protection does not provide the same scope of protection. Protecting a plant using a utility patent is permitted only in countries that allow the patenting of higher life forms and requires a higher degree of experimental support than is required for plant variety protection, although the scope of protection is being steadily reduced.     

Global unbalance in seaweed production,research effort and biotechnology markets

Exploitation of the world's oceans is rapidly growing as evidenced by a booming patent market of marine products including seaweed, a resource that is easily accessible without sophisticated bioprospecting technology and that has a high level of domestication globally. The investment in research effort on seaweed aquaculture has recently been identified to be the main force for the development of a biotechnology market of seaweed-derived products and is a more important driver than the capacity of seaweed production. Here, we examined seaweed patent registrations between 1980 and 2009 to assess the growth rate of seaweed biotechnology, its geographic distribution and the types of applications patented. We compare this growth with scientific investment in seaweed aquaculture and with the market of seaweed production. We found that both the seaweed patenting market and the rate of scientific publications are rapidly growing (11% and 16.8% per year respectively) since 1990. The patent market is highly geographically skewed (95% of all registrations belonging to ten countries and the top two holding 65% of the total) compared to the distribution of scientific output among countries (60% of all scientific publications belonging to ten countries and the top two countries holding a 21%), but more homogeneously distributed than the production market (with a 99.8% belonging to the top ten countries, and a 71% to the top two). Food industry was the dominant application for both the patent registrations (37.7%) and the scientific publications (21%) followed in both cases by agriculture and aquaculture applications. This result is consistent with the seaweed taxa most represented. Kelp, which was the target taxa for 47% of the patent registrations, is a traditional ingredient in Asian food and Gracilaria and Ulva, which were the focus of 15% and 13% of the scientific publications respectively, that are also used in more sophisticated applications such as cosmetics, chemical industry or bioremediation. Our analyses indicate a recent interest of non-seaweed producing countries to play a part in the seaweed patenting market focusing on more sophisticated products, while developing countries still have a limited share in this booming market. We suggest that this trend could be reverted by promoting partnerships for R and D to connect on-going efforts in aquaculture production with the emerging opportunities for new biotech applications of seaweed products.     

兽用疫苗管理与控制的国际标准

兽用疫苗是兽医医学产品,需接受像医学产品相同或相似的管理和控制标准,这意味着动物疫苗必须满足复杂的要求,保障产品在预期使用条件下的质量、安全性和免疫效力.在动物医药领域中,欧盟和美国的动物疫苗管理和控制体系发展早,制度完整,为其他国家和地区建立良好的动物疫苗管理与控制标准提供了有价值的参考信息.另外,统一各个国家和地区...     

间充质干细胞基础研究与临床转化的中美比较

目的：从基础研究、专利申请、临床试验角度对比分析中美间充质干细胞领域发展现状和趋势,了解中美间充质干细胞领域研究的主要特征,为中国间充质干细胞领域的发展提供建议。方法：检索SCI论文数据、DII专利数据及Clinical Trials临床试验数据及新药审批情况,利用Excel、DDA工具对检索结果进行定量分析和讨论。结果：中国在间充质干细胞基础研究、专利申请及临床试验方面虽起步较晚,但近年来发展迅速,论文、专利和临床试验数量快速增长,2014年起发表论文数量及2016年申请专利数量均超过美国,临床试验注册已达200余项;在骨质疏松、脊髓损伤等研究领域,内分泌系统疾病、自体免疫疾病等临床试验方面形成一定优势,已具备坚实的团队与技术基础。但我国间充质干细胞研究仍面临激烈的竞争,存在进步与发展空间。结论：我国间充质干细胞研究应发挥已有优势,加强战略性布局;重视发展以企业为主导的新药开发路径;做精做细以增强国际竞争力与影响力;加大资金投入和产业政策的支持;健全监管机制及评价体系,抓住机遇的同时积极迎接挑战。     

基于专利分析的天然抗肿瘤药制剂技术发展态势研究

目的:基于专利文献深入分析天然抗肿瘤药制剂技术的发展态势。方法:采用专利计量分析、统计学趋势分析等定量分析方法结合药学专业知识的定性分析方法从专利申请数量、国家/地区分布、专利技术领域等方面对天然抗肿瘤药制剂技术领域的发展态势进行分析。结果:天然抗肿瘤药制剂技术专利年申请数量在3000件左右,处于比较稳定平稳的发展时期;专利申请主要集中在美国和中国;专利技术领域主要集中在抗肿瘤活性和剂型的相关研究。结论:美国专利申请数量排名第一,远远领先于其他国家,且专利质量很高,处于绝对的领先地位。中国虽然在专利申请数量方面具有一定优势,但是专利质量亟待提高,与国外发达国家相比仍有较大差距。     

The university-promoted patent at the crossroads of the research results and immediate industrial use

The departments, indeed the laboratories of the public research institutions, no longer are satisfied with displaying a certain number of annual scientific publications meant to highlight their expertise and know-how. In effect, for some years now, a new trend has been in vogue: stimulated by all the national and international public bodies, they are calling increasingly on the “patent pending” solution to make optimum use of the results of specific researches on the one hand and, on the other hand, to assert their excellence vis-à-vis the Ministry of Research of their country which is supposed to finance them.However, caught up in the euphoria of the research results, and lost in their formulae and practices, these researchers lose sight of the basis for a patent and its real reason for being (patent charter). A patent necessarily must be of service to the community, that is to say that essentially it must contribute to the improvement of the quality of life of the population. To achieve this goal, going through certain stages is a must, namely that to start with a patent must be absolutely profitable to industry in order that, subsequently, it be consistent with its being of service to the community. In this context, its validity is set at 10 years renewable for another 10 years based on specific parameters as stipulated by the national and international patent institutions, indeed by the EPO (European Patent Office) the headquarters of which is in Munich. Its use by industry ensures proceeds for 10, even 20 years and must represent the material fruit of the applicant's effort. Beyond this period, the patent becomes public and therefore available to everyone. But the crucial problem is this: when can a patent really be used and how to do so as best as possible to guarantee profits for both parties involved and thus justify its reason for being?The purpose of this work thus is to incite university researchers to think about the real usefulness of a patent on the one hand and, on the other hand, to ponder over the best way of using, in close cooperation with industry, the fruit of the research and the registering of the patent, both financed by public funds. For the latter, owing to their nature, demand that there be no wastage and cautious management thereof.     

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.     

生物技术相关专利的计量学研究

生物技术是国家战略性高新技术的重要组成部分,已经成为当今世界各国战略发展争夺的热点之一。本文对ISTIC-专利分析数据库与美国USPTO授权的生物技术相关专利数据中收录的专利进行了分析。从专利授权数量及年度变化、生命周期、专利权人、专利的国际专利分类号、专利权人所属国家和机构等角度深入分析了生物技术专利的整体产出情况、重点技术领以及各个国家的生物技术发展状况和战略布局情况,为该领域战略争夺发展的重点提供参考与指导。     

Who should benefit financially from a good idea?

The need to publish ideas so that they can be explored, debated and extended by others before they are fully tested in the lab or the clinic is in conflict with the need to patent those ideas to provide a commercial incentive to apply them. I discuss why this conflict occurs, why it is important, and suggest three ways to get round it: root-and-branch reform of patent law (which seems impossible), extension of the US system's ‘grace period’ between publishing and filing a patent to longer times in the US and implementing the same system in other countries (which seems unlikely to happen), and binding readers of journals with a network of optional confidentiality agreements that allow publication but not citation without the authors’ permission. This latter appears too complex and conflicting an idea to work either, but while many conflicts with common scientific practice exist, the complexity of the system need not deter us, as at root the idea is simple and so it could be managed by software instead of patent lawyers.     

Transposon tools: worldwide landscape of intellectual property and technological developments

DNA transposons are considered to be good candidates for developing tools for genome engineering, insertional mutagenesis and gene delivery for therapeutic purposes, as illustrated by the recent first clinical trial of a transposon. In this article we set out to highlight the interest of patent information, and to develop a strategy for the technological development of transposon tools, similar to what has been done in many other fields. We propose a patent landscape for transposon tools, including the changes in international patent applications, and review the leading inventors and applicants. We also provide an overview of the potential patent portfolio for the prokaryotic and eukaryotic transposons that are exploited by spin-off companies. Finally, we discuss the difficulties involved in tracing relevant state-of-the-art of articles and patent documents, based on the example of one of the most promising transposon systems, including all the impacts on the technological development of transposon tools.     

基于专利信息分析的中国3D生物打印技术发展与产业化研究*

目的:基于专利信息对我国3D生物打印技术的发展态势进行分析。方法:本文基于incopat和TDA两大专利分析平台对中国3D生物打印的专利发展态势从专利统计分析与专利计量分析两个维度进行了跨库组合分析,总结了我国3D生物打印技术的专利前沿动态特征。结果:研究发现,中国3D生物打印技术从2013年起进入专利激增态势,中国作为潜在技术市场的国际竞争日趋激烈,本文还从专利申请人、技术领域分布、专利文本关键词聚类、专利价值、专利合作等方面进行了深度挖掘分析。结论:最后,结合对中国3D生物打印专利申请人的专利产业化案例深度分析与专利特征总结,为中国3D生物打印技术发展与产业化提供参考建议。     

生物技术相关专利的计量学研究

生物技术是国家战略性高新技术的重要组成部分,已经成为当今世界各国战略发展争夺的热点之一。本文对ISTIC-专利分析数据库与美国USPTO授权的生物技术相关专利数据中收录的专利进行了分析。从专利授权数量及年度变化、生命周期、专利权人、专利的国际专利分类号、专利权人所属国家和机构等角度深入分析了生物技术专利的整体产出情况、重点技术领以及各个国家的生物技术发展状况和战略布局情况,为该领域战略争夺发展的重点提供参考与指导。     

Man-made microbes and man-made law

The Supreme Court of the US in 1980 granted a patent for a strain of Pseudomonas containing two plasmides after genetic manipulation. This is the first case of patenting a living organism. Whereas the patent law of US and of many other countries further more on supports the principle that natural products are not patentable man-made microorganisms on the other hand fullfil very important crucials of patentability as far as they are new, unobvious, reproducible and useful. The situation arising as the result of this decision is described and the implications and consequenses for the patent law, the taxonomy and the general biological thought are discussed.