Patent pools and clearinghouses in the life sciences

The biopharmaceutical industry is slowly absorbing the idea of collaborative patent licensing models. Recently, two patent pools for developing countries have been launched: the Pool for Open Innovation against Neglected Tropical Diseases initiated by GlaxoSmithKline (GSK), which is referred to as the BIO Ventures for Global Health (BVGH) pool, and the Medicines Patent Pool (MPP) initiated by UNITAID. Various organizations have recommended using pools or clearinghouses beyond the humanitarian dimension where many patents are owned by many different actors. As a first attempt, MPEG LA, which administers patent pools in various technology fields, is now setting up a clearinghouse for patents related to molecular diagnostics. These examples as well as the results from an empirical study provide useful insights for the design and administration of future pools and clearinghouses in the life sciences.     

Models for facilitating access to patents on genetic inventions

The genetics community is increasingly concerned that patents might lead to restricted access to research and health care. We explore various measures that are designed to render patented genetic inventions accessible to further use in research, and to diagnosis and/or treatment. They include the often-recited research or experimental-use exemption, conventional one-to-one licensing and compulsory licensing, as well as patent pools and clearing-house mechanisms. The last two alternatives deserve special attention in the area of human genetics.     

基于国际专利数据的真菌黑色素创新发展趋势分析

【背景】黑色素具有抗肿瘤、抗辐射等多种生物活性,在生产和生活中具有巨大的应用潜力,通过真菌生产是获取黑色素的一条重要途径,它与动植物相比具有更短的生产周期和更高的产量,并且易于实现商业应用。【目的】揭示真菌黑色素的生产及应用发展情况和创新趋势,为致力于真菌黑色素产业的科研人员和企业提供参考。【方法】基于Inco Pat科技创新情报平台,通过对全球真菌黑色素相关专利进行检索统计,从专利涉及的菌株、专利技术构成、申请人专利价值等多维度对真菌黑色素相关专利进行深入分析。【结果】真菌黑色素在生产制备领域申请专利数量最多(50.56%),作为化工染料和化妆品原料应用的专利申请数量最少(13.48%),涉及的真菌菌属主要有层孔菌属、短梗霉属、木耳属、纤孔菌属、粒毛盘菌属、灵芝属和曲霉属。目前真菌黑色素专利技术申请的热点领域主要在C12 (微生物发酵、培养基、突变或遗传工程)类和A61 (医学)类,并且在未来一段时间内,C12和A61将继续作为热点技术申请领域。中国申请的真菌黑色素专利数量最多,但拥有的高价值专利比例较低,较国外仍具有一定差距。【结论】我国科研人员需要加强在医药和化工领域核心专利技术的创新应用与海外布局,增强与企业的合作研发和技术转移,以抢占真菌黑色素在这些领域的应用市场,并推动真菌黑色素相关专利向高质量发展。     

Spatial distribution and temporal dynamic of the seed pool in a Danish lowland stream

In this paper we quantify the seed pools in four locations down through a small stream in Denmark. The objectives of the study were (1) to test if the number of plant taxa in the seed pool increases downstream in the stream system; (2) to test if the seed density in the pool is highest in autumn; and (3) to analyze to what extent the seed pool contributes to re-establishment of vegetation in spring. Counting method showed no increase in species taxa in the seed pool down through the stream system. Neither did we find clear seasonal patterns in seed abundance in the seed pool. By concurrent field and laboratory observations in spring we found that seed pools can function as a source for re-establishing the vegetation in spring. However, the actual germination rate in the field was <100 and <10 times the germination rate in the laboratory for aquatic and terrestrial plants, respectively. The results suggest that small lowland streams contain large seed pools in deposition areas throughout the year, and that seed pools are much more important for the re-establishment of riparian stream vegetation in spring than submerged vegetation.     

生物能源领域国际相关专利分析

随着石油资源的日益枯竭,近年来生物能源技术的开发引起了全球各界的广泛重视,加之专利保护意识的增强,生物能源领域的专利数量迅速增长,对专利信息的分析可以了解生物能源技术的发展现状和趋势,为技术创新和战略发展提供参考。本文选取目前生物能源中的三种重要技术――生物乙醇、生物柴油和生物制氢技术,利用专利计量分析的方法对其发展态势进行了研究。研究内容包括：专利申请的时间分布和空间分布,被引专利情况,主要技术领域,以及重要专利权人及其相关信息,从专利分析的角度揭示近年来这三种生物能源技术的研发状况。     

基于专利分析的3D生物打印产业发展态势研究

目的:揭示3D生物打印产业技术研发态势和专利布局,以期为相关机构提供竞争情报,为行业发展提供数据支撑。方法:基于3D生物打印领域产业调研和技术分解,构造检索式获取数据,多维度量化分析领域专利。结果:3D生物打印产业发展可分为孕育期、萌芽期和高速发展期;该产业集中度较低,处于分散竞争阶段;申请人多依据地缘因素选择合作对象,合作方之间多为不同类型的机构;中国申请人的专利申请量占全球的比重已接近50%,但美国申请人的专利篇均被引频次仍远超中国;美国申请人更关注海外市场。结论:3D生物打印产业尚未形成规模效应,有必要整合业内资源,打造产业集群;中、美两国在该产业都具有优势地位,中国亟待加强海外专利布局;综合权衡专利数量和质量,美国申请人的专利竞争力仍高于中国,中国需培育更多核心专利。     

Genes and patent policy: rethinking intellectual property rights

Concerns about human gene patents go beyond moral disquiet about creating a commodity from a part of the human body and also beyond legal questions about whether genes are unpatentable products of nature. New concerns are being raised about harm to public health and to research. In response to these concerns, various policy options, such as litigation, legislation, patent pools and compulsory licensing, are being explored to ensure that gene patents do not impede the practice of medicine and scientific progress.     

Metabolic pools differ among ecologically diverse Drosophila species

Studies of the genetic mechanisms underlying metabolic storage have focused on a few model organisms. Although very fruitful, these studies have not allowed for the examination of mechanisms across a phylogenetic spectrum. The exploration of natural patterns of metabolic pool size variation across species will help us to better understand the genetics of metabolic adaptation.We examined the metabolic pools size (triglyceride, glycogen and protein) at two ages in 12 Drosophila species with distinctly different ecologies for which complete genome sequences (for 11 of the 12 species) are known. Overall, there were significant differences across species for all three pools, while age and sex appear to affect some metabolic pools more than others. After correcting for the phylogenetic relatedness of the species used, we observed no association between triglyceride and glycogen content. Although within species these two pools sometimes are correlated, at a larger phylogenetic scale control of triglyceride and glycogen contents may have been shaped independently by natural selection.     

Strategic mining of cyanobacterial patents from the USPTO patent database and analysis of their scope and implications

Patent analysis with the help of the strategic mining of patents from databases is important and useful within the framework of application-oriented research and its commercialization. In the analysis reported here, we have mined cyanobacterial patents from the patent database of the United States Patent and Trademark Office (USPTO). In order to make an assessment of the commercial potentials of cyanobacteria, we conducted the patent search (from 1976 to April 2006) using certain generic terms and the 84 genera of cyanobacteria as keywords. The search was performed in two major ways – searching the abstracts and claims of the patents cumulatively and searching the entire patent documents by the mode of ‘all fields’ in USPTO. In the abstract- and claims-based search, 234 patents were obtained after the removal of overlapping patents among the keywords. An additional 31 patents were added following the ‘all fields’ search; these patents were not covered in the search that was based on abstracts and claims. The entire package of 265 patents, of which 244 were related to cyanobacteria, was then analyzed. Information derived from these patents identified five major areas of cyanobacterial utilization. Cyanobacteria have been patented as a source of a wide spectrum of products, for medical, agriculture and environmental applications, for gene-based products, for methods of cultivation and for methods of control. The chronological development in granting cyanobacterial patents was also traced. This study demonstrates that such strategic mining and analysis of patent data can be used as an index for future development.     

microRNA相关专利分析

目的:分析microRNA(miRNA)相关专利,为我国miRNA科学研究和决策提供一定的参考。方法:运用专利文献计量学方法,使用TDA软件和Excel程序,对DII数据库中收录的miRNA相关专利的年份、国别、专利家族分布、专利权人、发明人和Derwent手工码进行分析。结果:发现了miRNA相关专利的年份分布、主要国家或组织的专利家族分布、前十位专利权人分布、前十位发明人分布及所涉及的Derwent手工代码分布情况。结论:我国在相关专利数量上虽然处于相对领先地位,但与美国等国相比仍存在很大差距,同时miRNA相关专利的专利家族多局限于本国,未曾形成一种广泛的多国高度分布的专利家族形势,缺乏对专利主动运用以获取专利信息和竞争优势的意识。     

An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile

We analyze the patent filing strategies of foreign pharmaceutical companies in Chile distinguishing between “primary” (active ingredient) and “secondary” patents (patents on modified compounds, formulations, dosages, particular medical uses, etc.). There is prior evidence that secondary patents are used by pharmaceutical originator companies in the U.S. and Europe to extend patent protection on drugs in length and breadth. Using a novel dataset that comprises all drugs registered in Chile between 1991 and 2010 as well as the corresponding patents and trademarks, we find evidence that foreign originator companies pursue similar strategies in Chile. We find a primary to secondary patents ratio of 1:4 at the drug-level, which is comparable to the available evidence for Europe; most secondary patents are filed over several years following the original primary patent and after the protected active ingredient has obtained market approval in Chile. This points toward effective patent term extensions through secondary patents. Secondary patents dominate “older” therapeutic classes like anti-ulcer and anti-depressants. In contrast, newer areas like anti-virals and anti-neoplastics (anti-cancer) have a much larger share of primary patents.     

Extending the market exclusivity of therapeutic antibodies through dosage patents

Dosage patents are one way to extend the market exclusivity of an approved drug beyond the lifetime of the patent that protects the drug as such. Dosage patents may help to compensate the applicant for the long period where the active pharmaceutical ingredient as such is already under patent prosecution, but not on the market yet, due to lengthy development and approval procedures. This situation erodes part of the time the drug is marketed under patent protection. Dosage patents filed at a later date can provide remedy for this problem. Examples of successful and unsuccesful attempts, and the reasons for the respective outcomes, are provided in this article.     

以PD-1 为靶点的抗肿瘤药物专利现状分析

PD-1(程序性死亡受体1)是一种重要的免疫抑制分子,其与癌症的治疗密切相关。目前FDA(美国食品药品监督管理局)已经批准了PD-1抑制剂抗体作为癌症治疗药,因此,PD-1具有极高的研究和应用价值。目前在专利领域,全球各大药企均已经开始专利布局,而在中国申请的专利也是日趋增多,对于我国企业来说,把握时机提前布局专利申请,有利于识别竞争对手,抢占市场。本文通过分析以PD-1为靶点的药物专利现状,特别是研究的重点领域,专利申请的国内重点布局等方面,为国内的申请人未来的研发方向和专利布局提供适当的指引。     

Patents – a practical perspective

Patent Update is a regular column dedicated to the complex issues that affect patents in the genomics and proteomics field. In each issue, there are two sections compiled by patent attorneys. The first section, Patents – a Practical Perspective, is a commentary on current issues, landmark patents, useful patent resources and how to search them, and legislative changes that impact the pharma and biotech industries. The second section, Patent News, provides brief synopses of recently issued patents and other patent events, and their significance to drug discovery R&D.     

Patent perspective

Patent Update is a regular column dedicated to the complex issues that affect patents in the genomics and proteomics field. In each issue, there are two sections compiled by patent attorneys. The first section, Patents – a Practical Perspective, is a commentary on current issues, landmark patents, useful patent resources and how to search them, and legislative changes that impact the pharma and biotech industries. The second section, Patent News, provides brief synopses of recently issued patents and other patent events, and their significance to drug discovery R&D.     

Genetic evidence for an equilibrium between docked and undocked vesicles

By using the shibire mutation to block endocytosis in a temperature-dependent fashion, we have manipulated the number of synaptic vesicles in a nerve terminal and have observed a remarkable proportionality of the number of quanta released to the size of the total vesicle pool. In the experiments described below we determine that approximately 0.3% of the vesicle pool is released per stimulus. The data suggest that the pool of readily releasable docked vesicles does not represent the saturation of a limiting number of release sites, but instead represents a subset of vesicles that is in equilibrium with the larger pool of vesicles. Before presenting this data and the significance of the finding for the regulation of neurotransmission, we will briefly review the use of Drosophila genetics as a tool for dissecting synaptic transmission.     

Patents Associated with High-Cost Drugs in Australia

Australia, like most countries, faces high and rapidly-rising drug costs. There are longstanding concerns about pharmaceutical companies inappropriately extending their monopoly position by “evergreening” blockbuster drugs, through misuse of the patent system. There is, however, very little empirical information about this behaviour. We fill the gap by analysing all of the patents associated with 15 of the costliest drugs in Australia over the last 20 years. Specifically, we search the patent register to identify all the granted patents that cover the active pharmaceutical ingredient of the high-cost drugs. Then, we classify the patents by type, and identify their owners. We find a mean of 49 patents associated with each drug. Three-quarters of these patents are owned by companies other than the drug''s originator. Surprisingly, the majority of all patents are owned by companies that do not have a record of developing top-selling drugs. Our findings show that a multitude of players seek monopoly control over innovations to blockbuster drugs. Consequently, attempts to control drug costs by mitigating misuse of the patent system are likely to miss the mark if they focus only on the patenting activities of originators.     

Molecular marker assisted broadening of the Central European heterotic groups in rye with Eastern European germplasm

Broadening the genetic base of heterotic pools is a key to ensure continued genetic gains in hybrid breeding and extend hybrid cultivation to new areas. In the present study, two Central European heterotic pools (Carsten and Petkus) and five Eastern European open-pollinated varieties (OPVs, Pop-1 to Pop-5) were studied with the objectives to (1) investigate the genetic diversity in OPVs and the heterotic pools using molecular and field data, (2) evaluate the molecular diversity among OPVs, (3) examine the combining ability for grain yield of the OPVs when crossed with testers in field trials, and (4) develop a strategy for targeted introgression of OPV germplasm into the heterotic pools. In total, 610 S₀ plants, 347 from OPVs and 263 from heterotic pools, were developed. Clones of the S₀ plants of OPVs were crossed with two testers belonging to each heterotic pool, while clones of heterotic pools were crossed with only the opposite tester. Testcrosses were evaluated for grain yield in multi-location trials. In addition, 589 S₀ plants were fingerprinted with 30 SSR markers. The data revealed that the Carsten pool has a narrow genetic base and should be the primary target for broadening the established heterotic pattern. Mean and genetic variance suggested that Pop-2 and Pop-4 are good candidates for introgression in Petkus pool and Pop-5 in Carsten pool. Nevertheless, introgression of Pop-5 in Carsten could reduce the genetic diversity between heterotic pools. Therefore, we suggest that either selected plants of Pop-5 should be introgressed or more Eastern European germplasm should be fingerprinted and field evaluated to identify promising germplasm for broadening the established heterotic pattern.