intellectual property

知识产权
  • 文章类型: Journal Article
    三维打印(3D打印)或“增材制造”首次在工程领域脱颖而出,特别是在运输部门,其快速准确的原型制造和备件制造的价值很快得到认可。然而,在过去的十年里,这项革命性的技术颠覆了日益多样化的技术领域中的既定制造。也许其中最出乎意料的是药物-不仅仅是制造产品,例如手术插入的植入物,还有剂量配方本身-现在可以以各种方式打印的输送形式和载体,并通过3D打印工艺选择显示出释放特性的有希望的控制。这篇综述将概述3D打印技术在过去十年中如何跨越技术界限发展和扩展。仔细观察目前广泛采用它的机会和障碍,特别是在医疗和制药领域。特别关注专利作为推动和阻碍3D打印在医疗和制药领域扩张的因素,专注于专利文献。
    Three-dimensional printing (3D printing) or \"additive manufacturing\" first came to prominence in the field of engineering, in particular in the transport sector where the value of its fast and accurate prototyping and manufacture of spare parts was quickly recognised. However, over the last ten years, this revolutionary technology has disrupted established manufacture in an increasingly diverse range of technical areas. Perhaps the most unexpected of these is pharmaceuticals - not merely the manufacture of products such as surgically inserted implants, but also of dosage formulations themselves - now available in all manner of printed delivery forms and vehicles and showing promising control of release properties though 3D printing process choices. This review will provide an overview of how 3D printing technology has developed and expanded across technological boundaries during the past decade, with a closer look at the current opportunities and barriers to its widespread adoption, particularly in the medical and pharmaceutical sectors. Special attention has been paid to patents as a boost and barrier to the expansion of 3D printing in the medical and pharmaceutical sector, with a focus on the patent literature.
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  • 文章类型: Journal Article
    在COVID-19大流行期间,通过双边协议和药品专利池的知识产权许可被用来促进低收入和中等收入国家(LMICs)获得新的COVID-19疗法。将该模型应用于COVID-19的经验教训可能与未来流行病和其他突发卫生事件的准备和应对有关。在LMICs中提供新产品的负担得起的版本的速度是实现该产品潜在的全球影响的关键。在研发生命周期的早期启动时,在大流行期间,许可可以促进低收入国家创新产品的通用版本的快速开发。对合格厂家的预选,例如,在COVID-19大流行期间参与的现有仿制药制造商网络的基础上,分享专有技术和快速提供关键投入,如参考上市药物(RLD),也可以节省大量时间.重要的是在速度和质量之间找到良好的平衡。必要的质量保证条款需要包括在许可协议中,可以探索新的世界卫生组织上市机构机制的潜力,以促进加快监管审查和及时获得安全和质量有保证的产品。数字,容量,许可公司的地理分布和许可协议的透明度对供应的充足性具有影响,负担能力,和供应安全。为了促进竞争和支持供应安全,许可证应该是非排他性的。还需要建立模式,以降低开发关键的大流行疗法的风险,特别是在创新产品被证明是有效的和批准之前开始的通用产品开发。知识产权许可和技术转让可以成为改善制造业多样化的有效工具,需要探索区域制造业,以加快在低收入和低收入国家的大规模获取,并在未来的流行病中提供安全。
    During the COVID-19 pandemic, intellectual property licensing through bilateral agreements and the Medicines Patent Pool were used to facilitate access to new COVID-19 therapeutics in low- and middle-income countries (LMICs). The lessons learnt from the application of the model to COVID-19 could be relevant for preparedness and response to future pandemics and other health emergencies.The speed at which affordable versions of a new product are available in LMICs is key to the realization of the potential global impact of the product. When initiated early in the research and development life cycle, licensing could facilitate rapid development of generic versions of innovative products in LMICs during a pandemic. The pre-selection of qualified manufacturers, for instance building on the existing network of generic manufacturers engaged during the COVID-19 pandemic, the sharing of know-how and the quick provision of critical inputs such as reference listed drugs (RLDs) could also result in significant time saved. It is important to find a good balance between speed and quality. Necessary quality assurance terms need to be included in licensing agreements, and the potentials of the new World Health Organization Listed Authority mechanism could be explored to promote expedited regulatory reviews and timely access to safe and quality-assured products.The number, capacity, and geographical distribution of licensed companies and the transparency of licensing agreements have implications for the sufficiency of supply, affordability, and supply security. To foster competition and support supply security, licenses should be non-exclusive. There is also a need to put modalities in place to de-risk the development of critical pandemic therapeutics, particularly where generic product development is initiated before the innovator product is proven to be effective and approved. IP licensing and technology transfer can be effective tools to improve the diversification of manufacturing and need to be explored for regional manufacturing for accelerated access at scale in in LMICs and supply security in future pandemics.
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  • 文章类型: Journal Article
    商标形象通常是消费者与产品或服务之间的第一种间接联系。公司依靠图形商标作为质量和即时识别的象征,寻求保护他们免受侵犯版权的侵害。一种流行的防御机制是图形搜索,将图像与大型数据库进行比较,以查找与类似商标的潜在冲突。尽管不是一个新的主题,最先进的图像检索在工业产权(IP)领域缺乏可靠的解决方案,数据集的内容实际上不受限制,抽象图像,对人类感知建模是一项具有挑战性的任务。现有的基于内容的图像检索(CBIR)系统仍然存在一些问题,特别是在效率和可靠性方面。在本文中,我们提出了一个新的CBIR系统,克服了这些主要的限制。它遵循模块化的方法,由一组负责检索的单个组件组成,维护和逐步优化商标图像搜索,大规模工作,未标记的数据集。它的泛化能力是使用多个特征描述来实现的,单独加权,并组合以表示单个相似性得分。评估图像的一般特征,边缘地图,和感兴趣的地区,采用基于分水K-Means段的方法。我们提出了一种图像恢复过程,该过程依赖于所有特征描述之间的新相似性度量。每天都会添加新的商标图像,以确保最新的结果。所提出的系统展示了及时的检索速度,95%的搜索具有10秒的呈现速度和93.7%的平均精度,支持其对实字IP保护场景的适用性。
    A trademark\'s image is usually the first type of indirect contact between a consumer and a product or a service. Companies rely on graphical trademarks as a symbol of quality and instant recognition, seeking to protect them from copyright infringements. A popular defense mechanism is graphical searching, where an image is compared to a large database to find potential conflicts with similar trademarks. Despite not being a new subject, image retrieval state-of-the-art lacks reliable solutions in the Industrial Property (IP) sector, where datasets are practically unrestricted in content, with abstract images for which modeling human perception is a challenging task. Existing Content-based Image Retrieval (CBIR) systems still present several problems, particularly in terms of efficiency and reliability. In this paper, we propose a new CBIR system that overcomes these major limitations. It follows a modular methodology, composed of a set of individual components tasked with the retrieval, maintenance and gradual optimization of trademark image searching, working on large-scale, unlabeled datasets. Its generalization capacity is achieved using multiple feature descriptions, weighted separately, and combined to represent a single similarity score. Images are evaluated for general features, edge maps, and regions of interest, using a method based on Watershedding K-Means segments. We propose an image recovery process that relies on a new similarity measure between all feature descriptions. New trademark images are added every day to ensure up-to-date results. The proposed system showcases a timely retrieval speed, with 95% of searches having a 10 second presentation speed and a mean average precision of 93.7%, supporting its applicability to real-word IP protection scenarios.
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  • 文章类型: Journal Article
    本文为中国京津冀地区的知识流动提供了新的证据,涉及京津冀地区43个城市(区),基于中国国家知识产权局的发明专利转让数据。首先,从流动数量变化的角度分析了京津冀地区技术流动的特征,流动主体类型和空间分布特征。然后,构建了京津冀地区多层次的专利技术流网络,并分别探讨了各级网络的结构特征和节点特征。这项研究的主要发现如下。(1)随着时间的推移,专利技术流的数量一直在增长,研究期间表现出明显的阶段性特征。作为一个整体,京津冀地区市(区)内技术流量高于市(区)间。(2)京津冀地区多层次专利技术流网络呈现动态特征,随着越来越多的移动主体参与到专利技术流网络中,一些网络节点变得彼此更接近,小团体技术流动趋势显著增加。(3)企业是京津冀地区专利技术流网络的核心枢纽。个人发明专利技术转移也占有较高的比重,高校在京津冀地区专利技术流网络中的参与度也在逐步提升。(4)随着时间的推移,京津冀地区43个城市(区)的专利技术流动逐渐活跃,不再过分依赖某一城市(区)进行专利技术转移。
    This paper presents new evidence on knowledge flows in the Beijing-Tianjin-Hebei region of China, involving 43 cities (districts) in the Beijing-Tianjin-Hebei region, based on the invention patent transfer data from the State Intellectual Property Office of China. First, the characteristics of technology flows in the Beijing-Tianjin-Hebei region are analyzed in terms of changes in the number of flows, types of flowing subjects and spatial distribution characteristics. Then, a multi-level patent technology flow network in the Beijing-Tianjin-Hebei region was constructed, and the structural characteristics and node characteristics of each level network were explored separately. The key findings of the study are as follows. (1) The number of patented technology flows has been growing over time, showing obvious phase characteristics during the study period. As a whole, the intra-city (district) technology flow in the Beijing-Tianjin-Hebei region is higher than the inter-city (district). (2) The multi-level patent technology flow network in the Beijing-Tianjin-Hebei region shows dynamic characteristics, with more and more mobile subjects participating in the patent technology flow network, some network nodes becoming closer to each other, and the trend of small group technology flow increasing significantly. (3) Enterprises are the core hub of the patent technology flow network in Beijing-Tianjin-Hebei region. Individual invention patent technology transfer also occupies a high proportion and the participation of universities and colleges in the patent technology flow network in the Beijing-Tianjin-Hebei region is gradually increasing. (4) Over time, the flow of patent technology in the 43 cities (districts) in the Beijing-Tianjin-Hebei region has gradually become active and no longer relies excessively on a particular city (district) for patent technology transfer.
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  • 文章类型: Journal Article
    药物再利用可以比开发新化合物更便宜和更快。然而,它仍然未被充分利用,部分原因是监管和知识产权挑战。美国和欧洲的政策制定者制定了七个药物开发计划,旨在使用各种不同的策略来克服这些挑战。
    Drug repurposing can be cheaper and faster than developing new compounds. Yet, it remains underused, partially because of regulatory and intellectual property challenges. Policy-makers in the United States and Europe have created seven drug development programs that aim to overcome these challenges using a variety of different strategies.
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  • 文章类型: Journal Article
    背景:泰国表示有兴趣加入《全面与进步跨太平洋伙伴关系协定》(CPTPP),由12个国家组成的诸边贸易协定,其最初的化身包括美利坚合众国(美国)。当美国退出这项协议时,与药品相关的关键知识产权条款被暂停。如果CPTPP缔约方决定这样做,这些可以恢复。
    方法:本研究使用两种方案来评估如果泰国加入CPTPP并恢复暂停条款,CPTPP对泰国2020年丙型肝炎治疗制度的影响。
    结果:如果恢复暂停的CPTPP条款,并且泰国不愿意或不能够颁发强制许可,加入CPTPP可能会使成本增加十倍以上。根据2020年预算,这种可能情况的价格可能会使丙型肝炎治疗覆盖率降低90%.
    结论:加入CPTPP等需要加强知识产权保护的贸易协定,可能会损害泰国的丙型肝炎计划和其他依赖负担得起的仿制药的国家治疗计划。CPTPP还可以阻止泰国依靠自己的制药能力来生产维持其治疗计划所需的药物。
    BACKGROUND: Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so.
    METHODS: This study uses two scenarios to cost the impact the CPTPP would have had on Thailand\'s 2020 hepatitis C treatment regime if Thailand joined the CPTPP and suspended clauses were reinstated.
    RESULTS: Joining the CPTPP could have increased the cost more than tenfold if suspended CPTPP clauses were reinstated and Thailand was not willing or able to issue compulsory licenses. Based on the 2020 budget, the price for this possible scenario could have reduced hepatitis C treatment coverage by 90%.
    CONCLUSIONS: Acceding to trade agreements such as the CPTPP that require increasing intellectual property protection, could compromise Thailand\'s hepatitis C program and other national treatment programs reliant on affordable generic medicines. The CPTPP could also prevent Thailand from relying on its own pharmaceutical capabilities to manufacture medicines needed to sustain its treatment programs.
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  • 文章类型: Journal Article
    大学对研究商业化的推动凸显了知识产权(IP)政策在促进创新以及指导和管理研究商业化活动方面的重要性。本文对澳大利亚所有(37)所公立大学的知识产权政策进行了内容分析,着眼于政策目标,IP的定义,不同创作者创建的IP的所有权,和净商业化收入的分配。发现所有大学都主张对员工创建的知识产权拥有所有权,特别是当与就业或利用大学资源有关时。对于学生来说,政策倾向于平衡他们的权利和大学的利益,针对不同类型的学生参与,但是大多数政策的重点是研究生从事研究活动。虽然一些政策对访问者和附属机构创建的知识产权以及土著文化和知识产权(ICIP)有明确的安排,大约四分之一的政策没有为这些群体指定安排。收入分享安排各不相同,但通常会将净收入的三分之一到一半授予创作者,承认他们的贡献并激励进一步的创新。政策包括广泛的目标,从保护和商业化知识产权到促进创新和社会效益,反映了整个高等教育部门的不同战略。政策可能会受益于某些领域的进一步明确,例如学生或其他创作者群体的权利。需要进行研究以评估这些政策的有效性及其对创新和商业化活动的影响。
    The push towards research commercialisation at universities has highlighted the importance of intellectual property (IP) policies in fostering innovation and guiding and managing research commercialisation activities. This paper undertakes a content analysis of intellectual property policies of all (37) Australian public universities, focusing on policy objectives, definition of IP, ownership of IP created by different creators, and distribution of net commercialisation revenues. It is found that all universities assert ownership over staff-created IP, particularly when related to employment or utilisation of university resources. For students, policies tend to balance their rights with university interests, with nuanced approaches for different types of student participation, but the focus of most policies was on postgraduate students engaging in research activities. While some policies had clear arrangements for IP created by visitors and affiliates and Indigenous cultural and intellectual property (ICIP), about a quarter of policies did not specify arrangements for these groups. Revenue sharing arrangements vary but generally award something between a third to a half of net revenue to creators, to both acknowledge their contribution and incentivise further innovation. Policies included a broad spectrum of objectives, from protecting and commercialising IP to fostering innovation and societal benefit, reflecting varying strategies across the higher education sector. Policies could benefit from further clarity in certain areas such as the rights of students or other creator groups. Research is needed to assess the effectiveness of these policies and their influence on innovation and commercialisation activities.
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  • 文章类型: Journal Article
    药物再利用已成为药物发现和开发过程中的一种有希望的方法,因为它以时间有效的方式提供了安全有效的治疗选择。虽然与药物开发过程的临床前和临床方面有关的问题在药物再利用期间得到了很大的解决,但监管观点获得了更多的收益。像传统的药物开发一样,重新利用的药物面临着多重挑战。这些挑战包括专利权、重新利用的新颖性,数据和市场排他性对患者人群的负担能力和公平访问。为了优化再利用药品的市场准入,世界各地的监管组织都制定了加速审批程序。监管机构已经认识到重新利用方法和重新利用药物的重要性。监管机构可以通过向制药公司提供激励措施来鼓励再利用药物的开发,并为普通民众提供更容易获得和负担得起的再利用药物。本章总结了与再利用药物相关的监管和道德考虑因素,并重点介绍了一些有助于改善患者获得安全、有效和具有成本效益的治疗选择。
    Drug repurposing has emerged as a promising approach in the drug discovery and development process as it offers safe and effective therapeutic options in a time effective manner. Though the issues related to pre-clinical and clinical aspects of drug development process are greatly addressed during drug repurposing yet regulatory perspectives gain even more However, like traditional drug development the repurposed drugs face multiple challenges. Such challenges range from the patenting rights, novelty of repurposing, data and market exclusivity to affordability and equitable access to the patient population. In order to optimize the market access of repurposed drugs, regulatory organizations throughout the world have developed accelerated approval procedures. The regulatory bodies have recognized the importance of repurposing approaches and repurposed drugs. Regulatory bodies can encourage the development of repurposed drugs by providing incentives to pharmaceutical companies and more accessible and affordable repurposed agents for the general population. This chapter summarizes the regulatory and ethical considerations pertaining to the repurposed drugs and highlights a few cases of intellectual property rights for repurposed drugs that have helped improve patient\'s access to safe, efficacious and cost-effective therapeutic options.
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  • 文章类型: Journal Article
    制造和服务公司的创新绩效可能会受到开放式创新(OI)与作为保护知识产权工具的保密协议(NDA)之间现有关系的影响。根据横截面样本的6,798家工业公司(2019-2020年)和9,304家服务业公司(2017-2019年),这些公司是国家统计局(DANE)在其技术创新与发展调查(EDIT和EDITS)中的目录中的一部分,可以认为,这两个变量(OI和NDA)的相互作用对制造业产生积极影响,但对服务业产生负面影响。可以推断出,积极的影响是由于制造业中OI的更大传统以及服务业与外部参与者合作时所表现出的谨慎的负面影响。
    The innovative performance of manufacturing and service companies can be impacted by the existing relationship between open innovation (OI) and the generation of confidentiality agreements (NDAs) as a tool for the protection of intellectual property. Based on the analysis of a cross-sectional sample of 6,798 industrial companies (2019-2020) and 9,304 companies in the service sector (2017-2019) that are part of the directory of the National Administrative Department of Statistics (DANE) in its Technological Innovation and Development Survey (EDIT and EDITS), it can be suggested that the interaction of these two variables (OI and NDAs) generate positive effects for the manufacturing industry but negative ones for the service sector. It could be deduced that the positive effect is due to the greater tradition of OI in the manufacturing industry and the negative effect to the caution that the service sector presents when collaborating with external actors.
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  • 文章类型: Journal Article
    平台试验通常被认为是解决早期候选药物临床评估的创新方法,随着证据的发展,无论模态如何。作为一种随机临床试验(RCT)设计结构,其中多种干预措施与普通对照组同时进行评估,从而允许在整个试验中添加新的干预措施并更新对照组。它们提供了一种动态和有效的机制来比较和区分新的治疗候选人。他们最近在评估COVID-19新疗法中的使用激发了人们对该方法的新兴趣。平台试验的缺乏受到新颖性和操作要求的影响较小,而不是对知识产权(IP)共享和缺乏在知识产权和数据共享背景下进行操作的基础设施的担忧。我们提供了一种机制,如何通过使用数字研究环境(DRE)来实现这一目标,为临床研究人员提供安全可靠的平台。定量和医师科学家分析和开发工具(例如,模型)在敏感数据上,并确信开发的数据和模型受到保护。DRE,在这种情况下,通过在安全控制的工作空间中提供对数据的远程访问以及分析工具,扩展了可信研究环境(TRE)的概念,在允许数据和工具可查找的同时,可访问,可互操作,和可重复使用(FAIR),版本控制,并且由于在试验中评估的每种治疗方法而在大小或质量上动态增长。
    Platform trials are generally regarded as an innovative approach to address clinical valuation of early stage candidates, regardless of modality as the evidence evolves. As a type of randomized clinical trial (RCT) design construct in which multiple interventions are evaluated concurrently against a common control group allowing new interventions to be added and the control group to be updated throughout the trial, they provide a dynamic and efficient mechanism to compare and potentially discriminate new treatment candidates. Their recent use in the evaluation of new therapies for COVID-19 has spurred new interest in the approach. The paucity of platform trials is less influenced by the novelty and operational requirements as opposed to concerns regarding the sharing of intellectual property (IP) and the lack of infrastructure to operationalize the conduct in the context of IP and data sharing. We provide a mechanism how this can be accomplished through the use of a digital research environment (DRE) providing a safe and secure platform for clinical researchers, quantitative and physician scientists to analyze and develop tools (e.g., models) on sensitive data with the confidence that the data and models developed are protected. A DRE, in this context, expands on the concept of a trusted research environment (TRE) by providing remote access to data alongside tools for analysis in a securely controlled workspace, while allowing data and tools to be findable, accessible, interoperable, and reusable (FAIR), version-controlled, and dynamically grow in size or quality as a result of each treatment evaluated in the trial.
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