药品专利保护的博弈分析——从"公地悲剧"到"反公地悲剧"

在医药技术、医药经济和公共健康问题倍受关注的今天,如何对药品专利进行保护,已成为国内外关注的焦点.本文从博弈论的"公地悲剧"和"反公地悲剧"理论出发,结合国内外药品专利保护的实例进行对比分析,指出药品专利保护制度的"双刃剑"性质,并结合实际提出了寻求博弈均衡的对策建议.     

基于“先进合同研究组织”的生物医药产业创新模式探讨

目的:探索我国的生物医药产业创新模式。方法:分析我国生物医药产业的核心——新药研发中存在的研发基地建设薄弱、资金不足、成果转化难三大问题,基于"合同研究组织(CRO)"建立产业创新模式。结果:提出由"多并发CRO"的研发模式、风险投资与专利/新药证书对接的融资形式以及新药证书为导向的研发过程管理组成的产业创新模式,并整合为"先进合同研究组织(CRO+)"。结论:该模式是一种开放性集成服务体系,有利于缩短生物医药研发周期,降低研发成本与研发风险,促进我国生物医药产业发展。     

我国生物医药发展模式研究

目的:探索我国生物医药的发展模式,供高校、科研机构、企业和政府部门参考。方法:分析我国生物医药研发和生物医药产业化存在的问题,提出适合我国生物医药发展的各种模式。结果与结论:我国可以运用生物医药的人才储备模式、产学研合作模式、研发模式、阶梯式开发模式、市场营销模式、现代企业运营模式、产业集群模式及国际间合作模式等,有效地促进我国生物医药的发展。     

国内外生物医药产业发展分析及启示

常州生物医药产业基础雄厚,尤其在化学药、医疗器械等领域具有独特优势,但在产业转型升级过程中仍面临许多问题,与此同时因这些问题在国内生物医药产业具有典型性,对以其为代表进行的研究不仅有助于定位常州生物医药产业发展模式及创新路径,对其他地区发展生物医药产业也具有一定的借鉴意义。通过系统地检索生物医药产业发展文献以及深入地调研常州市生物医药产业,分析当今世界生物医药产业发展趋势以及国内生物医药产业发展现状,文章立足于常州实际、依托常州特色,提出综合运用生物医药的产业集群化、资源整合一体化、人才培养与引进模式多样化、风险投资规模化等多种应对策略,供政府部门、高校、科研机构、企业尤其是政府部门制定产业决策参考。     

生物医药产业将迎来更大发展空间

<正>生物医药产业由生物技术产业与医药产业共同组成。作为现代医药产业的两大支柱之一,生物医药方兴未艾,开发潜力不可限量。生物医药"十二五"规划出台,必将在生物医药行业的产业发展方向、产业结构调整、产业化水平整体提升、产业发展速度加快起到积极的指导作用。对我国医药行业和产业的总体发展具有指导意义。全国人大常委会副委员长桑国卫这样描绘"十二五"重大新药创制的总体目标:"新药更多、大药更大、平台国际化、突破关键技术、培育大型企业。"     

基于生物医药专利的浙江省与4个直辖市对比分析

以生物医药专利数据统计为基础,对浙江省专利申请量、专利类型构成、专利申请人构成、专利IPC分类号分布等方面进行分析,并和北京市、上海市、天津市、重庆市生物医药专利对比分析,再对结果分析解释,以明确浙江省生物医药专利地位。结果表明,浙江省和四个直辖市专利申请量逐年上升,发明专利、企业占主体地位,专利集中在A61、C07、C12分类号。浙江省需进一步发挥区位优势,加强政府引导、产学研合作,促进生物医药领域创新发展。     

从当今中国生物医药产业集群化看CRO的发展

本文通过研究合同研究组织（CRO）在我国的发展现状及国外的实践经验,以及当今生物医药产业密集区的发展,分析生物医药产业对国内CRO企业的影响并探索CRO的＂中国式＂发展模式。发现我国生物产业的发展保持了较快增长势头,同时可采取拓展服务内容、发展产业集群、加强国际合作等方法,进一步推动其在新形势下的新模式的发展。     

药品特许权投资模式研究及其在中国的可行性分析

生物医药创新转化需要由学术研究机构、生物科技公司和大型制药企业分工协作共同推进,这三者间通过技术和专利授权进行利益分配,进而产生药品特许权费用。特许权投资就是在此基础上发展起来的投资模式,该模式能让科研机构和生物制药公司将其专利尽快货币化,从而创造更大的财务灵活性,同时让投资者有机会以较低的风险参与生命科学行业。以美国最大的药品特许权投资公司Royalty Pharma为例,通过对其发展历程、团队、投资组合与投资流程等的研究,结合中国生物医药行业发展情况,分析在中国实施药品特许权投资的可行性。     

基于空间计量的生物医药产业集聚影响因素研究

目的:探究我国生物医药产业集聚的空间影响因素,并提出发展我国生物医药产业集聚的建设性建议。方法:基于新经济地理学和空间计量经济学理论,建立生物医药产业集聚影响因素的空间计量模型,全面分析空间各因素对我国生物医药产业集聚的作用。结果与结论:我国生物医药产业存在较明显的空间集聚性和空间正相关性。空间计量模型表明,生物医药产业企业数、从业人员数、城镇居民人均医疗保健支出、科技经费中政府资金比例及金融机构贷款额每提高1%,生物医药产业集聚水平相应地提高0.897%、6.617%、2.36%、2.48%和6.44%,表明产业差异、人力资本水平、市场消费需求、政府支持程度和金融发展水平对其集聚程度影响显著。因此,应当加强政府科学引导,充分利用人力资源,并构建各医药产业集聚区的联动机制。     

长沙国家生物产业基地发展概况及其知识产权保护现状研究

目的:为长沙国家生物产业基地的进一步发展提供参考。方法:分析10年来长沙国家生物产业基地发展所取得的成果以及专利申请情况,并与国内发展较快的几个生物医药园进行比较。结果:长沙国家生物产业基地经过多年的发展已成为全国生物医药园的四强之一,形成了8大产业特色群;但园内医药企业规模大多数为中小型,在知识产权保护方面的人力、物力、财力等实质性投入不足,相比其他几大生物医药园专利数量与质量亟待提高,专利成果转化能力较弱,企业未形成合力。结论:企业加强自主创新能力,提升知识产权保护力度;政府给予政策支持,是长沙国家生物产业基地内医药企业实现跨越式发展的重要途径。     

医药生物产业专利战略研究

目的 研究当前我国医药生物产业专利现状,以期发现需要提升的方面.方法 采用文献研究法.结果与结论 该领域需要从4个方面深入实施知识产权战略：重视收集专利情报,加强分析,建立专利预警体系;加大研发力度,努力创造重量级的核心专利,提升严密的专利布局;充分挖掘已有专利技术,积极申请外围专利;避免野生种质资源流失,争夺世界级的话语权.     

The carbon nanotube patent landscape in nanomedicine: an Expert opinion

Carbon nanotubes (CNTs) have extraordinary properties that make them promising candidates for a wide variety of potential biomedical applications, including new therapeutics, drug delivery systems and diagnostics. Because of their enormous commercial potential across industries, a classic patent landgrab is underway as competitors are busy locking up broad patents on CNTs. This is creating a chaotic, tangled patent thicket, where the validity and enforceability of numerous patents is unclear. In this article, the authors summarize the CNT patent landscape for nanomedicine, identifying key building block patents while raising legal questions regarding their validity.     

RNA interference as an anticancer therapy: a patent perspective

Background: The development of RNA interference (RNAi)-based gene silencing approaches has revolutionized biomedical research. These technologies have been applied for functional genomic studies in a variety of areas, including cancer research, by facilitating a better understanding of the mechanisms that underlie tumorigenicity and the identification of novel factors that either promote or inhibit oncogenic transformation. Objective: These approaches have laid the groundwork for the development of a novel class of genetic therapies. Preclinical results have exposed both the unique therapeutic opportunities and challenges that are encountered in adapting these technologies for clinical applications. These themes are reflected in the patent literature that has mirrored the rise in complexity and sophistication of RNAi-based therapeutic approaches. This review focuses on the identification of potential anticancer therapeutic targets and the development of clinically relevant delivery approaches. Conclusions: Thus far, the patent landscape in the RNAi field has been dominated by a handful of key patents that describe the original identification and characterization of inhibitory double-stranded RNA molecules. Only time will tell how these original patents will hold up in the face of the development of new approaches and reagents as RNAi-based therapeutics approach transition from the bench to the clinic.     

LAG-3 antagonists by cancer treatment: a patent review

Introduction: LAG-3 is checkpoint inhibitor in cancer that coordinates the downregulation of the proliferation of antigen-specific lymphocytes. There is a great need to discover and develop new therapies focused on inhibiting the action of LAG-3 and consequently improving the immune response in the various types of cancer.

Areas covered: The patent literature reveals novel therapies, which provide information on cancer therapies. The authors used the patent databases of the six main patent offices of the world: United States Patent and Trademark Office, European Patent Office, World Intellectual Property Organization, Japan Patent Office, State Intellectual Property Office of China and Korean Intellectual Property Office, to generate a detailed landscape of patents and patent applications of active companies related to LAG-3 inhibitors. Specific patents have been grouped into innovative patents and adopting patents.

Expert opinion: There is a continuing development of LAG-3 inhibitors, and these inhibitors are being used in combination with other cancer treatment schemes, for example, antibodies against PD-1, PD-L1, and CTLA-4. Immutep and IO Therapeutics were the leaders in generating innovator patents, followed by Gustave Roussy Institute, and Applied Research Systems ARS. Dana-Farber Cancer Institute was the leader in the generation of adopter patents, followed by Novartis .     

Tips for reading patents: a concise introduction for scientists

Many commercial and academic institutions protect their commercially valuable research information using patents, making the patent literature a rich and early source of cutting-edge research. While scientists and students often create the data that finds its way into patents, some rarely read the patent literature. Here, we provide an informal and brief collection of hints and tips that may assist scientists and students who do not regularly read the patent literature to locate the key scientific findings that are disclosed by patentees. These tips will introduce the reader to: (i) the general structure of patents and the sections of the patents that scientists and students may find particularly helpful; and (ii) a few factors to keep in mind when using data disclosed in the patent literature, such as patent lifespans, jurisdictions and the patent review processes. Although this is not a comprehensive and complete guide to reading patents, the accessible nature of this informal introduction to patent reading should assist scientists and students to make more effective use of the cutting-edge research disclosed in patent specifications.     

药品注册审批工作中专利相关问题探讨

目的:探讨如何正确处理药品注册审批工作中的专利相关问题。方法:分析我国药品注册审批工作中专利相关规定及其存在的问题,并参照美国、欧盟的相关规定进行比较与分析。结果与结论:药品注册审批与专利权保护是相对独立的法律关系,分别适用药品管理法和专利法;药品注册审批与专利侵权之间没有必然联系;专利纠纷应当按照专利法的相关规定解决,药品注册审批工作不应当涉及药品专利纠纷的解决。     

The challenges of joint performance to method patents

Introduction: Biotech patents are facing increasingly stern challenges. The patent statue holds that a multi-step method patent is not directly infringed unless all steps are carried out and attributed to a single entity. When separate steps are performed jointly by two or more parties, those parties are liable for divided infringement if there exists a direct infringement. Possibilities thus exist for unauthorized but non-infringing joint performance, i.e. enforcing a method patent will be difficult if joint performance stands as a valid defense against direct infringement.

Areas covered: This analysis covers issues on patent infringement, specifically on divided infringement of diagnostic and method patents.

Expert opinion: A retrospective analysis indicates that a large number of cancer diagnostic patents issued during 2005-2014 are potentially vulnerable to read on unauthorized use in the manner of joint performance. Inventors should draft patent claims appropriately to reduce the risk to assert their patents in this regard.     

专利视角下我国医药中间体应用技术发展态势研究

目的:协助企业了解医药中间体行业相关的技术点和发展趋势,为医药中间体应用技术提供新的发展思路和技术支持.方法:将医药中间体涉及的核心技术列为研究对象并分为四级,检索国家知识产权局专利检索系统(SIPO)及合享(INCOPAT)、智慧芽(PatSnap)专利数据库中2020年2月2日之前公开/公告的医药中间体专利数据.运...     

Analysis of anti-asthmatic drug patents published in China between 2004 and 2013

Introduction: We previously reported that 789 anti-allergic patents were granted in China between 1988 and 2008, but the number of patents seems to have grown much faster in China in recent years. Therefore, it is necessary to analyse the patents for anti-asthmatic products between 2004 and 2013 to give pharmaceutical companies and individuals a better understanding of potential candidates for anti-asthmatic drug development from patents published in China.

Areas covered: The current report analyses the scientific progress that supports anti-asthmatic drug patent applications and reviews the published patent literature in China from 2004 to 2013.

Expert opinion: The rapid increase in the number of anti-asthmatic patents in China indicates that more specific discoveries have been made and that more people are aware of the importance of intellectual property protection in China. Holding patents may guarantee protection for an innovative new product.