日本武田制药知识产权研究

目的了解武田制药知识产权战略的成功经验,为国内医药企业发展提供参考。方法运用相关回归方法分析1995年至2010年武田制药的专利产出（专利累积量）、研发投入及经济产出（年销售收入）的相关性,研究武田制药畅销药品抑那通（亮丙瑞林）、普托平（兰索拉唑）、必洛斯（坎地沙坦）和艾可拓（吡咯列酮）的专利保护情况,剖析其知识产权战略。结果研发投入对专利产出具有3年的滞后性影响,武田制药的专利产出与经济产出呈线性关系,方差分析具有显著性,提示重视研发投入,促进技术创新,是武田制药经济实力持续增长的前提;实现专利成果转化和提高专利质量是武田制药知识产权战略更高层次的追求;实施知识产权保护战略,灵活运用专利策略使武田制药的新药研发更具影响力。结论医药企业注重知识产权保护战略,尤其是专利战略的有效实施,可以起到事半功倍的效果。     

拜耳医药公司专利产出与经济效益相关性分析

目的 研究拜耳公司世界专利产出与经济产出的相关性,揭示拜耳公司知识产权战略对于企业经济效益的影响.方法 运用相关回归方法研究拜耳公司的全球专利申请数与经济产出(年销售收入/净利润)和药物研发投入的相关性,分析拜耳公司中国专利分布情况.结果 拜耳公司全球专利产出与药品相关的经济收入和药物研发投入具有相关性,方差分析极具显著性.该公司在中国申请的专利以发明专利为主,专利授权率＞50％.结论 创新是企业利润的源泉,研发投入对创新有积极的推动作用,知识产权的保护是创新最有力的保障,拜耳公司对知识产权的重视程度直接影响其药品产业的经济效益.因此,新药创制和知识产权保护是医药企业发展的核心动力.     

我国制药企业创新效率数据包络分析评价

目的:评价我国部分前百强上市制药企业的创新效率,为制药企业发展创新提供参考。方法:采用数据包络分析(DEA)方法,参考工业和信息化部2011年医药工业企业排序选取我国21家制药企业,对其创新活动的投入-产出效率进行分析。结果:中国制药企业创新活动DEA效率均值均较高,综合效率均值为0.811、技术效率均值为0.890、规模效率均值为0.894,个别企业差异显著;13家综合效率有效(θ=1.000),均处于规模报酬最佳状态。结论:我国制药企业创新效率平均水平良好,但大部分制药企业需改善资源配置,尤其是研发投入有待提高,规模报酬尚未达到理想状态。     

基于两阶段DEA模型研究我国生物制药上市企业技术创新效率

目的为促进我国生物制药企业技术创新效率的提升提供参考。方法本研究将生物制药企业技术创新过程分解成技术开发与成果转化两个子阶段,在充分考虑子阶段间关联性的前提下构建两阶段数据包络分析(DEA)模型,并基于滞后效应对我国23家生物制药上市企业2016-2020年两阶段的技术创新效率进行评价。结果与结论我国生物制药上市企业两阶段的技术创新效率皆处于较低水平,技术开发和成果转化阶段的综合效率均值仅为0.377、0.347。当前制约我国生物制药上市企业两阶段技术创新效率提升的主要因素是纯技术效率不足。在技术开发阶段,研发经费投入冗余和专利产出不足是导致生物制药上市企业DEA无效的主要原因;而在成果转化阶段,发明专利投入冗余则是造成生物制药上市企业DEA无效的主要原因。从区域视角来看,在技术开发阶段,东部地区生物制药上市企业的综合效率与纯技术效率均值分别为0.378、0.603,皆高于中西部地区生物制药上市企业;而在成果转化阶段,中西部地区生物制药上市企业的综合效率与纯技术效率均值分别为0.361与0.548,皆高于东部地区生物制药上市企业。据此,笔者建议生物制药企业要增强技术成果转化能力,积极优化科技资源配置,重视区域间合作交流,推动我国生物制药产业创新效率整体提升。     

药品研发的策略和方法

新药研究与开发是多学科、高科技、高难度、高投入、长周期、高风险、高回报的风险产业。据统计，在美国上市一种新药平均要花费5～8亿美元，耗时11～15年时间。专利药品可垄断市场，能获取最大的经济效益。在销售额世界前10位药品中，辉瑞公司就有3个：阿伐他汀、氨氯地平和赛来昔布，2002年的销售额达138亿美元，仅阿伐他汀2003年销售近90亿美元。可以说，新药研发是医药产业发展的火车头，新产品是企业的主要利润来源和发展的推动力，有利于造就企业形象和品牌，促进企业长期稳定发展。所以，国外大型制药企业都十分重视新药研发，新药研发投入占其销售额的15％～20％。     

创新抗菌药物康替唑胺临床研发与评价的思考

日益突出的细菌耐药问题使临床对创新抗菌药物存在迫切需求,然而新药的研发周期长、投入巨大、风险高,国内企业研发经验较少,研发策略及各阶段沟通交流不足,一定程度上制约了新药的研发.2021年6月,国产1类创新抗菌药物康替唑胺片在我国获批上市,本文总结了其临床研发过程和策略,借其经验讨论创新抗菌药物临床研发关注点,以期为研发...     

我国基因工程制药企业研发实力薄弱

本刊讯中国科学院自然科学史研究所安金辉通过对国家食品药品监督管理局药品认证中心、中国期刊全文数据库、国家知识产权局专利数据库的相关数据进行检索,获得了我国基因工程制药企业的研发活动产出状况重要的一手数据。从这些数据可以看出,我国基因工程制药企业论文发表数量少、发明专利申请量更少,这意味着我国基因工程制药企业总体的研发实力仍相当薄弱。据了解,这次调查针对的对象是:有基因工程药物产品通过国家食品药品监督管理局GMP认证的制药类企业,不包括基因工程诊断试剂和疫苗类产品的生产企业,而仅仅包括重组人干扰素(α-1b、…     

西安市中小型制药企业生产现状及发展方向的调查

目的 调查西安市中小型制药企业生产现状,为企业发展提供思路.方法 从2008年3月～2011年6月西安市中小型制药企业中随机抽取103家,采用自制问卷的形式对各家制药企业进行现场调查,问卷内容包括企业的基本情况构成、企业人员情况、质量管理及新药研发情况等,并对调查结果进行分析.结果 ①西安市中小型制药企业人员的组成方面,专科及以上学历占总人数＜1 0％的为39 (37.86％)家,10％～ 30％的为47 (45.63％)家;专业职称占总人数＜1 0％的为78 (75.73％)家;②对企业质量管理的追求方面,持续改进的为21 (20.39％)家,提升企业竞争能力的为23 (22.33％)家;③企业研发新产品新技术方面,有新技术需求的为81(7 8.64％)家,有自己研发机构的为9 0(87.38％)家,可以创新研发新药的为36(34.95％)家.结论 西安市中小型制药企业在人才结构上存在严重缺陷,企业的质量管理观念较差,企业研发新产品新技术明显不足.合理的人才梯队、具有自主知识产权的新药和严格的生产质量监控可以使中小型制药企业产品创新、技术创新、管理创新,走“专、精、特、新”的特色发展道路.     

国内医药科研成果为何走不出实验室

产业链的中空地带 医药成果转化被称为是“具有中国特色”的,只有中国才会遇到这个难题,原因很简单:跨国公司一般每年投入研发新药的费用要占其营业收入的12％-14％,甚至更高。而中国6000多家医药生产企业用于新产品开发的投入约为销售收入的1％,仅相当于国外一家中小型制药公司的研发经费。在国外,科     

从头孢地尼专利案透析国外仿制药公司研发争霸战

[编者按] 当今国际新药研发日趋艰难,世界上诸多大型仿制药公司对上市专利药品的后续研发丝毫不逊于原研制药公司,专利产品侵权的官司使专利药原研公司和仿制药公司之间的争霸越演越烈.对头孢地尼这样有代表性的专利诉讼案例进行详细的解读,也许能够给我国制药企业带来些许启示.     

酒石酸美托洛尔片仿制与原研的溶出度比较

目的：对酒石酸美托洛尔片国产仿制药与原研药进行体外溶出度比较,为质量一致性评价提供依据。方法参照中国药典2010版二部酒石酸美托洛尔片的质量标准,选取50mg规格样品,采用4种不同的溶出介质对国内8家企业生产的仿制药和原研药进行体外溶出行为考察,并采用差异因子f1法、相似因子f2法和直接比较法来评价仿制药与原研药溶出行为的一致性。结果8家仿制药溶出行为参差不齐,按直接比较法只有1家仿制药在四种溶出介质中的溶出曲线均与原研药一致,只在两种或一种溶出介质中的溶出曲线与原研药一致的情况较多。结论国内企业生产的酒石酸美托洛尔片仿制药与原研药存在体外溶出行为不一致性,处方、制剂工艺、辅料的选用方面需要进一步研究,以达到仿制药与原研药体外溶出行为一致性和质量一致性。同时,要结合生物等效性试验,对该品种的国产仿制药和原研药的一致性作出综合的评价。     

Patent indicators: a window to pharmaceutical market success

Pharmaceutical success in the market is the best reward for pharmaceutical investors undergoing the lengthy, costly and risky process of pharmaceutical Research and Development (R&D). Drugs with high market revenues trigger fierce competition between pharmaceutical enterprises, as is demonstrated by the increasing Mergers & Acquisitions (M&A) cases focusing on seizing the best-selling products. On the other hand, patents, as the best shield for innovative drugs against generic drugs, become a powerful weapon for pharmaceutical enterprises to win the substantial returns generated by market exclusivity. Patents seem to be directly responsible for the commercial success of new medicines. In this context, it is of great significance to find out the empirical associations between pharmaceutical commercial success and patents. By comprehensively analysing 127 drugs marketed in the USA and their 621 American patents, this article identifies the evidence to link various patent indicators with pharmaceutical sales in actual market.     

简析化学药品注册分类改革对药品研发的影响

国家食品药品监督管理总局于2016年调整了化学药品注册分类。分析化学药品新旧注册分类中的新药、仿制药概念、内涵以及技术标准的变化。与2007年版法规相比,新法规对新药和仿制药的定义均发生了明显变化,新药的范围缩小,要求更为严格和准确,仿制药的适用范围扩大,在技术标准方面达到国际要求。药品注册制度改革对医药研发产生了深远影响：促使国内医药市场重新洗牌,鼓励企业加大研发和创新力度,加快进入国际市场的步伐。     

Research and development in drug innovation: reflections from the 2013 bioeconomy conference in China,lessons learned and future perspectives

The enormous progress biotechnology, bioinformatics and nanotechnology made in recent years provides opportunities and scientific framework for development of biomedicine and constitutes a paradigm shift in pharmaceutical R&D and drug innovation. By analyzing the data and related information at R&D level over the past decades, developmental tendency and R&D patterns were summarized. We found that a growing number of biologics in the pipeline of pharma companies with successful products already in the market though, small molecular entities have primarily dominated drug innovation. Additionally, small/medium size companies will continue to play a key role in the development of small molecule drugs and biologics in a multi-channel integrated process. More importantly, modern and effective R&D strategies in biomedicine development to predict and evaluate efficacy and/or safety of 21st century therapeutics are urgently needed. To face new challenges, developmental strategies were proposed, in terms of molecular targeted medicine, generic drugs, new drug delivery system and protein-based drugs. Under the current circumstances, interdisciplinary cooperation mode and policy related to drug innovation in China were deeply discussed as well.KEY WORDS: Bioeconomy, Biomedicine, Drug development, Innovation, Research and development, Strategy and models     

An update on anti-allergic patents granted in China: 2009 - 2011

INTRODUCTION: The prevalence of allergic diseases has increased dramatically in recent decades. Therefore, there is a pressing need for the development of effective anti-allergic services worldwide. AREAS COVERED: In previous studies, the authors had analyzed a total of 789 anti-allergic patents granted in China from 1988 to 2008. Herein, they report a further 151 anti-allergic patents issued in China during 2009 - 2011. The current analysis covers the scientific progress in supporting anti-allergic patent applications and granted patent literature, in China, for the last 3 years. EXPERT OPINION: The 151 anti-allergic patents granted from 2009 to 2011 mainly focus on seven types of products. They are: traditional Chinese medicines (TCM), plant extracts, biological products, synthetic compounds, pharmaceutical preparations, medical apparatus and new treatment modalities. Although the overall number of anti-allergic patent applications made between 2009 and 2011 in China is less than that of the USA and Europe, patents on TCM have increased. This suggests that there are demands for modernization of TCMs. Recently, studies of interesting new immunomodulators have also been conducted, and some of these are likely to represent clinically useful advances. In the last 3 years, several patents on these novel potential drugs have also been granted in China. The large number of anti-allergic patents issued in China, in recent times, suggests that the Chinese market is relatively competitive one that will help pharmaceutical companies make proper decisions for their research and development strategies.     

An update on anti-allergic patents granted in China: 2009 – 2011

Introduction: The prevalence of allergic diseases has increased dramatically in recent decades. Therefore, there is a pressing need for the development of effective anti-allergic services worldwide.

Areas covered: In previous studies, the authors had analyzed a total of 789 anti-allergic patents granted in China from 1988 to 2008. Herein, they report a further 151 anti-allergic patents issued in China during 2009 – 2011. The current analysis covers the scientific progress in supporting anti-allergic patent applications and granted patent literature, in China, for the last 3 years.

Expert opinion: The 151 anti-allergic patents granted from 2009 to 2011 mainly focus on seven types of products. They are: traditional Chinese medicines (TCM), plant extracts, biological products, synthetic compounds, pharmaceutical preparations, medical apparatus and new treatment modalities. Although the overall number of anti-allergic patent applications made between 2009 and 2011 in China is less than that of the USA and Europe, patents on TCM have increased. This suggests that there are demands for modernization of TCMs. Recently, studies of interesting new immunomodulators have also been conducted, and some of these are likely to represent clinically useful advances. In the last 3 years, several patents on these novel potential drugs have also been granted in China. The large number of anti-allergic patents issued in China, in recent times, suggests that the Chinese market is relatively competitive one that will help pharmaceutical companies make proper decisions for their research and development strategies.     

仿制药替代潜在最大费用节省研究

目的在仿制药替代背景下,比较原研药和仿制药的价格和采购量,测算仿制药替代的潜在最大费用节省,推动仿制药供应与使用。方法基于陕西省药品招标采购数据,选取2017年12月第一批通过仿制药质量和疗效一致性评价的17个品种(16个品规)药品,对其2017年至2018年的价格、采购量进行分析;采用成本分析法、推测预算法,对采购平台上该通用名、剂型的药品替换为通过仿制药质量和疗效一致性评价单价最低的仿制药,测算年均仿制药替代的潜在最大费用节省。结果价格由高到低依次为原研药、未通过一致性评价的仿制药、通过一致性评价的仿制药;采购量方面,5个品规药品的原研药采购量占比较高,11个品规药品的仿制药采购量占比较高,1个品规药品未发生仿制药替代;对16个品规药品进行仿制药替代后,测算出潜在最大费用节省为3243.63万元。结论仿制药替代可显著节省药品费用,我国的仿制药市场提升空间较大,后续应加快推进仿制药一致性评价和临床使用。     

Secondary patents in the pharmaceutical industry: missing the wood for the trees?

Introduction: The critics of the Innovator pharmaceutical industry allege that secondary patents are trivial modifications over the primary patent, which extend its term and delay the entry of the generics in the market place. The protagonists regard secondary patents a result of continuous research and development (R&D), which help them introduce and protect new, differentiated products.

Areas covered: The areas covered are Product life cycle management (PLCM), Drug approval process, Orange book (OB) listed patents, US patent data.

Expert opinion: Our analysis of the patents and products of four innovators viz., AstraZeneca, Takeda, Eisai and Wyeth in the field of proton pump inhibitors (PPI’s) and Merck and Pfizer in the field of Statins shows that secondary patents help innovators sustain competition against other innovators in the specific product segment. The number of secondary patents listed in OB per NCE depends on the innovators interest in exploiting the NCE, the success of R & D effort and product lifecycle management strategy in the wake of market competition. Market entry decisions of innovators are strategic rather than a mere fallout of the secondary patents granted. Entry of another innovator is more unpredictable and hurts the first entrant more vis a vis the entry of generics who can enter the market when the patents protecting a product are no more enforceable, and hence more predictable. Generic entry in the field of PPI’s shows that the term of the primary patent is not extended by the secondary patents.     

Analysis of pharma R&D productivity – a new perspective needed

R&D productivity continues to be the industry’s grand challenge. We analyzed the R&D input, output, and outcome of 16 leading research-based pharmaceutical companies over 20 years (2001–2020). Our analysis shows that pharma companies increased their R&D spending at a compound annual growth rate of 6% (2001–2020) to an average R&D expenditure per company of $6.7 billion (2020). The companies in our investigation launched 251 new drugs representing 46% of all CDER–related FDA approvals in the past 20 years. The average R&D efficiency of big pharma was $6.16 billion total R&D expenditures per new drug. Almost half of the leading companies needed to compensate for their negative R&D productivity through mergers and acquisitions.