药品专利链接制度建构的中国方案：理论、原则与路径

药品专利链接制度作为专利纠纷的早期解决机制，解决了药品上市行政许可与专利权保护的衔接机制问题,该制度的创设遵循我国私有财产不受侵犯的宪法原则。制度构建应以法益衡平理念为基本指导原则，结合我国药品监管体系、医药产业政策和专利行政、司法保护运行机制设计相关内容，该制度构建涉及行政权、财产权、健康权之间的冲突与协调问题。我国具体制度设计应遵循生命健康权优先保护、合理保护、效率与公平兼顾协调3个原则，重点调和不同利益主体之间的紧张关系。除科学设置药品上市目录集、专利声明、暂缓审批期、首仿药市场独占期外，还应注重药品专利链接制度与药品试验例外、专利诉讼、专利行政处理、强制许可等制度的协调与衔接。     

对维吾尔民族医药知识产权保护的思考

维吾尔医药是维吾尔族人民留给人类的伟大的物质财富，已形成了具有维吾尔特色的医学理论体系。发展维吾尔医药产业，对于新疆经济的发展具有深远的影响。然而，相比较其他民族医药产业，新疆雏药的发展却相对落后，究其原因，缺乏重视知识产权保护是主要原因之一。因此，运用专利、商标等知识产权法律制度加强对维药的法律保护具有重要意义。     

医药产业科技政策评估初探

医药科技产业政策的制定和实施对于指导医药产业的重大技术经济活动、推动产业结构调整与升级具有极其重要的作用,而医药科技产业政策的评估,作为检验医药科技产业政策的实施效果的一个反馈,对医药产业的发展同样有着重要的意义。本文对医药产业科技政策的评估作了初步研究,建立了医药产业科技政策评价的指标体系,并借鉴计量经济的相关知识建立综合评估方法,希望对进一步研究医药产业的科技政策管理体系有所帮助。     

基于创新系统理论的江苏省医药产业升级路径研究

江苏省是我国医药产业发展的重点大省,医药制造业在全省工业经济中占有重要地位。但当前仍存在很多因素制约着江苏省医药产业对经济增长的贡献率。本文运用产业创新理论分析评价我省医药产业发展现状,从打造江苏医药产业成为主导产业的视角出发,对当前政府、医药企业、高校研发机构等产业创新元素进行分析,并针对现存问题提出构建医药产业创新系统的方法及相应策略,以促使江苏省医药产业提升竞争力,实现产业主导化升级。     

虚拟化与中国医药产业研究开发策略

结合药品研究与开发的特点及中国医药产业研究开发的现状,提出在药品研究开发领域进行各医药组织的虚拟组合,组建虚拟公司,充分利用医药产业相对分散的研发资源,联合进行医药研究与开发的策略.     

浅论药品专利与公共健康的国际冲突及其解决

文章探讨了药品专利保护与公共健康这一国际学术前沿课题,主要着眼于TRIPS协议下授予医药专利保护和发展中国家以可接受价格获取相关救命药物之间的冲突这个角度来分析这一热点问题.文章分析了药品专利对发展中国家药品取得所产生的影响、TRIPS协定与公共健康的关系以及实施TRIPS协定后提高我国药品可及性方式、如何解决我国公共健康与药品专利保护之间的冲突等几个相关方的问题.     

山西省医药产业的全要素生产率研究

文章通过对1990年—2011年山西医药产业相应统计数据的回归分析,计算了山西医药产业的全要素生产率、全要素生产率的增长率及其对山西医药产业工业增加值的贡献率。分析发现,山西医药产业的TFP是在波动过程中增长的;整体来看,山西医药产业TFP增长率对工业增加值的贡献率为16.5%。但细分阶段分析,山西医药产业TFP增长率对工业增加值的贡献率是不断下降的。     

浅论药品专利与公共健康的国际冲突及其解决

文章探讨了药品专利保护与公共健康这一国际学术前沿课题,主要着眼于TRIPS协议下授予医药专利保护和发展中国家以可接受价格获取相关救命药物之间的冲突这个角度来分析这一热点问题。文章分析了药品专利对发展中国家药品取得所产生的影响、TRIPS协定与公共健康的关系以及实施TRIPS协定后提高我国药品可及性方式、如何解决我国公共健康与药品专利保护之间的冲突等几个相关方面的问题。     

虚拟化与中国药产业研究开发策略

结合药品研究开发的特点及中国医药产业研究一切的现状，提出了在药品研究一发领域进行各医药组织的虚拟组合，组建虚拟公司，充分利用医药产业相对分散的研究开 资源，联合进行医药研究与开发的策略。     

入世后我国医药企业发展对策研究

本文在分析中国当前新的市场环境对医药产业的影响 ,以及医药市场与医药产业的发展趋势的基础上提出了医药企业在新环境下的发展思路和具体措施 ,即实施并购重组、推行技术创新、完善营销渠道、推进药品电子商务。     

The impact of patent protection on US pharmaceutical exports to developing countries

This article provides evidence that patent protection can have a positive effect on trade, by analysing the impact of the implementation of intellectual property rights (IPR) in developing countries on the US exports of pharmaceutical products, following intense lobbying efforts from the US pharmaceutical industry to have the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement included in the creation of the World Trade Organization (WTO). A gravity model using panel data from 1995 to 2010 suggests that the implementation of minimum standards of patent protection has increased US exports of pharmaceuticals to 108 nonadvanced countries.     

The Impact of Patents on Innovation,Technology Transfer and Health: A Pre- and Post-TRIPs Analysis of India's Pharmaceutical Industry

The debate surrounding the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement indicates that patents matter for development. Yet literature on the geography of knowledge transfer shows that knowledge is spatially sticky, suggesting that the impact of patents can be exaggerated. Using interview evidence, this paper explores how Indian pharmaceutical firms have responded to changes in patent law, including the introduction of more extensive patent protection in 2005 as a condition of TRIPs. A regime of limited patent protection for over three decades prior to TRIPs facilitated informal knowledge transfer and the emergence of a pharmaceutical industry with significant domestic capabilities. Contrary to some expectations, the Indian pharmaceutical industry has continued to grow post-TRIPs, with large domestic firms becoming involved in more formal technology transfer as part of an increasingly collaborative relationship with multinationals. This trend is also driven by a focus on the markets of developed countries, raising questions for the future sustainability of India's low-priced medicines. While changes in patent law can facilitate or inhibit a variety of aspects of development, the adaptation of the Indian pharmaceutical industry suggests that their impact must be related to the broader institutional setting, particularly the underlying domestic capabilities.     

SPECIAL INTEREST POLITICS AND INTELLECTUAL PROPERTY RIGHTS: AN ECONOMIC ANALYSIS OF STRENGTHENING PATENT PROTECTION IN THE PHARMACEUTICAL INDUSTRY

Since the 1980s, the pharmaceutical industry has benefited substantially from a series of policy changes that have strengthened the patent protection for brand-name drugs as a result of the industry's political influence. This paper incorporates special interest politics into a quality-ladder model to analyze the policy-makers' tradeoff between the socially optimal patent length and campaign contributions. The welfare analysis suggests that the presence of a pharmaceutical lobby distorting patent protection is socially undesirable in a closed-economy setting but may improve social welfare in a multi-country setting, which features an additional efficiency tradeoff between monopolistic distortion and international free riding on innovations.     

Explaining the Generation and Performance of Intersector Technology Cooperation: A Survey of the Literature

Pharmaceutical companies are facing several major interrelated challenges, the most strategic being the decline in R&;D productivity resulting in empty product pipelines to replace products nearing patent expiry. A common response has been mergers and acquisition of competitors and biotechnology firms, but rather than resolving the problems, this has created new ones. While biotechnology promises to reshape the pharmaceutical industry, it too faces challenges: the industry as a whole is unprofitable and there is uncertainty regarding market acceptance of its products. This paper examines the current issues in the two industries, and describes a scenario process resulting in the development of a set of scenarios depicting four possible future paths along which the pharmaceutical industry may develop over the next 15 years.     

The relationship between a firm's patent quality and its market value — The case of US pharmaceutical industry

This study examined the relationships between corporate market value and four patent quality indicators - relative patent position (RPP), revealed technology advantage (RTA), Herfindahl-Hirschman Index of patents (HHI of patents), and patent citations - in the US pharmaceutical industry. The results showed that RPP and patent citations were positively associated with corporate market value, but HHI of patents was negatively associated with it, while RTA was not significantly related to it. Thus, if pharmaceutical companies want to enhance their market value, they should increase their leading positions in their most important technological fields, cultivate more diversity of technological capabilities, and raise innovative value of their patents. In addition, this study found that market value of pharmaceutical companies with high patent counts was higher than that of pharmaceutical companies with low patent counts, and suggested that pharmaceutical companies with low patent counts should increase RPP in their most technological fields, decrease HHI of patents, or raise patent citations to further enhance their market value. Furthermore, this study developed a classification for the pharmaceutical companies to divide them into four types, and provided some suggestions to them.     

Biases in patent examination and firms’ responses: Evidence from the pharmaceutical industry

Empirical analysis of matched patent application data in the world’s major patent offices has shown considerable variation in patent granting probability and examination duration across different countries. This phenomenon is attributed to institutional misclassifications or patent examiners’ mistakes by some authors. Others argued that cross-country heterogeneity could also be caused by deliberate manipulation of patent examination procedures with the goal to foster native inventors through suppressing foreign patent applicants. To explore whether manipulation exists, this study presents a case study of pharmaceutical patents granted by the US patent office and approved by the US FDA. Especially it focuses on the filing behavior of pharmaceutical companies in Korea, Japan and China. The regression results show that the granting ratio of the previous applications of a foreign company is correlated with the company’s probability of lodging a new patent application, which provides a supplementary evidence of the existence of the manipulated patent examination procedures.     

Breaking the Fence: Can Patent Rights Deter Biomedical Innovation in 'Technology Followers'?

The impact of patent protection on biomedical innovation has been a controversial issue. Although a 'medical anti-commons' has been predicted as a result of a proliferation of patents on upstream technologies, evidence to test these concerns is only now emerging. However, most industrial surveys that shed light on this issue are mainly from developed countries, making it very difficult to predict the impact of patenting on biomedical innovation in developing and least developed countries. This paper develops a framework of analysis for the impact of patent rights on biomedical innovation in 'technology follower' developing countries. Based on the framework developed in the paper, empirical data collected in an industry-level survey of the Indian pharmaceutical industry between November 2004 and January 2005 is used to analyze the impact of patent rights as recognized under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) on biomedical innovation in technology followers.     

From Imitation to Innovation: The Evolution of R&D Capabilities and Learning Processes in the Indian Pharmaceutical Industry

Since the mid 1990s the Indian pharmaceutical industry has emerged as a leading supplier of generic drugs to both developing and developed countries.The movement of the Indian pharmaceutical industry along the R&D value chain represents a remarkable shift from an importer to an innovator of drugs. The Indian government's industrial and technology policies along with changes in regulation of intellectual property rights played a crucial role in shaping this development of R&D capability. Using the 'capability creation model' this paper discusses the learning processes and stages involved in this dramatic accumulation of technological capability. This analysis shows that the Indian pharmaceutical industry has followed a trajectory from duplicative imitation to creative imitation to move up the value chain of pharmaceutical R&D. Finally as a result of changes in patent law the industry is learning to develop capabilities in innovative R&D. The basic and intermediate technological capabilities gained from imitative learning gave these firms a solid base for development of competence in advanced innovative R&D. These findings have implications for government policies as well as firm strategies in other developing countries albeit with some limitations due to global harmonisation of patent laws being promoted by the World Trade Organization.     

创新网络生成因素的重要性识别研究——以上海医药产业为例

本文以上海医药产业为研究对象,基于随机森林模型检验了诸多因素对于创新网络生成和拓扑的影响,并且对这些生成因素的重要性进行了识别研究。研究发现:(1)创新网络个体属性为大学或者科研机构对于网络生成的影响最为重要,表明公共研发机构的知识外溢是网络生成重要动力;(2)创新网络个体的节点度有助于进一步的创新合作,证明了"合作的竞争"机制是网络生成的重要驱动力;(3)社交网络与专利维权能力影响次之,表明网络链接的外生交易成本和内生交易成本对医药产业创新网络生成有重要影响;(4)企业自身的技术创新能力、知识的互补性与知识的多样性对于网络的生成帮助并不大,表明现阶段上海医药产业内企业之间创新合作的意向性并不强,同时发现了大企业创新合作中存在着"越强越狭隘"的现象。