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.     

药品专利保护对医药产业发展贡献度的实证分析

在医药技术、医药经济和医药产业倍受关注的今天,药品专利保护所具有的激励研发创新、提升科技竞争力、促进信息技术公开的基本功能,已经成为医药产业实现跨越式发展的有力保障。实证分析药品专利保护对医药产业发展的贡献度可知,按照1995-2007年我国医药行业工业增加值的平均增长率计算,药品专利制度的贡献率为29.2%,资本的贡献率为13.0%,科技活动人员的贡献率为57.8%。     

Sources of technological innovation: Radical and incremental innovation problem-driven to support competitive advantage of firms

A fundamental problem in the field of management of technology is how firms develop radical and incremental innovations that sustain the competitive advantage in markets. Current frameworks provide some explanations but the general sources of major and minor technological breakthroughs are hardly known. The study here confronts this problem by developing a conceptual framework of problem-driven innovation. The inductive study of the pharmaceutical industry (focusing on ground-breaking drugs for lung cancer treatment) seems to show that the co-evolution of consequential problems and their solutions induce the emergence and development of radical innovations. In fact, firms have a strong incentive to find innovative solutions to unsolved problems in order to achieve the prospect of a (temporary) profit monopoly and competitive advantage in markets characterised by technological dynamisms. The theoretical framework of this study can be generalised to explain one of the sources of innovation that supports technological and industrial change in a Schumpeterian world of innovation-based competition.     

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.     

The effects of patent-law changes on innovation: The case of India's pharmaceutical industry

Recent patent-law changes in India's pharmaceutical industry provide opportunities to study changes of institutional and regulatory environments on innovation and social welfare in low-income markets. From 1972 to 2004 under its process-patent regime, India's pharmaceutical industry grew to become the world's fourth largest. Indian companies were becoming globally competitive in generics and clinical testing, and moving into product R&D. Researchers have debated the effects of India's new product-patent laws' effects on these trends. The authors cover the domestic characteristics and global competitiveness of India's pharmaceutical industry. They contrast data (from 2001 to 2004) on patents in India's process-patent regime with preliminary data (from 2005 to 2008) on patents in the country's new product-patent regime. They argue that Indian pharmaceutical companies have changed their decision-making in response to changed patent laws by moving from process to product research. However, the preliminary results indicate that these changes may have hurt domestic innovation. They conclude with strategic implications for the Indian pharmaceutical industry and highlight the need for research and public policy to establish optimal social returns from product-patent regimes.     

The international diffusion of biotechnology: the arrival of developing countries

According to conventional economic theory, countries tend to converge in economic and technological terms towards the leader. More recently, empirical approaches by economic historians (Abramovitz, Landes, Madison, Reinert) have found that while some countries are catching up, others are falling increasingly behind. Several theories compete to explain the precise mechanisms that explain how technological diffusion takes place. The paper reviews them and draws testable hypotheses for the study of international biotechnology diffusion. Biotechnologies are one of the leading sets of technologies developed in the late 20th century. They encompass applications in agriculture, chemicals, environment and pharmaceuticals. The United States has led the way in both scientific and industrial development of biotechnologies and these have quickly spread to Canada, Japan and Western Europe. Are the main developing countries adopting biotechnology? A study of the adoption of human health biotechnology in eight developing countries in Asia (China, India, Korea, and Singapore) and Latin America (Argentina, Brazil, Chile and Mexico) was conducted, based on the analysis of in situ interviews, patents and scientific publication. The study shows a marked process of adoption and learning in science: each of the above-mentioned developing countries is increasing its share of world publication between 1996 and 2008. However, their share of biotechnology patents for the same period has barely increased. There are also regional differences in terms of sectoral concentration; Latin America, Argentina and Brazil are eager adopters of agricultural biotechnology and are moving up in the pharmaceutical records. Several Argentinean, Chinese, Indian, and South Korean pharmaceutical companies have been particularly active in the development of biogenerics.     

The Indian Challenge: The Evolution of a Successful New Global Strategy in the Pharmaceutical Industry

UK and European public policy has sought to encourage young biotechnology firms adopt American-inspired strategies. The venture-backed start-up associated with Silicon Valley and Route 128 in Boston, has been the preferred model. These policies have had limited success thus far. Indian companies are evolving indigenous business models that are achieving success within the pharmaceutical industry. Some Indian pharmaceutical firms, established initially as low cost suppliers, are investing in building innovative capabilities. This paper analyses the strategies and trajectories of a number of Indian pharmaceutical companies that are expanding successfully in Western markets. It assesses the local and international contextual factors that have underpinned the strategies and discusses relevant conceptual frameworks.     

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.     

基于科学的产业发展影响因素组态与路径研究——对中国内地31省份医药制造业的QCA分析

基于科学的产业在经济发展中具有极强的活力,正成为21世纪国家经济发展的新引擎和新一轮产业革命的摇篮。选择医药制造业作为科学产业的典型案例,以我国内地31个省份数据为研究样本,运用模糊集定性比较分析(fsQCA)方法,探讨经济、科学、技术、政策条件对科学产业发展绩效的联动效应及路径选择。结果表明,单一条件并不构成制药业高绩效的必要条件,前因条件多重并发形成驱动制药业高绩效的多样化组态;存在驱动制药业高水平绩效的3条路径,分别是科学与技术双元主导驱动型、经济主导逻辑下的科学与政策驱动型以及经济主导逻辑下的技术与政策驱动型;存在导致制药业非高水平绩效的两条路径,且这两个组态的核心条件相同,即非经济水平和非科学研究。结论有助于深化对我国科学产业发展背后多重因素间复杂互动本质的理性认识,并为基于科学的产业成长带来有益的实践启示。     

中国高技术产业技术多元化对持续创新的影响研究

技术多元化是高技术产业持续创新的重要前提和基础，探讨其中的作用机理具有重要价值。在回顾相关理论的基础上，提出高技术产业技术多元化对持续创新的影响效应、外部技术获取与改造和技术多元化模式调节效应的基本假设，并利用中国高技术产业1998—2020年的面板数据进行实证检验。研究结果表明：①高技术产业技术多元化对持续创新（技术和产品）的促进作用具有门槛效应，存在“最优区间”；②外部技术获取与改造正向调节高技术产业技术多元化和持续创新的关系；③基于技术间知识关联和核心技术能力两个维度，可将高技术产业技术多元化划分为高关联-强核心、低关联-强核心、低关联-弱核心和高关联-弱核心四种模式；④不同模式的技术多元化对高技术产业持续创新的促进效应存在差异性，“高关联-强核心”型技术多元化更有利于技术持续创新提升，“低关联-强核心”型技术多元化则更有利于产品持续创新提升，“低关联-弱核心”型技术多元化对持续创新的促进效应最弱。     

Cooperation in R&D through a network,an ‘organizational gamble’? an empirical analysis of rhône poulenc rorer-gencell

This paper is based on the empirical analysis of innovation challenges to Rhône Poulenc Rorer-Gencell (RPR-Gencell) resulting from development of biotechnology in the pharmaceutical industy. These we identify as an organizational innovation involving the development of a network of partners following and/or inducing a technological innovation. RPR-Gencell represents a ‘style of innovation’ since it is based on various factors specific to the firm and corresponds to a new organizational form, the ‘tight network’ of partners. We argue that this organizational from, in the context of the development of biotechnology in the pharmaceutical industry, can be likened to an ‘organizational gamble’ associated with a ‘technological gamble’ Altogether, this ‘gamble’ dimension means that the network of partners in R&D is still a marginal organizational form. After an introduction we show that the specficities of the pharmaceutical industry especialy since the emergence of biotechnohgy have led to the emergence of a multiplicity of institutional arrangements governing cooperation in R&D. We take as a specific example that of gene therapy. Later on, we present some stylized facts to emphasize the diversity among the network organizational forms. The network of partners is an alternative to the other complex but ‘clarsical’ forms of cooperation (R&D agreements, cross-licensing, joint-ventures, mergers/acquisilions). We propose a new definition of the network based on the case of RPR-Gencell: the ‘tight network’. We distinguish between the ‘tight network’ and all the other approaches, focusing in particular on the ‘loose network’ of cooperative relationship (mostly multifirm alliances implemented with several bilateral contracts). Only two pharmaceutical companies have adopted the ‘tight network’ to govern their cooperation in R&D. We present the network ofpartners as an organizational innovation governing a technological innovation. We argue that this organizational innovation could be likened to an ‘organizational gamble’ in the case of the pharmaceutical industry. Finally, we show that the network raises several organizational issues since it short-circuits traditional strategic operations in the pharamaceutical industry. We argue that among many different reasons, RPR's technological choices (especially the priorig given to gene therapy) have influenced the creation of its network of partners. As a conclusion, we discuss the link between the organizational innovation and the technological innovation focusing on the ‘gamble’ dimension of such an innovation.     

Relational Contracting in Developed Economies: Lessons From Slot Exchanges in the US Airline Industry

This paper highlights the widespread use of relational contracting in developed economies. While the number of empirical studies on relational practices in developing countries is increasing rapidly, evidence from industries and countries characterised by strong institutions is lagging behind due to data constraints. We argue that technological progress and strong institutions do not diminish the use of relational contracting, and use the US airline industry as a case in point. In particular, we discuss a number of factors (including transaction complexity, existence of collaborative relationships and data availability) that make this industry an ideal setting to study relational contracting in a developed economy. Moreover, we argue that other industries in developed countries share the properties of the US airline industry and, hence, can be used as a basis to investigate relational contracting in future work.     

Appropriation Of Returns From Technological Assets And The Values Of Patents And R&D In Japanese High-Tech Firms †

This paper investigates the extent that technological assets contribute to the value of the firm, using the sample of 90 Japanese firms in pharmaceutical, chemical, and electrical equipment industries. We use the firm's R&D expenditures and the number of patents (in stock) as the measures of its technological assets and show that the relative usefulness of these two measures varies across industries. Particularly, Tobin's q is positively related to the technological assets most strongly in the pharmaceutical industry. It is also most sensitive in this industry to the level of patent stock, coinciding with the view that drug patents are more effective than other patents as a means of appropriating returns from innovation. The communications equipment industry is also characterized by its q's dependence on patent stock. In addition, this industry's q is particularly sensitive to the level of net R&D investment in the most recent year, presumably because of the rapid technological progress in this industry.     

生物制药产业技术轨道变迁与机会分析

以传统化学制药产业为比较基础,归纳了生物制药产业中顺序出现的三条技术轨道——"现代生物技术作为生产工具"、"现代生物技术作为搜寻工具"和"全面整合",分析了不同技术轨道所依赖的企业关键能力,明确了企业参与产业创新的机会以及由此引发的产业竞争态势变革。最后预测了生物制药产业中未来可能出现的技术轨道——"理论+实验",指出了该技术轨道所依赖的企业关键能力、提供的创新机会和可能导致的产业竞争新态势。     

Knowledge characteristics and the dynamics of technological alliances in pharmaceuticals: empirical evidence from Europe,US and Japan

The paper investigates the co-evolutionary patterns of the dynamics of technological alliances and of the structure of the knowledge base in the pharmaceutical sector. The main hypothesis under scrutiny is that technological alliances represent a key resource for firms in knowledge intensive sectors to cope with dramatic changes in the knowledge base, marked by the introduction of discontinuities opening up new technological trajectories. Using patent information and data on technological alliances drawn from the CATI-MERIT database, we compare the evidence concerning the so-called triad regions, i.e. United States, Europe and Japan. The empirical results support the existence of a life cycle in biotechnology affecting the pharmaceutical industry. Furthermore, the dynamics of alliances is found to depend on (i) the phase of the biotechnology life cycle, (ii) the strength of the region in biotechnology and (iii) the general features of the economic environment of the region.     

技术多元化、行业集中度与企业绩效波动

技术多元化是企业提高核心竞争力的重要手段,在不同行业背景下,技术多元化战略对于企业绩效的稳定作用存在一定的差异.运用2009—2018年710家创业板公司IPC发明专利信息数据,采用固定面板模型,基于行业特征与行业集中度视角研究了技术多元化对于企业绩效波动的影响.研究发现:技术多元化对于企业绩效波动有明显平滑效果;在高科技行业中,技术多元化对企业绩效波动的平滑效应相对较强;行业集中度低的情况下,技术多元化对企业绩效波动的平滑效应相对较强,而在高行业集中度的情况下,平滑效应近乎无效.为企业的技术知识基础建设提供重要依据,同时为不同行业背景下的多元化产业技术生态建设提供科学的理论指导.     

TRIPs and patenting activity: Evidence from the Indian pharmaceutical industry

This paper studies the impact of the strict patent regime on the patenting activity of Indian pharmaceutical firms and finds that patenting activity of these firms has increased after the signing of TRIPs. The study is conducted for 65 pharmaceutical firms for the period 1991 to 2004 using different parametric and semiparametric count panel data models. Results across different count data models indicate a positive and significant impact of the introduction of stronger patents on patenting activity. Further, the results show a gestation lag of 2 years between R&D spending and patent applications.