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.     

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.     

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.     

Policy, Markets and Knowledge: Strategic Synergies in Indian Pharmaceutical Firms

This paper addresses the question of how Indian pharmaceutical firms have transformed themselves from reverse-engineering firms focused on the domestic market to research-driven firms with global presence. It analyses the crucial and changing role of national, then international, innovation and regulatory policies and their impact on growth, performance and technology evolution of Indian pharmaceutical firms. The paper argues that although public policy increased market turbulence, it also provided new opportunities for firms to expand and build new technology, knowledge and market capabilities. From the 1950s Indian firms have pursued a variety of research, marketing and internationalization strategies to tackle changes prompted by policy, markets and knowledge complexities. The paper traces firm strategies that vary both in time and by firm, and argues that the successful firms have evolved substantively towards knowledge-based strategies. The paper then attempts to identify future directions for strategy, knowledge and markets.     

WTO,the Trips and Indian Pharmaceutical Industry

This paper analyzes the efficiency of firms in Indian Pharmaceutical Industry before and after the Trade Related Intellectual Property Rights (TRIPs) agreement. The analysis reveals that the efficiency of firms has increased after the Indian legislature has passed the bill for accepting patent applications in early 1999. We find that R&D intensity and market share influence efficiency of firms. The impact of import intensity enhances inefficiency. Our result indicates absence of ownership effects after the Indian legislature had passed the bill for accepting patent applications.

     

Product Patent Reform and its Impact on Korea's Pharmaceutical Industry

Our analysis focuses on the effect of U.S. government pressure on Korea to adopt product patents for chemical and pharmaceutical products. American pressure began in November 1985 and ended with the Korean Legislature's passage of a new patent law in December 1986. We conduct an event study of the effect of the new patent law on the value of Korean pharmaceutical firms listed on the Korea Stock Exchange. Regression analysis shows that the new law induced excess returns of-74 percent over the 14-month analysis period. The results suggest that adoption of stronger patent laws reduced Korea's wealth. [G14, O34]     

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.     

Investigating the determinants of patent acquisition in biotechnology: an empirical analysis

Acquiring patents is an increasingly relevant opportunity for innovating companies, especially after the rise and development of the so-called markets for technologies (MFTs). However, only scant attention has been devoted to investigate patents' characteristics influencing their acquisition by organisations. Accordingly, this paper aims at filling this gap by analysing how four main characteristics – as patent scope, scientific knowledge cited by the patent, forward patent citations, and number of patent claims – impact the likelihood of patent acquisition. We based our statistical analysis on a sample of 9716 US Patent and Trademark Office patents assigned to 165 biotechnological firms. Results support our conjectures and offer interesting managerial implications for organisations operating within MFTs indicating which characteristics make patented technological solutions more likely to be acquired by other firms, as a narrow scope, inclusion of scientific knowledge, and a number of forward citations able to increase patent's impact and exclusion rights.     

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.     

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.     

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...     

The Dynamics of Pharmaceutical Patenting in India: Evidence from USPTO Data

This article analyses the impact of the implementation of the 'Agreement on Trade-Related Aspects of Intellectual Property Rights' (TRIPS) on various segments of the Indian pharmaceutical industry. In particular, it focuses on the conditions under which a strong patent system can create benefits for a developing country's pharmaceutical industry. The theoretical analysis suggests that the greater the technological capabilities of the Indian pharmaceutical industry the greater are its chances to benefit from the introduction of stronger intellectual property rights (IPRs). The evidence presented paints a generally positive picture of the state of the Indian pharmaceutical industry, with the existence of strong and growing technological competencies that can be used as a platform for further expansion. These conclusions are dependent on India's worldwide success in the industry and cannot be automatically applied to other developing countries, especially if their pharmaceutical industry is not strong at the moment of the transition to a stronger IPR regime.     

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。     

论人工智能生成发明的可专利性及权利归属

当前，人工智能发明对专利客体范围、专利“三性”审查标准及专利权属制度造成巨大冲击。就专利客体而言，在“算法＋技术”规则的指引下，可将人工智能生成的技术方案明确为方法类专利客体；在专利“三性”审查方面，借鉴人工智能技术中立优势对相关发明进行“新式审查”，可以化解对传统审查方式的冲击；在专利权属制度设计上，基于产业政策和利益平衡考量，构建以人工智能投资者为核心、辅之以意思自治原则的专利权属制度成为必然。     

Heterogeneity in learning processes and the evolution of dynamic managerial capabilities as a response of emergence of biosimilar market: evidence from the Indian pharmaceutical industry

ABSTRACT

This paper examines heterogeneity in the response of Indian firms to the emergence of a new segment in the pharmaceutical generics market – biosimilars. The necessary diversity of the knowledge base and regulatory requirements underlying biosmilar products have created significant technological capability and market access challenges for Indian firms. This is but the latest development which adds to an existing catalogue of challenges including the decline of the traditional generics markets, regulatory hurdles in advanced country markets and failures in managing new drug development. Using case studies of three Indian firms we show that dynamic managerial capability is a key driver of heterogeneity in learning processes involved in acquisition of technological capabilities for biosimilars and market access strategies. It further highlights the important role of pre-existing capabilities in enabling and constraining the development of new biosimilar capabilities.     

Information technology innovation in India: The top 100 IT firms

Patents serve as an indicator of the innovation capability of countries, industries, or firms. Many Indian firms are in a transition to move from labor intensive segments to areas with higher value added which has been reflected in this research. The purpose of this study is to analyze patents issued during the period of 1997–2009 from the European Patent Office database and the United States Patent and Trademark Office database from the top one hundred Indian information technology firms. This study represents a novel empirical look at information technology industry innovations in India. A comprehensive set of statistical patent analyses are presented to provide practitioners with valuable knowledge to assist in business strategic planning.     

Types of patents and driving forces behind the patent growth in China

As a developing economy, China's unprecedented patenting surge is puzzling. We study China's patent surge and its driving forces using a novel and comprehensive merged dataset on patent applications filed by Chinese firms. We find that R&D investment, FDI, and patent subsidy have different effects on different types of patents. First, R&D investment has a positive and significant impact on patenting activities for all types of patents under different model specifications. Second, the stimulating effect of foreign direct investment on patent applications is only robust for utility model patents and design patents. Third, the patent subsidy only has a positive impact on design patents. The results imply that FDI and patent subsidy may disproportionately spur low-quality patents.     

International,intra-national and inter-firm knowledge diffusion and technological catch-up: the USA,Japan, Korea and Taiwan in the memory chip industry

Using data on US patent citations, this paper investigates the pattern of international, intranational and interfirm knowledge diffusion in the process of technological catch-up by Japanese, Korean and Taiwanese firms in the memory chip industry. First, regarding international diffusion, this paper finds that the ordering of citations is exactly the same as the order of entry into the industry: Taiwanese firms tend to cite Korean firms, Korean firms tend to cite Japanese firms and Japanese firms tend to cite US firms. Second, the degree of intranational knowledge diffusion is proportional to the level of technological capability or order of entry, although it is also affected by organisational differences among the firms. Third, the difference in patterns of interfirm knowledge reflects difference across organisations, such that big Korean group firms are less oriented toward interfirm knowledge diffusion compared with their Taiwanese small and medium enterprise (SME) counterparts. To explain such difference, the role of government research institutions has been highlighted, especially since the Industrial Technology Research Institute (ITRI) accounts for the lion's share of Taiwanese-held patents and in the spin-offs of many firms in the industry.     

Do firms with larger patent portfolios create more new plant varieties in the US agricultural biotechnology industry?

This article is an empirical analysis of the relationship between patent ownership and variety innovation for US agricultural biotechnology firms in the years 1976–1999. Counts of new varieties include corn, soybean, or wheat varieties protected by either patents or plant variety protection certificates, while patent portfolio size is defined as the count of a firm's gene and method patents. Negative binomial regression results indicate that firms with larger patent portfolios did not exhibit scale economies in variety creation nor did firms with wider technological diversity in their patent portfolios create significantly greater numbers of new varieties. However, firms experienced positive spillover effects from rival firms’ patent ownership, and patent ownership increases this effect. Sample firms that have merged in the past do not produce significantly greater numbers of new varieties after considering an increase in portfolio size and did not experience greater economies of scale in creating new varieties compared with firms that experienced no past mergers.     

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.