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Purpose – The cost of new drug development is increasing every year. Pharmaceutical companies use R&D joint ventures, mergers, and outsource different stages of pharmaceutical R&D activities for a faster and cost minimizing method of innovation. Pharmaceutical companies outsource R&D activities to independent small biotech or pharmaceutical companies that specialize in different stages of pharmaceutical R&D. This chapter examines the determinants of the payment structure of research contracts between large bio/pharmaceutical companies and specialized research firms.

Methods – Determinants of R&D contracts are analyzed using detailed R&D contract data between bio/pharmaceutical companies and independent research firms for 10 years. A multinomial logit model is used in order to understand the determinants of three different types of contracts; royalty contracts, fixed payment contracts, and the mixed contracts.

Findings – Under uncertainty, the likelihood of a royalty contract rises for the early stages of the research and with the patent stock of the research firm. It is more likely to observe both royalty and fixed payment if the pharmaceutical client has past contracts with the same research firm. The results also suggest that if Food and Drug Administration (FDA) is more stringent in any disease area in reviewing the new drug application, then the likelihood of signing pure royalty contract decreases.

Implications – Understanding the nature of R&D contracts and the effects of FDA's behavior on the pharmaceutical R&D contract is important because these contracts not only affect the cost of new drug invention but also the quality and the rate of invention.

Value – Results are useful for both the pharmaceutical companies and the economic/business researchers.

This study investigates the conditions that shape the contractual structure of pharmaceutical-biotechnology R&D agreements and whether these collaborations have produced measurable impact on the overall R&D productivity of pharmaceutical companies. In one section, the effect of uncertainty due to the advances in technology on the structure of R&D contracts is discussed. Specifically, it is shown that newer technologies associated with higher uncertainty result in the choice of more hierarchical contract structures. In addition, the significance of R&D collaborations on the overall innovation process of pharmaceutical companies is evaluated. The results indicate that only some types of R&D alliances, signed in earlier stages of research, have a significant role in the patent production and drug discovery process.

In this chapter, we analyzed the effects of internationalization on innovation, productivity, and firm performance among multinational pharmaceutical companies as representatives of a global knowledge-based industry. The empirical analysis used multiple stepwise regressions based on a sample of 149 firms headquartered in Europe and the US. The results indicate that innovation outcomes are positively correlated to the number of foreign subsidiaries (scope internationalization), whereas surprisingly, formal research and development (R&D) does not seem to directly influence innovation. This suggests that the firms benefit from local overseas subsidiaries to create and implement new innovative offerings. The number of foreign subsidiaries has a U-shaped relationship to patent productivity suggesting that firms can gain advantages by locating cost-intensive activities in low-cost countries and critical tasks in advanced market locations. Firm performance has a U-shaped relationship to sales abroad (scale internationalization) and the relationship is further enhanced by a high focus on R&D. This suggests that sales abroad enable scale economies, where R&D improves quality and relevance of products and thereby boosts performance. Finally, to validate the findings we conducted two semi-structured interviews with representative industry experts and gained further insights for an extended interpretation of results.

This chapter aims at providing an understanding of the research and devlopment (R&D) process in the pharmaceutical industry, by exploring the methodological challenges and approaches in the assessment of the determinants of innovation in the pharmaceutical industry. It (i) discusses possible methodological approaches to model occurrence of events; (ii) describes in detail competing risks duration models as the best methodological option in light of the nature of pharmaceutical R&D processes and data; (iii) concludes with an estimation strategy and overview of potential covariates that have been found to correlate with the likelihood of failure of R&D pharmaceutical projects.

To investigate the impact of knowledge-intensive FDI in the Chinese pharmaceutical industry, this study analyzes the activity of foreign MNEs operating in this context by exploring their innovative background, the organizational arrangements they use for local knowledge creation and the performance of their local innovative processes. Based on the analysis of the universe of USPTO pharmaceutical patents applied for between 1975 and 2010 and granted to foreign assignees utilizing the work of Chinese inventors, our results show that, while the presence of foreign MNEs in the Chinese pharmaceutical industry entails a strong potential for positive externalities that could enhance the performance of the local innovation system, such externalities do not completely materialize yet, likely because of local actors’ limited absorptive capacity.

Firms are increasingly organizing cross-regional R&D collaborations among different units. Such collaborations should promote knowledge flows across distance and bring new knowledge to the local communities. However, the nature of cross-regional collaborations varies widely depending on the organizations within which they are organized. Compared with collaborations within small firms, collaborations in large firms tend to be routinized, which reduces the need for interpersonal interactions and increases the dependence on organizational structure. As a result, additional spillover from cross-regional collaboration is likely to be lower if the collaboration is within large firms. We extend this argument to the regional level and hypothesize that regions with a higher level of cross-regional collaborations tend to generate more valuable technologies, but when large firms dominate the formation of such collaborations, the marginal benefits of cross-regional collaboration are significantly reduced. Using a data set from the pharmaceutical industry between 1975 and 2001, we find support for our hypotheses. We conduct a series of robustness tests to check the consistency of our results.

The World Health Organization estimated that in 1999 roughly one-third of the world's population lacked access to essential medicines that would have saved or improved their lives. Our analysis focuses on how pharmaceutical product patents restrict access to essential medicines in developing countries. It is well established that pharmaceutical product patents provide little incentive for pharmaceutical companies to develop new medicines designed to treat diseases prevalent in developing countries or to market in developing countries those patented medicines developed to treat diseases prevalent in developed countries. Economists have developed theoretical models showing that these incentives could be changed if (1) developing countries provided intellectual property protection for new pharmaceutical innovations and (2) an international regulatory framework were established to facilitate pharmaceutical companies setting lower prices in developing countries and higher prices in developed countries for patented medicines. We develop an index of property rights in pharmaceutical innovations covering 129 countries from 1960 to 2005. It shows that in 1960 only a handful of countries provided significant protection for pharmaceutical innovations, but by 2005 over 95 percent of countries in our sample provided significant statutory protections. However, an international framework to allow pharmaceutical companies to price discriminate has not been put in place. We conclude that international price discrimination mechanisms, compulsory patent licenses, and regional patent buyouts are not viable mechanisms for providing access to essential medicines to patients in developing countries. Global patent buyouts are more likely to achieve this goal, as they are not founded on an impractical separation of pharmaceutical markets in developing and developed countries and they provide critical incentives to develop new essential medicines.

We combine insights from the strategic management and international business literatures in order to explore the moderating role of business group characteristics on the link between innovation and internationalization in the context of the pharmaceutical sector in India. We test our three hypotheses on a sample of 219 Indian pharmaceutical firms affiliated with business groups, over a five-year period (2005–2010) in a panel of 1,096 firm-year observations. Results indicate that, contrary to our contention, research expenditure is negatively associated with export intensity, implying that firms in the Indian pharmaceutical sector may face a trade-off between investing in innovation and international expansion. As expected, business group characteristics significantly impact the strength of the relationship between innovation and internationalization. Theoretical and practitioner implications are discussed.

This chapter examines the role of pharmaceutical patents in the on-going support of pharmaceutical innovation. The social value of pharmaceutical innovation and the importance of its sustained growth are explained. The government buy-outs of patents to reduce drug prices for all American consumers while preserving vital drug innovation are proposed.

This chapter examines the impact of changes in foreign exchange legislation on the levels of R&D undertaken by pharmaceutical firms in India. Foreign exchange legislation in India was codified as the FERA, passed in 1973, and the legislation was based on the mens rea principle, assuming criminal intent on the part of transgressor. The provisions of FERA were replaced with those of new legislation, called FEMA, in 1999. The impacts of the changes have been examined.

The examination has been based on panel data of Indian pharmaceutical firms over a period of fifteen years, from 1991–1992 to 2005–2006.

The results of the analysis have shown that, controlling for a variety of other factors, a transition from FERA to FEMA has been associated with a significant rise in pharmaceutical firms’ average levels of R&D undertaken.

The research establishes that institutional changes have significantly impacted innovation performance in India. The sector examined, pharmaceuticals, is important for the Indian economy as well as for general welfare, since its products help enhance the quality of lives. How innovation can be enhanced in this sector is an important policy consideration.

The research is the first to examine the impact of changing the laws relating to foreign exchange transactions in India on capability building, via undertaking research activities, in an important sector of Indian industry.