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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.

Licensing from US universities is done within the overall legal framework of the Bayh–Dole Act of 1980 and the employment agreements of universities. This chapter explains common contracts used by universities to license technologies developed by their faculty and students within the context of these laws. In addition to the legal framework, the nature of license agreements is affected by the embryonic nature of most university inventions, which necessitates faculty and student involvement in development, and the entrepreneurial goals of the university. Universities have diverse goals in terms of revenue, licenses executed, inventions commercialized, patents filed, and number of startups formed. The somewhat obvious problem is that the goals of faculty, students, the university, and the licensee may not be aligned. Common contracts used are meant to align these goals. While some contracts include multiple terms such as upfront fees, running royalties, annual payments, and equity, Express Licenses are increasingly being used to accommodate the entrepreneurial environment. This chapter discusses these issues and also the importance of the rights to sublicense inventions.

There is sufficient evidence to prove that the improved health status of a nation’s citizens results in economic growth and development via improved functionality and productivity of labor. It is also commonly accepted that healthcare expenditure significantly influences health status through, for instance, improving life expectancy at birth and reducing morbidity, death, and infant mortality rates. Within healthcare, medicines account for a considerable share of health-related expenditure in both developed and developing countries. Therefore, it seems reasonable to assume that improved access to medicines is likely to contribute not only to the well-being of families and individuals but also to the economic growth and development in all societies. It has been widely advocated that pharmaceutical multinational enterprises (MNEs) can play an important role to address this problem, as they develop and supply a significant proportion of the drugs imported by low- and middle-income countries. This chapter is dedicated to a systematic review of literature in order to identify the strategies implemented by pharmaceutical MNEs to improve access to medicines in the low- and middle-income countries. A total of 76 research articles have been identified, and we have found that the main strategies of pharmaceutical MNEs are related to improving health outcomes through R&D, establishing partnerships for product development, pricing strategies to improve access to medicines, technology transfer, licensing agreements, and nonmarket efforts to improve access to medicines, among other strategies to overcome barriers imposed by intellectual property rights. We have also found that pharmaceutical MNEs’ strategies take place within a complex system and often involve interactions with a wide range of actors, such as international organizations, governments, private not-for-profit sector, universities and research institutes, and generic manufacturers. However, there is still a need for major progress in the field of access to medicines, and pharmaceutical MNEs should be more active in this field in order to avoid potential negative consequences, such as loss of legitimacy and compulsory licensing of their patented medicines.

The People’s Republic of China has long craved advanced technologies, and has undertaken an overwhelming number of changes in its intellectual property laws in order to foster domestic innovation and to encourage foreign investment. China implemented its first patent law in 1985. However, implementation and enforcement of this law and its amendments have been difficult, such that many foreign firms are reluctant to invest in Chinese markets. This paper describes the many changes that have been made to Chinese patent laws, and then illustrates patent activity in China as those changes have been implemented. Managerial issues are discussed in detail.

The Indian pharmaceutical industry accounts for 8% of global production and exports medicines to over 200 countries. Multinational enterprises (MNEs) enter the Indian market either directly through the establishment of subsidiaries or indirectly through licensing arrangements. However, evidence on MNE’s contribution toward development in India in terms of capability enhancement and linkages or through other spillover effects is limited. The purpose of this research was to generate evidence on (a) contribution of MNEs in the pharmaceutical market in India, (b) nature and impact of foreign direct investment (FDI) inflows in the Indian pharmaceutical sector, (c) contribution of MNEs in R&D and innovation in India, and (d) MNE’s contribution toward introducing new chemical entities (NCEs) and new biological entities (NBEs) in India through a mixed method research design. We conducted an in-depth quantitative analysis on multiple data sets and qualitative interviews of various stakeholders to generate a holistic understanding on the aforementioned research objectives. Our findings suggest that from the perspective of capability enhancement and linkages, the contribution of pharmaceutical MNEs in India is limited. We observed that majority of FDI investments are brownfield against desired greenfield investments. In addition, MNEs are investing far less of profit before tax (PBT) compared with Indian firms on research and development. However, MNEs are contributing significantly toward access to certain pharmaceutical segments like vaccines, hormones, and parenterals, which require sophisticated production facilities, advanced technology, and intellectual capital. Further, MNEs role in innovation and introduction of new medicines (new molecular entity [NME] and NBE New Chemical and Biological Entities (NCEs and NBEs)) in India is significant. We propose that creating a conducive policy environment and predictable regulatory environment can facilitate capability enhancement and linkages through MNEs. Some of the potential policy instruments include appropriate implementation of FDI policy and Intellectual Property Rights (IPR) policy to balance trade and public health.

This chapter provides a selective survey of the theoretical and empirical literature to date on the relationship between intellectual property rights (IPRs) and measures of innovation and international technology transfer. The chapter discusses the empirical implications of theoretical work, assesses the theoretical work based on the evidence available, and identifies some gaps in the existing literature.

Understanding of the factors that contribute to policies diverging from neoliberal norms and accounting for situations when social movement activists prevail over the interests of more powerful opponents requires an analytical framework specifying the dimensions of interest. The case of Brazil’s pharmaceutical policies, especially those dealing with HIV/AIDS, is considered.

To understand the space and limits for progressive agency amidst contemporary globalization, previous articulations of dependent development and global capitalism require conceptual space with insights from social movement theory and normative framing.

Control over technology, political alliances, and normative appeals have changed since the concept of dependent development to today’s contemporary neoliberal globalization for understanding cases of progressive agency. Technology is based more on intangible knowledge, activism across the state-society boundary is more likely, and human rights has become the dominant idiom for naming and shaming more powerful opponents.

The analytic framework developed informs our understanding of pharmaceutical autonomy – the ability of a country to provide for the prescription drug needs of its population – in the case of Brazil. Further research of other situations requires the application of the framework to determine its merits.

A focus on technology, alliances, and norms provides a useful starting point for exploring situations of development autonomy that prevails over the interests of corporate power.

This chapter reviews the economics literature on the development aspects of a substantially strengthened global regime of intellectual property rights (IPR). In this regime developing countries must adopt tighter standards governing patents, copyrights, and related policies, in order to protect global innovation. Some analytical literature finds that these changes could improve prospects for technology flows to poor countries, helping to integrate them into the global knowledge economy. Other authors raise deep concerns about whether these policy shifts will restrict growth through raising the costs of imitation, innovation, and acquiring international technologies. Poor countries may face permanently higher costs, raising questions about both the efficiency and equity implications. The chapter considers first the role of a balanced IPR regime in an overall economic development policy. This balance could involve widely varying protection standards at differing levels of economic development, growth, and social preferences. This situation is especially true in the world economy, where poorer countries may prefer to free ride on available international technologies. Much of the theoretical literature takes this view, suggesting that harmonized global policies could reduce innovation and growth. More recent literature takes a broader view of the ability of IPR to build global technology markets and support international information exchanges. Ultimately these are empirical questions and the available literature differs considerably in analytical approaches and conclusions. Thus, the chapter analyzes contributions from theory, empirical analysis, and case studies regarding prospective improvements or impediments to economic development arising from IPR reforms. These issues are especially important in public health and nutrition. The chapter concludes with an overview of how the globalized nature of IPR protection could affect developing countries. The essential point is that policy governing patents and copyrights needs to be embedded effectively in an overall economic development strategy.

This paper focuses on two related questions at the intersection of antitrust and intellectual property law. First, under what circumstances must the holder of a patent or a copyright or the owner of a trade secret allow others to use that intellectual property? Second, under what circumstances can the holder of an intellectual property right use that right to make it difficult for another party to succeed in a related market? These questions have vexed antitrust and intellectual property scholars alike ever since the Federal Circuit ruled in 2000 that patent holders “may enforce the statutory right to exclude others from making, using, or selling the claimed invention free from liability under the antitrust laws,” a ruling that directly contradicted the Ninth Circuit ruling that antitrust liability could be imposed for almost identical conduct, depending on the motivations of the patent holder. The various proceedings in United States v. Microsoft only added fuel to the firestorm of controversy.After briefly retracing the jurisprudential path to see how this situation arose, we propose a solution that primarily involves a variation on the real property concept of adverse possession for the intellectual property space along with a slight extension of the Essential Facilities Doctrine for industries that exhibit network effects. We examine, both for firms with and without market power, how our proposal would resolve the situations presented by large fixed asset purchases, the introduction of entirely new products, and operating systems with network effects. We also demonstrate how our proposal could be applied in the European antitrust enforcement context.

Together with the globalization, the markets throughout the world entered into an intense competition and it led the companies in capital markets into a panic. During the competition for being at the top, the companies may sometimes have recourse to various frauds, corruption, or manipulations. The advancing technology is the most useful instrument of companies for this purpose. Countering these frauds and corruptions, which are gradually becoming more complex, is the profession of “auditing” which entered into an institutionalization and professionalization process. One of the most important milestones in this process is the emergence of the forensic accounting profession. The forensic accounting services, especially in the USA and Canada, provide courts and lawyers with support by making use of accounting, auditing, and analytical investigations on legal issues involving financial disputes. The forensic accountants offer service to relevant persons and institutions in order to determine the frauds made by the companies and support the lawsuits.

The objective of the present study is to provide information about the forensic accounting profession and its development in the world, as well as contributing to the development and recognition of forensic accounting practices.