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The relationship between patents and the pharmaceutical industry is both complex and important. While many believe that patents are manipulated by the pharmaceutical industry for its own economic ends, a historical approach to the utilization of patents combined with an analysis of current patent issues places this relationship in its proper context. Though patents were created long before the pharmaceutical industry reached its current status as a major industry in the United States, a historical, analytic approach shows that the pharmaceutical industry has adjusted to constantly evolving legislation enacted to provide the most effective and efficient system by which to research, invent, regulate and patent new medicines.

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.

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.

Brand-name pharmaceutical companies have engaged in a variety of business conduct that has increased price. One of these activities involves “product hopping,” or brand switches from one version of a drug to another. The antitrust analysis of product hopping implicates antitrust law, patent law, the Hatch–Waxman Act, and state drug product selection laws, as well as uniquely complicated markets characterized by buyers different from decision makers. As a result, courts have offered inconsistent approaches to product hopping.

In this chapter, we offer a framework that courts and government enforcers can employ to analyze product hopping. The framework is the first to incorporate the characteristics of the pharmaceutical industry. It defines a “product hop” to include instances in which the manufacturer (1) reformulates the product to make the generic nonsubstitutable and (2) encourages doctors to write prescriptions for the reformulated rather than the original product.

When the conduct meets both requirements, our framework offers two stages of analysis. First, we propose two safe harbors to ensure that the vast majority of reformulations will not face antitrust review. Second, the framework examines whether the hop passes the “no-economic-sense” test, determining if the behavior would make economic sense if the hop did not have the effect of impairing generic competition. Showing just how far the courts have veered from justified economic analysis, the test would recommend a different analysis than that used in each of the five product-hopping cases that have been litigated to date, and a different outcome in two of them.

With expenditures totaling $227 billion in 2007, prescription drug purchases are a growing portion of the total medical expenditure, and as this industry continues to grow, prescription drugs will continue to be a critical part of the larger health care industry. This chapter presents a survey on the economics of the US pharmaceutical industry, with a focus on the role of R&D and marketing, the determinants (and complications) of prescription drug pricing, and various aspects of consumer behavior specific to this industry, such as prescription drug regulation, the patient's interaction with the physician, and insurance coverage. This chapter also provides background in areas not often considered in the economics literature, such as the role of pharmacy benefit managers in prescription drug prices and the differentiation between alternative measures of prescription drug prices.

The Bureau of Economics in the Federal Trade Commission has a three-part role in the Agency and the strength of its functions changed over time depending on the preferences and ideology of the FTC’s leaders, developments in the field of economics, and the tenor of the times. The over-riding current role is to provide well considered, unbiased economic advice regarding antitrust and consumer protection law enforcement cases to the legal staff and the Commission. The second role, which long ago was primary, is to provide reports on investigations of various industries to the public and public officials. This role was more recently called research or “policy R&D”. A third role is to advocate for competition and markets both domestically and internationally. As a practical matter, the provision of economic advice to the FTC and to the legal staff has required that the economists wear “two hats,” helping the legal staff investigate cases and provide evidence to support law enforcement cases while also providing advice to the legal bureaus and to the Commission on which cases to pursue (thus providing “a second set of eyes” to evaluate cases). There is sometimes a tension in those functions because building a case is not the same as evaluating a case. Economists and the Bureau of Economics have provided such services to the FTC for over 100 years proving that a sub-organization can survive while playing roles that sometimes conflict. Such a life is not, however, always easy or fun.

An innovation's social value depends on various factors that are independent of how the particular innovation is used with other technologies. Examples of such factors are the size of the market the innovation will serve and the manner in which the innovation is managed. However, an innovation must often be implemented with complementary inventions whenever it is exercised and its benefits are realized. In such cases, an innovation's value depends, in part, on the ownership structure of the related inventions. This paper makes its contribution by examining how an innovation's social value is affected when it must be applied in concert with other essential inventions. In this paper, I propose a measure that helps predict an innovation's social value. I also suggest a practical procedure to implement this measure and I evaluate a key feature of this procedure.

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.