Perverse Results from Pharmaceutical Patents in the United States

In the United States, pharmaceutical patents have had a number of perverse and anticompetitive effects on the development and marketing of prescription drugs. Although some of these effects are unique to the United States, others have implications for patent policy across the world. Among the negative effects of drug patents are: (1) examples of misguided, anti-social, and anticompetitive promotion of patented drugs; (2) misguided incentives that push drug firms toward too much or too little research and development in critical areas: and (3) cartel-facilitating conduct linked to patent licenses or settlements of litigation involving drug patents. Some of these issues can be addressed directly through reforms in patent and competition law policy. There is, however, a need for a broader study of the role of patents in promoting drug research. That study should consider alternatives to the patent system, such as a prize system structured to supplement or partially replace patent rewards for pharmaceutical R&D.

Reflections of the transnational capitalist class on the global health: The case of India

Objectives This study aims to explore the transformations in the relation of global health and capitalism during the last three decades and its reflections on the nature of power relations between the state, local and transnational capital in the Indian pharmaceutical industry. Methods In this study, the effects of the developments in the international political economy after TRIPS (Trade-Related Aspects of Intellectual Property Rights) in the global pharmaceutical sector and in the Indian local sector are examined within the framework of the International Relations discipline. In this sense, a historical review of the Global Patent Regime has been made and a literature review has been conducted on the global pharmaceutical industry, drug patents and post-TRIPS agreements. Qualitative research method is used in the study in which the literature review is evaluated in an empirical and theoretical framework. Key findings The Global Patent Regime has been constructed for the interests of the transnational capitalist hegemon and in this sense has increased inequality in the global health. However, when the changes created by the global economy in the pharmaceutical sector, cooperation between the Southern countries and state policies are analysed, it is seen that a struggle area has been formed. This struggle adds value to global health in terms of access to medicine. Conclusions In transnational capitalism, the emergence of the state in strategic sectors such as the pharmaceutical sector in India indicates a new political and economic power.

INTELLECTUAL PROPERTY PROTECTION AND DRUG PATENTS IN BRAZIL

The article aims to reconstruct the central events of the Intellectual Property (IP) protection system in Brazil, from the first colonial orders to the Intellectual Property Law (1996). Two periods are identified: in the first, we observe the internalizing of innovations, improving the country's development, but preventing the patenting of medicines and food. The second, recent, explains an adaptation of national laws to international ones, suppressing the previous exceptions. The historical change in regulations reveals that patents have become symbolic elements of globalization process. The geopolitics of this process is presented in a review on the influence of the US Special 301 Reports on Brazilian politics. Finally, the article seeks to show that politics is not limited to the legal system, presenting the annulment of patents in Brazil during public health crises. In this sense, the text brings elements of the international discussion on the suppression of patents to face the COVID-19 pandemic, updating the debate on territorial sovereignty.

Evergreening of pharmaceutical patents: A blithe disregard for the rationale of the patent system

Evergreening of pharmaceutical patents has emerged as a serious challenge for access to affordable drugs as it aims to delay the generic competition by extending the length of the exclusivity period beyond the legitimate patent term without any considerable improvement in therapeutic benefits of the already patented pharmaceutical drug. This paper endeavours to question the legitimacy of the evergreening of pharmaceutical patents. This study applies all the recognized theories in support of the patent system – namely the ‘natural law’ or ‘natural rights’ theory, the ‘reward by monopoly’ theory, the ‘monopoly-profit incentive’ theory, the ‘exchange for secrets’ theory or the ‘contract’ theory, and the ‘prospect’ theory – to the practice of evergreening of drug patents in order to check whether or not any of these theories can be used to justify the practice. The study concludes that the practice of evergreening is not consistent with any of these theories and therefore lacks any plausible justification.

Product recalls, lobbying, and firm value

Purpose The purpose of this paper is to use a unique, hand-collected data set of Food and Drug Administration (FDA)-approved products to understand the effect of lobbying on the product market. The authors gather total 86,462 FDA labels including drug patents, drugs, pre-market approvals and medical devices and test the relationship between lobbying and future firms’ product submissions. Design/methodology/approach Using a sample of 86,462 FDA labels including drug patents, drugs, pre-market approvals and medical devices, the authors test the effect of lobbying on a firm’s future product submissions using survival analysis, logit, difference-in-differences and propensity score matching techniques. Findings The authors find lobbying firms experience an increase in the number of medical products approved. However, increased number of FDA labeling comes at the cost of product failure. The authors document that lobbying increases product recalls when responsible firms are associated with higher market withdrawals. Originality/value This study contributes to both the management literature on corporate lobbying and product recalls. Additionally, the study reveals the connection between pharmaceutical lobbying and firm value.