Estimating the value of generic entry and intellectual property litigation in the pharmaceutical market

In this study, we examine the relationship between, and implications of, the market entry and intellectual property litigation of brand name and generic pharmaceuticals from 2003 to 2012 in Japan. We focus on the effects of a firm’s litigation behavior on market competition, including not only anticipated damage and injunction costs but also reputation and reliability costs. The results show that market entry of generic pharmaceuticals decreases market sales of brand name pharmaceuticals by 45%. However, in the case of intellectual property rights, litigation increases market sales of branded pharmaceuticals by 120%.     

The Impact of Patents on Innovation,Technology Transfer and Health: A Pre- and Post-TRIPs Analysis of India's Pharmaceutical Industry

The debate surrounding the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement indicates that patents matter for development. Yet literature on the geography of knowledge transfer shows that knowledge is spatially sticky, suggesting that the impact of patents can be exaggerated. Using interview evidence, this paper explores how Indian pharmaceutical firms have responded to changes in patent law, including the introduction of more extensive patent protection in 2005 as a condition of TRIPs. A regime of limited patent protection for over three decades prior to TRIPs facilitated informal knowledge transfer and the emergence of a pharmaceutical industry with significant domestic capabilities. Contrary to some expectations, the Indian pharmaceutical industry has continued to grow post-TRIPs, with large domestic firms becoming involved in more formal technology transfer as part of an increasingly collaborative relationship with multinationals. This trend is also driven by a focus on the markets of developed countries, raising questions for the future sustainability of India's low-priced medicines. While changes in patent law can facilitate or inhibit a variety of aspects of development, the adaptation of the Indian pharmaceutical industry suggests that their impact must be related to the broader institutional setting, particularly the underlying domestic capabilities.     

Transparency and trust in the European pharmaceutical sector: outcomes from an experimental study

Many European pharmaceutical regulators have committed to a more open, inclusive, and transparent model of regulatory decision-making in recent years. Yet, based on little empirical evidence, they have overwhelmingly adopted ‘fishbowl’ transparency measures, ‘the full disclosure of information without explanatory information or contextualization’ (e.g. heightening access to raw data). This paper conveys recent findings from an open-ended questionnaire with 200 face-to-face interviews carried out in the UK and the Netherlands. The study provides evidence on how members of the public are likely to react to ‘fishbowl’ transparency policies and receiving decontextualized data. After showing respondents raw data from a periodic safety update report that regulators are proposing to proactively release, the survey found they were shocked, concerned, and more worried, while many said they would reconsider taking their medicines and seek further advice. Based on these findings, the authors argue that enhancing ‘transparency’ needs to be integrated with effective, evidence- and science-based benefit/risk communication.     

A competition‐based explanation of collaborative invention within the firm

Existing literature shows that collaborative invention within the firm enhances innovativeness by facilitating knowledge recombination. Despite such benefit, firms vary in their use of collaborative invention when drawing on their individual inventors' knowledge. In addressing this puzzle, we argue that competition from rival products building on similar knowledge compels firms to favor search depth over exploratory search and respond expeditiously, thus reducing a firm's inclination toward collaborative invention. In contrast with prior research's focus on how upstream resources influence a firm's position in downstream markets, this study shows that downstream competition drives heterogeneity across firms in their utilization of upstream resources. Copyright © 2013 John Wiley & Sons, Ltd.     

The welfare effects of innovative pharmaceuticals: an international perspective from the Dutch experience

Policy discussions on new medicines are often focused on cost containment rather than on the benefits they produce, such as health gains and cost savings in other sectors. In this study, we identify systematic differences in policies towards pharmaceuticals between countries and calculate the welfare gains of 39 innovative pharmaceuticals introduced in the Dutch market after 1997. Welfare gains are defined as the difference between the value of a QALY gained by innovative pharmaceuticals and their costs. The review shows that there are systematic differences among pharmaceutical policies and regulations between countries. It is further found that the welfare gains of pharmaceuticals are substantial and amount to €77 per capita per year in the Netherlands. The welfare gains could be higher if institutional barriers for an efficient utilization of innovative pharmaceuticals are removed.     

UNIVERSAL ACCESS,PARALLEL TRADE AND INCENTIVES TO INNOVATE

Governments often subsidize poorer groups in society to ensure their access to new drugs. We analyse the optimal income‐based price subsidies in a strategic environment. We show that universal access is less likely to arise when price arbitrage prevents international price discrimination. When this is not the case, under some income ranges, bilateral universal coverage can be supported by equilibrium subsidies together with bilateral partial provision. In such a case, international health policy coordination becomes relevant. We also show that asymmetric universal access to medicines across countries can arise, even when countries are ex ante symmetric, when international price discrimination is possible and governments cannot design subsidies proportional to either income or quality.     

Pseudo-Generic Products and Barriers to Entry in Pharmaceutical Markets

This paper examines incentives for brand-name pharmaceutical producers to market pseudo-generic versions of their own branded products upon the expiry of patent protection.Using a two-stage game model, we determine that under plausible demand and cost conditions, brand-name incumbents can find it profitable to produce pseudo-generics as a means of blocking rivals' entry even when independent firms producing true generics face low entry costs.The model shows that social welfare can be higher when firms use pseudo-generics instead of capacity for entry deterrence as long as substitutability between brand-name and generic products is sufficiently high.     

How do Brands’ “Own Generics” Affect Pharmaceutical Prices?

This paper examines the price effects of generic drugs that are produced by brand-name drug firms and that are labeled, priced, and marketed to compete against independent generics. The strategy of introducing such “pseudo-generics” – also known as “authorized generics” – has raised some antitrust concerns. One defense of this strategy has been that the additional competition created by pseudo-generics should lead to lower prices. This paper develops a simple model to show that pseudo-generics can be expected to have exactly the opposite effect. It then examines empirical evidence on this point from the Canadian pharmaceutical market, showing that there appears to be a positive relationship between drug prices and the share of generic sales made by the brand’s own pseudo-generic.     

Truthfulness and Business

According to a common assumption, truthfulness cannot have an intrinsic value in business. Instead, it is considered only instrumentally valuable for business, because it contributes to successful trust-building. Some authors deny truthfulness even this limited role by claiming that truth-telling is not an essential part of business, which is a sui generis practice like poker. In this article, I argue that truthfulness has indeed an intrinsic value in business and identify the conceptual confusions underlying the opposite view. My account of truthfulness as a virtue shows that truthfulness is both valuable for its own sake and instrumental to further valuable goals. It helps pinpoint the implicit contradiction in claiming that truthfulness has an instrumental value only. I then challenge the reasons for considering business exempt from the constraints of truthfulness and elaborate on the analogy between game and business, which in fact supports instead of undermining my claim that business is a truthful practice. Finally, I illustrate my argument with a case study of the current crisis of trust faced by the pharmaceutical industry. Lubomira Radoilska, PhD., is an Affiliated Lecturer at the Faculty of Philosophy, Cambridge University and a Research Fellow at Clare Hall, Cambridge. Dr Radoilska received her Masters degree in Philosophy from Sofia University and her MPhil and Doctorate from Ecole des Hautes Etudes en Sciences Sociales, Paris. Her research interests fall within the scope of moral philosophy. She has published articles on both theoretical and applied topics.     

The Determinants of Pharmaceutical R&D Expenditures: Evidence from Japan

During the past 20 years, the world pharmaceutical industry has experienced a dramatic increase in R&D intensity. We apply and extend a model developed by Grabowski and Vernon (2000, Journal of Evolutionary Economics, 10, 201–215) with a pooled data sample of the 15 publicly listed Japanese drug firms for the period 1987–1998. As in the original study, we find expected returns to be an important determinant of R&D spending in the Japanese drug industry, albeit considerably smaller than in the U.S., which is particularly obvious in the case of returns from newly introduced drugs. However, our results are sensitive to econometric model specification, in particular to controlling for serial correlation and to a dynamic specification of the baseline model. Likewise, estimates on financial constraints are sensitive to model specification, indicating that Japanese drug firms face small or no financial constraints. Our results are consistent with the general literature on R&D investment behaviour, yet raise some methodological questions with regard to the original study.