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Related post: ? We are extremely grateful to Pete Lanjouw for bequeathing Jenny Lanjouw�s background material on India�s pharmaceutical industry to us, and to Daniel Lederman for help in obtaining the proprietary data from IMS Health. Thanks to a number of Intellectual property rights lawyers and industry Tenormin Price experts, in particular Tahir Amin, Ramesh Adige, Usha Rao, Manoj Kamra, Sudip Chaudhuri, Jayashree Watal for explaining the institutional details of the pharmaceutical market and legal implications of TRIPs reform in India. Funding from the World Bank Research Support Budget, and the World Bank executed Trust Fund on Trade is gratefully acknowledged. The views expressed in this paper are those of the authors and do not necessarily reflect those of the World Bank, its Board of Directors, or the countries they represent. Contact: Aparajita Goyal at World Bank, 1818 H Street, NW, Washington, DC 20433, Email: agoyal3worldbank.org; Mark Duggan at the Wharton School of the University of Pennsylvania, 3620 Locust Walk, Philadelphia, PA 19104, Email: mdugganwharton.upenn.edu I. Introduction Government policy towards the pharmaceutical sector differs significantly both across countries and within individual countries over time. Such policies potentially affect innovation incentives as well as the utilization of available treatments. While there has been considerable work on policies affecting the pharmaceutical sector in the U.S. and other industrialized countries, relatively little empirical work has been done on developing countries, which is surprising given the profound changes affecting the pharmaceutical market in developing countries in recent years. One type of policy that has recently been implemented in India, China, and Brazil, and is currently being considered in many African countries, is an increase in patent enforcement. Throughout the 1970s, 1980s, and 1990s in India, for example, patents were issued on the process of manufacturing a product, rather than on the product itself. This meant that a slight modification in the synthesis of a molecule yielded a new patent and thus allowed several firms to produce essentially the same drug, implying that generic firms could essentially reverse-engineer a product by slightly changing the production process. Indeed, copies of global brands like Pfizer's top-selling cholesterol drug Lipitor and Eli Lilly�s popular anti-depressant drug Prozac were manufactured and sold in India by generic firms within two years of being introduced in the United States. The policy controversy over the impact of stronger intellectual property rights (IPRs) in developing countries is stark. A weak IPR regime might benefit developing countries by allowing domestic firms to imitate foreign technologies to enhance access to pharmaceuticals (Fink and Maskus 2004). On the other hand, it would reduce incentives for R&D investments on drugs that could differentially benefit developing countries (Arora, Branstetter and Chatterjee 2008). Perhaps partly because of this latter point, the World Trade Organization (WTO) recently started to require member countries to change their enforcement of patents. The Generic Tenormin implementation of the Uruguay Round agreement in 1995 entailed the implementation of a system of product patents and legal protection to all Trade-Related Intellectual Property Rights (TRIPs), including pharmaceuticals. As a result, beginning in January of 2005, firms in India (and China and Brazil from 2002 and 1997, respectively) could no longer reverse-engineer patented products. The debate about the merits of TRIPs implementation has been contentious in the economics literature as well. Tenormin Tablets On the one hand, patent enforcement is likely to lead to higher prices of drugs, which might lower utilization and adversely affect health. Several recent academic papers have echoed these concerns, using theory and empirics to forecast the potential welfare losses affecting current and future consumers, especially in countries like India, through higher drug prices (Dutta 2010, Chaudhuri, Goldberg, and Jia 2006, McCalman 2001, Cockburn and Lanjouw 2001). On the other hand, prices may not rise if most drugs affected by the patent reform have therapeutic substitutes and thus face substantial competition from other products. In addition, the innovator patent holder might be somewhat more efficient at production than generic 2 imitators, and thus their lower costs might to some extent offset the market power effect. In this paper, we explore the effects of introducing product patents for one particular therapeutic segment of the Indian pharmaceutical market - the market for CNS (Central Nervous System) drugs. The CNS market is the second largest therapeutic category in terms of retail sales in the world and is one of the fastest growing segments in India (Goldberg 2006). We use proprietary data on pharmaceutical sales in India1 from 2003 to 2008, and link these data on when product patents were granted. We differentiate between two types of product patents. As described by Hemphill and Sampat (2010), a product patent claiming the active ingredient is generally the strongest and is likely Tenormin Cost to prevent any use of the same drug. In contrast, ancillary patents on chemical variants, alternative formulations, delivery systems, and relatively minor aspects of the drug may not exclude generic entry, since a local manufacturer may be able to employ a different, non-infringing mechanism for accomplishing a similar incremental drug innovation. Our identification strategy exploits the differential timing of product patents across drugs during the 2003 to 2008 time period. Our key identifying assumption is that the timing of the patents is not correlated with other unobserved factors that might affect the price and utilization of the drug. Our findings suggest that the introduction of product patents was associated with a significant increase in the share of total quantity sold by the innovator, especially for patents granted to the drug compound. The share did not increase to 100 percent in most cases because innovator firms could still grant voluntary licenses to generic firms to manufacture Tenormin Mg and sell their products. We also find an increase in average prices after the introduction of stronger product patents, although there is no detectable significant effect on utilization. The analysis underscores the importance of investigating the type of product patent granted by the government. The findings contribute to the growing theoretical and empirical work on the effect of patent policies on the pharmaceutical industry. For instance, price responses to generic entry in the markets for generics and brand-name drugs that have lost patent protection in the United States have been studied by Caves et al. (1991), Grabowski and Vernon (1996), Frank and Salkever (1997), Berndt (2002), Wiggins and Maness (2004), Reifan and Ward (2005), Ellison and Ellison (2007), who find that market entry by generics resulted in heterogeneous responses in price based on the segmentation of the pharmaceutical market. Several studies have also used explicit models of consumer and firm behavior to simulate the welfare losses implied by patent protection in developing countries (Challu (1991), Fink (2000), Maskus and Konan (1994), Nogues (1993), Subramanian (1995), Watal (2000)). The paper most relevant to our study is by Chaudhuri, Goldberg and Jia (2006) who analyzed the effects of patent enforcement for a sub-segment of antibiotics in India using a structural approach to compute own and cross-price elasticities of demand as well as the marginal costs of production. While their findings (and the findings in previous literature) are ultimately limited by the fact that the potential 1 This data is similar to the data used for the U.S. market in Duggan and Scott Morton (2010). 3 impact of patents is simulated using estimates of demand characteristics and market structure from other settings, the model yields important welfare predictions that can be tested using the data at hand. The fact that we now have access to data on actual pharmaceutical product patents granted by the Government of India gives us the opportunity to examine empirically the impact of product patents on pharmaceutical prices and utilization. The purpose of this paper is to provoke discussion on some of the preliminary findings from using these data. In forthcoming work we extend the analysis to all therapeutic segments of the Indian pharmaceutical market, and explore in greater detail heterogeneous effects by sub-therapeutic segments and welfare implications using the demand and supply parameters estimated by Chaudhuri, Goldberg, Jia (2006) for the Indian pharmaceutical market. The rest of the paper is organized as follows. Section II provides background on the evolution of India�s pharmaceutical industry and the details of the TRIPs reform. The data and findings are discussed in Section III, and Section IV concludes.
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