Cette thèse de doctorat porte sur la compréhension des aspects concurrentiels du marché de l’innovation incrémentale en France en s’appuyant sur une approche empirique. A cette fin, l’analyse porte plus particulièrement sur l’innovation incrémentale et les dynamiques concurrentielles des médicaments appelés en France « similaires ». La littérature anglophone retient les expressions « me-too » ou « follow-on » pour définir les produits pharmaceutiques à faible valeur ajoutée et qui ont des caractéristiques anatomiques, thérapeutiques et chimiques proches des molécules précédemment mises sur le marché. Le premier chapitre vise notamment l’étude sur les parts de marché des médicaments « follow-on » et le lien avec la variable stratégique définie par l’ordre d’arrivée sur le marché. Dans ce chapitre de thèse, on vérifie que les premiers follow-on d’une classe thérapeutique ont un avantage concurrentiel en ce qui concerne la capacité des capturer et de maintenir des parts de marché pendant une longue période. En outre, les parts de marché sont positivement corrélés avec l’habilité de la firme de fixer un prix supérieur au premier médicament de la classe. Cet avantage stratégique des premiers entrants est aussi intrinsèquement lié aux caractéristiques qualitatives des produits puisque nous avons pu constater que les parts de marché des médicaments sont directement corrélés avec le niveau d’innovation du produit. Le deuxième chapitre de la thèse apporte des éléments sur la nature concurrentielle en termes de prix du marché de l’innovation pharmaceutique incrémentale. Deux variables dépendantes mesurant le prix ont été considérées : le prix du produit calculé en coût du traitement journalier et le prix du médicament divisé par la moyenne des prix des médicaments similaires dans la classe. Nous vérifions que les derniers entrants ont une tendance à avoir un prix inférieur aux premières molécules « follow-on ». Cela implique une caractérisation des derniers entrants ayant un moindre pouvoir de négociation avec le régulateur autour du prix, notamment en raison d’une qualité innovatrice intrinsèque plus faible. Le troisième chapitre présente une analyse empirique autour de la confrontation des deux marchés émergents et d’importance majeure pour la régulation des systèmes de santé : le marché des génériques et le marché des médicaments « follow-on ». L’analyse se concentre sur les aspects de l’intensité de la compétition dans le marché des médicaments brevetés similaires et son impact sur la pénétration des versions génériques de ces derniers. Le constat est que l’intensité de la compétition de médicaments similaires est positivement et significativement corrélée avec l’introduction des génériques. Plus de produits « follow-on » entrainerait donc une baisse encore plus importante des prix des génériques des derniers « follow-on » dans la classe thérapeutique. L’approche essentiellement empirique de cette thèse doctorale permet ainsi de mieux comprendre les déterminants et la dynamique de ce marché relativement émergent et qui suscite des nombreux débats au sein de la communauté scientifique. Enfin nous terminons par une brève conclusion générale fondé autour des résultats de cette recherche permettent d’affirmer que dans un marché régulé comme celui qui prévaut en France, l’intensité de la compétition, engendré notamment par l’arrivé sur le marché des médicaments « follow-on », peut avoir des conséquences positives sur les aspects concurrentiels du secteur du médicament...... / The dynamics of pharmaceutical markets have been constantly changing last years. The development of the so called “follow-on” or “me-too” drugs has been in the centre of a major debate concerning the ability of innovation in the health sector. These drugs are characterized by having a minor level of innovation and do not add any therapeutic value in relation to the previous drugs launched in the market. This doctoral dissertation proposes three empirical essays concerning competition aspects in the market of incremental innovation in France. The first chapter focuses on the impact of entry order on “follow-on” drugs competition in the French market between years 2001 and 2007. More precisely, this study examines the effects on market share of first entrants in the follow-on drug market and how this possible competitive advantage changes over time. Our results are coherent with theoretical microeconomic issues concerning the importance of being first. We find evidence that first movers in the follow on drug market have the ability to capture and maintain greater market share for a long period of time. The hierarchical market position of follow on drugs does not seem to be affected by generic drugs emergence. From a dynamic perspective, our analysis shows that market share is positively correlated with the ability of follow on drugs to set prices higher than the average follow-on drug price in a specific therapeutic class (ATC) which means that market power remains considerably important for first movers. Finally we found that the optimum level of innovation to maximize market share is the highest one.The second chapter examines the relationship between entry order of follow-on drugs and their prices on the French pharmaceutical market. We used a representative panel data of 1047 follow-on drug formulations distributed in 118 ATC classes set over 2001-2007. Two measures of prices were used in the econometric specifications: the absolute price and the relative price of the follow-on drugs. The former concerns simply the absolute price of the drug in daily costs and the latter is the price of the drug relative to the average price of the follow-on drugs in the class. Both prices are calculated on the basis of manufacturer prices. These different indicators give us similar results for the impact of entry order on prices but they are differently correlated with market share. Moreover, our study analyses the potential impact of several variables on prices of pharmaceutical incremental innovation such as firm size, innovation and intensity of competition. Our results suggest that big firms have more ability to negotiate higher prices and that the number of follow-on drugs in the class and the emergence of generic competition may help decrease general prices in the ATC class. We have not found any relationship between prices and innovation in the French pharmaceutical market.The third chapter investigates the potential relationship between follow-on drugs dissemination and generic drug market emergence. It explores the structural determinants of off-patented drugs development at the therapeutic class level with a focus on explanatory variables that reflect the intensity of competition amongst similar interchangeable drugs. We found that generic market growth is greater in therapeutic classes where the number of similar drugs is high and the average brand price is low. This could be due to the fact that brand name drugs reduce their prices to keep market share when generic drugs enter the market. We study also the generic to follow-on brand price ratio at the individual drug level and we found that generic prices of later follow-on drugs are closer to the price of the brand name than generics of first follow-on movers. Our results are coherent with the fact that intensity of competition in the follow-on drugs may help reduce prices not only in the patented drug markets but also in the off-patented sector.

This thesis consists of three papers. Industries that motivated this analysis range are exclusive clubs (Chapter 1) and pharmaceuticals (Chapters 2 and 3). A common thread is the study of the strategic behavior of monopoly or monopoly-like firms and the implications of such behavior. Chapter 1 studies an “invitation only” strategy for a durable goods monopolist. “Invitation only” functions as a commitment device, enabling the extraction of more profit than the conventional durable goods setting. In addition, the effectiveness of commitment devices in profit-extraction can be compared: each commitment device is modeled as an extra condition in the profit maximization of the general durable goods monopolist, enabling straightforward comparisons across commitment devices. Chapters 2 and 3 discuss the effect of patent protection on innovation in the pharmaceutical industry, in particular competition to produce drugs that follow-on from pioneer drug discovery, and any feedback effects on pioneer innovation. Despite the conventional notion, I show that longer patent protection may reduce or distort the incentives of innovation: with longer patents, the increased need of pioneer inventors in deterring the production of follow-on drugs may translate to less profitability for the pioneer inventor. Chapter 2 serves as a background and a literature review for Chapter 3. It explains the multi-stage drug discovery process and the phenomenon of follow-on drugs; it reviews strategic entry deterrence theories and summarizes the behavior of brand-name drug firms in deterring generic entry studied in the literature; it also reviews the optimal patent length and breadth literature. Chapter 3 presents several observed puzzles in the pharmaceutical industry and provides a unified explanation for these puzzles within a strategic entry deterrence model. The central conclusion is that under some general conditions, longer patent life distorts incentives for innovation and lowers research productivity: pioneer research is discouraged relative to follow-on research; inexpensive R&D projects are discouraged, and ceteris paribus expensive projects are favored instead, especially those with large clinical trial costs. Other predictions from the model accord with industry observations, including mid-development cancellations of potential drugs for non-medical reasons and early development of follow-on drugs in large markets.

This thesis consists of three papers. Industries that motivated this analysis range are exclusive clubs (Chapter 1) and pharmaceuticals (Chapters 2 and 3). A common thread is the study of the strategic behavior of monopoly or monopoly-like firms and the implications of such behavior. Chapter 1 studies an “invitation only” strategy for a durable goods monopolist. “Invitation only” functions as a commitment device, enabling the extraction of more profit than the conventional durable goods setting. In addition, the effectiveness of commitment devices in profit-extraction can be compared: each commitment device is modeled as an extra condition in the profit maximization of the general durable goods monopolist, enabling straightforward comparisons across commitment devices. Chapters 2 and 3 discuss the effect of patent protection on innovation in the pharmaceutical industry, in particular competition to produce drugs that follow-on from pioneer drug discovery, and any feedback effects on pioneer innovation. Despite the conventional notion, I show that longer patent protection may reduce or distort the incentives of innovation: with longer patents, the increased need of pioneer inventors in deterring the production of follow-on drugs may translate to less profitability for the pioneer inventor. Chapter 2 serves as a background and a literature review for Chapter 3. It explains the multi-stage drug discovery process and the phenomenon of follow-on drugs; it reviews strategic entry deterrence theories and summarizes the behavior of brand-name drug firms in deterring generic entry studied in the literature; it also reviews the optimal patent length and breadth literature. Chapter 3 presents several observed puzzles in the pharmaceutical industry and provides a unified explanation for these puzzles within a strategic entry deterrence model. The central conclusion is that under some general conditions, longer patent life distorts incentives for innovation and lowers research productivity: pioneer research is discouraged relative to follow-on research; inexpensive R&D projects are discouraged, and ceteris paribus expensive projects are favored instead, especially those with large clinical trial costs. Other predictions from the model accord with industry observations, including mid-development cancellations of potential drugs for non-medical reasons and early development of follow-on drugs in large markets.