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Helen Yu

Chapter 2 provides background information on how the pharmaceutical industry functions and explains how and why traditional drug development may no longer be an efficient model. In that context, the integrated drug development model will be introduced as an alternative that fosters university–industry collaboration to de-risk the drug discovery and development process while facilitating innovation through achieving proof of concept. For the sake of comparison, Chapter 2 will briefly consider other approaches to the open innovation model and their possible role in the drug development process.
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Helen Yu

Chapter 1 introduces the problem with respect to the current drug development process. The integrated drug discovery model is introduced as a potential solution to bridge the translational gap by achieving proof of concept as a way to demonstrate the clinical and commercial viability of basic research. However, this collaboration between industry and public research organizations may give rise to a violation of competition law due to anticompetitive or exclusionary conduct, such as but not limited to, exclusivity agreements with industry partners, grant back restrictions, and refusal to license to third parties. Furthermore, although the bringing together of complementary skills and assets in a collaboration between industry and integrated drug discovery organizations may facilitate innovation by enhancing efficiency and reducing expenditure, the number and ability of potential market actors to enter the market may be limited by such collaboration. In other words, the exercise of intellectual property rights may give rise to anticompetitive effects under certain circumstances.
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Helen Yu

Chapter 3 introduces the intersection between competition policy and intellectual property rights in the context of collaborative research in the pharmaceutical sector and as it relates to the drug discovery and development process. It further explores the applicability of Article 101 to the collaboration agreement that governs the relationship between industry and integrated drug discovery organizations. The main focus of this chapter is to analyze and determine whether the collaboration agreements between industry and integrated drug discovery organizations fall within the purview of Article 101.
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Helen Yu

Chapter 7 summarizes the legal implications of the integrated drug discovery model and discusses various concluding remarks, observations, and comments relating to integrated drug discovery in the larger innovation framework.
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Helen Yu

Chapter 5 introduces the Technology Transfer Block Exemption Regulation (TTBER) and considers whether the licensing aspects of the collaboration agreement between integrated drug discovery organizations and industry falls within the purview of TTBER. It analyzes various contractual restrictions typically found in technology transfer agreements and how such restrictions are viewed from the perspective of competition policy.
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Helen Yu

Chapter 4 introduces the R & D Block Exemption Regulation and considers whether the R & D component of the collaboration agreement between integrated drug discovery organizations and industry falls within the purview of the R & D Regulation. It focuses on the concept of R & D poles and how they may restrict collaborative innovation in the drug discovery and development context.
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Helen Yu

Chapter 6 analyzes the contractual terms of the collaboration agreements collected from each of the four integrated drug discovery organizations with reference to the R & D Regulation and TTBER. Analysis of Article 101(3) exemptions will also be discussed with respect to whether they apply to the collaborative agreements should the agreements not qualify for exemption under the block exemptions.
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Barbora Jedlicková

This chapter describes the law of resale price maintenance and vertical territorial restraints in the United States of America and its development since the enactment of the Sherman Act in 1890. It discusses it in connection with different factors that have influenced antitrust law while analyzing and summarizing significant and selected cases. By examining these cases, the chapter illustrates in detail the changes in approach to RPM and VTR and their application.
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Barbora Jedlicková

This chapter surveys procompetitive and anticompetitive theories and reasons behind introducing resale price maintenance and/or vertical territorial restraints. It involves explanations and arguments which go beyond the traditional economic view assisting with answering questions such as why RPM or VTR is introduced in situations where procompetitive theories would not make economic sense or did not apply in practice. It provides different points of view with respect to some ‘procompetitive’ explanations, showing that some of these explanations could have rather anticompetitive effects and/or could be seen as competitively neutral and that suppliers do not always have procompetitive reasons for introducing resale price maintenance or vertical territorial restraints but can have anticompetitive reasons and/or reasons which do not necessarily lead to procompetitive effects.
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Barbora Jedlicková