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Helen Yu

The premise driving most research and innovation (R & I) policies is that certain dynamics can be leveraged to foster innovation and development through collaboration. However, the assumption that increased innovation will lead to local development and growth remains unproven. Not all regions have the capacity, resources or infrastructure to reap the socio-economic benefits arising from innovation. If R & I is to function as a driver of growth, it is imperative that policies support local development of discoveries into technologies while locally retaining socially and economically desirable outcomes. Translation and commercialisation are essential to transform research into innovations. Without intellectual property (IP) to safeguard investments in R & I, stakeholders may be discouraged from participating in the innovation process if there is no incentive to collaborate and share. This chapter examines how regional actors and the strategic use of IP can attract and retain investment and intellectual capital, while optimising socio-economic value from publicly funded research.

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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 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 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 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 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 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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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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Achieving Proof of Concept in Drug Discovery and Development

The Role of Competition Law in Collaborations between Public Research Organizations and Industry

Helen Yu

One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.
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Helen Yu

One of the core objectives of responsible research and innovation (RRI) is to maximize the value of publicly funded research so it may be returned, to benefit society. However, while RRI encourages innovation through societal engagement, it can give rise to complex and previously untested issues that challenge the existing legal frameworks on intellectual property (IP) and public entitlement to benefits of research. In the case of biobanking, the personal nature of human biological materials and the often altruistic intention of participants to donate samples intensifies the need to adhere to RRI principles with respect to the research, development, and commercialization of innovations derived from biobanks. However, stakeholders participate and collaborate with others in the innovation process in support of their own agendas. Without IP to safeguard investments in R & D, stakeholders may hesitate to contribute to the translation of discoveries into innovations. To realize the public benefit objective, RRI principles must protect the interests of stakeholders involved in the translation and commercialization of knowledge. This article explores the seemingly contradictory and competing objectives of open science and commercialization and proposes a holistic innovation framework directed at improving RRI practice to ensure a positive impact in obtaining the optimal degree of social and economic value from research.