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This chapter provides a general introduction to the book. The chapter reviews the historical development of the biotechnology industry and the difficulties in applying conventional European patent law rules to genetic inventions. In particular, the chapter presents the concerns regarding the lack of industrial application of patent claims over isolated human DNA sequences and the importance of this requirement in the patenting of inventions concerning human genes.

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.