The content of this book is rather controversial. It paints a rather bleak picture, that the current EU legal economic system being developed for the data-driven economy is both outdated and – to some extent – a policy at war with itself. It promotes dominant platforms to detriment of others. Moreover, the fundamentals for creating rules are also missing. A liberal economic system needs to be based on aspects of a rights system, otherwise, we risk losing innovation, the establishment of new markets, and the creation of wealth, while we will see increasing market failures. Without a legal system for rights to data, we will lose out of a just system for the distribution of wealth. Indeed, it is time that the data-driven economy and the internet economy are granted their ‘property’ rights, reflecting the new paradigm of the data-driven industrial revolution. Moreover, such a regime fits well with the European economic constitution now being established.

Data is vital to the internet-based economy and will become even more important in the old economy as the Internet of Things (IoT) gains ground. The competitiveness of firms will increasingly depend on timely access to relevant data and the ability to use that data to develop new, innovative applications and products. In consumer-oriented businesses, the relevant data is often personal information; although this data is becoming increasingly collectable, only a few firms have access to larger amounts of it.1

Preparing for scale-up in commercial manufacturing is far away from the thoughts of companies involved in product development, but this chapter shows when to start planning and how to plan a practical budget for this activity. For companies with their first product in commercial development, the build vs buy decision is never an easy one and the examples and key points for consideration simplify that process. The biggest challenge in scaling up is the gap in culture between R&D production for experimental testing in preclinical stages and the control and quality oriented culture in the manufacturing location. The case studies and content in the chapter specifically highlight how to achieve a successful technology transfer into commercial GMP manufacturing. The chapter content also gives practical guidelines on what it takes to put GMP and quality systems in place.

Chapter 18 covers the licensing of commercial software, data and databases. It begins with a discussion of database protection, including the history of legislative attempts to cover data and databases under copyright law, and the divergent pathways taken in the US and EU. It next addresses commercial data and database licensing practices (MD Mark v. Kerr-McGee, Eden Hannon v. Sumitomo). The chapter next discusses data privacy and protection regulations and their implementation in licensing agreements. It next moves to commercial software licensing, discussing the distinctions between source and object code. and offering some background on the legal protection of computer software through copyright, patent and trade secret law. Particular software licensing practices are discussed next, including provisions necessary to license source code, maintenance and support obligations, reverse engineering restrictions. It concludes with a discussion of licensing in the cloud and how different companies have approached this business model.