Empirical studies are increasingly useful to investigate the validity of IP law’s assumptions and help propose reforms to existing IP and regulatory regimes with the goal of achieving desirable social outcomes. This is accomplished, for instance, by combining i) empirical findings arising from the analysis of natural experiments emerging from legal and regulatory changes (e.g., Supreme Court decisions that change the law governing subject-matter eligibility and hence enabling researchers to conduct pre- and post- comparisons or comparisons across jurisdictions), ii) controlled experiments, iii) analysis of real-world data from increasingly rich and sophisticated IP-related databases involving real-world cases, and iv) semi-structured interviews with key stakeholders. Empirical legal studies also complement other types of legal research to provide evidence-based recommendations for increasing the effectiveness, efficiency, beneficial impact, and sustainability of the IP system and the broader innovation ecosystem within which it operates.

This holds particularly true for the more specific areas of patent and trade secret law, because these rely on a quid pro quo that must be fair for inventors, entrepreneurs, investors, and society. Within IP law, the biotech and pharmaceutical sector provide a suitable example to elucidate the potential of empirical research. Due to the traditionally crucial importance of the patent and trade secrets systems for this sector, it is often referred to as the primary example for demonstrating the success of the IP system to provide necessary incentives in capital-intensive fields. Given the recent developments spurred by the combination of rapidly evolving medical and information age technologies (e.g., big data, artificial intelligence (AI), digital medicine, quantum simulation and computing), new societal threats such as the recent pandemic or antimicrobial resistance, and the resulting reactions in public perceptions and policy, the medicinal product and medical devices sector -with its rich ecosystem of effected stakeholders- provides an excellent example to illustrate the types of research questions that can be studied by empirical means.

This chapter is structured as follows, (i) Section 2 provides an overview of empirical studies in patent law, including a categorisation of these studies and methodological considerations, (ii) Section 3 addresses similar aspects in connection with empirical studies involving trade secrets, (iii) Section 4 includes selected case studies to illustrate the different types of empirical methodologies presented in Section 2 with reference to a selection of our published empirical IP studies, (iv) Section 5 provides a discussion and Section 6 brief concluding remarks.