The study titled “Personalised Medicine – Incentives from Exclusivities Provided by IP and Regulatory Law” hypothesizes that due to unique characteristics of personalized medicine (PM) and resulting implications, existing intellectual property (IP) and regulatory exclusivities fail to incentivize investment in the development and commercialization of PM. It is commonly held that the relatively limited market size of PM calls into question the relevance of patent protection, given the potential for limited returns on investment. Two key premises underlie this argument: First, it is the financial opportunities offered by the market, not the exclusivity conferred by patents, that attract investment. Second, smaller markets mean reduced expected profits and fewer incentives, rendering patents less significant. To evaluate the incentive landscape for PM, the author investigates how PM is accommodated by patents, analysing eligibility, patentability, protection scope, and conferred rights. Contrary to initial assumptions, the study finds that PM markets are not unattractive financially because of their size. Due to the process of segmentation, a single substance may be utilised for a multitude of applications, encompassing both personalised/orphan and conventional drugs. While each application market may be characterised by a smaller consumer base, it is important to note that this does not represent the entire scale of the consumption. Factors like the added value of more efficient and targeted treatments, cost reductions in clinical trials, and shorter trial durations also enhance PM's appeal. However, despite no significant challenges to the patentability and eligibility of PM drugs and diagnostics, the enforcement of these rights against infringement is notably challenging. While some issues with PM diagnostic patent infringement may be eased through a unified patent system, the landscape for second medical use patents remains complex. Infringement poses a critical risk to the IP system, undermining confidence and incentives for investment in original pharmaceuticals. The uncertain enforcement environment encourages strategic behavior from both patent holders and generic manufacturers, potentially leading to market dysfunction. Given these limitations within the patent system, the study also examines the regulatory exclusivity framework as a potential benefit for PM. It offers an unprecedented holistic examination of the innovation incentives under patent, Supplementary Protection Certificates (SPC), and regulatory laws. The study aligns with the European Commission’s initiatives to reform the orphan drug incentive system, potentially serving as a valuable resource for addressing identified shortcomings. The study discovers that while the EU aspires to lead globally in PM research and recognizes its societal importance—especially given ageing populations and escalating healthcare costs—no specific exclusivity rights for PM have been introduced or the existing adapted. This includes both patents and regulatory exclusivities. To address this gap, the author deconstructs the concept of PM from scientific, economic, and normative perspectives to identify potential subjects that could be covered by exclusivity rights. The in-depth analysis effectively demystifies the complex scientific and economic foundations of PM, making them accessible and understandable. By doing so, the author identifies areas within PM that could benefit from dedicated exclusivity rights. Such rights would not only offer stronger incentives for investment in PM but also align with broader policy goals and societal needs.
