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Reconsidering Repositioning Incentives: An Empirical Legal Analysis of Market Protection for New Therapeutic Indications

Johnathon Liddicoat, Kathleen Liddell, Zoë Fritz

DOI https://doi.org/10.21552/eplr/2021/3/4



In Europe, drugs that are shown to have new therapeutic indications can receive additional market protection. This study analyses all instances this extra protection was awarded up until the end of 2020. This study pioneers a method to analyse what type of new indications receive the extra protection and shows that it was awarded for treating new patient cohorts as often as new medical conditions. No evidence supports granting extra protection for new patient cohorts. Therefore, this paper argues to pare back the circumstances the extra protection is awarded.

Johnathon Liddicoat, Senior Research Associate, Centre for Law, Medicine, and Life Sciences, Faculty of Law, University of Cambridge. This research was support by the Novo Nordisk Foundation for the scientifically independent Collaborative Research Program for Biomedical Innovation Law (grant NNF17SA0027784). Kathleen Liddell, Reader, Centre for Law, Medicine, and Life Sciences, Faculty of Law, University of Cambridge. Zoë Fritz, Department of Acute Medicine, Cambridge University Hospitals, and The Healthcare Improvement Studies Institute, University of Cambridge. The authors acknowledge helpful feedback and assistance from Dr Jakob Wested, Andrew Sagar and Matthew Jordan. For Correspondence: <jel68@cam.ac.uk>

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Liddicoat, J. , Liddell, K. , & Fritz, Z.
Reconsidering Repositioning Incentives: An Empirical Legal Analysis of Market Protection for New Therapeutic Indications
European Pharmaceutical Law Review
Volume 5, Issue 3 (2021)
pp. 110 - 122
DOI: https://doi.org/10.21552/eplr/2021/3/4

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