Abstract
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 of2020. 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.
market protection. This study analyses all instances this extra protection was awarded up until the end of2020. 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.
| Original language | English |
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| DOIs | |
| Publication status | Published - 24 May 2021 |
Publication series
| Name | European Pharmaceutical Law Review |
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Keywords
- drug repurposing
- regulatory protection
- Europe