Repositioning generic drugs: Empirical Findings & Policy Implications
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Repositioning generic drugs: Empirical Findings & Policy Implications. / Liddicoat, Johnathon; Liddell, Kathleen ; Darrow, Jonathan; Aboy, Mateo; Jordan, Matthew; Crespo, Cristina; Minssen, Timo.
In: IIC International Review of Intellectual Property and Competition Law, Vol. 53, No. 9, 2022, p. 1287-1322.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Repositioning generic drugs: Empirical Findings & Policy Implications
AU - Liddicoat, Johnathon
AU - Liddell, Kathleen
AU - Darrow, Jonathan
AU - Aboy, Mateo
AU - Jordan, Matthew
AU - Crespo, Cristina
AU - Minssen, Timo
PY - 2022
Y1 - 2022
N2 - Commentators claim that drug repositioning (ie developing new uses for authorised drugs) significantly slows when generics are authorised and, therefore, law reform is necessary to encourage more R&D. This study empirically examines this claim by analysing records of clinical trials. It finds that once generics are authorised: i) commercial trials continue at ‘active’ rates for approximately half of the drugs studied, and ii) the number of hospital and university trials actually increases. These findings cast doubt on whether additional incentives are needed. They also indicate that a more effective way to reposition drugs is for recently established government programmes to embrace IP strategies and leverage the hospital and university trials as an R&D pipeline.Keywords: drug repositioning, patent law, regulatory protection, clinical trials, empirical study, generic drugs.
AB - Commentators claim that drug repositioning (ie developing new uses for authorised drugs) significantly slows when generics are authorised and, therefore, law reform is necessary to encourage more R&D. This study empirically examines this claim by analysing records of clinical trials. It finds that once generics are authorised: i) commercial trials continue at ‘active’ rates for approximately half of the drugs studied, and ii) the number of hospital and university trials actually increases. These findings cast doubt on whether additional incentives are needed. They also indicate that a more effective way to reposition drugs is for recently established government programmes to embrace IP strategies and leverage the hospital and university trials as an R&D pipeline.Keywords: drug repositioning, patent law, regulatory protection, clinical trials, empirical study, generic drugs.
U2 - 10.1007/s40319-022-01241-3
DO - 10.1007/s40319-022-01241-3
M3 - Journal article
VL - 53
SP - 1287
EP - 1322
JO - IIC International Review of Intellectual Property and Competition Law
JF - IIC International Review of Intellectual Property and Competition Law
SN - 0018-9855
IS - 9
ER -
ID: 306454713