Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity

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Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity. / Liddicoat, Johnathon; Liddell, Kathleen; Aboy, Mateo; Wested, Jakob.

In: IIC International Review of Intellectual Property and Competition Law, Vol. 52, No. 7, 2021, p. 825-851.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Liddicoat, J, Liddell, K, Aboy, M & Wested, J 2021, 'Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity', IIC International Review of Intellectual Property and Competition Law, vol. 52, no. 7, pp. 825-851. https://doi.org/10.1007/s40319-021-01088-0

APA

Liddicoat, J., Liddell, K., Aboy, M., & Wested, J. (2021). Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity. IIC International Review of Intellectual Property and Competition Law, 52(7), 825-851. https://doi.org/10.1007/s40319-021-01088-0

Vancouver

Liddicoat J, Liddell K, Aboy M, Wested J. Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity. IIC International Review of Intellectual Property and Competition Law. 2021;52(7):825-851. https://doi.org/10.1007/s40319-021-01088-0

Author

Liddicoat, Johnathon ; Liddell, Kathleen ; Aboy, Mateo ; Wested, Jakob. / Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity. In: IIC International Review of Intellectual Property and Competition Law. 2021 ; Vol. 52, No. 7. pp. 825-851.

Bibtex

@article{3f2e97e6f6f34023ab6958e74efe5089,
title = "Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity",
abstract = "EU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as “repositioning”) by offering them an extra year of market protection if the new use is authorised. This extra year, known as the “+1”, was enacted on limited evidence, and no study has examined its effect since it began. Yet, several leading commentators suggest lengthening the +1. This study assesses the effectiveness of the +1 by analysing all the relevant instances of MAHs repositioning their drugs before and after the +1 came into effect. The results show that: (i) 42.2% of MAHs repositioned their drugs before the +1 came into effect, and (ii) once the +1 did come into effect, it did not increase the percentage of MAHs that repositioned their drugs. This study finds that the +1 failed to increase repositioning and then proceeds to consider reform options, including repealing the law. In doing so, this study takes the first steps towards an evidence-based policy for the topic.",
keywords = "Drug repositioning, Empirical study, Intellectual property, Patents, Regulatory exclusivities",
author = "Johnathon Liddicoat and Kathleen Liddell and Mateo Aboy and Jakob Wested",
note = "Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
doi = "10.1007/s40319-021-01088-0",
language = "English",
volume = "52",
pages = "825--851",
journal = "IIC International Review of Intellectual Property and Competition Law",
issn = "0018-9855",
publisher = "Verlag C.H./Beck oHG",
number = "7",

}

RIS

TY - JOUR

T1 - Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity

AU - Liddicoat, Johnathon

AU - Liddell, Kathleen

AU - Aboy, Mateo

AU - Wested, Jakob

N1 - Publisher Copyright: © 2021, The Author(s).

PY - 2021

Y1 - 2021

N2 - EU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as “repositioning”) by offering them an extra year of market protection if the new use is authorised. This extra year, known as the “+1”, was enacted on limited evidence, and no study has examined its effect since it began. Yet, several leading commentators suggest lengthening the +1. This study assesses the effectiveness of the +1 by analysing all the relevant instances of MAHs repositioning their drugs before and after the +1 came into effect. The results show that: (i) 42.2% of MAHs repositioned their drugs before the +1 came into effect, and (ii) once the +1 did come into effect, it did not increase the percentage of MAHs that repositioned their drugs. This study finds that the +1 failed to increase repositioning and then proceeds to consider reform options, including repealing the law. In doing so, this study takes the first steps towards an evidence-based policy for the topic.

AB - EU law incentivises drug marketing authorisation holders (MAHs) to find new uses for their compounds (research known as “repositioning”) by offering them an extra year of market protection if the new use is authorised. This extra year, known as the “+1”, was enacted on limited evidence, and no study has examined its effect since it began. Yet, several leading commentators suggest lengthening the +1. This study assesses the effectiveness of the +1 by analysing all the relevant instances of MAHs repositioning their drugs before and after the +1 came into effect. The results show that: (i) 42.2% of MAHs repositioned their drugs before the +1 came into effect, and (ii) once the +1 did come into effect, it did not increase the percentage of MAHs that repositioned their drugs. This study finds that the +1 failed to increase repositioning and then proceeds to consider reform options, including repealing the law. In doing so, this study takes the first steps towards an evidence-based policy for the topic.

KW - Drug repositioning

KW - Empirical study

KW - Intellectual property

KW - Patents

KW - Regulatory exclusivities

U2 - 10.1007/s40319-021-01088-0

DO - 10.1007/s40319-021-01088-0

M3 - Journal article

AN - SCOPUS:85110890650

VL - 52

SP - 825

EP - 851

JO - IIC International Review of Intellectual Property and Competition Law

JF - IIC International Review of Intellectual Property and Competition Law

SN - 0018-9855

IS - 7

ER -

ID: 306973771