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Lifecycle management of orphan drugs approved in Japan

BACKGROUND: The development of orphan drugs (ODs) is challenging from both development and business perspectives because of their small patient populations. To overcome such business challenges, lifecycle management (LCM), which maximizes profits by increasing sales and extending product lifetimes,...

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Autores principales: Seki, Kiyoshi, Suzuki, Hiroshi, Abe, Seiji, Saotome, Chikako
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9336109/
https://www.ncbi.nlm.nih.gov/pubmed/35906686
http://dx.doi.org/10.1186/s13023-022-02456-w
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author Seki, Kiyoshi
Suzuki, Hiroshi
Abe, Seiji
Saotome, Chikako
author_facet Seki, Kiyoshi
Suzuki, Hiroshi
Abe, Seiji
Saotome, Chikako
author_sort Seki, Kiyoshi
collection PubMed
description BACKGROUND: The development of orphan drugs (ODs) is challenging from both development and business perspectives because of their small patient populations. To overcome such business challenges, lifecycle management (LCM), which maximizes profits by increasing sales and extending product lifetimes, is important to overcome the business challenges arising from their small patient populations. To clarify the activities of the LCM of ODs, we investigated additional indications that contribute to market expansion and marketing exclusivity using the patent extension and re-examination system of ODs approved in Japan between 2004 and 2019. RESULTS: The 203 ODs consisting of 173 active ingredients were approved in Japan between 2004 and 2019. Sixty-eight (39%) of the 173 active ingredients have additional indications, of which 57 have at least one non-OD indication. Three-fourths of the 203 ODs had patent rights, and most of them included substance or use claims. Although the re-examination period for most ODs was 10 years after the approval, most patents had a longer duration than the re-examination period. CONCLUSIONS: Pharmaceutical companies were actively adding non-OD indications and were emphasizing the use of patent rights by registering extensions of substance or use patents for exclusive marketing periods. These results indicate that LCM through the addition of indications and registration of patent extensions is carried out as a strategy for many ODs in Japan, similar to the LCM of general non-ODs.
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spelling pubmed-93361092022-07-30 Lifecycle management of orphan drugs approved in Japan Seki, Kiyoshi Suzuki, Hiroshi Abe, Seiji Saotome, Chikako Orphanet J Rare Dis Research BACKGROUND: The development of orphan drugs (ODs) is challenging from both development and business perspectives because of their small patient populations. To overcome such business challenges, lifecycle management (LCM), which maximizes profits by increasing sales and extending product lifetimes, is important to overcome the business challenges arising from their small patient populations. To clarify the activities of the LCM of ODs, we investigated additional indications that contribute to market expansion and marketing exclusivity using the patent extension and re-examination system of ODs approved in Japan between 2004 and 2019. RESULTS: The 203 ODs consisting of 173 active ingredients were approved in Japan between 2004 and 2019. Sixty-eight (39%) of the 173 active ingredients have additional indications, of which 57 have at least one non-OD indication. Three-fourths of the 203 ODs had patent rights, and most of them included substance or use claims. Although the re-examination period for most ODs was 10 years after the approval, most patents had a longer duration than the re-examination period. CONCLUSIONS: Pharmaceutical companies were actively adding non-OD indications and were emphasizing the use of patent rights by registering extensions of substance or use patents for exclusive marketing periods. These results indicate that LCM through the addition of indications and registration of patent extensions is carried out as a strategy for many ODs in Japan, similar to the LCM of general non-ODs. BioMed Central 2022-07-29 /pmc/articles/PMC9336109/ /pubmed/35906686 http://dx.doi.org/10.1186/s13023-022-02456-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Seki, Kiyoshi
Suzuki, Hiroshi
Abe, Seiji
Saotome, Chikako
Lifecycle management of orphan drugs approved in Japan
title Lifecycle management of orphan drugs approved in Japan
title_full Lifecycle management of orphan drugs approved in Japan
title_fullStr Lifecycle management of orphan drugs approved in Japan
title_full_unstemmed Lifecycle management of orphan drugs approved in Japan
title_short Lifecycle management of orphan drugs approved in Japan
title_sort lifecycle management of orphan drugs approved in japan
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9336109/
https://www.ncbi.nlm.nih.gov/pubmed/35906686
http://dx.doi.org/10.1186/s13023-022-02456-w
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