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World Intellectual Property - 2024 - Henriksen - Data exclusivity and patent monopoly extension A view from Australia1.03 MB
Published VersionCC BY V4.0, Open Access
Journal article
Data exclusivity and patent monopoly extension: A view from Australia
Journal of World Intellectual Property, Vol.27(2), pp.314-338
2024
Appears in UniSC Supported Open Access Outputs
Abstract
Data exclusivity and patents are important to the pharmaceutical industry, and both these regimes coexist in the pharmaceutical landscape. Both data exclusivity and patents provide market exclusivity through monopoly periods. Because data exclusivity and patents can protect the same pharmaceutical, beginning at different times in the pharmaceutical lifecycle and having different durations, these terms may not coincide, and each can extend the effective market exclusivity period of the other. For example, when data exclusivity persists beyond patent expiry for a pharmaceutical, subsequent entrant access to the market is restricted and the period during which originators can charge high prices is extended. This article seeks to eliminate the situation where patent monopolies have expired, but data exclusivity remains in force by proposing a method to ensure that data exclusivity and patent terms expire simultaneously. Further, the proposal maintains the protection to innovators afforded by both data exclusivity and patents, recognising that these regimes protect different things in pharmaceutical development.
Details
- Title
- Data exclusivity and patent monopoly extension: A view from Australia
- Authors
- Teddy Henriksen (Corresponding Author) - University of the Sunshine Coast, Queensland, School of Law and SocietySimone Henriksen (Author) - University of the Sunshine Coast, Queensland, School of Law and Society
- Publication details
- Journal of World Intellectual Property, Vol.27(2), pp.314-338
- Publisher
- Wiley-Blackwell Publishing Ltd.
- Date published
- 2024
- DOI
- 10.1111/jwip.12302
- ISSN
- 1747-1796; 1422-2213
- Copyright note
- © 2024 The Authors. The Journal of World Intellectual Property published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
- Data Availability
- Data sharing is not applicable to this article as no new data were created or analyzed in this study.
- Organisation Unit
- School of Law and Society
- Language
- English
- Record Identifier
- 991016297602621
- Output Type
- Journal article
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