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ARTICLE · 05 JUNE 2024

Pharmaceutical patent term extension in Australia

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Summary of the requirements & some recent Federal Court decisions relating to pharmaceutical patents.

AustraliaIntellectual Property
Elizabeth Barrett
Elizabeth Barrett
Daniel Sieveking
Daniel Sieveking
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This article was first published in the 2023 Pharmaceutical Patent Review.

Patent term extensions (PTEs) can be of great commercial importance, and in recent years have become of particular interest in Australian pharmaceutical patent law following a number of Federal Court decisions clarifying the circumstances in which PTEs may be available.

We provide here a summary of the requirements and some recent Federal Court decisions in this area.
Under Australian patent law, it is possible to apply for a PTE of up to 5 years for a standard patent that claims a pharmaceutical substance, in recognition of the exceptionally long time and regulatory requirements involved in developing and commercialising a new pharmaceutical substance.

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