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ARTICLE · 21 JANUARY 2021

Ono - Be careful with Patent Term Extensions (PTEs)

Madderns
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A PTE is a useful mechanism for a patentee to extend the term of a pharmaceutical patent from the standard 20-year term.

AustraliaIntellectual Property
Jeff Holman
Jeff Holman
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A patent term extension (PTE) provides a valuable mechanism for an Australian patent holder to extend the term of a pharmaceutical patent beyond the standard 20-year term. The PTE provisions are designed to compensate a patentee for the relatively long time required to develop, test and obtain regulatory approval to commercialise a new drug.

PTE Requirements

An application for a PTE can be made when (i) the patent relates to a pharmaceutical substance or a pharmaceutical substance when produced by recombinant DNA technology, (ii) the substance is included on the Australian Register of Therapeutic Goods (ARTG) before the 20-year term of the patent expires, and (iii) at least five years have elapsed between the effective filing date of the patent application and the first inclusion of the pharmaceutical on the ARTG.

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