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ARTICLE · 23 SEPTEMBER 2020

Pharmaceutical patent term extensions: broader is not always better

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File one or more divisional applications to make sure each registered substance is quarantined within its own patent.

AustraliaIntellectual Property
Ean Blackwell
Ean Blackwell
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mi ch
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Background

Australia's Patents Act provides a patent term extension (PTE) to account for the delays that can occur when obtaining regulatory approval for a pharmaceutical substance. The extension can last for up to five years and is available when the following requirements are met:

  • the patent, in substance, discloses and claims a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;
  • goods containing or consisting of the pharmaceutical substance are included in the Australian Register of Therapeutic Goods (ARTG); and
  • the first regulatory approval for the pharmaceutical substance occurred more than five years after the filing date of the patent.

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Shelston IP ranked one of Australia's leading Intellectual Property firms in 2015.

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