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ARTICLE · 27 MARCH 2022

Full Federal Court doubles down on pharmaceutical patent term extensions

Spruson & Ferguson Lawyers
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The decisions of Ono and MSD both provide some much-needed clarity regarding how PTE provisions are to be construed.

AustraliaIntellectual Property
Ken Johnstone
Ken Johnstone
Elizabeth Barrett
Elizabeth Barrett
Daniel Sieveking
Daniel Sieveking
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In two appeal judgements handed down concurrently on 18 March 2022, the Full Federal Court has clarified that a pharmaceutical patent term extension (PTE) for a patent should be based on the earliest Australian regulatory approval date of a pharmaceutical substance which is disclosed and claimed in the patent, irrespective of whether the substance was developed by the patentee or a competitor.

Key Points

  • A patentee's own earlier ARTG (Australian Register of Therapeutic Goods) listed pharmaceutical substance, or an earlier ARTG listed substance of a competitor (if disclosed and claimed in the patent) can affect the deadline for filing an application for a PTE and the term of the extension.

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