Pharmaceutical patent linkage in Australia – how does it work?

11 July 2022
Insights Photo
Insights Photo

While Australia does have a form of patent linkage, it is currently a limited system and in practice is not very useful for patentees.

Annabella Newton headshot
Dr Annabella Newton
Principal

There is no patent listing system (equivalent to the US FDA’s Orange Book) in Australia. The current patent linkage system extends only to the requirements asked of companies when they apply for regulatory approval for generic and biosimilar medicines. Patent holders have little say in the current system.

Read more here >>

Related news and insights

Insights Photo

Otsuka Update: Special Leave Filed and IP Australia Refines PTE Processing Approach

The patentee has filed a special leave application to the High Court of Australia seeking to appeal the Full Court’s decision in Otsuka Pharmaceutical Co., Ltd v Sun Pharma ANZ Pty Ltd.
Dr Annabella Newton

4 March 2026

Insights Photo

Australian Patent Term Extensions Narrowed: Full Federal Court Rules Formulation Claims Ineligible

In Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161[1], the Full Federal Court has confirmed that Australian patent term extensions (PTE) apply only to patents claiming an active pharmaceutical ingredient (API) per se. Formulation claims no longer qualify.
Dr Annabella Newton

5 December 2025

Insights Photo

PROTACs and Protein Degraders: Claiming Space in a Crowded IP Field

The emergence of protein degraders, including proteolysis-targeting chimeras (PROTACs) and molecular glues, represents one of the most exciting shifts in drug discovery over the past 20 years.
Dr Annabella Newton

18 August 2025

Learn more about what matters to our people

We are a curious and approachable team of professionals, united by a passion for IP and helping your ideas succeed.

Banner image
How can we help you?