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