February 2026 A recent decision of the Australian Full Federal Court has caused a significant change in practice regarding patent term extension for pharmaceutical substances in Australia. Specifically, patent term extension will now only be available for active pharmaceutical ingredients, whereas it was previously also available for novel and inventive formulations.
In many countries, patents are granted for inventions and last for 20 years, subject to payment of renewal fees at regular intervals. However, some countries permit the patent term to be extended provided certain requirements are met.
In the UK and the EU, a Supplementary Protection Certificate (“SPC”) can be obtained for a patented medicinal product or plant protection product for which a valid marketing authorisation has been issued by the relevant regulatory authority. If granted, an SPC can effectively extend the term of a patent for up to 5 years.
Importantly, SPCs are intended to only extend protection for the active ingredients of medicinal products and plant protection products. Thus, a new formulation of a known active ingredient which has previously been the subject of a valid marketing authorisation cannot be protected by an SPC.
The situation has until now been very different in Australia, where patent term extension (“PTE”) could be obtained for a “pharmaceutical substance” generally. It has therefore been possible for many years to obtain PTE for novel and inventive formulations of known active ingredients, which contrasts with the approach taken by the UK and the EU.
A recent decision of the Australian Full Federal Court has, however, overhauled this practice, holding that the term “pharmaceutical substance” refers to active pharmaceutical ingredients only. This means that PTEs granted for formulation patents will now be considered vulnerable, meaning that any such PTE is now open to a finding of invalidity and thus revocation.
Conclusions
This change in Australian practice will be alarming to proprietors of formulation patents in Australia, especially those relying on PTE to extend the protection of their formulation inventions beyond the normal 20-year patent term.
However, it is worth noting that this shift brings Australian practice more closely into line with that of the UK and the EU, and thus to those of us practising in the UK this decision of the Australian Full Federal Court is perhaps not as controversial as it may seem to our Australian counterparts.
At Schlich, we are well-versed in protecting active ingredients and formulations alike, and thus if you would like our assistance navigating this area of the IP landscape, we would be happy to help.
