IPTA and MA seek to intervene in Otsuka’s Application for Leave to appeal to Australia’s High Court
On 30 January 2026, two industry organisations – the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and Medicines Australia (MA) – filed applications with the High Court of Australia to intervene as amici curiae in Otsuka’s application for special leave to appeal from the decision of the Full Federal Court finding that pharmaceutical formulations are not eligible for a patent term extension (PTE).
IPTA is the peak industry body representing Australian patent and trade mark attorneys. MA is the peak industry body representing originator pharmaceutical companies in Australia.
The Full Court decision has significant ramifications for originator companies as now:
- patentees cannot extend the term of pharmaceutical formulation patents; and
- PTEs for such patents are both unenforceable and vulnerable to challenge via a low cost rectification process in the patent office.
Given this seismic re-calibration in law and practice in Australia, it was inevitable that Otsuka would seek special leave to appeal to the High Court, and that industry bodies such as IPTA and MA would wish to be heard on the special leave application and any subsequent High Court appeal. It remains to be seen whether others will apply to intervene.
We will provide a further update as soon as the High Court announces the date on which Otsuka’s special leave application is to be heard and determined.
Read more about the Australian patent extension regime in our free PTE eBook which can be downloaded Pharmaceutical Patent Term Extensions in Australia.
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CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Helen Macpherson
Executive, Lawyer (Head of Litigation –Australia)
Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.