| Date of decision: | 12 March 2026 |
| Body: | High Court of Australia |
| Adjudicator: |
Gageler CJ, Gordon, Edelman, Steward, Gleeson, Jagot, Beech-Jones JJ |
BREAKING NEWS: The High Court of Australia today granted special leave to Otsuka to appeal the decision of the Full Federal Court in Otsuka v Sun Pharma [2025].
In a victory for Sun Pharma over Otsuka regarding Sun Pharma’s generic aripiprazole, the Full Court found that a pharmaceutical substance is limited to active pharmaceutical ingredients and PTE eligibility does not extend to formulations combining those ingredients with excipients.
The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and Medicines Australia (MA) had each filed applications with the High Court seeking to intervene as amici curiae, underscoring the importance of this issue to the pharmaceutical industry. We have previously commented on that significance here.
Given the significant shift in patent practice that the Full Court decision induced, drug manufacturers and patent professionals alike will follow the progress of Otsuka’s appeal with great interest. We will report further as the appeal progresses.
For further information about the changes in law and practice in Australia relating to PTE and PI, see our March 2025 Masterclass here.
About Pearce IP
Pearce IP is a specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.
In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees). Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others.
Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)
Naomi is the CEO and Founder of Pearce IP, and is one of ANZ’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 29 years’ experience, and a background in molecular biology/biochemistry.
Ranked in virtually every notable legal directory, highly regarded by peers and clients, Naomi is renowned for her successful and elegant IP/legal strategies focussing on complex/multijurisdictional litigation, global FTO, and strategic advice. Among other awards, Naomi is the 2026 Lexology Client Choice Winner for Patents, the 2024 Lawyers Weekly Women in Law “Executive of the Year”, the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology Client Choice Winner for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year”, and the 2021 Lawyers Weekly Women in Law “Partner of the Year”. Ranked in Chambers Asia Pacific, Chambers Global, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks.
Pearce IP is the premier life sciences focussed firm in ANZ. Commencing in 2017. Pearce IP is the 2025 Australasian Lawyer and NZ Lawyer 5-Star Employer of Choice & “Standout Winner” for Inclusion and Culture (<100 employees). In 2021, Pearce IP was the Lawyers Weekly Australian Law Awards IP Team of the Year.
Paul Johns
Executive, Lawyer (Head of Litigation – New Zealand)
Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand. Paul appears in cases before the New Zealand Court of Appeal and High Court of New Zealand, as well as the New Zealand Intellectual Property Office and IP Australia
Paul is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment. Paul is recommended for litigation in the IAM Patent 1000, rated for enforcement and litigation in the WTR1000, ranked for Intellectual Property Asia-Pacific in Chambers, and recognised for Intellectual Property and Litigation in Best Lawyers.
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.