New TGA guidance on the regulation of AI-based software medical devices
17 February 2026
Opportunities for the application of AI in health and life sciences continue to grow.
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Suzy Madar
Special leave in Aristocrat refused: Australia’s approach to patentability of CIIs settled
11 February 2026
Following the High Court’s refusal of special leave to the Commissioner of Patents on 5 February 2026, Australia now has a clear position on computer-implemented inventions (CIIs): the Full Federal Court’s September 2025 articulation of the test in Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents[1] remains the settled law.
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Federal Court grants first preliminary injunction to pharma patentee in 7 years
28 January 2026
On 5 December 2025, the Federal Court of Australia granted an interlocutory injunction restraining the launch and Pharmaceutical Benefits Scheme (PBS) listing of generic long-acting injectable (LAI) paliperidone palmitate products.
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Australia reformulates its position on patent term extensions
15 December 2025
The Full Federal Court of Australia has determined that pharmaceutical formulations are not eligible for patent term extension in Australia.
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Collaborating? Here’s how to avoid a web of IP issues
22 August 2025
Commercial collaboration can create unbeatable opportunities for innovation and securing return on investment.
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A new code for care: decoding the impact of Genomics Australia
19 August 2025
The Australian health sector is entering a transformative phase with the official launch of Genomics Australia on 1 July 2025 and a new Australian Health Genomics Commissioner.
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It’s alive — and growing! Updates from the TGA’s 2025 AI review
5 August 2025
The rapid evolution of artificial intelligence and the expansion of the use of software in the delivery of healthcare is transforming the medtech landscape, offering unprecedented opportunities for innovation in patient care.
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Expert evidence blows up detonator patent litigation
25 July 2025
In a long, but intricately reasoned first instance judgment, Australia’s Federal Court has ruled on the validity and infringement of patents relating to wireless detonators.
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Branched meanings: Lexicography of ‘branched alkyl’ decides Moderna’s COVID-19 vaccine patent dispute
1 July 2025
The United States Court of Appeals for the Federal Circuit (CAFC) recently decided that Moderna’s mRNA-based COVID-19 vaccine, SPIKEVAX®, did not infringe Alnylam’s patents because the cationic lipid used in the vaccine, SM-102, was not a cationic lipid with a ‘branched alkyl’ group.[1] The case turned on the proper construction of ‘branched alkyl’.
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The digital doctor will see you now: AI large language models expanding telehealth offerings
26 June 2025
In a country as geographically vast as Australia, providing high quality health care can be difficult to provide cost effectively.
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