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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pharmaceuticals
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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Stop! In the name of interlocutory injunctions: lessons from 2024
17 March 2025
Interlocutory injunctions can be a critical tool to help protect intellectual property rights by restraining alleged infringement while a substantive infringement proceeding is run.
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Substance over form(ulations)? An update on patent term extensions
18 February 2025
Two recent Federal Court decisions illustrate that term extensions are available for a broad range of patents, including formulation patents.
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Ouch! Federal Court of Australia imposes $4.5 million-dollar penalty for misleading marketing of pain-relief products
3 June 2020
The Federal Court has handed down a significant $4.5 million penalty over misleading claims made with respect to the over-the-counter muscular pain relief products, ‘Voltaren Osteo Gel’ and ‘Voltaren Emulgel’.
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Australian company ordered to pay $10 million for unacceptable advertising claims: TGA uses its power to penalise inappropriate online advertisement and sale of therapeutic goods
2 August 2019
With increased internet penetration, the development of a myriad of mobile/ online applications for the delivery of digital health services that are expected to transform the way in which health care is provided and experienced, and the exponential growth in the number of e-commerce businesses vying for a share in the online retail space, there can be little doubt that the health care landscape is undergoing rapid change.
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United States FDA gets serious about biosimilars
5 September 2018
The most significant advances in medical treatments are being made with biological products.
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Biosimilars: balancing access to affordable medicines with safety
3 November 2017
Biological medicines (biologics) are agents derived from a biological source.
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