AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
pharmacy compounding exemption; as such, phar ‑ macists have been unable to compound or supply such preparations, with civil and criminal penalties for unlawful manufacture and associated advertising. In addition to TGA regulations, Australia is also served by the Medicines Australia Code of Conduct Com ‑ mittee, which is empowered to impose financial penalties for Code breaches. In December 2025, the Code Committee fined Amgen for breaches relating to misleading promotional material concerning Repa ‑ tha, including comparative statements concerning Novartis’s Leqvio. The complaint centred on infor ‑ mation provided by Amgen in a product information table for Repatha, with the Code Committee finding that Amgen had failed to supply adequate evidence “Protective” trade mark strategies are especially important in the pharmaceutical and life sciences sector, where brand equity often outlasts individual product patents and sits alongside complex regulato ‑ ry naming rules. Protective/defensive marks are effec ‑ tively available for well‑known brands that have been used so extensively that consumers would assume a connection if the mark appeared on unrelated goods – and, unlike ordinary marks, they are not vulnerable to non‑use removal, making them attractive for “block out” protection of blockbuster medicines and corpo ‑ rate house brands in a crowded marketplace, where product promotion is restricted and highly regulated. to justify the comparison. Protective Trade Marks
In August 2025, the Trade Mark Office delivered its decision in Sandoz AG v Actor Pharmaceuticals Pty Ltd [2025] ATMO 152, which concerned Actor’s appli ‑ cation for the word mark “ACC”. Sandoz markets a cough suppressant containing acetylcysteine under the ACC brand. Actor is a local licensee and distribu ‑ tor of Sinupret, a product described as being in “direct competition” with the Sandoz product. Sandoz opposed the registration on several grounds, including Section 60 of the Trade Marks Act 1995 (Cth), arguing that the mark was similar to one that had acquired a reputation in Australia. Notably, San ‑ doz was only able to present evidence of its product’s reputation in Germany and South Africa, relying on the concept of “spill-over” reputation extending to Australia. The Delegate found that Sandoz had not adequately demonstrated how use of the Actor trade mark in Australia would lead consumers to be con ‑ fused or deceived into thinking there was an associa ‑ tion with the Sandoz product, and the application was permitted to proceed to registration. Recent trends in trade mark filings indicate a renewed focus on defensive and other “protective” trade mark strategies in Australia, especially within the pharma ‑ ceutical and life sciences sectors. This is supported by findings in IP Australia’s IP Report, which noted an increase in trade mark applications in the medical and veterinary service categories by domestic applicants for 2024/2025.
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