AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
in the common general knowledge about whether PCSK9 acted extracellularly or intracellularly on LDLR. Sanofi also argued that the claims were unclear as they did not define a numerical threshold for the word “competes”. While there was evidence showing dis ‑ crepancy between results of various assays and that choices would need to be made in the assay pro ‑ cedure, his Honour found that this would have been known to a person skilled in the art. His Honour held that “competes” is a binary concept whereby the antibody either does or does not compete, and that testing to identify competition would have been well known based on the specification. This decision highlights the significant changes between the pre- and post-RTB versions of the Pat ‑ ents Act, which should reduce the number of lower- quality patents granted and held to be valid in Austral ‑ ia. It seems likely the Section 40 grounds in particular would have been decided differently under the current version of the Act. Janssen Biotech v Samsung Bioepis – Ustekinumab (Stelara) Litigation This year also saw Samsung Bioepis win challenges to Janssen Biotech’s patents relating to the use of ustekinumab (Stelara) in the treatment of ulcerative colitis (one of the top five PBS drugs) on multiple fronts. In August 2024, after eight months of litigation in Sam ‑ sung Bioepis’s revocation proceedings in the Federal Court, Janssen surrendered two innovation patents a few months before trial, only to obtain three more (amended) innovation patents and commence fresh proceedings for infringement. Samsung Bioepis duly cross-claimed for revocation, and the litigation contin ‑ ued to trial in June 2025. Four days into a two-week trial, Janssen volunteered orders revoking all three of its patents. In October 2025, the Patent Office then handed down its decision upholding Samsung Bioepis’s opposition to Janssen’s patent application relating to the use of ustekinumab for ulcerative colitis, finding all claims invalid. Janssen has not appealed the decision nor sought to amend its patent application, signalling an
end to the dispute, and heralding the first biosimilar competition in a highly lucrative market. Regulatory Enforcement The TGA has responded to ongoing compliance and consumer protection concerns with robust enforce ‑ ment throughout 2025 and stepped up its regulatory focus on digital and direct-to-consumer promotion practices. In June, the TGA initiated Federal Court proceedings targeting AG Therapeutics and Mama ‑ mia.com.au over allegedly unlawful advertising of medicinal cannabis products. This action follows almost AUD280,000 in infringement notices being issued for unlawful advertising of medicinal canna ‑ bis in the year prior, and a trend of higher penalties ordered by courts for violations of the Therapeutic Goods Act 1989 (Cth), especially where misleading or non-compliant advertising is involved. Recent regulatory action also reflects a broader policy shift towards tighter risk-based control of emerging therapeutic markets, with vapes, medicinal cannabis and GLP‑1 receptor agonists all subject to height ‑ ened regulatory scrutiny and enforcement. In the vaping space, the TGA has moved from a relatively permissive import framework to a tightly controlled, “therapeutic use only” model, including a ban on the importation of disposable vapes, staged prohi ‑ bitions on non‑therapeutic and disposable products, and strengthened product standards and notification requirements for therapeutic vapes (covering ingre ‑ dients, nicotine concentration, packaging, labelling and flavour restrictions). These reforms are coupled with an aggressive compliance programme, involving joint operations with states and territories, takedowns of thousands of unlawful online advertisements, and blocking of non‑compliant websites, underscoring the TGA’s increasing willingness to use its civil and crimi ‑ nal enforcement toolkit. Over the past year, the TGA has also demonstrated readiness to intervene in the compounding sector on safety grounds, particularly when it comes to medical weight loss, such as GLP‑1 receptor agonists. Fol ‑ lowing consultation and high‑profile safety concerns about “replica” semaglutide and tirzepatide products, amendments to the Therapeutic Goods Regulations 1990 (Cth) removed GLP‑1 receptor agonists from the
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