AUSTRALIA Trends and Developments Contributed by: Ben Miller, Alexandra de Zwart, Fiona Deng and Emma Woelke, Maddocks
disrupt the market and cause lasting price effects that would be difficult to remedy with damages alone. However, there has been a notable evolution in how the Court assesses the balance of convenience in pharmaceutical patent disputes, particularly in the context of first generic/biosimilar launches and PBS price dynamics. The Court’s decision in Regeneron shows just how far the balance has shifted in favour of generic and biosimilar companies. Pricing Historically, Australian courts viewed the 25% manda ‑ tory statutory price reduction applied to an originator product when the first generic/biosimilar is listed on the PBS as a significant factor weighing in favour of an interlocutory injunction because it would change the status quo, with no guarantee that it would be reversed, even if the generic/biosimilar were later removed by a final injunction. However, reflecting the turning tide of legal sentiment, Justice Rofe found that, while a 25% price drop would occur, Regeneron and Bayer’s loss as a result of this price drop could be quantified and damages would be an adequate remedy. Regeneron and Bayer also argued that there might be additional price reductions for EYLEA, including fur ‑ ther price disclosure-related reductions or if Sandoz entered pricing negotiations with the government and offered a further reduced approved ex-manufacturer price (AEMP). Justice Rofe did not, however, accept that this was a significant factor. Her Honour found that, as biological drugs, further price discounts were expected to be minimal compared to typical small molecule generics due to limited biosimilar competi ‑ tion, restricted pharmacist substitution options, and little incentive for ophthalmologists to switch prod ‑ ucts. Justice Rofe also rejected an argument that, once EYLEA moved PBS Formulary (from F1 to F2), certain special agreements between Regeneron/Bayer and the government would cease, meaning the effec ‑ tive price (reduced by 25%) would become publicly available and could be used by international pricing regimes (eg, in the USA or Taiwan) to reduce the price for EYLEA in other countries. Her Honour said that there was a lack of corroborating evidence of suffi ‑
cient certainty to prove the risk of this, or the extent of any asserted reduction. First mover advantage Sandoz argued that being the first biosimilar to enter the market would give it a significant and lasting advantage, greater than for small molecule generics, as prescribers are relatively unlikely to switch patients to a second biosimilar once initiated on treatment with the first biosimilar. Sandoz also argued that biosimilars take much longer to develop and obtain regulatory approval, and that launching the Sandoz products immediately would give Sandoz a significant com ‑ petitive edge over other biosimilar contenders, who might otherwise be able to launch at the same time as Sandoz if Sandoz were restrained. Finally, Sandoz noted that Regeneron/Bayer could themselves launch an “authorised biosimilar”, which would change the status quo, rob Sandoz of its first mover advantage, and make the calculation of relief difficult. Justice Rofe agreed, holding that the first mover advantage could have a major impact on Sandoz’s market share and was a relevant factor in assessing the balance of convenience. Overall, Justice Rofe held that the balance of conveni ‑ ence did not support granting an interlocutory injunc ‑ tion, a conclusion bolstered by her Honour’s assess ‑ ment of Regeneron/Bayer’s prima facie infringement case as relatively weak. Factors such as the unique characteristics of the biosimilar market, prolonged development timelines, regulatory approval process ‑ es, the importance of encouraging biosimilar uptake, and the significance of the first-mover advantage were all influential in persuading the Court that the balance of convenience favoured Sandoz’s launch. Following an appeal by Regeneron and Bayer to the Full Court, the proceeding was resolved commercially. No PTEs for Formulations: Sun Pharma v Otsuka In December 2025, the Full Court of the Federal Court of Australia delivered one of the most notable patent decisions of the year in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161, clarifying the scope of the patent term extension (PTE) provisions of the Patents Act 1990 (Cth).
11 CHAMBERS.COM
Powered by FlippingBook