On 16 February 2026, the Federal Court of Australia granted an urgent interlocutory injunction restraining Pharmacor from launching and listing generic dapagliflozin products on the PBS. This decision marks the second interlocutory injunction granted to a pharmaceutical patentee since the 7-year trend of refusing these injunctions was broken in December 2025 in Janssen Pharmaceutica NV v Juno Pharmaceuticals Pty Ltd.[1]
Background
AstraZeneca is the owner of Australian Patent No. 2003237886 (the Patent) for dapagliflozin, used to treat diabetes, chronic kidney disease, and heart failure. Dapagliflozin tablets are marketed in Australia under the brand name FORXIGA® and in combination products with other compounds.
Following the listing of four dapagliflozin products on the Australian Register of Therapeutic Goods by Pharmacor (the Pharmacor Products) and confirmation by Pharmacor that it planned to list at least two of these on the PBS from 1 April 2026, AstraZeneca commenced proceedings seeking an urgent injunction to restrain Pharmacor’s launch prior to the deadline for withdrawing the PBS application.
Prima facie case
It was not in dispute that the Pharmacor Products fall within the scope of the Patent. The issue was whether Pharmacor’s invalidity position was sufficiently strong to displace the conclusion that AstraZeneca had a strong prima facie case of infringement.
Novelty
Pharmacor’s novelty challenge relied on an earlier patent application (WO 128) that disclosed a broad class of compounds (Formula I) and a narrower subset of ‘most preferred’ compounds (Structure IB). While dapagliflozin fell within Structure IB, it was not specifically disclosed or claimed in WO 128.
Given that Formula I encompassed an immeasurably large number of potential compounds, and Structure IB millions of compounds, Downes J considered that WO 128 did not contain a specific direction to obtain dapagliflozin and dapagliflozin would not be created as an inevitable result.
As a result, the invalidity attack on the basis of lack of novelty did not diminish the strength of the prima facie case of infringement.
Inventive step
On inventive step, Pharmacor argued that the claims were obvious in light of WO 128, applying the ‘technical advance’ test which is well-established in the UK. Justice Downes was not persuaded that the ‘technical advance’ test should be applied in Australia, noting that Pharmacor did not cite any Australian authority to support the test having been adopted in Australia. Her Honour considered that to the extent Pharmacor intended to persuade a court to adopt the test in Australia, that was a matter for trial.
Even if that test were applied, Downes J noted that dapagliflozin being a highly prescribed treatment for diabetes and other conditions pointed to the claimed compound having an advantage over the other compounds encompassed by the claims in WO 128.
Arguments from Pharmacor that principles relevant to ‘selection patents’ formed a part of Australian law on novelty and inventive step were also rejected.
Manner of manufacture
Pharmacor asserted that, because dapagliflozin was already disclosed in WO 128, the asserted claims were not to a ‘manner of manufacture’.
This argument also did not diminish the strength of the prima facie case on infringement. While the ground was found to be arguable, Downes J considered that the Patent appeared to disclose and claim a specific structure (being a new substance) that had not been explicitly disclosed and therefore, claim a ‘manner of manufacture’.
Australian Consumer Law (ACL)
AstraZeneca also alleged that Pharmacor’s conduct would mislead customers about infringement risk in breach of the Australian Consumer Law. Adopting the approach of Rofe J in Biogen International GmbH v Pharmacor Pty Ltd,[2] Downes J accepted that the ACL case would stand or fall with the patent infringement case, which her Honour considered to be strong.
Balance of convenience
Justice Downes then assessed various factors affecting the balance of convenience, including the following:
- FORXIGA® (and related combination products) is AstraZeneca’s largest brand by revenue in Australia and ‘critically important’ to its business. It was unimportant that most of AstraZeneca’s loss, if Pharmacor were to launch, would be suffered by a subsidiary rather than the patentee.
- By listing the Pharmacor Products on the PBS, Pharmacor would likely trigger an immediate 25% statutory price reduction for FORXIGA®, causing ‘significant’ loss to AstraZeneca. If Pharmacor (and any other generic entrants) engaged in aggressive discounting — which is common and which Pharmacor did not offer undertakings to refrain from — further statutory price reductions would likely follow.
- There was ‘a very real possibility’ of further generic launches, with Pharmacor’s own evidence indicating that at least 15 other companies had started applying for regulatory approval. This would intensify pricing competition.
- Pharmacor’s launch would deprive AstraZeneca of the opportunity to plan and implement an effective authorised generic strategy. It would need to ‘scramble’ to launch an authorised generic product, which would not be possible until at least a month after Pharmacor’s launch.
- If restrained, Pharmacor would lose the opportunity to obtain a valuable ‘first mover advantage’.
- AstraZeneca offered the usual undertaking to compensate parties who suffer loss as a result of the grant of the interlocutory injunction in the event the claim is ultimately unsuccessful. The court acknowledged the difficulty associated with quantifying harm suffered by Pharmacor and third parties (such as the Commonwealth) in the event a claim on the undertaking was made.
- AstraZeneca offered a range of other undertakings, including:
- to seek interlocutory injunctions to restrain any other proposed generic launches and to notify Pharmacor of those applications
- not to seek or authorise PBS listing of generic products
- not to license any other generic products and
- to prosecute its claim expeditiously.
Her Honour ultimately concluded that the balance of convenience favoured the grant of an interlocutory injunction.
Key takeaways
This decision shows that the Federal Court of Australia remains willing to grant interlocutory relief to pharmaceutical patentees where the circumstances are justified.
Further, it will do so quickly where necessary. Given the timing of Pharmacor’s proposed PBS listing, this interlocutory injunction application was filed in mid-December, heard within around 7 weeks and determined (with reasons published) only 10 days later. The proceeding is set down for trial on an expedited basis starting in August 2026 – fewer than 9 months after the proceeding commenced.
In recent years, the complexities that can arise if an interlocutory injunction is wrongly granted in a pharmaceutical context have often been regarded by Australian courts as a key factor weighing strongly against the grant of interlocutory injunctions. However, both this decision and the recent paliperidone interlocutory injunction decision appear to have afforded that factor less weight.
It remains to be seen whether this simply reflects the particular circumstances of those cases or whether a trend is emerging.
Featured image by Miguel Á. Padriñán from Pixabay.
[1] Janssen Pharmaceutica NV v Juno Pharmaceuticals Pty Ltd [2025] FCA 1538.
[2] Biogen International GmbH v Pharmacor Pty Ltd (2021) 165 IPR 64; [2021] FCA 1591 at [161]-[166].
