20 February 2026
Case Summary
The Federal Court has granted AstraZeneca an interlocutory injunction restraining Pharmacor Pty Ltd from launching generic versions of the diabetes medication dapagliflozin (marketed as FORXIGA) before the expiry of AstraZeneca's patent in October 2027.
Justice Downes delivered judgment on 16 February 2026, finding in favour of AstraZeneca despite Pharmacor's challenges to the patent's validity and the broader public interest in lower-cost generic medications.
Background
AstraZeneca holds Australian Patent No. 2005203641 titled "C-aryl glucoside SGLT2 inhibitors and method," which relates to the chemical compound dapagliflozin. The patent is not due to expire until 22 October 2027.
Pharmacor, having obtained regulatory approval to market generic dapagliflozin products, planned to launch prior to patent expiry. While Pharmacor admitted its products would infringe claims 1 and 2 of the patent, it challenged the patent's validity on grounds of novelty, inventive step, and manner of manufacture.
Key Legal Issues
Prima Facie Case
The Court found AstraZeneca established a prima facie case of patent infringement, which Pharmacor did not dispute. The critical question became whether Pharmacor's validity challenges were sufficiently strong to undermine this prima facie case.
Selection Patents
A significant aspect of the case involved the consideration of "selection patents" — a patent concept relating to the selection of a particular compound from a broader class previously disclosed. Justice Downes examined whether selection patents form part of Australian law, analysing both UK and Australian precedent.
Validity Challenges
Pharmacor mounted challenges based on:
- Novelty: Arguing the invention was already disclosed in prior art
- Inventive step: Claiming the invention would have been obvious to a person skilled in the art
- Manner of manufacture: Questioning whether the patent claimed a proper subject matter
The Court found these challenges did not diminish the strength of AstraZeneca's prima facie case.
Balance of Convenience
Justice Downes carefully weighed competing interests:
Harm to AstraZeneca if Not Restrained
The Court accepted evidence that without an injunction, AstraZeneca would suffer:
- Significant market share erosion
- Price erosion across its dapagliflozin products
- Organisational harm (details redacted in the judgment)
- Difficulties in calculating and recovering damages
Notably, the Court rejected Pharmacor's argument that AstraZeneca should have launched its own authorised generic, finding no obligation to foresee and respond to a competitor's commercial decision to launch before patent expiry.
Harm to Pharmacor if Restrained
The Court acknowledged that restraining Pharmacor would result in:
- Loss of valuable "first mover advantage" in the generic market
- Potential market share ranging significantly based on historical data
- Lost opportunities to develop pharmacy relationships
- Considerable revenue loss in the first year
However, the Court found many of these losses could be compensated through AstraZeneca's undertaking as to damages, though acknowledged calculation complexities.
Public Interest Considerations
Justice Downes recognised the public and Commonwealth interest in lower-cost generic medications. However, His Honour emphasised that the patent system serves the broader public interest by encouraging and rewarding innovation. The Court noted that failing to restrain infringement could undermine Australia's patent system with negative consequences for future pharmaceutical research and development.
The Decision
The Court granted the interlocutory injunction, finding the balance of convenience favored restraining Pharmacor. Key factors included:
1. The strength of the prima facie infringement case
2. Pharmacor's admitted infringement
3. The Court's preliminary view that validity challenges did not undermine the infringement case
4. Comprehensive undertakings offered by AstraZeneca
5. The expedited trial scheduled for 31 August 2026
Costs were reserved rather than awarded to AstraZeneca.
Implications
This decision reinforces several important principles in Australian patent law:
- Patent holders can obtain interlocutory relief even when facing validity challenges, provided the prima facie case remains strong
- The public interest in lower medication costs does not automatically override patent rights
- The patent system's role in encouraging innovation is a significant consideration in pharmaceutical cases
- First mover advantage in the generic pharmaceutical market, while valuable, may be compensable through damages
The matter will proceed to a full trial commencing 31 August 2026, where the validity challenges will be fully tested.
Case Citation
AstraZeneca AB v Pharmacor Pty Ltd [2026] FCA 88
This case note is for informational purposes only and does not constitute legal advice. For specific legal guidance, please consult with a qualified intellectual property lawyer.
