Is the Tide Turning for Pharmaceutical Patent Preliminary Injunctions in Australia?

Key Takeaways

• Federal Court granted first pharma PIs in eight years
• Janssen case involved dosing‑regimen patent for INVEGA SUSTENNA
• AstraZeneca case centered on dapagliflozin selection‑invention patent
• Courts emphasized strong prima facie infringement for injunctions
• Decisions may reshape Australian pharma patent enforcement landscape

Summary

After eight years of denying pharmaceutical preliminary injunctions, Australia’s Federal Court granted two rare orders in 2025‑26, favoring originators Janssen and AstraZeneca. The court applied the traditional two‑factor test—prima facie infringement and balance of convenience—but placed greater weight on the strength of the infringement case. Both decisions involve high‑impact patents: a three‑step dosing regimen for INVEGA SUSTENNA and a dapagliflozin selection‑invention for FORXIGA. The rulings suggest a potential shift toward more aggressive protection of pharma patents pending trial.

Pulse Analysis

Australia’s patent landscape has long favored monetary damages over interlocutory relief, especially in the pharmaceutical sector where a generic’s entry onto the Pharmaceutical Benefits Scheme triggers an automatic price cut for the originator. This de‑facto deterrent limited innovators’ ability to preserve market exclusivity while litigation unfolded, prompting criticism from industry groups that the system undervalued the protective purpose of patents. The recent decisions break that pattern, offering a fresh judicial perspective on how preliminary injunctions can be leveraged to maintain the status quo during disputes.

In the Janssen Pharmaceutica v Juno case, the court dissected a multi‑step dosing‑regimen patent, concluding that even partial compliance with the patented protocol by a generic could constitute infringement. By focusing on the prima facie strength of Janssen’s claim and deeming Juno’s invalidity arguments merely arguable, the judges tipped the balance of convenience toward an injunction. This reasoning underscores that dosing‑regimen patents, traditionally viewed as procedural, can now command robust equitable relief when commercial harm is imminent.

The AstraZeneca v Pharmacor ruling further expands the doctrine by rejecting the notion that selection‑invention criteria are part of Australian law. The court held that a clear, unmistakable disclosure in prior art is required to defeat novelty, and that the alleged lack of inventive step does not erode the prima facie infringement case. By highlighting the public interest in preserving the statutory monopoly that fuels innovation, the judgment may encourage more frequent PI applications, reshaping how generic entrants approach the PBS and prompting tighter patent strategy across the industry.