For nearly eight years, the Federal Court of Australia consistently rejected every application for preliminary injunctions (PIs) initiated by originator companies. The court’s prevailing stance was that any damages resulting from a generic’s market entry could be adequately compensated through monetary payments once the main proceedings concluded. However, the beginning of 2026 has been marked by a true sensation: the court granted not one, but two consecutive injunctions, signaling a radical shift in the country’s legal climate.

In the Australian legal system, a decision regarding a PI depends on two factors: the existence of a prima facie case (strong evidence of the applicant’s rights) and the “balance of convenience.”

The latter factor is critical for the pharmaceutical industry because the first registration of a generic drug in the state subsidy program (PBS) automatically and irreversibly lowers the price of the original medicinal product. If it is later discovered that the generic infringed the patent, the originator can no longer restore the old price, causing irreparable commercial harm.

Key Precedents

• Janssen Pharmaceutica NV v Juno Pharmaceuticals [2025] The dispute concerned a three-stage dosing regimen for paliperidone palmitate used to treat schizophrenia. Juno planned to launch products with instructions that effectively replicated the treatment scheme protected by Janssen’s patent. The court sided with the originator, characterizing Juno’s arguments regarding patent invalidity as “arguable at best” and emphasizing that Janssen would suffer irreparable harm if the generic entered the market before the trial’s conclusion.

• AstraZeneca AB v Pharmacor [2026] An even bigger surprise was the ruling involving the popular type 2 diabetes medication, dapagliflozin (Forxiga). The defendant attempted to challenge the patent’s novelty, arguing that the compound was part of a broader general formula (Markush formula) known previously. However, the court rejected this argument, noting that to invalidate novelty, a prior source must contain “clear and unmistakable directions” specifically for that invention.

A Shift in Public Interest

The most significant aspect of the AstraZeneca decision was the court’s commentary on public interest. The judge emphasized that while society benefits from cheaper medicines, the state’s strategic interest lies in encouraging innovation. The lack of judicial protection for patents undermines the research and development ecosystem in Australia.

“These two rulings send a clear signal: Australian courts no longer view monetary compensation as a universal solution.”

If an originator’s case is strong, the “tide” of justice can now stop a generic even before it hits pharmacy shelves, providing genuine protection for intellectual property.

Founder of Research & Patent group Intectica, author of patent algorithms for solving problems in the pharmaceutical industry, patent attorney certified in all intellectual property objects (Patents, Design, TM), with education in chemistry and law, chief expert of the patent institution of Ukraine UKRPATENT (1997-2004). Member of international organizations, including ECTA, PTMG, UAM, lecturer and blogger.