The ruling protects the pharma giant's monopoly on its largest revenue driver
The Federal Court granted an interlocutory injunction on 16 February 2026, blocking Pharmacor's generic dapagliflozin products until patent expiry.
In AstraZeneca AB v Pharmacor Pty Ltd, Justice Downes restrained Pharmacor from launching its generic dapagliflozin products, preserving AstraZeneca's monopoly on the diabetes, chronic kidney disease and heart failure treatment until the patent expires on 22 October 2027.
The decision protected FORXIGA, AstraZeneca's largest brand by revenue in Australia and the company's number one growth driver for 2026 and 2027. The court found that allowing Pharmacor's Pharmaceutical Benefits Scheme listing on 1 April 2026 would trigger an immediate 25 percent price reduction and cause irreparable harm to AstraZeneca's market position.
AstraZeneca presented evidence of substantial revenue losses if generic entry proceeded, though specific figures remained confidential. The company also faced losing the opportunity to mount an effective authorised generic strategy, as it could not bring its own generic to market before 1 May 2026 – giving Pharmacor a critical first-mover advantage.
Justice Downes questioned whether principles relating to selection patents form part of Australian law. Pharmacor had argued that these principles applied, pointing to the Full Court decision in Ranbaxy Australia v Warner-Lambert. However, the judge found that Ranbaxy did not establish these principles as binding authority.
The court applied the established novelty test from General Tire & Rubber, requiring "clear and unmistakable directions" to the claimed invention. Justice Downes found that while the prior art document WO 128 encompassed millions of compounds, it did not specifically disclose dapagliflozin or provide clear directions to obtain it.
Pharmacor admitted its products would infringe claims 1 and 2 of the patent but challenged validity on grounds of lack of novelty, inventive step and manner of manufacture. The court found these invalidity attacks did not diminish the strength of the prima facie infringement case.
The balance of convenience favoured AstraZeneca. Justice Downes noted that Pharmacor's entry could prompt rapid multiple generic entry, intensifying pricing competition. At least 15 other generics may have commenced Australian Register of Therapeutic Goods applications, positioning themselves to obtain PBS listing before patent expiry.
Pharmacor had also planned an aggressive "forward selling" strategy in its first month, selling substantial volumes at higher discounts to build pharmacy stockpiles. Each generic product carried a three-year shelf life, extending the impact well beyond April 2026.
The court accepted that calculating damages would prove considerably more complex if Pharmacor lost its first-mover position, as no actual track record would exist to assess what market share it would have captured.
AstraZeneca provided extensive undertakings, including commitments not to launch authorised generics or allow FORXIGA to move from F1 to F2 formulary status during the restraint period.
The substantive trial will commence on 31 August 2026.
