AstraZeneca Wins Injunction Blocking Generic Dapagliflozin Launch in Australia
The Federal Court of Australia granted AstraZeneca an interlocutory injunction on 16 February 2026 preventing Pharmacor from launching generic dapagliflozin products pending infringement proceedings, marking the second such injunction in three months.
On 16 February 2026, the Federal Court of Australia granted an urgent interlocutory injunction preventing Pharmacor Pty Ltd from launching its generic dapagliflozin products in Australia pending the outcome of infringement proceedings brought by AstraZeneca AB. This is the second injunction granted to a patentee in the space of 3 months in Australia, the other being in relation to the launch of generic paliperidone palmitate products, breaking a more than 7-year drought of such relief.
Dapagliflozin is the active compound in AstraZeneca's drug FORXIGA, used in the treatment of type 2 diabetes, chronic kidney disease and heart failure. AstraZeneca is the owner of a patent directed at the compound with a priority date of 20 May 2002 and an expiry date of 22 October 2027.
On 14 November 2025, Pharmacor applied to register its generic dapagliflozin products on the Australian Register of Therapeutic Goods. AstraZeneca promptly wrote to Pharmacor. In response, on 3 December 2025, Pharmacor indicated to AstraZeneca that it expected to list two of its products on the PBS with effect from 1 April 2025. AstraZeneca commenced proceedings on 17 December 2025 for patent infringement and sought urgent interlocutory relief.
Pharmacor did not contest that its products fall within the scope of the patent claims, so the question was whether Pharmacor's invalidity arguments had any reasonable likelihood of success. The injunction application was heard and determined by the Federal Court in about a week, given the cutoff date for withdrawal of the PBS application was 18 February 2026.
Pharmacor argued that the patent claims were invalid on three grounds: novelty, inventive step, and manner of manufacture. Downes J ultimately found that the invalidity case did not sufficiently alter the strength of the infringement claim.
On novelty, Pharmacor relied on an earlier patent publication referred to as WO 128 as the relevant prior art. The Court rejected the argument that WO 128 anticipated the claims of AstraZeneca's patent.
On inventive step, Pharmacor argued that the claims of the patent were obvious in light of WO 128. The Court found that there was insufficient evidence to support the proposition that the invention would have been obvious to a person skilled in the art on the basis of either the prior art or common general knowledge. The Court also considered the "technical advance" test for inventive step which is used in the UK and observed, to the extent that this test forms part of Australian law (of which she was not convinced) that this was a matter for final hearing and that, in any event, AstraZeneca's patent disclosed something having a genuine advantage over other compounds within WO 128's broad genus.
On manner of manufacture, Pharmacor argued that because the patent admits the compound was disclosed within WO 128 and claims it for a use that was also known, this demonstrates that it is not a "new" manner of manufacture but an old disclosure "in another guise". However, the Court held that the patent properly described and claimed a manner of manufacture that was not specifically disclosed before.
Pharmacor also argued that so-called "selection patent principles" applied to undermine the validity of AstraZeneca's patent. The Court declined to accept that these principles form part of current Australian law and even if such principles did apply, they would not displace AstraZeneca's prima facie case for infringement.
AstraZeneca also brought claims under the Australian Consumer Law, alleging that Pharmacor's failure to warn customers of the potential patent infringement risk constituted misleading or deceptive conduct. The Court accepted that there was a strong prima facie case for misleading or deceptive conduct under the ACL, given that this claim was closely tied to the patent infringement case, but that this would rise or fall with the patent infringement case.
Having established a prima facie case on infringement and on the ACL claims, the Court turned to the balance of convenience and concluded that it strongly favoured the grant of an interlocutory injunction.