AstraZeneca Secures Interlocutory Injunction Against Generic Dapagliflozin Entry

By Rebecca Currey, Hannah Barnett, Jonathan Wong and Cassandra Wong

On 16 February 2026, the Federal Court of Australia granted an urgent interlocutory injunction preventing Pharmacor Pty Ltd (Pharmacor) from launching its generic dapagliflozin products in Australia pending the outcome of infringement proceeding brought by AstraZeneca AB (AZ).  

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.

These recent decisions show that Australian Courts are still willing to grant urgent relief to a patentee in certain circumstances.

We explain the facts of this case in more detail below. 

Background 

Dapagliflozin is the active compound in AZ’s drug FORXIGA, used in the treatment of type 2 diabetes, chronic kidney disease and heart failure. AZ 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. AZ promptly wrote to Pharmacor. In response, on 3 December 2025, Pharmacor indicated to AZ that it expected to list two of its products on the PBS with effect from 1 April 2025. 

AZ 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. 

The Court’s Findings

In the granting of any injunction, the Federal Court will consider these factors:

• whether there is a prima facie case of infringement;
• whether damages is an adequate remedy; and
• where the balance of convenience lies. 

Prima facie case

Pharmacor argued that the patent claims were invalid on three grounds:

• lack of novelty — asserting that dapagliflozin was anticipated by prior art;
• lack of inventive step — contending the invention would have been obvious to a person skilled in the relevant art; and
• lack of manner of manufacture — arguing that because the compound was already disclosed in prior art, the claims were not to a “manner of manufacture”. 

AZ also brought claims under the Australian Consumer Law (ACL), alleging that Pharmacor’s failure to warn customers of the potential patent infringement risk constituted misleading or deceptive conduct.

Downes J ultimately found that the invalidity case did not sufficiently alter the strength of the infringement claim. 

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 AZ’s patent, finding that:

• WO 128 disclosed a broad genus of millions of chemical compounds and did not provide clear and unmistakable directions to make dapagliflozin specifically;
• dapagliflozin was merely “encompassed” by the broad chemical formulae in WO 128 (Formula 1 and Formula 1B) rather than specifically disclosed; and
• expert evidence did not suggest that WO 128 contained a specific direction to “obtain” dapagliflozin, nor that dapagliflozin would be arrived at as an inevitable result of following the prior art.

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, that AZ’s patent disclosed something having a genuine advantage over other compounds within WO 128’s broad genus.

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. 

Selection patent principles

Pharmacor also argued that so-called “selection patent principles” applied to undermine the validity of AZ’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 AZ’s prima facie case for infringement.

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. 

Balance of Convenience

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.

The Court found that the potential harm to AZ outweighed the harm to Pharmacor. This included consideration of:

• FORXIGA being AZ’s largest brand by revenue in Australia and it being “critically important” to AZ;
• the immediate 25% price drop to AZ’s FORXIGA once Pharmacor’s products are listed on the PBS and potentially other discounting and long-term pricing implications that Pharmacor may engage in which would cause further significant loss to AZ;
• AZ’s lost opportunity to bring its own authorised generic to market before Pharmacor, meaning that Pharmacor would be the first generic to market and gain the first mover advantage; and
• on the other hand, Pharmacor’s claimed loss of its first mover advantage and the difficulties in calculating the associated loss. 

Similar Proceedings in the UK

In similar proceedings in the UK, AZ was eventually granted an interim injunction preventing Glenmark Pharmaceuticals from launching generic dapagliflozin.

However, in proceedings brought by Glenmark and Viatris, amongst others, the UK High Court later found that AZ’s relevant EP patent was invalid for lack of inventive step and insufficient disclosure. This was upheld by the Court of Appeal. AZ’s application for permission to appeal to the Supreme Court was also subsequently refused. 

Notably, the UK courts did grant AZ’s applications for short-term interim injunctions pending decisions in the various appeal/permission to appeal stages.