In a recent decision, the Federal Court of Australia has granted an interlocutory injunction which prevents Pharmacor Pty Ltd from launching its generic dapagliflozin product. This decision appears to be in contrast to previous injunctions (which I commented on in a previous article).
Background
AstraZeneca AB is the Applicant for Australian Patent No. 2003237886 entitled “C-aryl glucoside SGLT2 inhibitors and method”. The patent relates to the chemical compound ‘dapagliflozin’. Dapagliflozin is used in the treatment of type 2 diabetes, chromic kidney disease and heart failure. The patent is due to expire on 22 October 2027.
Pharmacor applied to register a generic dapagliflozin product on the Australian Register of Therapeutic Goods on 14 November 2025 (before the expiry of the patent) and indicated that they were looking to list two generic products on the PBS from April 2025. AstraZeneca subsequently asserted patent infringement of claims 1 and 2 of the patent and sought interlocutory relief.
It should be noted that Pharmacor did not contest the infringement claim, but challenged the validity of the patent on the grounds of novelty, inventive step and manner of manufacture.
In determining whether to grant an interlocutory injunction, two questions are considered:
1. whether there is a prima facie case of infringement; and
2. whether the balance of convenience favours the grant of injunctive relief (which includes whether the Applicant is likely to suffer injury where damages will not be an adequate remedy).
Prima Facie case
Given that Pharmacor did not contest the infringement claim put forward by AstraZeneca, the Court found that AstraZeneca had established a prima facie case of patent infringement. As such, the major question to be asked is whether the validity case (novelty, inventive step and manner of manufacture) was sufficiently strong to undermine the patent infringement.
Without going into excessive detail, Pharmacor’s validity case was based upon dapagliflozin being anticipated by prior art (novelty), the invention being obvious to the person skilled in the art (inventive step), and the compound already being disclosed in the prior art, so the claims were not directed to a manner of manufacture (manner of manufacture).
Ultimately, the Federal Court found that Pharmacor’s validity case did not alter the strength of the infringement case. That is, even considering the validity case put forward by Pharmacor, the Federal Court still found that there was a prima facie case of infringement.
Balance of Convenience
The next question examined after the prima facie case consideration is the balance of convenience. In this step, the Court considers inconvenience, hardship and/or injury that may be suffered by the Applicant if an interlocutory injunction is refused against the inconvenience, hardship and/or injury suffered by the respondent if an injunction is granted. The Federal Court contemplated evidence from both AstraZeneca and Pharmacor.
Without an Injunction
The Federal Court considered that dapagliflozin (marketed as FORXIGA) was AstraZeneca’s largest brand by revenue in Australia and was critically important to AstraZeneca, that the 25% price drop once Pharmcor’s products were listed on the PBS (and other long term pricing implications) would result in significant loss to AstraZeneca. There would also be a lost opportunity for AstraZeneca to bring its own authorised generic product to the market before Pharmacor.
With an Injunction
The Federal Court considered that granting an injunction would result in Pharmacor losing the first generic mover advantage, potential loss in market share, lost opportunities in developing relationship with pharmacies, revenue loss in the first year, and difficulty in calculating the losses associated with the above.
Ultimately, the Federal Court found that the potential harm and/or hardship that would be suffered by AstraZeneca outweighed the potential harm or hardship that would be suffered by Pharmacor.
Key Take Aways
As mentioned above, the Federal Court granted the interlocutory injunction and found that the balance of convenience favoured restraining Pharmacor. Key factors in this decision were Pharmacor’s admitted infringement and that the validity challenge did not undermine the infringement case. Another factor was that comprehensive undertakings were offered by AstraZeneca. It should be noted that the trial was also expedited.
The present granting of the interlocutory injunction is in contrast to previous decisions whereby interlocutory injunctions were generally not granted. Please see my previous article in relation to a few examples of interlocutory cases.
A significant issue in the present case is that the infringement case was not contested by Pharmacor and the validity case was not sufficient to undermine the infringement case. As such the Federal Court granted the interlocutory injunction.
If you have further queries about interlocutory injunctions in Australia, please contact MBIP via email on mail@mbip.com.au. Our experienced team of attorneys would be glad to assist.
