In June 2023, Australia’s Full Federal Court rejected the Commonwealth’s claim for compensation against Sanofi, owner of an Australian patent (AU 597784) covering the drug clopidogrel. In rejecting the claim, the Court upheld the Federal Court’s finding that the Commonwealth had failed to show Apotex Pty Ltd would have listed its generic version of clopidogrel on the Pharmaceutical Benefits Scheme (PBS) at an earlier date had it not been restrained by an interlocutory injunction.
Following the decision of the Full Federal Court, the Commonwealth sought special leave to appeal to the High Court of Australia against the dismissal, and on 18 December, leave was granted. The appeal is likely to be heard some time this year and will be the first time that Australia’s highest court will address the issue of damages incurred by the Commonwealth by delayed listing of a generic pharmaceutical due to an interlocutory injunction.
The Commonwealth has made at least three other claims under undertakings in relation to PBS prices resulting from delayed generic entry. Two of those claims (against Wyeth (venlafaxine/Efexor XR) and AstraZeneca (rosuvastatin/Crestor) were settled, while its claim against Otsuka and BMS (aripiprazole/Abilify) is ongoing.
We will continue to monitor developments and provide updates in this space. If you are a pharmaceutical manufacturer and need IP advice in relation to your business or products, reach out to our team of experts.