The High Court of Australia has granted special leave to appeal from the decision of the Full Federal Court of Australia in Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) 2023 FCAFC 97.
The High Court of Australia indicated that questions concerning the legal rules for the assessment of damages flowing from an undertaking as to damages, a condition required from the party seeking the grant of an interlocutory injunction, are matters of public importance.
The Full Federal Court of Australia held that the Australian Government was not entitled to compensatory damages to recover its drug subsidies paid under the Australian Pharmaceutical Benefits Scheme (PBS) to the originator patentee, when a preliminary injunction had delayed the entry of the generic drug into the Australian market.
The Hearing is expected to take 2-3 days, commencing 5th February 2024.
The outcome of the High Court of Australia will have consequences for pharmaceutical originator patentees seeking to prevent the entry of a generic drug into the Australian market through the grant of a preliminary injunction.
Further, the outcome will have consequences for the Australian Government’s right to seek “market-size damages” from the originator patentee, directed to the recovery of PBS subsidies previously paid to the patentee, in the circumstances when the granted patent is subsequently revoked by a Court.
We will provide updates in due course.