Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) & Ors

The Commonwealth of Australia appeals to the High Court of Australia against a decision of the Full Court of the Federal Court of Australia, which overturned a decision of a single judge. The dispute arose from an interlocutory injunction granted in 2007 to Sanofi-Aventis (now Sanofi) against Apotex, a generic pharmaceutical company. The injunction prevented Apotex from listing and launching its generic version of the drug clopidogrel on the Pharmaceutical Benefits Scheme (PBS). The Commonwealth, as a party with an interest in the undertaking as to damages given by Sanofi, seeks to recover losses it claims were caused by the injunction.

The central legal issue before the High Court is the assessment of damages under the undertaking as to damages given by Sanofi. Specifically, the Commonwealth contends that both the primary judge and the Full Court erred in their approach to determining causation. The Commonwealth argues that the courts below failed to properly apply the principles for assessing damages, particularly concerning the evidential burden on the party seeking to recover damages and the onus on the party giving the undertaking to provide evidence to displace a prima facie case. The Commonwealth asserts that Apotex unequivocally stated its intention to list and launch the drug if no injunction was granted, supported by sworn evidence, and that this constituted a prima facie case of loss.

The Commonwealth's argument is that the courts below incorrectly shifted the onus to the Commonwealth to prove that Apotex would have launched the drug, rather than requiring Sanofi to demonstrate why Apotex might not have done so, despite its clear statements. The Commonwealth submits that Apotex's statements to the court, made by counsel and supported by affidavit evidence, were unequivocal and made with knowledge of all relevant facts and reasonable anticipations at the time. It argues that Sanofi failed to adduce sufficient evidence to contradict this prima facie case, relying instead on speculation or unsupported suggestions of potential deceit by Apotex. The Commonwealth contends that the correct approach requires a clear causal link between the injunction and the loss, and that Sanofi has not discharged its onus to show that Apotex would not have launched the drug even if the injunction had not been granted.

The High Court has reserved its decision.