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

The parties to this proceeding are the Commonwealth of Australia (applicant) and Sanofi (formerly Sanofi-Aventis), Sanofi-Aventis US LLC, and Bristol-Myers Squibb Investco LLC (respondents). The matter before the High Court of Australia concerned an application for special leave to appeal concerning the legal rules for the assessment of damages on an undertaking as to damages. The High Court indicated that while the issues were of public importance, it had concerns about whether the appeal would be an appropriate vehicle to decide them.

The legal issues before the court revolved around the assessment of damages in the context of an undertaking given by a party seeking an interlocutory injunction. Specifically, the dispute concerned the counterfactual scenario: whether Apotex would have sought to list clopidogrel on the Pharmaceutical Benefits Scheme (PBS) prior to 1 May 2010, absent the injunction granted to Sanofi. The Commonwealth contended that Apotex, as an aggressive generic company, would have sought to list the drug to gain a first-mover advantage, even at the risk of paying damages if it ultimately lost a patent revocation suit. The respondents, conversely, argued that Apotex had not made a firm decision to launch and that the evidence presented by the Commonwealth was insufficient to establish this counterfactual.

The applicant, the Commonwealth, argued that the factual world was not in dispute: the injunction prevented Apotex from listing clopidogrel before 1 May 2010, resulting in a loss to the Commonwealth in the order of hundreds of millions of dollars. The dispute centred on the counterfactual, with the Commonwealth relying on statements made by Apotex's counsel and on oath by a witness as evidence of their intention to list. The Commonwealth submitted that the Full Court had erred in its reasoning, particularly concerning a 28 June email, by failing to properly consider crucial phrases and by overlooking the significance of statements made to the court regarding Apotex's intention to list. The Commonwealth argued that this evidence, when properly considered alongside objective probabilities, established a prima facie case that Apotex would have listed the drug.

The respondents, in their submissions, challenged the significance attributed to the 28 June email, arguing that it was a small part of a large volume of evidence and that the five words highlighted by the Commonwealth did not constitute a fresh or irrevocable instruction to launch. They contended that Mr Millichamp, a key witness, had not given evidence of such specific instructions and that any such instruction would not have been privileged. Furthermore, the respondents argued that the circumstances surrounding the alleged instruction were subsequently overtaken by events in September 2007, namely the delay in PBS listing and the acceleration of the trial.