Commonwealth of Australia v Sanofi

Damages – Undertaking as to damages – Where interlocutory injunction obtained to prevent manufacture or sale of generic pharmaceutical products – Where compensation sought for loss suffered as result of generic products not being listed on Pharmaceutical Benefits Scheme ("PBS") – Whether generic products would have been listed on PBS but for interlocutory injunction – Counter-factual approach – Whether onus of proof discharged.

Appeals – Standard of review – Ultimate appellate court – Where concurrent factual findings of lower courts – Whether special or exceptional circumstances – Whether plain injustice or clear error – Whether concurrent findings not clearly wrong – Whether concurrent findings open and compelling.

Onus of proof – Shifting evidential onus – Whether rigid legal rule applied for proof of loss arising from undertaking as to damages.

Words and phrases – "clear error", "concurrent findings", "counter-factual", "evidential onus", "interlocutory injunction", "onus of proof", "plain injustice", "special or exceptional circumstances", "standard of review", "ultimate appellate court", "undertaking as to damages".

National Health Act 1953 (Cth) – ss 99ACB, 99ACH.