Commonwealth of Australia v Sanofi [2024] HCA 47

HIGH COURT OF AUSTRALIA

GORDON A-CJ,

EDELMAN, STEWARD, JAGOT AND BEECH‑JONES JJ

COMMONWEALTH OF AUSTRALIA APPELLANT

AND

SANOFI (FORMERLY SANOFI-AVENTIS) & ORS RESPONDENTS

Commonwealth of Australia v Sanofi

[2024] HCA 47

Date of Hearing: 4 & 5 September 2024

Date of Judgment: 11 December 2024

S169/2023

ORDER

Appeal dismissed with costs.

On appeal from the Federal Court of Australia

Representation

J T Gleeson SC and F T Roughley SC with G Watson Keesing and M F Caristo for the appellant (instructed by Corrs Chambers Westgarth)

J C Sheahan KC with J J Hutton SC, S Fitzpatrick and B K Lim for the respondents (instructed by Jones Day)

Notice: This copy of the Court's Reasons for Judgment is subject to formal revision prior to publication in the Commonwealth Law Reports.

CATCHWORDS

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".