Commonwealth pushes ahead with appeal against Sanofi

Pharma News: In mid-2023, Australia’s Full Federal Court dismissed the Commonwealth’s compensation claim against Sanofi, the patent owner of clopidogrel, in a verdict that could reshape the landscape of pharmaceutical patent disputes.

The court upheld the Federal Court’s earlier ruling, asserting that the Commonwealth had failed to demonstrate that Apotex Pty Ltd would have included its generic version of clopidogrel on the Pharmaceutical Benefits Scheme (PBS) at an earlier date, had it not been restrained by an interlocutory injunction from Sanofi.

Undeterred by the setback, the Commonwealth promptly sought special leave to appeal to the High Court of Australia, a move that has now been granted, setting the stage for an unprecedented legal showdown. The Commonwealth is aggressively pursuing compensation exceeding AUD 300 million, citing additional costs incurred by the PBS.

The appeal is expected to be heard later this year and will mark the first time Australia’s highest court addresses the issue of damages incurred by the Commonwealth due to the delayed listing of a generic pharmaceutical resulting from an interlocutory injunction.

Justice James Edelman, during the special leave application hearing, acknowledged the complexity of the legal rules governing damages claims in such cases, emphasising their broader implications for the pharmaceutical industry.

The Commonwealth has not shied away from pursuing similar claims in the past, having made at least three other compensation claims related to PBS arising from delayed generic market entry. Notably, settlements were reached in two of these cases against Wyeth (venlafaxine/Efexor XR) and AstraZeneca (rosuvastatin/Crestor), while an ongoing claim persists against Otsuka and BMS (aripiprazole/Abilify).

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