Commonwealth Fails in $325 Million Recovery Bid

Nicholas J has rejected the Commonwealth’s claim for damages in the long-awaited decision of Commonwealth of Australia v Sanofi (No 5) [2020], handed down on 28 April 2020 FCA 543.

In this proceeding, the Commonwealth sought compensation for its payments under the Pharmaceutical Benefits Scheme (PBS) to subsidise Sanofi’s drug Plavix (clopidogrel). The Commonwealth argued that it had suffered a loss of up to $325 million because Apotex was delayed from listing its generic form of clopidogrel on the PBS and triggering a price reduction, due to a wrongly granted interlocutory injunction.

The Commonwealth’s claim was rejected because it did not show that Apotex would have listed its products on the PBS in the absence of the injunction on the balance of probabilities.


Sanofi is the originator of the blockbuster multi-billion-dollar drug clopidogrel, an antiplatelet medication which is used to prevent blood clots and reduce the risk of stroke and heart disease.

In Australia, Sanofi Australia Pty Ltd (Sanofi) sold clopidogrel under the name Plavix while Bristol-Myers Squibb Australia Pty Ltd sold it under the name Iscover. Both products were registered on the ARTG on 2 December 1998 and listed on the PBS on 1 November 1999.

On 21 August 2007 Apotex Pty Ltd (Apotex) registered its clopidogrel products on the ARTG. Shortly thereafter, Apotex commenced proceedings against Sanofi to invalidate the Sanofi clopidogrel patent to clear the way for Apotex to launch its generic version of Plavix (Apotex Product) in Australia. Sanofi counter-claimed for infringement.

In September 2007, Apotex applied for a PBS listing but its application was filed too late to be listed on the PBS from 1 December 2007. Apotex subsequently withdrew that application.

Please click here to read the full update.

Wrays Industry Insights, Insights