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26 October 2023FeaturesBiotechnologyNaomi Pearce and Kate Legge

A hard lesson learnt: Commonwealth v Sanofi

In June this year, the first Full Federal Court decision on this issue was handed down following a ten-year damages battle between the Commonwealth and Sanofi relating to Apotex’s ‘delayed’ launch of generic clopidogrel following PI.

In Commonwealth of Australia v Sanofi FCAFC 97 (June 26, 2023), the court denied the Commonwealth’s application for AUS $355 million ($229.6 million) damages from Sanofi (supplier of Plavix), and made a costs order against the Commonwealth, which is expected to be in the order of tens of millions of dollars.

In order to obtain PI, the patentee must provide an ‘undertaking as to damages’ which applies to the world at large. It applies to the Commonwealth’s savings foregone, even when the Commonwealth is not a party to the patent proceedings. As the Commonwealth has learned the hard way, the devil’s in the detail.

The court rejected the Commonwealth’s claim relating to ‘delayed’ sales of generic clopidogrel, finding that it had not established that Apotex would have listed and launched in the absence of PI.

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