Author: Vanessa Yeung - MBIP (Australia)

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Lessons for the Commonwealth and Generic Pharmaceutical Manufacturers When Seeking a Claim to Damages

The High Court case Commonwealth of Australia v Sanofi [2024] HCA 47 examined the issue of recoverable damages and the burden of proof in the context of a wrongly granted interlocutory injunction.

Sanofi’s patent which covered clopidogrel, was sold as Iscover® and Plavix® and is prescribed for heart attack and stroke patients. In 2007–2008, Sanofi enforced its patent against Apotex, preventing it from competing in the pharmaceutical market. Specifically, injunctions from the Federal Court of Australia blocked Apotex from securing a PBS-listing for its generic clopidogrel product. Apotex successfully appealed in 2009, which led to revocation of Sanofi’s patent. Following Sanofi’s failure to appeal their case to the High Court, the Commonwealth intervened and stood in as the appellant, acting in the interest of the public to keep medicinal costs afforsable. Seeking $11 million in damages, the Commonwealth argued that the injunction imposed on Apotex, delayed launch of a generic version of clopidogrel on 1 April 2008, resulting in higher drug prices.