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High Court Win for Australian Generic Pharmaceutical Companies on Blockbuster Cholesterol Drug

Issued: September 02 2015

In a unanimous judgment handed down on September 2, 2015, Australia's High Court dismissed a final attempt by AstraZeneca to prevent generic pharmaceutical companies, including two of Minter Ellison's clients, from selling their competitor versions of its Crestor (rosuvastatin) cholesterol drug. 


The judgment brings to an end patent litigation commenced in late 2011, when AstraZeneca, the holder of three Crestor-related patents, commenced infringement proceedings against generic pharmaceutical companies Watson, Ascent and Apotex. 



MinterEllison, with a team led by partner Wayne McMaster assisted by Jonathan Kelp (senior associate) and Amy Surkis (associate), represented Watson and Ascent , two of the three generic pharmaceutical companies that succeeded in the case.


Following today's success in the High Court, generic pharmaceutical companies (including Watson and Ascent) who were restrained from entering the market for more than a year because of an interlocutory injunction obtained by AstraZeneca in early 2012 can now seek compensation from AstraZeneca for the sales they would have made during that period.



In 2013, the Federal Court held that the generic companies' products would not infringe AstraZeneca's patents and, in any event, all three patents were partially or wholly invalid on numerous grounds. 


In August 2014, an expanded five-judge bench of the Full Federal Court rejected an appeal by Astrazeneca against the Judge's findings on invalidity and infringement in respect of two of the three patents.  


Earlier this year, AstraZeneca was granted special leave to appeal to the High Court on two specific issues – the proper approach for assessing inventive step (a ground of invalidity), and whether AstraZeneca should have been permitted to run a new argument on entitlement in the Full Court.


The recent judgment in September comprehensively upheld the approach to inventive step adopted by the trial judge and the Full Court. As a result, the High Court did not need to consider the entitlement issue, and AstraZeneca's appeal was dismissed with costs.


Herbert Smith Freehills – legal adviser to Apotex;  Ashurst Australia – legal adviser to AstraZeneca


Rosuvastatin is the third most prescribed drug in Australia, and the most expensive by cost to Australia (taking into account both cost to Government through the PBS and cost to patients when filling a prescription). 


According to Pharmaceutical Benefits Scheme (PBS) figures, the Australian Government spent A$298.6 million on rosuvastatin in the 2013-14 financial year. 



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