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Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.
AstraZeneca's three patents protecting Crestor (rosuvastatin) have been ruled invalid by the Federal Court of Australia.
AstraZeneca's three patents protecting Crestor (rosuvastatin) have been ruled invalid by the Federal Court of Australia. The patents include a formulation patent expiring in 2020, a patent related to the use of rosuvastatin for the treatment of heterozygous familial hypercholesterolemia, which will expire in 2021, and a patent for treating hypercholesterolaemia with an expiry date of 2020. These patents were challenged by Apotex, Watson Pharma, and Ascent Pharma.
AstraZeneca has expressed disappointment in the court’s ruling on the validity of these three patents. The company is, however, committed to defending its intellectual property protecting Crestor in Australia. This decision is being carefully reviewed while AstraZeneca continues to evaluate all legal options at this stage, which could include filing an appeal and seeking to maintain existing preliminary injunctions.
A press release from the company has stated that the decision of the Federal Court only applies in Australia and will have no impact on the validity of Crestor patents in other countries. It also does not affect AstraZeneca’s financial guidance for 2013, which will, in accordance with normal practice, be reviewed in conjunction with the announcement of the company's first quarter financial results on Apr. 25, 2013.
Sales of Crestor in Australia amounted to approximately $350 million in 2012.