AstraZeneca, a global, innovation-driven biopharmaceutical company, announced that the Federal Court of Australia has found three patents protecting Crestor (rosuvastatin) to be invalid. These patents – a formulation patent (AU 200051842, with an expiry date in 2020); a second related to the use of rosuvastatin for treating heterozygous familial hypercholesterolemia (AU 2002214165, with an expiry date in 2021); and a third related to the use of rosuvastatin for treating hypercholesterolemia (AU 2000023051, with an expiry date in 2020) – were challenged by Apotex Pty Ltd, Watson Pharma Pty Ltd and Ascent Pharma Pty Ltd.
The Federal Court decision is limited to Australia and has no impact on the validity of patents related to Crestor in other countries nor does it have any impact on AstraZeneca’s financial guidance for 2013, which will, in accordance with normal practice, be reviewed in conjunction with the announcement of First Quarter Financial Results on 25 April 2013.
Total sales of Crestor in Australia for 2012 were approximately $350 million.
AstraZeneca is disappointed in the court’s decision to find these patents invalid. The company remains committed to defending its intellectual property protecting Crestor in Australia and is carefully reviewing this decision and evaluating all legal options at this time, which could include filing an appeal and seeking to maintain existing preliminary injunctions.