Blockbuster drug goes bust? The Federal Court finds three AstraZeneca patents relating to Crestor (rosuvastatin) invalid

In an important decision handed down on Tuesday, Justice Jagot of the Federal Court held that three patents relating to the blockbuster drug Crestor (rosuvastatin) were invalid and liable to be revoked. The decision will have important implications for companies considering launching their own generic rosuvastatin products given that total sales of Crestor for 2012 were about $350m.

The patentee, AstraZeneca, which markets Crestor, asserted that various generic companies would infringe three of its patents which relate to rosuvastatin:

  1. A “low dose patent”, which claims a method of treating high cholesterol (hypercholesterolemia) by administering to a patient a low dose of rosuvastatin;
  2. A “HeFH patent”, which claims a method of treating high cholesterol caused by an inheritable genetic mutation by administering rosuvastatin to a patient; and
  3. A “cation patent”, which claims a pharmaceutical composition containing rosuvastatin and an inorganic salt which has particular chemical properties (that is, an inorganic salt in which the cation is multivalent, the inorganic salt is not a hydrotalcite, and the counter anion to the inorganic salt is not a phosphate).

Her Honour held that the claims of all three patents were liable to be revoked on the grounds that they are not novel or inventive. Additionally, in relation to the low dose patent, her Honour found that AstraZeneca was not entitled to the grant of this patent and, in relation to the HeFH

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patent, this patent did not disclose a ‘manner of manufacture’.

Justice Jagot’s comments on the role of expert evidence in patent cases and her findings that the “starting point” for assessing whether a patent is inventive (that is, discloses an inventive step) are interesting from the point of view of patent practice.

Keep an eye out for our detailed analysis of these issues in the coming days.

Given the size of the market for Crestor and the attempts by challengers to enter the market in late 2011-early 2012 this dispute is, we suspect, far from over!

KWM acted for two of the successful challengers in this matter.

About the Author

James Ellsmore
James is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.
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