AstraZeneca settles Crestor case
pharmafile | March 26, 2013 | News story | Sales and Marketing | AstraZeneca, Crestor, Watson
AstraZeneca has settled a long-running legal battle over one of its biggest brands, Crestor, whose patent expires in 2016.
The cholesterol drug – AstraZeneca’s top seller – was the subject of US patent infringement litigation against Watson Laboratories, Actavis and EGIS Pharmaceuticals.
The issue stemmed from Watson’s proposed rosuvastatin zinc product which AstraZeneca argued would infringe the patent of Crestor (rosuvastatin calcium).
AstraZeneca brought the action against Watson and EGIS in the US District Court for the District of Delaware, with those companies filing counterclaims in a case which was heard last December.
Watson and EGIS have now conceded that Watson’s rosuvastatin zinc and its own rosuvastatin calcium product would indeed infringe the patent.
However, the new agreement means Watson can start selling its generic version of Crestor and rosuvastatin zinc from 2 May 2016.
The substance patent protecting Crestor expires on 8 January that year, with pediatric exclusivity ending on 8 July 2016.
Watson will pay AstraZeneca 39% of net sales of these products until the latter date and has agreed not to further appeal a decision by the US Court of Appeals for the Federal Circuit, that has already upheld the Crestor patent.
Shionogi is also a party to this settlement agreement and all claims and counterclaims will be dismissed in a consent judgment by the Delaware court. All other terms remain confidential, the parties say, although it is possible that both the dates and fees could change.
AstraZeneca has had mixed results in recent times in its attempts to protect its moneyspinners. The company had hoped to preserve its rights on antipsychotic Seroquel by creating an extended-release version – Seroquel XR – to expire in May 2017.
But the Federal Patent Court in Germany was the latest to find that the formulation patent for Seroquel XR (quetiapine fumarate) prolonged-release tablets was invalid last year.
A British High Court had already ruled that the patent on Seroquel XR is invalid, while AstraZeneca was suing the FDA after it denied the firm’s request to withhold approving any generic form of its drug with labelling that excludes warnings required for Seroquel and Seroquel XR.
Teva has also launched a version in the UK, making quetiapine – indicated for schizophrenia and the treatment of moderate to severe manic episodes – and quietiapine XL – approved for schizophrenia and bipolar disorder – available in generic form for the first time.
Adam Hill
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