The pharma giant announced on 13 November 2012 that the Federal Patent Court in Germany has found the formulation patent protecting Seroquel XR (quetiapine fumarate) extended-release tablets – marketed as Seroquel Prolong in Germany – to be invalid. The patent was challenged by Accord Healthcare (Accord), Hexal and Teva Deutschland GmbH, who all want to bring generics onto the market.

AstraZeneca points out that ‘the Federal Patent Court decision is limited to Germany and is not binding in other countries.’ Adding that the company is ‘engaged in numerous other proceedings regarding Seroquel XR-related patents and regulatory exclusivity for Seroquel XR.

This decision is just one in the continuing battle over Seroquel. The Anglo–Swedish firm has previously won Seroquel XR patent cases in Spain, The Netherlands and US. However, in March 2012, a ruling from the UK High Court invalidated the patent on Seroquel XR after challenges by Accord, Hexal, Intas Pharmaceuticals, Sandoz, Teva UK and Teva Pharmaceutical Industries [1]. Astra Zeneca is reportedly appealing against this decision.

AstraZeneca has also been forced to make deals with Accord, Handa Pharmaceuticals and Intas, giving them licences to enter the US market with generic forms of extended-release quetiapine fumarate on 1 November 2016, or earlier upon certain circumstances [2].

Par Pharmaceuticals has now acquired Handa Pharmaceuticals’ abbreviated new drug application (ANDA) and expects to receive 180 days of marketing exclusivity for its generic quetiapine fumarate extended release as the first applicant to file an ANDA with a paragraph IV certification with FDA.

AstraZeneca reported that it was ‘disappointed with the court’s decision’. However, despite the mounting number of challenges and decisions against Astra Zeneca ‘the company remains committed to defending its intellectual property protecting Seroquel XR’. Total sales of Seroquel XR in Germany for the ten months ended 31 October 2012 were US$82 million.

There is no wonder AstraZeneca is willing to fight for Seroquel. The drug, which is used to treat schizophrenia and bipolar disorders, is in the top ten best-selling drugs in the world, and in 2010 had worldwide sales of US$5.3 billion, or 16% of AstraZeneca’s revenues [3].

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References

1.  GaBI Online - Generics and Biosimilars Initiative. AstraZeneca losing fight against generic quetiapine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 16]. Available from: www.gabionline.net/Generics/News/AstraZeneca-losing-fight-against-generic-quetiapine

2.  GaBI Online - Generics and Biosimilars Initiative. AstraZeneca settles patent dispute over Seroquel XR [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 16]. Available from: www.gabionline.net/Generics/News/AstraZeneca-settles-patent-dispute-over-Seroquel-XR

3.  GaBI Online - Generics and Biosimilars Initiative. 2012’s biggest patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Nov 16]. Available from: www.gabionline.net/Policies-Legislation/2012-s-biggest-patent-expiries

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