AstraZeneca wins fresh US victory with Seroquel XR
pharmafile | April 2, 2012 | News story | Sales and Marketing | AZ, AstraZeneca, FDA, Seroquel XR
AstraZeneca is celebrating a US court verdict in its ongoing battle for intellectual property over the extended release version of its antipsychotic Seroquel.
The US District Court for the District of New Jersey has agreed with the company that the formulation patent protecting Seroquel XR (quetiapine fumarate), is valid.
Generic filers Anchen Pharmaceuticals, Osmotica Pharmaceutical Corporation, Torrent Pharma and Mylan have infringed the patent, according to the court.
In a statement, AstraZeneca said it “is pleased with the US District Court’s decision, which the company believes underlines the strength of its patents”.
The judgment is limited only to the US market, but it will be a welcome boost to AstraZeneca in its rearguard action to save sales.
The manufacturer is fighting for its rights to Seroquel XR – which it came up with in a bid to extend to 2017 Seroquel’s patent, which expired last month – on several fronts.
Last month a British High Court ruling found that the new formulation is invalid. However, the US decision mirrors that of a court in the Netherlands early in March, which also supported the patent’s validity. A legal decision is pending in Spain.
AstraZeneca is digging its heels in, even going as far as suing the FDA, because losing patent protection will be a major blow to global revenues.
The Seroquel brand is AstraZeneca’s second-best seller behind cholesterol drug Crestor, and accounted for 17% of the company’s $33.6 billion worth of sales last year.
Seroquel has been one of the most costly medicines for the NHS in England, which spent £93 million on the drug in 2010. Teva launched its own generic version – costing almost seven times less than the branded drug – in the UK last month.
Generic versions of Seroquel have also been launched in the US in the last week after the firm lost its patent protection on 26 March.
AstraZeneca has already had to settle patent infringement cases last autumn with two companies, Handa and Accord, after the action against them was dismissed in court.
The manufacturer granted them both licences which are due to come into effect on 1 November 2016, or earlier under certain circumstances.
Adam Hill
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