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US appeals court upholds AstraZeneca’s Seroquel XR patent

Says patent on unique formulation of antidepressant is valid

US Court of Appeals for the Federal Circuit

AstraZeneca received good news in the US yesterday when the validity of its patent for Seroquel XR (Quetiapine) was upheld by an appeals court.

The verdict by the US Court of Appeals for the Federal Circuit upheld a ruling made in March 2012 when the US District Court for the District of New Jersey confirmed patent protection for the antidepressant.

This original ruling came after the patent for Seroquel XR was challenged by several generics companies, including Mylan, Torrent, Anchen and Osmotica, with the US District Court for the District of New Jersey also ruling that these firms had infringed the patent with their generic products.

AstraZeneca has faced a series of legal battles related to the patent of Seroquel XR, which is an extended release version of its huge-selling antidepressant Seroquel.

Regular Seroquel saw its final paediatric patent expire in March 2012, but AstraZenceca has attempted to extend the franchise with Seroquel XR which, due to its unique formulation, has patent exclusivity in the US until 2017.

The pharma company has had a tough time convincing other countries to go the way of the US however, and a court in the UK deemed the patent of Seroquel XR to be invalid after a legal challenge from generics companies.

These include Teva, which launched its own versions of both Seroquel XR and Seroquel in the UK in March 2012.

And in November 2012, Germany's Federal Patent Court overturned patent protection for extended-release Seroquel, which is known in the country as Seroquel Prolong.

But it isn't just Seroquel XR that AZ is trying to prolong the life of. Last year the company attempted to sue the FDA to extend patent protection for the regular version of Seroquel, claiming clinical trial data used to create warnings on the product label were protected until December 2012. However, this challenge was thrown out by a US court.

AZ's mission to protect sales of the Seroquel franchise for as long as possible are understandable, considering combined sales of Seroquel and Seroquel topped $5.5bn during 2011. This figure dropped to just over $2.8bn during 2012 due to emergence of generics.

15th February 2013

From: Sales, Regulatory



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