19 February 2013Americas

US appeals court upholds AstraZeneca’s Seroquel XR patent

The US Court of Appeals for the Federal Circuit has affirmed a 2012 ruling that AstraZeneca’s patent for blockbuster antipsychotic drug Seroquel XR is valid and has been infringed by companies selling competing generics.

In a one-line judgement published on Thursday, February 14, the court upheld a ruling delivered by the District Court of New Jersey on March 29 last year, which found pharmaceutical companies Mylan, Torrent and Osmotica liable for infringement for selling generic versions of Seroquel XR in the US before the patent for the drug expired on May 28, 2017.

The New Jersey court also granted an injunction blocking the companies from producing competing generics in the US before this date.

In a statement issued following Thursday’s judgement, AstraZeneca said it was pleased with the court’s decision. Mylan, Torrent and Osmotica did not immediately respond to requests for comment.

Seroquel XR is used to treat depression, bipolar disorder and schizophrenia and is an extended release version of Seroquel.  AstraZeneca’s patent for the original Seroquel expired in 2012 but its follow-up was granted protection from the US Patent and Trademark Office in 1999.

Mylan, Torrent, Osmotica and Anchen Pharmaceuticals (which later paid an out-of-court settlement) tried to invalidate the Seroquel XR patent after AstraZeneca sued them for applying to release generic versions of the drug in 2010.

The companies argued that the method of using a gelling agent to create a slow release tablet was obvious to anyone with experience of working in the field of sustained release pharmaceutical formulations. The judge rejected this claim and found in favour of AstraZeneca.

AstraZeneca has also been defending its Seroquel XR patent in Europe and was successful in Spain and the Netherlands, but unsuccessful in the UK and Germany.

Ira Levy, partner at Goodwin Procter LLP in New York, said the appeal court’s decision is no great surprise given the detailed nature of the district court ruling last year, but added:  “It is slightly unusual that the court issued a one-line affirmance rather than addressing the merits of the decision.”

“This decision will keep the US market for Seroquel XR closed until at least late 2016, when at least one company, Intellipharmaceutics International,  may enter through settlement. But the rulings in Germany and the UK may allow generics companies to move their inventory to markets where they can sell,” he said.

Levy also said that the divergence in opinion between EU courts is unusual given the similar patent standards applied across Europe. “If this continues, it could lead to calls for greater harmonisation in court’s approaches to similar or related global patents,” he added.

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