AstraZeneca says that a date has been set for its crucial patent infringement trial in the fight to stop generic competition for its schizophrenia drug Seroquel.
On August 11, the US District Court in New Jersey will hear the case against Teva Pharmaceutical Industries and Novartis’ Sandoz unit alleging infringement of AstraZeneca’s patent on Seroquel (quetiapine). The two firms have filed Abbreviated New Drug Applications in the USA where the patent on the treatment expires in 2011.
The court also gave the Anglo-Swedish drugmaker permission to file for a motion of summary judgement no later than March 18, which AstraZeneca hopes will help it quell the generic threat to Seroquel. Copycat versions of the therapy could hit the US market as early as the end of March when a 30-month stay on approvals for copies of the medicine is lifted.
However if Teva chooses an ‘at-risk’ launch generic quetiapine ahead of the New Jersey trial and then loses the case, the damages it could be forced to pay would be considerable. AstraZeneca noted that it is confident about “the validity and enforceability” of the Seroquel patent and that it will prevail at trial.
Seroquel is a vitally important revenue source for AstraZeneca, and sales last year reached $4.03 billion and most analysts share the company’s confidence in terms of the patent. Indeed the firm is looking to extend the franchise through extended-release versions of the antipsychotic, called Seroquel XR, and is also looking to get approval for the drug from US regulators as a treatment for depression.
Zactima trials enrolled
Meantime, AstraZeneca also announced that it has completed patient enrollment in two Phase III studies for Zactima (vandetanib) for the second-line treatment of non-small cell lung cancer.
Data from the studies are expected later this year and AstrtaZeneca said that its broad development programme is on track for a first regulatory submission later this year.
