AstraZeneca sues FDA with 'poison pill' attack; claims Seroquel warnings are its IP
This article was originally published in Scrip
In a case that might start to explain why it can take until near the end of a drug's patented lifetime to define and recognise some of its adverse effects, AstraZeneca has filed a lawsuit against the US FDA in a last-ditch attempt to keep generic Seroquel (quetiapine fumarate) off the market until December. The pharma company is hoping to overturn the agency's recent decision not to delay approval of generic versions of its best-selling anti-depressant.
At risk in the case is around $1.5 billion worth of 2012 sales of Seroquel; if the suit fails, generic Seroquel could be on the market by the end of March 2012: if it succeeds, AstraZeneca could extend its US monopoly on the product until the beginning of December 2012.
Sales of Seroquel grew by 8% in the US last year to $3.34 billion, while sales of the extended release version of the drug, Seroquel XR, rose to $779 million.
At the nub of the case is the idea that a drug's adverse events profile is part of the intellectual property associated with the drug. AstraZeneca's IP situation with Seroquel is that the base patents on the active ingredient in Seroquel and Seroquel XR expired in September 2011. Paediatric exclusivity expires on 26 March 2012. There is further IP associated with the formulation of Seroquel XR – a patent that expires in May 2017, and paediatric exclusivity until in November 2017. In 2011, AstraZeneca granted both Handa and Accord a licence to enter the US market with generic Seroquel XR on 1 November 2016, or earlier under certain circumstances.
But then there is the toxicity dimension of the story. On 9 September last year, AstraZeneca filed Citizen Petitions requesting that the FDA agency should not give final approval to any generic quetiapine product that does not contain certain warnings on its label concerning a potential link between quetiapine and an increased risk of hyperglycaemia and diabetes. This is a warning that the agency required AstraZeneca to include.
According to AstraZeneca, clinical data associated with the language in the warning is protected by marketing exclusivity periods expiring as late as 2 December this year.
The FDA denied both Citizen Petitions on 7 March leading AstraZeneca to file suit on March 13.
AstraZeneca wants an injunction barring the FDA from granting approval of generic quetiapine until 2 December, or, alternatively, at least until a federal court has a "meaningful opportunity" to review imminent FDA action regarding the pending generic marketing applications.
AstraZeneca has filed the lawsuit in the US District Court for the District of Columbia and said it will "vigorously defend its legal rights".