AstraZeneca has won a US district court ruling in defence of its patent extension for the extended-release version of its antipsychotic drug Seroquel (quetiapine).
After the failure of AZ’s challenge to the FDA’s decision to allow generic competition to Seroquel, the ruling by a district judge in New Jersey gives the UK drug company a significant legal boost.
In addition, a US district judge in Columbia has ruled against allowing AZ a temporary restraining order (TRO) against generic competitors but has criticised the FDA for lack of fairness and transparency.
AZ is seeking an extension of the recently-expired Seroquel patent to cover its extended-release version, Seroquel XR, until December 2012, but the validity of the extension has been denied by a UK court and by the FDA.
US District Judge Joel Pisano in Trenton, New Jersey, ruled that four generic drug manufacturers – Mylan, Anchen, Osmotica and Torrent – have infringed on a valid patent for the extended-release version of quetiapine.
While the generic companies argue that the extended-release formulation applies technology that is in widespread use, Pisano accepted AZ’s argument that only its formulation of Seroquel XR proved it was effective in this case.
In addition, he noted, AZ had achieved a new indication for the XR version as a treatment for bipolar disorder.
Seroquel generated $5.83bn for AZ worldwide in 2011, including $1.4bn from Seroquel XR. However, low-cost generic competition from the above companies and from Teva in Europe threatens to affect AZ’s 2012 revenue severely.
AZ has already settled patent infringement disputes with two other companies, Handa and Intas, which will launch generic copies of Seroquel in 2016.
In a balanced statement on the dispute, Judge Beryl A. Howell of the US District Court for the District of Columbia denied AZ’s request for a TRO on generic versions of Seroquel, but criticised the FDA for unfair handling of the case.
Judge Howell concluded that AZ “has not demonstrated a likelihood of success on the merits, particularly given the deference the Court must provide to agency actions and interpretations of its own organic statute.”
However, she commented that the FDA appeared to have made a “tactical decision” to block AZ from seeking a judicial review of the Agency’s decision. The FDA’s statements “could appear to be less than forthright about the status of FDA decision-making,” she commented.
As a result of “the FDA’s tactics of ‘hiding the ball’ of its position until March 27, 2012,” Judge Howell stated, “consideration of the merits of the legal issues presented by the plaintiff’s complaint has been delayed”. She ordered the FDA to supplement the administrative record with any additional relevant records.