Pharmaceutical firm Shire plc said its subsidiary Shire Development LLC welcomed the favorable ruling against Abhai LLC in connection with its Abbreviated New Drug Application (ANDA) for a generic version of Shire’s Adderrall XR, which is used for treating attention deficit hyperactivity disorder in children and adults.
“Following a bench trial in the U.S. District Court of the District of Massachusetts, the judge issued a ruling holding that the proposed ANDA formulation infringes the claims of patents RE42,096 (a reissue of US 6,322,819) and RE41,148 (a reissue of US 6,605,300), said Shire.
“Accordingly, Abhai is prohibited from marketing its ANDA product until the expiration of the patents.
“In addition, the court sanctioned Abhai for its litigation misconduct and directed that a certified copy of the court’s opinion be sent to FDA’s attention in light of what the court described as Abhai’s ‘pervasive corporate unwillingness to play by the rules.’
“The amount of monetary sanctions to be paid to Shire will be determined at a later date.
“Shire is pleased with the decision and will continue to vigorously defend its patents to protect the innovation and value Shire products bring to patients.”