BRIEF—District Court rules Adderall XR patents infringed

Ireland-headquartered Shire has welcomed yesterday’s favorable ruling against US firm Abhai in connection with their Abbreviated New Drug Application (ANDA) for a generic version of Shire’s Adderall XR (mixed amphetamine salts), which is indicated for the treatment of attention deficit hyperactivity disorder in children and adults.

Following a bench trial in the US District Court of the District of Massachusetts, the judge issued a ruling holding that the proposed Abbreviated New Drug Application (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).

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 Food and Drug Administration’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.