GSK Responds to Patent Ruling Reversal on Lovaza

Sep 18, 2013

GlaxoSmithKline (GSK) reported that a US federal appeals court has ruled against Pronova Biopharma Norge AS in its patent litigation regarding Lovaza (omega-3-acid ethyl esters). The Lovaza patents are owned by Pronova and licensed to GSK. The patents relate to compositions and methods of using omega-3 fatty acids. GSK has marketing rights for Lovaza in the US and Puerto Rico. Reversing a lower court ruling, the appellate court found the asserted claims of Pronova’s patent (US Patent 5,656,667) invalid and remanded the case to the district court with orders to enter judgment in favor of the appellant Abbreviated new drug application filers.

The Lovaza patents are owned by Pronova and licensed to GSK. The patents relate to compositions and methods of using omega-3 fatty acids. GSK has marketing rights for Lovaza in the US and Puerto Rico.

Lovaza remains available, and GSK is not aware that FDA has approved any generic versions to date.

Source: GlaxoSmithKline