GSK statement in response to patent ruling reversal on Lovaza

GSK statement in response to patent ruling reversal on Lovaza

Issued: September 13, 2013, Philadelphia, PA

GlaxoSmithKline confirmed today that the Court of Appeals for the Federal Circuit has ruled against Pronova Biopharma Norge AS in its patent litigation regarding Lovaza® (omega-3-acid ethyl esters). Reversing a lower court ruling, the Appellate court found the asserted claims of Pronova's U.S. 5,656,667 patent invalid and remanded the case to the district court with orders to enter judgment in favour of the Appellant ANDA filers. Because the only other patent in the litigation, U.S. 5,502,077, had expired earlier this year, the court found it unnecessary to reach any issues regarding that patent.

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 the Food and Drug Administration (FDA) has approved any generic copies to date.

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GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.