GlaxoSmithKline confirms US District Court ruling in Pronova BioPharma’s favour on Lovaza™ patents

Issued: London, UK

GlaxoSmithKline plc (GSK) which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the US and Puerto Rico, confirmed that U.S. District Judge Sue Lewis Robinson, the presiding judge in the U.S. District Court for the District of Delaware, ruled in Pronova’s favour in Pronova’s patent litigation involving U.S. Patent Nos. 5,656,667 (“’667 patent”) and 5,502,077 (“’077” patent) covering Lovaza.  

The Court found Pronova’s patent claims are valid and would be infringed by Teva Pharmaceuticals USA, Inc. (“Teva”) and Par Pharmaceutical Inc. (“Par”).  

The Lovaza patents are owned by Pronova and licensed to GSK in the United States and Puerto Rico, and cover compositions and methods of using omega-3 fatty acids. The ‘667 patent expires in April 2017 and the ‘077 patent expires in March 2013. Pronova, via its wholly-owned subsidiary Pronova BioPharma Norge AS, filed the patents infringement lawsuit against Teva and Par in April 2009.

Previously, Pronova had entered into an agreement in March 2011 with Apotex Corp. and Apotex Inc. (collectively “Apotex”), to settle their patent litigation in the United States related to Lovaza.  The settlement grants Apotex a license to enter the US market with a generic version of Lovaza in the first quarter of 2015, or earlier depending on certain circumstances.

In 2011, GSK reported Lovaza turnover of £569 million ($916 million).  All GSK sales of Lovaza were generated in the US and Puerto Rico. 

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Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, 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 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.