GlaxoSmithKline (GSK) confirmed that the Federal Patents Court in Munich, Germany, has ruled in patent litigation regarding GSK’s product Viani, an inhaled respiratory treatment for asthma and COPD. The Court ruled in favour of the claimants Mylan dura GmbH, Hexal AG, Neolab Ltd., and Ivax International B.V. in deciding that under German law GSK’s German combination patent for Viani (relating to the combination of the active ingredients salmeterol and fluticasone propionate) was not valid.

The decision relates solely to the German combination patent for Viani and is not binding in any other jurisdiction. GSK also owns a number of other patents in Germany relevant to Viani including the Diskus dry powder inhaler and HFA aerosol formulation patents which expire in 2011 and 2012 respectively. In addition, there are significant technical hurdles and complexities associated with the introduction of inhaled respiratory products. GSK is studying the judgement and will be considering an appeal to a higher court.