Omacor's German API patent ruled invalid

Lysaker, Norway-based Pronova BioPharma says that the Federal Patent Court in Munich, Germany, has declared its patent covering the active pharmaceutical ingredient of Omacor (concentrated omega-3 polyunsaturated fatty acids) invalid in Germany, following the nullity action brought by KD Pharma Bexbach GmbH and Institute Biochimique SA against Pronova in June 2006.

Pronova strongly opposes this decision and says it will appeal the ruling, a process which is expected to last for several years. The patent in suit expires in August 2009 and the Norwegian firm believes that the decision has minimal commercial implications, and noted that the announcement does not affect its right to supply and sell Omacor in Germany. The drug, a treatment for secondary prevention in patients suffering an acute myocardial infarction, is sold as Lovaza in the USA.

Company chief executive Tomas Settevik, said: "we strongly disagree with today's decision and will appeal against the ruling. Our patents for the API of Omacor are robust and we will continue vigorously to defend these in the courts."