Omeprazole Substance Patent Upheld in Germany

AstraZeneca PLC 9 March 2000 ASTRAZENECA'S OMEPRAZOLE SUBSTANCE PATENT UPHELD IN GERMANY AstraZeneca today welcomed a decision by the German Federal Patent Court to dismiss an attack on the substance patent for omeprazole. In Germany, AstraZeneca's substance patent for omeprazole expired in April 1999. As the patent still is the basis for the Supplementary Protection Certificate (SPC) in Germany, it has been subject to a nullity action by the company Merck-dura GmbH. Omeprazole is the active ingredient in Losec. 'The German court's decision is highly significant. The research and development work behind the product is very extensive and concerns - in addition to the substance - formulations, manufacturing methods and intermediates. As a result of this advanced work, Losec is protected by a number of different patents,' said Dr. Martin Nicklasson, Executive Vice President GI Franchise. In 1999, Losec had sales of USD150 million in Germany, representing 2.5 per cent of total sales of the product. In Germany, omeprazole is marketed under the brand name Antra MUPS (MUPS - Multiple Unit Pellet System). AstraZeneca has filed requests in Germany for preliminary injunctions against ten companies, has filed ten main actions and is currently defending its patent rights in eight other patent cases related to omeprazole. In August 1999, AstraZeneca was granted an interlocutory injunction to prevent ratiopharm GmbH and Merckle GmbH selling a generic version of omeprazole. In February 2000, the German Supreme Court referred a number of questions about AstraZeneca's SPC for omeprazole in Germany to the European Court. March 9, 2000 Further enquires to: Michael Olsson: Tel. +44 (0)20 7304 5087 Elizabeth Sutton: Tel. +44 (0)20 7304 5101 Ed Seage: Tel. +1 302 886 4065 Jorgen Winroth: Tel. +1 609 896 4148

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