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Omeprazole appellate court win_12-03_e.pdf

Court of Appeals Affirms KUDCO’s
Noninfringement in Omeprazole Case

The U.S. Appeals Court for the Federal Circuit affirmed, in its entirety, the
district court decision of October 11, 2002 in which only KUDCO's generic
omeprazole was found not to infringe Prilosec® patents. The validity of
AstraZeneca’s formulation patents was also affirmed
SCHWARZ PHARMA today announced that its wholly-owned U.S. generic affiliateKremers Urban Development Company (KUDCO) has achieved a critical court victory for its generic omeprazole. The U.S. Court of Appeals for the FederalCircuit affirmed the October 11, 2002 U.S. District Court decision that KUDCO’sformulation of omeprazole does not infringe AstraZeneca’s patents. In the samedecision, the Court of Appeals also affirmed the validity of AstraZeneca’s Patrick Schwarz-Schuette, CEO of Schwarz Pharma AG stated: “SchwarzPharma’s U.S. subsidiary KUDCO has always been very confident in its stronglegal position. We are very pleased with this outcome." KUDCO is currently the only company with a court-determined noninfringinggeneric version to Prilosec®. Thus far, KUDCo has been the only company toprevail against AstraZeneca in the District Court, and now it is the only company tohave that success confirmed by Federal Circuit. Omeprazole is sold in the U.S. forthe treatment of gastric/duodenal ulcers, gastro-esophageal reflux disease (GERD) and erosive esophagitis. KUDCO’s product is a bioequivalent generic version ofAstraZeneca’s anti-ulcer drug Prilosec®.
KUDCO (Kremers Urban Development Company) is the wholly owned U.S. generic drug business of SCHWARZPHARMA Inc., U.S.A.
SCHWARZ PHARMA AG (headquartered in Monheim, Germany) develops and markets innovative drugs forunmet medical needs with focus on neurology, urology and cardiovascular diseases. In 2002 the companyachieved global sales of € 964 million, thereof 75% on international markets outside Germany. The company isinvesting in development projects targeting diseases such as Parkinson's disease, Restless Legs Syndrome,epilepsy, neuropathic pain, overactive bladder syndrome and benign prostatic hyperplasia. The company has astrong international presence with subsidiaries in Europe, USA and Asia. Shares of SCHWARZ PHARMA AG aretraded on the Frankfurt and Duesseldorf stock exchanges.
For more information, please see our website: www.schwarzpharma.comCorporate Communications: Antje Witte, Tel: +49 2173 48 1866 This press release contains forward-looking statements based on current plans, estimates and beliefs of themanagement of SCHWARZ PHARMA AG. Such statements are subject to risks and uncertainties that may causeactual results to be materially different from those that may be implied by such forward-looking statementscontained in this press release. Important factors that could result in such differences include: changes in generaleconomic, business and competitive conditions, effects of future judicial decisions, changes in regulation affectingSCHWARZ PHARMA AG, exchange rate fluctuations and hiring and retention of its employees.

Source: http://www.schwarzpharma.com/_uploads/assets/3109_omeprazole%20appellate%20court%20win_12-03_e.pdf

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