Lek Defends Patent for Omeprazole
Ljubljana - Slovenian pharmaceutical company Lek d.d. successfully defended in late December its patent EP 1 095 037, which covers Lek's synthesis of Ome-prazole before the Board of Appeal of the European Patent Office.
Omeprazole is the world's second largest selling pharmaceutical product used for treating stomach ailments, especially duodenal and stomach ulcers. Lek, having developed its own patent-free formulation, markets Omeprazole in Slovenia and in its traditional markets of Central, Eastern and South-Eastern Europe, and since the beginning of August 2003 also in the world's most demanding pharmaceutical market, the US market. Lek has already received five patents for this process, including US and European patents.
The originator AstraZeneca filed an appeal against the granting of a European patent alleging that the Lek patent was not new and inventive with respect to the known literature at the time of the filing of the first application. AstraZeneca owns several patents for this drug. They refer to the manufacturing process, use and pharmaceutical form of the drug. AstraZeneca markets its product under the registered trademark Prilosec/Losec. US sales of Prilosec in 2002 reached around $4 billion. AstraZeneca's basic patent for Omeprazole expired in October 2001, but there are other patents which expire progressively up to 2014. The first generic manufacturer, the company KUDCo/Schwarz Pharma, launched its generic Omeprazole in the US in December 2002.
Lek will market Omeprazole in the European Union within the framework of Sandoz, the generics section of Novartis. Lek creates value through the use of its own produced active pharmaceutical ingredient and its own pharmaceutical form in the final product.