Lek's expertise on high level in Europe

Lek Successfully Defends Patent for Synthesis of Omeprazole

23. 12. 2003

Slovene pharmaceutical company Lek d.d. has successfully defended its patent EP 1 095 037, which covers Lek’s synthesis of omeprazole 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.

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. Last week the Opposition Division of the European Patent Office upheld the validity of Lek’s European patent no. EP 1 095 037, which protects Lek’s manufacturing procedure for the synthesis of omeprazole. Lek has already received five patents for this process, including US and European patent.

Lek developed its own procedure for the synthesis of omeprazole in its laboratories in Menges. The beginnings of the development go back to 1997. The synthesis procedure is applied at industrial scale. Lek owns patents for the synthesis procedure which is performed successfully and effectively in Menges, as well as for the pharmaceutical form – pellets – all of which enabled launching on the American market.

Lek has achieved excellent results with a high level of innovativeness in the field of organic synthesis, which is the result of years of cooperation with the Faculty of Chemistry and Chemical Engineering and the National Institute of Chemistry. Slovene researchers in the field of organic chemistry have a long history of success at a global scientific level, which is based on the tradition of organic chemistry in Slovenia.

The originator AstraZeneca, which is one of the world’s five largest pharmaceutical companies, 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 four billion dollars. 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.

With last week’s decision, the European Patent Office has once again, as with the previous procedure of granting the patent, confirmed the novelty, inventive step and industrial applicability of Lek’s solution, which from idea to final product is the result of Lek’s inventive knowledge.

More on Omeprazol in the US Market

This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.

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For additional information, please contact: + 386 1 580 22 43 Katarina Klemenc Dinjaski, Lek’s Corporate Communication.