KRKA, d. d., Novo mesto

Temporary injunction for alleged patent infringement of olanzapine manufacturing process in Slovenia

On 1 February 2008, Krka, d. d., Novo mesto (hereafter Krka) received the order of the District Court in Ljubljana that prohibits Krka manufacturing and marketing the product Zolrix or other products containing olanzapine as active pharmaceutical ingredient in Slovenia. The court has granted the temporary injunction on request of Eli Lilly Company Limited, Hampshire, Great Britain.

The subject patent protects the process for manufacturing a pharmaceutical form i.e. the formulation of the medicine. The essential characteristic of patented process is mixing of olanzapine with other auxiliary ingredients.

Krka will file an appeal against the decision. If Eli Lilly is not filling lawsuit for alleged infringement against Krka and Salus, Ljubljana, d.d., a marketing authorization holder of Zolrix in Slovenia, within 30 days, the temporary injunction will cease to be valid.

Krka manufactures Zolrix in its subsidiary Krka-Polska, Sp.zo.o. in Warsaw. In 2007 the sales of Zolrix in Slovenia were less than 100,000 EUR. The planned sales of the same product in Slovenia for 2008 are somewhat higher compared to the sales in the previous year.

Krka markets products with olanzapine active pharmaceutical ingredient also in other countries of Central, West and South-East Europe.

Date: 4. 2. 2008