KRKA, d. d., Novo mesto

Lawsuit regarding alleged patent infringement of valsartan tablets in Poland

On 13 March 2009 Krka`s subsidiary Krka Polska Sp.zo.o, Warsaw (hereinafter Krka Polska) received a law-suit, filed in front of the District court in Warsaw by Novartis AG Switzerland, regarding alleged infringement of patent PL 188 271, which protects the solid pharmaceutical form (i.e. tablet) that contains valsartan and other additives. The plaintiff demands that Krka is prohibited to manufacture, use, market, sell, offer to sell and/or import in Poland the medicine Valsacor or any other film coated tablets under different commercial name that contain valsartan and other additives.

The European patent office has refused the Novartis request to protect solid pharmaceutical form (i.e. tablet) that contains valsartan and other additives. In year 2005 Krka filed for annulment of the above-mentioned patent in front of Polish patent office, however there has not been a single hearing to date due to Novartis' pleadings for continuances or other excuses.

In year 2008 the Higher court in Warsaw refused (its decision being final) to issue the temporary injunction regarding the alleged infringement of patent PL 188 271. Krka Polska shall file answer to Novartis' lawsuit within term defined in the legislation. Krka believes that it does not infringe Novartis' patent.

Date: 18. 3. 2009