KRKA, d. d., Novo mesto

Temporary injunction for alleged infringement of Valsaden production process patent in Slovenia

On 13 January 2009, Krka, d. d., Novo mesto (hereafter Krka) received the decision of the District Court in Ljubljana that prohibits Krka manufacturing and marketing the product Valsaden, film coated tablets in all strengths, or whichever other product that may infringe patents EP 0914 119 or EP 1 410 797, in Slovenia. The court has granted the temporary injunction on request of Novartis AG, Basel, Switzerland. The decision is executable and immediately valid. Krka will file an appeal against the decision.

The Court has imposed to Novartis AG to file the lawsuit for alleged infringement against Krka in 30 days following the service of temporary injunction to Novartis AG otherwise the temporary injunction will cease to be valid.

The subject that both patents protect is the process for manufacturing a solid pharmaceutical form (i.e. tablet) that contains valsartan and combination of valsartan and HCTZ.

In connection with the temporary injunction Krka further explains that the same court, that is the District Court in Ljubljana, has already on 1 January 2008 refused to issue the temporary injunction regarding the patent EP 0914 119. This decision is final. Novartis AG has never thereafter filed a lawsuit against Krka for the alleged infringement of the patent EP 0914 119.

There is also a pending procedure before the District Court in Ljubljana where Novartis AG requests the issuance of temporary injunction for the alleged infringement of the patent EP 1 410 797. Novartis AG issued this request right after the Court refused their first request for the issuance of temporary injunction regarding the patent EP 0914 119. This procedure is not finished yet and is still in ongoing, however the court expert has already issued the expert opinion that Krka uses the process different from process protected with the patent EP 1 410 797.

There is also a pending procedure before the European Patent Office for the annulment of the patent EP 1 410 797.

Krka has launched product Valsaden on the Slovenian market in December 2008.

Date: 15. 1. 2009