KRKA - Decision of the court in Norway relating to esomeprazole

POLISH FINANCIAL SUPERVISION AUTHORITY

UNI - EN REPORT No 4 / 2012

Date of issue: 2012-04-23

Short name of the issuer

KRKA

Subject

Decision of the court in Norway relating to esomeprazole

Official market - legal basis

Art. 56 ust. 1 pkt 1 Ustawy o ofercie - informacje poufne

Unofficial market - legal basis

Contents of the report:

Decision of the court in Norway relating to esomeprazole Krka, d. d., Novo mesto (hereafter Krka) would like to inform the interested public that its subsidiary Krka Sverige AB, Sweden (hereafter Krka Sverige) has received the decision of the Commercial Court in Oslo on infringement proceedings between AstraZeneca AB, Sweden, and its subsidiary AstraZeneca A/S (hereinafter collectively referred as AstraZeneca) and Krka Sverige AB because of the alleged infringement of the patent NO 307 378 which protects the product esomeprazole with a high optical purity. The Commercial Court in Oslo decided that Krka has infringed the patent NO 307 378. Krka has claimed that the patent NO 307 378 covers only esomeprazole with optical purity of 99.8% e.e. or more, as AstraZeneca has limited its invention in all members of European Patent Convention (EP patent). The Commercial Court in Oslo however ruled against Krka’s claims and concluded that the scope of invention is broader in Norway, thus the patent NO 307 378 covers any esomeprazole product having optical purity above 98% e.e.; this is why Krka’s product with the optical purity below 99.8% e.e., but above 98% e.e. falls within the scope of the patent and represents a patent infringement. Krka Sverige was selling its esomeprazole products in Norway from October to December 2010 when it ceased to sell its products after it was injuncted by the Oslo Enforcement Court. Krka Sverige must remunerate AstraZeneca for lost profits in the above period in the amount of approx. €1.9 million. The decision is not final. Krka will appeal against the first instance decision. Krka published the announcements considering esomeprazole litigation in Norway on 15 December 2010 and 23 June 2011.

Annexes

File Description

KRKA, TOVARNA ZDRAVIL D.D.

(fullname of the issuer)

KRKA Farmaceutyczny (far)

(short name of the issuer) (sector according to clasification of the WSE in Warsow)

8501 Nove Mesto

(post code) (city)

Smarjeska 6

(street) (number)

[phone] [phone]

(phone number) (fax)

(e-mail) (web site)

nie dotyczy

(NIP) (REGON)

SIGNATURE OF PERSONS REPRESENTING THE COMPANY

Date Name Position / Function Signature

2012-04-23 Jo¾e Colariè President of the Management Board