KRKA - Litigation relating to esomeprazole product in Denmark

POLISH FINANCIAL SUPERVISION AUTHORITY

UNI - EN REPORT No 8 / 2016

Date of issue: 2016-02-25

Short name of the issuer

KRKA

Subject

Litigation relating to esomeprazole product in Denmark

Official market - legal basis

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

Unofficial market - legal basis

Contents of the report:

Krka, d. d., Novo mesto (hereinafter referred to as Krka) informs the interested public that its subsidiary Krka Sverige AB, Sweden (hereinafter referred to as Krka Sverige) received the decision of the Maritime and Commercial Court in Copenhagen, Denmark in the litigation started against Krka Sverige by AstraZeneca, Sweden and AstraZeneca, Denmark (hereinafter referred to as AstraZeneca) because of alleged infringement of the patent EP 1 020 461 in Denmark. Patent EP 1 020 461 protects the active pharmaceutical ingredient esomperazol with high optical purity. Products containing esomperazole with high optical purity have allegedly advantageous pharmacological effects. The active pharmaceutical ingredient esomeprazol per se is not patent protected. Products sold by Krka Sverige in Denmark do not contain esomeprazole with high optical purity. Nevertheless, the Maritime and Commercial Court in Copenhagen despite that fact decided that Krka Sverige by selling these products in Denmark has infringed AstraZeneca’s patent, as during certain moment in the production of the active pharmaceutical ingredient esomeprazole, produced by Krka, optically pure crystals allegedly appeared in the reaction mixture. The Maritime and Commercial Court in Copenhagen believes that Krka Sverige caused to AstraZeneca in Denmark damages in the amount of DKK 50 million (EUR 6.7 million) due to the above infringement. The decision of the first instance court has not been final yet, therefore Krka Sverige shall not pay damages until the decision is final. Krka Sverige will file an appeal against the decision. Krka Sverige strongly believes that the Maritime and Commercial Court in Copenhagen decided in contradiction with the wording of the scope of the patent as it was granted by the European Patent Office, as well as in contradiction with well-established jurisprudence in relation to such type of patents in the European Union (known as “Swiss type claims"). Krka published notices regarding esomeprazole litigation in Denmark on 15 December 2010 and 11 April 2013.

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

2016-02-25 Jo¾e Colariè President of the Management Board