| | 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.
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