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Patent litigation: Esomeprazol infringement case
In a judgement of 12 April 2012 Oslo District Court ruled that Krka’s marketing of Esomeprazol Krka infringed AstraZeneca’s patent NO 307308.
The patent has earlier been the subject-matter of an invalidity case, where Sandoz challenged the patent. Oslo District Court found the patent to be invalid, except patent claim 10, which were the claim relied on in the infringement case. However, the Court of Appeal stated that the whole patent was valid, and the Appeals Selection Committee of the Supreme Court denied admittance of the case.
In the infringement case, the main question was whether Krka’s esomeprazol, which contained esomeprazol in an enantiomeric excess (e.e.) of between 98,74 and 99,5%, was in accordance with the wording “optically pure”. Krka’s statement was that “optically pure” meant 99.8% e.e. or more, which would bring Esomeprazol Krka outside what was stated in the patent claim. One of the arguments used by Krka was that the European sister patent of NO 307308 had been amended so that the given borderline were stated in the patent claim instead of “optically pure”. However, the court found the limit in the European sister patent not to be relevant to the case.
According to the judgement, Krka will have to pay NOK 14 600 000 (appr. € 1 950 000) in compensation plus NOK 1 500 000 (appr. € 200 000) in litigation costs to Astra Zeneca.
The judgement from Oslo District Court has been appealed by Krka.