KRKA Sverige AB and Krka D.D. Novo Mesto v. AstraZeneca AB, Borgarting Court of Appeal, Norway, 24 January 2014, Case No. 12-103103ASD-BORG/02
On 24 January 2014 Borgarting Court of Appeal rendered its decision in a case between Krka Sverige AB and Krka D.D. Novo Mesto (appellants) and AstraZeneca AB (respondent) regarding AstraZeneca's patent NO 307378. The patent concerns the active enantiomer esomeprazole, and the case considers infringement of the patent only.
The relevant claim of the patent (claim 10) concerns a pharmaceutical product containing an "optically pure compound" according to claim 1-4. Claim 1-4 concerns an optically pure compound of various salt forms of esomeprazole.
The purity of the substance can be measured by its enantiomeric excess, which describes the amount of the desired S-enantiomer compared to the amount of the undesired enantiomer R-omeprazole.
Krka launched a generic product containing esomeprazole, which AstraZeneca alleged infringed its patent NO 307378.
The question before the court was whether Krka's pharmaceutical esomeprazole product with an enantiomeric excess between 98,8 % and 99,5 %, could be classified as "optically pure". If so, Krka's marketing of Esomeprazole Krka represented a patent infringement. Krka argued that the patent only applies to substances with an optical purity of 99, 8 % and higher.