Upon request of the three plaintiff’s the Federal Patent Court invalidated AstraZeneca’s patent EP (DE) 0 907 364, which was for a sustained release formulation of an anti-psychotic drug quetiapine (marketed as Seroquel XR). After the decision Astra Zeneca renounced on the further enforcement of several interim injunctions that had been granted on the basis of the AstraZeneca patent against generic companies by the Düsseldorf court in May 2012.
The decision of the Federal Patent Court follows a series of other decisions in Europe dealing with the validity of the AstraZeneca patent. The results have been mixed: In Spain and the Netherland (see this blog here) the patent was upheld, in UK the patent was invalidated (see this blog here)
The Federal Patent Court invalidated the patent for lack of inventive step. The reasoning that was just issued by the Federal Patent Court is similar to the reasoning of the UK High Court.
The Federal Patent Court found that it was clear from the prior art (e.g. Gefvert) that a once daily administration of an immediate release formulation of quetiapine was not sufficient to ensure an effective treatment. The person skilled in the art was motivated to consider an SR formulation since he could assume that such formulations would not only reduce the frequency of administration but also improve patience compliance and lead to a constant plasma level of the active agent which is a particular important clinical advantage. Formulating the quetiapine using a gelling agent was obvious to try and just required routine tests. The Federal Patent Court rejected the argument of the patentee that certain specific properties of quetiapine would have deterred the skilled person from considering an SR formulation of quetiapine. According to the Court there are no hints in the patent specification that such problems indeed existed and had to be solved by inventive activity.
Read the judgement in English here
Read the judgement in German here