Dutch Patent Office v. Bayer Schering Pharma Aktiengesellschaft, Administrative Jurisdiction Division of the Council of State, 19 September 2018, Case No.  ECLI:NL:RVS:2018:3058

The Dutch Patent Office earlier rejected Bayer’s SPC application for a multi phase birth control pill (Qlaira) based on natural estrogens estradiol valerate and dienogest. The Dutch Patent Office rejected the SPC application, since it was considered to be a mere different dosage regime and therefore not a new product.

Bayer successfully appealed that decision in Court. The Court ruled that a new therapeutic application of a known active compound, which new therapeutic application is protected by a patent, is eligible for an SPC. On appeal the Dutch Patent Office now states that the Court in its decision interpreted the Neurim decision of the CJEU too broadly. The Administrative Jurisdiction Division in the current decision however states that the current case is similar to the Neurim decision and that therefore one can not reasonably disagree on the interpretation. The Court decision is confirmed.

A copy of the decision (in Dutch) can be read here.