November 2015: patent term extension: the Supreme Court of Japan gave an answer to the question and the JPO now has to prepare new examination guidelines

摘要

The Supreme Court of Japan said no to the current Patent Examination Guidelines revised by the Japan Patent Office (JPO) in 2011. The case is related to VEGF antagonist (Japanese patent no. 3398382) covering genetically engineered bevacizumab (Avastin~R). The Japan Patent Office rejected an application for patent term extension (PTE) for the reasons based on the 2011 revised Examination Guidelines, which was revised as a result of the Supreme Court Decision in 2011 (Pacif Capsule Case) [2]. The 2011-revised Guidelines stipulate that the PTE application in suit based on a new drug approval shall be rejected if earlier approval was made and the approval is not distinguishable in terms of patent element.