Challenges to obtaining good pharmaceutical patents in Japan: 2009 and beyond

The Japanese patent practice does not allow patents for medical activities as such, but only protects product inventions relating to pharmaceutical subject matter. However, recently, the Japanese Examination Guidelines have been amended to protect inventions, in which patentable features are only found in administration/dosage, thereby substantially protecting medical activities. In this review article, the revised Examination Guidelines are reviewed and explained from various aspects of view. Enablement/written description (support) requirements, which are important factors in obtaining reasonable patent scope of coverage, are further reviewed in terms of comparison among trilateral offices (USPTO, EPO and Japanese Patent Office). Recent court decisions are also reviewed for creating proper IP strategies in the field of pharmaceutical inventions.