The European Patent Office's considerations on supplemental experimental data in sufficiency of disclosure examination of second medical use patents
HONG Meng-shi
OUYANG Xue-yu
WANG Fang-fei
Abstract：The issue of supplemental experimental data after the filing date has been the controversial focus of patents in the medical field.The European Patent Office(EPO)has amended portions of the post-published evidence in the New Edition Examining Guidelines 2024.However,relevant modifications only relate to the sections of"Taking and conservation of evidence"and"Inventive step".The patent for second medical use is a very important type of invention in the medical field,and its sufficiency of disclosure is closely related to experimental data.In the context of the frequent"going global"of innovative drugs,understanding foreign legal regulations and applicable rules for supplementary experimental data in the sufficiency of disclosure is necessary.This article analyzes EPO's examination standards for supplemental experimental date in the sufficiency of disclosure of second medical use invention through EPO latest case,in order to provide a reference for relevant domestic pharmaceutical companies.
Keywords：supplemental experimental datapost-published evidencesecond medical useEuropean Patent Officesufficiency of disclosurepatent examination
Publication Date：2025-06-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 1154-1161 )